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 only on patients already connected to participating providers. Authors recommend modifications including leveraging Medicare’s 1.3 percent administrative costs rather than replacing them with private insurance overhead of 12-15 percent, starting with modest discount requirements of 1-2 percent instead of the original 3-5 percent, and building on existing provider-led ACOs rather than insurance companies. The successor ACO REACH program generated $1.6 billion in gross savings and $695 million in net savings to CMS in 2023, with 73 out of 83 participating ACOs meeting continuous improvement requirements. The authors argue a revised model could combine Medicare’s efficiency with population health innovations while serving as regional sentinels against fraud, waste, and abuse. Source: Health Affairs
AI Transcription
Healthcare organizations using AI scribes to transcribe patient encounters face HIPAA compliance risks that could result in unauthorized disclosure of protected health information. AI scribes function as third-party service providers that listen to doctor-patient conversations, requiring healthcare providers to establish Business Associate Agreements with vendors. There are two main compliance challenges: (1) data use rights and (2) patient consent requirements under federal wiretapping laws. Many AI scribe vendors are new to healthcare and unfamiliar with regulatory requirements, while some doctors download and use these apps without organizational oversight. Healthcare leaders must vet vendors, build governance into EHR workflows, limit unauthorized data use, update risk analyses, and train providers to ensure compliance. Source: HealthLeaders Media
Antitrust
Washington and Colorado will require companies filing Hart-Scott-Rodino premerger notifications to simultaneously submit copies to state attorneys general starting this summer. Washington’s law takes effect July 27, 2025, while Colorado’s becomes effective August 6, 2025, applying to companies with their principal place of business in the state or with annual net sales of at least $25.28 million in goods or services involved in the transaction. The laws impose no filing fees but carry penalties of up to $10,000 per day for non-compliance, and they do not create waiting periods that would prevent deal closings. Both states based their legislation on the Uniform Antitrust Premerger Notification Act approved by the Uniform Law Commission in July 2024, which provides a model for state attorneys general to receive HSR filings at the same time as federal antitrust agencies. Hawaii, West Virginia, District of Columbia, California, and New York are considering similar legislation, with New York’s proposed law extending beyond the model act to require all businesses conducting operations in the state to file with the attorney general. Source: Hogan Lovells
Business Entities
Texas enacted two bills in May 2025 that reshape corporate governance to attract businesses away from Delaware. Senate Bill 29, effective immediately, codifies the business judgment rule for directors and officers, allows companies to require internal disputes be heard exclusively in Texas courts, permits jury trial waivers, and restricts shareholder inspection rights to exclude emails and social media unless they directly relate to corporate actions. The law also requires minimum ownership thresholds of up to 3% for derivative suits and prohibits attorney fee awards in disclosure-only cases. Senate Bill 1057, effective September 1, 2025, imposes stricter requirements on shareholder proposals by mandating that shareholders hold $1 million in market value or 3% of voting stock for at least six months and solicit 67% of voting power. These changes position Texas to compete with Delaware in the corporate law space as states seek to attract incorporation business. Source: Seyfarth Shaw LLP
Compassionate Use
Texas expanded its medical cannabis program through HB 46, which Governor Greg Abbott signed into law on June 21, 2025. The law, effective September 1, 2025, adds chronic pain, Crohn’s disease, traumatic brain injury, terminal illnesses, and hospice care as qualifying conditions. The legislation increases THC limits from 1% by weight to 10 milligrams per dose with packages not exceeding 1 gram of THC, and expands delivery methods to include lotions, patches, suppositories, and non-smoked inhalation devices. The Department of Public Safety will issue 12 additional licenses for dispensing organizations, bringing the total to 15, while the Texas Board of Pharmacy will monitor dispensed cannabis through the Prescription Monitoring Program. Patient recommendations remain valid for one year with four 90-day refills, and patient registry information stays confidential with access limited to the department, registered physicians, and dispensing organizations. Source: Marijuana Policy Project
Concierge Medicine
President Trump signed the “One Big Beautiful Bill Act” on July 4, 2025, allowing Health Savings Account holders to use their funds for direct primary care services. The law removes the previous disqualification that prevented individuals from contributing to HSAs when they paid direct primary care fees, which were formerly considered health plans. Under the legislation, monthly fees are capped at $150 for individuals and $300 for families, and must cover only primary care services provided by primary care practitioners. The law excludes procedures requiring general anesthesia, prescription drugs other than vaccines, and laboratory services not typically administered in ambulatory primary care settings. The legislation takes effect after December 31, 2025. Source: Roetzel & Andress
Data Privacy
Colorado and California became the first US states to enact privacy laws governing neural data in 2024, with at least six other states now proposing similar legislation. The two states took different approaches, with Colorado requiring opt-in consent before collecting neural data while California only provides consumers with limited opt-out rights for uses beyond requested services. Current federal laws like HIPAA provide minimal protection for neural data, covering it only when collected by healthcare entities. Connecticut, Illinois, Massachusetts, Minnesota, Montana, and Vermont have pending bills that vary in scope, with some treating neural data as biometric information and others creating standalone protections. Companies collecting neural data from brain-computer interfaces and neurotechnology devices face compliance challenges due to the inconsistent state-by-state regulatory approach. Source: Arnold & Porter
Healthcare organizations face mounting cybersecurity threats as data breach costs reach $4.88 million globally, representing a 10 percent increase from the previous year. Electronic health records containing protected health information have become prime targets for cybercriminals using phishing and ransomware attacks. Generative AI tools are expanding the attack surface by introducing vulnerabilities through flawed code, data exposure risks, and threats like prompt injection and deep fakes. A HIMSS/Trimex study reveals that 74 percent of healthcare organizations feel understaffed to handle rising cyber threats. Healthcare providers must implement staff education programs, physical and technical security controls, data encryption, role-based access control, and vetted third-party partnerships while achieving HITRUST certification as the gold standard for data security compliance. Source: HIT Consultant
Eliminating Kickbacks in Recovery Act
The Ninth Circuit Court of Appeals expanded the scope of the Eliminating Kickbacks in Recovery Act (EKRA) to include payments to marketing intermediaries who induce patient referrals through misleading practices. On July 11, 2025, the court affirmed laboratory operator’s convictions for paying marketers percentage-based compensation to pitch his laboratory services to medical professionals using misleading information about tests that were unnecessary, costly, and inferior to other methods. The court rejected a district court interpretation that limited EKRA’s application only to direct payments to referring providers, ruling instead that the law covers any payment designed to cause downstream referrals. The Ninth Circuit clarified that percentage-based compensation alone does not violate EKRA, but payments combined with undue influence or wrongful inducement do constitute violations. The decision provides healthcare providers with guidance on sales staff compensation but stops short of establishing clear-cut rules for compliance. Source: Healthcare Law Blog
Fraud & Abuse
UnitedHealth Group disclosed Thursday it faces criminal and civil investigations from the Department of Justice. The company said in an SEC filing it was complying with DOJ requests and had reached out to the department after media reports about probes into its Medicare practices. The investigation adds to a year of challenges for the healthcare company, which became the worst performer on the Dow Jones Industrial Average during the first half of 2025 following the fatal shooting of CEO Brian Thompson and the departure of the company’s CEO in May. The Wall Street Journal previously reported the DOJ’s healthcare-fraud unit was investigating possible Medicare fraud at the company, along with potential antitrust violations and Medicare billing practices. UnitedHealth’s stock declined 1.5 percent in morning trading following the announcement, though the company maintains it has “full confidence” in its practices. Source: ABC News
Medical Debt
A federal court has vacated the Consumer Financial Protection Bureau’s Medical Debt Rule after finding the agency exceeded its authority under federal law. The United States District Court for the Eastern District of Texas approved a consent judgment this month, ruling that the CFPB violated the Fair Credit Reporting Act and the Administrative Procedure Act when it finalized the rule in January 2025. The rule would have prohibited credit reporting agencies from including any medical debt information in consumer reports and barred creditors from considering such information in credit decisions. Trade associations representing credit unions and consumer data industries challenged the rule, and the CFPB under new leadership agreed with the challengers. The decision restores the framework where credit reporting agencies can report coded medical debt information that protects patient privacy. Source: Health Care Law Matters
Medicare Reimbursement
CMS released the calendar year 2026 Medicare Physician Fee Schedule and Quality Payment Program proposed rule that establishes different payment rates for physicians based on their participation in alternative payment models. The proposed conversion factor for qualifying alternative payment model participants is $33.59, representing a 3.83% increase, while non-participants would receive $33.42, a 3.62% increase from 2025. CMS proposes applying a -2.5% efficiency adjustment to work relative value units for non-time-based services, excluding evaluation and management services, care management, behavioral health, and telehealth services. The agency will recognize higher indirect practice expense costs for office-based practitioners compared to facility settings due to the decline in private practice physicians. CMS also introduced a mandatory Ambulatory Specialty Model for specialists treating low back pain or heart failure that will assess individual physicians on quality metrics and apply payment adjustments ranging from -9% to +9% from 2027 through 2031. Source: AAMC
CMS launched the WISeR model in June, using artificial intelligence to review Medicare payments for select services during a six-year pilot program from January 2026 to December 2031. The program applies only to original Medicare plans and initially covers skin and tissue substitutes, electrical nerve stimulator implants, and knee arthroscopy for osteoarthritis, while excluding emergency services and treatments that pose risks if delayed. Model participants receive compensation based on a percentage of savings from denied services, raising concerns about financial incentives for denials given that similar AI programs have faced lawsuits where over 90% of denials were later overturned on appeal. A Senate subcommittee report from October 2024 found that Medicare Advantage plans using predictive analysis increased automatic denials for post-acute services without regard to patient need. Providers can earn “gold card” status to become exempt from reviews by demonstrating high authorization approval rates, and experts recommend that providers engage with CMS during the pilot phase and monitor denial patterns for algorithm errors. Source: Phelps Dunbar LLP
Reproductive Rights
A Texas man filed a federal lawsuit against a California doctor for allegedly mailing abortion pills to his girlfriend, marking a new strategy to challenge blue state shield laws that protect abortion providers. Jerry Rodriguez, represented by anti-abortion lawyer Jonathan Mitchell, seeks $75,000 in damages from Dr. Remy Coeytaux and claims his girlfriend used the medications to terminate two pregnancies in 2024. The federal court filing differs from previous state court challenges and could potentially bypass the enforcement issues seen in a similar case where New York refused to honor a Texas judgment against another doctor. The lawsuit also invokes the 19th century Comstock Act, which has not been enforced for over a century, as part of what legal experts describe as a multi-pronged attack on abortion access. The litigation coincides with the Texas Legislature’s consideration of sweeping legislation to crack down on the manufacturing and mailing of abortion pills during a special session. Source: The Texas Tribune
Skilled Nursing Facilities
CMS has extended the deadline for skilled nursing facilities to submit enhanced ownership disclosure requirements from August 1, 2025, to January 1, 2026. The new guidance implements Section 1124(c) of the Social Security Act through a revised Form CMS-855A that requires SNFs to disclose detailed information about governing body members, additional disclosable parties with operational or financial control, and organizational structures of related entities. The enhanced requirements, effective October 1, 2024, apply to all SNFs enrolling, revalidating, reactivating, or undergoing ownership changes, expanding beyond current Section 1124(a) disclosures to include parties providing management services, leasing real property, or exercising control over facility operations. All SNFs must complete revalidation applications by the uniform January 1, 2026 deadline regardless of when they received notification letters from Medicare Administrative Contractors. SNFs experiencing difficulty obtaining required information from third parties must document maximum feasible efforts to secure the data before notifying their contractors of any gaps. Source: CMS Guidance for SNF Attachment on Form CMS-855A
