Insights on Health Care

Last month, a federal court in Maine halted the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) 340B Rebate Model Pilot Program in its tracks — a mere four days before it was to go into effect.

As we approach the end of the first year of the second Trump Administration, many in the health care sector continue to closely watch federal enforcement trends to identify government priorities going forward.

For the past several years, the use of contract sales forces by pharmaceutical and device manufacturers and other suppliers has been under a heightened enforcement spotlight.

The California Department of Public Health (CDPH) denied two petitions to amend the hospital licensing regulations in Title 22 of the California Code of Regulations to allow advanced practice providers to be members of organized medical staffs in general acute care hospitals.

On December 18, President Trump issued an executive order (EO) directing the Attorney General to complete rulemaking to reschedule “marijuana” from Schedule I to Schedule III under the Controlled Substances Act (CSA) and to expand federal research and policy development on medical marijuana and hemp derived cannabinoids.

The Centers for Medicare & Medicaid Services (CMS) Innovation Center has announced the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, a 10‑year voluntary payment model that introduces outcome‑aligned payments (OAPs) to expand access to technology‑supported care for Medicare beneficiaries with common chronic conditions.

The past year has been unusually active on the health care antitrust front. Providers are pressing price-fixing and information-exchange theories against payers and claims intermediaries and a landmark class settlement moving into its implementation phase.

Headlines that Matter for Companies and Executives in Regulated Industries

Public-facing debates over pharmaceutical drugs and life sciences products are as pronounced as ever. Although the ongoing scuffle over Tylenol has received the most attention, similar controversies abound. Just last month, Aurinia Pharmaceuticals filed a defamation complaint against a now-resigned US Food and Drug Administration (FDA) official over critical statements made about one of its drugs.

In recent months, three federal courts have refused to enforce expansive US Department of Justice (DOJ) administrative subpoenas issued to providers of gender-affirming care, concluding the subpoenas were issued for an improper purpose or exceeded the government’s statutory authority. These rulings are significant.

On December 12, the Eleventh Circuit heard the much-anticipated oral arguments in United States ex rel. Zafirov v. Florida Medical Associates LLC concerning the constitutionality of the False Claims Act’s (FCA) qui tam provisions.

Headlines that Matter for Companies and Executives in Regulated Industries

Federal regulators are taking a coordinated step to accelerate the responsible integration of digital health technologies into routine care.

Headlines that Matter for Companies and Executives in Regulated Industries

Judge Kathryn Kimball Mizelle’s ground-breaking decision in Zafirov v. Florida Medical Associates LLC and Justice Clarence Thomas’ solo dissent in US ex rel. Polansky v. Executive Health Resources Inc. have revived what many had viewed as a settled constitutional question.

A putative class action against Whoop, the wearable technology company, uses the US Food and Drug Administration’s (FDA) July 2025 warning letter regarding its new blood pressure product feature as a litigation springboard. The case shows how misalignment with regulators’ expectations can quickly cascade from agency scrutiny to consumer litigation.

Partner Hillary Stemple was featured in an article discussing a recent HHS Office of Civil Rights settlement resolving allegations related to the use of photos and other protected health information (PHI) in health care provider marketing materials without patient authorization in violation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.

On November 21, the Centers for Medicare & Medicaid Services (CMS) issued a final rule announcing changes for Medicare payments for hospital outpatient services under the Hospital Outpatient Prospective Payment System (HOPPS).

Generally, the Employee Retirement Income Security Act of 1974 (ERISA) prohibits discrimination based on a plan participant’s health status-related factor, such as a medical condition, medical history, or genetic information.

After issuing the Physician Fee Schedule (PFS) on October 31, the Centers for Medicare & Medicaid Services (CMS) has now published templates for manufacturers to utilize when complying with new requirements regarding the submission of reasonable assumptions related to their average sales price (ASP) calculations. CMS also mandates that manufacturers submit Bona Fide Service Fee (BFSF) certification or warranty letters for new or renewal contracts dated January 1, 2026, or later that contain BFSFs with quarterly ASP.

Headlines that Matter for Companies and Executives in Regulated Industries

Headlines that Matter for Companies and Executives in Regulated Industries

On October 31, the Centers for Medicare & Medicaid Services (CMS) issued a final rule announcing changes for Medicare payments under the Physician Fee Schedule (PFS), effective on or after January 1, 2026.

Health Care Practice Leader Douglas Grimm was quoted in a recent article discussing the rising popularity of joint operating agreements (JOAs) among health systems facing industry pressures.

The US Food and Drug Administration (FDA) regulates the products hospitals and health systems use, make, or study. As health system innovations increasingly leap quickly across service lines, regulatory obligations can shift in real time.