JD Supra Healthcare

NYBOP May 2026 Deadline Requires Pharmacy and Pharmacist Licensure for Shared Services

The New York State Board of Pharmacy issued guidance in December 2025 requiring individual licensure for pharmacists participating in shared pharmacy services arrangements when servicing New York patients, effective May 22, 2026. Nonresident pharmacy registration alone is no longer sufficient. Pharmacies must identify and license all pharmacists supporting New York operations, including remote personnel, by the May deadline.

CVR pays $4M FCA settlement for unnecessary procedures

Center for Vein Restoration (CVR) Management LLC agreed to pay $4 million to settle False Claims Act allegations that it billed Medicare, Medicaid, and TRICARE for medically unnecessary vein procedures. The settlement resolves two qui tam actions filed in 2015 and 2018, with proceeds distributed among eight state Medicaid programs, DC, the federal government, and the original whistleblowers.

Tennessee Health Care AI Bill - Prohibition on AI as Mental Health Professional

Tennessee enacted SB 1580 (signed April 1, 2026, effective July 1, 2026) prohibiting AI developers and deployers from advertising AI systems as qualified mental health professionals. Violations constitute unfair or deceptive acts under the Tennessee Consumer Protection Act, subject to civil penalties up to $5,000 per violation and private right of action.

Private Equity Healthcare Impact Analysis

The NYU Stern Center for Business and Human Rights released a report on private equity's expanding role in healthcare, noting over $1 trillion in largely debt-financed transactions over the past decade. The report identifies patterns including elevated debt levels, staffing reductions, and a 25% increase in in-hospital complications following private equity investments. The analysis highlights dividend recapitalizations and sale-leaseback transactions as contributing factors, with private equity-sponsored healthcare entities showing 10X increased insolvency risk.

Greene v. Progressive Corp. - Tobacco Premium Surcharge ERISA Claims Dismissed

The Northern District of Ohio dismissed Greene v. Progressive Corp., a lawsuit challenging tobacco premium surcharges under ERISA. This is the third federal court to hold that employers are not required to provide retroactive reimbursement of premium surcharges when employees complete tobacco cessation courses during a plan year. The court also dismissed breach of fiduciary duty claims, finding the employer acted as a settlor rather than a fiduciary when implementing the wellness program.

AHLA Conference Government Fraud Enforcement Healthcare Analysis

This Morgan Lewis Health Law Scan article covers the American Health Law Association (AHLA) Institute on Medicare and Medicaid Payment Issues conference held March 18-20, 2026 in Baltimore. Government representatives from CMS, HHS OIG, and HHS OGC made presentations on fraud enforcement priorities including the CRUSH (Comprehensive Regulations to Uncover Suspicious Healthcare) rule, Milliman Inc. winning CMS's AI fraud detection competition, and OIG noting $6.8 billion in FCA settlements for FY 2025.

Group Health Plan Compliance Audit Requirements ERISA ACA

Bradley Arant Boult Cummings LLP published an educational article advising employers on compliance audit requirements for ERISA-covered group health plans. The article identifies key review areas including plan documentation, participant disclosures, Form 5500 reporting, fiduciary governance, and COBRA administration. Employers are encouraged to conduct proactive systematic compliance reviews with legal counsel to reduce legal exposure and prepare for regulatory inquiries.

Fourth Circuit Blocks West Virginia 340B Contract Pharmacy Law as Preempted

The Fourth Circuit affirmed a preliminary injunction blocking West Virginia's S.B. 325, which would have restricted how drug manufacturers implement 340B contract pharmacy policies. The court held that the state law is likely preempted because it impermissibly rewrites the federal contractual bargain Congress struck with manufacturers under its spending power. Manufacturers sued over $50,000 per violation penalties.

HIPAA Compliance in Healthcare Analytics Podcast

Roetzel & Andress law firm published a podcast episode discussing HIPAA compliance considerations for healthcare providers using health analytics. Ericka Adler and Christina Kuta cover how patient data is collected through digital tools and when such data constitutes protected health information.

Federal AI Framework and Trump America Act Healthcare Analysis

The Trump administration released its National Policy Framework for Artificial Intelligence (March 20, 2026) outlining seven legislative priorities including federal preemption of state AI laws and intellectual property protections. Senator Marsha Blackburn introduced a discussion draft of the Trump America AI Act, which would codify Executive Order 14179 and establish a single federal rulebook for AI governance. Both proposals would introduce new liability frameworks, mandatory bias audits, copyright-based training data requirements, and transparency obligations affecting health care and life sciences organizations using AI applications.

