BIO Leads Group Challenging Administration’s “Most Favored Nation” Rule

The Biotechnology Innovation Organization (BIO), the California Life Sciences Association (CLSA), and BIOCOM California today filed a challenge against 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.

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 acknowledgement, 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. 

Dr. Michelle McMurry-Heath, BIO president and CEO, made the following comments after the complaint was filed:

“We have made clear our intentions to use all tools at our disposal to fight this legally suspect and operationally unworkable policy. Today we are following through on that promise.

“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.

“BIO will continue to fight against policies that threaten future medical innovation and the health and wellbeing of our most vulnerable Americans.”

You can read the complaint here. 

You can read the preliminary injunction here.