Generated by All in One SEO v5.0.0.1, this is an llms.txt file, used by LLMs to index the site. # Healthcare Empowered Texas Health Law Highlights ## Sitemaps - [XML Sitemap](https://texashealthlaw.com/sitemap.xml): Contains all public & indexable URLs for this website. ## Posts - [Wade's Health Law Highlights for July 28, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-july-28-2026/) - Fraud & Abuse Enforcement A Dallas clinical laboratory, its owners, and its investors agreed to pay $24 million to resolve False Claims Act allegations that it billed Medicare for medically unnecessary respiratory pathogen panels bundled with COVID-19 tests Magnolia Diagnostics and owners John and Kelly Bains will pay $19.2 million and the laboratory's investors $4.8 - [Wade's Health Law Highlights for July 21, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-july-21-2026/) - Fraud, Abuse & False Claims Act Enforcement Laboratory Corporation of America will pay $14,500,000 to resolve False Claims Act allegations that it billed Medicare Part B for medically unnecessary urine drug testing under its "ToxAssure Comprehensive" panel. From January 1, 2018, through November 22, 2023, Labcorp ran presumptive and definitive tests simultaneously on the same - [Wade's Health Law Highlights for July 14, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-july-14-2026/) - Fraud & Abuse / Enforcement Ruthia He, founder and former CEO of digital mental health company Done Global Inc., was sentenced to six years in prison and a $1 million fine for a scheme that distributed more than 37 million Adderall pills and defrauded insurers of over $12 million Co-defendant David Brody, Done's former clinical - [Wade's Health Law Highlights for July 7, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-july-07-2026/) - Fraud & Abuse and Enforcement OIG Advisory Opinion No. 26-15 concludes that a home health agency's payment of subscription fees to a vendor for online referral management software would generate prohibited remuneration under the Federal anti-kickback statute if the requisite intent were present. The Requestor, which operates home health agencies (HHAs) serving Federal health care - [Wade's Health Law Highlights for June 30, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-june-30-2026/) - Fraud & Abuse Enforcement The Justice Department charged 455 defendants, including 90 doctors and licensed medical professionals, in the 2026 National Health Care Fraud Takedown tied to more than $6.5 billion in false claims. The action spanned 56 federal districts and 45 states and territories, with 50 state Medicaid Fraud Control Units participating and 295 - [Wade's Health Law Highlights for June 23, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-june-23-2026/) - Fraud, Abuse & Enforcement OIG Advisory Opinion No. 26-14 grants a favorable determination to a pharmaceutical manufacturer sponsoring free antibody testing to identify patients potentially eligible for its drug. Under the Arrangement, the Requestor contracts with a third-party laboratory to provide no-cost antibody tests to patients in all 50 states who present with symptoms of - [Wade's Health Law Highlights for June 16, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-june-16-2026/) - Reimbursement & Payment CMS has proposed a rule that would cut $774.8 billion in state and federal Medicaid spending over 10 years by capping State Directed Payments (SDPs), far exceeding the $72 billion in cuts anticipated under the One Big Beautiful Bill Act, which the rule purports to implement. Beginning with rating periods on or - [Wade's Health Law Highlights for June 9, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-june-9-2026/) - Artificial Intelligence in Healthcare AI adoption in healthcare has moved from hesitation to integration, with roughly 40% of life sciences organizations reporting AI embedded throughout their operations. The speed of adoption is illustrated by AI scribes reaching 50% penetration across US healthcare systems in 18 months, compared to seven years for electronic medical records, with - [Wade's Health Law Highlights for June 2, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-june-2-2026/) - Fraud & Abuse: OIG Advisory Opinions OIG has approved an orthopedic surgery provider's proposed warranty program that refunds concierge fees to patients requiring revision surgery within two years of their initial procedure. In Advisory Opinion No. 26-12, the Requestor offers a voluntary Concierge Program, covering items such as wellness coaching, nutritional supplements, app-based health monitoring, - [FTC Cleared To Sue Texas Anesthesia Co., But Not PE Firm](https://texashealthlaw.com/ftc-cleared-to-sue-texas-anesthesia-co-but-not-pe-firm/) - Summary of article from Law360, by Bryan Koenig: A Texas federal judge has ruled that the Federal Trade Commission (FTC) lacks the authority to pursue antitrust claims against private equity firm Welsh Carson Anderson & Stowe, but can proceed against the anesthesia group the firm created, U.S. Anesthesia Partners Inc (USAP). The judge ruled that - [Wade's Health Law Highlights for July 1, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-july-1-2025/) - Cybersecurity Texas has enacted a law that shields small businesses from punitive damages in data breach lawsuits if they maintain compliant cybersecurity programs. Governor Greg Abbott signed S.B. 2610, which applies to businesses with fewer than 250 employees that implement cybersecurity programs containing administrative, technical, and physical safeguards conforming to industry-standard frameworks. The law scales - [Wade's Health Law Highlights for May 26, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-may-26-2026/) - Fraud, Abuse & Enforcement CMS has imposed six-month, nationwide moratoria on new Medicare enrollment for hospices and home health agencies, blocking both initial enrollment applications and certain changes in majority ownership. The moratoria do not affect existing providers, who may continue serving Medicare beneficiaries. CMS has already suspended payments to approximately 800 hospices and home - [Wade's Health Law Highlights for May 19, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-may-19-2026/) - Fraud, Abuse & Enforcement CMS has imposed six-month, nationwide moratoria on new Medicare enrollment for hospices and home health agencies (HHAs), blocking initial enrollment applications and certain changes in majority ownership. The moratoria, coordinated with Vice President JD Vance's Anti-Fraud Task Force, do not affect existing providers, who may continue serving Medicare beneficiaries. CMS has - [Wade's Health Law Highlights for May 12, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-may-12-2026/) - Fraud, Abuse & False Claims Enforcement The Justice Department's Civil Division launched the FOCUS (Fraud Oversight through Careful Use of Statistics) initiative to formalize its relationship with data miners filing qui tam complaints under the False Claims Act. Qui tam filings have surged in recent years, driven increasingly by data miners — companies or individuals - [Before You Add Peptides to Your Practice](https://texashealthlaw.com/before-you-add-peptides-to-your-practice/) - Peptide therapy has moved from elite biohacker circles into mainstream wellness offerings, and the marketing pitches arriving in your inbox suggest the legal questions are settled. They are not. Most of the peptides being sold by wellness clinics today cannot be legally compounded in the United States, and the practitioners who add them to their - [Wade's Health Law Highlights for May 5, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-may-5-2026/) - Cybersecurity, Data Privacy & HIPAA Fragmented identity systems across healthcare force patients to maintain separate credentials for patient portals, EHRs, pharmacies, PBM claims platforms, and insurer authorization — multiplying security risks and driving the average cost of a healthcare data breach to $7.42 million in 2025, the highest of any industry for the 12th consecutive - [Wade's Health Law Highlights for April 28, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-april-28-2026/) - Fraud, Abuse & Government Enforcement The HHS Office of Inspector General will not impose sanctions on a Medicare Advantage organization that proposes to share a percentage of its savings with employer groups through its Employer Group Waiver Plans. The arrangement would involve the MA organization making "Gainshare Payments" to groups such as employers, trusts, and - [Wade's Health Law Highlights for April 21, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-april-21-2026/) - Fraud, Abuse & Enforcement The Texas Health and Human Services Office of Inspector General recovered more than $95.7 million from home health providers between December 1, 2025, and February 28, 2026, according to its quarterly report. Home health agencies accounted for 21 percent of preliminary investigations and 15 percent of full-scale investigations during this period. - [Wade's Health Law Highlights for April 14, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-april-14-2026/) - Fraud, Abuse & Enforcement Aetna agreed to pay $115 million to settle allegations that it manipulated diagnosis codes to inflate risk scores for Medicare Advantage enrollees. A former risk-adjustment coding auditor filed the lawsuit on behalf of the federal government, claiming Aetna received inflated payments from the Centers for Medicare & Medicaid Services through a - [Wade's Health Law Highlights for April 7, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-april-7-2026/) - Healthcare Transactions & Private Equity Private equity firms have invested over $1 trillion in debt-financed healthcare transactions over the past decade, with 93% of healthcare companies carrying speculative debt being private equity-sponsored. A JAMA 2023 study showed a 25% increase in complications such as infections and falls following private equity investment in healthcare facilities. Private - [Wade's Health Law Highlights for March 31, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-march-31-2026/) - [Wade's Health Law Highlights for March 31, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-march-31-2026-2/) - Fraud & False Claims Act Enforcement The U.S. Department of Justice recovered more than $6.8 billion in False Claims Act settlements and judgments in fiscal year 2025, marking the largest annual total in the statute's history. The DOJ reported 1,297 qui tam actions filed by whistleblowers and 401 government investigations during the year. Health care - [HIPAA Update - Q1 2026](https://texashealthlaw.com/hipaa-update-q1-2026/) - The first quarter of 2026 has brought a wave of regulatory activity, enforcement actions, and emerging compliance challenges under HIPAA. From a proposed overhaul of the Security Rule to new obligations around substance use disorder records, artificial intelligence, and vendor oversight, healthcare organizations are navigating one of the most consequential periods for health information privacy - [Wade's Health Law Highlights for March 24, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-march-24-2026/) - Fraud & Abuse / Anti-Kickback The OIG issued a favorable advisory opinion allowing a medical device manufacturer to subsidize Medicare cost-sharing obligations for patients enrolled in a clinical trial testing an implantable device that delivers electrical pulses to baroreceptors in the carotid artery. The study will test the device in heart failure patients with left - [Wade's Health Law Highlights for March 17, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-march-17-2026/) - Healthcare Fraud and False Claims Aetna Inc. agreed to pay $117,700,000 to resolve allegations that it violated the False Claims Act by submitting inaccurate diagnosis codes for Medicare Advantage enrollees to inflate payments from the Centers for Medicare & Medicaid Services. The government alleged that in 2015, Aetna operated a chart review program that added - [Wade's Health Law Highlights for March 10, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-march-10-2026/) - Healthcare Fraud Enforcement & Anti-Kickback The Office of Inspector General approved an arrangement allowing a management company affiliated with urgent care centers to establish an independent clinical laboratory without violating the Anti-Kickback Statute. OIG issued Advisory Opinion No. 26-02 on February 12, 2026, concluding that the arrangement would not generate prohibited remuneration because the laboratory - [Wade's Health Law Highlights for March 3, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-march-3-2026/) - Drug & Device The FDA issued a warning about Generation 1 Purge Cassettes in Johnson & Johnson MedTech's Impella heart pumps after the components were linked to 4 injuries. The cassettes can leak, which may lead to low purge pressure, biomaterial ingress, pump stop, and potentially patient death. On Feb. 18, Johnson & Johnson MedTech - [No, You Can't Just Not Take Medicare: What Every Chiropractor Needs to Know](https://texashealthlaw.com/no-you-cant-just-not-take-medicare-what-every-chiropractor-needs-to-know/) - A growing number of chiropractors are moving away from insurance panels in favor of cash-pay practice models built around direct-pay patient relationships. The appeal is understandable—simplified billing, transparent pricing, and greater clinical autonomy. But this shift has created a widespread compliance problem that many chiropractors do not realize they have: an obligation to Medicare that - [Wade's Health Law Highlights for February 24, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-february-24-2026/) - Antitrust The DOJ Antitrust Division awarded its first whistleblower payout of $1 million to an individual who exposed a bid rigging and fraud scheme at EBlock Corp.'s online vehicle auction platform. The payment stems from the DOJ Whistleblower Rewards Program, which launched in July 2025 in partnership with the U.S. Postal Service to incentivize reporting - [Wade's Health Law Highlights for February 17, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-february-17-2026/) - Data Breach Texas Attorney has launched an investigation into what he describes as potentially the largest data breach in U.S. history, issuing Civil Investigative Demands to Blue Cross Blue Shield of Texas and Conduent Business Services LLC. The breach of Conduent's system occurred between Oct. 21, 2024, and Jan. 13, 2025, exposing sensitive personal data - [Wade's Health Law Highlights for February 10, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-february-10-2026/) - Ambulatory Surgery Centers Ambulatory surgery centers now treat patients with conditions far beyond their original design parameters. ASCs increasingly care for patients with diabetes, obesity, cardiovascular disease, arrhythmias, anticoagulation therapy, pulmonary disease, and renal impairment, often in combination. Facilities face operational challenges including tracking postoperative infections when patients receive dialysis multiple times per week, determining - [Wade's Health Law Highlights for February 3, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-february-3-2026/) - Drug & Device Reference product exclusivity grants biological products 12 years of market protection under the Biologics Price Competition and Innovation Act, during which the FDA will not approve biosimilar applications referencing the product. The FDA may not issue licensure of a biosimilar product under a 351(k) BLA until 12 years after the reference product - [Wade's Health Law Highlights for January 27, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-january-27-2026/) - Antitrust Epic Systems filed 29 affirmative defenses against Texas Attorney General Ken Paxton's antitrust lawsuit, arguing the state's claims are invalid under the Texas Deceptive Trade Practices Act. The electronic health record vendor stated that healthcare organizations, not Epic, serve as legal custodians of medical records and determine patient data access through its configurable software. - [Wade's Health Law Highlights for January 20, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-january-20-2026/) - 340B A federal judge issued a preliminary injunction on December 29, 2025 halting the Department of Health and Human Services' 340B Rebate Model Pilot Program, which was set to launch January 1, 2026. The program would have restructured the 340B Drug Pricing Program from upfront discounts to post-sale rebates for ten drugs under the Medicare - [Wade's Health Law Highlights for January 13, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-january-13-2026/) - Advisory Opinions The Department of Health and Human Services Office of Inspector General issued Advisory Opinion 25-11 addressing whether a biopharmaceutical manufacturer's vaccine discount arrangements would violate the federal Anti-Kickback Statute. The manufacturer sought guidance on four types of discounts for three vaccines reimbursed under different Medicare programs: upfront discounts, upfront discounts with purchase requirements, - [Wade's Health Law Highlights for January 6, 2026](https://texashealthlaw.com/wades-health-law-highlights-for-january-6-2026/) - 340B A federal district court has blocked the Health Resources and Services Administration from implementing a 340B Rebate Model Pilot Program, days before its January 1, 2026 start date. The court found HRSA likely violated the Administrative Procedure Act by failing to build an adequate administrative record, provide reasoning for the program's design, or consider - [Wade's Health Law Highlights for December 16, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-december-16-2025/) - Antitrust Texas Attorney General Ken Paxton filed a lawsuit against Epic alleging the company monopolizes the electronic health record market and restricts parental access to children's medical records. The lawsuit claims Epic, which controls 42% of the hospital EHR market and maintains records for 325 million patients, uses exclusionary tactics to prevent competition from partners, - [Wade's Health Law Highlights for December 9, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-december-9-2025/) - Ambulatory Surgery Centers Ambulatory surgery centers are becoming essential to health system growth strategies as clinical, financial, regulatory, and competitive forces push care beyond hospital walls. Technology improvements and post-pandemic comfort with higher-acuity procedures have made ASCs viable for surgeries previously limited to hospitals, while federal and state policy changes, including inpatient-only list removals and - [Wade's Health Law Highlights for December 2, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-december-2-2025/) - Antitrust U.S. Judge Jeffrey Cummings denied the Federal Trade Commission's request to block GTCR LLC's $627 million acquisition of Surmodics Inc. on November 10. The FTC, joined by Illinois and Minnesota, argued the merger would give GTCR control of more than 50% of the U.S. outsourced hydrophilic coatings market, as GTCR already owns Biocoat, the - [Wade's Health Law Highlights for November 25, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-november-25-2025/) - 340B HRSA has approved plans from 10 manufacturers to participate in the 340B Rebate Model Pilot Program, which will inform the development of future models consistent with the 340B statute. The participating manufacturers include Bristol Myers Squibb (Eliquis), Immunex Corporation (Enbrel), AstraZeneca (Farxiga), Pharmacyclics (Imbruvica), Merck Sharp Dohme (Januvia), Boehringer Ingelheim (Jardiance), Novo Nordisk (Novolog - [Wade's Health Law Highlights for November 18, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-november-18-2025/) - 340B 340B covered entities face new rebate models and Medicare Part D claims reporting requirements starting January 1, 2026. The rebate models extend to all 340B covered entity types, all payors, and all dispensing locations, using the Beacon software platform with eight manufacturers participating under different policies. CMS will identify Medicare Part D claims for - [Wade's Health Law Highlights for November 11, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-november-11-2025/) - 340B HRSA has finalized the 340B Rebate Model Pilot Program with nine manufacturers approved to participate starting January 1, 2026. The approved manufacturers include Bristol Myers Squibb, Immunex Corporation, AstraZeneca AB, Pharmacyclics, Merck Sharp & Dohme, Boehringer Ingelheim, Novo Nordisk Inc., Janssen Biotech, Inc., and Janssen Pharmaceuticals, Inc., each participating with specific drugs and all - [Does a Doctor of Pastoral Medicine Degree Expand a Practitioner's Scope of Practice?](https://texashealthlaw.com/does-a-doctor-of-pastoral-medicine-degree-expand-a-practitioners-scope-of-practice/) - There is a mistaken belief that a D.PSc., PSC.D or Doctor of Pastoral Medicine degree from the Texas-based, Pastoral Medical Association, will expand the scope of practice of non-physician, medical providers. Will such a degree allow a nurse practitioner, for example, to provide services or perform medical assessments that they could not otherwise perform? Or, - [Wade's Health Law Highlights for November 4, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-november-4-2025/) - Cybersecurity Healthcare remains the sector with the costliest data breaches, with incidents averaging $7.42 million in damages and marking the 12th consecutive year the industry topped breach costs. Health records sell for up to $250 on the dark web. It is projected that ransomware will impact 40% of US healthcare systems by 2026, causing care - [Wade's Health Law Highlights for October 28, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-october-28-2025/) - Artificial Intelligence Insurance companies face lawsuits alleging AI algorithms denied patient care without human oversight. UnitedHealth Group, Cigna, and Humana are defending against claims that their AI programs led to denied care, though the companies deny using AI for coverage denials. A May survey from the National Association of Insurance Commissioners found 84% of 93 - [Wade's Health Law Highlights for October 21, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-october-21-2025/) - AI Governance Joint Commission and the Coalition for Health AI released the first national guidance for responsible AI implementation in U.S. healthcare systems. The guidance establishes policies for local validation, monitoring, and use that healthcare organizations can integrate into existing or new processes. The organizations plan to release governance playbooks later this year and in - [Wade's Health Law Highlights for October 14, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-october-14-2025/) - AI Governance Health systems possess the expertise to monitor AI tools but lack the infrastructure to implement comprehensive governance at scale. The Joint Commission and Coalition for Health AI released guidance covering AI policies, data security, quality monitoring, and safety event reporting, while the National Association of Insurance Commissioners established a model bulletin on AI - [Wade's Health Law Highlights for October 7, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-october-7-2025/) - Alternative Medicine Texas Medical Board now requires physicians to obtain structured consent before providing complementary and alternative medicine therapies. Effective January 2025, the rules apply to any non-conventional treatment including peptides, stem cells, and exosomes, regardless of FDA approval status. Physicians must use an unmodified TMB consent form that covers assessment requirements such as medical - [Consent Requirements for Complementary and Alternative Medicine](https://texashealthlaw.com/consent-requirements-for-complementary-and-alternative-medicine/) - Effective January 2025, the Texas Medical Board (TMB) adopted new Complementary and Alternative Medicine (CAM) standards that require physicians to use a specific disclosure and consent process before providing any CAM therapy. These rules apply broadly to any non-conventional treatment—whether or not it is FDA-approved—including popular offerings such as peptides, stem cells, and exosomes. What - [Texas’s New IV Therapy Law: What Patients, Clinics, and Clinicians Need to Know](https://texashealthlaw.com/texass-new-iv-therapy-law-what-patients-clinics-and-clinicians-need-to-know/) - After a highly publicized death linked to an IV infusion at a Texas spa in 2023, state lawmakers moved to bring clearer rules and stronger oversight to IV services offered outside traditional medical settings. The result is House Bill 3749—formally “Jenifer’s Law”—signed by Governor Greg Abbott on June 20, 2025, and effective September 1, 2025. - [Wade's Health Law Highlights for September 30, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-september-30-2025/) - Artificial Intelligence Shadow AI tools used without IT oversight create security risks that cost healthcare organizations $200,000 more per data breach than sanctioned AI incidents. IBM's 2025 Cost of a Data Breach report found that 20% of organizations across all sectors suffered breaches due to shadow AI incidents, compared to 13% for sanctioned AI tools. - [Wade's Health Law Highlights for September 23, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-september-23-2025/) - Advertising The FDA announced a crackdown on direct-to-consumer pharmaceutical advertising on September 9, following a presidential memorandum directing action against misleading advertising practices. The agency issued thousands of template letters to pharmaceutical companies warning them to remove misleading advertising and sent hundreds of cease-and-desist letters to companies violating advertising rules. FDA plans to increase enforcement - [Wade's Health Law Highlights for September 16, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-september-16-2025/) - OIG Advisory Opinion No. 25-10 The OIG issued a favorable advisory opinion for a grant-funded family-powered therapy arrangement. The Company’s mission is to provide care for individuals with a certain disorder, particularly for those individuals who lack adequate access to care. The therapy for the disorder is generally covered by insurance, including Medicare. The Company - [Wade's Health Law Highlights for September 2, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-september-2-2025/) - Antitrust Hospital associations challenge new merger notification rules as burdensome and unnecessary. The Federal Trade Commission under Lina Khan adopted changes to Hart-Scott-Rodino premerger notification requirements that took effect February 10, 2025, increasing information volume and preparation time by four times. On August 8, 2025, the American Hospital Association and Federation of American Hospitals filed - [New Restrictions on Non-Compete Agreements for Physicians and Health Care Practitioners](https://texashealthlaw.com/new-restrictions-on-non-compete-agreements-for-physicians-and-health-care-practitioners/) - Texas Enacts Significant New Restrictions on Non-Compete Agreements for Physicians and Health Care Practitioners Effective September 1, 2025, Texas Senate Bill 1318 (SB 1318) will substantially alter the landscape for non-compete agreements involving physicians and other health care practitioners. This new law amends the Texas Business & Commerce Code to impose strict requirements on the - [Wade's Health Law Highlights for August 26, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-august-26-2025/) - Accountable Care Organizations (ACOs) Hospital participation in Medicare accountable care organizations failed to reduce emergency department admission rates, length of stay, or costs for unplanned admissions, according to a new study that challenges the effectiveness of hospital-led ACO cost-saving strategies. Researchers analyzed 995 hospitals that joined Medicare ACOs between 2012 and 2017, tracking their performance - [Wade's Health Law Highlights for August 19, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-august-19-2025/) - 340B HRSA launched a pilot program on August 1, 2025 that will change how drug manufacturers provide 340B discounts to safety net healthcare providers. Under the new rebate model, covered entities will pay full price for drugs upfront and receive rebates later, rather than receiving discounts at the time of purchase as traditionally done. The - [Wade's Health Law Highlights for August 12, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-august-12-2025/) - Breach Notifications Two Texas healthcare facilities disclosed data breaches affecting nearly 10,000 patients combined. Nova Recovery Center in Wimberley detected unauthorized network access on May 25, 2025, which compromised personal information of 7,713 individuals including names, addresses, Social Security numbers, and financial data. The facility confirmed the breach on June 17, 2025, and provided credit - [Wade's Health Law Highlights for August 5, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-august-5-2025/) - 330 Grants The U.S. Department of Health and Human Services now classifies the Health Center Program as a "Federal public benefit" under the Personal Responsibility and Work Opportunity Reconciliation Act, restricting non-qualified aliens' access to most federally funded services at community health centers and federally qualified health centers. The policy, effective immediately with no grace - [Wade's Health Law Highlights for July 29, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-july-29-2025/) - Accountable Care Organizations Health policy experts anticipate the second Trump administration will revive the Geographic Direct Contracting Model that was suspended by the Biden administration before implementation. The model would assign entire geographic regions to accountable entities responsible for managing care and costs for all Medicare beneficiaries in those areas, unlike current models that focus - [Wade's Health Law Highlights for July 22, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-july-22-2025/) - Business of Healthcare Healthcare organizations face financial losses from compliance failures, with non-compliance leading to penalties, reputational damage, and operational disruption. The company helped an academic institution save $310,000 using their Compliance Risk Analyzer software, which provides statistical analysis of audit risk for physician claims. VMG Health offers services including fair market value opinions, coding - [Wade's Health Law Highlights for July 15, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-july-15-2025/) - Texas Public Emergency The Department of Health and Human Services has waived certain HIPAA sanctions and penalties for Texas hospitals responding to a public health emergency in Kerr County. President Donald J. Trump signed a Major Disaster Declaration for Kerr County, Texas, and Secretary Robert F. Kennedy, Jr. declared a public health emergency to address - [Wade's Health Law Highlights for July 8, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-july-8-2025/) - Emerging Tech CMS will launch the Wasteful and Inappropriate Service Reduction (WISeR) Model on January 1, 2026, to combat healthcare fraud through artificial intelligence-enhanced prior authorization processes in Traditional Medicare. The model will focus on services vulnerable to fraud, waste and abuse, including skin and tissue substitutes, electrical nerve stimulator implants, and knee arthroscopy for - [Transforming Texas Long-Term Care: The Upcoming PDPM LTC Methodology](https://texashealthlaw.com/transforming-texas-long-term-care-the-upcoming-pdpm-ltc-methodology/) - Big changes are on the horizon for long-term care in Texas. The Texas Health and Human Services Commission (HHSC) is gearing up to implement a new payment methodology, the Patient Driven Payment Model for Long-Term Care (PDPM LTC), set to take effect on September 1, 2025. This marks a significant shift from the current Resource - [Wade's Health Law Highlights for June 24, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-june-24-2025/) - OIG Advisory Opinions The HHS OIG approved a telehealth platform arrangement involving management service organizations and physician corporations. The arrangement allows a management support organization and physician-owned professional corporation to contract with third-party telehealth platforms to lease clinicians and obtain administrative services including accounting, marketing, and IT support. OIG determined the proposal was protected by - [Wade's Health Law Highlights for June 17, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-june-17-2025/) - Accountable Care Organizations Hospitals participating in CMS accountable care organizations require more than two years of maturity before seeing improvements in patient care costs and quality, according to a study comparing 121 ACO-participating hospitals with 853 non-participating hospitals from 2010 to 2013. Researchers found that hospitals with an ACO maturity score of zero performed worse - [Wade's Health Law Highlights for June 10, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-june-10-2025/) - Accountable Care Organizations The CMS Innovation Center is implementing significant updates to the ACO REACH Model financial methodology starting in 2026 to achieve cost savings while maintaining care quality. These changes respond to a preview evaluation report showing increased net spending despite positive gross savings and quality care results in the program's first year. The - [Wade's Health Law Highlights for June 3, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-june-3-2025/) - Emerging Tech Alibaba's healthcare AI model has achieved medical expertise comparable to senior physicians in China. The model, powered by Qwen 2.5-32B foundation technology, passed medical qualification exams at the "Deputy Chief Physician" level across 12 disciplines with 74.8% accuracy, outperforming competitors including OpenAI's GPT-4o. Now integrated into Alibaba's Quark AI assistant app with 200 - [Wade's Health Law Highlights for May 27, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-may-27-2025/) - Antitrust State attorneys general are intensifying antitrust enforcement across multiple fronts. States are implementing "baby HSR" statutes requiring merging companies to file notifications directly with state AGs, with Washington recently adopting such laws and Colorado's taking effect in August 2025. Litigation activity is increasing around healthcare and labor issues, exemplified by Michigan's lawsuit against pharmacy - [Wade's Health Law Highlights for May 20, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-may-20-2025/) - Academic Medical Centers The Department of Justice's Final Rule implementing Executive Order 14117 creates significant restrictions for Academic Medical Centers engaged in international clinical research. The rule, published January 8, 2025, prohibits or limits transactions involving sensitive personal data with "Countries of Concern" including China, Russia, Iran, North Korea, Cuba, and Venezuela, targeting eight categories - [Wade's Health Law Highlights for May 13, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-may-13-2025/) - Artificial Intelligence in Healthcare Bipartisan senators have introduced the Health Tech Investment Act (S. 1399), which would create a Medicare reimbursement pathway for FDA-cleared AI-enabled medical devices. The bill, sponsored by Senators Mike Rounds (R-S.D.) and Martin Heinrich (D-N.M.), would establish a new technology ambulatory payment classification for eligible algorithm-based devices with pricing determined by - [Wade's Health Law Highlights for May 6, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-may-6-2025/) - Artificial Intelligence Houston Methodist is teaming up with Ambience Healthcare to integrate AI into emergency departments and inpatient care settings to address documentation and workflow challenges. The technology will capture provider-patient conversations, gather details for admissions and documentation, extract information from charts, and understand specific coding needs of each care setting. Emergency department clinicians report - [Wade's Health Law Highlights for April 29, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-april-29-2025/) - Affordable Care Act The U.S. Supreme Court heard arguments on April 21 regarding the constitutionality of the U.S. Preventive Services Task Force, which determines what preventive care health insurers must cover at no cost under the Affordable Care Act. The case centers on whether the task force's 16 members, appointed by the HHS Secretary without - [Think Twice Before Responding to That Negative Online Review](https://texashealthlaw.com/think-twice-before-responding-to-that-negative-online-review/) - It’s natural to want to defend your practice—especially when a negative online review feels unfair, misleading, or outright false. But for healthcare providers, responding to a bad review isn’t just a public relations concern—it’s a legal one. You could be walking straight into a HIPAA violation. Under HIPAA—and many state privacy laws—healthcare providers are prohibited - [Wade's Health Law Highlights for April 22, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-april-22-2025/) - AI in Healthcare A recent survey found that healthcare professionals expect AI to have the greatest impact on administrative tasks (52.4%), followed by EHR management (47.6%) and diagnostic accuracy (41.9%). The survey of 105 professionals across 73 U.S. healthcare organizations revealed that 81.6% of physicians and 78.8% of administrators are eager to adopt AI tools - [Legal Risks of Patient Marketing](https://texashealthlaw.com/legal-risks-of-patient-marketing/) - Health care providers seeking to grow their practice must tread carefully when it comes to marketing arrangements. While increasing patient volume is a common business goal, not all marketing tactics are legally permissible—especially when they involve payment structures tied to patient referrals. Even seemingly harmless agreements, such as paying a company based on the number - [Wade's Health Law Highlights for April 15, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-april-15-2025/) - OIG Advisory Opinion No. 25-02 Favorable opinion regarding an arrangement whereby Requestor— designated as a community health center pursuant to Section 330 of the Public Health Service Act—proposes, during the provision of certain social services to individuals, to: (1) identify individuals in need of primary care services; (2) inform them of the availability of such - [Wade's Health Law Highlights for April 8, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-april-8-2025/) - Antitrust The Department of Justice announced the formation of an Anticompetitive Regulations Task Force aimed at eliminating state and federal laws that undermine market competition. The Task Force will focus on five key sectors: housing, transportation, food and agriculture, healthcare, and energy, while taking a whole-of-government approach with attorneys and economists from across the Antitrust - [Wade's Health Law Highlights for April 1, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-april-1-2025/) - Abortion Senate Bill 31, known as the Life of the Mother Act, aims to clarify medical exceptions to Texas abortion laws that currently permit the procedure only when the mother's life or major bodily function is at risk. The bill would specify that doctors need not delay treatment if doing so increases risk to the - [Wade's Health Law Highlights for March 25, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-march-25-2025/) - Abortion Texas Attorney General Ken Paxton announced the arrest of Maria Margarita Rojas, a 48-year-old midwife who operated multiple clinics in the Houston area. Rojas, known as "Dr. Maria," was charged with performing illegal abortions and practicing medicine without a license, both serious offenses under Texas law. Her network included three clinics—in Waller, Cypress, and - [Can Compounding Pharmacies Continue to Compound Name Brand Weight Loss Drugs by Adding B12?](https://texashealthlaw.com/can-compounding-pharmacies-continue-to-compound-name-brand-weight-loss-drugs-by-adding-b12/) - In the world of pharmaceuticals, compounding pharmacies play a crucial role in customizing medications to meet the unique needs of individual patients. However, the practice of compounding is tightly regulated to ensure patient safety and maintain the integrity of the drug approval process. One contentious issue is whether compounding pharmacies can continue to compound name - [Wade's Health Law Highlights for March 18, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-march-18-2025/) - 🚨Are Your Vendors Protecting Patient Data? 