Health Care Counsel Blog
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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.
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.
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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.
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Federal regulators are taking a coordinated step to accelerate the responsible integration of digital health technologies into routine care.
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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.
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).
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.
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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.
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.
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Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
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Headlines that Matter for Companies and Executives in Regulated Industries
Earlier this month, the US Department of Health and Human Services (HHS) and US Food and Drug Administration (FDA) announced a nationwide crackdown on direct-to-consumer (DTC) drug advertisements.
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Following nearly two years of litigation, Cigna Health and Life Insurance Company and the named plaintiffs in Hecht v. Cigna Health and Life Insurance Co., Case No. 1:24-cv-05926 (N.D. Ill.) have announced a class action settlement in principle.