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
On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative dispute resolution (ADR) process...more
On April 2, 2024, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Notice of Benefit and Payment Parameters (NBPP) final rule (Final Rule), finalizing policies applicable to qualified health plans offered...more
On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s motion for summary judgment and vacating (i.e.,...more
On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s motion for summary judgment and vacating (i.e.,...more
Last week, the Centers for Medicare & Medicaid Services (CMS) issued Manufacture Release 116, available here, which provides technical guidance to manufacturers on the multiple best prices (BPs) reporting option for...more
On 18 April 2019 the Centers for Medicare & Medicaid Services (CMS) released the Notice of Benefit and Payment Parameters final rule for 2020 (2020 Payment Notice) applicable to qualified health plans (QHPs) offered on health...more
Yesterday, the Health Resources and Services Administration (HRSA) issued a Final Rule (Final Rule) that accelerates the effective and implementation date of the 340B Ceiling Price and Civil Monetary Penalties final rule...more
The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more
1/9/2017
/ Affordable Care Act ,
Civil Monetary Penalty ,
Covered Entities ,
Drug Pricing ,
Final Rules ,
Healthcare ,
HRSA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B ,
Trump Administration