The HHS Office of Inspector General imposed over $1.6 million in penalties against 20 healthcare facilities for employing individuals excluded from federal healthcare programs. On May 29, 2025, HHS-OIG announced a $1,565,374.11 settlement with 19 skilled nursing facilities across California, Texas, Ohio, and Nevada to resolve allegations that they knew or should have known they employed excluded individuals who provided services billed to federal programs. The agency also reached a separate $35,597.37 settlement with CareLink Home Health, LLC in Illinois for employing an excluded individual who worked as a nurse and case manager while on the exclusions list. HHS-OIG excludes individuals and entities from Medicare and Medicaid programs for various reasons, with exclusion periods ranging from discretionary terms to permanent bans for repeat offenders. Healthcare organizations must check the HHS-OIG List of Excluded Individuals/Entities before hiring new employees or vendors and conduct regular checks of current staff to avoid civil monetary penalty liability. Source: HIPAA Journal
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 audits, transaction support, and staff training to help healthcare organizations navigate compliance challenges. The firm has developed FMV-MD software to standardize valuation management processes and reduce risks associated with physician compensation arrangements under Stark Law. With 30 years of experience focused on healthcare, VMG Health provides compliance services across all healthcare sectors. Source: VMG Health
Physician groups must evaluate tax efficiency, legal structure, and compliance issues before considering strategic transactions to avoid pitfalls and devaluation. Medical practice consolidation has increased in recent years with lucrative valuations, but groups need consensus before exploring transactions—full consensus for smaller groups of 2-4 physicians and substantial consensus of 80% or more for larger groups of 5-30+ physicians. Groups must agree on proceeds allocation early and address compliance issues including monthly exclusion checks, Stark/DHS compliance, HIPAA policies, co-pay waiver violations, and employee classification problems. Real estate leases between physician owners and practices should reflect fair market value terms rather than friendly arrangements. Engaging experienced healthcare transaction attorneys and advisors is crucial for proper advance planning and positioning. Source: Medical Economics
Clinical Laboratories
The U.S. Department of Health and Human Services Office of Inspector General announced in June 2025 a new Work Plan review examining Medicare payments for clinical diagnostic laboratory tests in 2024. This annual review, mandated by the Protecting Access to Medicare Act of 2014, will analyze the top 25 laboratory tests by Medicare expenditures, including tests such as comprehensive metabolic panels, complete blood counts, Hemoglobin A1c, and lipid panels. The OIG’s findings could result in future payment rate adjustments, increased audit scrutiny, or enforcement actions against providers identified as outliers. Clinical laboratories and healthcare providers must ensure their billing practices comply with Medicare regulations, maintain documentation supporting medical necessity, and implement compliance programs with internal audits and staff training. Recent False Claims Act litigation, including Jensen ex rel. United States of America v. Genesis Laboratory, demonstrates the risks laboratories face for non-compliance with federal regulations regarding medical necessity and the Anti-Kickback Statute. Source: Healthcare Law Insights
Cybersecurity & Data Breaches
Healthcare became the most targeted industry for ransomware attacks in 2024, with data breaches costing organizations an average of $9.77 million. Medical records sell for up to 50 times more than credit card numbers on the dark web because they cannot be cancelled and enable identity theft and insurance fraud. The sector faces vulnerabilities from outdated systems, with 71% of medical devices running obsolete software in 2019 and 60% of French hospitals operating on outdated infrastructure in 2022. Human error accounts for 70% of successful cyberattacks in healthcare in France, with phishing serving as the most common entry point. The analysis recommends treating obsolete IT systems as systemic risks, reimagining spending models to allow flexibility between capital and operational expenditures, mandating cybersecurity training, encouraging regional collaboration, and securing electronic health records as priorities. Source: Cisco
Healthcare organizations face mounting pressure to deliver personalized care while protecting patient data privacy. A 2023 poll found 95% of patients worry about medical record breaches, while a 2022 American Medical Association survey revealed 92% of respondents believe privacy is a right regarding their health data. Patients trust healthcare providers more than tech companies with their information, with 64-75% comfortable sharing data with doctors and hospitals compared to over 67% who are uncomfortable sharing with technology companies. Nearly half of patients report not getting all questions answered during provider visits, creating opportunities for health plans to fill gaps through educational content that uses aggregate data analysis rather than accessing protected health information. Solutions exist that allow care management teams to personalize member experiences through tiered approaches including self-service resources, automated engagement for rising-risk members, and care manager support for higher-risk populations. Source: Wolters Kluwer
Texas HB 3595 establishes statewide emergency preparedness standards for assisted living communities while allowing providers flexibility in how they meet backup power requirements. The law, effective September 1, requires communities to maintain areas of refuge with temperatures between 68 and 82 degrees during emergencies and conduct full building evaluations of electricity needs. Communities must report power outages lasting more than 12 hours to state agencies, triggering ongoing monitoring conversations to ensure resident safety. The legislation was prompted by Winter Storm Uri, which killed 107 Texas older adults from hypothermia in 2021, and Hurricane Beryl, which caused 28 deaths among older adults, half from overheating. Industry groups support the flexible approach over statewide generator mandates, noting that only 47% of Texas assisted living communities have generators, and more than half of the state’s 2,000 communities house fewer than 17 residents. Source: McKnight’s Senior Living
Healthcare platforms combining artificial intelligence, Internet of Things, and blockchain technology are creating self-learning ecosystems that transform patient care from reactive to proactive. These cognitive healthcare platforms use IoT devices such as fitness trackers and hospital equipment to continuously collect patient data including heart rate, blood pressure, and glucose levels, enabling early intervention before symptoms appear. Blockchain technology ensures secure, tamper-proof storage and sharing of medical records, allowing authorized healthcare providers to access complete patient histories while preventing data breaches and fraud. AI analyzes the real-time data streams to identify patterns and predict health risks such as early signs of diabetes or cancer from subtle changes in body metrics. The platforms reduce administrative burdens for healthcare providers while offering patients transparent access to their health records and remote consultation capabilities, though implementation faces challenges including infrastructure limitations in rural areas and interoperability issues between different hospital systems. Source: Healthcare Asia Magazine
Fraud & Abuse
The HHS Office of Inspector General issued an unfavorable advisory opinion on July 7, 2025, ruling that flat fee payment structures do not protect healthcare arrangements from Anti-Kickback Statute violations. The Advisory Opinion 25-08 involved a proposed arrangement between a medical device company and a software vendor, where the device company would pay $395 per license annually (totaling $1.2 million) to access software that facilitates device sales to hospitals and surgical centers. The OIG determined the arrangement failed to meet the Personal Services and Management Contracts Safe Harbor because the software services were “redundant” to the company’s existing accounts receivable processes and provided no tangible benefits beyond accessing referrals from surgical providers. The opinion emphasized that payments primarily intended to access referrals rather than obtain legitimate services can violate the Anti-Kickback Statute regardless of whether compensation is structured as a flat fee. The OIG also expressed concerns about anti-competitive behavior, noting that such arrangements could inappropriately steer healthcare providers toward companies willing to pay these fees while disadvantaging competitors. Source: Holland & Knight
Medical practices must navigate two federal laws designed to prevent financial conflicts of interest that could influence patient referrals. The Stark Law prohibits physicians from referring Medicare patients for designated health services to entities with which they or their family members have financial relationships unless specific exceptions apply, and violations can occur regardless of intent since it is a strict liability statute. The Anti-Kickback Statute criminalizes exchanges of value to induce referrals for federal healthcare program services and requires proof of intent but applies more broadly to all federal programs. In 2024, the Department of Justice resolved multiple cases involving alleged violations, including a Delaware health system that paid $42.5 million to settle allegations it provided free clinical support to a neonatology practice that then billed for services performed by staff. The Office of Inspector General recommends medical practices implement a seven-element compliance framework that includes internal audits, written policies, designated compliance officers, training programs, prompt violation response, open communication, and disciplinary standards. Source: CSH Law
Medicare Reimbursement
CMS will require specialists in selected regions to participate in a new payment model targeting heart failure and low back pain starting January 1, 2027. The Ambulatory Specialty Model will run for five years through December 31, 2031, and initially cover specialists in roughly one-quarter of core-based statistical areas who treat Original Medicare patients. Participation will be mandatory for cardiologists treating heart failure and specialists in anesthesiology, pain management, neurosurgery, orthopedic surgery, and physical medicine treating low back pain, provided they have historically treated at least 20 episodes per year. The model rewards specialists for improving patient health outcomes and coordinating with primary care providers to reduce avoidable hospitalizations and unnecessary procedures. CMS expects the program to lower costs to Original Medicare while improving patient experience and outcomes. Source: CMS
CMS announced a proposed rule to slash Medicare reimbursement for skin substitutes by nearly 90% to combat what it calls “abusive pricing practices” in the wound care industry. The 2026 Medicare Physician Fee Schedule would pay for skin substitutes as incident-to-supplies at a flat rate of $125.38 per square cm instead of the current biologicals framework, which allows products to be priced as much as $2,000 per square inch. Medicare spending on these cellular and tissue-based products that treat chronic wounds jumped from $252 million in 2019 to more than $10 billion in 2024. The proposal would categorize skin substitutes by their FDA regulatory status and aims to incentivize products with clinical evidence while saving billions in taxpayer dollars. Industry stakeholders have until September 12 to provide comments, with manufacturers warning the cuts could limit patient access and reduce innovation while advocacy groups support the cost-control measures. Source: MedPage Today
Mergers & Acquisition
Healthcare mergers and acquisitions demonstrate resilience in 2025, with transaction levels nearly double pre-2020 volumes despite economic and regulatory challenges. Private equity participates in roughly 40% of healthcare transactions, driven by large reserves of undeployed capital and urgency to generate returns. Behavioral health and home health/hospice sectors remain top targets for deals, while revenue cycle management and infusion therapy show increased momentum due to their tech-enabled potential and operational scalability. The Federal Trade Commission and state attorneys general have heightened scrutiny around private equity ownership and market concentration, slowing deal timelines but not halting activity. Organizations now conduct annual strategic portfolio reviews instead of three- to five-year planning cycles, with many preparing to bring deals to market for the remainder of 2025. Source: Modern Healthcare
Transgender Care
Physician groups must evaluate tax efficiency, legal structure, and compliance issues before considering strategic transactions to avoid pitfalls and devaluation. Medical practice consolidation has increased in recent years with lucrative valuations, but groups need consensus before exploring transactions—full consensus for smaller groups of 2-4 physicians and substantial consensus of 80% or more for larger groups of 5-30+ physicians. Groups must agree on proceeds allocation early and address compliance issues including monthly exclusion checks, Stark/DHS compliance, HIPAA policies, co-pay waiver violations, and employee classification problems. Real estate leases between physician owners and practices should reflect fair market value terms rather than friendly arrangements. Engaging experienced healthcare transaction attorneys and advisors is crucial for proper advance planning and positioning. Source: Medical Economics
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 consequences of storms, straight-line winds, and flooding. The waiver allows hospitals to bypass five specific HIPAA Privacy Rule requirements, including obtaining patient agreement to speak with family members, honoring opt-out requests from facility directories, distributing privacy notices, and processing patient requests for privacy restrictions and confidential communications. The waiver applies only in the emergency area to hospitals with disaster protocols and lasts up to 72 hours from when the hospital implements its disaster protocol. Hospitals must resume full HIPAA compliance for all patients under their care once the Presidential or Secretarial declaration terminates, regardless of the 72-hour timeframe. Source: HHS.gov
