JD Supra Healthcare

EPA Draft Sixth CCL Covers PFAS, Microplastics, Pharmaceuticals

The EPA published its draft Sixth Contaminant Candidate List (CCL) in the Federal Register, listing 75 individual chemicals, 9 microbes, and 4 chemical groups including disinfection byproducts, microplastics, PFAS, and pharmaceuticals not yet subject to national drinking water regulations. The comment period closes June 5, 2026.

CMS Releases Fiscal Year 2027 IPPS and LTCH Proposed Rule

CMS released its fiscal year 2027 proposed rule for the Hospital Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System on April 10, 2026. The proposed rule would increase IPPS operating payment rates by 2.4 percent for hospitals meeting quality reporting and EHR requirements, with an estimated $1.9 billion increase in total IPPS payments. Key changes include expansion of the CJR Model into mandatory nationwide CJR-X, refinements to CAR-T therapy reimbursement under MS-DRG 018, and proposals affecting New Technology Add-on Payments. Comments are due June 9, 2026.

Federal Circuit Reverses JMOL on Antibody Patent Claims for Method of Treatment

The Federal Circuit reversed a district court JMOL and held that Teva's method of treatment claims using anti-CGRP antagonist antibodies to treat headaches satisfied both written description and enablement requirements under 35 U.S.C. § 112. The court found that the prior art demonstrated the antibody genus was well known, humanization methods were routine, and all antagonistic anti-CGRP antibodies work for headache treatment. The decision clarifies that method-of-treatment claims with a specific indication differ from broad functional claims requiring disclosure of every species in a genus.

Health Care Non-Compete Legislation Q1 2026 Update

Several states enacted new restrictions on non-compete agreements for healthcare workers in Q1 2026. Washington passed H.B. 1155 banning all non-compete covenants effective June 30, 2027. Virginia enacted a law prohibiting non-compete enforcement when employees are terminated without cause unless severance is provided, and passed legislation broadly prohibiting non-competes with health care professionals pending the governor's signature. Utah prohibited non-compete agreements with health care workers effective May 6, 2026. Montana expanded its physician non-compete ban effective January 1, 2026. California enacted legislation targeting private equity and hedge fund influence in healthcare practices.

FDA Expands Home Devices, Seeks Statutory Authority Changes

This Mintz newsletter covers two FDA regulatory developments: (1) FDA's READI-Home innovation challenge inviting medical device manufacturers to submit home-health devices aimed at reducing hospital readmissions, with submissions due September 30, 2026 and selections by December 4, 2026; and (2) HHS's FY2027 budget request containing FDA legislative proposals including changes to compounded drug advertising rules, a new biological product licensure pathway, and an alternative IND pathway for Phase 1 clinical trials to encourage biotechnology investment.

LEAD Replaces ACO REACH, 10-Year Model Starts 2027

The Centers for Medicare & Medicaid Services Innovation Center announced the Long-term Enhanced ACO Design (LEAD) model to replace the ACO REACH model. LEAD offers a 10-year commitment (2027-2036) with a fixed spending baseline, eliminating the benchmark rebasing that reduced savings under REACH. The model opens participation to smaller, rural, and independent practices and adds new payment tools including Non-Primary Care Capitation (NPCC) for specialists and CARA risk arrangements. ACOs must apply by May 17, 2026, for the first performance year starting January 1, 2027.

DOJ Sues NYPH Hospital for Antitrust Violations

The DOJ filed an antitrust lawsuit against The New York and Presbyterian Hospital on March 26, 2026, alleging the hospital used its Manhattan market power to force payors into favorable contractual terms that harmed patients and employers. The complaint closely follows a template used in a similar February 2026 lawsuit against OhioHealth, with approximately half of the 60 paragraphs being nearly identical. The NYPH lawsuit differs in that it does not include state law claims (the NY State AG did not join) but contains more documented evidence suggesting the DOJ has incriminating emails from NYPH representatives.

Sixth Circuit Holds Tennessee PBM Network and Steering Rules Are ERISA-Preempted

The Sixth Circuit held that Tennessee's PBM laws requiring any-willing-pharmacy access and prohibiting differential copays and steering incentives are ERISA-preempted as applied to self-funded ERISA plans. The court found these laws impermissibly dictate plan structure and administration rather than merely regulating costs. The ruling establishes that employers sponsoring self-funded ERISA plans and their PBMs cannot be compelled to include all willing pharmacies or prohibited from tiered cost-sharing.