🚨 If you’re a healthcare provider, you likely rely on vendors who handle patient information—your EHR system, billing company, IT support, and more. But how well do you know their security practices? Before entrusting them with PHI (protected health information), conduct due diligence. Here are some red flags to - [Wade's Health Law Highlights for March 11, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-march-11-2025/) - False Claims Act Dr. David Young, 61, of Fredericksburg, Texas, has been sentenced to 10 years in prison for Medicare fraud. The physician signed thousands of fake prescriptions and medical records for orthotic braces and cancer genetic testing for over 13,000 Medicare beneficiaries, resulting in more than $70 million in fraudulent healthcare program billing. Young - [Wade's Health Law Highlights for March 4, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-march-4-2025/) - Advertising Twenty US states have enacted comprehensive privacy laws that regulate health data usage in digital advertising. The Federal Trade Commission and state regulators have expanded definitions of health data to include browsing histories, location information, and medical purchases, with Washington and Nevada implementing specific consumer health data laws requiring detailed consent. The Dobbs v. - [Wade's Health Law Highlights for February 25, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-february-25-2025/) - Artificial Intelligence A recent American Medical Association survey of 1,183 physicians shows AI usage among doctors increased from 38% in 2023 to 66% in 2024. Physicians use AI primarily for visit documentation, discharge summaries, care plans, translation services, and medical research summaries, with 68% reporting AI provides advantages in patient care. While 36% of physicians - [Wade's Health Law Highlights for February 18, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-february-18-2025/) - AI in Healthcare A new American Medical Association survey reveals that physician acceptance of AI in healthcare has increased, with 35% now showing enthusiasm compared to 30% in 2023. The adoption rate of AI tools among physicians has jumped from 38% to 66% between 2023 and 2024. The survey, conducted from August 2023 to November - [Wade's Health Law Highlights for February 11, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-february-11-2025/) - Ambulatory Surgery Centers United Surgical Partners International, Surgical Care Affiliates, and Amsurg Corporation lead the ambulatory surgery center market with 520, 320, and 250 centers respectively. CMS approved 21 new procedures for ASC coverage in 2025, focusing on dental and regenerative therapy services, while implementing a 2.9% Medicare payment increase. Major consolidation occurred through acquisitions - [Wade's Health Law Highlights for February 4, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-february-4-2025/) - Data Privacy Data breach incidents in 2024 affected 1.7 billion individuals, marking a 312% increase from 2023 despite a 1% decrease in total breaches. Six major breaches accounted for 85% of all notices, including Change Healthcare with 190 million records. Cyberattacks caused 80% of all data compromises, with four of the largest breaches resulting from - [Wade's Health Law Highlights for January 28, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-january-28-2025/) - Antitrust & Competition The Federal Trade Commission has reached a settlement with private equity firm Welsh, Carson, Anderson & Stowe over U.S. Anesthesia Partners' market consolidation in Texas. USAP, which operates in 700 facilities with 4,500 clinicians nationwide, acquired multiple anesthesia practices in Dallas between 2014 and 2016, gaining control of 40-50% of the market. - [Wade's Health Law Highlights for January 21, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-january-21-2025/) - Advisory Opinion The Office of Inspector General (OIG) issued Advisory Opinion 25-01, concluding that a pharmaceutical company’s arrangement to provide free access to a specific drug for eligible patients does not warrant administrative sanctions under the Federal anti-kickback statute or the Beneficiary Inducements Civil Monetary Penalty (CMP) provisions. The drug in question is an infusion - [Wade's Healthcare Privacy Advisor for January 15, 2025](https://texashealthlaw.com/wades-healthcare-privacy-advisor-for-january-15-2025/) - Confidentiality & Cybersecurity The US Court of Appeals has struck down net neutrality regulations, allowing Internet Service Providers (ISPs) to monitor, prioritize, and control Internet traffic. The ruling impacts healthcare privacy as ISPs can now track and sell patient data from telehealth sessions, mental health searches, and digital health app usage to third parties. Healthcare - [Wade's Health Law Highlights for January 14, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-january-14-2025/) - Advanced Practice Providers Advanced Practice Providers (APPs), including nurse practitioners, physician assistants, and other specialists, are filling healthcare gaps caused by physician shortages and increased demand for services. Chief APPs (CAAPs) have emerged as leaders who manage APP integration within healthcare organizations. APPs can diagnose conditions, prescribe medications, conduct exams, and interpret tests, while spending - [Wade's Healthcare Privacy Advisor for January 8, 2025](https://texashealthlaw.com/wades-healthcare-privacy-advisor-for-january-8-2025/) - AI Legislation The Texas Legislature is considering the Texas Responsible AI Governance Act, which would establish regulations for high-risk AI systems that make consequential decisions affecting areas like employment, education, and government services. The Act requires developers and deployers to protect consumers from algorithmic discrimination, maintain oversight of AI systems, and provide detailed disclosures about - [Wade's Health Law Highlights for January 7, 2025](https://texashealthlaw.com/wades-health-law-highlights-for-january-7-2025/) - Antitrust The US antitrust agencies have withdrawn the Antitrust Guidelines for Collaboration Among Competitors, directing businesses to rely on case law instead of formal guidelines. This action follows the 2023 removal of healthcare-related enforcement policy statements, creating a guidance vacuum for businesses seeking to comply with antitrust laws. The DOJ and FTC now refer companies - [Wade's Healthcare Privacy Advisor for December 18, 2024](https://texashealthlaw.com/wades-healthcare-privacy-advisor-for-december-18-2024/) - AI Implementation A recent report reveals that AI is primarily used for administrative tasks in healthcare settings, with clinical applications still in early adoption stages. Most medical facilities have been using AI for at least 10 months, and there is an expectation for AI to play a larger role in reviewing electronic health records and - [Wade's Health Law Highlights for December 17, 2024](https://texashealthlaw.com/wades-health-law-highlights-for-december-17-2024/) - Centers for Medicare & Medicaid Services On November 1, the Centers for Medicare & Medicaid Services (CMS) finalized an extension of virtual direct supervision through real-time audio-visual technology until December 31, 2025, and permanently for certain "incident to" services. These changes are part of the CY 2025 Medicare Physician Fee Schedule (MPFS) and Medicare Hospital - [Wade's Healthcare Privacy Advisor for December 11, 2024](https://texashealthlaw.com/wades-healthcare-privacy-advisor-for-december-11-2024/) - AI Governance At the HLTH health innovation conference, a panel of AI experts expressed skepticism about appointing a chief AI officer in health organizations, advocating instead for improving AI literacy across the board. Some providers have established an AI oversight committee and an AI Enablement Center to democratize AI governance and ensure responsible integration of - [Wade's Health Law Highlights for December 10, 2024](https://texashealthlaw.com/wades-health-law-highlights-for-december-10-2024/) - Centers for Medicare & Medicaid Services The Centers for Medicare & Medicaid Services (CMS) implemented a final rule in October requiring casualty insurers, defined as Responsible Reporting Entities (RREs), to report certain payments to Medicare beneficiaries or face Civil Money Penalties (CMPs). The rule focuses on "Non-Group Health Plans" (NGHPs), including liability insurers, no-fault carriers, - [Wade's Healthcare Privacy Advisor for December 4, 2024](https://texashealthlaw.com/wades-healthcare-privacy-advisor-for-december-4-2024/) - Artificial Intelligence Ensuring AI models provide faithful and reliable explanations is challenging, particularly in high-stakes fields like healthcare and finance, as current interpretability paradigms—intrinsic and post-hoc—fall short. Intrinsic models, though inherently interpretable, often lack general applicability and competitive performance, while post-hoc methods, although flexible, frequently produce explanations that do not align with the model’s logic. - [Wade's Health Law Highlights for December 3, 2024](https://texashealthlaw.com/wades-health-law-highlights-for-december-3-2024/) - Elderly & Aging Older adults increasingly require more clinical care and social services, which places a significant burden on an already strained healthcare system. The integration of data analytics in senior care can enhance patient-centered care by enabling predictive analytics for proactive health interventions and personalized treatment plans tailored to individual needs. This approach improves - [Wade's Healthcare Privacy Advisor for November 27, 2024](https://texashealthlaw.com/wades-healthcare-privacy-advisor-for-november-27-2024/) - Cybersecurity The Office of Inspector General (OIG) has once again found the U.S. Department of Health and Human Services' (HHS) information security program to be ineffective, as detailed in their report. The OIG's annual audit, required by the Federal Information Security Modernization Act of 2014, revealed that HHS failed to meet maturity in all five - [Wade's Health Law Highlights for November 26, 2024](https://texashealthlaw.com/wades-health-law-highlights-for-november-26-2024/) - Dr. Death Redux Dr. Raynaldo Ortiz was sentenced to 190 years in prison for injecting dangerous drugs into patient IV bags at Baylor Scott & White Surgicare North Dallas, leading to at least 12 cardiac complications and the death of a colleague. Ortiz was convicted in April after an eight-day trial on multiple counts of - [Wade's Healthcare Privacy Advisor for November 20, 2024](https://texashealthlaw.com/wades-healthcare-privacy-advisor-for-november-20-2024/) - Artificial Intelligence The Department of Homeland Security (DHS) has released a voluntary framework outlining AI responsibilities for critical infrastructure sectors. The framework, developed with industry input, addresses risks like AI-based attacks and design failures, emphasizing practical implementation for safety and security. While the future of the framework under a potential Trump administration remains uncertain, DHS - [Wade's Health Law Highlights for November 19, 2024](https://texashealthlaw.com/wades-health-law-highlights-for-november-19-2024/) - Behavioral Health Behavioral health is a rapidly growing area in the healthcare sector, but it faces significant operational and financial challenges as companies scale and investor interest increases. Behavioral health organizations need to adopt innovative strategies to improve operations and financial performance, often requiring external expertise to navigate these complexities. They highlight the importance of - [Wade's Healthcare Privacy Advisor for November 11, 2024](https://texashealthlaw.com/wades-healthcare-privacy-advisor-for-november-11-2024/) - Blockchain The integration of AI and Blockchain technologies promises to revolutionize industries by enhancing transparency, security, and efficiency. While offering significant benefits, this convergence also raises challenges related to scalability, data privacy, and regulatory compliance. Despite these obstacles, the potential applications and innovations stemming from this synergy are vast and promising. HIPAA & Cybersecurity The - [Wade's Health Law Highlights for November 11, 2024](https://texashealthlaw.com/wades-health-law-highlights-for-november-11-2024/) - Fraud & Abuse Horizon Medical Center of Denton, owned by Corinth Investor Holdings, L.L.C., paid $14.2 million to settle potential violations of Medicare regulations and the Stark Law. The center self-disclosed omitting a modifier and location for services provided at off-campus facilities, as well as financial relationships with physician-owners. This settlement, along with two others, - [Wade's Healthcare Privacy Advisor for November 6, 2024](https://texashealthlaw.com/wades-healthcare-privacy-advisor-for-november-6-2024/) - Access & Privacy A new law took effect Friday, Nov. 1, in Texas, requiring hospitals to ask patients about their immigration status. It’s part of a mandate from the state’s Republican Governor, who wants to know exactly how much Texans are paying to treat undocumented migrants. The new rule is raising concerns about healthcare access - [Wade's Health Law Highlights for November 5, 2024](https://texashealthlaw.com/wades-health-law-highlights-for-november-5-2024/) - Access & Privacy A new law took effect Friday, Nov. 1, in Texas, requiring hospitals to ask patients about their immigration status. It’s part of a mandate from the state’s Republican Governor, who wants to know exactly how much Texans are paying to treat undocumented migrants. The new rule is raising concerns about healthcare access - [Wade's Healthcare Privacy Advisor for October 30, 2024](https://texashealthlaw.com/wades-healthcare-privacy-advisor-for-october-30-2024/) - Navigating AI: A Quick Start Guide for Healthcare Professionals To get started with AI in healthcare, clinicians should set clear goals, create a personalized learning roadmap, and identify essential resources. Understanding AI fundamentals, including programming skills, is crucial for effective collaboration and decision-making. Clinicians can enhance their knowledge and skills through formal education, online courses, - [Wade's Health Law Highlights for October 29, 2024](https://texashealthlaw.com/wades-health-law-highlights-for-october-29-2024/) - Eli Lilly Targets Compounding Kits Eli Lilly has filed a lawsuit against Pivotal Peptides, a drug vendor in Washington state, accusing them of selling do-it-yourself kits for making knockoff versions of their weight-loss and diabetes drugs, Zepbound and Mounjaro. Pivotal Peptides allegedly sold these kits without requiring a prescription or medical consultation, labeling the ingredients - [Wade's Health Law Highlights](https://texashealthlaw.com/wades-health-law-highlights/) - Litigation Texas Attorney General Ken Paxton sued a Dallas doctor for providing gender-affirming treatments to minors, violating a state ban. The lawsuit alleges the doctor used false diagnoses and billing codes to mask the care. The doctor practices at UT Southwestern and Children’s Health, both affiliated with the state. The FTC appealed a Texas ruling - [Wade's Healthcare Privacy Advisor](https://texashealthlaw.com/wades-healthcare-privacy-advisor/) - Legislation In 2024, states continued to enact sectoral privacy laws, particularly focusing on children’s data and AI regulation. The New York Child Data Protection Act and SAFE for Kids Act aim to protect children’s privacy and safety online, while the Maryland Age-Appropriate Design Code Act seeks to regulate online content for children. Other states, such - [Online Tracking Technologies and HIPAA Misconceptions](https://texashealthlaw.com/online-tracking-technologies-and-hipaa-misconceptions/) - Summary of article from IAPP, by John Haskell: Misconceptions persist about the use of online tracking technologies (OTTs) for marketing under HIPAA compliance. HIPAA mandates that covered entities must obtain explicit authorization from individuals before using or disclosing their personal health information (PHI) for marketing purposes. Simply signing a Business Associate Agreement (BAA) does not - [People Are Overdosing on Off-Brand Weight-Loss Drugs, FDA Warns](https://texashealthlaw.com/people-are-overdosing-on-off-brand-weight-loss-drugs-fda-warns/) - Summary of article from Ars Technica, by Beth Mole: The FDA has issued a warning about overdoses related to off-brand versions of the weight-loss drug semaglutide, commonly known as Wegovy and Ozempic. Due to high costs and supply shortages, patients are turning to compounded versions, which lack standardized dosing and safety assurances. These compounded drugs - [P-R-I-V-A-C-Y is Priceless to Me: The 2024 Privacy Rule](https://texashealthlaw.com/p-r-i-v-a-c-y-is-priceless-to-me-the-2024-privacy-rule/) - Summary of article from Holland & Hart, by Leslie Thomson: The Department of Health and Human Services has issued the 2024 Privacy Rule, amending HIPAA privacy regulations to restrict the use or disclosure of an individual's Protected Health Information (PHI) related to reproductive healthcare for certain non-healthcare purposes. This rule aims to protect individual privacy - [AI and Healthcare: Decoding the Latest 1557 Non-Discrimination Regulations](https://texashealthlaw.com/ai-and-healthcare-decoding-the-latest-1557-non-discrimination-regulations/) - Summary of article from Bricker Graydon LLP, by N. Bradford Wells: The 2024 Final Rule under Section 1557 of the Affordable Care Act reinstates and expands anti-discrimination provisions for healthcare providers and health plans receiving federal reimbursement. Notably, it extends these provisions to entities participating exclusively in Medicare Part B and introduces regulations for the - [Stakeholder Perspectives on Ethical and Trustworthy Voice AI in Health Care](https://texashealthlaw.com/stakeholder-perspectives-on-ethical-and-trustworthy-voice-ai-in-health-care/) - Summary of article from Sage Journals, by Jean-Christophe Bélisle-Pipon, Maria Powell, Renee English, Marie-Françoise Malo, Vardit Ravitsky, Bridge2AI–Voice Consortium, Yael Bensoussan: Voice as a health biomarker using artificial intelligence (AI) is gaining momentum in research. The noninvasiveness of voice data collection through accessible technology (such as smartphones, telehealth, and ambient recordings) or within clinical contexts - [OIG Updates Fraud and Abuse Authorities FAQs](https://texashealthlaw.com/oig-updates-fraud-and-abuse-authorities-faqs/) - Summary of article from King & Spalding, by Doug Comin: On July 8, 2024, the Office of Inspector General (OIG) updated its Frequently Asked Questions regarding fraud and abuse authorities, adding four new questions and answers. The updates address the legality and conditions under which hospitals may waive cost-sharing charges for patients under financial assistance - [“Incident To” Billing Promotes Productivity, But Presents Many Potential Pitfalls](https://texashealthlaw.com/incident-to-billing-promotes-productivity-but-presents-many-potential-pitfalls/) - Summary of article from Burr & Forman, by Catherine Kirkland: “Incident to” billing allows physician practices to bill Medicare for non-physician practitioners (NPPs) under a supervising physician’s provider number at the full physician rate, enhancing productivity and reducing appointment wait times. However, this arrangement carries significant compliance risks, requiring specific conditions such as the physician - [HHS Releases Final Part Two Guidance to Help People with Medicare Prescription Drug Coverage Manage Prescription Drug Costs](https://texashealthlaw.com/hhs-releases-final-part-two-guidance-to-help-people-with-medicare-prescription-drug-coverage-manage-prescription-drug-costs/) - Summary of article from CMS Press Release: The Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS), has released the final part two guidance for the Medicare Prescription Payment Plan under the Inflation Reduction Act. This plan, effective in 2025, allows Medicare beneficiaries to spread their prescription drug - [HHS Aligns AI, Tech Strategy Under its Policy Agency](https://texashealthlaw.com/hhs-aligns-ai-tech-strategy-under-its-policy-agency/) - Summary of article from GovCIO, by Silvia Oakland: The Department of Health and Human Services (HHS) has restructured its technology and data strategy responsibilities, consolidating them under its policy office. This reorganization primarily affects the Office of National Coordinator for Health IT (ONC), now renamed the Assistant Secretary for Technology Policy and ONC (ASTP/ONC). A - [A Lifecycle Management Approach Toward Delivering Safe, Effective AI-Enabled Health Care](https://texashealthlaw.com/a-lifecycle-management-approach-toward-delivering-safe-effective-ai-enabled-health-care/) - Summary of blog post from FDA, by Troy Tazbaz: AI's continuous learning and adaptability pose risks, such as exacerbating biases, which can harm patients and underrepresented populations. Lifecycle Management (LCM), integral to reliable software since the 1960s, can address these challenges through structured frameworks. The AI Lifecycle (AILC) concept maps traditional Software Development Lifecycles to - [Medicaid Overpayment Audits: What Medical Providers Need to Know](https://texashealthlaw.com/medicaid-overpayment-audits-what-medical-providers-need-to-know/) - Summary of article from Nelson Mullins, by Gabriel Imperato, Hannah Kays, Melissa Scott: Medicaid overpayment audits ensure program integrity but can be challenging for medical providers. Auditors review medical records and billing documents, typically involving notification, document submission, preliminary findings, appeals, and final determination. Common audit triggers include high claim volumes, unusual billing patterns, frequent adjustments, specific - [Microsoft, Mass General Developing AI Models for Radiology](https://texashealthlaw.com/microsoft-mass-general-developing-ai-models-for-radiology/) - Summary of article from Fierce Healthcare, by Heather Landi: Microsoft is collaborating with Mass General Brigham and the University of Wisconsin-Madison to enhance AI in medical imaging. The partnership aims to develop, test, and validate AI algorithms to improve the accuracy and consistency of medical image analysis. These AI models will be integrated into clinical - [Healthcare Organizations at Risk of Data Breach Due to Insecure File Sharing Practices](https://texashealthlaw.com/healthcare-organizations-at-risk-of-data-breach-due-to-insecure-file-sharing-practices/) - Summary of article from HIT Consultant, by Fred Pennic: A resent report highlights significant vulnerabilities in healthcare organizations' data security practices, particularly concerning insecure file sharing. Key findings reveal that 25% of publicly shared files and 68% of externally shared private files contain Personally Identifiable Information (PII), while 77% of internally shared private files also - [Pharmacy Association and 40 Providers Sue Change Healthcare Over Cyberattack](https://texashealthlaw.com/pharmacy-association-and-40-providers-sue-change-healthcare-over-cyberattack/) - Summary of article from The HIPAA Journal, by Steve Adler: The National Community Pharmacists Association (NCPA) and over 40 healthcare providers from 22 states are suing Change Healthcare, Optum, and UnitedHealth Group following a February 2024 ransomware attack. This Blackcat ransomware incident resulted in significant disruptions, as Change Healthcare's critical systems were taken offline, affecting - [6 Steps to Release a Medical IoT Device](https://texashealthlaw.com/6-steps-to-release-a-medical-iot-device/) - Summary of article from Edge Industry Review, by Gilad David Maayan: Releasing a medical IoT device involves a detailed process to ensure its effectiveness, compliance, and market viability. The first step is conducting market research to assess demand, compare with competitors, and evaluate market size and acceptance, guiding stakeholders on investment decisions. Regulatory planning is - [Vanishing Texas Companies Linked to Millions in Fraudulent Medicare Billings](https://texashealthlaw.com/vanishing-texas-companies-linked-to-millions-in-fraudulent-medicare-billings/) - Summary of article from MSN, by Brian New: CBS News Texas' investigation into alleged Medicare fraud uncovered over $200 million in fraudulent activities linked to several companies, prompting numerous viewers to report their own experiences with Medicare fraud. A subsequent report identified 11 additional Texas-based medical supply companies potentially involved in fraudulent practices. Many of - [Balancing Act: Industry Concerns Over CISA’s Proposed Cyber Incident Reporting Rule](https://texashealthlaw.com/balancing-act-industry-concerns-over-cisas-proposed-cyber-incident-reporting-rule/) - Summary of article from Bradley Arant Boult Cummings LLP, by Sinan Pismisoglu, Eric Setterlund: The proposed cyber incident reporting rule by the Cybersecurity and Infrastructure Security Agency (CISA) aims to enhance national cyber defenses but has raised concerns about its broad scope and potential overreporting, which could overwhelm CISA with low-value data. Industry groups, particularly - [HSBC Venture Healthcare Report: 1H 2024](https://texashealthlaw.com/hsbc-venture-healthcare-report-1h-2024/) - Summary of article from Foley & Lardner LLP, by Antoinette F. Konski: Key findings include a reversal of the 2023 decline in Healthtech investments, stable Med Device investments driven by first-financing deals, and a notable 35% increase in Biopharma investments with significant private deals. The Dx/Tools sector saw a decline in first-financing deals but benefited - [No Surprises Act Implementation Faces Challenges](https://texashealthlaw.com/no-surprises-act-implementation-faces-challenges/) - Summary of article from Proskauer Rose LLP, by D. Austin Rettew, Vinay Kohli: Two district courts have issued conflicting rulings on the enforceability of arbitration awards under the No Surprises Act (NSA), highlighting ongoing challenges in its implementation. The NSA, enacted in 2020, aims to protect patients from unexpected medical bills by capping out-of-network charges - [The TDPSA: A New Sheriff in Town for Texas Data Controllers and Processors](https://texashealthlaw.com/the-tdpsa-a-new-sheriff-in-town-for-texas-data-controllers-and-processors/) - Summary of article from Vinson & Elkins LLP, by Maggie Eller, Briana Falcon, Jeffrey Johnston, Michael Kurzer: The Texas Data Privacy and Security Act (TDPSA), effective from July 1, 2024, mandates compliance from businesses operating in Texas or providing products/services to Texas residents, excluding small businesses and specific entities like state agencies and nonprofits. It defines consumer rights, - [Does HIPAA Apply to Veterinarians?](https://texashealthlaw.com/does-hipaa-apply-to-veterinarians/) - Summary of article from The HIPAA Journal, by Steve Adler: HIPAA does not apply to veterinarians because they do not conduct electronic healthcare transactions for which the Department of Health and Human Services has adopted standards, thus not qualifying as HIPAA covered entities. However, veterinarians are subject to various state-level data privacy and breach notification - [The Impact of the EU AI Act on the Healthcare Sector](https://texashealthlaw.com/the-impact-of-the-eu-ai-act-on-the-healthcare-sector/) - Summary of article from DataGuidance, by Michael Borrelli: The EU AI Act aims to regulate AI systems within the EU, categorizing them by risk levels and imposing stringent requirements on high-risk systems, particularly in healthcare. This legislation emphasizes transparency, accountability, and ethical considerations to ensure AI technologies are safe and trustworthy. High-risk AI systems in - [You Can’t Surf With a Ventilator. The Problems with AI in Health Care, and Some Solutions](https://texashealthlaw.com/you-cant-surf-with-a-ventilator-the-problems-with-ai-in-health-care-and-some-solutions/) - Summary of article from California Health Report, by Jennifer McLelland: The author tested three major AI chatbots—Google Gemini, Meta Llama 3, and ChatGPT—on medical questions to evaluate their accuracy, finding that their responses were often incorrect or misleading. This raises concerns about AI's potential to spread harmful misinformation, especially for families seeking information on rare - [HHS and FBI Release Joint Cybersecurity Advisory Statement for Healthcare Providers](https://texashealthlaw.com/hhs-and-fbi-release-joint-cybersecurity-advisory-statement-for-healthcare-providers/) - Summary of article from Morgan Lewis, by Amy M. Magnano, Michael J. Madderra, Roshni Edalur: The Department of Health and Human Services (HHS) and the Federal Bureau of Investigation (FBI) released a joint cybersecurity advisory (CSA) to alert healthcare providers about phishing attacks and the associated tactics used by threat actors. The advisory emphasizes the - [Pharmacies and Pharmacists in the Crosshairs: DOJ’s $408 million Settlement with Rite Aid](https://texashealthlaw.com/pharmacies-and-pharmacists-in-the-crosshairs-dojs-408-million-settlement-with-rite-aid/) - Summary of article from Woods Rogers, by Justin Lugar: The Department of Justice (DOJ) announced a $408 million settlement with Rite Aid and its affiliates over allegations of violating the Controlled Substances Act (CSA) and the False Claims Act (FCA) by filling unnecessary opioid prescriptions. This settlement underscores the DOJ's commitment to enforcing pharmacists' responsibilities - [The Promise Artificial Intelligence Holds for Improving Health Care](https://texashealthlaw.com/the-promise-artificial-intelligence-holds-for-improving-health-care/) - Summary of blog post from FDA, by Troy Tazbaz: The FDA emphasizes the importance of integrating AI responsibly, ensuring safety and effectiveness through collaboration and adherence to standards and best practices. Key strategies include adopting risk management frameworks, quality assurance practices, and maintaining transparency and accountability throughout the AI development lifecycle. Grassroots efforts and federal - [Data Privacy in Healthcare: Balancing Innovation with Patient Security](https://texashealthlaw.com/data-privacy-in-healthcare-balancing-innovation-with-patient-security/) - Summary of article from Healthcare IT Today, by Ganesh Nathella: The integration of digital technologies in healthcare has improved patient care but also raised significant data privacy concerns. Healthcare organizations are investing in robust data protection measures as they adopt tools like telemedicine and remote monitoring. Emerging technologies such as blockchain, AI, and IoT offer - [Navigating the Legal Boundaries of Telehealth](https://texashealthlaw.com/navigating-the-legal-boundaries-of-telehealth/) - Summary of article from Womble Bond Dickinson, by Melissa Ratliff: Telehealth, which has evolved significantly over centuries, has revolutionized modern healthcare by providing patients with remote access to medical services. However, this advancement brings complex legal challenges, including state-specific licensure requirements, standards of care, privacy and confidentiality under HIPAA, informed consent, online prescribing regulations, reimbursement - [The Overturning of Chevron Deference: Implications for AI in Medical Research](https://texashealthlaw.com/the-overturning-of-chevron-deference-implications-for-ai-in-medical-research/) - Summary of article from Husch Blackwell, by Ragini A. Acharya. Matthew Deutsch: The Supreme Court's recent decision to overturn Chevron deference marks a significant shift in administrative law, transferring interpretive authority from federal agencies to the courts. This ruling, driven by concerns over judicial abdication and regulatory inconsistency, is expected to slow the pace of - [Advanced Analytics in Predicting Healthcare Billing & Coding Audits](https://texashealthlaw.com/advanced-analytics-in-predicting-healthcare-billing-coding-audits/) - Summary of article from VMG Health, by Frank Cohen: In the evolving healthcare landscape, advanced analytics, including predictive analytics, AI, and machine learning, are transforming billing and coding processes by enhancing accuracy and efficiency, thereby mitigating audit risks. These technologies analyze vast amounts of data to predict potential audit triggers, automate coding, and reduce human - [Patenting Power Plays For AI Drug Discovery](https://texashealthlaw.com/patenting-power-plays-for-ai-drug-discovery/) - Summary of article from Foley & Lardner LLP, by Nikhil T. Pradhan: The analysis of patent portfolios for nine AI drug discovery companies reveals a predominant focus on conventional pharmaceutical technologies over AI/machine learning (ML) innovations, though AI/ML filings are increasing. Companies' patent strategies generally align with their commercial targets, though AI/ML patents often lack - [AI and Digital Governance: Exploring Platform Liability](https://texashealthlaw.com/ai-and-digital-governance-exploring-platform-liability/) - Summary of article from IAPP, by Uzma Chaudhry: The modern internet, integrating AI, IoT, and advanced cybersecurity, is a rapidly evolving ecosystem with significant societal impact, accessible to 5.35 billion people globally. This digital landscape has increased the influence of intermediaries like search engines and social media, raising concerns about privacy, misinformation, and intermediary liability - [Wave of the Future: Are AI and Data Mining the Next Generation of “Professional Whistleblowers”?](https://texashealthlaw.com/wave-of-the-future-are-ai-and-data-mining-the-next-generation-of-professional-whistleblowers/) - Summary of article from Arnall Golden Gregory LLP, by Kara Gordon Silverman: The integration of AI and data mining in False Claims Act (FCA) litigation presents both opportunities and challenges, enabling whistleblowers to analyze vast datasets and detect potential fraud without insider knowledge. However, these technologies must navigate legal hurdles such as the public disclosure bar - [Texas Medical Center Wrestles With Promise, Perils of AI](https://texashealthlaw.com/texas-medical-center-wrestles-with-promise-perils-of-ai/) - Summary of article from Houston Chronicle, by Jim Magill: The Texas Medical Center is increasingly integrating AI into healthcare, recognizing both its potential and risks. Key concerns include maintaining patient confidentiality and trust, with institutions like Methodist Hospital developing protocols to disclose AI's role in patient interactions. Researchers at UTHealth Houston are creating AI models - [Post-Chevron Health Care Regulations: The Dawn of a New Day](https://texashealthlaw.com/post-chevron-health-care-regulations-the-dawn-of-a-new-day/) - Summary of article from ArentFox Schiff, by Douglas a. Grimm, Lowell C. Brown, David S. Greenberg, Pascal Naples: The Supreme Court's decision in Loper Bright Enterprises v. Raimondo overturns the Chevron deference, requiring courts to independently interpret ambiguous statutory provisions rather than deferring to federal agencies. This shift, particularly impacting the health care industry, reinstates - [An Introduction to Healthcare AI Innovation in an Evolving Regulatory Landscape](https://texashealthlaw.com/an-introduction-to-healthcare-ai-innovation-in-an-evolving-regulatory-landscape/) - Summary of article from Benesch, by Arielle Lester, Vince Nardone, Amanda Ray, Kathrin Zaki: The expansion of AI applications in healthcare is revolutionizing the industry, enhancing clinical diagnostics, enabling personalized medicine, and addressing workforce shortages. By 2028, the Healthcare AI market is projected to reach $102.7 billion USD. Despite its futuristic perception, AI has historical roots dating - [The Limits of AI in Healthcare: Exploring Ethical and Practical Challenges](https://texashealthlaw.com/the-limits-of-ai-in-healthcare-exploring-ethical-and-practical-challenges/) - Summary of article from Nelson Hardiman, LLP, by Harry Nelson: The integration of AI in healthcare, exemplified by companies like RealtimeMed and initiatives such as Eureka Health's AI doctor, raises significant ethical and practical challenges. Physicians must navigate their responsibilities when AI influences differential diagnoses and consider the risks associated with AI-induced errors. The shift - [False Claims Act Settlements to Know from Q2 2024](https://texashealthlaw.com/false-claims-act-settlements-to-know-from-q2-2024/) - Summary of article from Bass, Berry & Sims PLC, by Latazia Carter, Scott Gallisdorfer: In Q2 2024, the Department of Justice announced significant False Claims Act settlements, highlighting ongoing enforcement in areas such as unlawful kickbacks, improper billing, and subcontracting violations. Notable settlements included a $27.9 million agreement with a laboratory owner for fraudulent cancer genomic - [OCR Settles Alleged HIPAA Violations for $950,000 Following 2017 Ransomware Attack](https://texashealthlaw.com/ocr-settles-alleged-hipaa-violations-for-950000-following-2017-ransomware-attack/) - Summary of article from King & Spalding, by Elizabeth Kimball Key: On July 1, 2024, the HHS Office of Civil Rights (OCR) announced that Heritage Valley Health System agreed to pay $950,000 to settle alleged HIPAA violations following a 2017 ransomware attack. The settlement includes a corrective action plan (CAP) to address compliance gaps, marking the - [CMS’ First No Surprises Audit Targets Aetna, Finds Some Noncompliance](https://texashealthlaw.com/cms-first-no-surprises-audit-targets-aetna-finds-some-noncompliance/) - Summary of article from Healthcare Dive, by Rebecca Pifer: The CMS' first audit under the No Surprises Act found Aetna in Texas noncompliant with several key requirements, particularly in its calculation of qualifying payment amounts (QPAs) for air ambulance services. Aetna used incorrect methodologies, leading to both overestimations and underestimations of QPAs, and failed to - [Addressing Patient Transportation Needs](https://texashealthlaw.com/addressing-patient-transportation-needs/) - Summary of article from Dentons, by Susan Freed: A significant barrier to accessing healthcare services is the lack of transportation, with one in five patients forgoing needed care due to this issue, particularly in rural areas lacking public transport and ride-share options. Hospitals are increasingly offering free transportation to ensure patients, especially the most vulnerable, - [OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug](https://texashealthlaw.com/oig-issues-favorable-advisory-opinion-involving-financial-risk-mitigation-arrangements-for-high-cost-rare-disease-drug/) - Summary of article from Arnall Golden Gregory LLP, by David Blank: On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 24-04, favorably evaluating a refund and discount program for a high-cost regenerative therapy for a rare pediatric immunodeficiency disorder. The program, initiated by an - [FTC to Sue Drug Middlemen Over Insulin Prices, Source Says](https://texashealthlaw.com/ftc-to-sue-drug-middlemen-over-insulin-prices-source-says/) - Summary of article from Reuters, by Jody Godoy, Mariam E Sunny: The U.S. Federal Trade Commission (FTC) plans to sue UnitedHealth, Cigna, and CVS Health over their roles as pharmacy benefit managers (PBMs) in negotiating drug prices, including insulin, due to concerns about rebates and pricing practices. CVS has vowed to defend itself, while UnitedHealth - [Fourth Circuit Broadens TCPA’s Reach Over ‘Unsolicited Advertisements’](https://texashealthlaw.com/fourth-circuit-broadens-tcpas-reach-over-unsolicited-advertisements/) - Summary of article from Faegre Drinker Biddle & Reath LLP, by Bridgette Lehman, William Wright: The Fourth Circuit Court of Appeals has broadened the interpretation of "unsolicited advertisements" under the TCPA in the case of Family Health Physical Medicine, LLC v. Pulse8, LLC. The court reversed a lower court's dismissal, ruling that a fax inviting - [FTC Rule Addressing Noncompete Covenants: Impact of Senior Executive Exception on Health Care Entities](https://texashealthlaw.com/ftc-rule-addressing-noncompete-covenants-impact-of-senior-executive-exception-on-health-care-entities/) - Summary of article from ArentFox Schiff, by Douglas a. Grimm, Moyosore O. Koya: The new Rule, effective September 4, introduces potential confusion and regulatory risks for health care providers, especially concerning noncompete covenants for senior executives. Defined as individuals earning at least $151,164 annually and holding policy-making positions, the implementation of this Rule is complicated - [Chevron’s End Means Uncertainty and Opportunity for the Healthcare Industry](https://texashealthlaw.com/chevrons-end-means-uncertainty-and-opportunity-for-the-healthcare-industry/) - Summary of article from Schwabe, Williamson & Wyatt PC, by Gary Bruce, Jon French: The U.S. Supreme Court's decision in Loper Bright Enterprises v. Raimondo, which overruled the Chevron Doctrine, will significantly affect the healthcare industry by allowing courts to independently interpret statutory ambiguities rather than deferring to administrative agencies. This shift is expected to increase - [Chevron Runs Out of Gas: The Bumpy Road Ahead for Health Regulations After Loper Bright](https://texashealthlaw.com/chevron-runs-out-of-gas-the-bumpy-road-ahead-for-health-regulations-after-loper-bright/) - Summary of article from Akin Gump Strauss Hauer & Feld LLP, by Anna Abram, Sudhana Bajracharya, Jenna Becker, Craig Bleifer, Nathan Brown, Kelly Cleary: The Supreme Court's decision in Loper Bright Enterprises v. Raimondo overturns the Chevron doctrine, which previously allowed federal agencies to interpret ambiguous statutes with judicial deference. This change raises the bar for agencies like CMS and - [‘Data Is the Differentiator’: How an Integrated Data Strategy Supports Healthcare AI Success](https://texashealthlaw.com/data-is-the-differentiator-how-an-integrated-data-strategy-supports-healthcare-ai-success/) - Summary of article from HealthTech Magazine, by Jordan Scott: At the AWS Summit in Washington, D.C., Dr. Naqi Khan emphasized the critical role of high-quality data in the successful implementation of generative AI in healthcare. He highlighted that while healthcare generates vast amounts of data, much of it remains unstructured and unused. A robust integrated - [Healthcare Groups Say Cyber Rule Should Explicitly Name Insurers, Vendors](https://texashealthlaw.com/healthcare-groups-say-cyber-rule-should-explicitly-name-insurers-vendors/) - Summary of article from Healthcare Dive, by Emily Olsen: Healthcare and hospital groups are urging the Cybersecurity and Infrastructure Security Agency (CISA) to explicitly include insurers and third-party vendors in its proposed cybersecurity reporting rule, citing the interconnected nature of the healthcare sector and the potential widespread impact of cyber incidents. The rule, which mandates - [Perspectives of Oncologists on the Ethical Implications of Using Artificial Intelligence for Cancer Care](https://texashealthlaw.com/perspectives-of-oncologists-on-the-ethical-implications-of-using-artificial-intelligence-for-cancer-care/) - A survey conducted by Harvard Medical School, published in JAMA Network Open, reveals that oncologists agree AI tools must be explainable, patients must consent to AI use, and oncologists must protect patients from AI biases. Despite this, many oncologists lack confidence in recognizing AI biases, highlighting a need for structured AI education and ethical guidelines. - [Fifth Circuit Grants Motion Relating to New CMA Compensation Rule](https://texashealthlaw.com/fifth-circuit-grants-motion-relating-to-new-cma-compensation-rule/) - Summary of article from Troutman Amin, LLP, by John H. Henson: On July 3, 2024, the US District Court of Northern Texas issued a Memorandum Opinion and Order in the combined cases challenging new CMS rules regarding compensation for Medicare Advantage and Part D plans. The court found the compensation changes to be arbitrary and - [Whether “Willful” Under the Anti-Kickback Statute Requires Knowledge that the Conduct is Unlawful](https://texashealthlaw.com/whether-willful-under-the-anti-kickback-statute-requires-knowledge-that-the-conduct-is-unlawful/) - Summary of article from Mintz, by Laurence J. Freedman, Laura E. Martin: The Supreme Court has the opportunity to clarify the definition of “willfulness” under the Anti-Kickback Statute (AKS) in a case involving McKesson Corporation. The Second Circuit upheld the dismissal of a False Claims Act (FCA) case, ruling that “willfulness” under the AKS requires - [How the Chevron Doctrine’s Overturn Could Effect Public Health, FDA](https://texashealthlaw.com/how-the-chevron-doctrines-overturn-could-effect-public-health-fda/) - Summary of article from The Washington Post, by David Ovalle, Joel Achenbach, Rachel Roubein: Recent Supreme Court decisions have significantly curtailed the power of federal health-care agencies, leading to potential challenges in regulating drugs, tobacco products, and medical technologies. The court's ruling in Loper Bright Enterprises v. Raimondo overturned the Chevron doctrine, which had required - [Judge Temporarily Blocks Biden Administration's Restoration of Transgender Health Protections](https://texashealthlaw.com/judge-temporarily-blocks-biden-administrations-restoration-of-transgender-health-protections/) - Summary of article from AP News, by Devna Bose: A federal district court judge has temporarily blocked parts of a Biden administration rule that would prevent insurers and medical professionals from denying hormone therapy and gender transition surgeries for transgender individuals. Judge Louis Guirola Jr. ruled in favor of 15 states, arguing that the 1972 - [FTC Seeks to Secure First Disgorgement in Nearly a Decade](https://texashealthlaw.com/ftc-seeks-to-secure-first-disgorgement-in-nearly-a-decade/) - Summary of article by Womble Bond Dickinson (US) LLP: The FTC announced that Cardinal Health, Inc. has agreed to pay $26.8 million to settle allegations of anticompetitive behavior, marking the agency's first disgorgement in a competition case in nearly a decade. The Complaint, filed in the Southern District of New York, accuses Cardinal of monopolizing - [Healthcare Execs Face Federal Drug Charges in Landmark Telehealth Case](https://texashealthlaw.com/healthcare-execs-face-federal-drug-charges-in-landmark-telehealth-case/) - Summary of article from Bradley Arant Boult Cummings LLP, by Jonathan Ferry, Stephen Moulton, Virginia Wright: Federal prosecutors have charged two healthcare executives of Done Global Inc. and Done Health P.C., with unlawfully distributing controlled substances like Adderall via a telehealth platform. This unprecedented case highlights the Department of Justice's focus on enforcing controlled substances laws within - [Texas Retina Associates Cyberattack Affects 312,000 Patients](https://texashealthlaw.com/texas-retina-associates-cyberattack-affects-312000-patients/) - Summary of article from The HIPAA Journal, by Steve Adler: A cyberattack on Texas Retina Associates, the largest ophthalmology practice in Texas, has