The OIG concluded that a pharmaceutical manufacturer’s program to assist eligible patients with travel, lodging, and related expenses for a one-time gene therapy does not violate federal anti-kickback or beneficiary inducement laws. The manufacturer’s gene therapy treats a rare, fatal genetic disease in children and costs over $4 million, with treatment limited to a small number of specialized centers. Under the arrangement, patients with household incomes below 600% of the Federal Poverty Level and who lack other travel assistance may receive covered transportation, lodging, and daily expenses for themselves and up to two caregivers, but only for medically necessary phases of treatment and only when no other support is available. The program uses a vendor to verify eligibility and prevent duplicate coverage, requires documentation of expenses, and does not promote the assistance as a reason to prescribe the therapy. The OIG found that the arrangement promotes access to care, poses a low risk of fraud or abuse, and does not improperly influence provider or patient choice. Source: OIG Advisory Opinion No. 25-06 (Favorable)
The OIG determined that a pharmaceutical manufacturer’s program to sponsor a free companion laboratory test for eligible patients prior to prescribing a specific drug does not violate federal anti-kickback or beneficiary inducement laws. The manufacturer’s drug is approved for certain conditions and requires a companion diagnostic test to determine patient eligibility, with the test being offered at no cost to patients who meet specific criteria and have not previously received the test. The arrangement prohibits providers and the laboratory from seeking reimbursement from any third party, ensures that no patient or provider receives direct remuneration, and limits data sharing to de-identified, aggregated information. The program is designed to identify patients who may benefit from the drug and does not promote the drug during disease-awareness activities or use data to target providers or patients for marketing purposes. The OIG concluded that the arrangement poses a low risk of fraud or abuse, does not interfere with clinical decision-making, and satisfies exceptions for promoting access to care. Source: OIG Advisory Opinion No. 25-07 (Favorable)
The OIG found that a medical device company’s proposal to pay a third-party vendor for access to an electronic billing system used by some customers would generate prohibited remuneration under the Federal anti-kickback statute. The company supplies “bill-only” surgical devices to health care providers, and some customers require the use of a vendor’s billing portal for purchasing these items, for which the vendor charges the company a licensing fee per representative. The company stated that the portal is redundant to its existing billing processes and provides no necessary or desired services, but it would pay the fees to retain and potentially expand business with customers who require use of the portal. The OIG determined that the arrangement could inappropriately steer customers to the company over competitors, presents anti-competitive risks, and does not serve a commercially reasonable business purpose for the company. As a result, the OIG concluded that the arrangement is not sufficiently low risk to warrant a favorable opinion. Source: OIG Advisory Opinion No. 25-08 (Unfavorable)
Cybersecurity
Healthcare organizations face cybersecurity risks when storing Protected Health Information in cloud environments. PHI includes medical records, diagnoses, treatment details, billing information, patient names, medical record numbers, health insurance details, Social Security numbers, test results, prescriptions, dates of birth, addresses, and billing information. When compromised, PHI can lead to identity theft, medical fraud, unauthorized use of insurance benefits, reputational harm, and loss of trust in healthcare providers. Cloud storage challenges include meeting HIPAA compliance requirements, understanding shared responsibility between providers and organizations, preventing misconfigurations, managing third-party integrations, maintaining visibility and control, and ensuring data location compliance. Healthcare organizations must implement encryption, identity and access management, secure cloud architecture, continuous monitoring, regular backups, disaster recovery plans, and staff training to protect PHI in cloud environments. Source: Geek Vibes Nation
Food & Drug Administration
The FDA implemented sweeping changes in June 2025 that created uncertainty for cell and gene therapy developers while launching new programs to accelerate drug approvals. The agency halted new clinical trials involving transfer of genetic material to foreign countries including China and terminated both the director and deputy director of the Office of Therapeutic Products, which oversees gene therapy and cellular therapy reviews. FDA also launched the Commissioner’s National Priority Voucher program that promises to reduce drug review times from 10-12 months to 1-2 months for companies aligned with national health priorities such as domestic manufacturing. The agency issued a warning letter to a Florida drug distributor for Drug Supply Chain Security Act violations just two months after inspection, signaling accelerated enforcement of prescription drug security laws. Meanwhile, medical device regulation remained stable and the FDA hired a new deputy director of the Center for Drug Evaluation and Research to advance psychedelic therapy development. Source: Mintz
Fraud & Abuse
DOJ and HHS of Health and Human Services announced the creation of the False Claims Act Working Group to strengthen civil enforcement of the False Claims Act in healthcare. The Working Group will be jointly led by DOJ’s Civil Division and top HHS officials, including representatives from CMS, the HHS Office of Inspector General, and U.S. Attorneys’ Offices. The initiative will focus on six priority enforcement areas: Medicare Advantage risk adjustment fraud, drug and device pricing, barriers to patient care, kickbacks, defective medical devices, and EHR manipulation designed to inflate Medicare reimbursements. The Working Group will make high-priority FCA referrals from HHS to DOJ, coordinate enforcement decisions, leverage data mining to uncover leads, evaluate payment suspensions, and encourage voluntary disclosures. This marks a shift toward more government-led enforcement and potentially less whistleblower-led enforcement, with healthcare companies facing increased scrutiny and faster investigations. Source: Healthcare Law Insights
Marketing
Healthcare fraud through phone calls cost Americans over $16 million in the first quarter of 2024. Americans received more than 4.4 billion robocalls in April 2024, with an average of 146.9 million calls per day and 1,700 calls per second. Scammers target the healthcare sector because consumers trust calls from health providers, often using caller ID spoofing to appear as legitimate hospitals or physicians’ offices. Common scams involve fraudsters posing as Medicare or Medicaid workers who request personal data or money while threatening loss of coverage. New technology offers solutions through branded calls that display business logos, names, and reasons for calling, verified through end-to-end call verification systems. Source: HIT Consultant
The Fifth Circuit ruled that the No Surprises Act does not allow healthcare providers to bring private lawsuits to enforce Independent Dispute Resolution awards. The case involved two air ambulance providers, Guardian Flight, LLC and Med-Trans Corporation, who sued Health Care Service Corporation after receiving delayed or no payment on IDR awards they had won under the No Surprises Act. The Fifth Circuit rejected all three of the providers’ claims, including violations of the NSA itself, ERISA benefit denials, and state law unjust enrichment. The court determined that Congress intended enforcement to occur through the administrative complaint process overseen by the U.S. Department of Health and Human Services rather than through private litigation. This decision conflicts with district court rulings in Connecticut and other jurisdictions that have found implied enforcement rights, creating a judicial divide that may require Supreme Court resolution. Source: Proskauer Rose LLP
Restrictive Covenants
Eight states have enacted legislation in 2025 that restricts or bans non-compete agreements for healthcare professionals. Colorado now voids non-compete and non-solicitation covenants for healthcare providers regardless of salary thresholds, while Illinois expanded restrictions for mental health professionals treating veterans and first responders. Indiana banned non-compete agreements between physicians and hospitals or hospital systems, and Montana extended its existing ban to all licensed physicians. Oregon declared non-competition agreements void and unenforceable for physicians, physician assistants, and nurse practitioners, while Texas now requires buyout options capped at annual salary and extended restrictions to dentists, nurses, and physician assistants. Utah prohibits healthcare staffing platforms from requiring non-compete agreements from healthcare workers. Source: Littler
States are implementing varied restrictions on non-compete agreements for healthcare professionals following the Federal Trade Commission’s failed attempt to ban such agreements nationwide. The new state laws range from blanket prohibitions in states like Arkansas and Wyoming to defined limitations on duration and geographic scope, with most states allowing non-competes lasting up to one year and geographic restrictions varying from five-mile radii in Texas to 30-mile radii in West Virginia. Some states condition enforceability on termination circumstances, while others like Maryland use hybrid approaches that combine compensation thresholds with medical-specific limitations. Texas enacted legislation in June 2025 requiring buyout caps not exceeding annual salary, while Florida passed a bill excluding healthcare practitioners from expanded non-compete limitations and Nevada’s governor vetoed a healthcare non-compete prohibition. The varied approaches reflect competing interests between employer investment protection, practitioner mobility rights, and patient care continuity concerns. Source: Seyfarth Shaw LLP
Governor Abbott signed Senate Bill 1318 into law, imposing new restrictions on noncompete agreements for physicians and health care practitioners effective September 1. The law limits physician noncompete agreements entered into or renewed after September 1 to one year in duration and five miles in geographic scope from where the physician primarily practiced. Buyout provisions cannot exceed the physician’s total annual salary and wages at the time of separation, and agreements must include clearly written terms. The legislation expands these restrictions to health care practitioners including licensed dentists, nurses, and physician assistants, and voids noncompete agreements when physicians are involuntarily discharged without good cause. While the law only applies to new or renewed agreements after September 1, courts may use these restrictions as guidelines when evaluating the reasonableness of existing noncompete agreements. Source: BakerHostetler
Texas passed two laws regulating artificial intelligence use in healthcare and other sectors. House Bill 149, the Texas Responsible Artificial Intelligence Governance Act (TRAIGA), was signed June 22, 2025, and takes effect January 1, 2026, requiring healthcare providers to disclose AI use in patient diagnosis or treatment. Senate Bill 1188, signed June 20, 2025, and effective September 1, 2025, mandates that licensed practitioners review all AI-generated records and prohibits offshoring electronic medical records. TRAIGA also prohibits discriminatory AI use and requires organizations to implement risk assessment and documentation procedures. The Texas attorney general will enforce TRAIGA through civil penalties. Source: Holland & Knight
Researchers developed a privacy-preserving artificial intelligence system that achieves 99.48% accuracy in classifying skin lesions while protecting patient data through advanced encryption. The model combines block-scrambling-based encryption with three neural networks (MobileNetV2, GoogLeNet, and AlexNet) to extract features from skin images while maintaining data confidentiality during transmission and storage. The system uses a conditional variational autoencoder for classification and hippopotamus optimization for parameter tuning to enhance performance. Testing on the skin cancer ISIC dataset showed the model outperformed existing methods with superior accuracy and faster execution time of 8.85 seconds compared to competing approaches. The research addresses the critical need for secure medical image analysis, particularly important given that skin diseases affect 30-70% of people globally. Source: Scientific Reports
Fraud & Abuse
The Justice Department charged 324 defendants in connection with over $14.6 billion in health care fraud schemes, marking the largest health care fraud takedown in the department’s history. The defendants include 96 doctors, nurse practitioners, pharmacists, and other licensed medical professionals across 50 federal districts and 12 state attorneys general offices. The government seized over $245 million in cash, luxury vehicles, cryptocurrency, and other assets, while the Centers for Medicare and Medicaid Services prevented over $4 billion from being paid on fraudulent claims and suspended or revoked billing privileges for 205 providers. The schemes included transnational criminal organizations submitting over $12 billion in fraudulent claims, with Operation Gold Rush alone involving $10.6 billion in fraudulent Medicare claims using stolen identities of over one million Americans. The Justice Department announced plans to create a Health Care Fraud Data Fusion Center to leverage artificial intelligence and advanced analytics to identify emerging fraud schemes. Source: United States Department of Justice
More than a dozen Houston-area medical professionals have been indicted in what prosecutors call the largest health care fraud crackdown in Department of Justice history. The nationwide operation charged over 320 people and uncovered nearly $15 billion in false claims, with 22 cases filed in federal court in Houston. Among those charged are Dr. David Jenson and his business partner, who allegedly billed Medicare $90 million for unnecessary “second skin” procedures and received $45 million in reimbursements, and the owners of United Palliative & Hospice Care in Fort Bend County, accused of fraudulently billing $87 million for end-of-life care for patients who were not dying. Other schemes involved fraudulent COVID-19 testing that netted $293 million, illegal kickbacks for genetic testing, and billing for mental health services never provided. The cases represent various types of health care fraud including Medicare and Medicaid billing fraud, pandemic relief fund fraud, and the unlawful distribution of controlled substances. Source: Houston Chronicle
