United States: 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 Drugs. Comments on the Interim Rule are due to CMS by July 6, 2015.

CMS Update

The Update implements several measures intended to facilitate affected stakeholders' compliance with the new regulatory requirements.

Delayed Enforcement—to June 1, 2016—of Prescriber Enrollment and Provisional Supply Requirements

The Medicare Prescriber requirement, as promulgated in May 2014 and modified by the Interim Rule, became effective June 1, 2015. To allow additional time for health care professionals eligible to be Medicare Prescribers to enroll in or opt out of Medicare, the Interim Rule postponed applicability of the regulatory requirements to January 1, 2016. In response to the strong concerns voiced by Sponsors and PBMs about their ability to make timely the complex system enhancements needed to comply with the Interim Rule (such as determining when to provide a Provisional Supply and to notify the affected prescriber and member), CMS through the Update is further delaying its enforcement of the enrollment requirement until June 1, 2016. 

Practical Considerations: Practitioners who are eligible to become Medicare Prescribers (such as dentists, medical students, and interns) remain subject to the enrollment/opt-out requirement, and their patients may be negatively affected if these practitioners do not become Medicare Prescribers by June 1, 2016.

Sponsors and their PBMs must provide members with a Provisional Supply of Part D drugs prescribed by an individual who is eligible to become, but has not yet become, a Medicare Prescriber on or after June 1, 2016. CMS' Update does not provide additional guidance to Sponsors and PBMs concerning other considerations relating to the Provisional Supply, such as how to coordinate the Provisional Supply requirement with other applicable Part D policies (e.g., Schedule II controlled substances, transition policy and the Sponsor's applicable utilization management policies). CMS may find helpful comments on the Interim Rule addressing any substantive issues associated with coordinating these policies.

Outreach by Sponsors and PBMs

To help maximize prescribers' compliance with the enrollment requirements, CMS "strongly encourages" Sponsors and PBMs to begin by January 1, 2016, outreach to practitioners who are eligible to become, but have not yet become, Medicare Prescribers. Although recognizing that outreach strategies may vary, CMS nonetheless provides two proposed models: Sponsors may contact prescribers either (i) on a rolling basis, prioritizing top prescribers (in terms of the number of affected claims and/or the number of affected members) for the Sponsors' membership, or (ii) simultaneously, through outreach to all prescribers at one time. Regardless of the outreach approach, Sponsors are "encouraged" to re-contact 90 or 120 days later any top prescriber who still has not enrolled or opted out. CMS will provide by August 1, 2015, a sample communication that Sponsors can use for prescriber outreach. CMS also encourages Sponsors to reach out to members and will provide additional guidance on such communications by the 4th quarter 2015.

Practical Considerations: Sponsors are temporarily relieved from the requirement to provide to members a Provisional Supply of Part D drugs prescribed by an individual who is eligible to become, but has not yet become, a Medicare Prescriber. CMS contemplates that Sponsors will begin outreach to such practitioners by January 1, 2016, and procedures must be in place to make Provisional Supplies available come June 1, 2016.

The two outreach models proposed by CMS present various tradeoffs: targeted outreach may help Sponsors maximize the quantity of claims that it will be able to adjudicate successfully and/or minimize the number of negatively affected members, but targeted outreach requires resource commitment to identify those top prescribers and stagger the outreach messages. Conversely, simultaneous outreach may require earlier identification of all practitioners who are eligible to become, but have not yet become, Medicare Prescribers in order for the outreach campaign to be timely managed prior to the June 1, 2016, deadline. Either approach contemplates that Sponsors will re-verify prescribers' enrollment status and follow up shortly before the June 1, 2016, enforcement of the prescriber enrollment requirements.

Claims Procedures to Ensure Compliance After January 1, 2016

Beginning in Contract Year 2016, claims for covered Part D drugs must include a valid prescriber NPI, pursuant to the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) § 507. The existing Part D claims procedures provide that:

  1. Sponsors must communicate at point-of-service (POS) whether or not a claim for a covered Part D drug contains an active and valid prescriber NPI (hereinafter, NPI Compliance);
  2. If a Sponsor determines NPI Compliance, the Sponsor pays the claim; and
  3. If the Sponsor determines that the claim lacks NPI Compliance, but the pharmacy corrects the NPI or confirms NPI Compliance based upon more up-to-date information, the Sponsor pays the claim.

In addition to following these procedures, for Sponsors to comply with § 507 during the period from January 1, 2016, through May 31, 2016, (prior to enforcement of the Medicare Prescriber enrollment requirement), Sponsors cannot pay claims that it determines lack NPI Compliance, unless the pharmacy corrects the NPI or confirms NPI Compliance. These claims procedures will continue for so-called Other Authorized Prescribers and for claims when a Sponsor must cover a Provisional Supply, even beyond the June 1, 2016 Medicare Prescriber enrollment enforcement date. However, beginning June 1, 2016, Sponsors need not take the extra step to verify NPI Compliance for prescribers determined at POS to be Medicare Prescribers.

CMS will provide guidance to Sponsors in the near future to implement the § 507 requirement that an affected beneficiary be properly informed at POS when a claim for a covered Part D drug is not paid because the claim lacks NPI Compliance concerning such notification procedures.

Practical Considerations: To comply with § 507 from January 1, 2016, through May 31, 2016, Sponsors cannot pay claims unless NPI Compliance is confirmed. Beginning June 1, 2016, Sponsors can rely on the prescriber's status as a Medicare Prescriber to avoid the requirement to verify NPI Compliance. System processes and procedures to validate these requisite data elements will be necessary, as will protocols to verify appropriate claims adjudication and troubleshoot emerging issues in order to protect Medicare beneficiaries' access to medications.

Conclusion

Delayed enforcement of the Medicare Prescriber enrollment requirement provides additional time for practitioners to come into compliance to become Medicare Prescribers as well as for Sponsors, their PBMs, and their contracted pharmacies to consider how to operationalize these new policies. CMS nevertheless continues pursuing its goal to maximize prescriber compliance with the enrollment requirements. Sponsors, their PBMs and their contracted pharmacies will need to remain abreast of the forthcoming guidance from CMS concerning communications to affected prescribers and members as well as how to handle other operational challenges, such as identifying Other Authorized Prescribers, identifying individuals that are eligible to become, but have not yet become, Medicare Prescribers, and coordinating the Provisional Supply requirement with other applicable Part D policies.

The Saga Continues: CMS Further Delays Enforcement of Medicare Enrollment Requirements for Prescribers of Part D Drugs

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