compromised the sensitive data of 312,867 patients. The breach, which occurred from October 8, 2023, to March 27, 2024, exposed personal information including names, addresses, Social Security numbers, and medical details. Texas - [Report Reviews Updates on Health Cybersecurity and Ransomware](https://texashealthlaw.com/report-reviews-updates-on-health-cybersecurity-and-ransomware/) - Summary of article from Robinson & Cole LLP, by Linn F. Freedman: The Health Sector Cybersecurity Coordination Center (HC3) has recently issued two critical alerts for the healthcare sector. The first alert, dated June 18, 2024, concerns Qilin (also known as Agenda Ransomware), a ransomware-as-a-service (RaaS) that targets healthcare organizations through spear phishing and other - [Why Are Primary Care Physicians Optimistic About AI?](https://texashealthlaw.com/why-are-primary-care-physicians-optimistic-about-ai/) - Summary of article from MedCity News, by Katie Adams: Primary care physicians are optimistic about AI's potential to enhance care delivery efficiency, particularly through automated dictation and scribing tools, which have significantly reduced administrative burdens. A survey by Elation Health revealed that nearly 70% of primary care clinicians believe AI will be crucial for future - [Biden Administration Tells Doctors They Must Provide Emergency Abortions](https://texashealthlaw.com/biden-administration-tells-doctors-they-must-provide-emergency-abortions/) - Summary of article from AP News, by Amanda Seitz, Christine Fernando: In response to a recent Supreme Court ruling, the Biden administration has directed emergency room doctors to perform emergency abortions when necessary to save a pregnant woman's health, emphasizing compliance with the Emergency Medical Treatment and Active Labor Act (EMTALA). This follows the Supreme - [How AI Could Help Triage Emergency Department Care](https://texashealthlaw.com/how-ai-could-help-triage-emergency-department-care/) - Summary of article from Association of Health Care Journalists, by Karen Blum: Two recent studies highlight the potential of GPT-4, an AI model by OpenAI, to assist in emergency department triage and hospital admission predictions. Researchers at UCSF found that GPT-4 could identify patients with more severe conditions with 89% accuracy, slightly outperforming physicians. A - [5 Tips to Implement Artificial Intelligence in Health Care Organizations Successfully](https://texashealthlaw.com/5-tips-to-implement-artificial-intelligence-in-health-care-organizations-successfully/) - Summary of article from Medical Economics, by Ronen Lavi: The successful implementation of AI in healthcare organizations requires clear objectives, tailored technology, seamless integration with existing systems, effective clinician engagement, and robust analytics. Organizations should define specific, measurable goals to guide AI adoption and select healthcare-specific AI solutions that align with these objectives. Smooth integration - [HIPAA Unique Identifiers Explained](https://texashealthlaw.com/hipaa-unique-identifiers-explained/) - Summary of article from The HIPAA Journal, by Steve Adler: HIPAA mandates unique identifiers for employers, health plans, and healthcare providers to enhance transaction efficiency and reduce administrative costs, though no standards for individual identifiers were adopted due to cost and complexity. Employer identifiers use IRS-issued EINs, while health plan identifiers, initially introduced in 2012, - [Ramping Up: Antitrust Enforcement in Health Care](https://texashealthlaw.com/ramping-up-antitrust-enforcement-in-health-care/) - Summary of article from Dickinson Wright, by Patrick Masterson, Pahl Zinn: In early 2024, the Biden administration intensified antitrust enforcement, particularly targeting the healthcare sector. December 2023 saw the release of new Merger Guidelines by the FTC and DOJ, lowering thresholds for anti-competitive assessments and focusing on healthcare mergers. February 2024 marked a joint inquiry - [Information Blocking: Disincentives Established for Health Care Providers](https://texashealthlaw.com/information-blocking-disincentives-established-for-health-care-providers/) - Summary of article from Baker Donelson, by Julie Kilgore: The Disincentives Final Rule, established under the Cures Act, aims to deter information blocking among Medicare-enrolled health care providers by implementing specific penalties. These penalties include disqualifying providers from being recognized as meaningful EHR users, impacting their financial incentives under Medicare programs, and potentially excluding them - [ChatGPT Gives Better Answers to Health-Related Questions Than Human Physicians, Study Finds](https://texashealthlaw.com/chatgpt-gives-better-answers-to-health-related-questions-than-human-physicians-study-finds/) - Summary of article from PsyPost, by Vladimir Hedrih: A study published in JAMA Internal Medicine found that ChatGPT provided superior responses to health-related questions compared to human physicians in 79% of cases. Licensed healthcare professionals evaluated responses from both ChatGPT and physicians on Reddit’s r/AskDocs forum, rating ChatGPT's answers higher in quality and empathy. Despite - [5 Best Practices for Achieving Healthcare Cloud Compliance](https://texashealthlaw.com/5-best-practices-for-achieving-healthcare-cloud-compliance/) - Summary of article from Pro IT Today, by Christopher Tozzi: Healthcare organizations can ensure cloud compliance by adopting several key practices. Implementing a zero trust security strategy is essential to protect sensitive data by granting access only when necessary. Educating cloud engineers about specific compliance requirements and using cloud data loss prevention (DLP) tools to - [The Wearable Revolution: How to Use Personal Health Device Data in Litigation](https://texashealthlaw.com/the-wearable-revolution-how-to-use-personal-health-device-data-in-litigation/) - Summary of article from Butler Snow LLP, by Katelyn Ashton, Susanna Moldoveanu: Wearable technology can play an important role in civil litigation due to its ability to collect extensive health and activity data, such as heart rate, sleep patterns, and physical activity. This data can provide critical evidence in personal injury and product liability cases, helping - [CMS Releases Proposed Rule on Anomalous DME Spending and MSSP Financial Calculations](https://texashealthlaw.com/cms-releases-proposed-rule-on-anomalous-dme-spending-and-mssp-financial-calculations/) - Summary of article from American Hospital Association: The Centers for Medicare & Medicaid Services (CMS) released a proposed rule to address significant, anomalous, and highly suspect (SAHS) billing activity affecting the Medicare Shared Savings Program (MSSP) financial calculations for 2023. CMS proposes excluding payment amounts for certain intermittent urinary catheter codes from expenditure and revenue - [Texas Supreme Court Upholds Ban on Youth Gender Transitions. It's the Largest State With Such a Law](https://texashealthlaw.com/texas-supreme-court-upholds-ban-on-youth-gender-transitions-its-the-largest-state-with-such-a-law/) - Summary of article from AP News, by Jim Vertuno, Andrew Demillo: The Texas Supreme Court upheld a state law banning gender-affirming medical care for transgender minors, rejecting parental pleas that it violates their rights to seek care for their children. The 8-1 ruling maintains the law, effective since September 2023, making Texas the largest state - [Why Nurses Are Protesting AI](https://texashealthlaw.com/why-nurses-are-protesting-ai/) - Summary of article from Healthcare Brew, by Tom McKay: The National Nurses United (NNU) is protesting the increasing use of AI in healthcare, arguing it devalues nursing skills and exacerbates understaffing issues. They claim that AI-driven continuous data collection cannot replace the expertise and physical presence of nurses, often leading to inefficiencies and potentially harmful - [Blockchain-Based Healthcare Credentialing: A Solution to High Costs and Administrative Burdens](https://texashealthlaw.com/blockchain-based-healthcare-credentialing-a-solution-to-high-costs-and-administrative-burdens/) - Summary of article from Cureus, by Ebenezer Chinedu-Eneh, Priya Ramaswamy, Patrick E. Farmer: The healthcare sector faces significant inefficiencies in its credentialing system, leading to staff shortages, delayed patient care, and financial waste. The COVID-19 pandemic highlighted these issues, prompting temporary suspensions of credentialing processes. Blockchain technology offers a promising solution by automating and securing - [Eight Charged Locally as Part of National Health Care Fraud Enforcement Action](https://texashealthlaw.com/eight-charged-locally-as-part-of-national-health-care-fraud-enforcement-action/) - Press Release from United States Department of Justice, Southern District of Texas: On June 27, 2024, the U.S. Attorney's Office for the Southern District of Texas announced charges against eight individuals as part of the Justice Department’s 2024 National Health Care Fraud Enforcement Action. These charges involve various schemes, including fraudulent Medicare billing, kickbacks, and - [Federal District Court Finds Private-Insurer Relator Can Proceed with False Claims Action](https://texashealthlaw.com/federal-district-court-finds-private-insurer-relator-can-proceed-with-false-claims-action/) - Summary of article from The FCA Insider, by Michael Podberesky, Brett Barnett, Stephen Tagert: The U.S. District Court for the District of New Jersey allowed Allstate Insurance Company to proceed with its whistleblower action against Phoenix Toxicology and Lab Services, LLC, alleging the submission of false claims for unnecessary urine drug tests to federal programs. - [Six Months to Go: HIPAA Privacy Rule Changes Require Additional Diligence](https://texashealthlaw.com/six-months-to-go-hipaa-privacy-rule-changes-require-additional-diligence/) - Summary of article from Taft Privacy & Data Security Insights, by Scot Ganow: The Department of Health and Human Services (HHS) has issued final regulations modifying the HIPAA Privacy Rule to protect individuals' reproductive health information, effective June 25, 2024, with compliance required by December 23, 2024. These changes prohibit HIPAA-regulated entities from disclosing protected - [Healthcare Scores a B for Cybersecurity](https://texashealthlaw.com/healthcare-scores-a-b-for-cybersecurity/) - Summary of article from The HIPAA Journal, by Steve Adler: SecurityScorecard awarded the U.S. healthcare industry a B+ cybersecurity rating for the first half of 2024, despite significant breaches, including a major ransomware attack on Change Healthcare. The study assessed the top 500 publicly traded healthcare companies, revealing a mean security score of 88. Medical - [Cyber Attacks on Health Care Up 136% Last Year](https://texashealthlaw.com/cyber-attacks-on-health-care-up-136-last-year/) - Summary of article from Medical Economics, by Grace Koennecke: In 2023, the US experienced a significant rise in data breaches, with 3,205 incidents reported, marking a 78% increase from 2022. The healthcare industry saw a 136% increase in data breaches, affecting 56 million individuals, while the financial services sector experienced a 177% rise, impacting 61 - ["Wheels Fall Off" FTC's Latest Hospital Merger Challenge](https://texashealthlaw.com/wheels-fall-off-ftcs-latest-hospital-merger-challenge/) - Summary of article from Holland & Knight LLP, by Bill Katz, David Kully, Krithika Rajkumar: The Judge in FTC v. Community Health Systems Inc. & Novant Health Inc., denied the FTC's motion to block Novant Health's $320 million acquisition of two hospitals, marking a rare loss for the FTC in hospital merger challenges. The ruling revitalized the - [For All Intents and Purposes the Ninth Circuit Shakes Up Antitrust Law With Sidibe v. Sutter Decision](https://texashealthlaw.com/for-all-intents-and-purposes-the-ninth-circuit-shakes-up-antitrust-law-with-sidibe-v-sutter-decision/) - Summary of article from Proskauer Rose LLP, by David Munkittrick, Evelyn Blanco: The Ninth Circuit Court's decision in Sidibe v. Sutter Health may significantly alter the approach to rule of reason antitrust cases by emphasizing the importance of historical evidence and the intent behind challenged conduct. The court reversed the District Court's ruling due to - [Modernizing and Securing Hospital Technology Infrastructure](https://texashealthlaw.com/modernizing-and-securing-hospital-technology-infrastructure/) - Summary of article from MedCity News, by Derek Grant: The healthcare industry is undergoing a significant digital transformation, necessitating the modernization of technology infrastructure to improve patient outcomes and operational efficiency. Budget constraints and the complexity of integrating diverse systems across merged hospital networks pose significant challenges. Prioritizing security is critical, with a comprehensive strategy - [How Artificial Intelligence Is Changing Diabetes Care](https://texashealthlaw.com/how-artificial-intelligence-is-changing-diabetes-care/) - Summary of article from DiaTribe, by Michael Howerton: Experts at the ADA 2024 Scientific Sessions highlighted AI's potential to revolutionize clinical practice through applications like automated insulin delivery and AI-augmented clinical trials. While the benefits are substantial, concerns about data security and privacy must be addressed to ensure wider adoption. AI's integration into diabetes care - [Healthcare Chatbots: When Do They Help and When Do They Hurt?](https://texashealthlaw.com/healthcare-chatbots-when-do-they-help-and-when-do-they-hurt/) - Summary of article from Built In, by Alexandra Whitt: Healthcare chatbots offer significant benefits, including improved user engagement, quick responsiveness to minor health queries, reduced administrative workload, enhanced customer satisfaction, and better advocacy for health and wellness programs. They streamline processes such as appointment scheduling and insurance claims, providing 24/7 access to critical information. However, - [Three Key Areas Where Healthcare IT Leaders Can Deploy AI to Improve Patient Outcomes](https://texashealthlaw.com/three-key-areas-where-healthcare-it-leaders-can-deploy-ai-to-improve-patient-outcomes/) - Summary of article from CIO, by John Cox: Healthcare IT leaders can deploy AI to improve patient outcomes in three key areas: fully utilizing patient-related data, personalizing the patient experience, and easing administrative burdens on healthcare professionals. By consolidating patient data with tools like Microsoft Azure, AI can create a standardized data source, enhancing data - [Court Strikes Down HHS “Guidance” Regarding Online Tracking Technologies and HIPAA: Implications for Healthcare Providers](https://texashealthlaw.com/court-strikes-down-hhs-guidance-regarding-online-tracking-technologies-and-hipaa-implications-for-healthcare-providers/) - Summary of article from Health Law Attorney Blog: In a recent decision, the United States District Court for the Northern District of Texas partially granted summary judgment to the plaintiffs, striking down the HHS rule that expanded the definition of "Individually Identifiable Health Information" (IIHI) to include the combination of an individual's IP address and - [How Generative AI Is Shaping Drug Discovery](https://texashealthlaw.com/how-generative-ai-is-shaping-drug-discovery/) - Summary of article from Healthcare Brew, by Mikaela Cohen: Generative AI is revolutionizing drug discovery by significantly reducing the time and cost involved in developing new medicines, a process traditionally taking around a decade and $2.7 billion. Researchers are leveraging AI to identify new drug targets, design molecular structures, and expedite clinical trials, with AI-generated - [Texas Judge Upholds Hospitals’ Right to Use Online Tracking Technology](https://texashealthlaw.com/texas-judge-upholds-hospitals-right-to-use-online-tracking-technology/) - Summary of article from The Record, by Suzanne Smalley: A Texas federal judge ruled that the Biden administration's policy to limit hospitals' use of online tracking technology overstepped its authority. The policy, issued by the HHS in 2022, aimed to protect user privacy by warning that third-party data collection could violate HIPAA. Despite the HHS's - [PHI Compromised in Cyberattacks on South Texas Oncology and Hematology & Highland Health Systems](https://texashealthlaw.com/phi-compromised-in-cyberattacks-on-south-texas-oncology-and-hematology-highland-health-systems/) - Summary of article from The HIPAA Journal, by Steve Adler: South Texas Oncology and Hematology (STOH) in San Antonio, TX, and Highland Health Systems in Anniston, AL, have experienced significant cyberattacks, compromising the personal and protected health information of their patients and employees. STOH's breach, detected in February 2024, affected 176,303 individuals, exposing names and - [Texas Medical Center Institutions Agree to Pay $15M Record Settlement Involving Concurrent Billing Claims for Critical Surgeries](https://texashealthlaw.com/texas-medical-center-institutions-agree-to-pay-15m-record-settlement-involving-concurrent-billing-claims-for-critical-surgeries/) - Summary of article from U.S. Attorney's Office, Southern District of Texas: Baylor St. Luke’s Medical Center, Baylor College of Medicine, and Surgical Associates of Texas have agreed to a $15 million settlement to resolve allegations of improper concurrent billing for heart surgeries, violating Medicare regulations and informed consent rules. The investigation, initiated by a whistleblower - [Feds Announce Final Penalties for Information Blocking. Hospitals and Medical Groups Aren’t Happy](https://texashealthlaw.com/feds-announce-final-penalties-for-information-blocking-hospitals-and-medical-groups-arent-happy/) - Summary of article from Chief Healthcare Executive, by Ron Southwick: The U.S. Department of Health & Human Services has finalized rules to prevent information blocking, imposing significant financial penalties on hospitals, clinicians, and medical groups that fail to share health information freely. Hospitals could face reductions in federal aid and substantial financial disincentives, while clinicians - [Texas Medical Board Adopts Abortion Guidance](https://texashealthlaw.com/texas-medical-board-adopts-abortion-guidance/) - Summary of article from The Texas Tribune, by Eleanor Klibanoff: The Texas Medical Board has adopted new guidelines for interpreting the state's abortion laws, aimed at clarifying the conditions under which doctors can perform abortions without risking their medical licenses. The guidance reduces some documentation requirements but stops short of providing a comprehensive list of - [The Role of Nursing Education in Ensuring HIPAA Compliance](https://texashealthlaw.com/the-role-of-nursing-education-in-ensuring-hipaa-compliance/) - Summary of article from The HIPAA Journal, by Dr. Randolf F. R. Rasch: The escalating issue of HIPAA violations by nurses poses significant legal and financial risks for healthcare institutions. Despite mandatory annual training, many nurses are inadequately prepared for compliance due to gaps in both initial and ongoing education. A 2023 survey underscores these - [OCR Increases Focus on Phishing Attacks Against Healthcare Providers](https://texashealthlaw.com/ocr-increases-focus-on-phishing-attacks-against-healthcare-providers/) - Summary of article from Morgan Lewis, by Amy M. Magnano, Michael J. Madderra: In response to a significant rise in phishing attacks, the US Department of Health and Human Services' Office for Civil Rights (OCR) is emphasizing the importance of regular risk assessments and best practices to protect sensitive data. The OCR's first phishing cyberattack - [Hacking the Hippocratic Oath: Four Ways to Shield Patients from Ransomware Attacks](https://texashealthlaw.com/hacking-the-hippocratic-oath-four-ways-to-shield-patients-from-ransomware-attacks/) - Summary of article from MedCity News, by Mohammad Wagas: The healthcare industry is under increasing threat from cyberattacks, highlighting an immediate need for stronger security measures. To address this, four key strategies are recommended: enhancing analysis of security risks, fostering a cybersecurity culture among all staff, segmenting networks to limit potential damage, and ensuring robust - [Will Regulatory Scrutiny Impact Private Equity Investment in Healthcare?](https://texashealthlaw.com/will-regulatory-scrutiny-impact-private-equity-investment-in-healthcare/) - Summary of article from Ankura, by Anthony Metke, Robert Mundy: Private equity (PE) investment in healthcare has grown substantially in the past decade due to the sector's fragmentation, potential for scale, and attractive returns. However, this trend has raised concerns about the implications for patient care, costs, and industry structure. The Federal Trade Commission (FTC) and - [Healthcare Cybersecurity: Preventing Data Breaches](https://texashealthlaw.com/healthcare-cybersecurity-preventing-data-breaches/) - Summary of article from Security Boulevard, by Rom Carmel: The healthcare sector is facing an escalating threat from cyberattacks, with an unprecedented 725 large data breaches reported in 2023. The primary causes are system vulnerabilities, human errors, and a surge in sophisticated cyberattacks. The consequences of these breaches are manifold, including major financial burdens, significant - [Understanding Barriers to Cyber Resilience in Healthcare](https://texashealthlaw.com/understanding-barriers-to-cyber-resilience-in-healthcare/) - Summary of article from HealthIT Security, by Jill McKeon: Cyber resilience in healthcare, which enables swift response and recovery from cybersecurity incidents, faces several barriers including a lack of understanding of the concept, misalignment between cybersecurity and business, and the complexity of IT systems. Research by LevelBlue reveals that 76% of healthcare organizations view cyber - [Streamlining Hospital Operations, Optimizing Resource Allocation, and Improving Efficiency with AI Predictive Analytics and Machine Learning Algorithms](https://texashealthlaw.com/streamlining-hospital-operations-optimizing-resource-allocation-and-improving-efficiency-with-ai-predictive-analytics-and-machine-learning-algorithms/) - Summary of article from Healthcare IT Today, by Grayson Miller: AI-driven predictive analytics and machine learning algorithms are revolutionizing healthcare by streamlining hospital operations, optimizing resource allocation, and enhancing system efficiency. They help predict patient admission rates, manage bed occupancy, forecast staffing needs, and predict the demand for medical supplies with remarkable accuracy. AI technologies - [Hospitals and AI: Legal Questions, Liability and Consent](https://texashealthlaw.com/hospitals-and-ai-legal-questions-liability-and-consent/) - Summary of article from Chief Healthcare Executive, by Ron Southwick: The use of artificial intelligence (AI) in healthcare is raising complex legal issues, including the standard of care, liability, and patient consent. As AI becomes more prevalent in patient care, the standard of care could evolve, potentially leading to a "reasonable machine standard of care". - [Texas Company Connected to Alleged Scheme That Billed Medicare $3 Billion for Urinary Catheters](https://texashealthlaw.com/texas-company-connected-to-alleged-scheme-that-billed-medicare-3-billion-for-urinary-catheters/) - Summary of article from CBS Texas, by Brian New: A Texas-based company, Konaniah Medical Supplies, is implicated in a suspected Medicare fraud scheme involving billing for urinary catheters that beneficiaries never ordered or received. The company, along with its associated entity G&I Ortho Supply in New York and eight other medical supply companies, collectively billed - [Stark Law-Based FCA Lawsuits Multiply: Relators Targeting Physician Compensation](https://texashealthlaw.com/stark-law-based-fca-lawsuits-multiply-relators-targeting-physician-compensation/) - Summary of article from Davis Wright Tremaine, by Robert G. Homchick, Adam D. Romney, Gavin Keene: Several health systems, including Community Health Network Inc., University of Pittsburgh Medical Center, Erlanger Health System, and Steward Health Care System, have recently faced Stark Law-based False Claims Act (FCA) lawsuits. These lawsuits primarily focus on allegations of above - [How This Southlake Physician Ended Up Serving Federal Time](https://texashealthlaw.com/how-this-southlake-physician-ended-up-serving-federal-time/) - Summary of article from D Magazine, by Will Maddox: Dr. Rodney Sosa, a Southlake physician, was convicted of defrauding the United States government and sentenced to 46 months in federal custody. The conviction was related to a telemedicine scheme involving unnecessary medical equipment and testing, for which he submitted $1.4 million worth of claims. His - [What’s it to You? Justice Scalia’s 41-Year-Old Gatekeeping Question on “Standing” Influences Court to Uphold FDA’s Regulation of Mifepristone](https://texashealthlaw.com/whats-it-to-you-justice-scalias-41-year-old-gatekeeping-question-on-standing-influences-court-to-uphold-fdas-regulation-of-mifepristone/) - Summary of article from Akerman LLP, by Noam Fischman, Danielle Gordet: On June 13, 2024, the Supreme Court unanimously ruled that doctors and medical associations did not have standing to challenge the FDA's approvals of mifepristone, a drug used for terminating pregnancies. The court found that the plaintiffs' objections to abortion and the FDA's regulation of - [Texas Supreme Court Declines Opportunity to Hear Personhood Case](https://texashealthlaw.com/texas-supreme-court-declines-opportunity-to-hear-personhood-case/) - Summary of article from Epstein Becker Green, by Erin Sutton: The Texas Supreme Court has declined to review the case Antoun v. Antoun, which sought to establish whether frozen embryos are considered persons or property under Texas law. The case arose after a divorce trial awarded the couple's frozen embryos to the husband, based on - [Fort Worth Physicians Assistant Sentenced in Medicare Fraud Case](https://texashealthlaw.com/fort-worth-physicians-assistant-sentenced-in-medicare-fraud-case/) - Summary of article from WFAA, by Ben Sawyers: North Texas physician's assistant, Ray Anthony Shoulders, was sentenced to seven years in federal prison on counts of healthcare fraud, after submitting $788,000 in fraudulent medical claims and receiving over $614,000 in Medicare reimbursements. Shoulders was found to be injecting patients with amniotic fluid, a non-FDA approved - [Justice Department Unseals Documents in Texas Children's HIPAA Violation Case](https://texashealthlaw.com/justice-department-unseals-documents-in-texas-childrens-hipaa-violation-case/) - Summary of article from Becker’s Hospital Review, by Naomi Diaz: The U.S. Justice Department unsealed documents concerning Dr. Eithan Haim, who is accused of violating the Health Insurance Portability and Accountability Act (HIPAA) by illegally accessing and leaking internal documents from Texas Children's Hospital. The documents pertained to gender-affirming services and included patients' personal health - [Credentialing Is Burdening Small Hospitals—and Underserved Communities Pay the Price](https://texashealthlaw.com/credentialing-is-burdening-small-hospitals-and-underserved-communities-pay-the-price/) - Summary of article from HealthExec, by Chad Van Alstin: The credentialing process in healthcare, which verifies a provider's education, training, licenses, and professional experience, is a time-consuming manual task, especially burdensome for small hospitals and independent practices. The lack of a centralized data repository and varying state regulations complicate the process, with no current way - [Importance of Negotiating Holdover Provisions in Health Care Leases](https://texashealthlaw.com/importance-of-negotiating-holdover-provisions-in-health-care-leases/) - Summary of article from Epstein Becker & Green, by Zlata Fayer, Allison Zangrilli: Negotiating holdover provisions, clauses that account for situations when a tenant remains in the property after lease expiration, is crucial in health care leases. Tenants who fail to vacate on time face holdover rental rates which can be up to double the agreed - [As Federal Healthcare AI Regs Stall, States Take Matters Into Own Hands](https://texashealthlaw.com/as-federal-healthcare-ai-regs-stall-states-take-matters-into-own-hands/) - Summary of article from Medical Marketing & Media, by Lecia Bushak: States such as Colorado and California are introducing legislation to regulate the use of Artificial Intelligence (AI) in various sectors, including healthcare, in response to the lack of federal regulation. Colorado's Governor signed SB 205, the first comprehensive AI bias law in the nation, - [Can ChatGPT Be Trusted to Provide Medication Information to Patients?](https://texashealthlaw.com/can-chatgpt-be-trusted-to-provide-medication-information-to-patients/) - Summary of article from Drug Topics, by Lauren Massaro: A study published in the Journal of the American Pharmacists Association has found that while AI chatbot, ChatGPT, can provide correct answers to common medication questions, it may not always provide complete information. The study evaluated ChatGPT's responses to questions about the top 20 drugs, and - [Tips to Shorten Healthcare's Cybersecurity Learning Curve](https://texashealthlaw.com/tips-to-shorten-healthcares-cybersecurity-learning-curve/) - Summary of article from Healthcare IT News, by Andrea Fox: Healthcare organizations are struggling with cybersecurity, especially as threats become more sophisticated. Traditional endpoint detection and response systems are proving inadequate, with many able to be bypassed without triggering alerts. Healthcare organizations have unique blind spots due to reliance on basic security measures and a - [What to Learn From DOJ’s First Telehealth-Prescribed Controlled Substances Case](https://texashealthlaw.com/what-to-learn-from-dojs-first-telehealth-prescribed-controlled-substances-case/) - Summary of article from Husch Blackwell, by Jonathan Porter: On June 13, 2024, the Justice Department arrested two executives of Done Global Inc., a digital health company, marking the first criminal case against telehealth executives for allegedly causing illegal prescriptions of controlled substances. The charges include a drug dealing conspiracy, a healthcare fraud conspiracy, and - [OIG Testimony Puts a Spotlight on Clinical Documentation and Payer Risk](https://texashealthlaw.com/oig-testimony-puts-a-spotlight-on-clinical-documentation-and-payer-risk/) - Summary of article from Ankura, by Emily Petersen: In a recent testimony, the Inspector General of the Department of Health and Human Services (HHS), highlighted issues surrounding risk adjustment in Medicare Advantage (MA) and proposed stricter rules for diagnoses used in risk adjustment calculations. She underscored the issue of rising improper payments within Medicare and - [Artificial Intelligence Governance – First, Build On What You Have](https://texashealthlaw.com/artificial-intelligence-governance-first-build-on-what-you-have/) - Summary of article from Guidepost Solutions LLC, by Kenneth Mendelson: As AI technology rapidly advances, organizations must prioritize AI governance to ensure responsible and compliant use. Compliance involves adhering to global, federal, and state regulations, including new laws focused on AI use. Organizations should integrate AI considerations into their existing governance, risk-management, and compliance programs, - [The Rise of Fiduciary Health Plan Litigation](https://texashealthlaw.com/the-rise-of-fiduciary-health-plan-litigation/) - Summary of article from The Wagner Law Group, by Michael Schloss, Stephen Wilkes: In 2022, US health care spending reached $4.5 trillion, with $405 billion spent on prescription drugs and $800 billion paid through employer-sponsored health plans. A class action lawsuit, Lewandowski v. Johnson and Johnson, alleges mismanagement of the company's health plans' prescription-drug benefits, leading - [FTC Signals Its Intent To Pursue Nonprofit Health Care Entities With Its Non-compete Ban Whenever Possible](https://texashealthlaw.com/ftc-signals-its-intent-to-pursue-nonprofit-health-care-entities-with-its-non-compete-ban-whenever-possible/) - Summary of article from Seyfarth Shaw LLP, by Jesse Coleman, Yumna Khan: The Federal Trade Commission's (FTC) Final Rule banning non-competes in worker agreements may not exempt nonprofit health care entities, including most hospital systems in the US. The FTC asserts that merely claiming tax-exempt status is not enough to be beyond its jurisdiction; it will - [How Chief AI Officers Are Guiding Healthcare Companies Into The Future](https://texashealthlaw.com/how-chief-ai-officers-are-guiding-healthcare-companies-into-the-future/) - Summary of article from Forbes, by Andrei Kasyanau: Artificial intelligence (AI) is transforming healthcare, necessitating the role of a Chief AI Officer (CAIO) to guide AI strategy and implementation, foster AI innovation, ensure ethical AI use, and build AI talent and partnerships. The CAIO is pivotal in identifying high-value AI opportunities, driving AI adoption, and - [Leveraging AI In Healthcare Operations](https://texashealthlaw.com/leveraging-ai-in-healthcare-operations/) - Summary of article from Forbes, by Brian Fugere: The application of AI and machine learning in healthcare is transforming not only clinical areas but also operational and workforce management, with the global healthcare AI market projected to reach $427.5 billion by 2032. AI/ML can address pressing challenges in healthcare, such as complex workflows and administrative - [Four Ways Price Transparency Will Transform Healthcare](https://texashealthlaw.com/four-ways-price-transparency-will-transform-healthcare/) - Summary of article from D Magazine, by Dr. Eric Bricker: The lack of healthcare price transparency presents a significant challenge, particularly for insured individuals with high out-of-pocket costs. The federal government has mandated hospitals to disclose prices, but compliance remains low. Some health insurance companies are now linking out-of-pocket costs with healthcare providers' price and - [Enhancing the Humanity in Health Care With AI](https://texashealthlaw.com/enhancing-the-humanity-in-health-care-with-ai/) - Summary of podcast from Deloitte Insights: The World Health Organization predicts a shortage of 10 million healthcare workers by 2030, which could result in increased wait times, decreased health outcomes, and worker burnout. AI has the potential to alleviate these issues by automating administrative tasks, thereby freeing up clinicians' time and making healthcare more human-centric. - [Navigating the National Practitioner Data Bank: A Guide for Healthcare Professionals](https://texashealthlaw.com/navigating-the-national-practitioner-data-bank-a-guide-for-healthcare-professionals/) - Summary of article from Ward and Smith, P.A., by Amy G. Fitzhugh, James A. Wilson: The National Practitioner Data Bank (NPDB) is a repository of reports on actions taken against healthcare practitioners, providers, and suppliers, aiming to prevent practitioners from moving locations without disclosing adverse events. Entities such as hospitals, health plans, and state licensing - [With AI, Keep Patient Satisfaction Top of Mind, Says Health IT Investor](https://texashealthlaw.com/with-ai-keep-patient-satisfaction-top-of-mind-says-health-it-investor/) - Summary of article from Healthcare IT News, by Bill Siwicki: Artificial intelligence (AI) is poised to revolutionize healthcare, with investors viewing it with cautious optimism due to its potential for significant advancements and the need for careful consideration of secondary implications. AI can catalyze the shift towards value-based care by improving patient outcome measurement, personalizing - [A Pair of Texas-Based Schools Are on the Leading Edge of Teaching Doctors About AI](https://texashealthlaw.com/a-pair-of-texas-based-schools-are-on-the-leading-edge-of-teaching-doctors-about-ai/) - Summary of article from Health Leaders, by Christopher Cheney: The University of Texas Health Science Center at San Antonio and University College at the University of Texas at San Antonio are the first institutions to offer an MD/MS dual degree in artificial intelligence, recognizing the growing importance of AI in healthcare. The program, which began - [US Sues Telehealth Companies Over Data Sharing, Cancelation Policies](https://texashealthlaw.com/us-sues-telehealth-companies-over-data-sharing-cancelation-policies/) - Summary of article from mHealth Intelligence, by Anuja Vaidya: The US Department of Justice (DOJ) and the Federal Trade Commission (FTC) have filed an amended complaint against telehealth companies, including Cerebral Inc., Zealthy Inc., Gronk Inc., and Bruno Health P.A., alleging misuse of patients' personal health data, deceptive cancellation practices, and unauthorized disclosure of sensitive - [New Part II Rules](https://texashealthlaw.com/new-part-ii-rules/) - Summary of article from Gordon Feinblatt LLC, by Alexandria K. Monanio: The Confidentiality of Substance Use Disorder (SUD) Patient Records regulations, known as Part II, have been updated to better align with HIPAA privacy protections. Providers have until April 2026 to comply with these changes, which include allowing patients to sign a single consent for - [Texas Children’s Hospital Whistleblower Doctor Indicted on Four Counts of Criminal HIPAA Violations](https://texashealthlaw.com/texas-childrens-hospital-whistleblower-doctor-indicted-on-four-counts-of-criminal-hipaa-violations/) - Summary of article from The HIPAA Journal, by Steve Adler: Dr. Eithan Haim, a surgeon from Texas Children’s Hospital, has been indicted on four counts of violating the Health Insurance Portability and Accountability Act (HIPAA) by the Department of Justice. Dr. Haim allegedly leaked documents proving the hospital continued to provide gender-affirming care to minors, - [Checking the Pulse: An Approach to Telehealth Privacy and Cybersecurity Due Diligence](https://texashealthlaw.com/checking-the-pulse-an-approach-to-telehealth-privacy-and-cybersecurity-due-diligence/) - Summary of article from Troutman Pepper, by Brent Hoard, Emma Trivax, Erin Whaley: The rapid expansion of telehealth introduces complex privacy and cybersecurity challenges, impacting financing or acquisition decisions in the health care sector. A strategic pre-diligence review is advised to identify potential risks and regulatory environment, including HIPAA, FTC's Health Breach Notification Rule, state-specific privacy laws, - [Patients Are Bullish on the Benefits of genAI, but Still Have Qualms](https://texashealthlaw.com/patients-are-bullish-on-the-benefits-of-genai-but-still-have-qualms/) - Summary of article from Healthcare IT News, by Andrea Fox: The 2024 Deloitte Center for Health Solutions consumer survey reveals that while U.S. consumers are optimistic about generative artificial intelligence (genAI) in healthcare, their use has dropped slightly due to increased distrust in AI outputs. The report suggests that to overcome this distrust, healthcare organizations - [American College of Physicians Issues Policy Position Paper on AI use in Health Care](https://texashealthlaw.com/american-college-of-physicians-issues-policy-position-paper-on-ai-use-in-health-care/) - Summary of article from Dermatology Advisor, by Colby Stong: The American College of Physicians (ACP) has released a policy position paper detailing 10 recommendations for the use of artificial intelligence (AI) and machine learning in healthcare. The ACP emphasizes that AI should complement rather than replace physicians' decision-making and should adhere to medical ethics principles. - [Humana Can Challenge Medicare Clawback Rule](https://texashealthlaw.com/humana-can-challenge-medicare-clawback-rule/) - Summary of article from Reuters, by Brendan Pierson: Humana can proceed with its lawsuit against a Biden administration rule that enables Medicare to reclaim overcharges from insurers. The rule, established in January 2023, permits the government to recoup payments to Medicare Advantage plans when audits reveal charges for diagnoses not present in patients' medical records. - [HHS Must Take Immediate Action to Improve Cybersecurity at Large Healthcare Organizations](https://texashealthlaw.com/hhs-must-take-immediate-action-to-improve-cybersecurity-at-large-healthcare-organizations/) - Summary of article from The HIPAA Journal, by Steve Adler: Senator Ron Wyden has called on the Department of Health and Human Services (HHS) to take immediate action against large healthcare companies to strengthen their cybersecurity practices. He has criticized HHS for its lack of regulation and oversight, particularly in light of recent cyberattacks on - [Avoiding HIPAA Penalties: A Checklist for Covered Entities](https://texashealthlaw.com/avoiding-hipaa-penalties-a-checklist-for-covered-entities/) - Summary of article from Holland & Hart, by Kim Stanger: The Health Insurance Portability and Accountability Act (HIPAA) applies to healthcare providers, healthcare clearinghouses, and health plans, enforcing rigorous privacy, security, and breach notification rules. Non-compliance can lead to severe civil and criminal penalties, with a tiered penalty structure based on the severity and nature - [AI in the Health Insurance Industry: An Explainer and Research Roundup](https://texashealthlaw.com/ai-in-the-health-insurance-industry-an-explainer-and-research-roundup/) - Summary of article from The Journalist’s Response, by Rachel Layne: As artificial intelligence (AI) becomes increasingly prevalent in health insurance, U.S. states are seeking to regulate its use due to concerns of racial bias and flawed coverage determinations. Major health insurers like Humana, Cigna, and UnitedHealth face lawsuits over alleged improper use of AI in - [Texas Nursing Homes Face Continued Staffing Shortages, Low Ratings](https://texashealthlaw.com/texas-nursing-homes-face-continued-staffing-shortages-low-ratings/) - Summary of article from Community Impact, by Sarah Hernandez: In 2022, the median turnover rate for registered nurses and licensed vocational nurses in long-term care facilities exceeded 50%, according to the Texas Center for Nursing Workforce Studies. This increase is attributed to exhaustion after the pandemic, with long-term care proving more demanding than acute hospital - [Weighing the Pros and Cons of Synthetic Healthcare Data Use](https://texashealthlaw.com/weighing-the-pros-and-cons-of-synthetic-healthcare-data-use/) - Summary of article from Health IT Analytics, by Shania Kennedy: Healthcare data, while valuable for improved outcomes, faces challenges including data quality, patient privacy, and HIPAA compliance. Synthetic data, artificially generated information that mimics real-world data (RWD), offers a promising solution by maintaining statistical properties of RWD without containing personally identifiable information. Synthetic data provides - [Kickbacks and Medically Unnecessary Treatments: Five Major Qui Tam Settlements from May 2024](https://texashealthlaw.com/kickbacks-and-medically-unnecessary-treatments-five-major-qui-tam-settlements-from-may-2024/) - Summary of article from Kohn, Kohn & Colapinto LLP, by Geoff Schweller: In May, the U.S. Department of Justice (DOJ) and U.S. Attorneys' Offices announced several substantial settlements under the False Claims Act (FCA), resolving qui tam whistleblower lawsuits related to healthcare fraud. The settlements involved cases of kickbacks, billing for unnecessary treatments, and non-compliance - [3 Ways AI Can Improve Revenue-Cycle Management](https://texashealthlaw.com/3-ways-ai-can-improve-revenue-cycle-management/) - Summary of article from American Hospital Association: The integration of artificial intelligence (AI) and automation can enhance revenue-cycle management (RCM) in healthcare, reducing costs and boosting efficiency. AI applications in RCM include automated coding and billing, predictive analytics for denial management, revenue forecasting, patient payment optimization, data security, and operational efficiency. Case studies demonstrate that - [Privacy Abuses Will Meet ‘Full Force of the Law’ From New Texas Unit, Attorney General Says](https://texashealthlaw.com/privacy-abuses-will-meet-full-force-of-the-law-from-new-texas-unit-attorney-general-says/) - Summary of article from The Record, by Joe Warminsky: Texas Attorney General Ken Paxton has announced the formation of a new data-privacy team within the consumer protection unit of his office. The team will enforce Texas privacy laws, focusing on data privacy and security, identity theft, data brokers, biometric information, consumer protection, and federal laws - [Lessons Learned From Walmart, Amazon, and Walgreens: Healthcare's Retail Reset](https://texashealthlaw.com/lessons-learned-from-walmart-amazon-and-walgreens-healthcares-retail-reset/) - Summary of article from D Magazine, by Will Maddox: Walmart, Amazon, and other major corporations have struggled to make a profitable venture into primary care, often citing high operating costs and reimbursement challenges. Retail healthcare has proven complex due to the transient nature of providers in these settings and the difficulty in maintaining long-term patient - [Now is Not the Time to Relax: Record Settlements in Stark Law and False Claims Cases](https://texashealthlaw.com/now-is-not-the-time-to-relax-record-settlements-in-stark-law-and-false-claims-cases/) - Summary of article from Lathrop GPM, by Jesse A. Berg: In May 2024, the University of Pittsburgh Medical Center (UPMC) settled a False Claims Act case for $38 million, marking one of the largest settlements in U.S. history for alleged Stark Law violations. The case emphasizes the importance of fair market value compensation in hospital-physician - [Employers Must Keep Reproductive Health Information About Their Plan Participants Private Under New HIPAA Privacy Rule](https://texashealthlaw.com/employers-must-keep-reproductive-health-information-about-their-plan-participants-private-under-new-hipaa-privacy-rule/) - Summary of article from Akerman LLP, by Beth Alcalde, Elizabeth Hodge: The newly updated HIPAA Privacy Rule, effective June 25, 2024, provides enhanced protection for reproductive health care records, preventing their disclosure to state law enforcement agencies except under certain conditions. The definition of "reproductive health care" is broad, encompassing a wide range of male - [Pharmacy Owner Sentenced for Paying Illegal Kickbacks and Engaging in a Money Laundering Conspiracy](https://texashealthlaw.com/pharmacy-owner-sentenced-for-paying-illegal-kickbacks-and-engaging-in-a-money-laundering-conspiracy/) - Summary of press release from United States Department of Justice: A Texas pharmacy owner was sentenced today to four years and four months in prison and ordered to pay over $59 million in restitution for paying illegal kickbacks and engaging in a money laundering conspiracy. According to court documents and evidence presented at trial, Richard - [As Healthcare AI Advances, How Do We Balance the Benefits With Privacy Concerns?](https://texashealthlaw.com/as-healthcare-ai-advances-how-do-we-balance-the-benefits-with-privacy-concerns/) - Summary of article from HackerNoon, by Emmanuel Akin-Ademola: AI advancements are transforming the healthcare industry, with companies like GE Healthcare and Siemens Healthineers developing technologies for accurate scans and automating routine tasks. However, these innovations raise significant concerns about data privacy and potential breaches. To address these issues, technical approaches such as anonymizing, encryption, and - [How Generative AI Will Change Jobs In Healthcare](https://texashealthlaw.com/how-generative-ai-will-change-jobs-in-healthcare/) - Summary of article by Bernard Marr: Generative AI is poised to revolutionize healthcare by assisting in diagnosis and treatment, personalizing care, and accelerating research and development. It can analyze complex datasets, like medical images, and provide personalized treatment programs, while AI chatbots can offer specialized advice and patient monitoring. It can also expedite drug discovery - [What You Need To Know About Texas Consumer Data Privacy Law](https://texashealthlaw.com/what-you-need-to-know-about-texas-consumer-data-privacy-law/) - Summary of article from The National Review, by Elizabeth Rogers: The Texas Data Privacy and Security Act (TDPSA) is a comprehensive privacy law that applies broadly to individuals and businesses dealing with personal data in Texas. It introduces a strong set of consumer privacy rights, including the rights to access, correct, and delete personal data, - [Cybersecurity Policy – Developments to Watch](https://texashealthlaw.com/cybersecurity-policy-developments-to-watch/) - Summary of article from FiscalNote, by Nicole D’Angelo: Cybercrime costs are projected to rise from $9.22 trillion in 2024 to $13.82 trillion by 2028, with new threats emerging due to advancements in technology, particularly AI. Governments are increasingly focusing on cybersecurity, with several key legislations proposed in 2024, including the Healthcare Cybersecurity Improvement Act and - [Ethical Implications Surrounding Use of AI in Healthcare](https://texashealthlaw.com/ethical-implications-surrounding-use-of-ai-in-healthcare/) - Summary of article from BioSpectrum, by Arpita Goyal: Algorithmic biases in AI systems, which could perpetuate historical inequalities and affect healthcare quality, need to be addressed through diversified training data and sophisticated algorithms. Ensuring clinical validity and transparency in AI deployment is essential for establishing trust and accountability, and human clinical judgment should not be - [Wegovy Maker Novo Nordisk Sues Nine Spas, Clinics and Pharmacies Over Copycat Drugs](https://texashealthlaw.com/wegovy-maker-novo-nordisk-sues-nine-spas-clinics-and-pharmacies-over-copycat-drugs/) - Summary of article from Reuters, by Patrick Wingrove: Novo Nordisk, a Danish pharmaceutical company, has filed lawsuits against nine more U.S. entities, including medical spas, wellness clinics, and pharmacies, for selling products that allegedly contain semaglutide, the key ingredient in its weight-loss drug Wegovy. This brings the total lawsuits to 21 since June, targeting sellers - [FTC and DOJ Seek Public Help Identifying “Serial Acquisition Strategy” Targets](https://texashealthlaw.com/ftc-and-doj-seek-public-help-identifying-serial-acquisition-strategy-targets/) - Summary of article from Seyfarth Shaw LLP, by Brandon Bigelow, Robyn Marsh: The Federal Trade Commission (FTC) and the Department of Justice (DOJ) are expanding their investigation into businesses using "roll up" strategies to consolidate competitors and reduce competition across the U.S. economy. Previously, these agencies focused on the healthcare industry, but the new Request - [Is FTC’s Noncompete Rule a Concerning Development for Physicians?](https://texashealthlaw.com/is-ftcs-noncompete-rule-a-concerning-development-for-physicians/) - Summary of article from Medical Economics, by Amanda Hill: The Federal Trade Commission (FTC) has issued a rule prohibiting noncompete clauses, potentially impacting physicians nationwide. Critics argue this rule overreaches federal authority, creates ambiguities in exceptions, and exacerbates divisions between hospitals and physicians. While some physicians support the ban, arguing noncompetes give undue leverage to - [How AI Is Enhancing Health Care](https://texashealthlaw.com/how-ai-is-enhancing-health-care/) - Summary of article from Dallas Morning News, by James B. Milliken: The University of Texas System is embracing the potential of artificial intelligence (AI) in healthcare, despite concerns about job losses and bias. The inaugural UT System AI Symposium in Health Care will bring together AI experts from eight institutions to discuss the responsible integration - [Chief AI Officers in Healthcare: Strategy, Tactics and Evangelism](https://texashealthlaw.com/chief-ai-officers-in-healthcare-strategy-tactics-and-evangelism/) - Summary of article from HealthTech Magazine, by Nathan Eddy: The rise of artificial intelligence (AI) in healthcare has led to organizations considering hiring a Chief AI Officer (CAIO) to spearhead their AI strategies. The role of a CAIO involves accelerating AI adoption while ensuring safety and innovation, managing investments, and addressing ethical and governance issues. - [AI, Health Care, and the Realities of Being Human](https://texashealthlaw.com/ai-health-care-and-the-realities-of-being-human/) - Summary of article from Undark, by Arjun V.K. Sharma: The "doorknob phenomenon" in medicine refers to patients revealing their most pressing concerns just as the doctor is about to leave. This article explores the tension between this deeply human aspect of healthcare and the rise of artificial intelligence (AI) in the medical field. While AI - [Healthcare Ransomware Attacks Lead to Uptick in ED Visits at Nearby Hospitals](https://texashealthlaw.com/healthcare-ransomware-attacks-lead-to-uptick-in-ed-visits-at-nearby-hospitals/) - Summary of article from Health IT Security, by Jill McKeon: A research letter in JAMA has revealed that ransomware attacks on hospitals not only disrupt the targeted facilities but also impact neighboring hospitals. The study, which analyzed emergency department (ED) visits and patient discharge data from 2014 to 2020, found a temporary decrease in ED - [Why Physicians Are Ditching Their 9-5](https://texashealthlaw.com/why-physicians-are-ditching-their-9-5/) - Summary of article from D Magazine, by Will Maddox: A recent survey by AMN Healthcare reveals that nearly half of physicians and advanced practice providers find locum tenens work more satisfying than full-time roles, citing improved schedules and burnout avoidance as key reasons. Locum tenens, a form of temporary healthcare staffing, has witnessed significant growth, - [Accelerated Approval Process Is Not Without Risk: Placing Recent FDA Action in Context](https://texashealthlaw.com/accelerated-approval-process-is-not-without-risk-placing-recent-fda-action-in-context/) - Summary of article from Troutman Pepper, by Kyle Dolinsky, Judith O'Grady: The FDA withdrew approval for Pepaxto, a multiple myeloma drug, after post-marketing studies failed to confirm its clinical benefit. The drug had been granted accelerated approval, a pathway for drugs treating serious illnesses that offer therapeutic benefits over existing treatments. However, post-marketing studies are required - [Using A Value-Based Enterprise to Integrate Specialists and Primary Care: Taking Value-Based Care to the Next Level](https://texashealthlaw.com/using-a-value-based-enterprise-to-integrate-specialists-and-primary-care-taking-value-based-care-to-the-next-level/) - Summary of article from Nelson Mullins Riley & Scarborough LLP, by Mike Segal, Edward White: Within the value-based healthcare model, the majority of medical expenses come from specialist sectors operating under traditional fee-for-service payment models. A potential solution to this challenge could be the implementation of a Value-Based Enterprise (VBE) that promotes mutually beneficial contractual relationships - [Concurrent Call Coverage: Key Considerations for a Compliant Structure](https://texashealthlaw.com/concurrent-call-coverage-key-considerations-for-a-compliant-structure/) - Summary of article from VMG Health, by Holden Godat, CVA, Taylor Harville, Trent Fritzsche: Concurrent call coverage, where a physician provides on-call services to multiple locations or specialties simultaneously, is increasingly being adopted due to a significant shortage of physicians and the growing demand for healthcare services. This approach aims to distribute work evenly and - [D.C. Circuit Holds 340B Program Does Not Prohibit Drug Manufacturers from Imposing Contract Pharmacy Restrictions](https://texashealthlaw.com/d-c-circuit-holds-340b-program-does-not-prohibit-drug-manufacturers-from-imposing-contract-pharmacy-restrictions/) - Summary of article from Foley Hoag LLP, by Patrick Brennan, Andrew London, Ross Margulies, Kian Azimpoor: On May 21, 2024, the U.S. Court of Appeals for the District of Columbia Circuit affirmed a lower court's decision in United Therapeutics Corporation v. Carole Johnson and Novartis Pharmaceuticals v. Carole Johnson, rejecting the government's position that the 340B statute - [How State-Level Psychedelic Medicine Legislation Raises Equity Concerns](https://texashealthlaw.com/how-state-level-psychedelic-medicine-legislation-raises-equity-concerns/) - Summary of article from Healthcare Brew, by Maia Anderson: The FDA is likely to decide on the approval of an MDMA-based psychedelic medicine this year, with multiple states considering legalization for therapeutic use. However, there is concern about equitable access to these treatments. Psilocybin, MDMA, and a form of LSD have been granted breakthrough therapy - [Louisiana Lawmakers Pass Bill Making Abortion Pills Controlled Dangerous Substances](https://texashealthlaw.com/louisiana-lawmakers-pass-bill-making-abortion-pills-controlled-dangerous-substances/) - Summary of article from AP News, by Sara Cline: Louisiana is set to reclassify abortion-inducing drugs, mifepristone and misoprostol, as controlled and dangerous substances under a new bill that has received final legislative approval. Supporters of the bill argue it will protect women from coerced abortions, while critics, including numerous doctors, fear it will hamper - [Ransomware Attack on Texas Ophthalmology Practice Exposes Data of 80,000 Patients](https://texashealthlaw.com/ransomware-attack-on-texas-ophthalmology-practice-exposes-data-of-80000-patients/) - Summary of article from The HIPAA Journal, by Steve Adler: A Texas-based ophthalmology practice, encompassing Victoria Surgery Center, Victoria Eye Center, and Victoria Vision Center, was hit by a ransomware attack on March 21, 2024, compromising the personal and health data of 80,122 patients. The attack encrypted files, making certain systems inaccessible, and an investigation - [Is Your Texas Data Protection Assessment Started?](https://texashealthlaw.com/is-your-texas-data-protection-assessment-started/) - Summary of article from Data Protection Report, by By David Kessler, Annmarie Giblin, Joe McClendon, Susan Ross: The Texas Data Privacy and Security Act (TDPSA), effective from July 1, 2024, applies to companies conducting business in Texas, processing personal data, and not classified as small businesses. Unlike other state laws, TDPSA requires companies to provide an - [Epic Releases Open-Source AI Validation Tool for Health Systems](https://texashealthlaw.com/epic-releases-open-source-ai-validation-tool-for-health-systems/) - Summary of article from Fierce Healthcare, by Heather Landi: Epic has launched an open-source tool to help healthcare organizations test and monitor artificial intelligence (AI) models. Available for free on GitHub, the AI validation software suite can be integrated with electronic health record (EHR) systems and used to validate AI models from various sources. The - [HHS Agency Launches Program to Improve Cyber Resiliency in Hospitals](https://texashealthlaw.com/hhs-agency-launches-program-to-improve-cyber-resiliency-in-hospitals/) - Summary of article from The HIPAA Journal, by Steve Adler: The Advanced Research Projects Agency for Health (ARPA-H), a Department of Health and Human Services (HHS) agency, has initiated a cybersecurity program aimed at enhancing and automating cybersecurity in U.S. hospitals. The program, called Universal PatchinG and Remediation for Autonomous DEfense (UPGRADE), will invest over - [Twin Brothers Plead Guilty to $45 Million Healthcare Fraud](https://texashealthlaw.com/twin-brothers-plead-guilty-to-45-million-healthcare-fraud/) - Summary of article from D Magazine, by Will Maddox: Drs. Desi and Deno Barroga have admitted to a healthcare fraud scheme involving false claims for steroid injections that were never provided, defrauding insurers including Blue Cross Blue Shield, Cigna, and United Healthcare. The scheme involved monthly office visits for patients on addictive drugs, where they - [The Colorado AI Act: What You Need to Know](https://texashealthlaw.com/the-colorado-ai-act-what-you-need-to-know/) - Summary of article from IAPP, by Cobun Zweifel-Keegan: The Colorado AI Act, the first U.S. cross-sector AI governance law, was signed into law on May 17, 2024, with key provisions effective from Feb. 2026. The law focuses on high-risk AI systems, defined as those making consequential decisions, and introduces stringent requirements to prevent algorithmic discrimination. - [New Practical Guidance for Balancing Fairness, Privacy](https://texashealthlaw.com/new-practical-guidance-for-balancing-fairness-privacy/) - Summary of article from IAPP, by Cobun Zweifel-Keegan: The tension between achieving fairness and maintaining privacy in the operation of advanced AI and machine learning systems is a major challenge for digital governance teams. To test for bias and ensure equity, demographic data is often needed, potentially infringing on privacy rights. A report by the - [Second Circuit Defines “Willful” under Anti-Kickback Statute](https://texashealthlaw.com/second-circuit-defines-willful-under-anti-kickback-statute/) - Summary of article from Policy & Medicine, by Thomas Sullivan: The United States Court of Appeals for the Second Circuit recently ruled that for a defendant to be considered "willful" under the federal Anti-Kickback Statute (AKS), they must be aware that their actions are somehow unlawful. This decision came from a qui tam case against - [Five Key Analyses for Healthcare Financial Due Diligence](https://texashealthlaw.com/five-key-analyses-for-healthcare-financial-due-diligence/) - Summary of article from VMG Health, by Grayson Terrell, CPA: In the complex landscape of healthcare mergers and acquisitions (M&A), informed decision-making and financial due diligence (FDD) are crucial for both buyers and sellers. FDD involves a detailed investigation of a company's financial information to validate its true operating potential, with the purchase price usually - [Implementing AI and Mitigating Compliance Risks – Part II](https://texashealthlaw.com/implementing-ai-and-mitigating-compliance-risks-part-ii/) - Summary of article from Dentons, by Susan Freed: With the increasing role of generative AI in the healthcare industry, there is a growing need for a clear, consistent approach to its implementation. To mitigate compliance risks, organization must have an AI strategy, identify current uses of generative AI, update relevant policies, and create a process - [New Telehealth Rule for Speech-Language Pathologists and Audiologists](https://texashealthlaw.com/new-telehealth-rule-for-speech-language-pathologists-and-audiologists/) - The Texas Department of Licensing and Regulation adopted a rule for speech-language pathologists and audiologists confirming that direct and indirect supervision may be performed through tele-supervision and that in-person supervision is not required. This rule also allows a licensee providing telehealth services to provide proof of licensure to a requestor through the department’s online license - [Profound Medical Wins FDA Nod for AI in Prostate Cancer Procedure](https://texashealthlaw.com/profound-medical-wins-fda-nod-for-ai-in-prostate-cancer-procedure/) - Summary of article from MassDevice, by Sean Whooley: Profound Medical has received FDA 510(k) clearance for its second AI model, the Contouring Assistant, designed to treat prostate cancer. The Contouring Assistant is part of the company's TULSA-Pro system, which uses transurethral ultrasound ablation (TULSA) to ablate diseased tissue in patients with various stages of prostate - [Health Plan Services Firm Notifying 2.4 Million of PHI Theft](https://texashealthlaw.com/health-plan-services-firm-notifying-2-4-million-of-phi-theft/) - Summary of article from GovInfo Security, by Marianne Kolbasuk McGee: Texas-based health plan administration services firm, WebTPA, is notifying over 2.4 million individuals about a hacking incident that occurred in 2023, which was detected in December of the same year. The breach potentially compromised personal data including names, contact information, birthdates, Social Security numbers, and - [Don’t Call It a Breach Rule: FTC Health Breach Notification Rule Has Been Here for Years, Now Updated to Serve as a Backdoor Privacy Regulation](https://texashealthlaw.com/dont-call-it-a-breach-rule-ftc-health-breach-notification-rule-has-been-here-for-years-now-updated-to-serve-as-a-backdoor-privacy-regulation/) - Summary of article from Wyrick Robbins Yates & Ponton LLP, by Lynn Percival IV: In December 2021, the Federal Trade Commission (FTC) began a rulemaking process to update the Health Breach Notification Rule (HBNR), which mandates notice following a security breach of unsecured personal health records. The FTC has now finalized these updates, expanding the - [Telehealth: Regulatory Questions Amid Legislative Uncertainty](https://texashealthlaw.com/telehealth-regulatory-questions-amid-legislative-uncertainty/) - Summary of article from McDermott+Consulting, by Jeffrey Davis, Rachel Stauffer: The article discusses the potential expiration of temporary Medicare waivers for telehealth services, which were instated during the COVID-19 pandemic and are set to expire by the end of 2024. Without further action from Congress, Medicare telehealth will revert to a rural-only benefit from 2025, - [HHS Issues New Affordable Care Act Section 1557 Nondiscrimination Regulations](https://texashealthlaw.com/hhs-issues-new-affordable-care-act-section-1557-nondiscrimination-regulations/) - Summary of article from Seyfarth Shaw LLP, by Kristina Launey, Leon Rodriguez: Section 1557 of the Affordable Care Act prohibits discrimination in health programs receiving federal financial assistance. It has been subject to changes across different Presidential administrations since its inception in 2016. The latest regulations, effective from August 6, 2024, restore some repealed provisions - [OCR HIPAA Audit Program to Commence in 2024](https://texashealthlaw.com/ocr-hipaa-audit-program-to-commence-in-2024/) - Summary of article from The HIPAA Journal, by Steve Adler: The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 mandates periodic audits of HIPAA-regulated entities by the Office for Civil Rights (OCR) to assess HIPAA compliance, with a focus on the HIPAA Security Rule. OCR has confirmed that audits will be - [Health Care, AI and Antitrust: Analysis and Next Steps](https://texashealthlaw.com/health-care-ai-and-antitrust-analysis-and-next-steps/) - Summary of article from Manatt, Phelps & Phillips, LLP, by Dylan Carson, Harvey Rochman: As artificial intelligence (AI) becomes more prevalent in the health care industry, there are growing concerns about potential anticompetitive conduct, including algorithmic price fixing. This issue was highlighted in a recent New York Times report alleging that certain health plans and - [DOJ Introduces Task Force on Health Care Monopolies and Collusion](https://texashealthlaw.com/doj-introduces-task-force-on-health-care-monopolies-and-collusion/) - Summary of article from King & Spalding, by Catherine Behnke: The Department of Justice (DOJ) recently announced the establishment of a Health Care Monopolies and Collusion (HCMC) Task Force. This initiative is part of the Biden administration's broader effort to enhance antitrust enforcement in the health care sector, including measures aimed at increasing transparency, promoting - [Cracking the Whip: The FTC’s Clampdown on Healthcare Marketing](https://texashealthlaw.com/cracking-the-whip-the-ftcs-clampdown-on-healthcare-marketing/) - Summary of article from Nelson Hardiman, LLP, by Harry Nelson: The U.S. healthcare system, driven by a complex mix of economic considerations, permits direct-to-consumer pharmaceutical advertising, unlike many other Western nations. However, this practice can lead to misleading claims and deceptive marketing, especially affecting vulnerable individuals. Recently, the Federal Trade Commission (FTC) has increased scrutiny - [Medicaid: CMS Final Rules Aim to Expand Access, Provide Parity with Commercial Markets](https://texashealthlaw.com/medicaid-cms-final-rules-aim-to-expand-access-provide-parity-with-commercial-markets/) - Summary of article from Foley & Lardner LLP, by Anil Shankar: The Centers for Medicare & Medicaid Services (CMS) introduced two significant updates to its Medicaid regulations on May 10, 2024: the Medicaid Access Rule and the Medicaid Managed Care Rule. These updates aim to enhance and standardize reporting, monitoring, and evaluation of Medicaid services, - [Envisioning the Future of Health Care With OpenAI's GPT-4o](https://texashealthlaw.com/envisioning-the-future-of-health-care-with-openais-gpt-4o/) - Summary of article from KevinMD, by Harvey Castro, MD, MBA: OpenAI's GPT-4o promises to revolutionize health care with advanced predictive analytics, enhanced surgical assistance, personalized medicine, automated health monitoring, and virtual health assistants. It aims to improve emergency responses, offer immersive education and training, facilitate cross-border medical collaboration, enhance mental health services, streamline administrative processes, - [HIPAA Privacy Final Rule: Landmark Changes Related to Reproductive Health Care Information](https://texashealthlaw.com/hipaa-privacy-final-rule-landmark-changes-related-to-reproductive-health-care-information/) - Summary of article from Polsinelli, by Hiba AI-Ramahi, Iliana Peters, Rebecca Frigy Romine: The U.S. Department of Health and Human Services (HHS) and Office for Civil Rights (OCR) issued a "Final Rule" providing special protections and obligations related to Protected Health Information (PHI) about reproductive health care. The Rule applies to all HIPAA regulated entities and covers a - [Better Call Your Privacy Attorney: 3 New State Privacy Laws Begin July 1, 2024](https://texashealthlaw.com/better-call-your-privacy-attorney-3-new-state-privacy-laws-begin-july-1-2024/) - Summary of article from Dickenson Wright, by Sara Jodka: On July 1, 2024, Florida, Oregon, and Texas will join other states in implementing privacy laws to govern the collection, use, and transfer of consumer personal data, with Montana following on October 1, 2024. These laws will impose requirements on businesses collecting personal data, and although - [The Future of Technology in Health Care](https://texashealthlaw.com/the-future-of-technology-in-health-care/) - Summary of article from The Regulatory Review, by Alyson Diaz, Julia Englebert, and Carson Turner: The use of technology in healthcare, particularly AI and telemedicine, is increasing, but many Americans are uncomfortable with AI's role in diagnosis and treatment due to potential biases and errors. While AI can improve care quality and accessibility, especially for - [FTC Finalizes Expansion of Health Breach Notification Rule's Broad Applicability to Unauthorized App Disclosures](https://texashealthlaw.com/ftc-finalizes-expansion-of-health-breach-notification-rules-broad-applicability-to-unauthorized-app-disclosures/) - Summary of article from Davis Wright Tremaine, by Adam H. Greene, Apurva Dharia: The Federal Trade Commission (FTC) has finalized changes to the Health Breach Notification Rule (HBNR), expanding its scope to include virtually all health and wellness apps. The revised rule requires vendors of personal health records (PHRs) and related entities to notify individuals, - [Importance of Negotiating Maintenance, Repair and Replacement Obligations in Health Care Leases](https://texashealthlaw.com/importance-of-negotiating-maintenance-repair-and-replacement-obligations-in-health-care-leases/) - Summary of article from Epstein Becker Green, by Allison S. Zangrilli, Zlata Fayer: Tenants are often held responsible for the repair and maintenance of mechanical systems in leased premises, which can lead to significant costs. To mitigate this, tenants should inspect these systems before signing the lease and negotiate a warranty period with the landlord - [The Intersection of Artificial Intelligence and Utilization Review](https://texashealthlaw.com/the-intersection-of-artificial-intelligence-and-utilization-review/) - Summary of article from Sheppard Mullin Richter & Hampton LLP, by Lynsey Mitchel: California's SB 1120 bill aims to regulate the use of artificial intelligence (AI) in managed care, requiring AI tools to be fair, non-discriminatory, and based on a patient's medical history and individual circumstances. The bill aligns with the Centers for Medicare and - [Cloud-Based AI Services Could Help Fight Health Misinformation](https://texashealthlaw.com/cloud-based-ai-services-could-help-fight-health-misinformation/) - Summary of article from Healthcare IT News, by Andrea Fox: Several major universities are developing a platform named Project Heal to combat healthcare and public health misinformation. The platform will use machine learning, generative AI, and predictive analytics to identify and counteract misinformation before it spreads. The system also accounts for cultural, historical, and linguistic - [Tame The Private Equity Beast By Shifting Its Focus To Value-Based Care](https://texashealthlaw.com/tame-the-private-equity-beast-by-shifting-its-focus-to-value-based-care/) - Summary of article from Health Affairs, by Ken Terry: The influence of private equity (PE) firms on the healthcare industry has lead to several concerns, including reduced quality of patient care, increased expenses, and potential economic instability. However, PE firms could also play a constructive role in healthcare reform if their investments were directed towards - [Honest Services Fraud: A World Beyond the Anti-Kickback Statute](https://texashealthlaw.com/honest-services-fraud-a-world-beyond-the-anti-kickback-statute/) - Summary of article from Dorsey & Whitney LLP, by Nicole Engisch, Seth Goertz, Sarah Malham, Mara Sanders: The Department of Justice (DOJ) is increasingly using Honest Services Fraud (18 U.S.C. § 1346) to prosecute bribery, kickbacks, and other improper payments in the healthcare industry, in addition to traditional mechanisms like the Anti-Kickback Statute and the Federal False Claims - [Local Physician and Practice Agree to Pay Over $2 Million to Settle False Claims Act Allegations](https://texashealthlaw.com/local-physician-and-practice-agree-to-pay-over-2-million-to-settle-false-claims-act-allegations/) - Press Release from U.S. Attorney's Office, Eastern District of Michigan: I don’t normally report on False Claims Act (FCA) matters from other states, but this one serves as a cautionary tale on “incident to” billing. Under Medicare rules, covered services provided by non-physician practitioners (NPPs), like physician assistants, nurse practitioners, clinical nurse specialists, etc., are - [Is Your Compliance House In Order? Tips for Ensuring Private Equity and Portfolio Company Compliance](https://texashealthlaw.com/is-your-compliance-house-in-order-tips-for-ensuring-private-equity-and-portfolio-company-compliance/) - Summary of article from Bass, Berry & Sims PLC, by Angela Humphreys, Jennifer Michael: The recent Request for Information by federal agencies highlights the need for private equity (PE) firms to have robust compliance programs for their healthcare sector investments. Such programs should align with the Office of Inspector General’s General Compliance Program Guidance, and include - [Navigating Tax Due Diligence in Healthcare Acquisitions](https://texashealthlaw.com/navigating-tax-due-diligence-in-healthcare-acquisitions/) - Summary of article from VMG Health, by Grayson Terrell, CPA; Joe Scott, CPA; Lukas Recio, CPA; Wayne Prior, CPA; and the Baker Tilly team: Healthcare M&A transactions require a collaborative approach between financial and tax due diligence experts to identify potential problems and their tax consequences, which can impact the deal structure and negotiation process. - [Some Nurses Have a Deep Distrust of AI – but Transparency and Training Could Help](https://texashealthlaw.com/some-nurses-have-a-deep-distrust-of-ai-but-transparency-and-training-could-help/) - Summary of article from Healthcare IT News, by Andrea Fox: The California Nurses Association (CNA) has protested against the use of artificial intelligence (AI) in healthcare by Kaiser Permanente, citing concerns over patient safety, job displacement, and the devaluation of nursing practice. The CNA demands that workers and unions be involved in the development and - [What Parkland Can Teach Other Hospitals About AI in Health Care](https://texashealthlaw.com/what-parkland-can-teach-other-hospitals-about-ai-in-health-care/) - Summary of article from Dallas Morning News: Parkland Health is actively utilizing artificial intelligence (AI) in medical practices, including trauma patient treatment and assisting doctors with paperwork. The technology analyzes patient data and updates survival probabilities in real time, while also transcribing doctors' notes. Despite potential AI biases and inaccuracies, Parkland mitigates these risks through - [FDA Finalizes Rule Regulating Laboratory Developed Tests](https://texashealthlaw.com/fda-finalizes-rule-regulating-laboratory-developed-tests/) - Summary of article from Polsinelli, by Suzanne Bassett, Michael Gaba: The FDA's Final Rule regulating Laboratory-Developed Tests (LDTs) was published on May 6, 2024, and is expected to take effect in 60 days. The rule expands the definition of in vitro diagnostics (IVDs) to include LDTs and will significantly alter the regulatory landscape for LDTs, - [How HHS OCR Is Boosting HIPAA Enforcement; Here Come Audits](https://texashealthlaw.com/how-hhs-ocr-is-boosting-hipaa-enforcement-here-come-audits/) - Summary of article from BankInfo Security, by Marianne Kolbasuk McGee: The Department of Health and Human Services (HHS) is working on a proposed update to the HIPAA Security Rule and intensifying enforcement efforts, including resuming HITECH Act HIPAA audits. The focus is on the requirement for risk analysis, a significant weakness among regulated organizations, contributing - [Do Cosmetic Injections Involve The Practice Of Medicine?](https://texashealthlaw.com/do-cosmetic-injections-involve-the-practice-of-medicine/) - Summary of article from Hendershot & Cowart, by Keith Lefkowitz: Cosmetic injections, such as Botox and dermal fillers, are considered the practice of medicine in Texas and can only be performed under the authority of a physician. Texas law has seen a series of criminal cases involving unlicensed practice of medicine and cosmetic injections, resulting - [FTC Ban on Non-Competes Complicates NFP Hospital Staffing Issues](https://texashealthlaw.com/ftc-ban-on-non-competes-complicates-nfp-hospital-staffing-issues/) - Fitch Ratings reports that the Federal Trade Commission's (FTC) new rule banning non-compete clauses could cause staffing issues for not-for-profit (NFP) hospitals already grappling with wage increases. The rule, which is set to take effect 120 days after its April 30, 2024, publication in the Federal Register, has already faced legal challenges. It could potentially - [A Comprehensive Guide to Creating a Sustainable Cookie Program](https://texashealthlaw.com/a-comprehensive-guide-to-creating-a-sustainable-cookie-program/) - Summary of article from IAPP, by Jodi Daniels, CIPP/US: Managing cookies is essential for compliance with privacy and data protection laws worldwide. Establishing a cookie governance program involves designating roles for program leadership, creating a comprehensive policy for cookie use and removal, and implementing systems to manage user consent. Regular audits and privacy impact assessments - [UnitedHealth Paid Hackers $22 Million Ransom](https://texashealthlaw.com/unitedhealth-paid-hackers-22-million-ransom/) - Summary of article from CNBC, by Ashley Capoot: UnitedHealth Group confirmed the company paid a $22 million ransom after hackers breached its subsidiary, Change Healthcare, affecting the healthcare sector broadly. The breach left many doctors unable to fill prescriptions or get paid for their services temporarily. Witty revealed that the cybercriminals accessed Change Healthcare through - [Rehab Hospital Chain Hack Affects 101,000; Facing 6 Lawsuits](https://texashealthlaw.com/rehab-hospital-chain-hack-affects-101000-facing-6-lawsuits/) - Summary of article from GovInfo Security, by Marianne Kolbasuk McGee: Ernest Health, a Texas-based operator of rehabilitation hospitals, is facing multiple federal proposed class action lawsuits following a ransomware attack that potentially compromised the sensitive information of over 101,000 individuals across several states. The company reported 33 separate breaches involving a network server and a - [How ACOs Can Harness AI’s Transformative Potential](https://texashealthlaw.com/how-acos-can-harness-ais-transformative-potential/) - Summary of article from MedCity News, by Theresa Hush: Artificial intelligence (AI) is revolutionizing various sectors, including healthcare, by improving diagnoses, personalizing medicine, and developing less-invasive procedures. However, its application in accountable care organizations (ACOs) remains limited, mainly to patient-checking bots and robotic assistants, without fully exploring AI's potential for predictive healthcare and cost reduction. - [Drugmakers Exposed to Antitrust Probes if Patent Cache Added](https://texashealthlaw.com/drugmakers-exposed-to-antitrust-probes-if-patent-cache-added/) - Summary of article from Bloomberg Law, by Annelise Gilbert: The US Patent and Trademark Office (USPTO) has proposed a rule that would create a repository for all settlement agreements related to patent challenges, potentially exposing pharmaceutical companies to antitrust scrutiny. The proposed rule would expand the requirements for companies to file detailed reports after reaching - [US DEA Will Reclassify Marijuana, Ease Restrictions](https://texashealthlaw.com/us-dea-will-reclassify-marijuana-ease-restrictions/) - Summary of article from AP News, by Zeke Miller, Joshua Goodman, Jim Mustian, Lindsay Whitehurst: The U.S. Drug Enforcement Administration (DEA) plans to reclassify marijuana as a less dangerous drug, recognizing its medical uses and lower potential for abuse. The proposal, pending review by the White House Office of Management and Budget, would move marijuana - [Healthcare Industry Sees Increased Investment in Generative AI, LLMs](https://texashealthlaw.com/healthcare-industry-sees-increased-investment-in-generative-ai-llms/) - Summary of article from Health IT Analytics, by Shania Kennedy: A recent Generative AI in Healthcare Survey reveals that healthcare and life sciences organizations are increasingly investing in generative AI projects, with larger organizations and leadership roles reporting higher adoption rates. The survey found that 35% of respondents are not actively considering generative AI, while - [FDA Brings Lab Tests Under Federal Oversight](https://texashealthlaw.com/fda-brings-lab-tests-under-federal-oversight/) - Summary of article from AP News, by Matthew Perrone: The FDA has finalized a regulation that will gradually introduce oversight for new tests developed by laboratories. The rule mandates that these tests, including those for life-threatening diseases, must demonstrate accurate results within a timeframe of 3.5 to 4 years. However, existing tests will not require - [FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices](https://texashealthlaw.com/fda-proposes-updated-guidance-concerning-cybersecurity-of-medical-devices/) - Summary of article from Jones Day, by Maureen Bennett, Ryan Blaney, Alexis Gilroy, Colleen Heisey, Michael McFerran, Lauren Murtagh: The U.S. Food and Drug Administration (FDA) has proposed an updated draft Premarket Cybersecurity Guidance on March 13, 2024, to aid in meeting cybersecurity requirements for FDA medical device submissions. This guidance, under Section 524B of - [HHS Extends the Antidiscrimination Provisions of the Affordable Care Act to Patient Care Decision Support Tools, Including Algorithms](https://texashealthlaw.com/hhs-extends-the-antidiscrimination-provisions-of-the-affordable-care-act-to-patient-care-decision-support-tools-including-algorithms/) - Summary of article from Epstein Becker Green, by Bradley Merrill Thompson: The Office of Civil Rights (OCR) has published its final rule on algorithmic discrimination by payers and health care providers. The rule, based on section 1557 of the Affordable Care Act, prohibits discrimination on the basis of race, color, national origin, sex, age, or - [Health Care Giant Comes Clean About Recent Hack and Paid Ransom](https://texashealthlaw.com/health-care-giant-comes-clean-about-recent-hack-and-paid-ransom/) - Summary of article from Ars Technica, by Dan Goodin: Change Healthcare, a US health care services provider, was attacked by ransomware group ALPHV or BlackCat, disrupting the US prescription market for two weeks. The breach occurred due to a compromised account that lacked multifactor authentication (MFA), allowing hackers to access and exfiltrate data. The company - [How Pharmacies Can Protect Patient Data From Cyber Threats](https://texashealthlaw.com/how-pharmacies-can-protect-patient-data-from-cyber-threats/) - Summary of article from Specialty Pharmacy Continuum, by Karen Blum: Pharmacies, both large and small, are increasingly targeted by sophisticated cyberattacks due to their databases of patient financial and health information. The breaches can lead to identity theft and drug diversion, with hackers using advanced tactics to gain access to data. To mitigate these risks, - [Physician Group Integration: Trends & Challenges](https://texashealthlaw.com/physician-group-integration-trends-challenges/) - Summary of article from VMG Health, by Cordell J. Mack: Hospitals and health systems have been integrating with physician groups in an effort to improve healthcare quality, service, and efficiency, with mixed results. Despite this, health system employment of physicians continues to rise, currently accounting for over 50% of all practicing physicians. However, the multispecialty - [US Challenges 'Bogus' Patents on Ozempic and Other Drugs in Effort to Spur Competition](https://texashealthlaw.com/us-challenges-bogus-patents-on-ozempic-and-other-drugs-in-effort-to-spur-competition/) - Summary of article from AP News, by Matthew Perrone: The Federal Trade Commission (FTC) is challenging patents on 20 brand-name drugs, including Ozempic, as part of the Biden administration's efforts to target pharmaceutical industry practices that inflate prices. The FTC alleges that patents filed by companies such as Novo Nordisk, GlaxoSmithKline, and AstraZeneca are inaccurate - [DOJ Releases 2024 COVID-19 Fraud Enforcement Task Force Report](https://texashealthlaw.com/doj-releases-2024-covid-19-fraud-enforcement-task-force-report/) - Summary of article from Morrison Foerster, by Adam Braverman, Kate Driscoll, Kamran Jamil, Brian Kidd, Nathaniel Mendell: The U.S. Department of Justice (DOJ) has released a comprehensive report on the COVID-19 Fraud Enforcement Task Force, calling for an extension of the statute of limitations for pandemic fraud-related offenses and increased funding for investigations and prosecutions. Since May 2021, the - [False Claims Act Settlements to Know from Q1 2024](https://texashealthlaw.com/false-claims-act-settlements-to-know-from-q1-2024/) - Summary of article from Bass, Berry & Sims PLC, by Theresa Androff, Molly Ruberg: The first quarter of 2024 saw significant False Claims Act (FCA) and civil healthcare fraud settlements in the healthcare industry, despite a recent downward trend. These settlements, worth millions of dollars, were related to alleged kickbacks, medically unnecessary services and equipment, - [FTC Finalizes Changes to Health Breach