The U.S. Justice Department charged 324 individuals in a record-breaking healthcare fraud crackdown involving $14.6 billion in schemes. The DOJ debuted its Health Care Fraud Data Fusion Center, which uses AI, cloud computing, and analytics to shift from reactive investigation to proactive detection of fraud patterns. The centerpiece operation, “Operation Gold Rush,” exposed a transnational catheter supply fraud led by Russian and Eastern European criminal networks that filed over $10.6 billion in false claims using stolen U.S. identities. Authorities seized over $245 million in assets and the Centers for Medicare and Medicaid Services suspended payments on over $4 billion in pending claims deemed fraudulent. Source: PYMNTS
Healthcare Privacy
A Texas federal district court vacated the HIPAA Reproductive Health Rule nationwide on June 18, 2025, in the case Purl v. HHS. The court ruled that HHS exceeded its authority and violated procedural requirements when creating the rule, which the Biden Administration had implemented after Dobbs v. Jackson Women’s Health Organizations to prohibit disclosure of reproductive health information for investigating or prosecuting reproductive healthcare that was legal where performed. Healthcare providers can now disregard the rule’s requirements and must undo actions they took to implement it, as HIPAA reverts to its pre-December 2024 form where reproductive health information is treated like any other protected health information. HHS is unlikely to appeal the decision given Trump Administration policies and has not requested a stay. The ruling does not affect substance use disorder provisions, meaning providers must still update their privacy notices by February 2026. Source: Holland & Hart’s Health Law Blog
The Southern District of New York allowed eight privacy claims to proceed against Teladoc Health for using website tracking technologies that transmitted patient health information to third parties. On June 25, 2025, the court denied Teladoc’s motion to dismiss after plaintiffs alleged the company installed tracking pixels and APIs on its telehealth platform that shared protected health information for advertising purposes. The court ruled that Teladoc’s tracking technology created an independent criminal purpose through HIPAA violations, defeating consent-based defenses under the Electronic Communications Privacy Act. The court determined Teladoc functioned as a healthcare provider rather than a technology platform and that medical conditions constitute contents of communications under state privacy laws. Eight claims survived including federal wiretapping violations and state privacy claims under New York, Florida, and California laws. Source: Duane Morris LLP
US healthcare companies face restrictions when offshoring patient data operations due to state and federal privacy regulations. While HIPAA does not prohibit storing protected health information outside the United States, states including Wisconsin, Texas, Florida, and Arizona have enacted data localization laws that require patient information to remain within US borders. The Centers for Medicare & Medicaid Services requires Medicare Advantage Organizations to obtain attestation certificates from healthcare providers who use offshore vendors, detailing safeguards for patient information protection. Healthcare companies can mitigate offshoring risks through business associate agreements with international arbitration clauses, encryption requirements, and annual audits of offshore subcontractors. Offshore vendors must demonstrate HIPAA compliance and may need to establish US-based operations or partner with domestic intermediaries to work with American healthcare organizations. Source: MWE
Microsoft and Google email platforms may be transmitting healthcare data without encryption, potentially violating HIPAA requirements. A recent study found that Google Workspace still uses deprecated TLS 1.0 and 1.1 encryption protocols, while Microsoft 365 sends messages unencrypted when encryption fails without warning senders. The research involved controlled experiments where Paubox set up recipient mail systems that only accept legacy TLS protocols and sent test messages containing simulated protected health information. Healthcare organizations rely on email for lab results, care instructions, and appointment notifications, all of which must be encrypted under HIPAA regulations. The findings suggest that healthcare organizations depending on these platforms for compliance may be unknowingly transmitting unencrypted patient data. Source: MediaPost
Inpatient Rehab Facilities
Freestanding inpatient rehabilitation facilities are outperforming hospital-based units through partnerships, achieving 24% Medicare margins compared to 1% for departmental IRFs in 2023. The number of freestanding IRFs grew 7.4% from 345 to 371 facilities between 2022 and 2023, while Medicare IRF admissions increased 7.3% overall. States without certificate of need laws show higher IRF utilization rates at 7.5% of acute care discharges compared to 5.6% in CON states, prompting reforms in South Carolina, Florida, and Tennessee. Hospital systems are increasingly partnering with IRF operators through joint ventures, joint operating agreements, or management agreements to transition departmental units to freestanding facilities, which cost $15,000 per stay compared to $21,000 for hospital-based stays. Source: VMG Health
The Office of Inspector General approved a telehealth arrangement that allows physician-owned entities to lease healthcare professionals from telehealth platforms without violating federal anti-kickback laws. The June 6, 2025 advisory opinion covers an arrangement where a Requestor Professional Corporation leases healthcare professionals from Platform Professional Corporations on an hourly basis, with fees determined by provider type and paid regardless of third-party reimbursement. The OIG determined the arrangement complies with anti-kickback statutes because it includes written agreements, independent fee validation, and compensation structures that remain separate from referral volume or business generation. The arrangement aligns with federal safe harbor provisions for personal services and management contracts, which require detailed written agreements with fixed terms of one year or longer. The advisory opinion applies only to the specific parties involved, meaning other organizations must seek their own legal review for similar arrangements. Source: Hinshaw Law
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 the federal anti-kickback statute safe harbor for personal services and management contracts because payments are fixed at fair market value and not based on referral volume or value. The arrangement aims to expand access to in-network telehealth services for patients in underserved and rural areas through contracts covering over 400 payors representing 80% of commercially covered lives and 65% of Medicare Advantage covered lives. OIG noted the decision could serve as a model for other management services and care delivery organizations considering similar arrangements. Source: OIG Advisory Opinion No. 25-03
Medical device manufacturers face critical decisions in clinical trial planning that can determine company survival. Companies must collect clinical data for pre-market submissions through processes that consume time and money while putting business existence at risk. Three pathways exist for medical device investigations based on risk levels: minimal risk, nonsignificant risk (NSR), and significant risk (SR) studies, with each requiring different oversight and regulatory requirements. Before conducting pivotal trials, companies must define their intended use, indications, and claims since FDA market authorization depends on clinical trial results. Companies should establish FDA communication plans and work with expert statisticians, clinicians, and regulatory counsel to mitigate risks and ensure proper execution. Source: Gardner Law
Corporate Practice of Medicine
Healthcare entities face compliance challenges when expanding across state lines due to varying corporate practice of medicine laws and ownership requirements. The corporate practice of medicine doctrine varies significantly by state, with jurisdictions like New York establishing strict prohibitions while others allow more flexibility in corporate structures. Professional entity ownership requirements differ across states, with some mandating wholly or majority ownership by licensed professionals while others like Delaware permit non-physician ownership under certain limitations. Healthcare entities may need to create new entities, revise ownership agreements, or establish management services organization structures to comply with jurisdictional requirements. Legal counsel recommends conducting thorough due diligence and preparing new governance agreements before expanding operations into new markets. Source: Stevens & Lee
Cybersecurity
Congress introduced bipartisan legislation to strengthen cybersecurity coordination between federal agencies protecting the healthcare sector. The Healthcare Cybersecurity Act of 2025 was introduced in the House by Representatives Jason Crow (D-CO) and Brian Fitzpatrick (R-PA), with a companion bill in the Senate by Senators Jacky Rosen (D-NV) and Todd Young (R-IN). The legislation would require the Cybersecurity and Infrastructure Security Agency (CISA) and the Department of Health and Human Services (HHS) to collaborate on cybersecurity improvements, establish a liaison between the agencies, authorize cybersecurity training for personnel, and conduct a study identifying sector risks. Healthcare cyberattacks have escalated with over 700 data breaches affecting 500 or more individuals reported annually for the past four years, including 278 million individuals affected in 2024. The 2024 Change Healthcare ransomware attack, which compromised an estimated 190 million records and disrupted healthcare operations nationwide, exemplifies the sector’s vulnerability to cyber threats. Source: HIPAA Journal
Emerging Tech
Health systems across the U.S. are accelerating partnerships with tech companies to embed AI into clinical care, operations and administrative workflows. Mayo Clinic partnered with hellocare.ai in June to advance ambient clinical intelligence, aiming to support early detection, reduce clinician workload and enhance proactive inpatient care. Northwestern Medicine entered a multi-year collaboration with PathAI to transform pathology diagnostics through AI, including joint research, clinical innovation programs and co-development of machine learning-powered diagnostic algorithms. Oracle Health, Cleveland Clinic and G42 announced a partnership in May to build an AI-driven platform for healthcare delivery in both the U.S. and UAE, leveraging national-scale data analytics, clinical applications and precision medicine tools. These partnerships reflect a push among health systems and tech companies to ensure AI tools are grounded in clinical realities while benefiting from technical expertise. Source: Becker’s Hospital Review
Fair Market Valuations
Healthcare organizations must follow eight documentation steps to maintain compliance during fair market value processes for provider compensation arrangements. The documentation requirements include gathering provider profiles, service descriptions, business justifications, productivity metrics, compensation terms, FMV analyses, contract documents, and team approvals to meet Stark Law and Anti-kickback Statute requirements. Organizations should seek third-party FMV opinions when arrangements involve high referral risk, complex compensation structures, or when internal resources lack access to market data sources and valuation expertise. Primary care and orthopedic specialties present higher referral risks compared to pathology or emergency medicine, while arrangements involving co-management, telehealth, or value-based payments require specialized valuation approaches. Many healthcare organizations are moving FMV reviews in-house to reduce costs and improve turnaround times, but must ensure they have the resources and training to conduct these reviews effectively. Source: VMG Health
Health Data
Four states sent personal health data from their insurance websites to technology companies including Google, LinkedIn, and Snapchat. Nevada’s exchange transmitted prescription drug names and dosages to LinkedIn and Snapchat, while Maine and Rhode Island sent prescription information and doctor names to Google through analytics tools. Massachusetts Health Connector shared whether visitors reported being pregnant, blind, or disabled with LinkedIn. The Markup and CalMatters discovered this data sharing through web trackers on state exchanges established under the Affordable Care Act after auditing websites from all 19 states that operate their own health insurance marketplaces. Nevada and Massachusetts stopped transmitting data to these companies after reporters contacted them about the findings. Source: The Markup
HIPAA
The U.S. Department of Health and Human Services is implementing new HIPAA regulations in 2025 to strengthen patient privacy and security. The updates respond to the rise of telemedicine, growing use of electronic health records, and a 264% increase in ransomware attacks against healthcare systems in 2024. Healthcare organizations must comply with expanded patient access requirements by July 2025 and update vendor management practices by December 2025, while implementing multi-factor authentication, data encryption, and penetration testing. The regulations include new protections for reproductive health information and requirements for AI tools and telehealth platforms to comply with privacy and security rules. Healthcare professionals express concerns about the cost and technical complexity of implementing these changes, particularly for small practices with outdated technology. Source: Security Boulevard
Legislation
Texas lawmakers passed legislation requiring food manufacturers to remove certain ingredients or add warning labels to products. The Texas House approved SB 25 on May 26, 2025, with bipartisan support, targeting ingredients like Red 40 and titanium dioxide that are banned in other countries. The bill requires manufacturers to either eliminate these substances or display warnings stating the ingredient is not recommended by authorities in Australia, Canada, the European Union, or the United Kingdom. High fructose corn syrup was removed from the prohibited list after food companies opposed its inclusion, though legislators rejected industry efforts to eliminate the warning label requirement entirely. The legislation now awaits Governor Greg Abbott’s signature and would take effect September 1, 2025. Source: The Daily Intake
Private Equity