FDA Final Guidance on Voluntary Patient Preference Information for Medical Devices

FDA published updated final guidance on incorporating voluntary patient preference information (PPI) in medical device decision making, replacing the 2016 PPI guidance. The guidance fulfills MDUFA V commitments and provides recommendations on study design, submission practices, and inclusion of PPI in device labeling and decision summaries. PPI remains voluntary but FDA may consider it when meeting applicable requirements.

Drug Testing Guidance for Oklahoma Employers Under Medical Marijuana Law

McAfee & Taft published practical guidance on Oklahoma's medical marijuana employment law, explaining how employers may designate safety-sensitive positions and take adverse action based on positive marijuana tests under the Unity Bill (Okla. Stat. tit. 63, § 427.8(H)(2)(c)). The guidance analyzes the exception to the general anti-discrimination rule for positions involving safety-sensitive duties, including driving, equipment operation, and direct patient care.

CIPO Updated Patent Guidelines for Medical Diagnostics and CII

CIPO issued practice notice updating guidelines on patentable subject matter for computer-implemented inventions and medical diagnostic methods, superseding PN2020-04 and existing MOPOP provisions. The guidance emphasizes a physicality requirement for patentability and clarifies how claim elements characterized as common general knowledge will be evaluated during purposive construction.

Automatic Medicare Advantage Enrollment with Opt-Out Option

CMS is reportedly considering feasibility models for automatic Medicare Advantage (MA) enrollment with opt-out provisions for new Medicare beneficiaries, according to remarks by Chris Klomp, chief counselor at HHS and director of the Center for Medicare at CMS. The proposal would allow individuals to opt for traditional Medicare or accountable care organizations instead. This represents early-stage policy exploration and is not yet a formal regulatory proposal.

LEAD Model Request for Applications for Accountable Care Organizations

The Centers for Medicare & Medicaid Services (CMS) Innovation Center released the Request for Applications (RFA) for the Long-term Enhanced Accountable Care Organization Design (LEAD) Model, a 10-year voluntary demonstration program beginning January 1, 2027. The LEAD Model succeeds the ACO REACH model and introduces new features including CMS Administered Risk Arrangements (CARA) for episode-based risk arrangements with specialists. Applications must be submitted by May 17, 2026.

340B Litigation Roundup - Contract Pharmacy Disputes

McDermott Will & Emery published its weekly 340B litigation roundup covering March 24-30, 2026, summarizing developments across more than 50 pending cases involving the 340B drug pricing program. Drug manufacturers filed new suits challenging state contract pharmacy laws in Washington and pursued appeals in Tennessee cases, while four Utah cases advanced with plaintiffs responding to show cause orders.

FCA Claims Related to 340B Drug Pricing Program May Proceed

The Ninth Circuit reversed dismissal of a qui tam action in United States ex rel. Adventist Health System of West v. AbbVie Inc., holding that FCA claims tied to alleged 340B ceiling-price noncompliance may proceed at the pleading stage. The court rejected arguments that the absence of a private right of action under 340B bars FCA suits, finding FCA claims are 'free-standing and independent' and can proceed where relator alleges government overpayment harm.

Anthem Policy Penalizes In-Network Facilities for Out-of-Network Provider Use

Anthem (Elevance Health) implemented a Facility Administrative Policy effective January 1, 2026, imposing a 10% penalty on in-network facilities that use out-of-network providers for Anthem's commercial plan members. The policy applies to Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, Nevada, New Hampshire, Ohio, and Wisconsin, with California expansion planned for June 1, 2026. Facilities may face network termination for continued violations.

New ALF Specialty License for Memory Care Services

Florida Senate Bill CS/CS/SB 1404 proposes a new Assisted Living Facility (ALF) specialty license designation for memory care services. The bill would require ALFs serving memory care residents or advertising such services to obtain the designation from the Florida Agency for Health Care Administration (AHCA). AHCA must establish minimum standards including staff training requirements, safety protocols, and advertising restrictions by July 1, 2027.

Strict Scrutiny Applied to Colorado Conversion Therapy Ban

The U.S. Supreme Court ruled 8-1 in Chiles v. Salazar (No. 24-539) that Colorado's law banning conversion therapy by licensed counselors constitutes content- and viewpoint-based regulation of speech subject to strict scrutiny under the First Amendment. The Court rejected Colorado's argument that the law merely regulates professional conduct, finding instead that it directly targets speech and prescribes permissible viewpoints. The case was remanded to the Tenth Circuit for application of strict scrutiny.