Q1 2026 Hatch-Waxman ANDA Settlements Chart

Robins Kaplan LLP summarizes reported settlements in federal district court Hatch-Waxman ANDA patent litigation cases for Q1 2026. The chart covers 13 settlement summaries involving brand-name drugs including Jardiance, Spravato, Xarelto, Xifaxan, Wakix, and others, documenting case names, patent numbers, and publicly available settlement terms such as consent judgments, injunctions, and dismissal provisions.

DOJ Establishes National Fraud Enforcement Division, Consolidates Healthcare and Tax Fraud Enforcement

Acting U.S. Attorney General Todd Blanche announced the creation of the National Fraud Enforcement Division (NFED) on April 7, 2026, consolidating control over the Tax Section, Health Care Fraud Unit, and Market, Government and Consumer Fraud Unit under a new assistant attorney general. The division will centralize case tracking, mandate embedded prosecutors in all U.S. Attorney districts within 21 days, and create a National Fraud Detection Center to proactively identify fraud in taxpayer-funded programs including Medicare and Medicaid. The Civil Division must designate a liaison within 14 days and the Office of Legal Policy must evaluate further realignment within 120 days.

California AG Bonta Backs Strict CPOM Rules for MSO-PC Arrangements

California Attorney General Rob Bonta filed an amicus brief in Art Center Holdings v. WCE CA Art, LLC supporting strict interpretation of California's corporate practice of medicine (CPOM) prohibition for MSO-PC arrangements. The brief argues that contractual provisions giving MSOs the unilateral ability to replace physician-owners or control equity transfer create a 'captive PC' and violate CPOM. The filing aligns with S.B. 351 (enacted October 6, 2025), which expands state oversight of private equity and hedge fund involvement in physician practices.

FDA Removes 12 Peptides from Category 2, Schedules PCAC Review Meetings

FDA announced removal of 12 peptide bulk drug substances from Category 2 of its Section 503A bulk drug substances list, with removal effective approximately April 22, 2026. FDA will convene the Pharmacy Compounding Advisory Committee on July 23–24, 2026, and before the end of February 2027, to discuss whether these peptides should be added to the 503A bulks list. One peptide (GHK-Cu) is also being removed from Category 1 for the same reason.

DOJ Signals Intensifying California Healthcare Fraud Enforcement

DOJ and California Attorney General have intensified healthcare fraud enforcement targeting hospice and home health providers in California. The DOJ announced a $50 million hospice fraud takedown with eight arrests, a $270 million Medi-Cal fraud guilty plea, and AG Bonta dismantled a $267 million hospice fraud scheme with 21 suspects charged. US Attorney Bill Essayli stated this represents the beginning of increased enforcement activity, with additional charges and takedowns expected every few months.

Ohio SB 386 Proposes Replacing MCOs with ASO

Ohio Senators Louis Blessing and Beth Liston introduced Senate Bill 386, the 'Medicaid Savings Act,' proposing to replace the state's seven Medicaid Managed Care Organizations with Administrative Services Organization vendors paid flat fees instead of capitated rates. The bill, currently in Senate Medicaid Committee sponsor testimony, cites Connecticut's ASO transition and potential federal Medicaid cuts under HR1 as rationale.

FDA ANDA and 505(b)(2) Approvals - First Quarter 2026

JD Supra Healthcare published a compilation tracking FDA Abbreviated New Drug Application and 505(b)(2) Application approvals for Q1 2026 (January through late March). The chart lists over 100 final generic drug approvals, including approval dates, reference-listed drugs, generic drug names, NDA holders, ANDA applicants, and ANDA numbers. Companies represented include Taro, Glenmark, Sandoz, Amneal, Apotex, Zydus, and numerous other generic manufacturers.

Biotech Insights - Spring 2026

Haynes Boone published its Spring 2026 biotech regulatory update covering FDA post-approval change requirements for New Drug Applications and a Federal Circuit patent eligibility ruling. The article explains that NDA changes are categorized as major (prior FDA approval required), moderate (30 days after supplement filing), or minor (annual report only), with dosage form changes typically requiring a new NDA. The piece also analyzes the Federal Circuit's decision in REGENXBIO v. Sarepta upholding patent eligibility for engineered host cells containing heterologous non-AAV sequences.

