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CMS issues rule modifying the Part D enrollment requirement for prescribers

CMS issues rule modifying the Part D enrollment requirement for prescribers

CMS issues rule modifying the Part D enrollment requirement for prescribers 

On May 1, 2015, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment (IFC) to make changes to the final rule published on May 23, 2014 that requires prescribers of Part D drugs to enroll in or have validly opted out of Medicare. 

CMS issued the May 23, 2014 rule that requires a Part D sponsor to deny (or require its Pharmacy Benefit Manager (PBM) to deny) a pharmacy claim for a Part D drug if the physician or eligible professional who wrote the prescription is neither enrolled in nor opted-out of Medicare as an a crucial program integrity and basic quality assurance protection for Medicare beneficiaries.  We have identified 68,000 prescribers that have been removed from Medicare for reasons such as licensure issues, operational status, or exclusion by the OIG, and we have a responsibility to enforce these protections to beneficiaries as soon as possible without compromising continuity of care or beneficiary access to needed medications. 

Since the publication of the final rule, CMS has learned that certain pharmacists and other provider types who do not meet the statutory definitions of “physician” or “eligible professional” to enroll in Medicare are permitted to prescribe under state laws but without further action by CMS, valid prescriptions from these providers would be denied because the prescriber is neither enrolled in nor opted-out of Medicare. This rule modifies that requirement to allow Part D sponsors to pay for those claims.

In addition, based on analysis of enrollment trends and discussions with stakeholders about their concerns about beneficiary access, CMS has determined that a requirement is needed for Part D sponsors to cover a provisional supply and provide beneficiaries with individualized written notice before denying a Part D claim or beneficiary request for reimbursement on the basis of a prescriber’s Medicare enrollment status. This interim final rule with comment (IFC) will mitigate potential interruptions to beneficiaries’ access to needed medications that could arise in the scenarios described above.

This fact sheet summarizes CMS’ regulatory changes.


  • To prevent unintended interruptions in coverage and potential harm to beneficiaries, this IFC requires that pharmacy claims and beneficiary requests for reimbursement for Medicare Part D prescriptions, written by prescribers other than physicians and eligible professionals who are permitted by state or other applicable law to prescribe medications, not be rejected at the POS by the plan if all other requirements are met.  These prescribers are defined in this IFC as “other authorized prescribers.”
  • In addition, plans must first allow a provisional supply of 3 months (as prescribed by the prescriber and that would otherwise be covered by the plan) when the prescription is written by a prescriber who is eligible to enroll but who is not enrolled in or opted out of Medicare.  The plan must also provide individualized written notice to the beneficiary that the supply is being provided on a provisional basis. The three month provisional fill is intended to give the prescriber time to enroll or the beneficiary time to find a new prescriber.
  • The enrollment requirements in CMS-4159 had an applicability date of June 30, 2015.  CMS later announced that it would not enforce this requirement until December 2015 to allow additional time for Part D prescribers to enroll in or opt-out of Medicare.  Under this IFC, the requirements are now applicable on January 1, 2016.  Prescribers should submit their Medicare enrollment applications as soon as possible. More information is available on the CMS website here.

This IFC also makes certain technical changes designed to clarify existing Part D policy and to improve the readability of certain existing Part D regulations. 

The IFC can be downloaded at:

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