The CMS rule the establishes a new coverage pathway – MCIT – for breakthrough medical technologies.
Category Archives: Advocacy and Regulations
BIO Leads Group Challenging Administration’s “Most Favored Nation” Rule
On December 4, 2020, 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.Continue reading
What Comes Next as Election Week Draws to a Close
The 2020 Election Cycle has been historic and unique in many ways. As the sun rises on the 6th day after Election Day, here are some updates and resources to help you stay in the loop on what comes next.Continue reading
BIO’s Dr. Michelle McMurry-Heath Congratulates President-Elect Biden & Other Newly Elected Leaders of Both Parties Who Won
Statement from Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization (BIO)Continue reading
AdvaMed Issues MedTech Compliance Guidance For COVID-19 Response
WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) today announced availability of a newly created “Code of Ethics Compliance Guidance Related to the COVID-19 Response.”
“This guidance seeks to help AdvaMed members and other medical technology companies develop and implement processes that both support rapid decision-making in the context of the pandemic and mitigate any related compliance risks,” said Christopher L. White, AdvaMed COVID action team leader, chief operating officer and general counsel.Continue reading
House Members Ask CMS to Expand Home Infusion Services
On April 13, 2020, U.S. Representatives Eliot L. Engel (NY-16) and Fred Upton (MI-06), top Members of the Energy and Commerce Committee, led a bipartisan group of 181 House Members, including Arizona Representatives Andy Biggs, Ruben Gallego, Raul Grijalva, and Tom O’Halleran, in urging the Trump Administration to temporarily allow seniors to receive lifesaving drug infusions in their homes to prevent unnecessary trips to hospitals, which could potentially expose them to COVID-19.
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Becoming Part of the Process
The 2020 Arizona Legislative Session is in full swing. Take a look at what it can mean to you.Continue reading
Washington Watch – H.R. 3 and Last Minute USMCA Change Deliver 1-2 Punch on Life Science Innovation
Life Science leaders say two actions this week in Washington D.C. threaten to put life science innovation up against the ropes. Continue reading
State Biotech Associations Warn Part D Redesign Puts New Treatments for Patients at Risk
In a letter to Chairman Grassley (R-IA) and Ranking Member Wyden (D-OR), the leaders of the Senate Finance Committee, state biotech associations warn that the Committee’s proposed redesign of Medicare Part D puts new, innovative treatments for patients at risk.
Follow The Pill
Today, much of the public debate surrounding the cost of biopharmaceuticals is focused on the list price of an individual drug or treatment regimen. However, the list price is not what a manufacturer generally makes on the drug, and it typically has little to do with what a patient has to pay for his or her medicine. To help put this debate into context, here is a new educational video that helps explain how prescription drug costs are really determined and where the pharmaceutical dollar actually goes.Continue reading