LEAD Model Features, Five Legal Issues for ACOs

K&L Gates LLP published a primer on the Long Term Enhanced ACO Design (LEAD) Model, outlining its key features and five legal considerations for Accountable Care Organizations and providers evaluating participation. The article provides background on the model and discusses implications for accountable care arrangements under Medicare.

Federal Circuit Affirms Noninfringement on Blood Culture Patents

The Federal Circuit affirmed judgment of noninfringement for Kurin, Inc. in a patent dispute with Magnolia Medical Technologies over blood culture contamination reduction devices. The court held that claim 1 of the '483 patent requires separate "seal member" and "vent" structures, and that "diverter" in the '001 patent is a means-plus-function term that Kurin's device does not satisfy.

Healthcare Technology M&A Pulse Newsletter - April 2026

Bass, Berry & Sims PLC published its quarterly Healthcare Technology M&A Pulse Newsletter covering Q1 2026. The publication analyzes deal activity, regulatory developments, and trends at the intersection of healthcare and technology. This is a law firm newsletter providing market intelligence to clients and industry participants on digital health transactions.

CMS Finalizes Medicare Advantage and Part D 2027 Policies with 5.33% Growth Rate

CMS released a final rule and final rate notice for Medicare Advantage and Part D programs for contract year 2027. The final growth rate is 5.33%, up from the projected 4.97%, providing modest relief to MA plans. Key policy changes include removal of the Health Equity Index from Star Ratings, elimination of 11 of 12 proposed Star measure cuts, finalization of supplemental benefits debit-card provisions, and new marketing rules for agents and brokers. CMS also proposed risk model updates that would reduce MA risk scores by 3.32% in 2027, which stakeholders have challenged.

CMS LEAD Model Creates Specialist ACO Participation Pathways

Benesch attorneys analyze CMS's Long-term Enhanced ACO Design (LEAD) Model, which creates new pathways for specialist physicians to participate in Medicare ACO programs beyond traditional fee-for-service arrangements. The model offers two participation options—Participant Provider (full ACO membership with shared savings/losses) or Preferred Provider (contract-based collaboration)—alongside flexible payment structures including Non-Primary Care Capitation and Advanced Payment Option.

EMA Q2 2026 Pilot Programme for Breakthrough Medical Devices and IVDs

The European Medicines Agency (EMA) is launching a pilot programme in Q2 2026 to provide expert panel advice for developers of breakthrough medical devices and in vitro diagnostics (IVDs). Manufacturers may request expert panel opinions on whether their products meet breakthrough criteria (novelty and positive clinical impact) and, if confirmed, obtain advice on clinical development strategies and appropriate pre-clinical or clinical data. The pilot builds on MDCG 2025-9 guidance and will inform the European Commission's proposed revisions to the MDR and IVDR.

FDA Regulatory Burdens for Mid-Sized Pharma Under 100% Drug Tariffs

Maynard Nexsen published analysis on April 16, 2026 examining how mid-sized branded pharmaceutical companies and specialty biotech face significant FDA regulatory obligations when attempting to relocate manufacturing to mitigate the 100% drug tariffs announced by President Trump on April 2, 2026. The article explains that moving drug substance, drug product, fill-finish, or packaging operations to new facilities triggers FDA postapproval change requirements, including Prior Approval Supplements that can delay commercial shipments by 6-12+ months.

Hospices Face Increased Scrutiny Under New CMS Scoring

CMS has proposed a new Service and Spending Variation Index (SSVI) scoring system for hospice providers to be implemented in fiscal year 2027. The system will track metrics including non-hospice spending, length of stay, live discharge return rates, and average minutes per routine home care day. Facility SSVI scores will be publicly posted on the CMS Hospice Center webpage, with high scores triggering increased oversight, additional reviews, and potential license revocations.

