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CMS Greenlights Hemp Product Pilot for Medicare Beneficiaries

CMS launched the Substance Access Beneficiary Engagement Incentive pilot program on April 1, 2026, allowing healthcare providers participating in CMMI models to offer hemp products to Medicare beneficiaries. Products must be federally legal hemp-derived with no more than 0.3% delta-9 THC, limited to $500 per beneficiary annually. Providers must submit CMS-approved implementation plans and quarterly reports.

National Fraud Enforcement Division Shifts Healthcare Fraud Enforcement

On April 7, 2026, Acting Attorney General Todd Blanche issued a memorandum formally establishing the National Fraud Enforcement Division (NFED), consolidating DOJ's criminal fraud investigative capabilities under a single Assistant Attorney General. The NFED immediately vests operational control of the Criminal Division's Tax Section, Health Care Fraud Unit, and Market, Government, and Consumer Fraud Unit with AAG Colin McDonald. Organizations in healthcare, federal contracting, benefits administration, and trade fraud sectors face heightened federal enforcement scrutiny under the new structure.

2026 White Collar Year in Preview: Healthcare Fraud, FCA, HIPAA Enforcement

Foley Hoag LLP published its 2026 White Collar Year in Preview ebook analyzing anticipated enforcement trends across healthcare fraud, False Claims Act enforcement, HIPAA enforcement, SEC/CFTC/PCAOB priorities, anti-corruption, and international trade. The publication examines steady enforcement activity, evolving regulatory priorities, and significant court decisions expected to shape compliance and risk management strategies for organizations in 2026.

EU Pharma Package Reforms Drug Development, Animal Testing

A&O Shearman analyzes the EU Pharma Package reforms following the Council of the European Union and European Parliament's December 2025 trilogue agreement. The provisional texts include a new Regulation and Directive covering expanded scientific advice, a shift away from animal testing, new frameworks for platform technologies, faster marketing authorization pathways, and regulatory sandboxes. These reforms aim to reduce regulatory burden and accelerate authorization procedures for medicinal products addressing unmet medical needs.

Long Anticipated Medicare Advantage Compliance Guidance Heightens Investor and Provider Scrutiny

HHS-OIG issued its Industry Compliance Program Guidance for Medicare Advantage Organizations (MA ICPG), the first such guidance in over 25 years. The voluntary, nonbinding guidance signals heightened enforcement priorities and serves as a compliance benchmark for plans, providers, and investors. In 2024, Medicare Advantage covered 54% of all Medicare enrollees with estimated government spending of $462 billion.

FDA Issues RFI on Digital Health Clinical Trials

FDA Issues RFI on Digital Health Clinical Trials

Court Allows ECPA Claim Over Health Info Tracking

A federal court denied a motion to dismiss in a case alleging Federal Electronic Communications Privacy Act (ECPA) claims arising from sharing of health information through a website's online tracking technology. The court found that ECPA's crime-tort exception could apply where website publishers allegedly intended to violate HIPAA's criminal prohibition against unauthorized disclosure of individually identifiable health information.

OSHA and NY Workplace Violence Update in Health Care

Cozen O'Connor summarizes three workplace violence developments affecting healthcare employers. OSHA's proposed 'Workplace Violence in Health Care and Social Assistance' rule was moved to the Long-Term Action item in Spring 2025, effectively delaying federal action indefinitely. The 10th Circuit affirmed an OSHA citation against a psychiatric hospital in UHS of Delaware v. OSHRC for failing to protect employees from patient violence. New York enacted a law on December 12, 2025 requiring hospitals and nursing homes to establish workplace violence prevention programs with annual safety assessments beginning in 2027.

Managing Genetic Testing Risk and Lessons from Recent DOJ Enforcement

Genetic testing fraud, DOJ lessons from $328M cases

Task Force targets federal benefits fraud, healthcare focus

The White House signed Executive Order 14235 on March 16, 2026, establishing the Task Force to Eliminate Fraud, chaired by the Vice President and including representatives from Treasury, DOJ, HHS, USDA, Labor, HUD, VA, and other agencies. The interagency task force will coordinate a national strategy to combat fraud, waste, and abuse across federal benefits programs including healthcare, housing, food assistance, and medical care. The task force is directed to develop eligibility verification improvements, identify fraud-prone transactions, and establish minimum anti-fraud requirements for federal benefit programs.

