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Texas Home Health Providers - HHSC-OIG Common Billing Errors and $95.7M Recovered

The Texas Health and Human Services Office of Inspector General (HHSC-OIG) recovered more than $95.7 million from December 1, 2025, to February 28, 2026. Home health agencies ranked first among provider types in preliminary investigations at 21 percent of cases and third in full-scale investigations at 15 percent. Common billing errors identified include failure to perform required nursing assessments, documentation deficiencies, and billing irregularities such as billing for services when clients were at inpatient facilities or misrepresenting nurse credentials.

Georgia SB 220 THC Cap, 12,000mg Limit, SB 33 Hemp

Two Georgia Senate bills await Governor Brian Kemp's decision by mid-May 2026. Senate Bill 220 would eliminate Georgia's 5% THC concentration cap and replace it with a 12,000-milligram patient possession limit, while rebranding 'Low THC Oil' to 'Medical Cannabis' throughout state code. Senate Bill 33 would ban synthetic hemp products like HHC by 2027 while preserving delta-8 THC products on the market.

Life Sciences and Healthcare Insights (UPDATED)

A&O Shearman published its Life Sciences and Healthcare Insights report, offering a global compilation of legal and regulatory updates from the firm's international team. The report addresses commercial, legal, and regulatory issues affecting life sciences and healthcare companies worldwide. Topics covered include environmental sustainability, regulatory frameworks, and emerging compliance considerations across jurisdictions.

HIPAA PHI Disposal Requirements, Methods, and Training

Shumaker, Loop & Kendrick published a client alert summarizing HHS guidance on HIPAA Privacy and Security Rule requirements for disposing of protected health information. The alert explains that covered entities must implement reasonable safeguards, policies, and procedures for PHI disposal in any form, and must train workforce members on disposal practices. The article references 45 CFR 164.530(c) and 45 CFR 164.310(d)(2)(i) and (ii).

CAA 2026 Medicare Part D Pharmacy Provisions Primer

H.R.7148, the Consolidated Appropriations Act, 2026, became law on February 3, 2025, introducing new pharmacy-related requirements under Sections 6223 and 6224 focused on Medicare Part D. Section 6223 expands 'Any Willing Pharmacy' contracting requirements and creates new affiliate and non-affiliate pharmacy designations, while Section 6224 limits PBM compensation to bona fide service fees and requires passthrough of manufacturer rebates and discounts to PDP sponsors.

Federal Court Vacates HRSA 340B GPO Prohibition Replenishment Model Policy

The US District Court for the District of Columbia vacated HRSA's 2013 policy prohibiting 340B covered entities from using group purchasing organizations with replenishment (virtual inventory) models. The court granted Premier's motion for summary judgment, finding HRSA's policy arbitrary and capricious under the Administrative Procedure Act due to inadequate reasoned explanation. The court denied defendants' cross-motion for summary judgment.

FDA Clarifies GLP-1 Compounding Policy for Pharmacy Compounders

FDA Clarifies GLP-1 Compounding Policy for Pharmacy Compounders

FDA READI-Home Innovation Challenge for Medical Device Technologies

The FDA's Center for Devices and Radiological Health (CDRH) launched the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge on April 7, 2026. The challenge invites medical device innovators to develop home-based technologies that support patients and caregivers following acute hospital stays and help prevent readmissions. Submissions must meet the FD&C Act device definition and address unmet home healthcare needs.

Congress Returns, Healthcare Hearings, Kennedy Testifies

McDermott+ Consulting published a weekly healthcare preview noting Congress has returned from recess with a full agenda focused on DHS funding and potential reconciliation legislation. HHS Secretary Robert F. Kennedy Jr. is scheduled to testify before three House committees regarding the President's FY 2027 HHS budget priorities. Multiple healthcare-related committee hearings are scheduled, including sessions on chronic disease prevention, healthcare innovation, fraud prevention in state-run programs, and public health legislation.