OIG approves ASC estate planning transfers with safeguards

HHS-OIG issued Advisory Opinion AO-26-04 on March 4, 2026, providing a favorable opinion on proposed estate planning transfers of ownership in a Medicare-certified ASC. The opinion addresses transfers from a sole-physician owner to his spouse, surgeon children, and eventual estate beneficiaries. OIG determined the arrangement would not impose sanctions under the Anti-Kickback Statute when safeguards including independent third-party fair market value appraisals and physician non-referral certifications are in place.

Pharma Data Privacy and Cybersecurity under the Trump Administration

HHS has proposed significant updates to the HIPAA Security Rule that would represent one of the most consequential federal healthcare cybersecurity updates in years. The proposed changes would require comprehensive technology asset inventories, network maps, detailed risk analyses, stronger encryption, multifactor authentication, periodic vulnerability scanning, annual penetration testing, and formal disaster-recovery capabilities. Pharmaceutical companies operating adjacent to HIPAA-regulated workflows face new compliance obligations even when not directly covered entities.

Trump Administration Impact on Pharmaceutical Industry - State AG Oversight, Data Privacy, and Pricing

Foley & Lardner LLP published an analysis of the Trump administration's impact on the pharmaceutical industry after one year in office. The analysis identifies three primary regulatory pressure areas: increased State Attorney General enforcement as federal agency staffing declines, heightened data privacy concerns, and pharmaceutical pricing pressures. The firm announces an ongoing blog series to track developments in corporate, regulatory, and intellectual property law affecting life sciences companies.

DOJ Sues NYP for Sherman Act Antitrust Violations

The DOJ and U.S. Attorney's Office for the Southern District of New York filed a civil antitrust lawsuit against New York-Presbyterian Hospital (NYP), alleging Section 1 Sherman Act violations through anti-competitive contract provisions with commercial payors. The government seeks injunctive relief and a declaratory judgment that NYP's contract restrictions violate antitrust law.

Healthcare Digital Accessibility Standards Under Section 504

HHS Office for Civil Rights issued a final rule updating Section 504 regulations, establishing WCAG 2.1 Levels A and AA as the technical standard for digital accessibility. Recipients of HHS federal financial assistance—including hospitals, physician practices, health plans, and medical schools—must ensure websites and mobile apps comply. Organizations with 15+ employees have until May 11, 2026; those with fewer than 15 employees until May 10, 2027.

DOJ v. NewYork-Presbyterian - Hospital Antitrust Contract Restrictions

The DOJ Antitrust Division filed a civil lawsuit against NewYork-Presbyterian (NYP) in the US District Court for the Southern District of New York, alleging violations of Section 1 of the Sherman Act. The complaint alleges NYP's contracts with commercial payors contain 'all-or-nothing' and most favored nation provisions that prevent development of budget-conscious health plans. This marks the second DOJ antitrust action against hospital system contracting practices in 2026, following a similar suit against OhioHealth.

Digital Accessibility Requirements for Healthcare Websites, Apps, and Kiosks

HHS finalized a rule requiring recipients of federal financial assistance to make their websites, mobile applications, and kiosks accessible to individuals with disabilities per WCAG 2.1 Level AA standards. Large recipients with 15 or more employees must comply by May 11, 2026; small recipients with fewer than 15 employees have until May 10, 2027. Covered entities include healthcare providers accepting Medicare or Medicaid, health plans, and social services.

EU Pharma Package - Stricter Environmental Risk Assessment Rules for Pharma

The EU Council and Parliament have finalized the Pharma Package, introducing stricter Environmental Risk Assessment (ERA) requirements for pharmaceutical companies. The new rules extend ERA obligations to manufacturing and antimicrobial resistance, add ongoing monitoring requirements beyond initial MA application snapshots, and introduce real consequences for non-compliance including potential MA suspension or revocation.

Healthcare Private Equity Outlook Conference Takeaways

McDermott Will & Schulte published conference takeaways from HPE Miami 2026, a healthcare private equity summit attended by over 2,000 industry leaders. The report identifies operational execution, compliance and quality management, and talent leadership as key determinants of near-term PE performance. Deal momentum is driven by health IT and AI-enabled services according to 47% of poll respondents.

Johnson v. Amazon.com Services - Wage Compensation for Pre-Shift Activities

The Illinois Supreme Court in Lisa Johnson v. Amazon.com Services, LLC ruled that under the Illinois Minimum Wage Law (IMWL), employers must compensate nonexempt employees for preliminary and postliminary activities such as pre-shift COVID-19 screenings. This decision diverges from federal law under the Portal-to-Portal Act (PPA), which excludes such activities from compensable time. The ruling applies to all employers with nonexempt employees in Illinois and may expose them to class action liability for unpaid screening time.

