Unbiased Analysis of Today's Healthcare Issues
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…
That is the title of my article with Melanie Whittington and Louis Garrison in STAT News. An excerpt is below: The changing landscape of drug pricing policy in the U.S. has implications for the global pace and direction of innovation. Drug policy changes are being influenced by perceptions of the value of novel medicines relative…
To account for differences in disease burden across a Medicare Advantage (MA) plans patient population, uses risk adjustment based on patient disease burden. Specifically, MedPAC notes that: Medicare uses beneficiaries’ characteristics, such as age and prior health conditions, and a risk-adjustment model—the CMS hierarchical condition categories (CMS– HCCs)—to develop a measure of their expected relative…
ISPOR is next week…IRA is a hot topic. Spending on AI vs. the Manhattan Project. Competition and dating apps. Coverage of UnitedHealth cyberattack Good news Friday.
How does Medicare Advantage market share impact skilled nursing facility (SNF) profitability? That is the question asked by Marr and Shen (2024). Using data from Medicare SNF cost reports, LTCFocus.org data, and county MA penetration rates, the authors use an ordinary least squares regression with SNF and year fixed effects examining how MA penetration impacts…
In some exciting news, Bryan Perry has joined FTI Consulting’s Center for Healthcare Economics and Policy. Below is an excerpt from the press release. Washington, D.C., May 1, 2024 — FTI Consulting, Inc. (NYSE: FCN) today announced the appointment of economics and litigation expert Bryan Perry as a Senior Managing Director in the Center for Healthcare Economics and Policy…
In July 2018, FDA released the Biosimilars Action Plan (BAP), which outlined FDA’s approach for expanding access to biosimilars for the American public. The plan focused on 4 key areas: A recent FDA report reviews some of their accomplishments since then. Most of these efforts revolve around guidance documents, additional staff, education products and websites,…
A federal judge says ‘no’. Endpoints reports: A New Jersey federal judge on Monday tossed cases brought by Johnson & Johnson and Bristol Myers Squibb against the Inflation Reduction Act, another victory for the law while Medicare works through the first year of price negotiations with industry. In a summary judgment, Judge Zahid Quraishi ruled…
According to the 2019 NSDUH survey, 27.7 percent of 18-22 year olds who are not enrolled in college full-time and 33.0% of 18-22 year old full-time college students reported binge drinking in the past month. Should society impose stricter restrictions on drugs and alcohol for younger individuals? On the one hand, drugs and alcohol harm…