Notification Rule](https://texashealthlaw.com/ftc-finalizes-changes-to-health-breach-notification-rule/) - Summary of article from Fierce Healthcare, by Heather Landi: The Federal Trade Commission (FTC) has finalized the revised Health Breach Notification Rule (HBNR) to enhance data privacy protection for consumers using digital health apps. The rule mandates vendors managing digital health records to notify individuals, the FTC, and sometimes the media, of any breach of - [HIPAA Update to Include Cybersecurity Requirements for Health Care Organizations](https://texashealthlaw.com/hipaa-update-to-include-cybersecurity-requirements-for-health-care-organizations/) - Summary of article from Renal and Urology News, by John Schieszer: The Department of Health and Human Services (HHS) is updating the Health Insurance Portability and Accountability Act (HIPAA) Security Rule to include new cybersecurity requirements, in light of increasing cyber threats to the healthcare sector. The HHS has issued a concept paper providing voluntary - [Let’s Make a Deal with DOJ: The Impact of the DOJ’s New Whistleblower Reward Program on Corporate Compliance](https://texashealthlaw.com/lets-make-a-deal-with-doj-the-impact-of-the-dojs-new-whistleblower-reward-program-on-corporate-compliance/) - Summary of article from Husch Blackwell, by Christina Moore, Madison Rector: The DOJ announced a new whistleblower rewards program aimed at incentivizing reports of corporate or financial misconduct. This program, allowing individuals to report violations of any federal law, particularly criminal abuses of the U.S. financial system, fills gaps not covered by existing whistleblower initiatives - [HHS Warns Health Care Sector of AI-Driven Phishing, Social Engineering Attacks on IT Help Desks](https://texashealthlaw.com/hhs-warns-health-care-sector-of-ai-driven-phishing-social-engineering-attacks-on-it-help-desks/) - Summary of article from Carlton Fields, by Michael Bailey, John Clabby: The Health Sector Cybersecurity Coordination Center (HC3) has issued an alert about advanced cybersecurity threats targeting the healthcare sector, particularly IT help desks. These threats involve the use of publicly available information and AI to impersonate healthcare employees, gaining access to email accounts and - [What the FTC’s Rule Banning Non-Competes Means for Healthcare](https://texashealthlaw.com/what-the-ftcs-rule-banning-non-competes-means-for-healthcare/) - Summary of article from Nelson Mullins Riley & Scarborough LLP, by Candace Friel, Denise Gunter, Carrie Hanger: The Federal Trade Commission (FTC) has finalized a rule banning most non-compete agreements, with the rule set to take effect 120 days after its publication in the Federal Register. The rule applies to all workers, regardless of title, - [Fast Five: Important Law and Policy Updates for US Health Care Transactions](https://texashealthlaw.com/fast-five-important-law-and-policy-updates-for-us-health-care-transactions/) - Summary of article from ArentFox Schiff, by Michele L. Gipp, Jo-Ann Marchica, Kathryn L. Steffen: The first quarter of 2024 has seen significant changes in the US health care sector, with new guidelines from the Department of Justice (DOJ) and Federal Trade Commission (FTC) potentially affecting mergers and acquisitions, particularly those involving small health care - [CMS Finalizes Major Reforms to Medicaid, Part 1: Medicaid Access Reg](https://texashealthlaw.com/cms-finalizes-major-reforms-to-medicaid-part-1-medicaid-access-reg/) - Summary of article from McDermott+Consulting, by Jeffrey Davis, Kayla Holgash, Katie Waldo: The Centers for Medicare & Medicaid Services (CMS) has issued two new regulations pertaining to state-operated Medicaid programs, aiming to improve access to care for Medicaid enrollees. A notable policy within the 'Ensuring Access to Medicaid Services' regulation specifies that at least 80% of Medicaid - [Houston Transplant Scandal: Families of Patients Who Died Begin Legal Action](https://texashealthlaw.com/houston-transplant-scandal-families-of-patients-who-died-begin-legal-action/) - Summary of article from MedPage Today, by Associated Press: Relatives of deceased patients are demanding an investigation into a Houston doctor, J. Steve Bynon Jr., MD, who is accused of manipulating the liver transplant waitlist at Memorial Hermann-Texas Medical Center. The hospital has suspended its liver and kidney transplant programs after discovering "inappropriate changes" in - [Kaiser Permanente Notifying 13.4 Million of Tracker Breach](https://texashealthlaw.com/kaiser-permanente-notifying-13-4-million-of-tracker-breach/) - Summary of article from Gov Info Security, by Marianne Kolbasuk McGee: Kaiser Foundation Health Plan reported a data breach affecting 13.4 million individuals due to unauthorized access/disclosure from its previous use of online tracking technologies on its websites and mobile applications. Personal information potentially transmitted to third-party vendors like Google, Microsoft Bing, and Twitter includes - [A Regulatory Roadmap to AI and Privacy](https://texashealthlaw.com/a-regulatory-roadmap-to-ai-and-privacy/) - Summary of article from IAPP, by Daniel Solove: There is a complex relationship between AI and privacy. AI-related privacy issues are often extensions of existing digital privacy problems. Privacy law reform must address digital privacy holistically, not just in the context of AI. AI creates implicates privacy concerns in data collection and processing, decision-making, and - [Three Women Contract HIV From Dirty “Vampire Facials” at Unlicensed Med Spa](https://texashealthlaw.com/three-women-contract-hiv-from-dirty-vampire-facials-at-unlicensed-med-spa/) - Summary of article from Ars Technica, by Beth Mole: Unlicensed cosmetic procedures at a med spa have been linked to an outbreak of HIV, marking the first time cosmetic treatments have been associated with such an outbreak. At least three women who underwent "vampire facials", a treatment involving the injection of a patient's own platelet-rich - [Feds Launch Website for Reporting of Health Care Anticompetitive Practices](https://texashealthlaw.com/feds-launch-website-for-reporting-of-health-care-anticompetitive-practices/) - On April 18, 2024, the Federal Trade Commission (FTC), U.S. Department of Justice (DOJ), and U.S. Department of Health and Human Services (HHS) launched a public web portal for reporting anticompetitive practices in the health care sector. The portal, www.healthycompetition.gov, allows anyone to submit complaints about potential anticompetitive conduct in the healthcare industry. The portal - [Forecasting the Integration of AI into Health Care Compliance Programs](https://texashealthlaw.com/forecasting-the-integration-of-ai-into-health-care-compliance-programs/) - From Robinson Cole, by Kathleen Healy, Josh Yoo: Healthcare entities need to incorporate AI standards into their compliance programs to manage and mitigate legal risks. Executive Order No. 14110 outlines key principles for AI including confidentiality, security, transparency, governance, and non-discrimination. The National Institute of Standards and Technology (NIST) provides a Risk Management Framework for - [Online Tracking Technologies: Updated HIPAA Guidance Creates Uncertainty](https://texashealthlaw.com/online-tracking-technologies-updated-hipaa-guidance-creates-uncertainty/) - From Morgan Lewis, by W. Reece Hirsch, Amy M. Magnano, Michael J. Madderra, Sydney Reed Swanson: The US Department of Health and Human Services' (HHS's) Office for Civil Rights (OCR) updated its guidance on the use of online tracking technologies, causing further uncertainty for HIPAA-covered entities. OCR acknowledges that tracking technologies, such as cookies and - [CMS Issues Hospice Proposed Payment Rule](https://texashealthlaw.com/cms-issues-hospice-proposed-payment-rule/) - From King & Spalding, by Kate Karpenko: The CMS has issued a proposed rule for fiscal year 2025 to update Medicare hospice payments and aggregate cap amount, which includes a 2.6% increase in payments and an updated aggregate cap of $34,364.85. The proposal also introduces changes to the Hospice Quality Reporting Program (HQRP), including the - [Change Healthcare Faces Another Ransomware Threat—and It Looks Credible](https://texashealthlaw.com/change-healthcare-faces-another-ransomware-threat-and-it-looks-credible/) - From Ars Technica, by Andy Greenberg and Matt Burgess: Change Healthcare, a prominent healthcare company in the U.S., has been embroiled in a significant ransomware debacle, initially victimized by the group AlphV, which encrypted the company's network and received a $22 million ransom payment. Now, a new ransomware group, RansomHub, claims to possess 4 terabytes - [Consumer Health Information: Handle With (Extreme) Care](https://texashealthlaw.com/consumer-health-information-handle-with-extreme-care/) - From the Federal Trade Commission, Business Blog, by Lesley Fair: The Federal Trade Commission (FTC) has taken action against online healthcare providers Cerebral and Monument, Inc. for allegedly violating consumer privacy rights. Both companies were accused of sharing sensitive health data with third-party advertising platforms without consumer consent. Cerebral was also charged with misleading cancellation - [PE-Owned Health Care Saw Surge in 2023 Bankruptcies, Report Says](https://texashealthlaw.com/pe-owned-health-care-saw-surge-in-2023-bankruptcies-report-says/) - Summary of article from Mergers & Acquisitions, by Bloomberg News: Private equity (PE)-backed businesses accounted for about 20% of the 80 bankruptcies in the healthcare sector in 2023, according to the Private Equity Stakeholder Project. Additionally, venture-capital backed companies made up another 15% of these filings. The report predicts this trend of healthcare bankruptcies will - [Proposed FTC Order will Prohibit Telehealth Firm Cerebral from Using or Disclosing Sensitive Data for Advertising Purposes, and Require it to Pay $7 Million](https://texashealthlaw.com/proposed-ftc-order-will-prohibit-telehealth-firm-cerebral-from-using-or-disclosing-sensitive-data-for-advertising-purposes-and-require-it-to-pay-7-million/) - Cerebral, Inc., a telehealth company, has agreed to settle Federal Trade Commission (FTC) charges over its failure to secure and protect sensitive consumer health data. The settlement includes a $7 million fine for disclosing consumers' personal health information to third parties for advertising purposes and failing to uphold its cancellation policies. The FTC claimed that - [Ernest Health Sued Over 2024 Ransomware Attack and Data Breach](https://texashealthlaw.com/ernest-health-sued-over-2024-ransomware-attack-and-data-breach/) - Summary of article from The HIPAA Journal, by Steve Adler: Ernest Health, a Texas-based health system, is facing a lawsuit following a cyberattack that compromised the protected health information of approximately 94,747 patients. The breach, claimed by the LockBit ransomware group, occurred between January 16, 2024, and February 4, 2024, leading to unauthorized access to - [Healthcare Still Underprepared for Scope of Cyber Threats, Says Report](https://texashealthlaw.com/healthcare-still-underprepared-for-scope-of-cyber-threats-says-report/) - Summary of article from Healthcare IT News, by Andrea Fox: A new report from Kroll reveals a discrepancy between healthcare organizations' self-assessment of their cybersecurity maturity and the reality of their readiness. Despite healthcare being among the most breached sectors, many organizations in this industry believe their cybersecurity processes are "very mature". The report also - [Comprehensive Federal Privacy Bill May Open Backdoor for HIPAA Private Right of Action](https://texashealthlaw.com/comprehensive-federal-privacy-bill-may-open-backdoor-for-hipaa-private-right-of-action/) - Summary of article from Fox Rothschild, by Elizabeth Litten: The American Privacy Rights Act of 2024 (APRA) is a significant data privacy bill that aims to establish national data privacy rights and protections, superseding existing state data privacy laws. The Federal Trade Commission, states, and impacted individuals will enforce it. The bill includes a provision - [Companies with Strong Cybersecurity Programs Deliver Higher Returns for Shareholders](https://texashealthlaw.com/companies-with-strong-cybersecurity-programs-deliver-higher-returns-for-shareholders/) - Summary of article in The HIPAA Journal, by Steve Adler: A study by Diligent Institute and Bitsight reveals that organizations with strong cybersecurity programs yield better financial performance and higher shareholder returns. The study, which analyzed data from 4,149 mid to large-sized organizations, found that companies with advanced security ratings created almost four times more - [Change Healthcare Ransomware Attack: 10 Lessons Learned](https://texashealthlaw.com/change-healthcare-ransomware-attack-10-lessons-learned/) - Summary of article from Guidepost Solutions LLC, by Todd Doss: In February 2024, Change Healthcare fell victim to a ransomware attack due to vulnerabilities in its infrastructure, including outdated software and misconfigured settings. The attackers used sophisticated malware to access the network and breach sensitive data, including patient records, financial data, and administrative details. The - [Navigating HIPAA Compliance in the Age of AI: Privacy and Security Considerations in Healthcare](https://texashealthlaw.com/navigating-hipaa-compliance-in-the-age-of-ai-privacy-and-security-considerations-in-healthcare/) - Summary of article from HackerNoon, by mcmullen: Artificial intelligence (AI) is revolutionizing various aspects of healthcare, but it also presents privacy and security risks, particularly in the context of data breaches. Compliance with the Health Insurance Portability and Accountability Act (HIPAA) is crucial when integrating AI into healthcare. To remain HIPAA compliant, healthcare organizations must - [Security Principles: Addressing Vulnerabilities Systematically](https://texashealthlaw.com/security-principles-addressing-vulnerabilities-systematically/) - Summary of article from Federal Trade Commission, Office of Technology: The FTC has been enforcing national consumer protection laws for over two decades, focusing on companies with inadequate security practices such as failing to encrypt sensitive data and not using multi-factor authentication. The FTC and the Cybersecurity and Infrastructure Security Agency (CISA) recommend practices like - [Doctors Are Getting on Board With genAI, Survey Shows](https://texashealthlaw.com/doctors-are-getting-on-board-with-genai-survey-shows/) - Summary of article from Healthcare IT News, by Andrea Fox: A survey of 100 US physicians revealed that 81% believe generative AI can enhance care team interactions with patients. The majority (89%) of physicians require transparency about the sources of clinical decision support (CDS) data from vendors. However, physicians overestimate patients' readiness for AI in - [Washington’s My Health My Data Act and its Nevada Twin are Now in Effect – Are You Ready?](https://texashealthlaw.com/washingtons-my-health-my-data-act-and-its-nevada-twin-are-now-in-effect-are-you-ready/) - Summary of article from Davis Wright Tremaine, by David L. Rice, Adam H. Greene, Rebecca L. Williams: The "My Health My Data Act" in Washington, effective March 31, 2024, imposes strict regulations on the collection and use of "consumer health data" (CHD), even extending to data indirectly related to a consumer's health. The Act covers - [Houston Clinic Owner Sentenced for Healthcare Fraud Scheme](https://texashealthlaw.com/houston-clinic-owner-sentenced-for-healthcare-fraud-scheme/) - Summary of article from mytexasdaily.com: Gwendolyn Gibbs, the 72-year-old owner of a Houston-based mental health clinic, has been sentenced to seven years in federal prison for a healthcare fraud scheme. Gibbs pleaded guilty to conspiracy to commit healthcare fraud in December 2021 and was ordered to pay over $8.6 million in restitution to Medicare. The - [Clinic Owner Sent to Prison for Orchestrating $15M Medicare Fraud and Kickback Scheme](https://texashealthlaw.com/clinic-owner-sent-to-prison-for-orchestrating-15m-medicare-fraud-and-kickback-scheme/) - Gwendolyn Gibbs, the owner of the Houston-based Daybreak Rehabilitation Center, has been sentenced to 84 months in federal prison and ordered to pay $8.68 million in restitution to Medicare for conspiracy to commit healthcare fraud. Gibbs fraudulently billed Medicare for unnecessary mental health services provided to vulnerable adults with intellectual disabilities. From 2007 to 2016, - [FTC Bans Noncompete Clauses, Declares Vast Majority Unenforceable](https://texashealthlaw.com/ftc-bans-noncompete-clauses-declares-vast-majority-unenforceable/) - Summary of article from Ars Technica, by Jon Brodkin: The Federal Trade Commission (FTC) has issued a final rule banning noncompete clauses, rendering most existing clauses unenforceable, citing that they are an unfair method of competition and a violation of Section 5 of the FTC Act. The rule will take effect 120 days after its - [HHS Issues New Rule to Support Reproductive Health Care Privacy Under HIPAA](https://texashealthlaw.com/hhs-issues-new-rule-to-support-reproductive-health-care-privacy-under-hipaa/) - The Biden-Harris Administration has announced a Final Rule through the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) to enhance the HIPAA Privacy Rule and protect reproductive health care privacy. This rule prohibits the disclosure of protected health information (PHI) related to lawful reproductive health care under certain - [Artificial Intelligence Highlights from FTC’s 2024 PrivacyCon](https://texashealthlaw.com/artificial-intelligence-highlights-from-ftcs-2024-privacycon/) - Summary of article from Sheppard Mullin Richter & Hampton LLP, by Carolyn Metnick, Gianfranco Spinelli: PrivacyCon's takeaways for healthcare organizations highlighted key considerations for the use of AI in healthcare, focusing on privacy themes, Large Language Models (LLMs), and AI functionality. The study identified four privacy concerns: potential for data misuse, personal nature of data, lack of - [Bogus Botox Poisoning Outbreak Spreads to 9 States, CDC Says](https://texashealthlaw.com/bogus-botox-poisoning-outbreak-spreads-to-9-states-cdc-says/) - Summary of article from Ars Technica, by Beth Mole: The Centers for Disease Control and Prevention (CDC) reported that 19 women across nine US states have been poisoned by counterfeit Botox injections. Almost half of these cases resulted in hospitalization, with four individuals treated with botulinum anti-toxin. The Food and Drug Administration (FDA) reported these - [Pandemic Fraud Suits Have Yielded Over $100 Million, Report Says](https://texashealthlaw.com/pandemic-fraud-suits-have-yielded-over-100-million-report-says/) - From Bloomberg Law, by Daniel Seiden: The Covid-19 Fraud Enforcement Task Force has reported that over $100 million has been reclaimed by the US government through False Claims Act (FCA) cases related to pandemic fraud. These funds have been recovered from more than 400 settlements and judgments, including cases of Paycheck Protection Program fraud, Economic - [Healthcare Highlights from FTC’s 2024 PrivacyCon](https://texashealthlaw.com/healthcare-highlights-from-ftcs-2024-privacycon/) - From SheppardMullin, by Carolyn Metnick, Carolyn Young: The Federal Trade Commission's annual PrivacyCon highlighted three healthcare privacy research projects: tracking technology use by healthcare providers, women’s privacy concerns post Roe era, and bias propagation through large language learning models (LLMs). One key finding was the extensive use of tracking technologies on hospital websites, which can - [“Stark” Differences: DOJ’s Renewed Focus on Stand-Alone Stark Law Violations](https://texashealthlaw.com/stark-differences-dojs-renewed-focus-on-stand-alone-stark-law-violations/) - From Arnold & Porter, by Murad Hussain, Allison W. Shuren, Loreli (Lori) Wright: The Department of Justice (DOJ) has recently increased enforcement of the False Claims Act (FCA) based on the Stark Law, also known as the Physician Self-Referral Law. This law focuses on financial relationships between physicians and health care entities, particularly when compensation - [CMS Again Settles Record Stark Self-Disclosures in 2023](https://texashealthlaw.com/cms-again-settles-record-stark-self-disclosures-in-2023/) - From McGuireWoods, by Gretchen Heinze Townshend, Timothy Fry, Kristen H. Chang, Varsha Gadani, Micaela Enger: The Centers for Medicare & Medicaid Services (CMS) reported a record 176 settlements of voluntary self-disclosures related to past or potential violations of the physician self-referral law (Stark Law) in 2023, with settlements totaling over $12 million. This represents an - [Why You Need a Privacy Program](https://texashealthlaw.com/six-reasons-why-you-need-a-privacy-program/) - In a previous video, we talked about what a Privacy Program is. In this video, we look at six reasons why your organization needs a privacy program. Reason No. 1 - To Comply With the Law A privacy program may be essential for your organization to comply with federal and state law. Medical records Education - [Fair Market Value and Commercial Reasonableness Considerations Amid CMS Radiopharmaceutical Reimbursement Challenges](https://texashealthlaw.com/fair-market-value-and-commercial-reasonableness-considerations-amid-cms-radiopharmaceutical-reimbursement-challenges/) - From VMG Health, by Carla Zarazua, Preston Edison, and James Tekippe, CFA: Radiopharmaceutical drugs (RPs) are crucial for diagnosing and treating diseases. However, the current pricing structure by the Centers for Medicare and Medicaid Services (CMS) places a financial strain on hospitals and health systems and potentially restricts patient access to these vital resources. The - [Oklahoma Chiropractic Clinic, Owner, and Referring Physicians Pay $465,000 to Settle Federal False Claims Act and Kickback Allegations](https://texashealthlaw.com/oklahoma-chiropractic-clinic-owner-and-referring-physicians-pay-465000-to-settle-federal-false-claims-act-and-kickback-allegations/) - From United States Department of Justice: Chiropractic Associates and Dr. Scott Kirkpatrick paid $365,000 to settle allegations of wrongfully paying physicians to induce referrals of durable medical equipment (DME), leading to the submission of false claims to the Medicare program. Dr. Cash Biddle and Dr. Chad Keeney each paid $50,000 to settle allegations that they - [HHS’ Office for Civil Rights Settles HIPAA Investigation with Phoenix Healthcare](https://texashealthlaw.com/hhs-office-for-civil-rights-settles-hipaa-investigation-with-phoenix-healthcare/) - From U.S. Health and Human Services: The U.S. Department of Health and Human Services' Office for Civil Rights (OCR) has reached a settlement with Phoenix Healthcare over a potential violation of the HIPAA Right of Access provision. The case involved a daughter, acting as a representative for her mother, who could not access her mother's - [The Compounding Problems of Semaglutide, the Miracle Weight-Loss Drug](https://texashealthlaw.com/the-compounding-problems-of-semaglutide-the-miracle-weight-loss-drug/) - Semaglutide weight loss drugs are quite literally saving people’s lives. There are so many health benefits to losing weight that demand for the drugs is off the charts. Demand is so high that the manufacturer can’t keep up and the drugs are in short supply. Where there is money to be made, there will be - [New State Health Privacy Laws—Moving Beyond HIPAA and Recasting Consumer Health Data Rights?](https://texashealthlaw.com/new-state-health-privacy-laws-moving-beyond-hipaa-and-recasting-consumer-health-data-rights/) - From Jones Day, by Alexis S. Gilroy, Lisa M. Ropple, Ryan P. Blaney, Claire E. Castles, Jennifer C. Everett and Kristen Pollock McDonald: The new consumer health data (CHD) privacy laws enacted in Washington and Nevada aim to offer state-level protections for personal health data not covered by the Health Insurance Portability and Accountability Act (HIPAA). - [HHS Issues Guidance to Teaching Hospitals and Medical Schools on Informed Consent Requirements](https://texashealthlaw.com/hhs-issues-guidance-to-teaching-hospitals-and-medical-schools-on-informed-consent-requirements/) - From The HIPAA Journal, by Steve Alder: The Department of Health and Human Services (HHS) has issued a letter to teaching hospitals and medical schools, emphasizing the necessity of obtaining informed consent from patients before conducting sensitive examinations, particularly when the patient is under anesthesia. The letter comes in response to reports indicating that medical - [How to Start a Med Spa in Texas](https://texashealthlaw.com/how-to-start-a-med-spa-in-texas/) - I'm going to let you in on a little secret. Most med spas in Texas are not compliant with Texas law. Either they are formed as the wrong legal entity type, they lack proper ownership or oversight, they are not following the standard of care, or all of the above. The consequences can be significant - [ACA Health Insurance Plans Are Being Switched Without Enrollees' OK](https://texashealthlaw.com/aca-health-insurance-plans-are-being-switched-without-enrollees-ok/) - From National Public Radio, by Julie Appleby: Some consumers are being switched from one ACA insurance plan to another without their consent, potentially disrupting their medical care and prescription needs. This unauthorized switching can also lead to large IRS bills for back taxes. Agents can access a policyholder's coverage using only a person's name, date - [California Enacts First-in-Nation Pharmacy Medication Error Reporting Law](https://texashealthlaw.com/california-enacts-first-in-nation-pharmacy-medication-error-reporting-law/) - From Husch Blackwell, by Kevin Khachatryan: On October 8, 2023, the California Governor signed Assembly Bill 1286 (AB 1286), a comprehensive pharmacy bill aimed at enhancing patient safety. The bill's key mandate is a new requirement for community pharmacies to report outpatient medication errors to the California Board of Pharmacy. The legislation also includes several - [USPTO Issues Training Materials to Examiners for Searching FDA and NIH Resources](https://texashealthlaw.com/uspto-issues-training-materials-to-examiners-for-searching-fda-and-nih-resources/) - From Knobbe Martens, by Joseph Mallon, Ashley Morales: On March 20, 2024, the USPTO issued an alert about new training materials for patent examiners, developed to enhance searches for prior art in FDA and NIH databases. The training was first presented at the Biotechnology, Chemical, and Pharmaceutical Partnership Meeting on March 19, 2024. The materials guide - [Texas Physicians Push for More Regulation Over Med Spas](https://texashealthlaw.com/texas-physicians-push-for-more-regulation-over-med-spas/) - From KCENTV, by Baylee Bates: Physicians are raising concerns over the lack of regulation and policy enforcement in the medical spa (med spa) industry, following the death of Fairfield resident Jenifer Cleveland after an IV treatment at a med spa. Dr. Patricia Aronin, affiliated with the TX400, a group of Texas physicians, has called for - [Texas Medical Board Notice of Proposed Rule Amendments and Statement Regarding Abortion Ban Exceptions](https://texashealthlaw.com/texas-medical-board-notice-of-proposed-rule-amendments-and-statement-regarding-abortion-ban-exceptions/) - The Texas Medical Board (TMB) is proposing new rules to clarify how the state's abortion ban exceptions apply to its enforcement process. This marks the beginning of a rulemaking process that will invite public participation and written comment. The proposed rules, according to the TMB, are designed within the limits of existing laws to clarify - [Behavioral Health Industry Reshaping As a Result of AI](https://texashealthlaw.com/behavioral-health-industry-reshaping-as-a-result-of-ai/) - From The National Law Review, Jean Marie R. Pechette, Neal D. Shah, Joelle M. Wilson, Catherine Kozlowski, Matthew T. Lin: Artificial Intelligence (AI) is significantly influencing the field of behavioral health, offering potential advancements in diagnostics, treatment, and patient outcomes. The application of AI technologies ranges from virtual mental health assistants and predictive analytics to - [Health Care Groups Resist Cybersecurity Rules in Wake of Landmark Breach](https://texashealthlaw.com/health-care-groups-resist-cybersecurity-rules-in-wake-of-landmark-breach/) - From CyberScoop, by AJ Vicens and Elias Groll: A devestating cyberattack on payment processor Change Healthcare has spurred discussions in Washington about urgent cybersecurity regulations for the healthcare sector. Health and Human Services (HHS) is working on developing mandatory rules, including updating the Health Insurance Portability and Accountability Act with cybersecurity requirements. These updates are - [Updated: Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates](https://texashealthlaw.com/updated-use-of-online-tracking-technologies-by-hipaa-covered-entities-and-business-associates/) - From U.S. Department of Health and Human Services: The U.S. Department of Health and Human Services' Office for Civil Rights (OCR) updated its guidance to regulated entities when using online tracking technologies. These technologies, used to collect and analyze user interaction with websites or mobile applications, must comply with HIPAA rules if the information gathered includes - [Patient Inducements: Law and Limits](https://texashealthlaw.com/patient-inducements-law-and-limits/) - From Holland & Hart, by Kim Stanger: Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing improper inducements, especially if the patient is a federal program beneficiary. The government is concerned that offering - [Inside the Healthcare Industry: The Growing Importance of Intellectual Property Valuations](https://texashealthlaw.com/inside-the-healthcare-industry-the-growing-importance-of-intellectual-property-valuations/) - From J.S. Held, by Magi Curtis, Noor Al-Banna, Greg Campanella: Healthcare and life sciences companies are increasingly recognizing the importance of Intellectual Property (IP) in their strategic growth initiatives, investments, and licensing of data. A study by Ocean Tomo found that approximately 90% of the value of companies in the S&P 500 comes from intangible - [Justice Department, Federal Trade Commission and Department of Health and Human Services Issue Request for Public Input as Part of Inquiry into Impacts of Corporate Ownership Trend in Health Care](https://texashealthlaw.com/justice-department-federal-trade-commission-and-department-of-health-and-human-services-issue-request-for-public-input-as-part-of-inquiry-into-impacts-of-corporate-ownership-trend-in-health-care/) - From DOJ Office of Public Affairs: The Justice Department’s Antitrust Division, Federal Trade Commission (FTC), and Department of Health and Human Services (HHS) have launched a joint public inquiry into the increasing control of private-equity and corporate entities over healthcare. This inquiry aims to understand how certain healthcare market transactions may lead to increased consolidation, - [Healthcare Hit Hardest by Ransomware Last Year, FBI IC3 Report Shows](https://texashealthlaw.com/healthcare-hit-hardest-by-ransomware-last-year-fbi-ic3-report-shows/) - From Health IT Security, by Jill McKeon: The Federal Bureau of Investigation’s 2023 Internet Crime Report reveals that the healthcare sector experienced the highest number of ransomware attacks among all critical infrastructure sectors last year. The FBI's Internet Crime Complaint Center (IC3) recorded an unprecedented 880,418 complaints, marking a 10% increase from the previous year - [Six AI Applications to Transform Your Clinical Operations](https://texashealthlaw.com/six-ai-applications-to-transform-your-clinical-operations/) - From D Magazine, by Dr. Harvey Castro: Artificial Intelligence (AI) and Machine Learning (ML) are set to revolutionize the healthcare industry by enhancing clinical outcomes, improving access to care, and elevating the patient experience. The integration of sophisticated AI applications is expected to increase healthcare efficiency, accuracy, and personalization globally. AI can automate routine tasks, - [5th Circ. Backs NLRB On Nurse Fired Over COVID Complaints](https://texashealthlaw.com/5th-circ-backs-nlrb-on-nurse-fired-over-covid-complaints/) - From Law360, by Tim Ryan: The Fifth Circuit court upheld a 2022 National Labor Relations Board (NLRB) ruling that Texas-based Renew Home Health LLC unlawfully dismissed a nurse who raised concerns about the company's handling of the COVID-19 pandemic. The three-judge panel unanimously rejected Renew's argument that Bornschlegl was a supervisor and therefore not protected - [The Knowledge Requirement in a Case Alleging False Claims Act Violations](https://texashealthlaw.com/the-knowledge-requirement-in-a-case-alleging-false-claims-act-violations/) - From PharmacyToday, by David B. Brushwood, BSPharm, JD: This matter involved a pharmacy corporation accused of violating the FCA due to falsification of prior authorization (PA) forms by a Clinical Pharmacy Manager (CPM). The CPM allegedly completed these forms with false information, leading to coverage of Medicaid patients who did not meet criteria for payment. This - [The FTC Hosts Workshop on Private Equity in Health Care](https://texashealthlaw.com/the-ftc-hosts-workshop-on-private-equity-in-health-care/) - From Sheppard Mullin Richter & Hampton LLP, by John Carroll, Joy Siu, Jake Walker: On March 5, 2024, the Federal Trade Commission (FTC) hosted a workshop titled “Private Capital, Public Impact: An FTC Workshop on Private Equity in Health Care”. The event aimed to explore the effects of private equity (PE) investment on the health care system. - [Public Sector Predictions for Healthcare Utilization in 2024](https://texashealthlaw.com/public-sector-predictions-for-healthcare-utilization-in-2024/) - From VMG Health, by Jordan Tussy, Colin McDermott, Madi Whyde: VMG Health's analysis of 2024 healthcare sector trends, based on earnings calls from various companies, suggests continued growth in utilization driven by patient backlogs, recovering macroeconomic trends, and an aging population. Key findings include: Medical Equipment Suppliers and Distributors: Companies like Intuitive Surgical, Inc., Stryker - [Hey Doc, Be Careful on TikTok - Legal Pitfalls of Healthcare Providers in the Social Media Age](https://texashealthlaw.com/hey-doc-be-careful-on-tiktok-legal-pitfalls-of-healthcare-providers-in-the-social-media-age/) - From Buckingham, Doolittle & Burroughs, LLC, by Monica Davis: Impact of Social Media on Healthcare: Social media platforms have enabled physicians to expand their practices, increase marketing, discover new clients, and build their reputations. However, they also pose risks.. HIPAA Violations: The Health Insurance Portability and Accountability Act (HIPAA) ensures strict confidentiality in physician-patient relationships. - [Highlights from OIG’s New Compliance Program Guidance](https://texashealthlaw.com/highlights-from-oigs-new-compliance-program-guidance/) - From Gardner Law: The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) released the General Compliance Program Guidance (GCPG) in November 2023, a reference guide for health care compliance. It includes information about Federal laws, compliance program infrastructure, OIG resources, and other useful compliance-related information. The GCPG highlights primary sources - [Rise in Healthcare Data Breaches & the Impact for Healthcare Providers in 2024](https://texashealthlaw.com/rise-in-healthcare-data-breaches-the-impact-for-healthcare-providers-in-2024/) - From Bradley Arant Boult Cummings LLP, by Alexis Buese, Eric Setterlund The healthcare sector has seen a significant increase in cyber-threats, especially hacking and ransomware, with a 256% rise in hacking-related breaches and a 264% surge in ransomware incidents in the last five years. In 2023, these breaches affected over 134 million individuals, a 141% increase - [Insights into Healthcare Provider Compensation Trends for 2024](https://texashealthlaw.com/insights-into-healthcare-provider-compensation-trends-for-2024/) - From VMG Health, by Ben Minnis, Tyler Navarro, Anthony Domanico: Innovative Recruitment Strategies: Healthcare organizations are adopting creative methods to attract and retain physicians due to significant changes in the Medicare Physician Fee Schedule and an aging physician population. These methods include enhanced benefits, leadership development programs, broader loan forgiveness, adjustments to hard-to-recruit models, and - [How Hospitals Are Fighting to Keep Their Former Doctors From Seeing Patients](https://texashealthlaw.com/how-hospitals-are-fighting-to-keep-their-former-doctors-from-seeing-patients/) - From NBC News, by Shannon Pettypiece: Noncompete agreements, which prevent doctors from seeing patients for one to two years within a geographic region if they leave their job, have become increasingly common in the healthcare industry. Critics, including the American Medical Association and the American College of Physicians, argue that noncompete agreements contribute to physician - [The FDA and the Future of AI Oversight](https://texashealthlaw.com/the-fda-and-the-future-of-ai-oversight/) - From Manatt, Phelps & Phillips, LLP, by Nicholas Bath Jr., Rachel Sher, Daniel Weinstein: The U.S. Government Accountability Office (GAO) issued a report in January 2024 highlighting challenges faced by the U.S. Food and Drug Administration (FDA) in effectively regulating artificial intelligence (AI) and machine learning (ML) in medical devices and other emerging health care technologies. The - [Cyberattack Shuts Down Pharmacies Across the US](https://texashealthlaw.com/cyberattack-shuts-down-pharmacies-across-the-us/) - From Brew Healthcare, by Quinn Sental: Change Healthcare, a prominent health tech firm owned by UnitedHealth Group, suffered a cyberattack, disrupting patient payments and prescription processing across the US. The company, part of Optum, handles 15 billion healthcare transactions annually. The cyberattack was first noticed as disruptions in the company's applications, later identified as "enterprise-wide - [Ten Physicians and Local Execs Indicted in Pharmacy Kickback Scheme](https://texashealthlaw.com/ten-physicians-and-local-execs-indicted-in-pharmacy-kickback-scheme/) - From D Magazine, by Will Maddox: A pharmaceutical kickback scheme in the Northern District of Texas has led to the indictment of 14 people, including several podiatrists, local businessmen, and executives at Next Health, a healthcare holding company. The scheme involved physicians receiving bribes and kickbacks from pharmacies for referring prescriptions to be filled at - [The Risk of Criminal Charges in Hospice Fraud Cases](https://texashealthlaw.com/the-risk-of-criminal-charges-in-hospice-fraud-cases/) - From Hospice News, by Holly Vossel: Hospice providers face significant regulatory risks related to False Claims Act (FCA) violations, with potential criminal charges in instances of suspected fraud, waste and abuse. While most FCA cases don't result in criminal charges, the resolution process can be complex and challenging for providers. The burden of proof in - [New PCI DSS 4.0 Will Impact the Digital Health, Healthcare Industries](https://texashealthlaw.com/new-pci-dss-4-0-will-impact-the-digital-health-healthcare-industries/) - From McDermott Will & Emery, by Mark E. Schreiber, Brian Long, Jonathan Ende: The healthcare industry, particularly digital health, is increasingly adopting an e-commerce model, accepting direct payments from consumers. This necessitates compliance with the Payment Card Industry Data Security Standard (PCI DSS), even if payment card processing is outsourced. The new version of PCI - [How Post-Transaction Physician Compensation Structure Affects Fair Market Value of Physician Practices](https://texashealthlaw.com/how-post-transaction-physician-compensation-structure-affects-fair-market-value-of-physician-practices/) - From VMG Health, by Dylan Alexander, CVA and Gerrit Elzinga, CVA: As of January 2024, there are over 338,000 physician group practices in the U.S. The compensation structure for shareholder physicians, which often changes during business transactions, plays a significant role in the valuation of a practice. Higher post-transaction physician compensation typically results in a - [HHS’ Office for Civil Rights Settles Second Ever Ransomware Cyber-Attack](https://texashealthlaw.com/hhs-office-for-civil-rights-settles-second-ever-ransomware-cyber-attack/) - From HHS Press Release: The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), reached a settlement with Green Ridge Behavioral Health, LLC under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) due to potential violations identified during an investigation following a ransomware attack, which affected over 14,000 individuals' - [Ozempic, Wegovy, and the New Compliance Risks for Providers](https://texashealthlaw.com/ozempic-wegovy-and-the-new-compliance-risks-for-providers/) - From Dentons, by Susan Freed: Increase in Prescription of Diabetes and Obesity Drugs: There has been a significant rise in the popularity of diabetes and obesity drugs like Ozempic and Wegovy, with U.S healthcare providers writing over 9 million prescriptions in the last three months of 2022. This is a 300% increase from 2020, with - [US Department of Human Services vs Hospital & Tech Sector Showdown](https://texashealthlaw.com/us-department-of-human-services-vs-hospital-tech-sector-showdown/) - From Telehealth.org, by Marlene Maheu, PhD: Recent developments in digital privacy ethics in the healthcare sector have led to a lawsuit against the US Department of Health and Human Services (HHS) by the American Hospital Association (AHA), with support from hospitals, health centers, other hospital associations, and the tech sector. The issue stems from the - [Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation](https://texashealthlaw.com/telemedicine-prescribing-of-controlled-substances-when-the-practitioner-and-the-patient-have-not-had-a-prior-in-person-medical-evaluation/) - When the public health emergency ends, so do many of the waivers that were created to facilitate healthcare during the pandemic. One such concession involves the The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Act”). Generally, the Act provides that no controlled substance may be delivered, distributed, or dispensed by means of - [What Employers Need to Know about the Mental Health Parity Proposed Regulations](https://texashealthlaw.com/what-employers-need-to-know-about-the-mental-health-parity-proposed-regulations/) - Suzanne G. Odom, for JacksonLewis: On July 25, 2023, the tri-agencies of the Departments of Treasury, Labor, and Health and Human Services (the Departments) issued a compendium of guidance designed to facilitate compliance with the Nonquantitative Treatment Limitation (NQTL) comparative analysis requirements added by the Consolidated Appropriations Act, 2021 (CAA, 2021) as they relate to - [Complex AKS/Stark Complaint Survives Rule 9(b) Particularity Challenge – A Guide for FCA Complaints](https://texashealthlaw.com/complex-aks-stark-complaint-survives-rule-9b-particularity-challenge-a-guide-for-fca-complaints/) - Francis C. Oroszlan, Brett Barnett and Timothy Fry, for McQuireWoods: Generally, a complaint will survive a motion to dismiss if it states a plausible claim and allows a court to reasonably infer the defendant’s liability for the allegations made therein. Merely reciting the elements of a cause of action followed by a general statement of - [New Stark Law Exception and Anti-Kickback Statute Safe Harbor Aim to Combat Physician Burnout](https://texashealthlaw.com/new-stark-law-exception-and-anti-kickback-statute-safe-harbor-aim-to-combat-physician-burnout/) - From Stevens & Lee: The Stark Law exception requires that health care entities make their physician wellness program