Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
Looking Ahead: House to Vote on Compromise Budget Resolution On the heels of the U.S. Senate's passage of a compromise budget resolution, the U.S. House of Representatives is expected to consider the budget resolution on the...more
Mintz’s Pharmacy Benefits and PBM Contracting Practice is pleased to present the ‘Fourth Edition: Q1 2025’ of our Mintz IRA Update, a regular publication that delves into developments of the Inflation Reduction Act of 2022...more
At a public meeting held on January 15, 2025, the Federal Trade Commission (FTC) summarized the Second Interim Staff Report (Second Report) stemming from its investigation into pharmacy benefit managers (PBMs) and their...more
On November 26, 2024, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year 2026 proposed rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”),...more
Heading into the new year, a Trump-Vance administration will control the White House and the Republicans will hold a narrow majority in both the House and Senate. This control trifecta is likely to impact both legislative and...more
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more
A bipartisan group of attorneys general from 31 states and the District of Columbia filed an amicus brief in support of a petition for certiorari by Oklahoma’s insurance commissioner to review a decision by the U.S....more
The Centers for Medicare & Medicaid Services (CMS) updated its guidance on the Inflation Reduction Act of 2022’s (P.L. 117-169) (IRA) Medicare Prescription Payment Plan (M3P) with its release of the Final Part Two Guidance on...more
Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...more
The price of prescription drugs has brought scrutiny to the entire drug supply chain. Congress and other policymakers continue to seek opportunities to lower costs for patients and the federal government. Pharmacy benefit...more
August 31, 2023 – When it comes to prescription drug costs, policymakers have set their focus on the consumer: “Let’s lower drug prices for the consumer.” “Let’s give consumers more options in paying their out-of-pocket...more
On August 15, 2023, the U.S. Court of Appeals for the Tenth Circuit issued an opinion in Pharmaceutical Care Management Association v. Glen Mulready, in his official capacity as Insurance Commissioner of Oklahoma, Oklahoma...more
While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...more
The U.S. Court of Appeals for the 10th Circuit issued a sweeping decision that (1) maintains long-standing federal protections for employer and union-sponsored health plans to design their health benefit plans, including...more
The US Court of Appeals for the Tenth Circuit recently held in Pharmaceutical Care Management Association (PCMA) v. Mulready that the Employee Retirement Income Security Act (ERISA) and Medicare Part D preempted several...more
Despite a busy 2022, drug pricing remains a hot topic at the federal and state levels, with a number of recent developments and trends worth monitoring heading into 2023. In the past year, the FTC increasingly focused on the...more
Key Points - Patient outcomes studies suggest a clinical benefit of co-pay programs, and a negative impact of co-pay accumulator programs. Co-pay programs remain unavailable to participants in federal...more
Hogan Lovells has teamed up with Demy-Colton to host a special three-part webinar series focused on U.S. market access for life sciences firms, providing companies that are new to the U.S. market, or looking to launch in the...more
Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...more
With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway. What should...more
In November 2020, the Department of Health and Human Services (HHS) finalized a regulation aimed at lowering prescription drug prices and out-of-pocket spending for prescription drugs by excluding rebates on prescription...more
The Trump Administration recently announced two final rules that implement policy objectives to lower drug prices by tying certain Medicare Part B payments to prices paid by other countries and by replacing an anti-kickback...more
On 20 November 2020, the United States Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released its final rule on drug rebates entitled “Removal Of Safe Harbor Protection For Rebates...more
On November 20, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued a Final Rule to finalize a February 6, 2019 proposal stripping rebates received from drug manufacturers by...more