Clouds Over the Capitol

TRIPS Waiver, MCIT, HR3.  If you are not familiar with these policy developments, you probably should be.

The United States medtech and biotech industries make a tremendous impact on people’s lives.   When policy makers and Federal Agencies work together, the impact is made even greater.  However, some policy decisions can have the opposite effect.

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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

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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