BIO to Issue Legal Challenge to Most Favored Nation Rule

December 4, 2020

A letter written by BIO’s president and CEO Michelle McMurry-Heath dated December 4, 2020. 

Dear BIO Members,

Today BIO, together with California Life Sciences Association (CLSA) and BIOCOM California, will announce our plan to challenge the Department of Health and Human Services’ (HHS) attempt, during the final days of the Trump Administration, to implement for the first time ever a “Most Favored Nation” reimbursement policy for certain drugs administered by Medicare Part B providers – drastically altering this system in ways that will harm their ability to serve America’s most vulnerable senior citizens.

I want you to know that we are determined to protect the critical and necessary biotech infrastructure that drives medical innovation. As the president’s own team of economic advisors has indicated, not only will this rule have profound effects on patients’ ability to access important and life-saving medications, it will also dramatically hinder the operational capacity of America’s vibrant biotech companies – particularly smaller operations spearheading cutting-edge biomedical research.

There are several arguments outlined in the complaint, including HHS’ attempt to implement this plan without prior notice or opportunity for public comment, and it’s acknowledgment, in its own rule, that it cannot estimate the impact it will have on patients and providers. The complaint also argues that HHS lacks the authority to make sweeping changes to statutory Medicare rules through administrative fiat.

As a valuable member of BIO, I want to thank you for your support as we defend against counterproductive policies that hinder progress for biomedical breakthroughs. Once we file the complaint, it will appear on our website along with my full statement later today.

Sincerely,

Michelle McMurry-Heath, MD, PhD
President and CEO
Biotechnology Innovation Organization (BIO)