Healthcare Compliance

Freund v. Collins Class Settlement for VA Appeals

The U.S. Court of Appeals for Veterans Claims certified Freund v. Collins as a class action on March 18, 2026, and appointed class counsel to represent the certified class. The parties have now filed a proposed classwide settlement agreement for VA benefits claimants whose timely, substantive appeals have not been processed.

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.