When Congress adopted the Inflation Reduction Act (IRA) in 2022, creating the Medicare Drug Price Negotiation Program (MDPNP), the bill did not receive support from any Republican senators....more
On July 31, the Centers for Medicare and Medicaid Services (“CMS”) published its mammoth proposed rule entitled “Medicare and Medicaid Programs: Calendar Year 2025 Payment Policies under the Physician Fee Schedule and Other...more
8/16/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Prescription Drugs ,
Price Inflation ,
Rebates ,
Section 340B
On October 18, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) to conduct market research regarding the “availability and potential technical ability of health-care related...more
On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the ten (10) Medicare Part D drugs selected for the first round of negotiations of the Medicare Drug Price Negotiation Program (Program)—a few...more
In July, the Centers for Medicare & Medicaid Services made significant headway in its implementation of the drug pricing provisions of the Inflation Reduction Act (IRA).
How can stakeholders respond to, implement, and comply...more
On June 2, 2023, the Centers for Medicare & Medicaid Services (CMS) issued instructions for the process by which a manufacturer may submit a request for a qualifying single-source drug to be considered for the Small Biotech...more
On May 12, 2023, the Centers for Medicare & Medicaid Services (CMS) issued Draft Guidance on the Part D Manufacturer Discount Program (“Discount Program”)—a key component of the Part D Redesign provisions of the Inflation...more
The Inflation Reduction Act (IRA), signed into law in August 2022, included significant and controversial drug-pricing provisions.
What key compliance issues must industry stakeholders consider as these provisions are put...more
On April 18, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an Information Collection Request (ICR) addressing the “Drug Price Negotiation Process” for the Medicare Drug Price Negotiation Program, including...more
IRA Provision: The Medicare Drug Price Negotiation Program -
The Centers for Medicare & Medicaid Services (CMS) issued a fact sheet and initial guidance for the implementation of the Medicare Drug Price Negotiation...more
IRA Provision: The Medicare Prescription Drug Inflation Rebate Program -
The Centers for Medicare & Medicaid Services (CMS) issued a fact sheet and a list of 27 Part B “rebatable drugs”...more
On February 9, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued a fact sheet and its initial guidance documents addressing the Medicare Prescription Drug Inflation Rebate Program for Medicare Parts B and D...more
On January 23, 2023, CMS published in the Federal Register its first proposed rulemaking to implement the Medicare Drug Price Negotiation Program (the “Negotiation Program”), which is included in the Inflation Reduction Act...more
On August 16, 2022, President Biden signed into federal law the Inflation Reduction Act (IRA), which, among other priorities for the Biden administration, addresses prescription drug costs and drug prices in the Medicare...more