HRSA 340B Rebate Model RFI Comments Due April 20; Eli Lilly and Novo Nordisk Restrict 340B Pricing

HRSA has extended the deadline for comments on its proposed 340B rebate model pilot program to April 20, 2026. Eli Lilly and Novo Nordisk have implemented policies requiring covered entities to submit dispensing data for all 340B drugs within 45 days of dispense. These changes increase administrative burden and create risk of pricing denials and cash flow disruption for covered entities.

100% Section 232 Tariffs on Patented Drugs, APIs, and Key Materials

The White House issued a presidential proclamation on April 6, 2026, imposing 100% additional Section 232 national security tariffs on patented pharmaceuticals, active pharmaceutical ingredients, and key starting materials. The tariffs affect pharmaceutical manufacturers and U.S. importers, with phased implementation beginning July 31, 2026 for certain companies and September 29, 2026 for others. Generic pharmaceuticals and U.S.-origin products are excluded from these tariffs.

China Pharma Innovators Pursue Global Expansion via Licensing Deals

A&O Shearman published analysis on how Chinese pharmaceutical companies are expanding internationally through out-licensing, partnership, and NewCo deal structures. The article examines China's emergence as a leading pharma innovation hub responsible for 29% of the world's innovative drug pipeline, with regulatory approval times reduced from 663 days in 2017 to 105 days in 2024. Key legal and regulatory angles for these transaction structures are discussed.

EPA Releases Draft Sixth Contaminant Candidate List Including Microplastics for Public Comment

The EPA and HHS released a draft Sixth Contaminant Candidate List (CCL 6) on April 2, 2026, adding microplastics among other contaminants for public comment through June 5th. The listing is required under the Safe Drinking Water Act every five years but imposes no regulatory requirements. If microplastics are later included in the Unregulated Contaminant Monitoring Rule 6, public water systems would need to sample and report during 2027-2031. California already requires statewide microplastics monitoring under SB 1422.

FDA Form 483 Response Guidance, March 2026 Draft

FDA Form 483 Response Guidance, March 2026 Draft

FY 2027 HHS Budget Proposes Cuts, Restructuring

Holland & Knight LLP summarizes the Trump Administration's FY 2027 HHS Budget released April 3, 2026. The budget proposes targeted funding reductions across federal health programs, structural changes aligned with the Make America Healthy Again (MAHA) agenda, and increased oversight. Major entitlement reforms are notably absent, with the administration potentially pursuing Medicare and Medicaid changes through regulatory or congressional engagement rather than the budget process.

EU Commission Proposes MDR and IVDR Revision to Simplify Medical Device Rules

The EU Commission published a 170-page proposal on December 16, 2025, revising the Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746. The proposal aims to streamline requirements and reduce administrative burden for manufacturers and notified bodies while maintaining public health protection. Key changes include unlimited certificate validity, revised classification rules for surgical instruments and software, relaxed PRRC requirements for small enterprises, and reduced post-market surveillance reporting frequency.

FDA Reversal on Injectable Peptides Creates Investor Risk

Guidepost Solutions analyzes FDA's reversal of its 2023 ban on 14 injectable peptides, including BPC-157, ipamorelin, and Thymosin Alpha-1. The regulatory shift, driven by HHS Secretary Kennedy's advocacy, allows these compounds to return to Category 1 where licensed compounding pharmacies can prepare them under physician prescription. However, FDA's scientific leadership reportedly retains safety concerns including immunogenicity, organ toxicity, and product impurity that drove the original restrictions.

FDA Proposes 20+ Changes Streamlining Biosimilar, Generic Development

The FDA's FY 2027 budget justification includes more than 20 legislative proposals spanning drug and biologic approval pathways, supply chain oversight, and advertising standards. Key provisions include amending Section 351 of the Public Health Service Act to remove the separate statutory standard for biosimilar interchangeability, creating an abbreviated licensure pathway for biological products analogous to the 505(b)(2) pathway, and strengthening supply chain transparency requirements. The FDA has approved 83 biosimilars to date, with 37 approved between January 2024 and January 2026 alone.

