Author: WadeEmmert

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Health Law Highlights

CMS Finalizes Major Reforms to Medicaid, Part 1: Medicaid Access Reg

Summary of article from McDermott+Consulting, by Jeffrey Davis, Kayla Holgash, Katie Waldo:

The Centers for Medicare & Medicaid Services (CMS) has issued two new regulations pertaining to state-operated Medicaid programs, aiming to improve access to care for Medicaid enrollees. A notable policy within the ‘Ensuring Access to Medicaid Services’ regulation specifies that at least 80% of Medicaid fee-for-service (FFS) and managed care payments for home- and community-based services (HCBS) must be allocated towards compensation for direct care workers. The regulation also introduces new definitions, allows for state-specific flexibilities, and outlines reporting requirements for states. Other key provisions include the establishment of a grievance process for beneficiaries, regular review of person-centered service plans, and the creation of a Beneficiary Advisory Council. The regulation will take effect 60 days after publication, but specific provisions have varied effective dates.

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Health Law Highlights

Houston Transplant Scandal: Families of Patients Who Died Begin Legal Action

Summary of article from MedPage Today, by Associated Press:

Relatives of deceased patients are demanding an investigation into a Houston doctor, J. Steve Bynon Jr., MD, who is accused of manipulating the liver transplant waitlist at Memorial Hermann-Texas Medical Center. The hospital has suspended its liver and kidney transplant programs after discovering “inappropriate changes” in the national database for liver transplant recipients. A temporary restraining order has been filed to prevent Bynon from deleting or destroying evidence. Meanwhile, a lawsuit alleging negligence has been filed against the hospital and UTHealth Houston by a woman whose husband died while on the waitlist. The death rate for patients awaiting a liver transplant at Memorial Hermann was higher than expected, according to data from the Scientific Registry of Transplant Recipients.

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Health Law Highlights

Kaiser Permanente Notifying 13.4 Million of Tracker Breach

Summary of article from Gov Info Security, by Marianne Kolbasuk McGee:

Kaiser Foundation Health Plan reported a data breach affecting 13.4 million individuals due to unauthorized access/disclosure from its previous use of online tracking technologies on its websites and mobile applications. Personal information potentially transmitted to third-party vendors like Google, Microsoft Bing, and Twitter includes IP addresses, names, account sign-in information, website navigation data, and search terms. No sensitive information like usernames, passwords, Social Security numbers, or financial account details were disclosed. Kaiser Permanente has since removed these online technologies and implemented measures to prevent such incidents in future. Despite no known misuse of the personal information, the organization will notify affected individuals directly in May out of caution.

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Health Law Highlights

DOJ Releases 2024 COVID-19 Fraud Enforcement Task Force Report

Summary of article from Morrison Foerster, by Adam Braverman, Kate Driscoll, Kamran Jamil, Brian Kidd, Nathaniel Mendell:

The U.S. Department of Justice (DOJ) has released a comprehensive report on the COVID-19 Fraud Enforcement Task Force, calling for an extension of the statute of limitations for pandemic fraud-related offenses and increased funding for investigations and prosecutions. Since May 2021, the Task Force has charged over 3,500 defendants, recovered more than $1.4 billion in government funds, and filed over 400 civil suits. The report highlights cases involving False Claims Act liability, primarily related to the Small Business Administration’s Paycheck Protection Program (PPP), Economic Injury Disaster Loans (EIDL), and COVID-19 testing claims. The DOJ is seeking to establish a permanent interagency body to combat government benefits fraud. The report also calls for legislation to extend time limits for charging pandemic-related fraud cases and further resource fraud investigations.

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Health Law Highlights

A Regulatory Roadmap to AI and Privacy

Summary of article from IAPP, by Daniel Solove:

There is a complex relationship between AI and privacy. AI-related privacy issues are often extensions of existing digital privacy problems. Privacy law reform must address digital privacy holistically, not just in the context of AI. AI creates implicates privacy concerns in data collection and processing, decision-making, and data analysis. Current privacy laws are inadequate in handling these issues. AI also presents difficulties in oversight, participation, and accountability. Effective reform must include transparency, due process, and stakeholder involvement. Comprehensive overhaul of existing privacy laws needed to effectively regulate AI’s impact on privacy.

