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Rise in reported US maternal mortality rates largely due to change in measurement ChatGPT 4o and Khan Academy. FDA clinical trial snapshots: 2023. Do some Medicaid beneficiaries even know they are insured? Do PBMs reduce prices?

Risk compensation after COVID-19 vaccination

Could COVID-19 be more efficacious than effective? This could be the case if individuals receiving COVID-19 engaged in ‘risk compensation’. In short, without a COVID-19 vaccine, individuals may have refrained from travel and engaged in social distancing. After a COVID-19 vaccine, these same individuals could have been more likely to travel and less likely to…

CMS Guidance on IRA Price Negotiation: Part 2

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 Guidance on IRA Price Negotiation: Part 1

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…

Risk Adjustment and Incentives for Upcoding in Medicare

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…