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

CMS issued the CY 2027 Medicare Advantage and Part D Final Rule on April 2, 2026, along with the CY 2027 Rate Announcement on April 6, 2026. The Rate Announcement projects a net average increase in MA payments of 2.48%, representing over $13 billion in additional payments to plans. The Final Rule makes significant changes to the Star Ratings system, codifies IRA provisions, refines supplemental benefits regulations, and implements deregulatory measures under Executive Order 14192.

FinCEN Health Care Fraud Advisory and Proposed Whistleblower Rule

FinCEN issued a health care fraud advisory on March 30, 2026, urging financial institutions to identify and report suspicious activity tied to Medicare, Medicaid, and other federal and state health care benefit program fraud, in coordination with the FBI and HHS Office of Inspector General. One day later, FinCEN published a proposed rulemaking to implement its whistleblower incentives and protections program under the Anti-Money Laundering Act of 2020 and AML Whistleblower Improvement Act of 2022.

National AI Legislative Framework: Healthcare Entity Implications

The White House issued a National Policy Framework for AI on March 20, 2026, calling on Congress to establish a federal policy that preempts state AI laws imposing 'undue burdens.' The Framework has six objectives including protecting children and encouraging AI innovation. No legislation has been passed; current state AI laws (Utah AI Act, Colorado AI Act, California AI amendments) remain in effect. The Framework does not create a new federal rulemaking body—existing agencies like CMS, DOJ, and FDA will continue governing healthcare AI.

DOJ Indicts Osteopathic Physician for Receiving, Selling Misbranded Peptide Drugs

The DOJ indicted a licensed osteopathic physician in Utah for allegedly receiving and selling misbranded drugs from China, marking an escalation in federal peptide enforcement. A Massachusetts medspa owner also pleaded guilty to importing merchandise contrary to law and selling counterfeit drugs and devices. This enforcement wave aligns with the FDA's first warning letter to a clinic regarding unapproved drug sources for aesthetic treatments.

EU Pharma Faces New Environmental Risk Assessment Requirements Under Revised Pharmaceutical Legislation

A&O Shearman analyzes EU environmental and sustainability legislation affecting pharmaceutical manufacturers, including provisional agreements on the Corporate Sustainability Due Diligence Directive and Corporate Sustainability Reporting Directive. The analysis focuses on new environmental risk assessment requirements under revised pharmaceutical legislation that will be integrated into marketing authorization applications, with provisions allowing authorities to refuse, suspend, or revoke marketing authorizations for insufficient ERAs or unaddressed environmental risks.

Two Years On: How UPC Has Impacted European Patent Litigation in Life Sciences

A&O Shearman examines two years of Unified Patent Court (UPC) operations since its June 2023 launch. Over 480 patents have been litigated in the court, with actions steadily increasing. Initially reluctant pharmaceutical players have begun utilizing UPC proceedings, attracted by efficient case management and patentee-friendly decisions. The Court of Appeal has issued harmonizing guidance on key patent validity issues including claim interpretation, inventive step, added matter, sufficiency, and plausibility.

Taking The Pulse Episode 273: Navigating FDA Regulation for Life Sciences Companies

Maynard Nexsen published Episode 273 of its 'Taking The Pulse' healthcare and life sciences video podcast discussing FDA regulatory developments for life sciences companies. The episode features attorney Christin Carey covering tariffs affecting pharma and biotech, evolving FDA guidance for digital health and clinical decision support tools, and the agency's approach to AI, cybersecurity, and emerging technologies.

Q&A: Why Data Provenance Is Critical to AI-Powered Drug Discovery

A&O Shearman published a Q&A article examining data provenance considerations for AI-powered drug discovery. The article addresses transaction risks, IP ownership, data usage rights, and regulatory compliance in AI-biotech partnerships. It discusses challenges around patient consent for secondary use of clinical trial data in machine learning training and the importance of understanding where data comes from and under what terms it can be used.

