CMS Delays Medicare Part D Prescriber Enrollment Requirements until 2019

CMS has just announced that it will delay all enforcement of its Medicare Part D prescriber enrollment regulations until January 1, 2019. This requirement, finalized in the May 23, 2014 Medicare Advantage and Part D Final Rule, would only allow Medicare-enrolled providers, or those providers granted a valid opt-out affidavit issued by a Medicare Part A or B MAC, to prescribe a covered drug reimbursable under Medicare Part D.  View Holland & Knight’s original e-alert on the May 23, 2014 Final Rule.

While the Part D prescriber enrollment requirement has been codified at 42 C.F.R. § 423.120(c)(6), CMS has delayed enforcement of mandatory Part D prescriber enrollment no less than 4 times. On November 1, 2016, CMS announced a “phased approach” for Part D prescriber enrollment up until January 1, 2019, at which point the prescriber enrollment requirement would be fully enforced. CMS cited the need to minimize impact on beneficiaries and to align enforcement of prescriber enrollment requirements with other CMS initiatives. However, CMS never issued additional guidance on what this phased approach would require, and has since announced that it no longer intends to implement a phased approach for Part D prescriber enrollment before January 1, 2019.

While Part D prescriber enrollment is not yet required for reimbursement under Part D, CMS continues to encourage voluntary prescriber enrollment in Medicare now. We will keep monitoring CMS guidance for any additional guidance on this requirement, or notice of further delays.