available to all physicians who practice in the geographic area served by the provider, not just physicians who are a member of the entity’s medical staff or hold clinical privileges. Further, because the AKS applies to all - [Confidentiality of Substance Use Disorder Patient Records: What to Know About Updates to Part 2](https://texashealthlaw.com/confidentiality-of-substance-use-disorder-patient-records-what-to-know-about-updates-to-part-2/) - From Orrick, Herrington & Sutcliffe LLP, by Thora Johnson, Kyle Kessler, Cosmas Robless: The U.S. Department of Health & Human Services (HHS) has updated the Confidentiality of Substance Use Disorder Patient Records regulations (Part 2) to align with HIPAA and HITECH, aiming to improve care coordination while protecting patient privacy. Notably, patient consent for disclosure of - [Now in Effect: Texas Ends Surprise Bills for Ambulance Rides](https://texashealthlaw.com/now-in-effect-texas-ends-surprise-bills-for-ambulance-rides/) - From D Magazine, by Will Maddox: Surprise medical billing has largely been eliminated due to federal and state legislative efforts, but ambulance billing was not included in these regulations. A new Texas law now prevents surprise bills for ambulance services for those with state health insurance plans. Emergency physicians and anesthesiologists were the most common - [New Guidelines Anticipated Following HHS’s Health Cybersecurity Concept Paper](https://texashealthlaw.com/new-guidelines-anticipated-following-hhss-health-cybersecurity-concept-paper/) - From Shutts & Bowen LLP, by Kurtis Hutson, Timothy Monaghan, Ella Shenhav: Updates to HIPAA Security Rule: The Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) plan to update the Health Insurance Portability and Accountability Act (HIPAA) Security Rule and propose new cybersecurity requirements in Spring 2024. These changes aim to - [NIST Publishes SP 800-66 Revision 2, Implementing the HIPAA Security Rule](https://texashealthlaw.com/nist-publishes-sp-800-66-revision-2-implementing-the-hipaa-security-rule/) - From NIST Computer Security Resource Center: The National Institute of Standards and Technology (NIST) has released the final version of Special Publication (SP) 800-66r2 (Revision 2), "Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule: A Cybersecurity Resource Guide". SP 800-66 provides guidance for entities regulated by HIPAA on evaluating and managing risks - [The Corporate Transparency Act: Key Considerations for Health Systems and Practice Management Companies (MSOs/DSOs](https://texashealthlaw.com/the-corporate-transparency-act-key-considerations-for-health-systems-and-practice-management-companies-msos-dsos/) - From Proskauer - Health Care Law Brief, by Andrew Bettwy, Jeffrey Horwitz, David Manko, Jonian Rafti, Elanit Sno, Yuval Tal: The Corporate Transparency Act (CTA), effective January 1, 2024, mandates the creation of a national registry of "beneficial owners" and "company applicants" of entities across the U.S. to counter illicit activities such as money laundering and terrorism financing. - [CMS Updates Guidance to Allow Texting of Patient Orders](https://texashealthlaw.com/cms-updates-guidance-to-allow-texting-of-patient-orders/) - From Robinson & Cole, by Nathaniel Arden: On February 8, 2024, the Centers for Medicare and Medicaid Services (CMS) updated its 2018 memorandum to now allow the texting of patient orders among a patient's healthcare team. The 2018 memorandum stated that texting of patient orders did not comply with hospital and critical access hospital (CAH) - [Telehealth and the Evolving Landscape of Medicare Requirements](https://texashealthlaw.com/telehealth-and-the-evolving-landscape-of-medicare-requirements/) - From Verrill, by Amanda Beauregard, Andrew Ferrer: Telehealth Importance and Changes Post-Pandemic: Telehealth has been crucial during the COVID-19 pandemic, especially for behavioral and mental health services. The U.S. Department of Health & Human Services (HHS) facilitated its expanded use by easing Medicare regulations. Key changes included recognizing a patient's home as an "originating site" and allowing - [HIPAA and Part 2 Harmonized: What Health Care Organizations Need to Know](https://texashealthlaw.com/hipaa-and-part-2-harmonized-what-health-care-organizations-need-to-know/) - From Foley & Lardner LLP, by Jane Blaney, Jennifer J. Hennessy, Aaron T. Maguregui: Part 2 Final Rule Implementation: The U.S. Department of Health & Human Services (HHS) issued the Part 2 Final Rule to revise the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations. This rule, effective 60 days post-publication, implements provisions of the 2020 - [Corporate Transparency Act and Health Care Providers](https://texashealthlaw.com/corporate-transparency-act-and-health-care-providers/) - From AHLA, by Christopher Conn and Patrick Dunbar: The Corporate Transparency Act (CTA), effective from January 1, 2024, mandates domestic and foreign legal entities operating in the U.S. to report beneficial ownership information to the Financial Crimes Enforcement Network (FinCEN), with certain exemptions. This is to regulate "shell" companies often associated with illicit activities. Health - [Confidentiality of Substance Use Disorder Records Now More Closely Aligned With HIPAA](https://texashealthlaw.com/confidentiality-of-substance-use-disorder-records-now-more-closely-aligned-with-hipaa/) - From Fox Rothschild, by Elizabeth G. Litten: Part 2 records may be disclosed pursuant to the patient’s written consent, which may be a single consent for all future uses and disclosures for treatment, payment, and health care operations (as such terms are defined under HIPAA) Part 2 records may be disclosed to a public health - [HTI-1 Final Rule in Effect](https://texashealthlaw.com/hti-1-final-rule-in-effect/) - From The HIPAA Journal, by Steve Adler: The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule, issued by the HHS’ Office of the National Coordinator for Health Information Technology (ONC), took effect on February 8, 2024. It implements provisions of the 21st Century Cures Act and updates - [Rx for Safety: Workplace Violence Policies in Healthcare Settings](https://texashealthlaw.com/rx-for-safety-workplace-violence-policies-in-healthcare-settings/) - From Akerman, LLP, by Emily C. Ayvazian and Danielle C. Gordet: Healthcare workers are five times more likely to experience workplace violence than workers in other industries, according to the U.S. Bureau of Labor Statistics, a trend that has been exacerbated by the COVID-19 pandemic. The Occupational Safety and Health Administration (OSHA) has identified this - [Data Broker Allegedly Selling De-Anonymized Info to Face FTC Lawsuit After All](https://texashealthlaw.com/data-broker-allegedly-selling-de-anonymized-info-to-face-ftc-lawsuit-after-all/) - From Ars Technica, by Ashley Belanger: The Federal Trade Commission (FTC) has succeeded in keeping its case against geolocation data broker Kochava alive, alleging that the company has been selling vast amounts of data in violation of the FTC Act. The FTC accuses Kochava of selling data obtained from millions of mobile devices across the - [7 HIPAA Predictions For 2024](https://texashealthlaw.com/7-hipaa-predictions-for-2024/) - From Becker's Hospital Review, by Madeline Ashley: The Office for Civil Rights (OCR) is expected to increase enforcement actions for violations of HIPAA security and breach notification rules, with a predicted record number of civil monetary penalties and settlements in 2024. The HIPAA right of access will continue to be a focus for OCR enforcement - [2024 Privacy Compliance: Are You Ready For It?](https://texashealthlaw.com/2024-privacy-compliance-are-you-ready-for-it/) - From InfoLawGroup LLP, by Justine Young Gottshall: New State Privacy Laws: In 2024, Texas, Oregon, Florida, and Montana will implement new privacy laws, requiring businesses to update their policies, intake forms, and responses, and obtain opt-in consent for sensitive data collection. Similar laws will take effect in Delaware, New Hampshire, New Jersey, and Tennessee in - [Telehealth’s Roadblock: The Issue with State Licensure Requirements](https://texashealthlaw.com/telehealths-roadblock-the-issue-with-state-licensure-requirements/) - From Epstein Becker Green, by Amy Cooperstein, Amy Lerman, and Kyla Portnoy: The surge in telehealth services due to COVID-19 has highlighted regulatory challenges faced by providers. These regulations, which vary by state, govern aspects such as who can provide telehealth services, what services can be provided, and where providers must be located. A common requirement is - [New AI Technique Significantly Boosts Medicare Fraud Detection](https://texashealthlaw.com/new-ai-technique-significantly-boosts-medicare-fraud-detection/) - From Medical Xpress, by Florida Atlantic University: Medicare is frequently targeted by fraudulent insurance claims, with the estimated annual fraud amounting to over $100 billion. Traditional methods of detecting fraud, which involve manual inspection of claims by a limited number of auditors, are often insufficient due to the volume and complexity of the data. A - [DOJ, FTC Looking at Roll-Up Acquisitions for Anticompetitive Acts](https://texashealthlaw.com/doj-ftc-looking-at-roll-up-acquisitions-for-anticompetitive-acts/) - From The National Review, by Jessica Sprovtsoff of ArentFox Schiff LLP: In December 2023, the White House announced plans to intensify antitrust scrutiny in the healthcare sector, focusing particularly on "roll-up" acquisitions, a practice where a company acquires several smaller entities, potentially leading to market consolidation. This strategy can potentially violate antitrust laws, but each - [Wellness Apps and Privacy](https://texashealthlaw.com/wellness-apps-and-privacy/) - From Seyfarth Shaw LLP, by Diane Dygert: Employers are increasingly interested in providing wellness tools, such as apps and wearables, to enhance employee benefits. These tools, which cover various areas like mental health, physical fitness, and financial fitness, are relatively inexpensive and easily accessible. The Health Insurance Portability and Accountability Act (HIPAA) protects the privacy - [The Corporate Transparency Act: A Reporting Guide for Medical Groups and MSOs](https://texashealthlaw.com/the-corporate-transparency-act-a-reporting-guide-for-medical-groups-and-msos/) - From Sheppard Mullin Richter & Hampton LLP, by John Golembesky, Jordan Grushkin, Leonard Lipsky, Kathleen O’Neill, Richard Rifenbark, and Carolyn Young: The Corporate Transparency Act (CTA) of 2021 mandates that any "reporting company" must submit a Beneficial Ownership Information Report (BOIR) to the Department of the Treasury’s Financial Crimes Enforcement Network (FinCEN). This report includes identification details of - [Houston Dental Clinic Operator Convicted in $6M Pediatric Fraud Scheme](https://texashealthlaw.com/houston-dental-clinic-operator-convicted-in-6m-pediatric-fraud-scheme/) - From Press Release, United States Attorney’s Office, Southern District of Texas: Rene Gaviola, operator of Floss Family Dental Care clinic in Houston, admitted to submitting fraudulent claims to Medicaid for pediatric dental services that were not provided. Gaviola confessed to employing unlicensed individuals to practice dentistry on Medicaid-insured children and operating the clinic without any - [Researchers Observe Increase in Emerging Ransomware Groups Targeting Healthcare](https://texashealthlaw.com/researchers-observe-increase-in-emerging-ransomware-groups-targeting-healthcare/) - From HealthIT Security, by Jill McKeon: The healthcare sector experienced significant data breaches in 2023, with over 540 organizations reporting such incidents, largely due to ransomware attacks. Healthcare was the third-most targeted industry, following manufacturing and technology. The GuidePoint Research and Intelligence Team (GRIT) identified 63 distinct ransomware groups responsible for these attacks, with established - [CMS Finalizes its Proposal to Advance Interoperability and Improve Prior Authorization Processes](https://texashealthlaw.com/cms-finalizes-its-proposal-to-advance-interoperability-and-improve-prior-authorization-processes/) - From Sheppard Mullin Richter & Hampton LLP, by Gianfranco Spinelli and Krysten Thomas: Final Rule Issued by CMS: The Centers for Medicare and Medicaid Services (CMS) issued a final rule titled "CMS Interoperability and Prior Authorization" on January 17, 2024, which aims to advance interoperability and improve prior authorization processes. This rule impacts Medicare Advantage - [Physician's Assistant Convicted at Trial of Amniotic Fluid Scam](https://texashealthlaw.com/physicians-assistant-convicted-at-trial-of-amniotic-fluid-scam/) - From Press Release, United States Attorney’s Office, Northern District of Texas: A 36-year-old physician’s assistant at a Fort Worth pain management clinic has been convicted of conspiracy to commit health care fraud and 12 counts of healthcare fraud. The PA submitted claims to Medicare for injections of unapproved amniotic fluid for pain management. Although some - [HHS Releases Voluntary Cybersecurity Performance Goals to Beef Up Healthcare's Digital Defenses](https://texashealthlaw.com/hhs-releases-voluntary-cybersecurity-performance-goals-to-beef-up-healthcares-digital-defenses/) - From Fierce Healthcare, by Dave Mulio: The Department of Health and Human Services (HHS) has published voluntary cybersecurity performance goals for healthcare organizations, aiming to enhance industry-wide cybersecurity. The goals are hosted on a new website launched by the department to centralize cybersecurity resources from various government groups. The goals are divided into two categories: - [New California Law Imposes Significant Data Management Requirements for Sensitive Health Data](https://texashealthlaw.com/new-california-law-imposes-significant-data-management-requirements-for-sensitive-health-data/) - From Troutman Pepper, by Brent Hoard, Emma Trivax, and Erin Whaley: Effective January 1, AB 352 introduces significant changes to the management and sharing of sensitive health information in California, particularly related to reproductive health services. The bill amends the existing [[Reproductive Privacy Act and the Confidentiality of Medical Information Act (CMIA)]] and several other - [Recent $345 Million Settlement Underscores Critical Importance of Appropriate Physician Compensation](https://texashealthlaw.com/recent-345-million-settlement-underscores-critical-importance-of-appropriate-physician-compensation/) - From Baker Donelson, by Alissa Fleming and Joseph Keillor: An Indianapolis-based health system recently settled with the Department of Justice for $345 million due to allegations of Stark Law and False Claims Act violations related to its physician compensation arrangements, highlighting the importance of appropriately structuring physician compensation to avoid fraud and abuse enforcement. The - [Supreme Court Eyes World War II Era Doctrine for Agency Rules](https://texashealthlaw.com/supreme-court-eyes-world-war-ii-era-doctrine-for-agency-rules/) - From Bloomberg Law, by Kimberly Strawbridge Robinson: The Supreme Court signaled its intention to replace the Chevron doctrine with the Skidmore doctrine during arguments in recent cases. The Chevron doctrine, from a 1984 ruling, requires judges to defer to agency interpretations of a statute if reasonable, while the Skidmore doctrine, from a 1944 ruling, only - [Is Apple Pay HIPAA Compliant?](https://texashealthlaw.com/is-apple-pay-hipaa-compliant/) - From The HIPAA Journal, by Steve Alder: Apple Pay and HIPAA Compliance: Despite not being HIPAA compliant, Apple Pay can be used by healthcare providers and health plans to collect payments. The service is exempt from HIPAA under §1179 of the HIPAA Act, which applies to entities engaged in payment processing activities. How Apple Pay - [Hospitals Owned by Private Equity Are Harming Patients, Reports Find](https://texashealthlaw.com/hospitals-owned-by-private-equity-are-harming-patients-reports-find/) - From Ars Technica, by Beth Mole: Private equity firms, particularly Apollo Global Management, are increasingly acquiring hospitals across the US, a trend that has led to a decline in the quality of care, according to reports by the Private Equity Stakeholder Project (PESP) and a study in JAMA. Apollo Global Management, through Lifepoint and ScionHealth, - [Overlooking Executive Comp Packages Puts M&A Deals at Risk](https://texashealthlaw.com/overlooking-executive-comp-packages-puts-ma-deals-at-risk/) - From Bloomberg Law, by Ian Sherwin (Reed Smith): Compensation and Motivation: Understanding the compensation structures and philosophies of a target company is crucial in M&A transactions. This includes executive compensation, which can be a significant cost, involving base salary, bonuses, severance entitlements, and health and welfare programs. It's also subject to various tax, securities, corporate, - [What Do Threads, Mastodon, and Hospital Records Have in Common?](https://texashealthlaw.com/what-do-threads-mastodon-and-hospital-records-have-in-common/) - From Ars Technica, by Fintan Burke: The concept of "federated learning", inspired by the privacy-focused structure of new social media platforms, is being adopted by medical researchers to train AI in spotting disease trends. In this approach, user data is hosted on independent servers instead of a single corporate entity, which promotes data privacy and - [Up and Up and Up: Accounting for Supply Cost Inflation in Due Diligence](https://texashealthlaw.com/up-and-up-and-up-accounting-for-supply-cost-inflation-in-due-diligence/) - From VMG Health, by Johnny Zizzi, CPA, and Melissa Hoelting, CPA: Inflation-Adjusted Financial Analysis: In periods of high inflation, traditional financial metrics may not accurately depict a company's performance. It is essential to adjust financial analysis for inflation, especially in the healthcare sector where supply costs have been significantly rising. Businesses must assess their ability - [Providers Target Insurers in New Surprise Billing Legal Scuffles](https://texashealthlaw.com/providers-target-insurers-in-new-surprise-billing-legal-scuffles/) - From Bloomberg Law, by Sara Hansard: Health care providers are increasingly suing insurers for not making timely arbitration award payments under the No Surprises Act, creating a new hurdle in the implementation of the billing dispute resolution system. These lawsuits are expected to rise as more claims move through the system and are potentially batched - [Texas Medical Board Cracking Down on IV Hydration](https://texashealthlaw.com/texas-medical-board-cracking-down-on-iv-hydration/) - From Hendershot & Cowart, PC, by Keith Lefkowitz: The Texas Medical Board (TMB) has addressed the rise of medical business models offering intravenous (IV) vitamin therapy or hydration, cautioning that these could potentially violate Texas regulations. TMB President, Dr. Sherif Zaafran, emphasized that IV therapy is a medical procedure and must be conducted under the - [Key Considerations for Healthcare Providers Responding to Law Enforcement Requests](https://texashealthlaw.com/key-considerations-for-healthcare-providers-responding-to-law-enforcement-requests/) - From Quarles & Brady LLP, by Simone Colgan Dunlap, Sarah Coyne, Kaitlyn Fydenkevez, Meghan O’Connor: Current HIPAA rules permit healthcare providers to disclose protected health information (PHI) to law enforcement under specific circumstances, such as to comply with a court order, respond to an administrative request, or in cases of identifying a suspect or victim, - [HHS-OIG Determines Consultant’s Gift Cards Given to Physicians Recommending Services Do Not Implicate Anti-Kickback Statute](https://texashealthlaw.com/hhs-oig-determines-consultants-gift-cards-given-to-physicians-recommending-services-do-not-implicate-anti-kickback-statute/) - From Barnes & Thornburg, by Jason D. Schultz and Mary Elizabth “Lizzy” Ford: The U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) issued Advisory Opinion No. 23-15, permitting a consulting services company to offer gift cards as incentives for physician practices to recommend its services to other physicians. The company provides - [OIG Approves Hospital’s Redemption Offer to Retiring Physician-Owners](https://texashealthlaw.com/oig-approves-hospitals-redemption-offer-to-retiring-physician-owners/) - From Bass, Berry & Sims, PLC, by Justin Brown, Krista Cooper, Ashley Gholston Fowler, Travis Lloyd: The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 23-12 on January 3, approving a plan by a physician-owned hospital to redeem the ownership interests of physicians who retire at 67 - [Is Stripe HIPAA Compliant?](https://texashealthlaw.com/is-stripe-hipaa-compliant/) - From The HIPAA Journal, by Steve Adler: Stripe's Non-HIPAA Compliance: Despite being compliant with various US and international data privacy regulations, Stripe is not HIPAA compliant. This is due to its method of recording personal data within transaction data, which is then used for fraud detection and shared with third-party payment providers, some of which - [The Most Critical Elements of the FTC’s Health Breach Rulemaking](https://texashealthlaw.com/the-most-critical-elements-of-the-ftcs-health-breach-rulemaking/) - From Lawfare, by Justin Sherman and Devan Desai, The Federal Trade Commission (FTC) is considering modifications to its Health Breach Notification Rule (HBNR), which governs how non-HIPAA-covered entities handle health data breaches. The proposed changes aim to keep up with technological advancements and trends in the health tech and data landscapes. The FTC's proposal comes - [HHS Issues First Settlement for HIPAA Violations Related to a Ransomware Attack](https://texashealthlaw.com/hhs-issues-first-settlement-for-hipaa-violations-related-to-a-ransomware-attack/) - From Hall Benefits Law, by Anne Tyler Hall: The U.S. Department of Health and Human Services (HHS) reached a settlement with a Massachusetts-based medical management company for alleged violations of HIPAA's Privacy and Security Rules. The company, a HIPAA business associate, will pay $100,000 and comply with a three-year corrective action plan (CAP). The investigation - [Ownership Transparency: The New Normal in Healthcare?](https://texashealthlaw.com/ownership-transparency-the-new-normal-in-healthcare/) - From Davis Wright Tremain, LLP, by Megan Leonard and Robert G. Homchick, On November 17, 2023, the U.S. Department of Health and Human Services published a final rule requiring Medicare and Medicaid nursing facilities to provide more detailed ownership and managerial information on the Medicare Enrollment Application Form CMS-855A. Private equity's role in the healthcare - [US Enforcement of Emergency Abortion Rule Halted in Texas](https://texashealthlaw.com/us-enforcement-of-emergency-abortion-rule-halted-in-texas/) - From Bloomberg Law, by Mary Anne Pazanowski and Ian Lopez: The Fifth Circuit has ruled that the Biden administration's guidance document, intended to protect abortion access nationwide, cannot be enforced due to a failure to follow proper rulemaking procedures. The guidance document added new obligations under the Emergency Medical Treatment and Labor Act, rather than - [OCR Doubles Down: Two Settlements in Two Months for Two Common Cybersecurity Issues](https://texashealthlaw.com/ocr-doubles-down-two-settlements-in-two-months-for-two-common-cybersecurity-issues/) - From Taft Stettinius & Hollister LLP, by Ike Willett & Cory Brennan: On December 7, 2023, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR), announced a settlement with a Louisiana medical group following a phishing attack that affected the PHI of approximately 34,862 individuals. This marks the first settlement OCR - [FDA Warns Against Unauthorized Fat-Melting Injection Treatments](https://texashealthlaw.com/fda-warns-against-unauthorized-fat-melting-injection-treatments/) - From NBC News, by Berkeley Lovelace Jr.: The FDA has issued a warning about the dangers of using unauthorized versions of fat-dissolving injections, citing reports of severe side effects such as scarring, infections, and skin deformities. These injections, also known as lipolysis injections, are typically used in problem areas such as the chin, legs, upper - [FTC Seeks to Put Private Equity Roll-Up Strategies to Sleep With its Case Against U.S. Anesthesia Partners](https://texashealthlaw.com/ftc-seeks-to-put-private-equity-roll-up-strategies-to-sleep-with-its-case-against-u-s-anesthesia-partners/) - From Winston & Strawn, by Neely Agin and Hannah Gallagher, writing for AHLA (Subscription): FTC and DOJ have increased regulatory scrutiny on the health care industry, particularly private equity investors. FTC Chairwoman Lina Khan has expressed concern over "roll-up" or consolidation strategies in the health care industry, citing potential negative effects on quality of care - [Private Investors and Digital Health Attracting Oig Attention: General Compliance Program Guidance to Watch](https://texashealthlaw.com/private-investors-and-digital-health-attracting-oig-attention-general-compliance-program-guidance-to-watch/) - From McDermott, Will & Emery, by Tony Maida, Dale C. Van Demark, Monica Wallace: The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) has published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance community and other stakeholders. The GCPG specifically references technology companies - [HHS Finalizes Regulation of Certain AI](https://texashealthlaw.com/hhs-finalizes-regulation-of-certain-ai/) - From Manatt, Phelps & Phillips, LLP, by Alex Dworkowitz, Alice Leiter, and Randi Seigel: The U.S. Department of Health and Human Services (HHS) has finalized a rule to regulate the use of artificial intelligence (AI) in health care. The rule applies to predictive algorithms used in electronic health record (EHR) systems. It requires transparency in - [FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information](https://texashealthlaw.com/fdas-final-rule-on-direct-to-consumer-advertising-presentation-of-risk-information/) - From Foley & Lardner, LLP, by Kyle Gaget and Jordan Smiley: The FDA has released a final rule regarding direct-to-consumer (DTC) advertising for prescription drugs and biologics. The rule requires that DTC ads include the most important risks associated with the drug or biologic being advertised. The FDA has also clarified that companies can include - [Feds Levy First-Ever HIPAA Fine for a Phishing Breach](https://texashealthlaw.com/feds-levy-first-ever-hipaa-fine-for-a-phishing-breach/) - From Govinfo Security, by Marianne Colbasuk McGee: The Department of Health and Human Services has issued the first ever HIPAA fine for a phishing breach, highlighting the importance of cybersecurity in the healthcare industry. The fine was imposed on a medical practice that failed to adequately protect the sensitive information of its patients, resulting in - [The Growing Causal Divide: But-For Causation in AKS/FCA Actions](https://texashealthlaw.com/the-growing-causal-divide-but-for-causation-in-aks-fca-actions/) - From McGuireWoods, by Renee Kumon, Timothy Fry and Brett Barnett: The District of Massachusetts Court recently joined the Sixth and Eighth Circuits in requiring the government to show a direct tie between kickbacks and referrals that proximately caused claims to federal healthcare programs to prevail in Anti-Kickback Statute (AKS) and False Claims Act (FCA) actions. - [FDA Issues Revised Off-Label Communications Guidance](https://texashealthlaw.com/fda-issues-revised-off-label-communications-guidance/) - From Jones Day, by Anthony Dick, Harrison Farmer, Colleen Heisey, Laura Laemmle-Weidenfeld, Rebecca Martin: The FDA has issued a revised draft guidance on the sharing of scientific information with healthcare providers (HCPs) regarding unapproved uses of approved/cleared medical products. The 2023 Guidance expands the scope of recommendations to include independent clinical practice resources and firm-generated - [CMS Issues Interim Rule in Response to State Medicaid Disenrollment Trend](https://texashealthlaw.com/cms-issues-interim-rule-in-response-to-state-medicaid-disenrollment-trend/) - From Nelson Mullins Riley & Scarborough LLP, by Shane Duer, Knicole Emanuel, Cara Ludwig: The Centers for Medicare & Medicaid Services (CMS) has issued an interim rule in response to the trend of states disenrolling recipients from the Medicaid program. The rule aims to limit the removal of recipients from the program for procedural reasons - [What Cigna’s FCA Settlement Means for Other Medicare Advantage Plans](https://texashealthlaw.com/what-cignas-fca-settlement-means-for-other-medicare-advantage-plans/) - From HealthPayerIntelligence, Victoria Bailey: Cigna’s recent brush with False Claims Act violations serves as a reminder that Medicare Advantage organizations should be routinely assessing their risk and compliance activities. The United States alleged that Cigna submitted inaccurate and untruthful patient diagnosis data to receive additional payments from CMS and did not withdraw the inaccurate data - [Two Dallas Physicians Charged in $12 Million Fraud Scheme](https://texashealthlaw.com/two-dallas-physicians-charged-in-12-million-fraud-scheme-2/) - From D Magazine, by Will Maddox: Drs. Desi and Deno Barroga were indicted for allegedly receiving $12 million from fraudulent claims and illegally distributing hydrocodone to patients from the Dallas pain management clinic where they operated. While at the clinic, the Barrogas would bill insurance for injections of anti-inflammatory steroids without administering the medicine. According - [The New Health Privacy Landscape—Out of the Frying Pan and Into the Fire](https://texashealthlaw.com/the-new-health-privacy-landscape-out-of-the-frying-pan-and-into-the-fire/) - From Perkins Coie, by Stephanie Duchesneau, Susan Fahringer, Meredith Halama, Janis Kestenbaum: The legal landscape around health privacy has become much more complex in recent years, with more entities and types of data now subject to regulation and enforcement. The FTC has taken a broader view of what constitutes sensitive health data and has pursued - [Enhanced Nursing Home Ownership Data Required by Biden HHS](https://texashealthlaw.com/enhanced-nursing-home-ownership-data-required-by-biden-hhs/) - From Bloomberg Law, by Tony Pugh: The Biden administration finalized a rule requiring nursing homes to provide more detailed information about their ownership structure, including whether they are owned by private equity firms or real estate investment trusts (REITs). The additional data collected will be made public to allow families to make more informed choices - [OIG Publishes a New Guidance Resource and a Report](https://texashealthlaw.com/oig-publishes-a-new-guidance-resource-and-a-report/) - OIG released our General Compliance Program Guidance (GCPG). The GCPG is a reference guide for the health care compliance community and other health care stakeholders. The GCPG provides information about relevant Federal laws, compliance program infrastructure, OIG resources, and other items useful for understanding health care compliance. The GCPG is voluntary guidance that discusses general - [Defending Executive Compensation in Nonprofit Health Care Systems](https://texashealthlaw.com/defending-executive-compensation-in-nonprofit-health-care-systems/) - From American Health Law Association, by Albert Lin, Husch Blackwell LLP, and Connor Campbell, Weaver and Tidwell LLP: This article reviews the rules surrounding the IRS principles of executive compensation with a focus on health care organizations and discusses best practices that the governing boards of such organizations should look for in exercising their fiduciary - [Advisory Opinion 23-7 OIG Issues Favorable Opinion Regarding Proposal to Pay Bonuses to Its Employed Physicians Based on Net Profits](https://texashealthlaw.com/advisory-opinion-23-7-oig-issues-favorable-opinion-regarding-proposal-to-pay-bonuses-to-its-employed-physicians-based-on-net-profits/) - From Health Law Diagnosis, by Nathaniel Arden & Michael Lisitano: On October 13, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-07, in which the OIG issued a favorable opinion regarding a physician group employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain procedures performed by - [UnitedHealth Defends Lucrative Billing Tactic in Appeals Court](https://texashealthlaw.com/unitedhealth-defends-lucrative-billing-tactic-in-appeals-court/) - From Bloomberg Law, by Jacklyn Wille: "Cross-Plan Offsetting" is the practice by an insurer of clawing back benefits it says were overpaid to a provider under one plan by reducing future payments to the provider under a different plan that it administers. This common insurance billing tactic has invited litigation over its legality and opposition - [False Claims Act Risks for Cyber Device Manufacturers Arising Under New Requirements Subject to FDA Enforcement Beginning October 1, 2023](https://texashealthlaw.com/false-claims-act-risks-for-cyber-device-manufacturers-arising-under-new-requirements-subject-to-fda-enforcement-beginning-october-1-2023/) - From GibsonDunn, by Winston Chan, Jonathan Phillips, Gustav Eyler, John Partridge, Christopher Rosina, Carlo Felizardo, and Nicole Waddick: The FDA approval process for digital health "cyber devices" requires that premarket submissions contain cybersecurity information, including the company’s plans to address cybersecurity vulnerabilities, processes to provide a reasonable assurance that the devices are cybersecure, a software - [Ozempic’s Success Treating Other Ailments Is Bad News for Rivals](https://texashealthlaw.com/ozempics-success-treating-other-ailments-is-bad-news-for-rivals/) - From Bloomberg Law, by Madison Muller: Ozempic, and other GLP-1 receptor agonists, are diabetes medications that have become popular for weight loss. Now, there is evidence that they have other more far-reaching benefits too: They may have a protective effect on the heart, liver and kidneys. They may combat substance abuse or even Alzheimer’s disease. - [Woman’s Death After IV Therapy Leads to License Suspension for Frisco Anesthesiologist](https://texashealthlaw.com/womans-death-after-iv-therapy-leads-to-license-suspension-for-frisco-anesthesiologist/) - From D Magazine, by Will Maddox: The Texas Medical Board suspended Frisco anesthesiologist Dr. Michael Gallagher after a mother of four died in July at a med spa for which he was the medical director. She died after receiving an IV treatment administered by the non-licensed owner of the business. The med spa did not - [Congress Eyeing Broker Payments Behind Booming Medicare Sales](https://texashealthlaw.com/congress-eyeing-broker-payments-behind-booming-medicare-sales/) - From Bloomberg Law, by John Tozzi: About 31 million people – more than half of Medicare enrollees – opt to get their coverage through private plans known as Medicare Advantage. Lawmakers are examining the payments made by health insurers to brokers who sell their Medicare plans, concerned that the payments may be steering seniors to - [CMS Publishes Updated Data on Stark Law Voluntary Disclosures](https://texashealthlaw.com/cms-publishes-updated-data-on-stark-law-voluntary-disclosures/) - From Policy & Medicine, by Thomas Sullivan: 2022 was a stand-out year for Stark Law self-disclosures. It was the highest year in both the number of disclosures settled and the aggregate amount of all settlements for the year. In 2020, a total of 36 settlements were reached, ranging from $33 to $952,300, for a total - [Labs Take Note New OIG Opinion Highlights That Fair Market Value Per Test Payments Can Still Violate the Anti-Kickback Statute Publications](https://texashealthlaw.com/labs-take-note-new-oig-opinion-highlights-that-fair-market-value-per-test-payments-can-still-violate-the-anti-kickback-statute-publications/) - From Bass, Berry & Sims, by Jennifer E. Michael & Danielle M. Sloane: The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, wherein the OIG reiterated its longstanding position that carving out federal health care program (FHCP) business from an arrangement does not insulate the arrangement from - [Patient Privacy: Preventing Data Leakage in Healthcare](https://texashealthlaw.com/patient-privacy-preventing-data-leakage-in-healthcare/) - From Security Boulevard, by Chantel Rodrigues: Tracking pixels are tiny, invisible images or code snippets embedded in web pages, emails, or mobile apps. They can be used for legitimate purposes, such as monitoring website traffic, measuring user engagement, and improving user experience. They can also lead to data leakage and privacy breaches, which can constitute - [HHS OIG Introduces Managed Care Strategic Plan](https://texashealthlaw.com/hhs-oig-introduces-managed-care-strategic-plan/) - From Squire Patton Boggs, by Bevan Blake: In response to the continued growth of managed care in government-sponsored health plans over the last several years, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) introduced a new “Strategic Plan for Oversight of Managed Care for Medicare and Medicaid.” - [Healthcare AI and HIPAA Compliance](https://texashealthlaw.com/healthcare-ai-and-hipaa-compliance/) - From AI in Healthcare by Dave Pearson: AI can accumulate a large amount of data from many sources. Using large datasets, AI can realistically re-identify previously de-identified healthcare data. Under the HIPAA de-identification safe harbor, even if you remove the 18 specific identifiers, you cannot have actual knowledge that the information could be used alone - [HHS-OIG Says Anatomic Pathology Lab’s Purchased Service Arrangement Could Violate Anti-Kickback Statute](https://texashealthlaw.com/hhs-oig-says-anatomic-pathology-labs-purchased-service-arrangement-could-violate-anti-kickback-statute/) - From Barnes & Thornburg, LLP, by Jason D. Schultz, Anne B. Compton-Brown, Mary Elizabeth “Lizzie” Ford: U.S. Department of Health and Human Services issued an unfavorable opinion addressing an anatomic pathology laboratory that purchases services at fair market value from other labs, and bills commercial payors for such services Even though the proposed arrangement carved - [Federal Judge Rules Government Must Demonstrate "But-For" Causation for Anti-Kickback Statute Claims](https://texashealthlaw.com/federal-judge-rules-government-must-demonstrate-but-for-causation-for-anti-kickback-statute-claims/) - From ArentFox Schiff LLP, by D. Jacques Smith , Randall A. Brater , Michael F. Dearington , Nadia Patel , Heather M. Zimmer: Chief Judge Dennis Saylor of the US District Court for the District of Massachusetts ruled that the federal government must demonstrate but-for causation in order to prove that Regeneron Pharmaceuticals, Inc., the - [U.S. Supreme Court Declines to Clarify Key Provisions of the False Claims and Anti-kickback Statutes](https://texashealthlaw.com/u-s-supreme-court-declines-to-clarify-key-provisions-of-the-false-claims-and-anti-kickback-statutes/) - From Stevens & Lee, by Charles Honart: The Supreme Court declined to resolve a circuit court split on the issue of causation, to wit, when a provider’s claim for reimbursement results from a violation of the Anti-kickback Statute (“AKS”) for purposes of liability under the False Claims Act (“FCA”). Remuneration: A hospital’s decision not to - [Surprise… No Surprises Act Arbitration Is Too Expensive](https://texashealthlaw.com/surprise-no-surprises-act-arbitration-is-too-expensive-akerman-llp-health-law-rx-jdsupra/) - Kirk Davis, Danielle Gordet, writing for Akerman: In December of 2022, the Departments had increased the fee from $50 to $350, effective January 1, 2023, to address “the rising volume of disputes and additional expenditures associated with the Departments’ enhanced role in 2023 in conducting pre-eligibility reviews to address the backlog of disputes.” Thereafter, the - [Texas Amends Data Breach Notification Law](https://texashealthlaw.com/texas-amends-data-breach-notification-law/) - Julia K. Kadish, writing for SheppardMullin: Texas recently enacted an amendment to its data breach notification law. As of September 1, 2023, there are two changes to the requirements when notifying the Texas Attorney General. In Texas, breaches of 250 residents or more must be reported to the Attorney General. Now, as amended, this will need to - [The Evolution of Telehealth and What’s Next](https://texashealthlaw.com/the-evolution-of-telehealth-and-whats-next/) - James Tekippe, CFA, writing for VMG Health: For those in the healthcare industry, telemedicine has been viewed as a way to increase access to healthcare, while mitigating the challenges of limited resources of physicians and healthcare providers. Although the use of telehealth has steadily grown over the past two decades, the challenges presented by the - [New Texas Medical Billing Requirements Can Leave Hospitals and Other Health Care Facilities Unable to Collect for Services Provided](https://texashealthlaw.com/new-texas-medical-billing-requirements-can-leave-hospitals-and-other-health-care-facilities-unable-to-collect-for-services-provided/) - Joe Lecroy, Tracie Bedeauxm, writing for Katton: Starting September 1, 2023, health care facilities in Texas will have to make changes to their billing practices to comply with a newly passed law requiring greater transparency in medical billing ... A health care provider that requests payment from a patient after providing a health care service - [It’s a Long Way From Here to There: Advanced Healthcare Practitioners, EMTALA’s Call Coverage Requirements, and Rural Hospitals](https://texashealthlaw.com/its-a-long-way-from-here-to-there-advanced-healthcare-practitioners-emtalas-call-coverage-requirements-and-rural-hospitals/) - Nick Healey, writing for HuschBlackwell | Healthcare Law Insights: In an attempt to fill out the call schedule, however, some rural hospitals list advanced healthcare practitioners (AHP’s) with specialized training (such as psychiatric nurse practitioners, or certified nurse midwives) on the physician call schedule for those specialties. This practice, although well-intentioned, could lead a hospital - [Unfavorable OIG Advisory Opinion Issued for a Proposed Venture with Surgeon Owners but Managed by Others](https://texashealthlaw.com/unfavorable-oig-advisory-opinion-issued-for-a-proposed-venture-with-surgeon-owners-but-managed-by-others/) - Tom Greeson, writing for ReedSmith: Although it is possible to enter into business ventures with referral sources, care needs to be taken to ensure that the arrangement does not run afoul of the Medicare fraud and abuse laws. This month, the U.S. Health and Human Services Office of the Inspector General (OIG) refused to give - [Our Health Care System May Soon Receive a Much-Needed Cybersecurity Boost](https://texashealthlaw.com/our-health-care-system-may-soon-receive-a-much-needed-cybersecurity-boost/) - Lily Hay Newman, writing for Wired.com and Ars Technica: The Advanced Research Projects Agency for Health (Arpa-H), a research support agency within the United States Department of Health and Human Services, said today that it is launching an initiative to find and help fund the development of cybersecurity technologies that can specifically improve defenses for - [OIG Again Concludes That Online Health Care Provider Marketplace Does Not Violate Fraud and Abuse Laws](https://texashealthlaw.com/oig-again-concludes-that-online-health-care-provider-marketplace-does-not-violate-fraud-and-abuse-laws/) - Douglas A. Grimm, Gayland O. Hethcoat II, writing for ArentFox Schiff: In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online provider marketplace. As in an earlier 2019 opinion, OIG concluded that - [Antitrust & Competition Healthcare Quarterly Update Q2 2023](https://texashealthlaw.com/antitrust-competition-healthcare-quarterly-update-q2-2023/) - Andrew Lacy, Arman Oruc, John Goheen Kevin Walsh, and Andrew Jensen, writing for Goodwin Procter: In the second quarter, the US antitrust agencies continued efforts to bolster their aggressive enforcement agenda by rewriting long-standing policies and procedures, including