Will IRA increase CMS drug spending?

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…

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…