Private equity investors maintain interest in healthcare services and technology companies despite higher borrowing costs and increased regulatory scrutiny as of mid-2025. Macroeconomic volatility has compressed valuations and extended deal timelines through the first half of 2025, but demographic trends and fragmentation among provider groups continue to attract growth-oriented capital. PE firms are targeting outpatient care models, physician specialty platforms, behavioral health services, home-based care, AI-driven clinical decision support, and value-based care platforms. Federal enforcement from the FTC and DOJ has intensified challenges to physician group consolidation, while state laws increasingly require material change notifications for healthcare mergers and acquisitions. Labor shortages and wage inflation present additional risks, particularly for home health, skilled nursing facilities, and behavioral health settings. Source: ArentFox Schiff
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 than non-participants in acute myocardial infarction mortality rates and perioperative pulmonary embolism or deep vein thrombosis rates, but these differences disappeared as ACO maturity increased. The study showed that higher ACO maturity scores correlated with reductions in accidental punctures and lacerations among participating hospitals. Researchers noted that early ACOs focused primarily on enhancing care coordination and strengthening primary care rather than transforming inpatient care processes during the initial 18 months. Currently, only 1,450 of more than 5,000 Medicare-enrolled hospitals participate in CMS ACOs, leaving room for expansion as the agency aims to transition all traditional Medicare beneficiaries to accountable care by 2030. Source: American Journal of Managed Care
Cybersecurity
Healthcare organizations face an escalating cybersecurity crisis with 33 attacks recorded in 2025 and global healthcare ransomware surging 31%. Over 90% of healthcare cyberattacks are phishing scams enhanced by AI, while healthcare data sells for up to 50 times more than financial information on black markets. Third-party vendors cause 50-60% of data breaches, prompting healthcare organizations to adopt the HITRUST framework for vendor risk assessment. The government is implementing mandatory cybersecurity standards through the Health Infrastructure Security and Accountability Act and proposed HIPAA Security Rule modifications requiring encryption, multi-factor authentication, and vulnerability testing. Healthcare providers are deploying AI-powered threat detection systems and zero-trust architectures to combat these threats in real time. Source: Information Security Buzz
Drugs & Devices
Sixteen states have proposed or passed legislation to make ivermectin available over the counter despite scientific evidence showing the deworming drug does not treat COVID-19 or cancer. Idaho, Arkansas, and Tennessee have enacted such laws, while Louisiana passed a bill awaiting the governor’s signature, driven by social media claims that ivermectin treats cancer, COVID-19, foot pain, arthritis, lupus, and acne. High-quality clinical trials found ivermectin ineffective against COVID-19, and doctors report patients with treatable cancers have delayed treatment to try ivermectin, only to return with advanced disease. Despite state laws, pharmacies remain unable to sell ivermectin over the counter because it remains federally regulated by the FDA, with NBC News finding no pharmacists willing to dispense it without a prescription in states with permissive laws. Pharmacists cite liability concerns since the prescription drug lacks over-the-counter packaging with consumer directions and safety statements. Source: Ars Technica
EMTALA
CMS rescinded July 2022 guidance on EMTALA obligations for pregnant patients and pregnancy loss cases. The Department of Health and Human Services and Centers for Medicare & Medicaid Services announced on June 3, 2025, that they are withdrawing two hospital guidance documents (QSO-22-22-Hospitals and QSO-21-22-Hospitals) and a letter from the former Secretary of Health and Human Services because these documents do not reflect current administration policy. CMS stated it will continue to enforce EMTALA, which protects all individuals who present to hospital emergency departments seeking examination or treatment, including for emergency medical conditions that place the health of a pregnant woman or her unborn child in serious jeopardy. The agency said it will work to rectify perceived legal confusion and instability created by the former administration’s actions. Source: CMS
Fraud & Abuse
Healthcare fraud enforcement under the False Claims Act reached $1.67 billion in settlements and judgments in 2024, representing 57% of all FCA recoveries. The Department of Justice secured settlements from Independent Health ($98 million for upcoding Medicare diagnoses), Gilead Sciences ($202 million for kickbacks to HIV medication practitioners), and Teva Pharmaceuticals ($450 million for Medicare copay conspiracies and generic drug price fixing). Attorney General Pam Bondi and Deputy Assistant Attorney General Michael Granston have committed to enforcement, with DOJ guidance instructing prosecutors to prioritize healthcare fraud cases. The government recovers three dollars for every dollar spent fighting fraud, according to DOJ officials. Enforcement now extends beyond traditional healthcare to include Walgreens ($350 million for opioid prescription violations) and McKinsey ($650 million for consulting on OxyContin sales acceleration). Source: Forensic Risk
HIPAA
The US Department of Health and Human Services Office for Civil Rights has escalated enforcement of HIPAA risk analysis requirements through a dedicated initiative that has resulted in nine settlements totaling over $1 million in penalties since October 2024. The Risk Analysis Initiative targets healthcare entities that fail to conduct proper assessments of potential risks to electronic protected health information, a requirement under the HIPAA Security Rule that OCR describes as the foundation for cybersecurity practices. Healthcare organizations face increasing pressure as ransomware breaches have surged 264% since 2018, with settlements ranging from $10,000 to $350,000 for violations involving breaches affecting between 4,304 and 585,621 individuals. The enforcement effort has continued across both the Biden and Trump administrations, with OCR finding that many entities’ risk analyses were based on incomplete inventories of where protected health information is stored and transmitted. The initiative encompasses various breach types including ransomware attacks, server misconfigurations, and unauthorized access to medical imaging systems. Source: ArentFox Schiff
Healthcare organizations continue to struggle with HIPAA compliance implementation despite awareness of their obligations, according to survey results from hundreds of organizations across the United States. The survey found that many organizations have not appointed dedicated HIPAA Privacy Officers with sufficient decision-making authority and continue to provide training less frequently than annually, often excluding business associates from compliance education. Organizations also lack written documentation for complex or emerging risks, with some not updating their HIPAA risk assessments in several years despite increasing cybersecurity threats. Only a minority of respondents indicated they feel confident their organization could effectively respond to an Office for Civil Rights compliance audit or data breach investigation. The Office for Civil Rights is scrutinizing risk assessments under its enforcement initiative, with organizations facing a high probability of financial penalties for noncompliance. Source: HIPAA Journal
Medicare
Medicare paid $124 million for evaluation and management services billed alongside eye injections that violated federal requirements. The Office of Inspector General found that for 42 percent of the 3.3 million intravitreal injections provided during June 2022 through May 2023, providers billed for evaluation and management services on the same day using modifier 25, which bypassed system controls designed to prevent improper payments. Documentation for 22 of 24 sampled services did not support the use of modifier 25, as the services were not significant and separately identifiable from the injection procedures. The Centers for Medicare & Medicaid Services lacked adequate internal controls to detect and prevent these potentially improper payments, including clear requirements for modifier 25 use and medical reviews of claims. The audit recommends that CMS update billing requirements, conduct medical reviews to recover up to $124 million in improper payments, and provide better education to providers about appropriate billing practices. Source:HHS.gov
Med Spas
Private equity investment in med spa practices faces complex financial due diligence challenges that require careful analysis of cash-based accounting systems. The med spa industry experienced growth in 2024 driven by demand for neurotoxins, skin rejuvenation, and weight loss procedures including Semaglutides and CoolSculpting. Cash-pay business models create misleading financial statements due to prepaid packages, memberships, and gift card sales that distort revenue recognition timing. The industry faces margin pressure through Q1 2025 from rising supply and personnel costs while competition limits price increases. Med spas are expanding services to include hormone replacement therapy and regenerative medicine to boost same-store sales growth. Source: VMG Health
Patient Rights
The Fifth Circuit upheld Texas parental consent requirements that prevent minors from confidentially accessing contraception at federally funded Title X clinics. Alexander Deanda, a father of three daughters, filed suit in 2020 challenging the Department of Health and Human Services’ administration of Title X, arguing he wanted notification if his children sought contraceptives based on his Christian beliefs. Title X, enacted in 1970, provides family planning services to low-income individuals and in 2021 HHS prohibited parental consent requirements for minors seeking services. The district court ruled in Deanda’s favor, finding that federal law did not preempt Texas Family Code provisions requiring parental consent for medical care, but the Fifth Circuit avoided deciding the constitutional question of balancing parental and minor rights by using the doctrine of constitutional avoidance. The ruling threatens minors’ access to confidential reproductive care through mechanisms like judicial bypass. Source: Harvard Law Review
Senior Living Facilities
Cyber attacks on senior living and care facilities have escalated dramatically, with 92% of healthcare organizations reporting attacks in 2024 compared to 88% in 2023. Healthcare facilities averaged 2,434 attacks per week in the third quarter of 2024, representing an 81% increase from the previous year. In the first quarter of 2025, more than six nursing homes and rehabilitation centers reported hacking incidents affecting over 130,000 individuals. The sector’s vulnerability stems from lagging technology adoption, proliferation of network-connected devices, and the high value of healthcare data to criminals. The primary threat comes from employees opening malicious emails and clicking links that expose credentials, according to cybersecurity experts. Source: McKnight’s Senior Living
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 modifications aim to decrease net spending for 2026 while improving patient outcomes without disrupting care delivery. Accountable Care Organizations participating in ACO REACH serve as partners who assume financial risk for patients while offering enhanced benefits like telehealth visits, post-hospital home care, co-pay assistance, and condition management support. CMS has published both the financial methodology changes and the evaluation report that necessitated these updates to ensure the model meets the Innovation Center’s statutory mandate. Source: CMS
Value-based care adoption continues to accelerate across healthcare organizations, with more than 60% expecting revenue increases from VBC arrangements in 2025. A survey of 168 executives and clinical leaders at 142 healthcare organizations by Innovaccer and the National Association of ACOs found that 64% anticipate a revenue shift toward VBC this year compared to 2024. Currently, 30% of organizations derive at least 25% of their revenue from VBC contracts, while 13% have surpassed the 50% mark. Organizations are investing in data analytics and AI (31.2%), care management solutions (30%), and staff training (22.6%) to accelerate their VBC transitions, though barriers remain including financial risk (87%), provider resistance (80%), and data interoperability issues (75%). The report recommends a patient-centered approach, clinician support, financial risk management, and integrated data platforms to ease VBC transitions. Source: Advisory Board
Data Breach
U.S. Dermatology Partners (Texas), a network of over 100 dermatology practices across several states, recently announced a cyberattack and data breach that occurred in June 2024. The network disruption on June 19, 2024, was indicative of a cyberattack, and subsequent investigations by third-party digital forensics experts confirmed unauthorized access and data exfiltration. By April 2, 2025, a thorough review revealed that the stolen data included personal information such as names, dates of birth, medical record numbers, health insurance information, and specific details about dermatology services received. Additionally, a limited number of individuals had their Social Security and/or driver’s license numbers compromised. Notification letters to affected individuals began mailing on May 30, 2025. USDP has offered complimentary credit monitoring and identity protection services to those whose Social Security numbers and/or driver’s license numbers were involved. This breach underscores the importance of robust cybersecurity measures to protect sensitive health information. Source: HIPAA Journal
Emerging Tech
Intelligence Amplification technology is revolutionizing healthcare compliance management through systems like Compliance Risk Analyzer that detect and mitigate billing and coding risks. Unlike artificial general intelligence that aims to replace human decision-making, IA augments human capabilities through predictive analytics, statistical modeling, and heuristic methods that identify high-risk patterns by comparing provider data to national benchmarks. The system generates provider-specific risk analysis reports, creates targeted audit action plans, and enables benchmarking against industry standards, resulting in proactive risk mitigation, increased efficiency, cost savings, and improved audit accuracy. While delivering significant benefits, Compliance Risk Analyzer functions optimally as part of a hybrid model where IA supports human auditors, recognizing that healthcare compliance requires nuanced human judgment alongside computational assistance. Source: VMG Health
EMTALA
