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Prescription Drugs › Final Rules › New Regulations

Groom Law Group, Chartered

CMS Finalizes Updates to the Prescription Creditable Coverage Methodology Determination

Groom Law Group, Chartered on

In April 2025, the Centers for Medicare and Medicaid Services (“CMS”) issued multiple pieces of guidance related to Medicare Part D prescription drug coverage, including the Final CY 2026 Part D Redesign Program Instructions....more

McCarter & English, LLP

Federal Telehealth Update

McCarter & English, LLP on

Congress has extended telehealth flexibilities through its recent federal spending bill, H.R. 1968, titled “Full-Year Continuing Appropriations and Extensions Act, 2025” (the Act). Notably for health care providers, among...more

Hendershot Cowart P.C.

Major Changes to Texas Medical Board Rules: What Healthcare Providers Need to Know

Hendershot Cowart P.C. on

On January 9, 2025, the Texas Medical Board (TMB) implemented comprehensive changes to its rules, marking a significant shift in how medical spas, IV hydration clinics, and other healthcare facilities operate in Texas....more

Husch Blackwell LLP

FDA Bans the Use of Red No. 3 in Food and Ingested Drugs

Husch Blackwell LLP on

On January 16, the U.S. Food and Drug Administration (FDA) announced that it is revoking the authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. The dye is commonly used in...more

DLA Piper

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for...

DLA Piper on

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more

Mintz - Health Care Viewpoints

Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act

Mintz - Health Care Viewpoints on

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more

King & Spalding

CMS Issues Pared-Down Final Rule on Medicare Part D and Medicare Advantage

King & Spalding on

CMS recently issued a Final Rule with respect to the Medicare Part D and Medicare Advantage programs (the “Final Rule”) implementing certain Affordable Care Act provisions. The Final Rule follows a January 10, 2014 Notice of...more

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