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Health Law Highlights

Three Women Contract HIV From Dirty “Vampire Facials” at Unlicensed Med Spa

Summary of article from Ars Technica, by Beth Mole:

Unlicensed cosmetic procedures at a med spa have been linked to an outbreak of HIV, marking the first time cosmetic treatments have been associated with such an outbreak. At least three women who underwent “vampire facials”, a treatment involving the injection of a patient’s own platelet-rich plasma into their face, at the unregulated VIP Spa, tested positive for HIV. The spa, which had poor hygiene standards and reused disposable equipment, was shut down in 2018 and the owner was later convicted for practicing medicine without a license. Investigators tested nearly 200 other spa clients for HIV and found a total of five infections linked to the facility. The report highlights the importance of identifying potential novel sources of HIV transmission among people with no known risk factors.

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Alert

Feds Launch Website for Reporting of Health Care Anticompetitive Practices

On April 18, 2024, the Federal Trade Commission (FTC), U.S. Department of Justice (DOJ), and U.S. Department of Health and Human Services (HHS) launched a public web portal for reporting anticompetitive practices in the health care sector. The portal, www.healthycompetition.gov, allows anyone to submit complaints about potential anticompetitive conduct in the healthcare industry. The portal provides information about federal laws ensuring healthy competition and examples of conduct that can harm competition in healthcare. The agencies have not limited the sources of reports, implying a wide scope for potential informants, from the general public to industry insiders. The launch of this portal necessitates increased vigilance from healthcare entities, as any information could potentially trigger an investigation by the FTC or DOJ.

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Alert

HHS Issues New Rule to Support Reproductive Health Care Privacy Under HIPAA

The Biden-Harris Administration has announced a Final Rule through the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) to enhance the HIPAA Privacy Rule and protect reproductive health care privacy. This rule prohibits the disclosure of protected health information (PHI) related to lawful reproductive health care under certain conditions. The rule was issued in response to community feedback for better patient confidentiality and to prevent misuse of medical records related to reproductive health care. The rule mandates regulated health care providers and organizations to modify their Notice of Privacy Practices and obtain a signed attestation for certain requests for PHI related to reproductive health care. The current HIPAA Privacy Rule remains in effect until the new rule is implemented.

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Health Law Highlights

FTC Bans Noncompete Clauses, Declares Vast Majority Unenforceable

Summary of article from Ars Technica, by Jon Brodkin:

The Federal Trade Commission (FTC) has issued a final rule banning noncompete clauses, rendering most existing clauses unenforceable, citing that they are an unfair method of competition and a violation of Section 5 of the FTC Act. The rule will take effect 120 days after its publication in the Federal Register, affecting approximately 30 million US workers currently bound by such clauses. The rule will not apply to senior executives, defined as those earning more than $151,164 annually and in policy-making positions. The FTC argues that noncompete clauses suppress wages, innovation, and economic dynamism, and believes businesses can protect trade secrets through other means like nondisclosure agreements. The US Chamber of Commerce intends to sue the FTC, claiming the rule undermines the competitiveness of American businesses.

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Around the Web

Clinic Owner Sent to Prison for Orchestrating $15M Medicare Fraud and Kickback Scheme

Gwendolyn Gibbs, the owner of the Houston-based Daybreak Rehabilitation Center, has been sentenced to 84 months in federal prison and ordered to pay $8.68 million in restitution to Medicare for conspiracy to commit healthcare fraud. Gibbs fraudulently billed Medicare for unnecessary mental health services provided to vulnerable adults with intellectual disabilities. From 2007 to 2016, she submitted fraudulent claims for partial hospitalization program (PHP) services, falsified medical records, and paid kickbacks for patient referrals. Charles Guidry Jr., a manager at Daybreak and Gibbs’ ex-husband, was previously sentenced to 70 months imprisonment for his involvement. Gibbs will remain in custody until her transfer to a U.S. Bureau of Prisons facility. Source: Press Release.