The Trump administration rescinded Biden-era guidance requiring hospitals to perform emergency abortions under federal law. The Department of Health and Human Services issued guidance in July 2022 that required doctors to perform abortions in emergency departments under the Emergency Medical Treatment and Labor Act (EMTALA), even in states where abortion is banned, when the procedure serves as stabilizing treatment for conditions like ectopic pregnancy or preeclampsia. The guidance was part of the Biden administration’s efforts to preserve abortion access after the Supreme Court overturned Roe v. Wade. CMS announced they rescinded the guidance because it does not reflect current administration policy, though they said they will continue enforcing EMTALA for emergency medical conditions affecting pregnant women. Source: ABC News
A federal investigation found that a Texas hospital violated law by sending a woman home without treating her life-threatening ectopic pregnancy. The Centers for Medicare and Medicaid Services determined that Ascension Seton Williamson in Round Rock failed to provide proper medical screening and stabilizing treatment to Kyleigh Thurman in February 2023. Thurman returned to the hospital multiple times with bleeding before her fallopian tube ruptured, requiring surgery that removed part of her reproductive system. The hospital violated the federal Emergency Medical Treatment and Labor Act, which requires emergency rooms to provide stabilizing treatment to all patients. The Trump administration announced it would revoke Biden-era guidance that directed hospitals to provide emergency abortions for women experiencing medical emergencies. Source: PBS News
Food & Drug Administration
The Trump administration’s FY26 budget proposal for the FDA reveals significant structural changes while maintaining overall operational capacity. The $6.8 billion proposal represents a 3.9% decrease from FY25 levels, balancing reduced discretionary funding ($3.2 billion, down 11.4%) with increased user fees ($3.6 billion, up 4%). The budget prioritizes the “Make America Healthy Again” agenda with $234.6 million for food safety and chronic disease initiatives, including plans to phase out certain food dyes and modernize safety protocols. Workforce reductions continue with the budget reflecting cuts of 1,940 full-time employees and $456.6 million in support of the “Reduction of Federal Bureaucracy initiative,” while projecting $626 million in savings from streamlined agency functions. Congressional appropriations committees have begun reviewing the proposal and will continue the funding process through September 2025. Source: Akin Gump
The FDA will implement artificial intelligence across all its centers by the end of June to combat regulatory delays caused by recent layoffs. The agency completed a pilot scientific review using generative AI that will reduce non-productive busywork in the review process. The AI rollout comes as the FDA has missed target decision dates for drug approvals and faces staffing cuts from the Health and Human Services Secretary, who put 3,500 FDA jobs on the chopping block. All FDA centers must begin implementing the AI approach immediately, with plans to tailor AI models to each center’s needs. Source: BioSpace
Fraud & Abuse
Dr. Benjamin Tiongson, a pain management physician practicing in Houston, Sugar Land, and Katy, has agreed to pay $390,082 to resolve allegations of Medicare fraud. Between December 2021 and December 2022, Tiongson allegedly billed Medicare for surgical implantation of neurostimulator electrodes, procedures that typically require operating rooms and command thousands of dollars in reimbursement. Instead of performing these invasive surgeries, Tiongson reportedly provided electro-acupuncture treatments that merely involved inserting thin wires into patients’ ears and taping devices behind them, all conducted in clinic settings without surgical incisions. The settlement, reached after investigation by the U.S. Attorney’s Office and Department of Health and Human Services, resolves these allegations without determination of liability. Source: United States Department of Justice
A Frisco physician has agreed to pay $3.5 million to resolve allegations of COVID-19 billing fraud. Dr. Samad Khan, owner of SK Primary Care, allegedly submitted approximately 400,000 false claims to the COVID-19 Uninsured Program between April 2020 and October 2021 for evaluation and management services that were never performed. The United States contends that Khan’s COVID-19 testing sites were staffed by medical assistants who only performed specimen collection, yet he billed for higher-level services that required qualified healthcare professionals and often submitted two claims per patient—one for testing and another for providing results. Khan knowingly used incorrect billing codes that provided substantially higher reimbursements than the appropriate specimen collection codes, according to the settlement that resolves these allegations without a determination of liability. Source: United States Department of Justice
HIPAA
Healthcare organizations must implement comprehensive vendor management strategies to mitigate significant HIPAA compliance risks from third-party relationships. While properly executing Business Associate Agreements is crucial, experts emphasize it must be part of a broader risk-based approach that includes thorough initial vetting, continuous monitoring, and incident response planning. Organizations should implement tiered vendor assessments based on data access levels and sensitivity, with particular scrutiny for vendors handling Protected Health Information. Common compliance failures include treating BAAs as mere checkboxes, insufficient upfront diligence, inadequate ongoing monitoring, and failure to assess subcontractor relationships. Healthcare entities cannot outsource accountability and must treat vendors as extensions of their organization while maintaining clear boundaries regarding day-to-day operations to properly manage liability. Source: Relias Media
Med Spas
Texas House Bill 3749, known as “Jenifer’s Law,” has undergone complete revision from its original form that could have shuttered many IV hydration clinics to legislation that may actually reduce regulatory restrictions on the industry. The bill was prompted by the death of Jenifer Cleveland in July 2023 after receiving an IV infusion at a Wortham, Texas medical spa, where an investigation revealed an absent medical director, lack of protocols, and treatment by an unlicensed individual. The legislation passed both the House and Senate by large margins and awaits Governor Greg Abbott’s signature, with an effective date of September 1, 2025. The most significant change in the final bill is its characterization of IV therapy as “elective” rather than medically necessary treatment, shifting the focus from documenting medical necessity to ensuring safety through contraindication screening. This change may permit the return of “menu medicine” where patients can select IV treatments from a menu of options without requiring a diagnosis or proof that the treatment addresses a specific medical condition. Source: HCH Lawyers
Medicare & Medicaid
Trump directs Health and Human Services to cap Medicaid payments at Medicare rates to eliminate fraud schemes. The memorandum targets state programs that tax healthcare providers then return the money as Medicaid payments, which triggers federal matching funds and allows providers to receive nearly three times Medicare rates. State Directed Payments under this system quadrupled over four years and reached $110 billion in 2024. The directive instructs the Secretary of Health and Human Services to ensure Medicaid payment rates do not exceed Medicare levels. Trump claims the current system allows states to avoid contributing funds while enriching healthcare providers through federal matching payments. Source: The White House
CMS will audit all Medicare Advantage contracts for each payment year in newly initiated audits following an announcement on May 21, 2025. The agency plans to complete audits for payment years 2018 through 2024, as CMS is several years behind in completing Risk Adjustment Data Validation (RADV) audits that verify diagnosis codes submitted by MA plans are supported by patient medical records. The Medicare Payment Advisory Commission estimates MA plans may overbill the government $43 billion per year through risk-adjusted payments based on enrollee diagnoses. CMS Administrator Dr. Mehmet Oz stated the agency has a duty to ensure MA plans bill the government accurately, and the Trump Administration aims to complete remaining audits by early 2026. To meet this goal, CMS will increase medical coders from 40 to 2,000 people beginning in September 2025 and deploy technology to flag unsupported diagnoses. Source: King & Spalding
The Center for Medicare and Medicaid Innovation plans to expand digital health technology and artificial intelligence integration across federal health care programs. CMMI released a white paper on May 13, 2025, outlining its strategy that emphasizes virtual care expansion, mobile health applications, and AI implementation for value-based care organizations. CMS Administrator Dr. Mehmet Oz and CMMI Director Abe Sutton stated that AI can increase health care supply and announced plans to create clearer reimbursement pathways for AI technologies. The agency seeks public input on certifying health-focused mobile applications for Medicare inclusion and is requesting comments on digital health through June 16, 2025. Sutton cautioned that some AI systems may increase costs by enabling providers to capture more services, requiring targeted reforms to focus on technologies that both expand care supply and reduce expenses. Source: Jones Day
Price Transparency
CMS published guidance and a Request for Information on Hospital Price Transparency rules following President Trump’s February 25, 2025 Executive Order on healthcare pricing transparency. The guidance instructs hospitals to stop using “999999999” as a placeholder when calculating “estimated allowed amounts” and instead use actual average dollar amounts from electronic remittance advice data from the past 12 months. The Request for Information seeks public input on improving hospital compliance and enforcement processes through six questions covering data accuracy, completeness, and suggestions for enhancing the quality of machine-readable files. CMS wants feedback on defining data accuracy and completeness terms, identifying external data sources for validation, and improving compliance tools like the CMS validator. Source: King & Spalding
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 million users, the model automatically handles health-related inquiries and has been refined through collaboration with medical institutions. Source: South China Morning Post
Digital health companies using AI for patient communication face significant legal exposure under the Telephone Consumer Protection Act (TCPA). While many companies focus solely on HIPAA compliance, the TCPA restricts automated calls, texts, and artificial voice messages without prior express consent, with written consent required for marketing communications. The FCC’s 2024 ruling classified AI-generated voices as “artificial voices” under the TCPA, though courts continue to wrestle with how this applies to chatbots and text-based systems. Digital health companies should conduct TCPA risk assessments, audit consent processes, obtain express written consent when in doubt, and monitor evolving litigation trends. Despite a 2021 Supreme Court decision narrowing the definition of automatic telephone dialing systems, TCPA compliance remains challenging as state regulations may differ and create legal risks even for companies without telemarketing intent. Source: Foley & Lardner LLP
The U.S. House of Representatives has passed legislation imposing a 10-year federal moratorium on state AI regulation. The “One Big Beautiful Bill Act” (H.R. 1) narrowly passed on May 22, 2025 by a 215-214 vote, containing a provision that would preempt state laws regulating artificial intelligence systems, potentially nullifying healthcare protections enacted in states like California, Connecticut, and Maryland. The moratorium threatens state initiatives requiring human oversight of AI in healthcare decisions, particularly those preventing insurers from using AI to autonomously deny coverage or process claims. The proposal faces significant opposition from state officials, including a bipartisan group of 35 California lawmakers and the National Conference of State Legislatures, while also potentially violating the Senate’s Byrd Rule as it may be considered extraneous to budgetary matters in a reconciliation bill. Source: Arnall Golden Gregory LLP
Data Breaches
WellNow Urgent Care has reached a $4.4 million settlement following a 2023 ransomware attack that compromised the protected health information of approximately 597,000 individuals. The cyberattack exposed sensitive data including names, birth dates, and for some victims, Social Security numbers, leading to consolidated lawsuits filed in March 2024 that alleged negligence and breach of implied contract. The settlement divides affected individuals into two subclasses: 541,870 people whose Social Security numbers were not compromised (eligible for up to $3.3 million in benefits) and 55,131 people whose Social Security numbers were exposed (eligible for up to $1.1 million in benefits). Class members can claim compensation for lost time and documented expenses up to $7,500, with those in the SSN subclass having the additional option of receiving a pro rata cash payment. Source: HIPAA Journal
Four healthcare organizations across the United States recently reported data breaches exposing sensitive patient information.Cooper Health System in New Jersey experienced the largest breach, affecting 57,412 individuals whose names and Social Security numbers were compromised after unusual network activity was detected on May 14, 2024. Union County Children and Youth Services in Pennsylvania suffered a ransomware attack on March 13, 2025, with at least 501 individuals affected, while Balance Autism in Iowa reported unauthorized access affecting 1,281 clients between March 11-17, 2025. The Carpenter Health Network in Louisiana identified a security incident between February 4-28, 2025, compromising personal and health information of 878 individuals, with all four organizations implementing additional security measures and offering credit monitoring services to affected individuals. Source: HIPAA Journal
Food & Drug Administration
The FDA is expanding the use of artificial intelligence across all product centers following a successful pilot program that dramatically improved application review times. After years of providing AI guidance to industry, the FDA is deploying AI-based review programs targeting full integration by June 30, 2025. One reviewer reported completing tasks in minutes that previously took three days, with AI systems helping to summarize clinical trials, flag anomalies, identify safety signals, and support benefit-risk assessments. While promising efficiency gains, the FDA acknowledges risks requiring careful management, including maintaining scientific rigor, preventing algorithmic bias, and ensuring transparency to stakeholders. The agency’s AI implementation raises important questions about potential impacts on approval timelines, user fees, market readiness for accelerated approvals, and the value of Priority Review Vouchers. Source: Loeb & Loeb Quick Takes