DOJ's Bulk Sensitive Data Transfer Rule: Key Insights for Health Care Compliance

Epstein Becker Green analyzes the U.S. Department of Justice's Bulk Sensitive Data (BSD) Transfer Rule, which imposes compliance obligations on healthcare and life sciences organizations that transfer or provide access to sensitive data, including genomic information. The rule applies when data on as few as 100 individuals is shared, catching many organizations unprepared. The BSD Transfer Rule creates obligations that extend beyond HIPAA, applying even to de-identified or anonymized data, and covers any access by foreign vendors, board members, or investors—not only formal data-sharing agreements.

New York Requires Employers to Stock Opioid Antagonists

New York enacted NY Labor Law § 27-f, requiring private employers already mandated by OSHA standards to maintain first aid kits to also stock opioid antagonists (naloxone). Governor Hochul signed the amended bill on February 13, 2026, with the law taking effect December 13, 2026. The NY State Department of Labor must issue regulations addressing workplace training and required quantities.

HHS OIG Provides Succession Planning Roadmap for ASCs

HHS OIG issued Advisory Opinion 26-04 concluding it would not impose administrative sanctions under the Anti-Kickback Statute for a physician's proposed transfer of ownership interests in an ambulatory surgery center (ASC) as part of estate and succession planning. Despite the arrangement's failure to satisfy every element of the ASC investment safe harbor, the OIG determined the proposal presented sufficiently low fraud and abuse risk due to fair market value pricing, proportional profit distributions, and absence of referral-related conditions.

FDA Defaults to Single Pivotal Trial for Drug Approvals

FDA Commissioner Martin Makary and CBER Director Vinay Prasad announced FDA's new default standard requiring only one pivotal trial for drug approvals instead of two. The agency also released draft guidance establishing a Plausible Mechanism Framework for individualized gene-editing and RNA-based therapies targeting rare genetic conditions. Drug sponsors should note potential increased post-market data collection obligations under the new framework.

Sixth Circuit Holds ERISA Preempts Tennessee Pharmacy Anti-Steering Laws

In McKee Foods Corp. v. BFP Inc. (6th Cir., Apr. 7, 2026), the Sixth Circuit affirmed that ERISA preempts two Tennessee laws regulating pharmacy benefit managers (PBMs). The court held that the state's any-willing-provider provisions and incentive provisions, which aimed to prevent PBMs from steering patients to affiliated pharmacies, constituted impermissible interference with ERISA plan design and administration.

FCA Focus on Waste, Fraud, Data Analytics, Medicare Advantage

FCA Focus on Waste, Fraud, Data Analytics, Medicare Advantage

FY 2027 Budget Reconciliation Could Reshape Health Policy

The President submitted FY 2027 budget proposals to Congress on April 3, 2026, with Senate Budget Committee Chairman Lindsey Graham expected to move a budget resolution the week of April 20 containing reconciliation instructions. Budget reconciliation allows Congress to advance spending and policy changes with a simple 51-vote majority in the Senate. Health care provisions that were dropped from prior legislation, including Medicaid penalties, HSA/HRA expansions, and CHOICE arrangements, may be reconsidered in future reconciliation bills.

Sixth Circuit Upholds DOL Home Care Overtime Rule Post-Loper Bright

The Sixth Circuit in DOL v. Americare Healthcare Services upheld the DOL's 2013 rule requiring third-party home care agencies to pay overtime to live-in caregivers, rejecting arguments that Loper Bright invalidated the regulation. The court found Congress expressly delegated authority to the DOL to define FLSA companionship exemptions, so the rule remains valid. The decision comes as the DOL has separately proposed rescinding the same rule effective July 2025.

FDA Reassessing Dietary Supplement Framework, Ingredient Scope, Manufacturing Changes

The FDA held a public meeting on March 27, 2026 to reassess its dietary supplement regulatory framework under DSHEA. The agency is evaluating the scope of 'dietary substance' definitions, including novel ingredients and emerging production technologies such as synthesis, cell culture, precision fermentation, and recombinant methods. FDA is also considering when manufacturing changes may trigger new regulatory scrutiny or NDI submissions, and how the GRAS pathway intersects with dietary supplement regulation.