Healthcare Sector Targeted in 12% of 2025 Activist Campaigns

Healthcare Sector Targeted in 12% of 2025 Activist Campaigns

Virginia Senate Bill 170 and House Bill 627 Restrict Noncompete Agreements

Virginia has enacted SB 170 and HB 627, landmark legislation restricting covenants not to compete. SB 170 requires employers to provide severance benefits for noncompetes to be enforceable when terminating employees without cause, with civil penalties of $10,000 per violation. HB 627 categorically prohibits noncompetes with health care professionals licensed by the Board of Medicine, Nursing, Counseling, Optometry, Psychology, or Social Work, with an exception only for sale-of-business scenarios. The laws apply to all agreements entered, amended, or renewed on or after July 1, 2026.

EPA Draft CCL 6 Identifies Microplastics and Pharmaceuticals as Priority Drinking Water Contaminants

The EPA published its draft Sixth Contaminant Candidate List (CCL 6) on April 2, 2026, identifying microplastics and pharmaceuticals as priority contaminant groups for potential future drinking water regulation under the Safe Drinking Water Act. The draft also includes PFAS, disinfection byproducts, 75 individual chemicals, and nine microbes. EPA announced human health benchmarks for 374 pharmaceuticals. The draft CCL 6 is a procedural screening step that does not itself establish enforceable standards or require immediate action by water systems or industry.

Treasury Proposes Whistleblower Rewards for Reporting Healthcare Fraud

FinCEN released a proposed rule on March 30, 2026, to establish a new whistleblower reward program targeting financial crimes including fraud against government healthcare plans. Qualifying whistleblowers may receive 10 to 30 percent of funds recovered when enforcement penalties exceed $1 million. The program excludes certain employees involved in compliance, audit, or internal reporting processes from bounty eligibility unless 120 days pass without corrective action.

Health Care Week in Review: CMS CY 2027 MA Rate Announcement and FY 2027 IPPS/LTCH PPS Proposed Rule

Alston & Bird's weekly health care review summarizing CMS's finalized CY 2027 Medicare Advantage and Part D Rate Announcement and the proposed FY 2027 IPPS and LTCH PPS rule updating Medicare payment policies for inpatient and long-term care hospitals. The review also covers CDC's insufficient evidence finding on WTC Health Program petitions for hepatic steatosis, HHS/ACF's proposed rule to reduce burden for community services programs, and HRSA's funded extension for rural health care provider quality improvement programs.

Regulatory Overview: Post-Approval Changes to Marketed Drugs

Haynes Boone LLP published an overview of FDA reporting requirements for post-approval changes to approved New Drug Applications (NDAs). Drug sponsors must categorize proposed changes as major, moderate, or minor based on potential to affect drug product identity, strength, quality, purity, or potency. Major changes require FDA prior approval before implementation, moderate changes may be implemented 30 days after filing unless FDA objects, and minor changes are reported in annual reports.

Advertising Claim Substantiation Requirements for Health Products

Venable LLP published guidance on FTC and FDA substantiation requirements for health product advertising. The article explains that objective advertising claims for dietary supplements, foods, devices, and cosmetics must be supported by a 'reasonable basis' prior to making the claim. Health-related claims and structure/function claims require competent and reliable scientific evidence, with the specific level of evidence depending on the nature of the claim and what experts in the field would consider appropriate.

Astellas Pharma Inc. v. Ascent Pharms., Inc. — District of Delaware Finds ANDA Infringement of Myrbetriq Patents

A Delaware federal court ruled in favor of Astellas Pharma in patent litigation concerning Myrbetriq (mirabegron extended-release tablets) used to treat overactive bladder. The court found that Ascent Pharmaceuticals' ANDA product infringed all asserted claims of the four patents-in-suit and rejected Ascent's defenses of non-infringement, invalidity based on Section 101 patent eligibility, anticipation, obviousness, and judicial estoppel. The court rejected Ascent's argument that its ANDA product's extended-release characteristics differed meaningfully from Myrbetriq.

