Unbiased Analysis of Today's Healthcare Issues
In May 2025, CMS’s Center for Medicare & Medicaid Innovation (CMMI) unveiled it’s “Make America Healthy Again” vision. CMMI models focus on not only “protecting the federal taxpayer,” but also (i) promoting evidence-based prevention, (ii) empowering people to achieve their health goals, and (iii) driving choice and competition for people. CMMI has introduced a number…
That is the question asked in a recent Health Affairs Forefront article by Peter Neumann, Josh Cohen, Sean Sullivan and Feng Xie. They compare the CMS negotiated prices for Initial Price Applicability Year (IPAY) 2027 against value-based prices (using QALYs) from the Tufts Cost-Effectiveness Analysis (CEA) Registry. The authors found that cost-effectiveness estimates varied among…
That is the title of my article out today in The Evidence Base. Here is an excerpt: The Centers for Medicare and Medicaid Services (CMS) are now setting drug prices under the Medicare Drug Price Negotiation program. Unlike other health technology assessment (HTA) bodies worldwide, however, CMS will not consider quality-adjusted life years (QALYs) when setting drug…
Some hints–and only hints–were provided in a CMS press release on Wednesday. Lowering the cost of prescription drugs for Americans is a top priority of President Trump and his Administration. In accordance with the statutory requirements of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services (CMS) released the list of 15 drugs…
At the end of last year, CMS finalized a rate cut for Medicare reimbursement to physicians. The CMS Fact Sheet states: …average payment rates under the PFS [Physician Fee Schedule] will be reduced by 2.93% in CY 2025, compared to the average amount these services were paid for most of CY 2024 This sounds like…
That is the title of an interesting panel from USC Schaeffer Center on Coverage with Evidence Development (CED). It includes an interview with Tamara Syrek Jensen, Director, of the Coverage & Analysis Group within the Centers for Medicare & Medicaid Services. After the interview, there is a panel discussion of academics with Darius Lakdawalla of…
Recently, the Inflation Reduction Act (IRA) is getting a lot of attention, particularly for its provision that allows CMS to start drug price negotiation for selected drugs 9 (small molecules) or 13 (biologics) years after drug launch. However, the Centers for Medicare and Medicaid Innovation (CMMI) has proposed a number of a number of payment…
See my previous posts on IRA price negotiation on drug selection (Part 1) and manufacturer data submission (Part 2). Today we will talk about the negotiation process and how CMS will set the maximum fair price (MFP) How will CMS price across dosages? “CMS will base the single price on the cost of the selected…
What data do drug manufacturers need to submit to CMS as part of the IRA price negotiation? What data elements can they electively submit? The recent CMS guidance released May 3, 2024 outlines these elements. What mandatory data are manufacturers required to submit? On the mandatory side, drug manufacturers are required to provide CMS with…
One approach CMS has is the Cell and Gene Therapy (CGT) Access Model. Under the CGT Access Model, CMS (at the federal level) will negotiates outcomes based agreements (OBAs) with manufacturers, which will include pricing terms and outcomes to be evaluated. Then states can elect to participate in the contract terms negotiated by CMS or…