Unbiased Analysis of Today's Healthcare Issues
My FTI colleagues Mark Van Ert and Krunal Patel summarize some of the new quality measures that will be incorporated into the 2025 CMS Star Ratings that are used to evaluate Medicare Advantage (MA) plans. The CMS Star Ratings are very important as CMS payments to MA plans is expected to increase by 3.7% or…
Why were drugs not included in Medicare in 1965? And the answer is, because drugs didn’t matter. They were not all that good, and they didn’t do a lot… We now see pharmaceutical care as the heart of treating someone; not so then. Steven Grossman, Executive Director – Alliance for a Stronger FDA It’s amazing…
Medicare drug price negotiation is here. The maximum fair prices (MFP) set by Medicare lead to discounts between 38% and 79%. In fact, the real discounts are larger since the figures listed in the table below are discounts off of 2023 prices (rather than 2024 prices). How did the negotiation process work? CMS’s fact sheet…
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…
Potentially so, argues Adam Fein of Drug Channels. There are two mechanisms for this. First, for drugs not covered in the maximum fair price negotiations, Fein argues that drugs with high list prices and large rebates would lead to more net savings compared to drugs with lower list price and rebates in part because in…
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…
CMS released guidance on IRA price negotiation last week. Below are some highlights regarding how drugs will be selected. Which drugs are eligible for negotiation? For small molecules, drugs have to be (i) FDA-approved, (ii) be FDA-approved at least 7 years ago, and (iii) have no generic equivalent on the market. For biologic molecules, drugs…
The Biden Administration promised more access to Medicare data. Then the reverse happened. ProPublica explains: In January, the Biden administration pledged to increase public access to a wide array of Medicare information to improve health care for America’s most sick and vulnerable. Some Medicare plans’ lack of transparency “deprives researchers and doctors of critical data…
That is the finding from a recent report from the Congressional Budget Office (CBO) on the activities of the Centers for Medicare and Medicaid Innovation (CMMI) CBO previously estimated that CMMI’s activities would reduce net federal spending but now estimates that they increased that spending during the first 10 years of the center’s operation and will…