RIN 0938–AT92. Modernizing Part D and Medicare Advantage To Lower Drug Prices and Reduce Outof-Pocket Expenses. 83 Federal Register 231 (November 30, 2018) (“Proposed Rule”)
Dear Administrator Verma:
On behalf of the Regulatory Relief Coalition (the “Coalition”), we are writing to urge CMS to refrain
from finalizing those provisions of the Proposed Rule that would authorize Medicare Advantage
Organizations (MAOs) to institute step therapy restrictions (“Fail First Coverage Restrictions”) on access
to Part B drugs and biologicals and to expand the use of Fail First Coverage Restrictions for Part D
“protected class” drugs and biologicals.
The Regulatory Relief Coalition is a group of ten major professional organizations focused on
maintaining Medicare patient access to medically necessary services, through the reduction in
administrative burdens, including Prior Authorization (PA), that divert physician focus away from patient
care. Extensive use of PA by MAOs is creating significant barriers to access for MA enrollees and, for
this reason, over the past year and a half, the Coalition has urged CMS to increase its oversight of MAOs’
use of PA to conduct pre-service reviews. Our request for additional oversight of, and the issuance of
guidance to, MAOs has been echoed by virtually every medical specialty association, almost 50 patient
organizations, and over 100 members of Congress on both sides of the aisle. We are greatly concerned
that instead of responding to those calls for oversight and guidance, CMS issued the Proposed Rule
expanding the authority of MAOs to institute pre-service denials, using Fail First Coverage Restrictions.
Fail First Coverage Restrictions are essentially PA on steroids: Rather than conducting pre-service
reviews and denying coverage for physician’s prescribed services after review by a MAO physician, Fail
First Coverage Restrictions categorically deny coverage for a drug prescribed by a contracted physician
unless and until other “preferred” or less costly drug(s) are tried first. Fail First Coverage Restrictions
differ from other PA coverage restrictions only insofar as authorization is categorically denied in the first
instance.
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