CMS has issued a Final rule making revisions to the Medicare Advantage (MA) (Part C) and prescription drug benefit (Part D) programs based on its continued experience in the administration of these programs and to implement certain provisions of the Comprehensive Addiction and Recovery Act of 2016 (CARA) (P.L. 114-198) and the 21st Century Cures Act (P.L. 114-255). The major provisions of the Final rule include: (1) the implementation of the CARA provisions governing the establishment of drug management programs, (2) revisions to timing and method of disclosure requirements for MA and Part D plans, and (3) preclusion list requirements for prescribers in Part D and individuals and entities in MA, cost plans, and Programs of All-Inclusive Care for the Elderly (PACE) (Final rule, 83 FR 16440, April 16, 2018).
On November 28, 2017, CMS published the Proposed rule (see Proposed CY 2019 Part C and D changes address opioid misuse and numerous other policy concerns, November 17, 2017). While this Final rule finalizes several of the provisions from the Proposed rule, there are a number of provisions from the Proposed rule that CMS intends to address later and a few that it does not intend to finalize. These provisions are discussed in the Final rule.
CARA provisions. CARA includes new authority for Part D plans to establish drug management programs effective on or after January 1, 2019. This Final rule establishes a framework under which Part D plan sponsors may establish a drug management program for beneficiaries at risk for prescription drug abuse or misuse, or "at-risk beneficiaries." Specifically, under drug management programs, Part D plans will engage in case management of potential at-risk beneficiaries, through contact with their prescribers, when such beneficiary is found to be taking a specific dosage of opioids or obtaining them from multiple prescribers and multiple pharmacies who may not know about each other. Sponsors may then limit at-risk beneficiaries’ access to coverage of controlled substances that CMS determines are "frequently abused drugs" to a selected prescribers or network pharmacies after case management with the prescribers for the safety of the enrollee.
CMS also limits the use of the special enrollment period (SEP) for dually- or other low income subsidy (LIS)-eligible beneficiaries by those LIS-eligible beneficiaries who are identified as at-risk or potentially at-risk for prescription drug abuse under such a drug management program. Finally, these provisions will codify the current Part D Opioid Drug Utilization Review (DUR) Policy and Overutilization Monitoring System (OMS) by integrating this current policy with drug management program provisions.
The purpose of these CARA drug management program provisions is to create a lock-in status for certain at-risk beneficiaries. In addition to the benefits of preventing opioid and benzodiazepine dependency in beneficiaries, CMS estimates, in 2019, a reduction of $19 million in Trust Fund expenditures because of reduced opioid scripts. This $19 million reduction modestly increases to a $20 million reduction in 2023.
Timing and method of disclosure requirements. CMS is finalizing changes to align the MA and Part D regulations in authorizing CMS to set the manner of delivery for mandatory disclosures in both the MA and Part D programs. CMS will use this authority to allow MA plans to meet the disclosure and delivery requirements for certain documents by relying on notice of electronic posting and provision of the documents in hard copy when requested, when previously the documents, such as the Evidence of Coverage (EOC), had to be provided in hard copy. CMS is also changing the timeframe for delivery of the MA and Part D EOC to the first day of the Annual Election Period (AEP), rather than 15 days prior to that date.
Allowing MA and Part D plans to provide the EOC electronically will alleviate plan burden related to printing and mailing and reduce the number of paper documents that enrollees receive from plans. In addition, changing the date by which plans must provide the EOC to enrollees will (1) allow plans more time to finalize the formatting and ensure the accuracy of the information in the EOC, and (2) separate the mailing and receipt of the EOC from the Annual Notice of Change (ANOC), which describes the important changes in a patient’s plan from one year to the next.
CMS estimates that 67 percent of the current 47.8 million beneficiaries will prefer use of the internet versus hard copies. This will result in a savings to the industry of $54.7 million each year, 2019 through 2023, due to a reduction in printing and mailing costs.
Preclusion list requirements for prescribers and providers. The Final rule rescinds the current regulatory requirement that prescribers of Part D drugs and providers of MA services and items must enroll in Medicare in order for the drug, service, or item to be covered. Instead, a Part D plan sponsor will be required to reject, or require its pharmacy benefit manager to reject, a pharmacy claim for a Part D drug if the individual who prescribed the drug is included on the "preclusion list." Similarly, an MA service or item will not be covered if the provider that furnished the service or item is on the preclusion list.
The preclusion list will consist of certain individuals and entities that are currently revoked from the Medicare program under 42 CFR sec. 424.535 and are under an active reenrollment bar, or have engaged in behavior for which CMS could have revoked the individual or entity to the extent applicable if they had been enrolled in Medicare, and CMS determines that the underlying conduct that led, or would have led, to the revocation is detrimental to the best interests of the Medicare program.
CMS estimates that for 2019, the preclusion list provision will save providers $34.4 million. For 2020 and future years, there will be no savings. The $34.4 million in savings to providers arises because of removal of the requirement of MA providers and suppliers and Part D prescribers to enroll in Medicare as a prerequisite for furnishing health care items and services. Part C providers and suppliers will save $24.1 million in reduced costs while Part D providers will save $10.3 million in reduced costs.
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