Overview
This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2026, including three favorable Office of Inspector General (OIG) advisory opinions and the US Department of Health and Human Services’ (HHS’s) final rule adopting standards for healthcare claims attachments and electronic signatures. We also discuss the US Department of Justice’s (DOJ’s) recent antitrust suit against hospital systems; HHS and the Centers for Medicare & Medicaid Services’ (CMS’s) announcement of a new Healthcare Advisory Committee; and Florida’s implementation of a parallel Medicaid durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) enrollment moratorium after CMS’s nationwide Medicare moratorium. This issue also covers recent enforcement activity involving antitrust actions, the False Claims Act (FCA), and suits involving the Health Resources and Services Administration (HRSA) and the US Food and Drug Administration (FDA).
Read below for an overview of this month’s regulatory and enforcement activity roundup. For a deeper dive, subscribe to the newsletter to get our detailed analysis of all updates.
Click each heading below for a sneak peek of related content.
Notable enforcement resolutions and activities
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.
CMS regulatory updates
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 updates
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.
Other notable developments
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.
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Ashley Anumba, a law clerk in the New York office, also contributed to this newsletter.