Med Spas
Texas House Bill 3749 has been revised to focus solely on regulating elective IV therapies administered outside traditional medical settings, abandoning its original scope that would have increased oversight of med spas. The bill, which originally sought to establish comprehensive regulations for med spas including additional physician supervision requirements, now exclusively addresses IV therapy protocols and delegation of authority. Under the revised legislation, physicians may delegate IV therapy prescriptive authority to physician assistants and nurse practitioners, while administration can be performed by these professionals or registered nurses under adequate physician supervision. The bill has passed the Texas House and awaits Senate review, with potential implementation scheduled for September 1, 2025. Med spa operators not offering IV therapies will see no immediate regulatory changes, though industry observers note that future legislative sessions may revisit med spa regulations. Source: McQuire Woods
Medical spa owners face critical decisions when selling their businesses, with private equity partnerships and broker engagement representing two primary pathways. Private equity firms offer substantial capital, industry expertise, and growth acceleration but come with potential downsides including loss of control, high performance expectations, predetermined exit strategies, and capital costs. Brokers provide valuable market knowledge, industry connections, confidentiality protection, negotiation skills, and time savings, though their services include commission fees and require careful selection. The optimal approach depends on individual goals, risk tolerance, and long-term vision. Source: VMG Health
Medicare
The Center for Medicare and Medicaid Innovation has pivoted to a market-based approach that prioritizes prevention, patient choice, and competition. Announced on May 13, 2025, the new strategy includes preventive care measures in all models, provides patients with health data to support decision-making, and incentivizes participation from independent physician practices outside of larger health systems. This direction differs from the previous Biden administration focus on health equity, multi-payer alignment, and person-centered care, though some goals like expanding accountable care relationships remain. CMMI Director Abe Sutton emphasized the organization’s commitment to fiscally responsible models that protect taxpayer dollars while preserving quality of care. The strategy will likely result in new models that increase provider financial risk and discontinue programs that fail to meet cost-saving criteria. Source: Mintz
The Centers for Medicare and Medicaid Services (CMS) implemented the Accountable Care Prospective Trend (ACPT) in 2024 as part of changes to how benchmarks are set in the Medicare Shared Savings Program (MSSP). The ACPT growth rate (4.9%) falls significantly below the 7.5-9.0% growth reported by Accountable Care Organizations (ACOs) and independent analysts, creating financial challenges for organizations entering new agreements in 2024. The ACPT aims to address the “collective success problem” by separating benchmark updates from actual spending growth, potentially making participation more attractive long-term while creating short-term disincentives. CMS established guardrails for when gaps occur between projected and actual spending, including the option to reduce the ACPT weight, which the author recommends implementing for 2024 to mitigate financial impacts on participating ACOs. Source: Health Affairs
Private Equity
Private equity firms investing in healthcare face mounting legal and regulatory challenges across multiple fronts. The FTC and DOJ have intensified antitrust scrutiny of healthcare roll-up strategies, with enforcement actions targeting even smaller acquisitions that accumulate market power, as demonstrated by the recent USAP case resulting in a final consent order with notification and compliance requirements. States including New York, Massachusetts, Vermont, Rhode Island, and Connecticut have enacted laws requiring pre-transaction notice or approval for healthcare mergers and acquisitions, while the Corporate Practice of Medicine doctrine continues to restrict non-physician ownership of medical practices in states like New Jersey and New York. PE-backed healthcare entities face increased scrutiny through False Claims Act investigations related to billing practices, as seen in the $15.3 million settlement with Alliance Family of Companies, while simultaneously confronting public criticism that PE ownership prioritizes profits over patient care. Proactive legal planning and ongoing compliance monitoring have become essential for PE firms to navigate this complex environment and protect long-term investments in healthcare. Source: Greenbaum, Rowe, Smith & Davis LLP
Real Estate
Specialized appraisers are essential in healthcare real estate due to the sector’s unique complexities. Healthcare properties require appraisers with expertise in four critical areas: understanding healthcare operations across various facility types, navigating complex lease structures including timeshare arrangements, interpreting healthcare market trends and demographics that affect property values, and evaluating diverse property types from hospitals to specialized treatment centers with unique design requirements. These specialized appraisers can accurately determine property values by comprehending how buildings operate, evaluating unique lease structures, forecasting market trends, and recognizing the specific functional needs of different healthcare facilities. Source: VMG Health
Smart Devices
Smart devices are revolutionizing healthcare by shifting the industry from reactive treatment to proactive prevention through continuous monitoring technologies. These devices collect real-time physiological data including heart rate, blood oxygen levels, and glucose measurements, which AI algorithms analyze to detect patterns and predict health risks before symptoms appear. Wearable technologies like smartwatches with ECG capabilities can identify irregular heart rhythms, infectious diseases, and neurological disorders while enabling remote monitoring and integration with telehealth platforms. Emerging innovations include advanced biosensors that detect biomarkers through sweat or tears, miniaturized implantable devices for internal monitoring, and digital twins that create virtual replicas of patients to predict disease progression and optimal treatments. The transformation toward predictive healthcare faces challenges in ensuring data security, developing explainable AI systems that clinicians can trust, and providing equitable access across populations. Source: Healthcare Tech Outlook
Consumer health AI technologies are rapidly entering a complex regulatory environment as they shift from an unregulated space to one governed by various state privacy laws. These technologies often fall outside HIPAA’s scope but are increasingly subject to regulations like the California Consumer Privacy Act, Washington’s My Health My Data Act, and Texas’s Data Privacy and Security Act. The resulting regulatory patchwork varies by location and treats combined geolocation and healthcare data as particularly sensitive information. Tech companies using AI in consumer health applications will need to adapt to these unfamiliar privacy and security requirements that govern the collection and sharing of sensitive personal data. Source: GovInfoSecurity
Taxation
CMS has proposed new rules to eliminate a Medicaid financing loophole that could save the federal government $33 billion over five years. The May 15, 2025 proposal aims to prevent states from disproportionately taxing Medicaid services to draw down federal matching funds by adding stricter requirements for healthcare-related tax waivers. Seven states with existing waivers, including California, New York, Michigan, and Massachusetts, would be affected, with recently approved waivers receiving no transition period and requiring immediate compliance when the rule is finalized. The changes would prevent states from imposing higher tax rates on Medicaid-related services than on non-Medicaid services, forcing significant restructuring of state healthcare taxes. This regulatory effort parallels congressional action, as the House Energy and Commerce Committee recently advanced similar provisions in the 2025 budget reconciliation bill. Source: Sheppard Mullin Richter & Hampton LLP
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 benefit managers for price fixing and California’s action against no-poach agreements in the food processing industry. States are also bolstering criminal enforcement through initiatives like BRACE—a bid-rigging and criminal enforcement working group—while legislatures in California and New York advance bills to increase criminal penalties for antitrust violations. Companies must now consider state enforcement as carefully as federal oversight, with particular attention to transaction notifications, litigation risk, and enhanced criminal enforcement. Source: McCarter & English, LLP
3D printing is revolutionizing healthcare by enabling a shift from mass-produced solutions to customized treatments tailored to individual patients. The technology has transformed multiple medical fields, including prosthetics that can be made affordably for children, custom implants for facial reconstruction and spine repairs, and anatomical models that allow surgeons to practice complex procedures before operations. In pharmaceuticals, 3D printing creates personalized drug dosages and delivery systems, with the FDA approving the first 3D-printed drug Spritam in 2015. While bioprinting has progressed to creating tissue structures like liver tissue, developing full functional organs remains experimental, with current research focusing on smaller tissues and improving cell viability. Despite challenges with regulations, standardization, and accessibility, the integration of artificial intelligence with 3D printing promises further advances in medical applications through optimized designs and materials. Source: Ars Technica
Data Privacy
The Department of Justice’s new Data Security Program imposes extensive restrictions on healthcare organizations handling sensitive personal data with international partners. Effective April 8, 2025, the program regulates six categories of sensitive data including health information, biometric, and genomic data, with no exemptions for anonymized or de-identified information. Healthcare organizations must implement contractual safeguards when sharing data with any foreign entity, not just those in designated “countries of concern” (China, Russia, Iran, North Korea, Cuba, and Venezuela), with violations reportable within 14 days. The rule provides limited exemptions for federally-funded research, clinical investigations, and transactions required by federal law, while requiring organizations to develop comprehensive compliance programs before full enforcement begins July 8, 2025. Source: Baker Donelson
Drug & Devices
Biotech companies are increasingly turning to collaborative deal structures to navigate FDA staffing shortages and financial constraints. With FDA retirements and layoffs extending approval timelines, biotechs facing limited cash runways are using licensing agreements and development partnerships to secure alternative financing while reducing operational costs. These collaborations typically involve upfront payments, milestone-based compensation, and royalties, as exemplified by Zealand Pharma’s recent $5.3 billion collaboration with Roche for obesity treatment technology. However, Hart-Scott-Rodino filing requirements for transactions exceeding certain thresholds (now $126.4 million in 2025) may delay deal completions, with new rules extending filing timelines from under 10 days to at least 30 days and increased scrutiny from the FTC and DOJ on pharmaceutical industry transactions. Source: JD Supra
Emerging Technology
Brain-computer interface technology is advancing rapidly with four leading companies poised to expand human trials significantly in 2025. Paradromics, Synchron, Precision Neuroscience, and Neuralink each employ different implantation approaches, from Synchron’s blood vessel-based electrodes to Neuralink’s deep brain implants that penetrate seven millimeters into brain tissue. The number of people with these interfaces will more than double in the next 12 months as companies advance their FDA-approved trials, while Apple has announced plans to make its devices compatible with these implants. Though medical experts caution against viewing this technology as a consumer product due to surgical risks, Morgan Stanley projects the brain-computer implant market will reach $1 billion annually by 2041. These interfaces already enable paralyzed patients to control computers and communicate, with potential future applications including thought-to-speech translation and prosthetic limb manipulation. Source: Wall Street Journal
Taiwan is pioneering AI healthcare integration with Nurabot, an AI-powered robot nurse that handles routine hospital tasks to address nurse burnout. Developed through collaboration between Foxconn and Kawasaki Heavy Industries, Nurabot delivers medications, patrols wards, and guides visitors, allowing human nurses to focus on critical patient care as the world faces a projected shortage of 4.5 million nurses by 2030. The technology leverages NVIDIA supercomputers and digital twins—virtual replicas of hospital wards—to simulate and optimize operations before real-world implementation. Taichung Veterans General Hospital is currently conducting field trials with Nurabot, while future iterations may communicate in multiple languages, recognize faces, and assist in lifting patients. Despite challenges like data privacy concerns, Taiwan’s approach offers potential solutions to global healthcare staffing issues through AI integration. Source: Rude Baguette
IoT technology revolutionizes healthcare billing through automation and real-time data access. The systems enable automatic recording of usage and charges without manual compilation, providing staff with precise information for error-free bills while reducing labor costs. Patients gain transparency through digital portals displaying detailed bill breakdowns, which reduces disputes and encourages timely payments. Implementation challenges include data privacy concerns (59% of patients fear misuse of medical information), regulatory compliance with laws like HIPAA, compatibility issues between vendor systems, and high upfront costs despite long-term savings. Source: IoT For All
Fraud & Abuse