Ninth Circuit Finds First Amendment Right to Donate to Patient Assistance Charities, With Possible Impact on Anti-Kickback Statute Enforcement

The Ninth Circuit issued a published decision striking down California Assembly Bill 290 (AB 290) in full on First Amendment grounds, finding that Fresenius and other dialysis clinics have a protected constitutional right to donate to patient assistance charities that engage in expressive activity. The court held that donations driven by commercial self-interest remain constitutionally protected when made to expressive associations like the American Kidney Fund. While the case did not directly involve the federal Anti-Kickback Statute, the decision may call into question the constitutionality of AKS enforcement against pharmaceutical manufacturers making analogous donations.

Maine LD 2129 Bars Medical Debt Liens and Wage Seizure

Maine Governor Janet Mills signed LD 2129 into law on April 6, 2026, prohibiting medical debt collectors from placing liens on a consumer's principal residence or garnishing wages. The law also bars courts from enforcing wage garnishment orders based on medical debt and prohibits collection of interest on judgments related to liens or attachments on a debtor's principal residence. The legislation expands Maine's prior medical debt protections enacted under LD 558 in June 2025, which barred medical debt reporting to consumer reporting agencies. The law takes effect 90 days after adjournment of the current legislature's second regular session.

EPA Draft CCL 6 Lists Microplastics and Pharmaceuticals as Priorities for Drinking Water

EPA issued its draft Sixth Contaminant Candidate List (CCL 6) under the Safe Drinking Water Act on April 6, 2026, marking the first time microplastics and pharmaceuticals have been designated as priority contaminant groups for evaluation. The draft list was published with a public comment period closing June 5, 2026. While CCL listing does not itself impose enforceable limits or obligations on water systems, it signals EPA's research and monitoring priorities for the coming decade.

FDA Launches READI-Home Challenge for Home Medical Devices

FDA Launches READI-Home Challenge for Home Medical Devices

Healthcare Digital Accessibility Deadline Is May 11

Holland & Knight LLP summarizes the Section 504 of the Rehabilitation Act of 1973 digital accessibility compliance deadline of May 11, 2026. Healthcare providers receiving federal financial assistance and employing more than 15 persons must ensure their websites, patient portals, telehealth platforms, mobile apps, and other digital health technology meet accessibility standards. HHS Office for Civil Rights enforces Section 504 violations through complaints and compliance reviews, potentially resulting in corrective action plans, penalties, suspension of federal funding, and referrals to the Department of Justice. Private parties may also bring federal court litigation seeking damages for discrimination.

CMS Urges DGA-Aligned Hospital Menus and Procurement Under Conditions of Participation

On March 30, 2026, CMS issued a Quality & Safety Special Alert Memo (QSSAM) to hospitals and Critical Access Hospital (CAH) providers titled 'Hospital Nutrition Service Obligations in Light of Updated Federal Nutrition Guidelines.' CMS links existing hospital Conditions of Participation (CoPs) at 42 C.F.R. § 482.28 to the Dietary Guidelines for Americans, 2025–2030 (DGAs), urging hospitals to review and revise food service policies, standard menus, therapeutic diet orders and food procurement practices to align with DGAs that limit ultra-processed foods and added sugars.

FDA Warning Letter DSCSA Violations at Aesthetics Clinic

The FDA issued a Warning Letter to Pure Indulgence Aesthetics on April 1, 2026, escalating from a December 2025 Form FDA 483 inspection that identified Drug Supply Chain Security Act violations. Key findings include discrepancies between Botox units purchased and administered, and an unlabeled botulinum neurotoxin vial found in the facility's trash. The company's inadequate response to the 483 — lacking concrete corrective actions, SOPs, or verification documentation — led to the Warning Letter escalation.

HIPAA Security Rule Proposed Updates Address Cyber Threats

The HHS Office for Civil Rights published a Proposed Rule on January 6, 2025, to update the HIPAA Security Rule in response to increased cyberattacks targeting ePHI. The proposed changes would eliminate the distinction between 'required' and 'addressable' specifications, mandate written security documentation, require technology asset inventories and network mapping, and impose multi-factor authentication and encryption requirements. The OCR has indicated finalization is expected in May 2026, with compliance likely required within 240 days of Federal Register publication, or early 2027.

