The Saga Continues: CMS Further Delays Enforcement Of Medicare Enrollment Requirements For Prescribers Of Part D Drugs

The Centers for Medicare & Medicaid Services (CMS) on June 1, 2015, published its "Medicare Part D Prescriber Enrollment Requirement Update" (Update). The Update further delays—until June 1, 2016—enforcement of the regulatory requirement that health care professionals eligible to enroll in the Medicare Program (referred to herein as eligible to be a Medicare Prescriber) either enroll or opt out in order for drugs they prescribe to be covered under Medicare Part D. Besides providing additional time for prescribers to comply with the enrollment requirement, the Update also provides guidance for Part D Plan Sponsors (Sponsors), their pharmacy benefit managers (PBMs), and contracted pharmacies concerning how to alert prescribers to the enrollment requirement. The Update also explains Sponsors' obligations to verify that Part D claims contain an active and valid prescriber National Provider Identifier (NPI), as well as to issue notices to affected members.

Prescriber Enrollment Requirement Finalized in May 2014 Final Rule and Modified by the Interim Final Rule

In May 2014, CMS promulgated a final rule finalizing the requirement that Sponsors reject (or direct their PBMs to reject) a pharmacy claim or member reimbursement request for a Part D drug if (i) the claim does not contain the prescriber's active and valid NPI, or (ii) the physician or eligible professional, as the terms are defined in the Social Security Act, is neither enrolled in Medicare nor has a valid opt-out affidavit on file.

On May 6, 2015, CMS published an interim final rule with comment period (Interim Rule) requiring prescribers of Part D drugs to become Medicare Prescribers by January 1, 2016. The Interim Rule excepted prescribers who are not eligible to become Medicare Prescribers (referred to as "Other Authorized Prescribers," such as pharmacists), from the enrollment requirement, as long as their actions are otherwise consistent with applicable law. To protect Medicare beneficiaries' access to medications, CMS also announced the requirement that Sponsors (and their PBMs) provide members with a one-time, three-month "provisional supply" (Provisional Supply) of a medication prescribed by an individual who is eligible to become, but has not yet become, a Medicare Prescriber.

For a detailed analysis of the May 2014 Rule and the Interim Rule, please refer to our previously issued On the Subject, CMS Issues Interim Final Rule Reaffirming Requirements for Prescribers of Part D...