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

CMS released the CY2027 Final Rule for Medicare Advantage and Medicare Part D along with the MA Capitation Rates and Part C and Part D Payment Policies Rate Announcement. The Final Rule finalizes without modification much of the CY2027 proposed rule and unexpectedly includes provisions from the CY2026 proposed rule not previously finalized. CMS clarified the non-allowable SSBCI list to permit hulled hemp seed, hemp seed protein powder, and hemp seed oil as allowable items while maintaining prohibition on cannabis products illegal under state or federal law.

Benefits Brief: Responding to a HIPAA Breach of 25 Million Individuals - Conduent Incident

Vorys, Sater, Seymour and Pease LLP published guidance on the Conduent Business Services cybersecurity breach affecting approximately 25 million individuals, including over 15.4 million Texas residents, between October 21, 2024 and January 13, 2025. The article analyzes HIPAA obligations for covered entities and business associates when a third-party vendor experiences a breach of protected health information.

BDSI Loses Motion to Enforce Belbuca Injunction

The U.S. District Court for the District of Delaware denied BioDelivery Sciences International's July 2025 motion to enforce a 2022 final judgment and injunction against Alvogen regarding generic Belbuca (buprenorphine buccal film). The court found that Alvogen's new ANDA product was a reformulation with a more basic backing layer pH than the original ANDA product, and therefore not substantially identical to the enjoined product.

CMS Targets Hospice Providers With Prepayment Reviews in Six States

CMS Medicare Administrative Contractors have been conducting expanded prepayment reviews (EPRs) of existing hospice providers since September 2024 in Arizona, California, Nevada, and Texas. As of December 2025, hospices in Georgia and Ohio have also been added to the review program. Husch Blackwell attorneys discuss how hospices can differentiate EPRs from other audit types, what to expect throughout the process, and strategies to overcome claim denials.

CMS FY 2027 IPPS Proposed Rule: 2.4% Payment Increase

CMS issued the FY 2027 IPPS proposed rule on April 10, 2026, proposing a 2.4% increase in operating payment rates for general acute care hospitals participating in the Hospital Inpatient Quality Reporting Program and meaningful EHR users, reflecting a 3.2% market basket increase less a 0.8% productivity adjustment. The proposed rule would nationalize the Comprehensive Care for Joint Replacement Model, require hospitals billing Medicare Part A and Part B to use CJR-X or TEAM for joint replacement episodes, eliminate the breakthrough device designation alternate pathway for new technology add-on payments, and make various MS-DRG changes.

'We're Open for Business': OCR Enforcing Part 2 SUD Records; NPP Updates Required

The HHS Office for Civil Rights (OCR) has assumed enforcement authority over 42 CFR Part 2 (confidentiality of substance use disorder records) from the Department of Justice, effective Feb. 16, 2026. OCR Director Paula Stannard stated the agency is 'open for business' for Part 2 violations. Both covered entities (CEs) and Part 2 providers were required to update privacy notices by the compliance date, with Part 2 providers adopting HIPAA-like standards and CEs updating their Notice of Privacy Practices (NPPs) to address Part 2 records.

FCA Recoveries, HHS Cuts, OCR Investigations in Healthcare

Spilman Thomas & Battle's healthcare law newsletter covers record False Claims Act recoveries of $6.8 billion in fiscal year 2025, proposed HHS budget cuts, HHS Office for Civil Rights investigations of 13 states, Virginia medical malpractice developments, North Carolina hospital fee scrutiny, hospital bad debt increases, and FDA warnings to telehealth companies regarding GLP-1 product claims. The newsletter also reviews West Virginia legislative impacts on healthcare.

340B Drug Pricing Litigation Update Covers 50+ Cases

McDermott Plus published a weekly roundup of 340B drug pricing litigation covering more than 50 cases in federal and state courts for April 7–13, 2026. Key developments include the Fifth Circuit affirming denial of preliminary injunctions in Mississippi contract pharmacy cases, the Sixth Circuit staying a Tennessee case pending similar proceedings, a new drug manufacturer complaint challenging government audit enforcement and patient-definition determinations, and a trade association filing challenging a Washington state contract pharmacy law.

Congressional Investigations Quarterly: Healthcare Affordability, Drug Prices, Insurance in Q1 2026

Morrison & Foerster LLP published its Congressional Investigations Quarterly covering Q1 2026. The report examines congressional investigations into healthcare affordability, focusing on health insurance company CEO testimony on premium costs, pharmacy benefit manager (PBM) practices and prescription drug pricing, the 340B Drug Pricing Program, and vision care market consolidation. Additional investigations cover algorithmic pricing by technology platforms and college tuition pricing.