sweeping revisions to Merger Guidelines, significant changes to the HSR filing process, and withdrawing long-established antitrust healthcare - [After Hearing Arguments, Future of Planned Parenthood in Texas Rests with Federal Judge](https://texashealthlaw.com/after-hearing-arguments-future-of-planned-parenthood-in-texas-rests-with-federal-judge/) - Dallas Morning News: Texas officially ousted the organization from the state’s Medicaid program in 2021 after four years of trying and a subsequent legal battle. Planned Parenthood continued to collect Medicaid payments from the state during legal appeals, $17 million the state says the health care group should now pay back, in addition to fines - [Hospital Mergers Double the Risk of a Data Breach, Study Shows](https://texashealthlaw.com/hospital-mergers-double-the-risk-of-a-data-breach-study-shows/) - Joseph J. Lazzarotti, writing for JacksonLewis: A recent study suggests that the likelihood for hospitals to experience a data breach doubles during the year before and after a merger. As some expect an increase in hospital mergers in the coming year, one can expect the number of healthcare data breaches to increase. According to the - [CMS Unveils New Changes to ACO REACH Model](https://texashealthlaw.com/cms-unveils-new-changes-to-aco-reach-model/) - By Noah Tong, for Fierce Healthcarel: Among numerous tweaks, CMS reduced the beneficiary alignment minimum for new entrant accountable care organizations from 5,000 to 4,000. It also reduced minimums for high needs populations. A 10% buffer will be applied across all ACO types, allowing an ACO to temporarily drop below the new beneficiary minimum, but an - [Texas Attorney General’s Medicaid Fraud Control Unit Helps Secure 49-Month Sentence and Over $5 Million Restitution in Orthopedic Supplies Fraud Case](https://texashealthlaw.com/texas-attorney-generals-medicaid-fraud-control-unit-helps-secure-49-month-sentence-and-over-5-million-restitution-in-orthopedic-supplies-fraud-case-2/) - This is a common tale. It seems like most of my time is spent explaining to clients why you cannot pay marketers a percentage of the revenue derived from patients they refer to them. Press Release from Texas Attorney General: Griffin obtained patients by offering and paying kickbacks to marketers as well as disguising illegal - [Healthcare Industry Faces Heightened Antitrust Scrutiny Under New Merger Guidelines, HSR Rules](https://texashealthlaw.com/healthcare-industry-faces-heightened-antitrust-scrutiny-under-new-merger-guidelines-hsr-rules-healthcare-law-insights/) - By Wendy Arends, Mark Tobey & Kelsey Toledo, for HuschBlackwell: The draft Merger Guidelines were published on July 19, 2023, by the Agencies just weeks after the FTC issued newly proposed rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR). The Merger Guidelines represent a significant departure from the 2010 Horizontal and Vertical Merger - [OIG Issues Final Information Blocking Enforcement Rule and Highlights the Potential for Referrals to the FTC and FCA Liability](https://texashealthlaw.com/oig-issues-final-information-blocking-enforcement-rule-and-highlights-the-potential-for-referrals-to-the-ftc-and-fca-liability/) - By Ryan P. Blaney & Jonian Rafti, for Proskauer: The Final Rule codifies the prohibition on “information blocking” introduced by the 21st Century Cures Act (“Act”), which was enacted on December 13, 2016. In the Act, “information blocking” was defined as any activity that, in part, is “likely to interfere with, prevent, or materially discourage - [Private Equity in Healthcare Is Under A Microscope, So What’s Next?](https://texashealthlaw.com/private-equity-in-healthcare-is-under-a-microscope-so-whats-next/) - Jacqueline LaPointe, for RevCycle Intelligence: As of 2019, private equity entities accounted for 65 percent of physician practice acquisitions, representing the vast majority of physician deals, according to data from the American Hospital Association (AHA). ... Researchers from several universities, including the University of Chicago and Columbia University, found that private equity acquisitions in every - [5 Steps to Ensure HIPAA Compliance on Mobile Devices](https://texashealthlaw.com/5-steps-to-ensure-hipaa-compliance-on-mobile-devices/) - For mobile devices used by your providers and staff (your mobile endpoints), Michael Goad, for TechTarget, suggests: 1. Ensure devices and data are secure and encrypted … Encrypting mobile data prevents unauthorized access and protects patient information. [Use] strong encryption protocols for … Data transmission and storage … Regularly monitoring systems for potential security issues, OS - [New Regulations on Health Care Transactions in California](https://texashealthlaw.com/new-regulations-on-health-care-transactions-in-california/) - While this blog is focused on Texas and federal law, many of our clients offer telehealth or Internet-centric services which implicate the laws of other states. Andrew J. Demetriou, for HuschBlackwell, discusses new California regulations that "contemplate a dramatic expansion of state review of transactions affecting health care services." When approved, final regulations would be - [Attacks at US Hospitals Show Why Health Care Is One of the Nation’s Most Violent Fields](https://texashealthlaw.com/attacks-at-us-hospitals-show-why-health-care-is-one-of-the-nations-most-violent-fields/) - Rebecca Boone, for AP News: Data shows American health care workers now suffer more nonfatal injuries from workplace violence than workers in any other profession, including law enforcement. ... It’s not just deadly shootings: Health care workers racked up 73% of all nonfatal workplace violence injuries in 2018, the most recent year for which figures are - [Should Patient Consent Be Considered When Using AI/RPA Technology for Prior Authorization?](https://texashealthlaw.com/should-patient-consent-be-considered-when-using-ai-rpa-technology-for-prior-authorization/) - From Physician’s Weekly: The HIPAA Privacy Rule doesn’t specify provisions for protecting PHI data entered in AI technologies. What the rule does stipulate is that healthcare entities are not obligated to get patient consent for interoperability and electronic exchange of PHI. Certain states or entities, however, adopted bills, policies, regulations, or statutes requiring opt-in or - [How to Measure Acuity-Adjusted Panel Size for Contemporary Provider Compensation Plans](https://texashealthlaw.com/how-to-measure-acuity-adjusted-panel-size-for-contemporary-provider-compensation-plans/) - A report from VMG Health by Anthony Domanico, CVA, and Ben Minnis discussing the growing trend of introducing empanelment metrics into compensation formulas: Empanelment can take on many forms in the compensation system, but all metrics center around the size of a particular primary care provider's (PCP's) patient panel (i.e., panel size and/or acuity-adjusted panel size), - [FTC Emerges as Leader in Health Privacy Enforcement](https://texashealthlaw.com/ftc-emerges-as-leader-in-health-privacy-enforcement/) - Kirk J. Nahra, Ali A. Jessani, and Samuel Kane, for WilmerHale: In the past several weeks, the FTC has taken two additional actions that further signal its emergence as a leading regulatory force for health data. First, on July 20, the Commission issued a joint letter with the Department of Health and Human Services’ Office - [OAG Files Appeal to Texas Supreme Court, Blocking Judge’s Injunction in Lawsuit Over Exceptions to State Abortion Laws](https://texashealthlaw.com/oag-files-appeal-to-texas-supreme-court-blocking-judges-injunction-in-lawsuit-over-exceptions-to-state-abortion-laws/) - Erica Pauda, for KXAN: The Office of the Attorney General filed an appeal Saturday to the Texas Supreme Court after a Texas judge issued a temporary injunction over exceptions to state abortion laws, according to a news release from the OAG’s office. The ruling clears things up for doctors on when they can provide abortions. - [Physicians Who Lost Their License Elsewhere Can No Longer Practice in Texas](https://texashealthlaw.com/physicians-who-lost-their-license-elsewhere-can-no-longer-practice-in-texas/) - Will Maddox, for D Magazine: HB 1998 bars physicians who have committed moral terpitude felonies and misdemeanors from practicing in Texas and requires the Texas Medical Board to have closer oversight of physicians. This year’s legislative session scored significant victories for patient safety advocates. Until this year, it was possible for out-of-state physicians who have - [Why Doctors Using ChatGPT Are Unknowingly Violating HIPAA](https://texashealthlaw.com/why-doctors-using-chatgpt-are-unknowingly-violating-hipaa/) - From ScienceBlog: Physicians are using ChatGPT for many things, mainly to consolidate notes. There has been a lot of focus on using AI to quickly find answers to clinical questions, but a lot of practical interest among physicians has also been in summarizing visits or writing correspondence that everybody has to do, but nobody wants - [Texas Attorney General’s Medicaid Fraud Control Unit Helps Secure 49-Month Sentence and Over $5 Million Restitution in Orthopedic Supplies Fraud Case](https://texashealthlaw.com/texas-attorney-generals-medicaid-fraud-control-unit-helps-secure-49-month-sentence-and-over-5-million-restitution-in-orthopedic-supplies-fraud-case/) - Press Release, Texas Attorney General: Kenric Wakeen Griffin, co-owner of New Horizons Durable Medical Equipment based in Frisco, TX, was sentenced to 49 months of federal incarceration to be followed by a year of supervised release for his role in a medical equipment fraud scheme. In addition, Griffin was ordered to pay $5,114,016.19 in restitution - [Biden Administration Announces National Cyber Workforce and Education Strategy](https://texashealthlaw.com/biden-administration-announces-national-cyber-workforce-and-education-strategy/) - Steve Adler, for The HIPAA Journal: The Biden Administration has unveiled its National Cyber Workforce and Education Strategy (NCWES) which seeks to address the current cyber workforce shortages and prepare the country for a cyber future. The NCWES was developed by the Office of the National Cyber Director in collaboration with 34 agencies, departments, and - [Texas Medicaid Fraud Control Unit Helps Dismantle $142 Million Genetic Testing Fraud Scheme, Seizes $7.1M in Assets](https://texashealthlaw.com/texas-medicaid-fraud-control-unit-helps-dismantle-142-million-genetic-testing-fraud-scheme-seizes-7-1m-in-assets/) - Texas Attorney General Press Release: ApolloMDx offered illegal kickbacks in order to purchase both recipient information from marketers and orders for genetic testing from doctors. In some cases, doctors made fraudulent diagnoses to make it appear as though recipients were eligible for testing when they were not. In addition, ApolloMDx altered dates of service on - [Most Patients Using Weight-Loss Drugs Like Wegovy Stop Within a Year, Data Show](https://texashealthlaw.com/most-patients-using-weight-loss-drugs-like-wegovy-stop-within-a-year-data-show/) - Medical weight-loss locations have skyrocketed, driven by semaglutide medications. But a recent article from Chad Terhune, for Reuters, calls into question its staying power: Only about one-third of patients prescribed a popular weight-loss drug like Novo Nordisk’s (NOVOb.CO) Wegovy were still taking it a year later, while total healthcare costs for the group rose sharply, - [How Did This Happen? Understanding the Issue of Third-Party Tracking Tech in Healthcare](https://texashealthlaw.com/how-did-this-happen-understanding-the-issue-of-third-party-tracking-tech-in-healthcare/) - Jill McKeon, for Health IT Security: In June 2022, journalists discovered that a third of Newsweek’s top 100 hospitals in America had the Meta Pixel installed on their websites, which allegedly sent a packet of data to Facebook whenever a visitor clicked a button to schedule a doctor’s appointment. ... … The Markup, also observed - [HHS Office of Civil Rights Requiring Healthcare Providers to Use HIPAA-compliant Telehealth Platforms by August 10](https://texashealthlaw.com/hhs-office-of-civil-rights-requiring-healthcare-providers-to-use-hipaa-compliant-telehealth-platforms-by-august-10/) - HHS Office of Civil Rights is requiring all healthcare providers to use HIPAA-compliant telehealth platforms by Aug. 10. When the Public Health Emergency ended in May, CMS provided a transition period for covered health care providers to come into compliance with the HIPAA Rules with respect to their provision of telehealth. The transition period will - [Next-Gen Weight-Loss Drugs Receive Tentative Embrace by Medicaid](https://texashealthlaw.com/next-gen-weight-loss-drugs-receive-tentative-embrace-by-medicaid/) - Medicare does not currently cover Wegovy or other medications specifically for obesity. But some Medicaid programs, which are administered by individual states, are negotiating discounts for the popular semaglutide treatments. Ganny Belloni for Bloomberg Law: Nine states from California to Rhode Island have begun to cover expensive, next-generation weight-loss drugs like Novo Nordisk’s Wegovy on - [Think Like a Prosecutor: How Physicians Can Address the Threat of Data Mining-Based Fraud Investigations](https://texashealthlaw.com/think-like-a-prosecutor-how-physicians-can-address-the-threat-of-data-mining-based-fraud-investigations/) - Dan Martin, for Medical Economics: When you deviate from your peers, be especially sure to document the legitimate reasons for that deviation. Expect that insurance companies, regulatory agencies, and law enforcement officials will examine such deviations. Note any relevant information that supports why your treatment might differ from that of your peers. Such information might - [OIG: HRSA Made Improper Payments Through COVID-19 Uninsured Program](https://texashealthlaw.com/oig-hrsa-made-improper-payments-through-covid-19-uninsured-program/) - Victoria Bailey, for RevCycle Intelligence: The COVID-19 Uninsured Program, administered by HRSA, allowed providers to enroll and submit claims for reimbursement of COVID-19 testing and treatment provided to uninsured individuals. OIG conducted the audit to determine if claims reimbursed through the program complied with federal requirements. The audit covered claims for 19 million patients with - [U.S. Supreme Court Clarifies DOJ’s Authority to Dismiss Whistleblowers’ False Claims Act Suits, Questions Constitutionality of Qui Tam Provisions](https://texashealthlaw.com/u-s-supreme-court-clarifies-dojs-authority-to-dismiss-whistleblowers-false-claims-act-suits-questions-constitutionality-of-qui-tam-provisions/) - Edwin O. Childs, Michael J. Podberesky, Jonathan Ellis, Gretchen Heinze Townshend, Todd R. Steggerda, Charles Wm. McIntyre and Jason M. Vespoli, for The FCA Insider - McGuireWoods: In United States ex rel. Polansky v. Executive Health Resources, Inc., the U.S. Supreme Court recently resolved a circuit split by holding that in a False Claims Act - [Stark Law Changes Ramp Up in 2023](https://texashealthlaw.com/stark-law-changes-ramp-up-in-2023/) - Patsy Newitt, for Becker’s ASC Review: The Consolidated Appropriations Act of 2023 updated exceptions to Stark law and anti-kickback law that will allow hospitals and healthcare providers to improve mental health services for physicians. The law issues a new exception for physician wellness programs offered by healthcare entities, including ASCs, hospitals and physician practices. To - [Collin County Man Sentenced for Federal Violations Related to Health Care Fraud Scheme](https://texashealthlaw.com/collin-county-man-sentenced-for-federal-violations-related-to-health-care-fraud-scheme/) - Press Release for the Eastern District of Texas: Oscar Simon Ndereva, 45, pleaded guilty to wire fraud and was sentenced to 54 months in federal prison by U.S. District Judge Sean D. Jordan. According to information presented in court, Ndereva was involved in an intricate scheme to defraud private pay health insurance payors. Specifically, he - [Period of Enhanced Oversight for New Hospices in Arizona, California, Nevada, & Texas](https://texashealthlaw.com/period-of-enhanced-oversight-for-new-hospices-in-arizona-california-nevada-texas/) - CMS is placing newly enrolling hospices located in Arizona, California, Nevada, and Texas in a provisional period of enhanced oversight. Over the last 12 months, we’ve received numerous reports of hospice fraud, waste, and abuse. The number of enrolled hospices has also increased significantly in these states, raising serious concerns about market oversaturation. “New hospices” - [Just More Than a Third of Hospitals Are Complying with Price Transparency Rules](https://texashealthlaw.com/just-more-than-a-third-of-hospitals-are-complying-with-price-transparency-rules/) - Joseph Choi, for The Hill: More than two years after federal hospital price transparency rules went into effect, only about a third of hospitals are currently in compliance, according to a report released this week. The nonprofit Patient Rights Advocate (PRA) released its fifth semi-annual report, which found that only 36 percent of 2,000 surveyed - [Pain Management Physician's Assistant Charged in Amniotic Fluid Scam](https://texashealthlaw.com/pain-management-physicians-assistant-charged-in-amniotic-fluid-scam/) - Press Release for U.S. Attorney’s Office, Northern District of Texas: Certain amniotic products have been approved by the U.S. Food and Drug Administration for wound care, but not for pain management. (In fact, the FDA has issued repeated consumer alerts warning that biologics like amniotic fluid “have not been approved for the treatment of any orthopedic - [FTC Follows DOJ and Withdraws Antitrust Policy Statements](https://texashealthlaw.com/ftc-follows-doj-and-withdraws-antitrust-policy-statements/) - Charles Honart, for Stevens & Lee: On July 14, the Federal Trade Commission (“FTC”), as anticipated, announced that it was withdrawing two antitrust policy statements related to enforcement in health care markets: Statements of Antitrust Enforcement Policy in Health Care (August 1996) Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare - [EHR Clinical Note Length Continues to Grow Despite Coding Changes](https://texashealthlaw.com/ehr-clinical-note-length-continues-to-grow-despite-coding-changes/) - Here’s one for the med mal attorneys. Epic Research issued a report on clinical notes documented in their system. Researchers evaluated 1.7 billion clinical notes written by 166,318 outpatient providers from May 2020 to April 2023. They found that the average length across all clinical notes increased 8.1 percent from May 2020 to April 2023. - [Artificial Intelligence, Cybersecurity and the Health Sector](https://texashealthlaw.com/artificial-intelligence-cybersecurity-and-the-health-sector/) - HHS Health Sector Cybersecurity Coordination Center (HC3) has published a report (PDF) detailing cybersecurity concerns for healthcare providers. In particular, what can be done to remain secure, given AI-enhanced cyberthreats. The report provides an educational overview of regenerative IA, particularly ChatGPT and the difference between machine learning and neural networks. More importantly, the report discusses - [CMS Proposes to Expand 36-Month Rule to Hospice Agencies](https://texashealthlaw.com/cms-proposes-to-expand-36-month-rule-to-hospice-agencies/) - Ragini A. Acharya, for HuschBlackwell: The 36-Month Rule, found at 42 C.F.R. § 424.550(b), provides that where there is a change in majority ownership (“CIMO”) of an HHA by sale (including asset sales, stock transfers, mergers and consolidations) within 36 months after the effective date of the HHA’s initial enrollment in Medicare or within 36 - [Texas Lawyer Convicted of Conspiracy and Perjury for Laundering Kickbacks](https://texashealthlaw.com/texas-lawyer-convicted-of-conspiracy-and-perjury-for-laundering-kickbacks/) - This was intentional criminal conduct of conspiracy and perjury related to Anti-Kickback Statute violations. From a U.S. Attorney’s Office for the Eastern District of Texas Press Release: “By facilitating kickbacks, this defendant knowingly enabled theft from Medicare and Medicaid, putting personal profit before legitimate patient needs and ultimately costing taxpayers millions of dollars,” said Jason - [Mark Cuban's Drug Company Will Soon Be Selling Its Medicine Directly to Hospitals](https://texashealthlaw.com/mark-cubans-drug-company-will-soon-be-selling-its-medicine-directly-to-hospitals/) - Will Maddox, for D Magazine: Mark Cuban Cost Plus Drug Co. CEO Dr. Alex Oshmyansky is always busy disrupting the healthcare system. The latest iteration? Selling medicines directly to hospitals and clinics to address shortages and help providers save on needed medications. ... The company is focused on manufacturing drugs that are in shortage. The FDA keeps - [CMS Proposes Payment Cuts in CY24 Medicare Physician Fee Schedule](https://texashealthlaw.com/cms-proposes-payment-cuts-in-cy24-medicare-physician-fee-schedule/) - Victoria Baily, for Revcycle Intellegence: The agency has said that proposed payment increases for primary care and other direct patient care providers meant that payment cuts must occur in other specialties to achieve budget neutrality. While specialties like internal medicine (1 percent) and family practice (3 percent) would see reimbursement increases, others are facing cuts, - [Texas Data Privacy and Security Act, Data Breaches Notification](https://texashealthlaw.com/texas-data-privacy-and-security-act-data-breaches-notification/) - From Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., posted on National Review: Texas has joined the growing list of states enacting comprehensive consumer data privacy laws. On June 18, 2023, Governor Abbott (R) signed H.B.4, otherwise known as the Texas Data Privacy and Security Act (“TDPSA”). The TDPSA is another close cousin of the business-friendly Virginia - [The 2023 DOJ Health Care Fraud Enforcement: Big Dollars or Clever Packaging?](https://texashealthlaw.com/the-2023-doj-health-care-fraud-enforcement-big-dollars-or-clever-packaging/) - Zachary S. Taylor and Sarah M. Hall, for Epstein Becker Green: Of the numerous cases, three specific areas comprised the vast majority of the $2.5 billion in alleged fraud: Telemedicine Fraud: … 11 defendants were charged for their alleged connection to an $1.9 billion fraudulent scheme in the Southern District of Florida, which involved C-suite - [FDA Approves the First Over-The-Counter Birth Control Pill](https://texashealthlaw.com/fda-approves-the-first-over-the-counter-birth-control-pill/) - Beth Mole, for ArsTechnica: The OTC-approved pill is the Opill (norgestrel), a once-a-day progestrin-only pill manufactured by the Dublin-based company Perrigo. The company said it expects the pill will be available starting in the first quarter of 2024, though its pricing is not yet clear. For optimal efficacy, it needs to be taken consistently every - [OIG Advisory Opinion 23-04 - Favorable Opinion Regarding the Use of an Online Health Care Directory by Federal Health Care Program Beneficiaries](https://texashealthlaw.com/oig-advisory-opinion-23-04-favorable-opinion-regarding-the-use-of-an-online-health-care-directory-by-federal-health-care-program-beneficiaries/) - A website offers users the ability to search for physicians and other health care providers who have paid a fee to be included in the database. The website generates personalized results using a proprietary algorithim. The user can book an appointment with the provider directly through the website. No fee is charged to the user. - [Billing Medicare or Medicaid? Understanding Your Audit Risk](https://texashealthlaw.com/billing-medicare-or-medicaid-understanding-your-audit-risk/) - Jenna Godlewski and Alice Harrs, for MaynardNexsen: If you are a healthcare provider enrolled with Medicare and Medicaid, it is imperative that you know the governmental agencies’ expectations for compliant billing and understand that the agencies constantly monitor and audit provider claims to identify aberrant claims submissions and billing patterns. This article summarizes several primary - [AI’s Increasing Role in the Health Care Delivery System: Key Legal Considerations](https://texashealthlaw.com/ais-increasing-role-in-the-health-care-delivery-system-key-legal-considerations/) - Douglas A. Grimm, for ArentFox Schiff: In a recent Yale CEO Summit survey, 48% of CEOs indicated that AI will have its greatest effect as applied to the health care industry — more than any other industry. This alert analyzes how AI is already affecting the health care industry, as well as some of the - [Texas Lawmakers Enact New Laws Reforming Texas Medical Board Disciplinary Authority and Increasing Hospital Reporting Obligations](https://texashealthlaw.com/texas-lawmakers-enact-new-laws-reforming-texas-medical-board-disciplinary-authority-and-increasing-hospital-reporting-obligations/) - Jesse M. Coleman and Drew del Junco, writing for Seyfarth Shaw, LLP: On June 13, 2023, Texas Governor Greg Abbott signed a major new patient safety bill into law that is intended both to reform the disciplinary authority of the Texas Medical Board (TMB) and to better protect patients from potentially dangerous doctors. ... The - [What to Know About HIPAA Compliance OCR Settlement](https://texashealthlaw.com/what-to-know-about-hipaa-compliance-ocr-settlement/) - Employees of health care providers do not have carte blanche authority to access patient records. Any access of protected health information must be for an appropriate use, either the provision of care to the patient, one of the other authorized uses. When employees misuse PHI, the Health and Human Services Office for Civil Rights (OCR) - [14 Medical City Hospitals Part of Apparent HCA Healthcare Data Theft](https://texashealthlaw.com/14-medical-city-hospitals-part-of-apparent-hca-healthcare-data-theft/) - Will Maddox, for D-Magazine: Fourteen Medical City Healthcare hospitals are among the hundreds of facilities caught up in an apparent patient data theft at the North Texas hospital operator’s parent company, HCA Healthcare. HCA says that information from around 11 million patients was “made available by an unknown and unauthorized party” in an online forum. - [OIG Final Rule Expands OIG Enforcement Authority to Grant and Contract Fraud](https://texashealthlaw.com/oig-final-rule-expands-oig-enforcement-authority-to-grant-and-contract-fraud/) - James A. Cannatti, III, Tony Maida, and Niya Mack, for McDermott Will & Emery: On June 27, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule amending OIG’s civil money penalty (CMP) regulations implementing the 21st Century Cures Act (Cures Act) amendment to the CMP - [Navigating Scope And Applicability Of Texas Data Privacy Law](https://texashealthlaw.com/navigating-scope-and-applicability-of-texas-data-privacy-law/) - Wendell Bartnick, Christian Blair and Stuart Cobb for Law 360: On June 18, Texas enacted the Texas Data Privacy and Security Act, becoming the 11th state to enact a comprehensive consumer data privacy law. Businesses regulated by the TDPSA have until July 1, 2024, to come into compliance with the law. The TDPSA does not - [CMS Proposes ‘36-Month Rule’ to Curb Hospice License ‘Flipping’](https://texashealthlaw.com/cms-proposes-36-month-rule-to-curb-hospice-license-flipping/) - Jim Parker, for Hospice News: Some hospice owners have been selling their businesses soon after securing a license. This has prompted federal agencies to pursue new regulations to address the problem. The practice appears to stem from a rash of newly licensed hospices that have emerged in California, Nevada, Texas and Arizona. Some of these - [DOJ Charges Nearly 80 People in $2.5 Billion Health Care Fraud Scheme](https://texashealthlaw.com/doj-charges-nearly-80-people-in-2-5-billion-health-care-fraud-scheme/) - Telehealth has been a boon for fraud because it expands the reach of the fraudster. But this type of fraud is nothing new. It’s just a different mechanism for communicating with vulnerable targets. Joseph Choi for The Hill: The Department of Justice (DOJ) announced Wednesday it has charged 78 people relating to their alleged involvement - [U.S. Supreme Court: False Claims Act Liability Depends on Defendant’s Subjective Beliefs](https://texashealthlaw.com/u-s-supreme-court-false-claims-act-liability-depends-on-defendants-subjective-beliefs/) - Michael R. Bertoncini & William Kang for Jackson Lewis: Liability in False Claims Act (FCA) suits depends on whether a defendant subjectively believed its claims were false, not on whether it can offer an objectively reasonable basis for its claims, the U.S. Supreme Court has held in a unanimous decision authored by Justice Clarence Thomas. - [A Provider’s Guide to OIG's Self-Disclosure Protocol](https://texashealthlaw.com/a-providers-guide-to-oigs-self-disclosure-protocol/) - Recommending to clients that they self-disclose violations of the False Claims Act often creates a lot of anxiety. It is a certainty that self-disclosure will be percevied as a good faith effort to by the provider to correct the conduct. It is also true that, without the disclosure, OIG might not identify the wrongful conduct. - [New Texas Data and Privacy Security Act Aims to Increase Protections for Online User Data](https://texashealthlaw.com/new-texas-data-and-privacy-security-act-aims-to-increase-protections-for-online-user-data-the-texan/) - Matt Stringer, for The Texan: [T]he Texas Data and Privacy Security Act (TDPSA), was signed into law by Gov. Greg Abbott on Sunday and will take effect in two stages over the next two years. The act creates a list of rights for internet users over their personal data, including knowing when it is collected, - [Safeguarding Healthcare Data in the Age of AI: A Critical Imperative for Healthcare Executives](https://texashealthlaw.com/safeguarding-healthcare-data-in-the-age-of-ai-a-critical-imperative-for-healthcare-executives/) - Artificial Intelligence, particularly generative AI, is upending many industries. It will be years before we have an appreciation for the many ways AI can be used to improve quality and equity in healthcare. It will be even longer before laws catch up to protet patients from its inevitable misuse. Sarah M. Worthy, for The Fast - [Key Findings from Private Equity’s Healthcare Play: Management Service Agreements](https://texashealthlaw.com/key-findings-from-private-equitys-healthcare-play-management-service-agreements/) - Holden Godat, Taylor Anderson, CVA, and Trent Fritzsche, writing for VMG Health: With the emergence of private equity (PE) firms attempting to align with physician practices, VMG Health has seen an increase in the number of management services agreements (MSAs). Due to the highly fragmented and regulated nature of healthcare, PE investment in healthcare is - [How Often Should Med Spas Perform Good Faith Exams?](https://texashealthlaw.com/how-often-should-med-spas-perform-good-faith-exams/) - At a minimum, a Good Faith Exam (GFE) should be performed annually, but may be required more often depending on the circumstances. The good faith exam should be performed on any patient receiving treatment for the first time. From this GFE, the provider develops a treatment plan which will often include multiple treatments over several - [Healthcare Organizations and Practitioners Receive New Protection Against Frivolous Whistleblower Lawsuits](https://texashealthlaw.com/healthcare-organizations-and-practitioners-receive-new-protection-against-frivolous-whistleblower-lawsuits/) - Jose Vela, Jr., for Clark Hill: Last Friday, the U.S. Supreme Court (SCOTUS) handed down an important ruling that will give healthcare organizations and practitioners relief against meritless whistleblower lawsuits. The ruling could result in saving organizations and practitioners their time, money, and reputation. In a near-unanimous 8-1 decision, the SCOTUS affirmed the Third Circuit - [Texas Jury Renders $10 Million Verdict in Novel Corporate Practice of Medicine Case](https://texashealthlaw.com/texas-jury-renders-10-million-verdict-in-novel-corporate-practice-of-medicine-case/) - From HuschBlackwell, Healthcare Law Insights: Following two weeks of trial testimony, a Travis County jury recently rendered a $10 million verdict in a novel corporate practice of medicine (CPOM) case. The jury found in favor of a physician hospitalist group that claimed a management company repeatedly broke its promise to comply with the state’s CPOM - [10 HIPAA Violations to Watch Out for While Working Remotely](https://texashealthlaw.com/10-hipaa-violations-to-watch-out-for-while-working-remotely/) - Most improper disclosures are caused by complacency, poor training, or lack of attention. These kinds of lists are good reminders of some of the biggest types of violations. Of course, Covered Entities should provide this, and more, to employees and business associates. From Security Boulevard: 1. Unsecure internet access. Transmitting e-PHI over unsecured networks, such - [Toolkit: Analyzing Telehealth Claims to Assess Program Integrity Risks](https://texashealthlaw.com/toolkit-analyzing-telehealth-claims-to-assess-program-integrity-risks/) - This toolkit provides detailed information on methods to analyze telehealth claims to identify program integrity risks associated with telehealth services. It is based on the methodology that OIG developed for the report Medicare Telehealth Services During the First Year of the Pandemic: Program Integrity Risks , which identified Medicare providers whose billing for telehealth services - [Supreme Court Preserves Access to Abortion Pill Mifepristone](https://texashealthlaw.com/supreme-court-preserves-access-to-abortion-pill-mifepristone/) - The Supreme Court preserves access to the abortion pill mifepristone while the appeals play out. The case goes back to the 5th Circuit, where the FDA will pursue a full appeal of Kacsmaryk’s preliminary injunction. The agency and the anti-abortion groups will both have a chance to file briefs, and the case is scheduled to - [Supreme Court Pauses Abortion-Pill Case: What Next?](https://texashealthlaw.com/supreme-court-pauses-abortion-pill-case-what-next/) - U.S. Supreme Court Justice Samuel Alito has temporarily stayed until Wednesday a Texas federal court order imposing restrictions on the distribution of the abortion drug mifepristone while they consider a request by the Biden administration to block the restrictions. Brendan Pierson, writing for Reuters, discusses What Happens Next? Whether or not the Supreme Court decides - [Hospice in 2023: Dying and the Dollars](https://texashealthlaw.com/hospice-in-2023-dying-and-the-dollars/) - Interesting statistics on hospice care, its growth, and fraud from Deborah Abrams Kaplan, writing for Managed Healthcare Executive: Hospice care really started to take hold after Medicare started covering it in 1985. With Medicare paying the bills, hospice gained traction over time. Medicare spending on hospice nearly doubled from 2010 to 2020, increasing from $12.9 billion - [Office for Civil Rights Reminder HIPAA Flexibilities End May 2023](https://texashealthlaw.com/office-for-civil-rights-reminder-hipaa-flexibilities-end-may-2023/) - HHS Office of Civil Rights confirmed that that four Notifications of Enforcement Discretion (“Notifications”) will expire upon expiration of the COVID-19 PHE, which is currently scheduled for 11:59 p.m. on May 11, 2023. OCR’s notice applies to four Notifications of Enforcement Discretion of HIPAA related to the following circumstances: COVID-19 Community-Based Testing Sites during the - [HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care](https://texashealthlaw.com/hipaa-privacy-rule-and-disclosures-of-information-relating-to-reproductive-health-care/) - HHS Office of Civil Rights has proposed changes to HIPAA’s Privacy Rule which would prohibit disclosures to law enforcement related to obtaining or providing abortions. The current Privacy Rule permits covered entities to disclose Protected Health Information (PHI) about an individual for law enforcement purposes "pursuant to process and as otherwise required by law", under - [Supreme Court's False Claims Case Alleges Overbilling of Medicare and Medicaid](https://texashealthlaw.com/supreme-courts-false-claims-case-alleges-overbilling-of-medicare-and-medicaid/) - Violations of the False Claims Act require a requisite state of “knowledge” a claim’s falsity. To violate the statute, one must have "actual knowledge," "deliberate ignorance" or "reckless disregard of the truth or falsity" of the claim. Any of those broad levels of knowledge is sufficient to support a False Claims Act violation. But knowledge - [DOJ Settlements Are a Stark Reminder](https://texashealthlaw.com/doj-settlements-are-a-stark-reminder/) - Arrangements with referring physicians are common in healthcare, but they can be very danagerous if not structured properly. Too often they are used to obfuscate the purpose of payments to physicians. The Department of Justice for the Eastern District of Michigan announced three civil settlements which serve as good reminders of the types of arrangements - [Widespread Third-Party Tracking On Hospital Websites Poses Privacy Risks For Patients And Legal Liability For Hospitals](https://texashealthlaw.com/widespread-third-party-tracking-on-hospital-websites-poses-privacy-risks-for-patients-and-legal-liability-for-hospitals/) - Web tracking technology has been in the news a lot lately. Most websites use such tools to track users as they navigate through a particular site and around the web. Nothing new here. But in doing so, user data gets transferred from one site to another, or actively collected, posing privacy risks for healthcare providers. - [OIG Approves Gift Cards to Promote Patient Compliance with a Preventive Screening Measure](https://texashealthlaw.com/oig-approves-gift-cards-to-promote-patient-compliance-with-a-preventive-screening-measure/) - OIG has approved the use of gift cards to incentivize patients to return sample collection kits, provided there are certain safeguards in place: Mailing the gift cards only to those patients who return the kits by the deadline specified in the reminder letter. Advising patients that they may not use the gift cards on items - [Can Actions Be Considered Remuneration Under the Anti-Kickback Statute?](https://texashealthlaw.com/can-actions-be-considered-remuneration-under-the-anti-kickback-statute/) - When discussing the Anti-Kickback Statute (AKS), it’s common to say that “remuneration” can be “anything of value.” That board definition has been called into question by the Sixth Circuit in United States ex rel. Martin v. Hathaway et al., No. 22-1463. In that case, a qui tam relator (physician) alleged that a small-town hospital refused to - [FDA to Refuse Medical Device Submissions For Cybersecurity Reasons Beginning in October](https://texashealthlaw.com/fda-to-refuse-medical-device-submissions-for-cybersecurity-reasons-beginning-in-october/) - Jill McKeon, for Health IT Security: Effective immediately, the US Food and Drug Administration (FDA) will require medical device manufacturers to provide cybersecurity information in their premarket device submissions. Additionally, beginning October 1, the FDA will exercise its authority to refuse submissions for cybersecurity reasons. ... Key Medical Device Security Requirements Included in Omnibus Bill - [FDA Cybersecurity Requirements for Medical Devices Now in Effect](https://texashealthlaw.com/fda-cybersecurity-requirements-for-medical-devices-now-in-effect/) - From the HIPAA Journal: On Wednesday, March 29, 2023, the medical device cybersecurity requirements of the $1.7 trillion omnibus spending bill – The Consolidated Appropriations Act, 2023 – took effect and the FDA now requires all regulatory submissions for medical devices to include information about the cybersecurity measures that have been implemented for the devices. Section - [A Federal Judge Suspends FDA's Longtime Approval of an Abortion Pill, but Gives the Government 7 Days to Appeal](https://texashealthlaw.com/a-federal-judge-suspends-fdas-longtime-approval-of-an-abortion-pill-but-gives-the-government-7-days-to-appeal/) - Medication abortions typically use two drugs taken together: Mifepristone and Misoprostol. This ruling only affects Mifepristone. The other drug, Misopostol, is still available, but its use has always required the physician to prescribe it “off-label," meaning it is not FDA-approved for abortions. It is FDA-approved only for use to prevent stomach ulcers while taking NSAIDs. - [OIG Expands Topics for Frequently Asked Questions](https://texashealthlaw.com/oig-expands-topics-for-frequently-asked-questions/) - OIG has used various avenues to communicate its views on various healthcare compliance issues, such as advisory opinions, contractor self-disclosures, corporate integrity agreements, and exclusions. In March, the OIG has expanded the number of topics it will consider for FAQs submitted by the healthcase stakeholders: general questions regarding the Federal anti-kickback statute and the civil - [Judge Strikes Down ACA’s Preventive Care Requirement](https://texashealthlaw.com/judge-strikes-down-acas-preventive-care-requirement/) - A Fort Worth federal judge yesterday ruled that insurers cannot be compelled under the Affordable Care Act to provide preventative care free of charge to insureds. The basis of the ruling involves the U.S. Preventive Services Task Force, which is the body tasked with enforcing the ACA. The judge determined that the Task Force is - [The Med Spa on the Corner Is Probably Breaking the Law](https://texashealthlaw.com/the-med-spa-on-the-corner-is-probably-breaking-the-law/) - Look better. Feel better. Fountain of youth promises are making med spas one of the fastest-growing segments in healthcare. Botox injections, laser hair removal, IV hydration and therapy, medical weight loss, and hormone therapy seem to be available on every corner. But most med spas are not compliant with Texas law. Either they are formed - [Hospital to Pay False Claims Act Penalty for Allegedly Letting Unsupervised Residents Interpret X-Rays](https://texashealthlaw.com/hospital-to-pay-false-claims-act-penalty-for-allegedly-letting-unsupervised-residents-interpret-x-rays/) - When a healthcare provider submits claims to Medicare, they are making several implied representations: 1) the service was medicaly necessary; 2) the service was performed; and 3) the service was performed by someone with the proper credentials. If any of those implied representations are not accurate, and the provider has the requisite “knowledge” of the - [Two nurses sent to prison for illegal kickback scheme](https://texashealthlaw.com/two-nurses-sent-to-prison-for-illegal-kickback-scheme/) - Healthcare providers besides physicians can also violate the Anti-Kickback Statute. And, do not think that only physicians can make illegal refurrals. Paying anyone something of value for patient referrals—even a marketing company—can be illegal. Southern District of Texas Press Release: At the time of their pleas, they admitted that from 2014 through 2016, both obtained - [DSOs vs. Texas’ Corporate Practice of Dentistry Doctrine: What You Need to Know](https://texashealthlaw.com/dsos-vs-texas-corporate-practice-of-dentistry-doctrine-what-you-need-to-know/) - The Corporate Practice of Medicine (CPOM) is deeply rooted in Texas law. But the Corporate Practice of Dentistry similarly provides that "a person may not practice dentistry without a valid license issued by the Texas State Board of Dental Examiners. The Texas Dental Practices Act sets forth several categories of activities that constitute the practice - [The U.S. Fifth Circuit Court of Appeals Is Poised to Address Emergency Abortions and the Scope of EMTALA's Preemption of State Abortion Laws](https://texashealthlaw.com/the-u-s-fifth-circuit-court-of-appeals-is-poised-to-address-emergency-abortions-and-the-scope-of-emtalas-preemption-of-state-abortion-laws/) - Steven G. Pine, gina L. Bertolini, with K&L Gates: Shortly after the Dobbs decision, HHS laid out its position in a 11 July 2022 memorandum issued to state survey directors (the EMTALA