Upcoming ASM Payment Model Changes Impact Healthcare Lenders

Holland & Knight LLP analyzes the upcoming CMS Ambulatory Specialty Model (ASM), a mandatory two-sided risk payment model starting January 1, 2027. The model focuses on heart failure and low back pain specialists in specific geographic areas over five performance years (2027-2031). Healthcare lenders and specialty practices should prepare for new reimbursement variability tied directly to clinician performance metrics.

HIPAA Allows PHI Disclosure to Law Enforcement and Courts with Warrants

Shumaker, Loop & Kendrick published a client alert summarizing HHS guidance on when HIPAA permits covered entities to disclose protected health information to law enforcement. The alert covers court orders, warrants, subpoenas, and administrative requests under 45 CFR 164.512(f), noting that guidance is informal and subject to change.

Washington HB 2548 Expands Health Care Transaction Review Requirements

Washington Governor signed HB 2548 into law on March 25, 2026 (effective June 11, 2026), expanding the state's health care transaction review law under Chapter 19.390. The new law broadens the definition of material change to include changes in ownership or control, transfers of majority assets, and nonprofit-to-for-profit conversions. Parties to covered transactions must now provide additional ownership disclosures and pay tiered filing fees ranging from $2,500 to $25,000 based on transaction value.

Regulatory Horizons: Supply Chain Sovereignty - U.S. and EU Life Sciences Manufacturing

BakerHostetler published a podcast on April 7, 2026 analyzing how U.S. and EU regulatory priorities are reshaping life sciences manufacturing. The discussion covers the BIOSECURE Act, EU Critical Medicines Act, and FDA inspection priorities, examining how divergent regulatory execution creates new compliance challenges for global pharmaceutical companies.

Florida Appeals Court Invalidates DFS Rules on Physician Dispensing in Workers' Compensation

Florida's First District Court of Appeal invalidated two rules from the Department of Financial Services (DFS) that protected physician dispensing in workers' compensation cases. In Publix Super Markets v. Dep't of Fin. Servs., the court held the rules exceeded DFS's authority because the statutory "absolute choice" provision applies only to pharmacies and pharmacists, not dispensing practitioners. Workers' compensation insurers may now require injured workers to use pharmacies instead of receiving medications directly from treating providers.

Executive Order Imposing Section 232 Tariffs on Patented Pharmaceuticals

President Trump issued an Executive Order imposing Section 232 tariffs on imports of patented pharmaceuticals and associated pharmaceutical ingredients, citing national security concerns over U.S. reliance on foreign pharmaceutical supply. The Secretary of Commerce found that pharmaceutical imports threaten access to life-saving medications during supply chain disruptions. Tariffs take effect July 31, 2026 for certain companies and September 29, 2026 for others.

FDA Draft Guidance on 483 Responses for Drug Manufacturers

Cooley LLP summarizes FDA's new draft guidance providing, for the first time, formal recommendations for drug manufacturers on responding to Form FDA 483 observations following cGMP inspections. The guidance applies to domestic and foreign facilities manufacturing human or animal drugs regulated by CDER, CBER, or CVM, including combination-product manufacturers when CDER or CBER is the lead center. Key recommendations include structured response formatting, executive summaries, detailed remediation plans, risk assessments, and interim reporting requirements.

CMS Reaches $100 Million in Stark Self-Disclosure Settlements

CMS released 2025 settlement data for voluntary self-disclosures under the physician self-referral law (Stark Law), settling 244 cases totaling over $20.4 million. Aggregate settlements since the SRDP's inception in 2011 have now exceeded $105 million. A record single settlement of $2.68 million more than doubled the previous high from 2018.

CMS ACCESS Model and FDA TEMPO Pilot: Outcome-Based Payments and Digital Health

Offit Kurman analyzes CMS's ACCESS Model (a CMMI initiative) testing outcome-aligned payments tied to measurable clinical improvements for Medicare Part B providers, running concurrently with FDA's TEMPO pilot supporting digital health technology integration. The article details participation requirements, payment structures involving 50% upfront and 50% withheld amounts subject to reconciliation, and FDA enforcement discretion possibilities for digital health devices used within the model.

