While audits are part of doing business in the ordinary course, businesses are generally less than eager to open the books. And the same is true when it comes to the 340B Drug Pricing Program. Audits are now making the list...more
Through its passage, the Inflation Reduction Act (IRA) ushered in several reforms directed at rising prescription drug costs, aiming to lower costs for Medicare enrollees and reduce spending by the federal government....more
In what can only be characterized as a necessary but significant proposed departure from current political initiatives focused on lowering pharmaceutical drug prices, the Centers for Medicare & Medicaid Services (CMS)...more
Medicare Part B enrollees as of July 1, 2024 will experience savings on coinsurance for 64 drugs selected by the Biden administration. Pursuant to the Inflation Reduction Act and its Medicare Prescription Drug Inflation...more
Pharmaceutical drug pricing and reimbursement continues to make headlines nationwide. In a recent development, Maryland’s Prescription Drug Affordability Board (PDAB) finalized its list of selected drugs for affordability...more
In what is being touted as a significant win for pharmaceutical drug manufacturers, the DC Circuit affirmed on May 21, 2024 that Section 340B of the Public Health Service Act does not categorically prohibit manufacturers from...more
The Centers for Medicare & Medicaid Services on May 3, 2024, released its draft guidance on administration of the Medicare Drug Price Negotiation Program for initial price applicability year 2027. The program—established by...more
At a time when pharmaceutical drug prices are at the height of political scrutiny, manufacturers can breathe a small sigh of relief as the Centers for Medicare and Medicaid Services (CMS) announced on May 15, 2024 that it...more
2024 is shaping up to be a big year for prescription drug affordability boards (PDABs). Like state price transparency reporting laws, state legislation establishing PDABs continues expansion. In response to rising...more
Effective April 1, 2024, California will expand its existing prescription drug price transparency requirements by enacting legislation to amend and clarify requirements on wholesale acquisition cost increase reporting and...more
The US District Court of Delaware recently ruled against AstraZeneca in its case challenging the constitutionality of Medicare’s new Drug Price Negotiation Program (the Program). The court, in granting the federal...more