Unbiased Analysis of Today's Healthcare Issues
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…
Here is the CMS Factsheet and news coverage from NY Times. The companies that make each of these drugs is listed below. Eliquis – Bristol Myers Squibb and Pfizer Jardiance- Boehringer Ingelheim and Eli Lilly Xarelto – Johnson & Johnson Januvia – Merck Farxiga – AstraZeneca Entresto – Novartis Enbrel – Amgen Imbruvica,- AbbVie and…
The U.S. is one of the the few developed nations without a government-run health technology assessment (HTA) body. Or are they? A recent perspective in the New England Journal of Medicine by Peter Neumann and Sean Tunis argues that the Centers for Medicare and Medicaid Services (CMS) already is serving as a de facto HTA…
In the short-run, the answer is likely ‘yes’. As COVID-19 (hopefully) slows and if economic growth remains strong, health care spending will fall as a share of the US economy. At least this is what the Office of the Actuary (OACT) at Centers for Medicare and Medicaid Services (CMS) thinks in their Health Affairs study…
Today at the Academy of Managed Care Pharmacy (AMCP) 2019 Annual Conference, I attended a session titled “Medicare Formulary Updates Impact. How will proposed recent rulemaking affect formulary design? Some answers are below. CMS 2020 draft call letter Improved access to opioid reversal agents. The CMS 2020 draft call letter would place opioid reversal agents…
In December, CMS listed its quality measures that it is considering for incorporation into some of their value-based payment programs and quality reporting programs. However, which Medicare quality reporting and payment initiatives use quality measures? A full list is below. Ambulatory Surgical Center Quality Reporting Program (ASCQR) End-Stage Renal Disease Quality Incentive Program (ESRD QIP)…
That is the conclusion reacted by CMS’ Office of the Actuary. As published in a recent Health Affairs article: Under current law, national health expenditures are projected to grow at an average annual rate of 5.6 percent for 2016–25 and represent 19.9 percent of gross domestic product by 2025. For 2016, national health expenditure growth is anticipated to…