FDA clarifies compounded GLP-1 policies, warns telehealth companies

FDA clarifies compounded GLP-1 policies, warns telehealth companies

FDA Grants Limited Enforcement Discretion for CBD Dietary Supplements

The FDA announced a new enforcement discretion policy for orally administered, hemp-derived CBD products effective April 1, 2026. The policy only applies to CBD dietary supplements meeting four criteria and provided to Medicare beneficiaries at the direction of a treating physician. CMS has established a Substance Access BEI program allowing participating organizations to offer up to $500 per year of hemp products to eligible Medicare beneficiaries.

Trump Administration Announces Tariffs on Imported Patented Medication and Pharmaceutical Ingredients

Mayer Brown summarizes the Trump Administration's April 2, 2026 proclamation imposing sweeping tariffs on imported patented medications and active pharmaceutical ingredients (APIs) under Section 232 of the Trade Expansion Act of 1962. The proclamation establishes a 100% ad valorem duty on products of companies without approved MFN pricing or onshoring agreements, effective July 31, 2026 for non-compliant companies and September 29, 2026 for others. The tariffs are justified on national security grounds, citing that 53% of US patented pharmaceuticals and 85% of patented APIs were produced abroad as of 2025.

EU Design Act strengthens medical device design protection

Hogan Lovells analyzes the EU Design Act (effective May 1, 2025 with further reforms July 1, 2026) and its implications for medical device manufacturers. The reform extends design protection to digital and dynamic elements, strengthens enforcement against unauthorized digital replication and 3D printing, and addresses the repair clause for spare parts.

$3.2M DEA Settlement Should Caution Hospitals on Controlled-Substance Recordkeeping

The DEA reached a $3.2 million settlement with Sutter Medical Center, Sacramento and Sutter Fairfield Surgery Center to resolve 628 alleged violations of Controlled Substances Act recordkeeping and security requirements. SMCS faced 360 violations including failures to link CSOS records and notify DEA of theft/loss; SFSC faced 268 violations spanning recordkeeping, inventory, and security failures. The settlement underscores federal enforcement focus on holding healthcare providers accountable for safeguarding controlled substances against theft and diversion.

CMS Finalizes CY 2027 Medicare Advantage and Part D Rule

Holland & Knight LLP summarizes CMS final rule for CY 2027 Medicare Advantage and Part D, effective June 1, 2026. The rule codifies Inflation Reduction Act-driven Part D redesign including out-of-pocket caps and manufacturer discount programs, while finalizing Star Ratings reforms and TPMO oversight updates. CMS also clarifies that cannabis products illegal under federal or applicable state law cannot be offered as SSBCI.

Healthcare & Life Sciences: Drug Pricing Digest - April 2026

President Trump issued a proclamation under Section 232 imposing 100% ad valorem tariffs on imported patented pharmaceuticals and associated ingredients. Companies with approved onshoring plans receive a reduced 20% rate (rising to 100% after 4 years), while those negotiating Most Favored Nation pricing agreements with HHS may qualify for exemptions. Reduced rates of 10-15% apply to products from EU, Japan, South Korea, Switzerland, Liechtenstein, and the UK under existing trade commitments.

Antitrust Enforcers Intensify Scrutiny of Healthcare Algorithmic Pricing

At the ABA Antitrust Spring Meeting, a panel discussed the intensifying scrutiny of algorithmic pricing tools in healthcare and data-driven industries. The Department of Justice Antitrust Division continues to file Statements of Interest emphasizing the 'starting point' theory, asserting that competitors may coordinate simply by agreeing to use the same algorithm to generate benchmark prices. California Assembly Bill 325 (AB 325), effective January 1, 2026, prohibits the use of 'common pricing algorithms' that use competitor data to stabilize prices or wages, introducing potential criminal liability for coercive conduct.

100% tariffs on patented pharmaceuticals, key exemptions detailed

100% tariffs on patented pharmaceuticals, key exemptions detailed

FinCEN Healthcare Fraud Advisory - 24 Red Flags and Enhanced Reporting

FinCEN issued an advisory on March 30, 2026, urging financial institutions to be vigilant in identifying and reporting suspicious transactions related to healthcare fraud schemes targeting Medicare, Medicaid, and other federal and state health care benefit programs. The advisory applies broadly to banks, broker-dealers, investment companies, insurance companies, and certain real estate businesses, providing 24 red flag indicators for identifying fraud and money laundering activity. Financial institutions are encouraged to voluntarily report suspicious activity and notify law enforcement regarding fraud schemes targeting Health Care Benefit Programs.