FDA Approves Extended EYLEA HD Dosing Interval for Wet AMD and DME

The FDA approved an extension of the maximum dosing interval for Regeneron's EYLEA HD (aflibercept) from 16 weeks to 20 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The approval is based on 96-week data from the PULSAR and PHOTON pivotal trials, which demonstrated that the majority of patients maintained visual and anatomic improvements with extended dosing intervals. The new regimen allows patients to be treated as infrequently as 2 to 3 times per year.

CMS LEAD ACO 10-Year Program Launching Jan 2027

CMS is launching the Long-term Enhanced ACO Design (LEAD) Model on January 1, 2027, replacing the ACO REACH Model. The 10-year voluntary program (2027-2036) offers two risk tracks: Global Risk Option (100% shared savings/losses with 1.75-3% benchmark discount) and Professional Risk Option (50% shared savings/losses). New payment flexibilities include capitated payments, advanced monthly payments, and a Non-Primary Care Capitation mechanism enabling specialist sub-capitation.

California Senior Living–2026 Legal, Regulatory, and Insurance Update Webinar

Hinshaw & Culbertson LLP announces a webinar on April 29, 2026 for California senior living providers covering insurance market changes, claims trends affecting nursing homes and RCFEs, and legal developments influencing liability exposure. The webinar offers 1.0 hours of NAB and RCFE continuing education credits. This is an educational announcement with no regulatory changes or compliance mandates.

Healthcare Providers Warned About Medical Tech Contract AI, Evergreen Risks

Buchalter published an advisory warning healthcare providers about two emerging contract risks: (1) evergreen renewal provisions that automatically extend agreements without opportunity to renegotiate AI-related terms, and (2) expansive vendor data rights that may permit use of provider data for AI model training and product development without clear disclosure. The advisory identifies risks including re-identification of de-identified data, vendor IP accrual from provider operations, and unclear liability for AI-generated clinical or billing outputs.

Recent Court Decisions Favor Employers in Tobacco Surcharge Litigation

Warner Norcross + Judd summarizes three recent federal district court decisions (Plesha v. Ascension Health Alliance, E.D. Mo.; Greene v. Progressive Corp., N.D. Ohio; Noel v. PepsiCo, Inc., S.D.N.Y.) dismissing ERISA class action claims challenging employer tobacco surcharge wellness programs. Courts held that employers need not provide retroactive refunds of tobacco surcharges, that disclosure language substantially similar to DOL model notice satisfies requirements, and that tobacco surcharge design is a settlor function rather than a fiduciary duty. The analysis signals a trend generally favorable to employers while noting dozens of similar lawsuits remain pending nationwide.

FDA Public Meeting on Dietary Supplement Ingredients

FDA's Office of Dietary Supplement Programs held a public meeting on March 27, 2026, to discuss the evolving landscape of dietary supplement ingredients and how scientific and technological advances are shaping the industry. The meeting covered three sessions: the scope of 'dietary supplements' under DSHEA, emerging production technologies, and identification of proteins, enzymes, and microbials. FDA posed three feedback questions to stakeholders regarding novel ingredient types, production methodology changes, and characterization requirements.

A&O Shearman Releases Second Life Sciences and Healthcare Insights Report

A&O Shearman has released the second edition of its Life Sciences and Healthcare Insights report. The publication covers six topics including shareholder activism trends, AI use in drug discovery, China's emergence as a pharma innovation hub, proposed EU MDR and IVDR reforms, the UPC's impact on European patent litigation, and EU environmental sustainability requirements for pharmaceutical companies. The report is informational and does not create compliance obligations.

Healthcare Incentive Decisions Resurface in Audits and Diligence

This article examines how healthcare incentive compensation decisions resurface during audits, partner disputes, payer challenges, and transaction due diligence. It identifies documentation patterns that create risk for healthcare organizations, including discretionary payments without adequate records, one-off compensation adjustments that become permanent without review, and inconsistent explanations for incentive payments. The article advises that when documentation is thin or inconsistent, reviewers fill gaps with risk assumptions.