The Centers for Medicare & Medicaid Services (CMS) on May 6, 2015, published an interim final rule with comment period (Interim Rule) modifying the regulatory requirement that health care professionals enroll in or opt out of Medicare in order for drugs they prescribe to be covered under Medicare Part D. Part D Plan Sponsors (Sponsors), their pharmacy benefit managers (PBMs) and contracted pharmacies, and individuals that prescribe drugs to Medicare beneficiaries all are affected by the changes implemented under the Interim Rule, which apply beginning January 1, 2016.

Comments on the Interim Rule are due to CMS by July 6, 2015.

Prescriber Enrollment Requirement Finalized in May 2014 Final Rule

In May 2014, CMS promulgated the first of two final rules (May 2014 Rule) finalizing provisions proposed in January 2014. Among them was the requirement that Sponsors reject (or direct their PBMs to reject) a pharmacy claim or member reimbursement request for a Part D drug if (1) the claim does not contain the prescriber’s active and valid National Provider Identifier (NPI), or (2) 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.

This requirement has generated significant attention and push-back, particularly among health care professionals, such as dentists, that may prescribe drugs eligible for coverage under Part D but typically do not themselves furnish services coverable under Medicare Parts A or B and therefore may have elected not to enroll (or to opt out of enrolling) in the Medicare Program. There also has been discussion and concern regarding the number of health care professionals affected by this requirement who have not yet enrolled or affirmatively opted out of enrolling. For example, CMS already has delayed once enforcement of the requirement to reject affected claims in order to give health care professionals more time to submit their enrollment applications or opt-out affidavits.

Interim Rule Requires Provisional Supply and Other Member Protections

CMS holds course under the Interim Rule, requiring prescribers who are eligible to enroll in the Medicare Program either to enroll or to opt out (hereinafter, become a Medicare Prescriber) and to do so by January 1, 2016. Professionals who are able to prescribe medications but are not eligible to become Medicare Prescribers, such as pharmacists, however, now are excepted from this requirement and may continue to prescribe Part D drugs as long as their actions otherwise are consistent with applicable law. To protect Medicare beneficiaries’ access to medications, CMS via the Interim Rule now is requiring Sponsors (and their PBMs) to 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.

Medicare Program Enrollment Exception

The Interim Rule creates an exception to the enrollment requirement for health care professionals, other than physicians or eligible professionals as such terms are defined in the Social Security Act, who are authorized under applicable law to prescribe drugs but are not eligible to enroll in Medicare—so-called “other authorized prescribers.” Sponsors are not required to reject claims or member requests for reimbursement for prescriptions written by an “other authorized prescriber” solely because such prescriber is not a Medicare Prescriber; other requirements continue to apply, however, including the requirement for the claim form to include the prescriber’s active and valid NPI.

Practical Considerations: Although the Interim Rule provides relief for pharmacists and select other professionals who may prescribe drugs consistent with applicable law, the Interim Rule does not provide relief for dentists, medical students, interns or other practitioners who are eligible to become Medicare Prescribers. Such practitioners remain subject to the enrollment/opt-out requirement, and their patients may be negatively affected if these practitioners do not become Medicare Prescribers by January 1, 2016.

Dispensing a Provisional Supply

With respect to prescriptions written by prescribers who are eligible to become, but are not yet, Medicare Prescribers, Sponsors must cover a one-time, three-month Provisional Supply of the prescribed medication. After the Provisional Supply has been dispensed, the Sponsor must reject future claims (and future requests for reimbursement) for the same member for the same drug prescribed by the same prescriber as long as the prescriber remains eligible to be, but is not, a Medicare Prescriber. CMS is specific to describe the Provisional Supply as a three-month maximum supply, regardless of how the supply is dispensed.

The Interim Rule requires Sponsors to provide a Provisional Supply in coordination with other applicable Part D policies (e.g., Schedule II controlled substances, transition policy and the Sponsor’s applicable utilization management policies). Sponsors and their PBMs will need to take care in the design of system edits to confirm that the appropriate policies are applied—in the correct order of priority—to ensure compliance with Part D policies and appropriate member access to medications.

Practical Considerations: Sponsors and their PBMs must develop or modify their systems to identify and properly adjudicate claims that may trigger the Provisional Supply requirement, which ultimately ties to the coexistence of three variables: member, drug and prescriber. For example, a member would be able to receive a Provisional Supply of multiple medications from the same prescriber simultaneously, and potentially could obtain Provisional Supplies of one or more of the same medications if prescribed by another prescriber eligible to become, but not yet, a Medicare Prescriber. Sponsors and their PBMs should be sensitive to the potential for non-compliance with this requirement to lead to civil money penalties or other enforcement actions; CMS recently has taken enforcement action in other instances of non-compliance with Part D Program policies that affect beneficiary access to drugs (e.g., transition policies).

Member and Prescriber Notice Requirements

The Interim Rule requires Sponsors (or their PBMs) to provide personalized, written notice to each member to whom a Provisional Supply is dispensed “within 3 business days after adjudication” of the claim, in a form and manner to be specified by CMS. Also, Sponsors must make “reasonable efforts” to notify the affected prescriber regarding the dispensing of a Provisional Supply of medication because of his or her Medicare Prescriber status.

Practical Considerations: These member notices require personalized messaging and issuance in a limited time frame. Member notices in other contexts that have similar characteristics (e.g., coverage determination notices) have been the subject of Sponsor performance issues and CMS-imposed penalties. Sponsors and their contractors therefore should consider the best policies and procedures by which to monitor and verify compliance with this requirement.

Timing Changes

The Medicare Prescriber requirements, as adopted under the May 2014 Rule and modified by the Interim Rule, are effective June 1, 2015. CMS delayed enforcement until December 1, 2015, and now, to allow additional time for affected prescribers to enroll in or opt out of Medicare, the Interim Rule further postpones applicability of the regulatory requirements to January 1, 2016.

Conclusion

The Interim Rule will continue to generate attention because it does not provide relief for a large number of unenrolled prescribers, and because the Provisional Supply requirement may impose operational challenges on Sponsors. CMS has indicated that in the future it will release operational guidance on various points, which will require Sponsors, their PBMs and their contracted pharmacies to stay abreast of developments and be ready to incorporate further changes into systems to accommodate this new policy. The challenges associated with these new policies, particularly the system issues that can arise in connection with properly identifying claims that trigger the Provisional Supply and the coordination of its disbursement with other overlapping Part D policies, will require vigilance by Sponsors and PBMs to monitor compliance and quickly implement corrective action in order to avoid medication access issues for members.