Prop 65 Roundup - April 2026

ArentFox Schiff published its monthly Prop 65 Roundup covering California OEHHA regulatory activity for April 2026. Key items include OEHHA's final report finding synthetic turf crumb rubber poses insignificant health risks, confirmation that vinyl acetate warning requirements are now effective, a private enforcement action regarding lead in agar-agar powder, a new fish consumption advisory for Los Vaqueros Reservoir, and finalized hexavalent chromium health-protective concentration for drinking water.

NAIC Spring 2026 Meeting Update: PBM Working Group

The NAIC PBM Working Group met on March 23, 2026 in San Diego to advance PBM oversight including new examination standards expanding to affiliated entities like GPOs, pricing and rebate pass-through, network adequacy, and a new multi-state SBS complaint module targeting June 2026 availability. Federal reforms under the 2026 Consolidated Appropriations Act will require 100% manufacturer remuneration pass-through to plans in commercial markets and FMV-based flat-fee compensation in Medicare Part D, effective 2028-2029.

Webinar: Interoperability Wars - Information Blocking and EHR Data Access

Clark Hill PLC announces an April 21, 2026 webinar examining the legal and policy landscape of healthcare data interoperability under the Information Blocking Rule. The webinar will address conflicts among health systems, EHR vendors, digital health companies, and national exchange networks over data sharing obligations and regulatory exceptions.

Healthcare Task Force Antitrust Enforcement Initiative

The FTC announced a new Healthcare Task Force via Directive dated March 20, 2026, consolidating antitrust enforcement authority across all FTC bureaus. The Task Force will coordinate with DOJ and HHS to target information blocking and anticompetitive practices in healthcare markets. This follows a joint DOJ-FTC appearance at the ONC Annual Meeting in February 2026 signaling coordinated enforcement action.

Private Equity Healthcare Regulatory Analysis and Trump Policy Outlook

Akin Gump Strauss Hauer & Feld LLP published a regulatory outlook analyzing the impact of Trump administration policies on private equity investments in healthcare and life sciences. The analysis covers projected Medicaid spending cuts exceeding $800 billion under the One Big Beautiful Bill Act, expired ACA subsidies, and emerging opportunities in AI-driven health technology.

CMS Medicare Advantage and Part D Final Rule for Contract Year 2027

The White House released the President's FY 2027 budget request and CMS finalized policy and technical changes to Medicare Advantage, the Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly for contract year 2027. These changes affect MA organizations and Part D plan sponsors.

Healthcare Privacy Complexity Beyond HIPAA and AI Risks

WilmerHale published an analysis noting that healthcare privacy compliance has grown increasingly complex beyond traditional HIPAA frameworks, driven by evolving data security risks and expanding AI opportunities in healthcare. The article identifies meaningful compliance risks across the healthcare ecosystem but does not impose new regulatory requirements.

State AI Legislation Update: Chatbot and Healthcare AI Laws Enacted

Oregon and Idaho enacted chatbot bills into law, while Tennessee signed a healthcare AI bill. All three contain private rights of action with statutory damages. This weekly update tracks state AI legislation affecting private-sector AI developers and deployers, including bill movements in Nebraska, Hawaii, Missouri, Massachusetts, Rhode Island, Louisiana, and South Carolina.

Provider-Based Attestation and NPI Requirements for Off-Campus HOPDs

The Consolidated Appropriations Act of 2026 requires hospitals with off-campus HOPDs to submit provider-based attestations and obtain separate NPIs by January 1, 2028. Non-compliant off-campus HOPDs will lose Medicare payment eligibility and potentially 340B drug pricing access.

CMS Medicare Secondary Payer Enforcement for Workers' Comp Settlements

CMS announced enforcement actions for Medicare Secondary Payer Section 111 quarterly reporting, with penalties effective October 11, 2025 for settlements involving Medicare beneficiaries. CMS will conduct random quarterly audits using AI tools and publicly report results. Self-insured employers and insurance companies with workers' compensation claims settlements must ensure proper reporting to avoid penalties.

