On October 31, 2025, the Centers for Medicare & Medicaid Services (CMS) issued the physician fee schedule (PFS) final rule for calendar year (CY) 2026 (Final Rule). It has been several years since this annual rulemaking...more
11/6/2025
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Drug Pricing ,
Final Rules ,
Health Care Providers ,
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Healthcare ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Physician Fee Schedule ,
Reporting Requirements
On September 30, 2025, the Centers for Medicare & Medicaid Services (CMS) issued final guidance (Final Guidance) for initial price applicability year (IPAY) 2028 of the Inflation Reduction Act (IRA) Drug Price Negotiation...more
10/7/2025
/ Biologics ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs
In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
8/25/2025
/ Artificial Intelligence ,
Clinical Trials ,
Cybersecurity ,
Digital Health ,
Environmental Social & Governance (ESG) ,
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Government Agencies ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Supply Chain ,
Trump Administration
On May 12, 2025, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2028 of the Drug Price Negotiation Program (DPNP) established by the Inflation Reduction...more
On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program....more
The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more
On February 16, 2024, the U.S. District Court for the District of Oregon issued a ruling in Pharmaceutical Research and Manufacturers of America (PhRMA) v. Stolfi, granting in part PhRMA’s motion for summary judgment in its...more