CMS extends 36-month rule to DMEPOS suppliers

CMS extends 36-month rule to DMEPOS suppliers

New Jersey APNs gain independent practice, prescriptive authority

New Jersey Governor signed legislation on March 30, 2026, permitting qualified Advanced Practice Nurses (APNs) to practice and prescribe independently without joint protocols with physicians. Qualifying APNs must have over 5,000 hours of clinical experience in primary care (family/individual across lifespan), women's health, or behavioral health settings. The law establishes new continuing education, malpractice coverage, notice, and disclosure requirements.

Healthcare Deal Decks Risk Referral Law Violations

JD Supra published an analysis on April 1, 2026 warning healthcare organizations that deal materials (investor decks, board presentations, data room documents) can inadvertently create referral law compliance risks. The article identifies specific phrases and presentation formats that diligence teams may interpret as referral steering plans, including language around internal pipelines, capturing ancillaries, and driving cases to ASCs. Compliance officers and deal teams are advised to review materials for problematic language before transactions.

Informal HIPAA Q&A Guidance on Patient Communications

HHS published informal Q&A guidance clarifying HIPAA Privacy Rule requirements for patient communications. The guidance addresses when covered entities may leave appointment or prescription reminders via voicemail, mail, or with family members, and when they must accommodate requests for confidential communications. Healthcare professionals should note this guidance is informal and may be updated.

United States ex rel. Shea v. eHealth, Inc. - FCA Medicare Advantage Claims

Chief Judge Denise Casper of the District of Massachusetts denied defendants' motions to dismiss in United States ex rel. Shea v. eHealth, Inc., allowing FCA and Anti-Kickback Statute claims to proceed against Medicare Advantage Organizations and e-brokers. The government alleges defendants paid hundreds of millions in marketing funds to steer enrollments and discriminated against disabled beneficiaries from 2016-2021. The case now enters discovery.

FDA Protein Bar Labeling Class Action: Calorie Calculation Methodology Dispute

JD Supra published an analysis of a newly filed class action against David Protein alleging protein bars labeled as 150 calories actually contain 263-275 calories. The case centers on methodological dispute over caloric calculation, specifically whether esterified propoxylated glycerol (EPG), a largely undigested fat substitute, should be counted using traditional Atwater factors or ingredient-specific metabolic values under FDA's 21 C.F.R. Section 101.9.

Trademark Strategy, FDA Approval, Brand Protection for Pharma

Adler Pollock & Sheehan P.C. published an informational article on trademark strategy for life science companies, covering the dual regulatory landscape of USPTO trademark registration and FDA naming requirements for pharmaceutical products. The piece discusses practical steps for brand development including early integration of legal, regulatory, and marketing teams, and international protection strategies.

DOJ Corporate Enforcement Policy for Voluntary Self-Disclosure of Criminal Misconduct

The DOJ released its first-ever Department-wide Corporate Enforcement and Voluntary Self-Disclosure Policy for criminal matters, creating a uniform national framework that supersedes all prior component-specific enforcement policies. The CEP applies to all corporate criminal matters except Sherman Antitrust Act violations and establishes three tiers of incentives for companies that voluntarily self-disclose misconduct, cooperate with investigations, and remediate wrongdoing. Under Part I, qualifying companies that meet all requirements and lack aggravating circumstances receive declination of prosecution.

FTC Healthcare Task Force Announcement

The FTC announced creation of a dedicated Healthcare Task Force on March 20, 2026, combining antitrust and consumer protection enforcement under a single coordinated initiative. The task force will focus on healthcare consolidation, anticompetitive conduct, pharmacy benefit managers, medical device manufacturers, and deceptive advertising. Led by representatives from the Bureaus of Competition and Consumer Protection, the initiative expands collaboration with HHS and DOJ.

Healthcare Regulatory Developments Newsletter

JD Supra Healthcare newsletter summarizing March 2026 regulatory developments: FTC announces new healthcare task force for anticompetitive enforcement; bipartisan House bill proposes waiving $100,000 H-1B visa application fees for foreign healthcare professionals; HHS engages pharmaceutical companies on Most Favored Nation drug pricing legislation; PCMA seeks rollback of Labor Department PBM price transparency rule; and Supreme Court ruling pending on False Claims Act qui tam provisions.