CVR Management pays $4M for unnecessary vein procedures billed to federal healthcare programs

CVR Management, LLC (dba Center for Vein Restoration) and Center for Vascular Medicine, LLC, along with their CEO, agreed to pay $4 million to resolve False Claims Act allegations. The government alleged the defendants submitted claims to Medicare, Medicaid, and TRICARE for medically unnecessary vein procedures including sclerotherapy, radiofrequency ablation, and endovenous laser ablations. The settlement originated from a qui tam whistleblower lawsuit filed by two former employees.

Colorado Conversion Therapy Ban Unconstitutional - First Amendment

The Supreme Court ruled 8-1 in Chiles v. Salazar that Colorado's 2019 law prohibiting licensed mental health counselors from performing conversion therapy on minors is unconstitutional. The Court held the statute violated a counselor's First Amendment rights by directly regulating the content and viewpoint of speech during counseling sessions. Colorado's argument that the law regulated professional conduct with only incidental speech effects was rejected.

FDA Updates Patient Preference Information Guidance for Medical Devices

FDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research issued final guidance on Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle, superseding the August 2016 guidance. The 2026 guidance clarifies scope across the device lifecycle and substantially enhances methodological specificity for PPI studies. The guidance now expressly recognizes PPI relevance to 510(k) submissions and postmarket enforcement decisions.

Ninth Circuit Reverses FCA Case Against AbbVie for 340B Pricing Fraud

The Ninth Circuit reversed the district court in United States ex rel. Adventist Health System of West v. AbbVie Inc., holding that the False Claims Act provides an independent mechanism for relators to pursue claims alleging fraudulent drug pricing in violation of the 340B Program, even though Section 340B itself contains no private right of action. The court rejected manufacturers' arguments that FCA claims require a prior HRSA violation. The ruling exposes pharmaceutical manufacturers to significant FCA liability for 340B pricing practices.

Texas HB 4224 - Patient Health Information Posting Requirements

Texas HB 4224 added Section 181.105 to the Texas Health and Safety Code, effective September 1, 2025. The law requires covered healthcare entities to prominently post on their websites and at physical facilities instructions covering three topics: how patients can request healthcare records, how to contact the licensing board, and how to file a consumer complaint. Entities performing only claims processing, billing, or data analysis backend functions are exempt.

Idaho Minor Consent Law Amendments

Idaho amended Idaho Code § 32-1015 governing minor consent for healthcare services, effective March 31, 2026 (H0860E1). The amendments maintain parental consent requirements for minors while creating new uncertainties regarding noncustodial parent rights and interaction with existing laws allowing minor self-consent for specific services including contraceptives, communicable disease treatment, and substance abuse care.

EPA Draft CCL 6 Includes Microplastics and Pharmaceuticals for Drinking Water Regulation

The EPA announced the draft Sixth Contaminant Candidate List (CCL 6) under the Safe Drinking Water Act on April 2, 2026. For the first time, microplastics and pharmaceuticals have been designated as potential contaminants, alongside PFAS (as a class), disinfection byproducts, 75 chemicals, and 9 microbes. The draft is open for public comment until June 1, 2026. The CCL process identifies emerging contaminants for research but does not itself impose regulatory requirements.

Life Science Regulatory Update: AI IP, Biosimilar Approvals, Cell Therapy

FDA published new guidance in February-March 2026 allowing biosimilar applicants to use foreign clinical trial data to accelerate U.S. approval for rare and ultra-rare diseases. The agency also indicated increased flexibility for iterative manufacturing changes in cell and gene therapies, creating new IP strategy considerations. Knobbe Martens summarizes these regulatory developments for life science companies and their counsel.

All IPAY 2028 manufacturers agree to IRA negotiations

All IPAY 2028 manufacturers agree to IRA negotiations

FTC Creates Healthcare Task Force for Competition and Consumer Protection

The FTC has established a Healthcare Task Force drawing staff from multiple bureaus to coordinate competition and consumer-protection enforcement in healthcare markets. The Task Force formalizes ongoing enforcement against consolidation, exclusionary conduct, and deceptive practices, including a $945 million medical device acquisition block, IDD services merger challenge, and cataract surgery laser merger opposition.

Home Health Company Overtime Misclassification Settlement

ViaQuest Residential Services LLC agreed to pay $975,000 to settle a collective action alleging misclassification of program managers as exempt from overtime under the FLSA and Ohio wage laws. The case centered on whether program managers' primary duty was management or direct patient patient care. One hundred-six plaintiffs received pro rata payments representing approximately 76.4 percent of their calculated alleged unpaid overtime.