Texas rheumatologist Jorge Zamora-Quezada was sentenced to 10 years in prison for a massive health care fraud scheme that generated over $118 million in false claims. The 68-year-old doctor falsely diagnosed patients with rheumatoid arthritis and administered unnecessary toxic medications to defraud Medicare, Medicaid, TRICARE, and Blue Cross Blue Shield, resulting in insurers paying over $28 million. Patients suffered severe side effects including strokes, necrosis, hair loss, and liver damage from the unneeded treatments, while former employees described a workplace culture of fear with strict procedure quotas. Following his conviction on health care fraud and obstruction charges, Zamora-Quezada was ordered to forfeit $28,245,454 in assets, including 13 real estate properties, a private jet, and a Maserati that he purchased with his ill-gotten gains. Source: United States Department of Justice
The U.S. Department of Justice launched a new Civil Rights Fraud Initiative to leverage the False Claims Act against organizations receiving federal funding. The initiative, announced on May 19, 2025, targets entities that tolerate antisemitism, permit men in women’s spaces or female athletic competitions, or implement DEI practices deemed unlawful while certifying compliance with civil rights laws. DOJ will focus on organizations that knowingly engage in what the memorandum describes as “racist preferences” through DEI programs that allocate benefits based on race, ethnicity, or national origin. The department encourages private parties to participate by filing lawsuits as qui tam relators under the FCA, with potential implications for federal contractors, educational institutions, and other federal funding recipients. Source: The FCA Insider
A jury has convicted 64-year-old Paul Njoku on all counts for orchestrating a Medicare fraud scheme through his home health care agency in Houston. Evidence showed Njoku forged signatures of doctors and nurses on medical documents, continued using a departed nurse’s signature without permission, and bribed a doctor to approve services. From 2015 to 2019, his company Opnet Health Care Services billed Medicare over $400,000 and received more than $360,000 for claims without proper documentation. Njoku now faces maximum penalties of 10 years for conspiracy to commit health care fraud, five years for false statements, and two additional years for identity theft, along with potential fines of $250,000 per count. Source: United States Department of Justice
Fresno-based Community Health System and affiliate Physician Network Advantage paid $31.5 million to settle allegations of an elaborate kickback scheme involving their Epic EHR system. According to a 2019 whistleblower lawsuit, the organizations provided physicians with extravagant incentives to adopt the Epic EHR system, including access to a $1.1 million wine and cigar lounge, luxury trips, gifts worth tens of thousands of dollars, and hiring family members of executives and physicians. The former controller who filed the lawsuit discovered approximately 1,000 bottles of wine after a fire at the organization’s offices, which sparked the investigation into the alleged scheme that included subsidies for EHR adoption in exchange for government healthcare program referrals. While Community Health System claims the lawsuit contains inaccurate information that doesn’t reflect their standards, Physician Network Advantage stated the settlement concludes the matter without admission of legal liability. Source: Becker’s Hospital Review
Gender-Affirming Care
Attorney General Pam Bondi has directed the Department of Justice to pursue extensive investigations and prosecutions against providers of gender-affirming care for transgender minors. The unverified internal memorandum outlines three primary directives: criminal investigation of what the memo terms “FGM” cases with potential 10-year prison sentences, investigation of pharmaceutical companies for alleged violations of the Food, Drug and Cosmetic Act related to puberty blockers and hormones, and pursuit of False Claims Act violations for billing federal healthcare programs for gender-affirming procedures. Bondi has also instructed the Office of Legislative Affairs to draft legislation creating a private right of action for children and parents who received such care, with long statutes of limitations and retroactive liability. The Attorney General declared these directives a “top priority,” stating, “Under my leadership, the Department of Justice will bring these practices to an end.” Source: Healthcare Law Insights
The Texas House approved a bill requiring medical records to include a field for sex assigned at birth, with penalties up to $250,000 for providers who violate its provisions. The legislation includes provisions for healthcare providers’ use of digital servers and artificial intelligence while mandating disclosure of AI use for diagnoses. Democrats opposed the measure, arguing it forces transgender patients to have a gender marker they don’t identify with displayed in their records, while proponents contend it ensures physicians have complete medical information for accurate care. The bill also grants parents unrestricted access to their minor children’s medical records unless blocked by court order. The bill requires one more House vote before heading to the Senate and potentially to Governor Abbott’s desk. Source: The Texas Tribune
Medical Malpractice
Four key states are implementing significant medical malpractice reforms that fundamentally reshape how liability cases proceed through the legal system. Texas restricts evidence to actual payments rather than billed amounts while requiring disclosure of third-party litigation funding, Georgia eliminates “anchoring” tactics by plaintiffs and imposes procedural barriers including discovery stays, Utah establishes minimum insurance requirements and reporting mechanisms to address rural provider shortages, and South Carolina narrows joint liability by requiring fault allocation across all parties. These state-level reforms demonstrate a shift away from headline-grabbing damage caps toward granular changes to legal mechanics that advantage defendants earlier in proceedings, potentially signaling a nationwide trend in malpractice litigation rules. Source: Scott Righthand
Federal departments have suspended enforcement of the 2024 Mental Health Parity regulations until ongoing litigation concludes plus 18 months . The suspension, announced on May 15, 2025, reinstates the 2013 Final Rule and affects three key requirements: outcomes-based testing, mandatory meaningful benefits across classifications, and fiduciary certification obligations. Plan sponsors and insurers must still conduct nonquantitative treatment limitation comparative analyses and maintain compliance with statutory obligations under the Consolidated Appropriations Act. The departments indicated they will reexamine their enforcement approaches while encouraging states to adopt similar enforcement positions. Despite the suspension, health plans should continue good-faith compliance efforts with the remaining mental health parity requirements. Source: McDermott Will & Emery
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 of “Covered Data” such as biometric identifiers, genomic data, and health information. Academic Medical Centers must review existing and proposed international collaborations, ensure vendors aren’t affiliated with designated countries, and implement enhanced data governance frameworks to maintain compliance. Violations carry severe penalties, including civil fines up to $368,136 or twice the transaction amount, and potential criminal penalties of up to $1 million and 20 years imprisonment for willful violations. Source: Foley & Lardner LLP
The Department of Justice has prioritized False Claims Act theories in its criminal enforcement agenda. The Criminal Division’s top priorities include health care fraud and government contracts fraud, trade and customs fraud, and violations of controlled substances laws—all central focuses of False Claims Act enforcement. These enforcement priorities suggest the DOJ views civil FCA liability and criminal penalties as connected pathways in addressing high-priority misconduct. Businesses in regulated industries now face potential parallel criminal investigations alongside civil FCA scrutiny, making robust compliance systems increasingly critical. Recent changes to DOJ enforcement policies regarding self-disclosure, cooperation, and remediation further emphasize that compliance missteps may carry heavier penalties than before. Source: Skadden, Arps, Slate, Meagher & Flom LLP
Health Data
Patient data faces significant vulnerabilities when health tech companies fold, due to inadequate regulations and inconsistent security practices. Despite the health tech industry’s growth to $908.5 billion in 2023 with projections to reach $3.1 trillion by 2033, approximately 90% of health tech startups eventually fail, as exemplified by Forward’s abrupt closure in 2024 which left patients struggling to retrieve health records and maintain prescription access. Currently, only 20 states have instituted rules for patient health data protection, with most safeguards relying on user agreements that 91% of consumers don’t read, as seen when 23andMe’s bankruptcy prompted customers to rush to delete their data before possible transfer. Security experts recommend companies implement solid encryption, access controls, proper data deletion procedures with 30-day buffers, and rapid response plans to protect patient information when companies shut down. Source: Healthcare Brew
Insurance Coverage
The Tenth Circuit Court of Appeals has ruled that hospital excess liability insurance policies must treat each patient claim as a separate “medical incident.” The May 2, 2025 decision in AdHealth Limited v. PorterCare Adventist Health Systems affirmed that each claim must individually exceed the $2 million self-insurance retention to qualify for excess coverage. PorterCare had sought $40 million in coverage after settling lawsuits from thousands of patients exposed to infection risks due to inadequate sterilization procedures. The court rejected PorterCare’s argument that all claims constituted a single medical incident, instead interpreting the policy language “any one person” as unambiguously limiting coverage to individual claimants. The ruling highlights the importance of policy language in determining how multiple related claims will be treated for insurance purposes. Source: Carlton Fields
Long-Term Care
A federal court has struck down key provisions of the Centers for Medicare & Medicaid Services’ staffing mandate for long-term care facilities. The Northern District of Texas vacated requirements for 24/7 registered nurse staffing and minimum staffing ratios of 3.48 hours per resident per day that were set to begin implementation in May 2026. The court determined CMS exceeded its statutory authority by contradicting existing law that requires RN services for only eight consecutive hours daily and by imposing uniform staffing ratios that fail to account for facilities’ unique needs. This ruling follows the Supreme Court’s decision in Loper Bright Enterprises v. Raimondo, which limits federal agencies to authority clearly delegated by Congress and enhances judicial oversight of regulatory actions. While providing regulatory relief, long-term care facilities should continue addressing staffing challenges and monitor potential appeals of this decision. Source: Troutman Pepper Locke
Medicare Advantage
UnitedHealth Group faces multiple federal investigations amid leadership changes and financial struggles. According to The Wall Street Journal, the Department of Justice has been conducting a criminal fraud investigation into UnitedHealthcare’s Medicare Advantage business since at least summer 2024, though the company claims no knowledge of such an investigation. This comes alongside an existing antitrust probe examining the relationship between UnitedHealthcare and Optum, plus a civil investigation into Medicare Advantage billing practices. UnitedHealth reported poor first-quarter performance in 2025 with medical costs exceeding expectations. The company’s stock has reached multi-year lows following these developments. Source: Fierce Healthcare
Mergers & Acquisitions
Healthcare transaction activity hit its lowest point since Q3 2020, with Q4 2024 volumes decreasing 10.4% from Q3 and 11.7% compared to Q4 2023. Professional Services, Outsourced Services, and Behavioral Health dominated the landscape, accounting for 73.2% of all transactions, with significant deals including New Enterprise Associates’ $1.3 billion acquisition of NeueHealth and Cencora’s $4.6 billion purchase of Retina Consultants of America. Despite an overall 4.9% decline in 2024 transactions compared to 2023, certain sectors showed growth, including Behavioral Health (+7.5%), Managed Care (+10.6%), and Specialty Outpatient Facilities (+14.0%). Healthcare investors continue to face regulatory scrutiny and elevated interest rates, though the incoming Trump administration is expected to create a more favorable M&A environment in 2025 with a less aggressive approach to merger regulation and potential tax cuts. Source: [Ankura](https://www.jdsupra.com/legalnews/quarterly-healthcare-transactions-4427961/
Part 2
The U.S. Department of Health and Human Services has updated 42 CFR Part 2 to align substance use disorder record confidentiality requirements with HIPAA and HITECH standards. The New Rule allows patients to sign a single consent form for future disclosures rather than requiring separate authorizations for each disclosure, while also implementing HIPAA-like breach notification requirements. Penalties for violations now include both civil fines up to $1.5 million per calendar year and criminal penalties up to $250,000 with potential imprisonment from one to ten years. Healthcare entities subject to Part 2 must update their policies regarding patient consent, information disclosure, medical records, breach notification, privacy notices, and data storage. Organizations must comply with these new requirements by February 16, 2026 to avoid significant penalties in the increasingly stringent enforcement landscape. Source: Katton
Regulation
The Federal Trade Commission and Department of Justice have directed federal agency heads to identify anticompetitive regulations for potential elimination, with a focus on healthcare sector regulations. Following President Trump’s Executive Order 14267, agencies must submit their lists by June 18, 2025, to facilitate review of regulations that create monopolies, establish barriers to entry, or otherwise limit market competition. The May 5 joint letter specifically highlights concerns about healthcare regulations under the Affordable Care Act potentially pushing low-cost insurance plans out of the market and inducing vertical consolidation that raises prices. The letter also notes that pharmaceutical regulations may delay the introduction of more affordable medicines, though no specific regulations were identified for elimination. This initiative follows the DOJ’s launch of an Anticompetitive Regulations Task Force and the FTC’s Request for Information seeking public input on regulations with anticompetitive effects. Source: Epstein Becker Green