DOJ Establishes National Fraud Enforcement Division to Target Healthcare and Taxpayer Programs

Acting Attorney General Todd Blanche issued a memorandum on April 7, 2026, formally establishing the National Fraud Enforcement Division within the DOJ. The Division will investigate and prosecute fraud against taxpayer-funded programs, including coordination with the 93 U.S. Attorney's Offices. Assistant Attorney General Colin McDonald assumed operational control of three existing Criminal Division units: the Tax Section, the Health Care Fraud Unit, and the Market, Government, and Consumer Fraud Unit.

OIG Advisory Opinion 25-11 Provides Discount Arrangement Guidance

OIG Advisory Opinion 25-11 Provides Discount Arrangement Guidance

CMS Proposes 2-4% Medicare Advantage Payment Changes, Risk Adjustment Updates, Audit Focus for 2027

CMS has issued its Advance Notice and related rulemaking for Medicare Advantage (MA) and Part D programs for plan year 2027, projecting a net payment increase of approximately 2% to 4% depending on final rate-setting. The proposals advance revised Hierarchical Condition Categories (HCCs), continue efforts to reduce coding intensity, and expand Risk Adjustment Data Validation (RADV) audits with increased scrutiny of diagnosis reporting and supporting documentation.

OIG Advisory Opinion 25-11 on Medical Product Discount Compliance

Foley & Lardner LLP analyzed OIG Advisory Opinion 25-11, which provides guidance on structuring discount arrangements for medical products under the federal Anti-Kickback Statute. The advisory opinion offers detailed guidance on permissible discount practices and the requirements of the discount safe harbor. The analysis notes that while failure to precisely meet safe harbor requirements does not automatically violate the AKS, such arrangements lose guaranteed protection and become subject to OIG's facts and circumstances analysis.

DOJ Consolidates Health Care Fraud Enforcement Under New Division

The DOJ announced creation of the National Fraud Enforcement Division (NFED) on April 7, 2026, consolidating the Tax Section, Health Care Fraud Unit, and Market, Government, and Consumer Fraud Unit under Assistant Attorney General Colin McDonald. The NFED will coordinate fraud enforcement across federal, state, tribal, and local authorities targeting schemes against taxpayer-funded programs.

DOJ Civil Rights Investigations Target Medical School Admissions

The Department of Justice Civil Rights Division has initiated proactive civil-rights investigations into medical school admissions practices, requesting seven years of applicant-level data and internal communications by April 24, 2026. The investigations focus on potential race discrimination following the Supreme Court's 2023 decision restricting race-conscious admissions. Schools must produce test scores, zip codes, legacy/donor ties, DEI communications, and correspondence with pharmaceutical companies. These actions represent a significant expansion of federal oversight into graduate and professional education, complementing parallel Department of Education reporting initiatives.

FinCEN Advisory Warns Financial Institutions of Healthcare Fraud Targeting Medicare and Medicaid

FinCEN issued an advisory warning financial institutions to heighten scrutiny of transactions tied to healthcare fraud targeting Medicare, Medicaid, and other federal and state healthcare benefit programs. The advisory, coordinated with the FBI and HHS-OIG, identifies fraud schemes involving shell companies, stolen identities, false beneficial ownership, phantom billing, and money laundering through digital assets and real estate. Financial institutions supporting the healthcare industry and healthcare providers are advised to take proactive measures.

FDA's 2026 General Wellness Policy and What It Means for Manufacturers of Wearable Devices

Womble Bond Dickinson analyzes FDA's General Wellness Policy finalized January 6, 2026, which describes FDA's enforcement discretion approach for low-risk products marketed for general wellness purposes. The guidance establishes two key evaluation factors: whether the product's intended use is limited to general wellness, and whether it presents low risk to users and others. The article explains how FDA evaluates wearable devices that estimate physiological measures such as blood pressure, oxygen saturation, and heart rate variability.