New Medicare Advantage Compliance Program Guidance

The OIG released new Industry Segment-Specific Voluntary Compliance Program Guidance (ICPG) for Medicare Advantage Organizations (MAOs) for the first time in over two decades. The guidance identifies seven key risk areas including access to care, marketing and enrollment, and utilization management. This voluntary, nonbinding guidance is intended to complement CMS regulations and signal OIG enforcement priorities to the MA industry.

Illinois GIPA Genetic Privacy Case - No Liability Without Employment Harm

A federal court in Illinois granted summary judgment to AbbVie in Daniel Henry v. AbbVie, Inc., finding no GIPA violation despite a third-party nurse allegedly asking about family medical history during a pre-employment exam. The court held that requesting genetic information is not actionable under GIPA when the applicant's refusal had no bearing on employment decisions.

Alabama Office-Based Surgery Regulations - Three-Tier System

The Alabama Board of Medical Examiners finalized comprehensive overhaul of Office-Based Surgery (OBS) regulations, effective March 16, 2026, with full compliance required by January 1, 2027. The rules establish a new three-tier classification system (Levels I, II, III) based on procedural risk and depth of anesthesia, replacing regulations unchanged since 2003. Registration now applies to both physicians and physician offices.

Vermont AG Settles with UCS - Healthcare Provider Settlement

The Vermont Attorney General's Medicaid Fraud and Residential Abuse Unit settled with United Counseling Service of Bennington County for $483,464 over allegations of service failures and safety risks to Medicaid recipients. The settlement requires extensive organizational reforms including a development services oversight monitor and a new director of quality position. This highlights state AG focus on False Claims Act liability and public safety risk management for healthcare organizations serving vulnerable populations.

Stark Law SRDP Podcast Covers Physician Referral Prohibitions

McDonald Hopkins published Episode 8 of the Legal Diagnosis podcast, featuring healthcare attorneys Liz Sullivan and Emily Johnson discussing the Stark Law and Strategic Self-Referral Disclosure Protocol (SRDP). The podcast explains the strict-liability nature of the Stark Law, which prohibits physicians from referring Medicare or Medicaid patients for Designated Health Services to entities with which they have a financial relationship unless a specific exception applies. The episode is targeted at healthcare providers and legal professionals seeking to understand federal physician self-referral prohibitions.

Florida Medicaid Fraud Investigation Under Trump Administration Scrutiny

CMS Administrator Dr. Mehmet Oz has initiated a Florida Medicaid fraud investigation as part of a broader Trump Administration effort to identify excessive spending and reduce waste and abuse. Florida officials have 30 days to respond to questions regarding Medicaid program integrity, Medicaid provider oversight, and determination of high-risk Medicaid services. Healthcare facilities and practitioners should prepare for potential enhanced enforcement including increased audits, prepayment reviews, and provider revalidations.

California Hospice Fraud Investigation

The U.S. House Committee on Oversight and Government Reform, led by Chairman James Comer, has launched an investigation into California hospice fraud, sending a document request to Governor Gavin Newsom on March 23, 2026. The committee alleges $105 million in Medicare overbilling by Los Angeles County hospice providers and documents a 1500% increase in hospice providers between 2010-2022. California officials have responded that they have already revoked 280+ licenses and have hundreds more under investigation.

Brain-computer interface legal readiness, FDA regulation, neural data privacy

This legal analysis article examines the evolving regulatory landscape for brain-computer interfaces (BCIs), noting that Neuralink received FDA approval for human trials in 2023 under its PRIME Study and is enrolling 21 participants as of early 2026. The article discusses FDA device classification pathways, neural data privacy concerns, and competitive pressures from Samsung and Chinese research teams.

Assignment of Benefits in Payer Disputes - Federal Court Ruling

The U.S. District Court for the District of Connecticut issued a ruling in Abira Medical Laboratories LLC v. Aetna Inc. et al. clarifying that explicit assignment language conveying 'all rights and benefits' under health plans is sufficient to establish standing to sue in payer disputes, while power-of-attorney language alone does not permit the grantee to bring suit. The court allowed breach of contract claims to proceed for a subset of claims and limited state-law claims to non-ERISA plans.

Executive Order Establishes Fraud Task Force Targeting Federal Benefit Programs

President Trump signed an Executive Order creating a Task Force to Eliminate Fraud within the Executive Office of the President. The Task Force, chaired by the Vice President with the FTC Chairman as Vice Chairman, will coordinate a national strategy to combat fraud in federal benefit programs including housing, food assistance, medical care, and cash assistance. Federal agencies administering benefit programs must identify fraud-vulnerable transactions within 30 days, with minimum anti-fraud requirements due within 60 days.