Healthcare Regulatory Check-Up Newsletter | March 2026 Recap

MEDICAL DEVICE COMPANY ENTERS DEFERRED PROSECUTION AGREEMENT

A medical device company entered into a three-year deferred prosecution agreement, and its former chief regulatory officer pleaded guilty, in connection with failing to file adverse event reports with the intent to defraud and mislead the FDA.

DOJ FILES ANTITRUST SUIT AGAINST HOSPITAL SYSTEM

DOJ filed suit against a New York-based hospital system, alleging that the system imposed anticompetitive contractual restrictions that limited insurers’ and employers’ ability to offer lower-cost health plan options.

HRSA BLOCKED FROM REINSTATING PRE-PANDEMIC 340B POLICY

The US District Court for the District of Columbia ruled that HRSA improperly reinstated a pre-pandemic policy requiring 340B child sites to register to access discounted drugs, finding that the agency imposed an extra-statutory eligibility condition without proper rulemaking or rulemaking authority.

HHS FINALIZES STANDARDS FOR HEALTHCARE CLAIMS ATTACHMENTS, ELECTRONIC SIGNATURES

On March 24, 2026, HHS issued a final rule adopting standards for electronic healthcare claims attachment transactions and electronic signatures (CMS-0053-F), implementing HIPAA administrative simplification requirements.

OIG ISSUES FAVORABLE ADVISORY OPINION ON SOFTWARE-CONTINGENT DISCOUNTS FOR CATARACT SURGERY SUPPLIES

On March 4, 2026, OIG issued Advisory Opinion 26-03, a favorable opinion analyzing a proposed bundled discount arrangement involving different customers with common ownership.

OIG ISSUES FAVORABLE ADVISORY OPINION ON ASC OWNERSHIP TRANSFERS IN CONNECTION WITH RETIREMENT SUCCESSION PLANNING

On March 4, 2026, OIG issued Advisory Opinion 26-04, a favorable opinion analyzing a proposed transfer of physician ownership interests in a Medicare-certified ASC in connection with retirement.

OIG ISSUES FAVORABLE ADVISORY OPINION ON COST-SHARING SUBSIDIES FOR DEVICE CLINICAL TRIAL PARTICIPANTS

On March 11, 2026, OIG issued Advisory Opinion 26-05, a favorable opinion analyzing a medical device company’s proposal to subsidize certain cost-sharing obligations for federal healthcare program beneficiaries in a clinical trial.

OIG ANNOUNCES WORK PLAN AUDIT OF CCM PAYMENTS

On March 16, 2026, OIG added a new Work Plan item, announcing an audit of Medicare Part B payments for chronic care management (CCM) services.

FLORIDA FOLLOWS CMS WITH MEDICAID DMEPOS ENROLLMENT MORATORIUM

After CMS imposed a six-month nationwide freeze effective February 27, 2026, on new Medicare enrollment by DMEPOS companies, Florida announced a parallel six-month halt on enrollment of new durable medical equipment providers in the Florida Medicaid program.

HHS, CMS ANNOUNCE MEMBERS OF NEW HEALTHCARE ADVISORY COMMITTEE

On March 27, 2026, HHS and CMS announced the members of a new Healthcare Advisory Committee that will provide non-binding advice to HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz on care delivery and financing issues across Medicare, Medicaid, CHIP, and the Health Insurance Marketplace. HHS said the committee was selected through a competitive process that drew more than 400 nominations nationwide.