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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.
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