memo) that asserted, among other things, that state laws purporting to limit abortion services more narrowly than provided under EMTALA are preempted. Three - [Texas Small Businesses: Control Healthcare Prices and Regulate Hospital Consolidation](https://texashealthlaw.com/texas-small-businesses-control-healthcare-prices-and-regulate-hospital-consolidation/) - Will Maddox for D Magazine: Consolidation is on the rise as well. According to research from Deloitte, the largest 10 healthcare systems in the U.S. control nearly a quarter percent of all hospitals. Between 2013 and 2018, the ten largest health systems saw revenue increase 82 percent from $505 billion to $918 billion, five times faster than - [FBI: Healthcare Hit with Most Ransomware Attacks of Any Critical Sector](https://texashealthlaw.com/fbi-healthcare-hit-with-most-ransomware-attacks-of-any-critical-sector/) - More scary statistics related to ransomware attacks on healthcare providers. Nearly half (47%) of healthcare IT professionals said their organizations experienced a ransomware attack in the past two years, up from 43% in 2021, according to a survey released by the Ponemon Institute. Ill-prepared providers must make the hard choice to pay or not to - [Ophthalmology Practice Agrees to Pay Over $2.9 Million to Settle Kickback Allegations](https://texashealthlaw.com/ophthalmology-practice-agrees-to-pay-over-2-9-million-to-settle-kickback-allegations/) - From the Eastern District of Texas: Ophthalmology provider group, Arlington Ophthalmology Association, P.L.L.C. d/b/a Kleiman Evangelista Eye Centers (“K&E”), with offices located in Arlington, Dallas, Plano, Southlake, Mount Pleasant, and Gun Barrel City, Texas, has agreed to pay $2,902,505 to resolve False Claims Act allegations that it offered and paid kickbacks to optometrists to induce - [DOJ Continues to Eye Clinical Researchers](https://texashealthlaw.com/doj-continues-to-eye-clinical-researchers-and-the-universities-and-hospitals-employing-them/) - Jonathan Porter, writing for Healthcare Law Insights, highlights several types of fraud associated with medical research and clinical trials: Clinical trial fraud, grant fraud, and failure to disclose ties to foreign governments, are all types of fraud associated with medical research and clinical trials. The Department of Justice, through it’s consumer protection branch, has become more - [Safety vs. Hospitality: A Healthcare Dilemma](https://texashealthlaw.com/safety-vs-hospitality-a-healthcare-dilemma/) - The root problem is our society is mentally sick. Violence is the symptom. All the security in the world won't stop someone who is intent on hurting others. Any solution must address the problem. Will Mattox, writing for D Magazine: But the issue seems to be getting worse. The American Hospital Association says that 44 - [If the Government Cut Medicare Fraud, It Wouldn’t Have to Cut Medicare](https://texashealthlaw.com/if-the-government-cut-medicare-fraud-it-wouldnt-have-to-cut-medicare/) - From Merrill Matthews, writing for The Hill: The point is that if the federal government were better at preventing Medicare and Medicaid fraud, the programs could save perhaps $100 billion a year or more. While that wouldn’t solve Medicare’s long-term financial challenges, it would certainly help delay the day of reckoning. While no one defends - [Is Dropbox HIPAA Compliant?](https://texashealthlaw.com/is-dropbox-hipaa-compliant/) - A lot of my healthcare clients use Dropbox. Many assume, incorrectly, that it is HIPAA compliant. I am generally concerned with any service that declares itself to be HIPAA compliant. Like many services, Dropbox can be used in a HIPAA compliant manner, but the burden rests on the user, not on Dropbox. From Samuel Okoruwa, - [Exploring Data De-Identification in Healthcare](https://texashealthlaw.com/exploring-data-de-identification-in-healthcare/) - From Health IT Analytics: Adequately de-identifying healthcare data is critical for health systems, payers, and other stakeholders to ensure HIPAA compliance. However, the advent of newer technologies, such as artificial intelligence (AI) and connected devices, has created questions about ensuring patient privacy while enabling data sharing and access to improve care and drive medical breakthroughs. - [Healthcare Empowered Ep. 1](https://texashealthlaw.com/healthcare-empowered-ep-1/) - Dr. Chad Glines and Dr. Caleb Braddock are well-known in North Texas. They are the founders and owners of Genesis Back & Neck, a chiropractic practice that provides spinal decompression therapy to patients. What makes them different is their unique spinal decompression protocol. They have been clients of mine for many years. The last few - [Texas Med Spa FAQ](https://texashealthlaw.com/med-spa-faq/) - What is a med spa? The American Med Spa Association defines a medical spa as a hybrid between an aesthetic medical center and a day spa" with four core elements: (1) the provision of non-invasive (i.e. non-surgical) aesthetic medical services; (2) under the general supervision of a licensed physician; (3) performed by trained, experienced and - [Part II: The Investigation. Handling Licensing Board Investigations from Complaint to SOAH Hearing](https://texashealthlaw.com/part-ii-the-investigation-handling-licensing-board-investigations-from-complaint-to-soah-hearing/) - This is a four-part series on Handling Licensing Board Investigations from Complaint to SOAH Hearing. In preparation for this series, I talked to several of the staff attorneys and investigators for the Texas Medical Board, the Board of Nursing, and the Board of Chiropractic Examiners. I asked them what advice they would give lawyers practicing - [Part I: What's Going On? Handling Licensing Board Investigations from Complaint to SOAH Hearing](https://texashealthlaw.com/part-i-whats-going-on-handling-licensing-board-investigations-from-complaint-to-soah-hearing/) - This is a four-part series on Handling Licensing Board Investigations from Complaint to SOAH Hearing. In preparation for this series, I talked to several of the staff attorneys and investigators for the Texas Medical Board, the Board of Nursing, and the Board of Chiropractic Examiners. I asked them what advice they would give lawyers practicing - [Telehealth Expansion in Texas](https://texashealthlaw.com/telehealth-expansion-in-texas/) - The COVID-19 pandemic forced many patients and practitioners to find new ways to connect. The most obvious tool is telehealth, the use of audio-visual platforms to allow practitioners to assess and communicate with patients remotely. Patients and practitioners both were encouraged by how beneficial and flexible telehealth can be. Federal and state governments alike are - [Can a Professional Limited Liability Company Own Another Professional Limited Liability Company?](https://texashealthlaw.com/can-a-professional-limited-liability-company-own-another-professional-limited-liability-company/) - Question: Can a professional limited liability company own another professional limited liability company? Answer: Yes, a PLLC can own another PLLC provided it has the correct ownership and is formed for the same purpose as the PLLC it owns. For example, a physician can form John Doe, MD, PLLC, and that entity can be an - [Top Ten Health Law Myths](https://texashealthlaw.com/top-ten-health-law-myths/) - I have been practicing health law for more than 25 years and have had the benefit of working with a lot of healthcare providers. My clients will often repeat myths about the practice of healthcare they have heard from their colleagues. There are also occasions when my fellow attorneys will make assumptions about healthcare law - [The Shocking Truth About Neurostimulators and the Government's Efforts to Recoup Payments](https://texashealthlaw.com/the-shocking-truth-about-neurostimulators-and-the-governments-efforts-to-recoup-payments/) - For much of the past decade, peripheral neurostimulator devices have been used liberally by some practitioners to treat chronic pain. In addition to pain relief, any manufacturers also promise providers that these devices are reimbursable by Medicare. This combination of relief and reimbursement has proven irresistible. Why not use a device that gives patients relief - [The Facts About Medical Factoring](https://texashealthlaw.com/the-facts-about-medical-factoring/) - One of the immutable truths about healthcare is that it can take a long time to get paid. Though Texas has a prompt payment statute, it can take 60 days or longer for a claim to be paid. Disputed claims can get pushed out an additional 60 days. The wait is even longer – sometimes - [Texas-Sized Pitfalls for Med Spas](https://texashealthlaw.com/texas-sized-pitfalls-for-med-spas/) - Med spa growth across Texas and the nation continues to increase. The American Med Spa Association (AmSpa) found in 2018 that there were 5,431 med spas in the United States with average revenue of more than $1.5 million. That was up by 9% from the year before.1 Revenues during 2020 were strong relative to other - [Hospice, home health agency and owners pay over $1.8M to resolve claims concerning physician payments](https://texashealthlaw.com/hospice-home-health-agency-and-owners-pay-over-1-8m-to-resolve-claims-concerning-physician-payments/) - The founders of an Edinburg hospice and related home health agency have paid $1,847,279.36 to resolve allegations they submitted claims to Medicare that resulted from unlawful referrals. The company offered compensation to physicians who were responsible for a significant majority of their patient referrals. Specifically, they provided physicians with monthly payments pursuant to medical directorship agreements with Allstate and Verge. Those payments were in excess of fair market value for the services the physicians actually provided. They also sold interests in Allstate to five different physicians which ultimately netted them substantial quarterly dividends. They also provided physicians other gifts and benefits, such as travel and tickets to sporting events. - [2020 Health Antitrust Year in Review](https://texashealthlaw.com/2020-health-antitrust-year-in-review/) - The federal antitrust enforcement agencies brought three hospital merger challenges and three criminal antitrust enforcement actions in health care in the past year. Combined with the incoming Democratic administration, healthcare antitrust enforcement is likely to remain strong in 2021. - [Improper Billing of “P-Stim” Devices is Focus of Recent FCA Settlements](https://texashealthlaw.com/improper-billing-of-p-stim-devices-is-focus-of-recent-fca-settlements/) - Improper billing for electro-acupuncture using a “P-Stim” device (or peri-auricular stimulation device) has been the subject of two False Claims Act (FCA) settlements already in 2021, following a trend of such enforcement actions within the past year. And there are more to come. These prosecutions involve providers billing federal healthcare programs for acupuncture using P-Stim - [Texas Company Agrees to Reimburse Medicare for Improper Billing Related to Neurostimulators](https://texashealthlaw.com/texas-company-agrees-to-reimburse-medicare-for-improper-billing-related-to-neurostimulators/) - Spinal Decompression Clinic of Texas (“SDCT”) has agreed to pay $330,898.00 to resolve liability under the False Claims Act for the alleged improper billing of electro-acupuncture device neurostimulators. Medicare does not reimburse for acupuncture or for acupuncture devices such as P-Stim, nor does Medicare reimburse for P-Stim as a neurostimulator or as implantation of neurostimulator electrodes. - [New HHS Advisory Opinion Confirms Complete Federal Preemption for PREP Act Cases and Applicability of the Act’s Defenses in Non-Use Situations](https://texashealthlaw.com/new-hhs-advisory-opinion-confirms-complete-federal-preemption-for-prep-act-cases-and-applicability-of-the-acts-defenses-in-non-use-situations/) - Advisory Opinion 21-01 expands on the language of the amended Declaration to clarify that the PREP Act provides complete preemptive federal jurisdiction for cases in which it is a defense. Once invoked, the PREP Act provides complete preemptive federal jurisdiction, and the federal court retains the case to decide whether the immunity and preemption provisions apply; if they do not apply, then the court would try the case as it would a diversity case. - [HHS Issues Advisory Opinion on Contract Pharmacies Under the 340B Program](https://texashealthlaw.com/hhs-issues-advisory-opinion-on-contract-pharmacies-under-the-340b-program/) - Many covered entities enter into written agreements with pharmacies (contract pharmacies) to distribute their covered outpatient drugs to the entities’ patients. The covered entity orders and pays for the 340B drugs, which are then shipped from the manufacturer to the contract pharmacy. The contract pharmacy then sends the drug to the patient. The covered entity purchases the drug, and the contract pharmacy provides the pharmacy services to dispense the drug to a patient. In the advisory opinion, the HHS Office of the General Counsel asserts that the plain meaning of Section 340B requires manufacturers to sell covered drugs to covered entities at or below the ceiling price. - [CMS finalizes “reasonable and necessary” definition, expedited breakthrough device coverage process](https://texashealthlaw.com/cms-finalizes-reasonable-and-necessary-definition-expedited-breakthrough-device-coverage-process/) - On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule that, for the first time, adopts a regulatory standard for determining whether a particular item or service is “reasonable and necessary” under section 1862(a)(1)(A) of the Social Security Act (SSA) and sets the stage for commercial insurance coverage to be considered in assessing such coverage in prescribed circumstances. In addition, the final rule establishes a “Medicare Coverage of Innovative Technology” (MCIT) pathway, which is a voluntary and expedited mechanism to obtain national Medicare coverage for medical devices designated with “breakthrough” device status by the Food and Drug Administration (FDA). - [Large Health System Agrees To Pay $200,000 as Part of OCR’s Fourteenth Right of Access Initiative Settlement](https://texashealthlaw.com/large-health-system-agrees-to-pay-200000-as-part-of-ocrs-fourteenth-right-of-access-initiative-settlement/) - In its first enforcement action of 2021, on January 12th, the United States Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced it settled with Banner Health its fourteenth enforcement action as part of its HIPAA Right of Access Initiative (the “Initiative”). OCR announced the Initiative in 2019 to ensure individuals can easily and timely access their health information at a reasonable cost under the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy Rule. In 2020, OCR announced eleven settlements as part of the Initiative including most recently against a primary care provider. The Initiative has resulted in settlements with all sizes of providers. - [HIPAA Safe Harbor Bill Becomes Law; Requires HHS to Incentivize Security](https://texashealthlaw.com/hipaa-safe-harbor-bill-becomes-law-requires-hhs-to-incentivize-security/) - The legislation directs HHS to take into account a covered entity’s or business associate’s use of industry-standard security practices within the course of 12 months, when investigating and undertaking HIPAA enforcement actions, or other regulatory purposes. - [Texas, Pennsylvania hospitals lose lawsuit challenging Medicare payments](https://texashealthlaw.com/texas-pennsylvania-hospitals-lose-lawsuit-challenging-medicare-payments/) - The hospitals said HHS wrongly calculated their Medicare disproportionate share hospital payments for fiscal year 2015, using the wrong data. As a result, the hospitals appealed the DSH payment decision to the HHS provider reimbursement review board, where it was dismissed. In its dismissal, the review board said it lacked jurisdiction to consider the hospitals' objections to their payments. - [Improper CBD Product Marketing Lands in FDA’s Crosshairs](https://texashealthlaw.com/improper-cbd-product-marketing-lands-in-fdas-crosshairs/) - The FDA issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol (CBD) products. CBD is the primary non-psychotropic compound in Cannabis sativa plant. The FDA stated the companies who were served warning letters illegally marketed CBD products for the treatment - [The United States and Tennessee Resolve False Claims Act Claims Relating to "P-Stim" Devices](https://texashealthlaw.com/the-united-states-and-tennessee-resolve-false-claims-act-claims-relating-to-p-stim-devices/) - A physician and two chiropractors agreed to pay the United States and Tennessee a total of $1.72 million to resolve liability under the False Claims Act for the alleged improper billing for electro-acupuncture using a peri-auricular stimulation device known as “P-Stim” that does not qualify for reimbursement under Medicare. - [Revisions to Stark Law Rules Covering Physician Profit Sharing and Bonuses](https://texashealthlaw.com/revisions-to-stark-law-rules-covering-physician-profit-sharing-and-bonuses/) - CMS also clarified that if a group has five or fewer physicians, overall profits means the profits from DHS from the entire group; but if a group has more than five physicians, the group may designate a component of at least five physicians to aggregate the profits for the purpose of distribution. - [OIG Issues New Guidance Regarding Big-Box Store Gift Cards as Patient Incentives](https://texashealthlaw.com/oig-issues-new-guidance-regarding-big-box-store-gift-cards-as-patient-incentives/) - OIG has taken the position that gift cards to “big-box” retailers are identified as impermissible “cash or cash equivalent” incentives under the Civil Monetary Penalties Law. - [What Stark law, anti-kickback changes mean for value-based care at ASCs](https://texashealthlaw.com/what-stark-law-anti-kickback-changes-mean-for-value-based-care-at-ascs/) - The changes to the Anti-Kickback Statute make it easier to enter into value-based care arrangements, especially if providers take full risk. The exceptions create flexibility in how physicians are compensated. The exceptions don't require setting compensation in advance, consistency with fair market value or determined in a way that doesn't take the volume or value of physician referrals into account. But there is a commercial reasonableness standard for pay, and the exceptions apply to both Medicare and non-Medicare beneficiaries. - [The OCR Settles another Investigation under the HIPAA Right of Access Initiative](https://texashealthlaw.com/the-ocr-settles-another-investigation-under-the-hipaa-right-of-access-initiative/) - OCR has settled its thirteenth enforcement action under the HIPAA Right of Access Initiative, which involved a primary care physician practicing in the State of Georgia. The physician must pay a Resolution Amount of $36,000.00 and implement a two year Corrective Action Plan following the OCR’s second investigation. - [Patient Recruiter Convicted in $2.8 Million Telemedicine Scheme Against Medicare](https://texashealthlaw.com/patient-recruiter-convicted-in-2-8-million-telemedicine-scheme-against-medicare/) - The owner of an Orlando-area telemarketing call center was convicted for his role in a kickback scheme involving expensive genetic tests and fraudulent telemedicine services that resulted in the payment of approximately $2.8 million in false and fraudulent claims to Medicare. - [Hospital Price Transparency Rule in Effect](https://texashealthlaw.com/hospital-price-transparency-rule-in-effect/) - The Hospital Price Transparency Rule went into effect on January 1, 2021. The Rule requires all hospitals operating within the United States to make public a list of their standard charges for items and services via the Internet in a machine-readable format. Hospitals must also provide prices for a list of 300 shoppable services that - [Proposed Changes to HIPAA Privacy Rule](https://texashealthlaw.com/proposed-changes-to-hipaa-privacy-rule/) - HHS has proposed several important changes to the HIPAA Privacy Rule to bring it in line with HHS’s Sprint Toward Coordinated Care initiative. These proposed changes are not yet final. Comments on the proposed rules are due within 60 days of their publication in the Federal Register. Reducing the time that covered entities have to - [CMS Provides Additional Expansion Opportunities for High Medicaid Physician-Owned Hospitals](https://texashealthlaw.com/cms-provides-additional-expansion-opportunities-for-high-medicaid-physician-owned-hospitals/) - Under the Affordable Care Act’s amendments to the Stark Law, a Physician Owned Hospital (POH) cannot expand the aggregate number of operating rooms, procedure rooms or licensed beds beyond the number for which the hospital was licensed on March 23, 2010. The Secretary of Health and Human Services may grant an exception to this prohibition - [Texas Hospice Owner Sentenced for Fraud Scheme](https://texashealthlaw.com/texas-hospice-owner-sentenced-for-fraud-scheme/) - A jury found Rodney Mesquias guilty last week on charges of: conspiracy to commit healthcare fraud, conspiracy to commit money laundering, conspiracy to obstruct justice, conspiracy to pay and receive kickbacks, and six counts of healthcare fraud. Mesquias owned and operated Merida Group, a healthcare company with dozens of locations in Texas. The Department of Justice - [Texas Heart Hospital and Subsidiary Management Company to Pay $48 Million to Settle False Claims Act Allegations Related to Alleged Kickbacks](https://texashealthlaw.com/texas-heart-hospital-and-wholly-owned-subsidiary-thhbp-management-company-llc-to-pay-48-million-to-settle-false-claims-act-allegations-related-to-alleged-kickbacks-opa-department-of-justice/) - Huge qui tam settlement where the qui tam plaintiffs will recover $13.9 million. The underlying action involves allegations that the Heart Hospital violated the Stark Law and the Anti-Kickback Statute by requiring physician owners to satisfy the Heart Hospital’s yearly 48 patient-contact requirement in order to maintain ownership in the hospital. This settlement arises from - [Federal Regulatory Compliance Issues Can Arise in State Court Matters](https://texashealthlaw.com/federal-regulatory-compliance-issues-can-arise-in-state-court-matters/) - An interesting read regarding the use of federal regulatory compliance issues (e.g impermissible healthcare kickbacks) to support a state court tort claim. The plaintiffs sued the manufacturer of a immunoglobulin infusion product alleging that the manufacturer improperly induced a physician to misdiagnose their condition by paying the physician impermissible kickbacks through bonuses and commissions. The - [Two area home health agency owners charged in health care fraud and illegal kickback scheme](https://texashealthlaw.com/two-area-home-health-agency-owners-charged-in-health-care-fraud-and-illegal-kickback-scheme/) - A federal grand jury indicted two home health agency on allegations that they fraudulently billed Medicare more than $10 million. The indictment alleges that Tataw and Anglea Bisong, co-owners of SierCam Healthcare Services LLC, billed Medicare for home health services that were not medically necessary or not actually provided as billed. Under the alleged scheme, - [HHS Proposes Modifications to the HIPAA Privacy Rule to Empower Patients, Improve Coordinated Care, and Reduce Regulatory Burdens](https://texashealthlaw.com/hhs-proposes-modifications-to-the-hipaa-privacy-rule-to-empower-patients-improve-coordinated-care-and-reduce-regulatory-burdens/) - The proposed changes to the HIPAA Privacy Rule include strengthening individuals’ rights to access their own health information, including electronic information; improving information sharing for care coordination and case management for individuals; facilitating greater family and caregiver involvement in the care of individuals experiencing emergencies or health crises; enhancing flexibilities for disclosures in emergency or - [Former Owner of Health Care Staffing Company Indicted for Wage Fixing](https://texashealthlaw.com/former-owner-of-health-care-staffing-company-indicted-for-wage-fixing/) - A federal grand jury returned an indictment charging Neeraj Jindal, the former owner of a therapist staffing company, for participating in a conspiracy to fix prices by lowering the rates paid to physical therapists and physical therapist assistants in north Texas, including the Dallas-Fort Worth metropolitan area, the Department of Justice announced today. The indictment - [Health care company owner to pay $1 million to settle False Claims Act case](https://texashealthlaw.com/health-care-company-owner-to-pay-1-million-to-settle-false-claims-act-case/) - The former owner of Providence Home Health and Providence Hospice has agreed to pay $1.05 million to settle claims she knowingly and willfully paid improper kickbacks for referrals of Medicare patients to her businesses, announced U.S. Attorney Ryan K. Patrick along with Special Agent in Charge Miranda Bennett of the Department of Health and Human - [Cutting Out the “Middleman”? HHS Resurrects Anti-Rebate Rule for Medicare Part D](https://texashealthlaw.com/cutting-out-the-middleman-hhs-resurrects-anti-rebate-rule-for-medicare-part-d/) - [T]he Final Rule will modify the federal health care program’s Anti-Kickback Statute (“AKS”) safe harbors in three key ways: First, it will remove safe harbor protection under the AKS for rebates that a pharmaceutical manufacturer provides to Medicare Part D plan sponsors (either directly or indirectly through the PBMs with which they contract). In apparent - [Direct Contracting Model Comes to Medicare](https://texashealthlaw.com/direct-contracting-model-comes-to-medicare-medpage-today/) - Under the model, healthcare providers -- which CMS calls "direct contracting entities," or DCEs -- will competitively bid to manage 100% of the Medicare Part A and Part B costs for a certain number of Medicare beneficiaries within a geographic region, starting at a minimum of 30,000 enrollees. Who can be a DCE? "We anticipate - [CMS final 2021 physician fee schedule rule](https://texashealthlaw.com/cms-final-2021-physician-fee-schedule-rule/) - CMS issued the final rule for the 2021 Physician Fee Schedule and doctors will see a conversion factor of $32.41, a decrease of $3.68 from the 2020 PFS conversion factor of $36.09.According to CMS, the lower conversion factor is a result of the budget neutrality adjustment, as required by law, to account for changes in - [Jefferson County Doctor Convicted of Health Care Fraud Violations](https://texashealthlaw.com/jefferson-county-doctor-convicted-of-health-care-fraud-violations/) - The fraud and abuse laws can sometimes be obtuse, but this is a clear-cut case of intentional fraud. Grigoriy T. Rodonaia, of Port Neches, Texas, was convicted by a jury of 12 counts of health care fraud, three counts of aggravated identity theft, one count of making a false statement, and two counts of accepting - [OIG Finalizes Rebate Rules: Removal of Safe Harbor Protections for Rebates and Creation of New Safe Harbors for Other Discounts and Service Fees](https://texashealthlaw.com/oig-finalizes-rebate-rules-removal-of-safe-harbor-protections-for-rebates-and-creation-of-new-safe-harbors-for-other-discounts-and-service-fees/) - As the title implies, this final rule clarifies and amends the discount safe harbor at 42 C.F.R. § 1001.925(h) under the federal Anti-kickback statute (AKS) such that rebates paid from drug manufacturers to Medicare Part D prescription drug plan sponsors or their pharmacy benefit managers (PBMs) are not protected from liability under the discount safe - [Reimbursement Pressure in Radiation Therapy & Block Lease Arrangements](https://texashealthlaw.com/reimbursement-pressure-in-radiation-therapy-block-lease-arrangements/) - The finalized Radiation Oncology payment model and the Final CY 2021 Medicare Physician Fee Schedule (“MPFS”) have now been made public. Many in the industry will continue to face downward pressure on reimbursement during the coming year under the new MPFS payment rates set by Medicare which will drive overall cuts estimated to average 5.0% - [HHS Finalizes Highly Anticipated Final Rules Amending AKS and Stark Law Regulations, Part III: Value-Based Arrangements](https://texashealthlaw.com/hhs-finalizes-highly-anticipated-final-rules-amending-aks-and-stark-law-regulations-part-iii-value-based-arrangements/) - A value-based arrangement is an arrangement entered into between a value-based enterprise (VBE) and one or more of its participants, or among VBE participants in the same VBE, for the provision of one or more value-based activities for a target patient population. The final rule defines a VBE participant as an individual or entity that - [HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth](https://texashealthlaw.com/hhs-amends-prep-act-declaration-including-to-expand-access-to-covid-19-countermeasures-via-telehealth/) - On December 3, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19. Source: HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth | Holland & Hart Health - [New Stark and Anti-Kickback Statute Comparisons](https://texashealthlaw.com/new-stark-and-anti-kickback-statute-comparisons/) - A great resource of the a redline versions of the regulations that highlight the changes for the new revisions to Stark and the Anti-Kickback Statute. The documents may be accessed here: Revised Stark Regulations Revised Anti-Kickback Statute Regulations The Federal Register versions of the revised regulations and accompanying commentary may be accessed here: 42 CFR 411 - [OIG Issues Final Rules on Anti-Kickback Statute and the Civil Monetary Penalty](https://texashealthlaw.com/oig-issues-final-rules-on-anti-kickback-statute-and-the-civil-monetary-penalty/) - In its final rule, the OIG defined what constitutes “telehealth technologies” more broadly than in its proposed rule, but otherwise chose to track the conditions for the exception contained in the underlying statute and not to implement any of the additional conditions that were included in the proposed rule. Source: OIG Issues Final Rules on - [Fifth Individual Charged in Health Care Kickback Conspiracy](https://texashealthlaw.com/fifth-individual-charged-in-health-care-kickback-conspiracy/) - The defendants are alleged to have conspired to pay and receive kickbacks in exchange for physicians’ orders that were used to submit claims for payment to federal health care programs. The conspirators obtained patient information, including protected health information and personally identifiable information, and used the information to create fictitious physicians’ orders. The conspirators then - [Ways your Healthcare Company is Breaking the Law — Without Realizing it](https://texashealthlaw.com/ways-your-healthcare-company-is-breaking-the-law-without-realizing-it/) - According to the U.S. Department of Health & Human Services' Breach Portal, sometimes called the "Wall of Shame," 418 breaches of HIPAA were reported in 2019. Some 34.9 million Americans had their protected health information (PHI) compromised. How is this still happening?Healthcare companies and practices make the biggest mistake by believing human behavior can be - [Stark + AKS Final Rules](https://texashealthlaw.com/stark-aks-final-rules/) - The final rules for changes to the Stark Law and Anti-Kickback Statute (healthcare fraud & abuse laws) have been published and go into effect on January 19, 2020. Of course, health lawyers love this stuff, but it could impact other practice areas too. Transaction attorneys, you already know to be very careful if your transaction - [OIG Fraud Concerns Over Physician Speaker Programs](https://texashealthlaw.com/oig-fraud-concerns-over-physician-speaker-programs/) - In a Special Fraud Alert issued on November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS-OIG) raised significant fraud and abuse concerns with companies offering or providing remuneration in connection with physician speaker programs. Speaker programs typically involve one health care professional presenting to others on a company’s drug - [Houston physician sentenced to prison for $17M billing fraud](https://texashealthlaw.com/houston-physician-sentenced-to-prison-for-17m-billing-fraud/) - Yolanda Hamilton, MD, was found guilty by a federal jury of participating in a Medicare scheme that involved signing false "plans of care" and other medical documents for home health services that were used to submit fraudulent claims to Medicare. She allegedly received $30,000 in kickbacks during the four-year scheme. Prosecutors alleged that Dr. Hamilton - [Eleventh Circuit Extends Scope and Time Limits for People Who Sue under the Medicare Secondary Payer Act](https://texashealthlaw.com/eleventh-circuit-extends-scope-and-time-limits-for-people-who-sue-under-the-medicare-secondary-payer-act/) - Medicare is the Secondary Payor when other insurance is available to pay the claim. However, when the Primary Payor delays payment, Medicare will make a "conditional payment." If the Primary Payor fails to reimburse Medicare within 60 days, Medicare and other Medicare Advantage Organizations (MAOs) can recover double damages from the Primary Payor. This Eleventh - [FTC sues to block $350 million sale of 2 Tenet Healthcare-owned hospitals in Memphis area](https://texashealthlaw.com/ftc-sues-to-block-350-million-sale-of-2-tenet-healthcare-owned-hospitals-in-memphis-area/) - The Federal Trade Commission is suing to block Farmers Branch-based Tenet Healthcare’s $350 million sale of two hospitals in the Memphis area to another healthcare system. I don’t know the specifics of the transaction, but the FTC likely objected after the parties filed a “Hart-Scott-Rodino Premerger Notification,” or just “Hart-Scott filing.” These filings, which must - [California Doctor Pleads Guilty to EKRA Violations](https://texashealthlaw.com/california-doctor-pleads-guilty-to-ekra-violations/) - On September 15, 2020, Doctor Akikur R. Mohammad, a California resident and drug treatment facility owner, pled guilty before the U.S. District Court of New Jersey for violating the Eliminating Kickbacks in Recovery Act (“EKRA”), one of the country’s first convictions under this statute targeting opioid kickbacks. Enforcement under EKRA can help shed light on - [San Antonio ER hospital sued for alleged overbilling](https://texashealthlaw.com/san-antonio-er-hospital-sued-for-alleged-overbilling/) - A former patient has sued Baptist Emergency Hospital in San Antonio and its owner alleging they fraudulently overcharged for lab work to generate higher reimbursements. This is not a qui tam case, but rather a state court private action. The Plaintiff accuses Baptist Emergency Hospital at Shavano Park of carrying out a scheme known as - [Office of the National Coordinator for Health IT Extends Compliance Deadlines under Interoperability Final Rule](https://texashealthlaw.com/office-of-the-national-coordinator-for-health-it-extends-compliance-deadlines-under-interoperability-final-rule/) - In an effort to provide additional relief to a health care system strained by the COVID-19 pandemic, the Office of the National Coordinator for Health IT (“ONC”) released an Interim Final Rule with Comment Period (“IFC”) on October 29, 2020 that extends the compliance dates under the 21st Century Cures Act Interoperability, Information Blocking, and - [OCR Settles Tenth Investigation in HIPAA Right of Access Initiative](https://texashealthlaw.com/ocr-settles-tenth-investigation-in-hipaa-right-of-access-initiative/) - Riverside Psychiatric Medical Group (“RPMG”) has agreed to take corrective actions and pay $25,000 to settle a potential violation of the HIPAA Privacy Rule's right of access standard. RPMG, based in Riverside, California, is a group practice specializing in child and adolescent psychiatry, geriatric psychiatry, neuropsychiatry, psychology, and substance use disorders. OCR received a complaint - [OIG Semiannual Report to Congress](https://texashealthlaw.com/oig-semiannual-report-to-congress/) - OIG issued its Semiannual Report to Congress summarizing the activities of the Department of Health and Human Services (HHS), Office of Inspector General (OIG), for the 6-month period ending on March 31, 2020. The OIG noted that during this reporting period, there were 443 criminal actions, 370 civil actions, 903 exclusions, and an expected $1.51 - [Justice Department accuses Anthem of Medicare fraud](https://texashealthlaw.com/justice-department-accuses-anthem-of-medicare-fraud/) - Yet another allegation of Medicare Advantange risk adjustment fraud, this time by Anthem. I wrote about the government's case against Cigna here. The case alleges that Anthem falsely certified the accuracy of the diagnostic data it sent to the Centers for Medicare and Medicaid Services, causing CMS to calculate risk-adjustment payments to the insurer based - [Private Schools and the Intersection of HIPAA and FERPA](https://texashealthlaw.com/private-schools-and-the-intersection-of-hipaa-and-ferpa/) - My wife works as an Administrative Assistant at a local private school. As you might expect, they take very seriously their responsibility to help stop the spread of COVID-19 in the community. As part of their efforts, they require students who were in direct contact with persons diagnosed with COVID-19 to quarantine at home, away - [CMS Encourages Faster COVID-19 Diagnostic Testing](https://texashealthlaw.com/cms-encourages-faster-covid-19-diagnostic-testing/) - CMS is changing its payment methodology to encourage higher throughput of COVID-19 diagnostic testing. Previously, CMS would reimburse $100 per test Starting January 1, 2021, Medicare will pay lower the base rate to $75. However, if the laboratory can complete the test within two (2) calendar days from the date the specimens is collected, CMS - [DOJ sues Cigna, alleging $1.4B in Medicare Advantage fraud](https://texashealthlaw.com/doj-sues-cigna-alleging-1-4b-in-medicare-advantage-fraud/) - Cigna falsified the health conditions of its Medicare Advantage plan members to coax CMS into making larger payments to the insurer on behalf of beneficiaries, a U.S. Justice Department lawsuit alleges. Medicare Advantage organizations get reimbursed by Medicare based on a formula that takes into account the patient population’s acuity levels. Risk adjustment scores adjust - [CMS Issues Cease and Desist Orders to Uncertified Labs Performing COVID-19 Testing](https://texashealthlaw.com/cms-issues-cease-and-desist-orders-to-uncertified-labs-performing-covid-19-testing/) - Since August 12, 2020, CMS issued 171 cease and desist letters to entities across the U.S. that were testing for COVID-19 without the appropriate certifications under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Every facility that conducts COVID-19 testing is considered a “laboratory” and must be certified under CLIA, which verifies that labs meet - [Data Breaches Can Result in Federal and State Liability](https://texashealthlaw.com/data-breaches-can-result-in-federal-and-state-liability/) - Regulatory bodies continue to impose severe penalties on covered entities who fail to protect patient data from unauthorized disclosure. Community Health Systems, Inc. recently settled claims with HHS Office of Civil rights resulting from a 2014 data breach that exposed personal information of approximately 6.1 million patients for $2.3 million. But settlement with the federal - [Two charged in prescription and kickback scheme](https://texashealthlaw.com/two-charged-in-prescription-and-kickback-scheme/) - An 11-count indictment unsealed on Friday charges former Kindred Home Health employee Amber Price, 37, and Christopher Cruz, 46, owner of a medical marketing business, CP Cruz Management Group, LLC (Cruz), with one count of conspiracy to violate the federal anti-kickback law. Under the alleged scheme, Price and Cruz would create fraudulent prescriptions using actual - [Medical Device Maker to Pay $18 Million to Settle Allegations of Improper Payments to Physicians](https://texashealthlaw.com/medical-device-maker-to-pay-18-million-to-settle-allegations-of-improper-payments-to-physicians/) - This is not a Texas company, but it is a good example of how some manufacturers try to cloak improper payments under the veil of legitimate compensation. The device manufacturer paid millions of dollars in "advertising assistance, practice development, practice support, and purported unrestricted educational grants" directly to local healthcare providers to induce sales of - [OCR Settles Eighth Investigation in HIPAA Right of Access Initiative](https://texashealthlaw.com/ocr-settles-eighth-investigation-in-hipaa-right-of-access-initiative/) - Since 2019, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has been prioritizing enforcement actions against covered entities that do not allow patients timely access to their health records at a reasonable cost as required by HIPAA. This month, OCR settled an eighth investigation for $160,000 and - [VIDEO: TBCE Stem Cell Stakeholder meeting](https://texashealthlaw.com/tbce-stem-cell-stakeholder-meeting/) - Stem Cell Stakeholder meeting of the Texas Board of Chiropractic Examiners from Tuesday, October 13, 2020. - [HHS Renews Public Health Emergency Declaration through January 20, 2021](https://texashealthlaw.com/hhs-renews-public-health-emergency-declaration-through-january-20-2021/) - On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID‑19 will be renewed for another 90 days, beginning on October 23 (the date the PHE was previously scheduled to expire) and extending through January 20, 2021. Source: Renewal of Determination That A - [VIDEO: Bad Batch of Miracle Cure: Texas Response to Stem Cell Therapies](https://texashealthlaw.com/bad-batch-of-miracle-cure-texas-response-to-stem-cell-therapies/) - A presentation I gave to the Dallas Bar Association, Health Law Section on stem cell regulation in Texas. - [Professional Relators Have No Right to Sue for Beneficial Conduct](https://texashealthlaw.com/professional-relators-have-no-right-to-sue-for-beneficial-conduct/) - The Seventh Circuit determined that professional qui tam relators formed as "investment vehicles for financial speculators" should not be allowed to challenge conduct determined by the government likely to be lawful, and definitely beneficial to the government and the public. The court creates a new standard for dismissal, joining the standards articulated in Sequoia Orange - [FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products](https://texashealthlaw.com/fda-clarifies-types-of-evidence-relevant-to-determining-the-intended-use-of-fda-regulated-products/) - The FDA proposed updates to clarify the types of evidence it considers when determining the “intended use” of a product. A product’s “intended use” determines whether it is a medical product within the FDA’s jurisdiction. The proposed updates allow any source to be considered, even the subjective knowledge of the manufacturer. The proposed update clarifies, - [FDA Will No Longer Review EUA Requests for COVID-19 Laboratory Developed Tests](https://texashealthlaw.com/fda-will-no-longer-review-eua-requests-for-covid-19-laboratory-developed-tests/) - The Food and Drug Administration (FDA) will no longer require premarket review of laboratory developed tests (LDTs), including COVID-19 tests, decline to review emergency use authorization (EUA) request for LDTs. Instead, the FDA will prioritize review of EUAs for point-of-care tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput, - [Unapproved and Misbranded COVID Treatments Get FDA Attention](https://texashealthlaw.com/unapproved-and-misbranded-covid-treatments-get-fda-attention/) - There is no FDA-approved treatment for COVID-19, but that hasn’t stopped one compounding pharmacy from making bold claims. Marketing products as “COVID PACK” and “COVID ‘POSITIVE’ PACK” for the “treatment and recovery from the Covid-19 virus” apparently crossed the line. These products appear to be nothing more than vitamins. 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