Federal Register/Vol. 83, No. 73/Monday, April 16, 2018/Rules and Regulations

16440 Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Rules and Regulations DEPARTMENT OF HEALTH AND rule (Cost Sharing Limits for Medicare regulation meets the Administration’s HUMAN SERVICES Parts A and B Services)). Those priorities to reduce burden and provide provisions are applicable for contract the regulatory framework to develop Centers for Medicare & Medicaid year 2020 (January 1, 2020). E- MA and Part D products that better meet Services Prescribing and the Part D Prescription the individual patient’s health care Drug Program; Updating Part D E needs. These changes being finalized 42 CFR Parts 405, 417, 422, 423, 460, Prescribing Standards discussed in will empower MA and Part D plans to and 498 section II.D.8. of this final rule is meet the needs of enrollees at the local [CMS–4182–F] applicable January 1, 2020 conditioned level, and should result in more enrollee on The Office of the National choice and more affordable options. RIN 0938–AT08 Coordinator for Health Information Additionally, this regulation includes a Technology (ONC) adopting the same number of provisions that will help Medicare Program; Contract Year 2019 standard for use in its Electronic Health address the opioid epidemic and Policy and Technical Changes to the Record Certification Program by that mitigate the impact of increasing drug Medicare Advantage, Medicare Cost date. prices in the Part D program. Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit FOR FURTHER INFORMATION CONTACT: 2. Summary of the Major Provisions Theresa Wachter, (410) 786–1157, Programs, and the PACE Program a. Implementation of the Part C Issues. AGENCY: Centers for Medicare & Marie Manteuffel, (410) 786–3447, Comprehensive Addiction and Recovery Medicaid Services (CMS), HHS. Part D Issues. Act of 2016 (CARA) Provisions ACTION: Final rule. Kristy Nishimoto, (206) 615–2367, In line with the agency’s response to Beneficiary Enrollment and Appeals the President’s call to end the scourge SUMMARY: This final rule will revise the Issues. of the opioid epidemic, this final rule Medicare Advantage (MA) program (Part Raghav Aggarwal, (410) 786–0097, implements statutory provisions of the C) regulations and Prescription Drug Part C and D Payment Issues. Comprehensive Addiction and Recovery Benefit program (Part D) regulations to Vernisha Robinson-Savoy, (443) 826– Act of 2016 (CARA), which amended implement certain provisions of the 9925, Compliance Program Training the Social Security Act and was enacted Comprehensive Addiction and Recovery Issues. into law on July 22, 2016. CARA Act (CARA) to further reduce the Frank Whelan, (410) 786–1302, includes new authority for Medicare number of beneficiaries who may Preclusion List Issues. Part D plans to establish drug potentially misuse or overdose on Shelly Winston, (410) 786–3694, Part management programs effective on or opioids while still having access to D E-Prescribing Program. after January 1, 2019. Through this final important treatment options; implement SUPPLEMENTARY INFORMATION: rule, CMS has established a framework certain provisions of the 21st Century under which Part D plan sponsors may Cures Act; support innovative I. Executive Summary and Background establish a drug management program approaches to improve program quality, A. Executive Summary for beneficiaries at risk for prescription accessibility, and affordability; offer drug abuse or misuse, or ‘‘at-risk beneficiaries more choices and better 1. Purpose beneficiaries.’’ Specifically, under drug care; improve the CMS customer The primary purpose of this final rule management programs, Part D plans will experience and maintain high is to make revisions to the Medicare engage in case management of potential beneficiary satisfaction; address Advantage (MA) program (Part C) and at-risk beneficiaries, through contact program integrity policies related to Prescription Drug Benefit Program (Part with their prescribers, when such payments based on prescriber, provider D) regulations based on our continued beneficiary is found to be taking a and supplier status in MA, Medicare experience in the administration of the specific dosage of opioids and/or cost plan, Medicare Part D and the Part C and Part D programs and to obtaining them from multiple PACE programs; provide an update to implement certain provisions of the prescribers and multiple pharmacies the official Medicare Part D electronic Comprehensive Addiction and Recovery who may not know about each other. prescribing standards; and clarify Act and the 21st Century Cures Act. The Sponsors may then limit at-risk program requirements and certain changes are necessary to— beneficiaries’ access to coverage of technical changes regarding treatment of • Support Innovative Approaches to controlled substances that CMS Medicare Part A and Part B appeal Improving Quality, Accessibility, and determines are ‘‘frequently abused rights related to premiums adjustments. Affordability; drugs’’ to a selected prescriber(s) and/or DATES: • Improve the CMS Customer network pharmacy(ies) after case Effective Date: This rule is effective Experience; and management with the prescribers for the June 15, 2018. • Implement Other Changes. safety of the enrollee. CMS also limits The incorporation by reference of In addition, this final rule makes the use of the special enrollment period certain publications listed in the rule is technical changes related to treatment of (SEP) for dually- or other low income approved by the Director of the Federal Part A and Part B premium adjustments subsidy (LIS)-eligible beneficiaries by Register as of June 15, 2018. and updates the NCPDP SCRIPT those LIS-eligible beneficiaries who are Applicability Dates: The applicability standard used for Part D electronic identified as at-risk or potentially at-risk date of the provisions of this rule is prescribing. While the Part C and Part for prescription drug abuse under such January 1, 2019 except for the D programs have high satisfaction a drug management program. Finally, provisions in §§ 422.100(f)(4) and (5) among enrollees, we continually these provisions will codify the current and 422.101(d) (discussed in section evaluate program policies and Part D Opioid Drug Utilization Review II.A.4. of this final rule (Maximum Out- regulations to remain responsive to (DUR) Policy and Overutilization of-Pocket Limit for Medicare Parts A current trends and newer technologies, Monitoring System (OMS) by integrating and B Services)) and § 422.100(f)(6) and provide increased flexibility to this current policy with drug (discussed in section II.A.5. of this final serve patients. Specifically, this management program provisions. VerDate Sep<11>2014 21:39 Apr 13, 2018 Jkt 244001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\16APR2.SGM 16APR2 daltland on DSKBBV9HB2PROD with RULES2 Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Rules and Regulations 16441 Through the adoption of this policy, changing the timeframe for delivery of prescribers of Part D drugs and from 2011 through 2017, there was a 76 the MA and Part D EOC to the first day providers of MA services and items to percent decrease (almost 22,500 of the Annual Election Period (AEP), enroll in Medicare in order for the Part beneficiaries) in the number of Part D rather than 15 days prior to that date. D drug or MA service or item to be beneficiaries identified as potential very Allowing Part C and Part D plans to covered. As a replacement, a Part D plan high risk opioid overutilizers. Thus, provide the EOC electronically will sponsor will be required to reject, or drug management programs will expand alleviate plan burden related to printing require its pharmacy benefit manager to upon an existing, innovative, successful and mailing and reduce the number of reject, a pharmacy claim for a Part D approach to reduce opioid paper documents that enrollees receive drug if the individual who prescribed overutilization in the Part D program by from plans. Changing the date by which the drug is included on the ‘‘preclusion improving quality of care through plans must provide the EOC to enrollees list.’’ Similarly, an MA service or item coordination while maintaining access will allow plans more time to finalize to necessary pain medications, and will the formatting and ensure the accuracy will not be covered if the provider that be an important next step in addressing of the information in the EOC. Changing furnished the service or item is on the the opioid epidemic and safeguarding the date will also separate the mailing preclusion list. The preclusion list will the health and safety of our nation’s and receipt of the EOC from the Annual consist of certain individuals and seniors. Notice of Change (ANOC), which entities that are currently revoked from describes the important changes in a the Medicare program under 42 CFR b. Revisions to Timing and Method of patient’s plan from one year to the next. 424.535 and are under an active Disclosure Requirements The ANOC must be delivered 15 days reenrollment bar, or have engaged in Consistent with agency efforts prior to the AEP and will be received by behavior for which CMS could have supporting innovative approaches to enrollees ahead of the EOC, thus revoked the individual or entity to the improve quality, accessibility, and allowing enrollees to focus on materials extent applicable if they had been affordability and reduce burden, we are that drive decision-making during the enrolled in Medicare, and CMS finalizing changes to align the MA and AEP. We see this final change as an determines that the underlying conduct Part D regulations in authorizing CMS to overall reduction of burden that our that led, or would have led, to the set the manner of delivery for regulations have on plans and enrollees. revocation is detrimental to the best mandatory disclosures in both the MA In aggregate, we estimate a savings (to interests of the Medicare program.

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