Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 417, 422, 423, 455, and 460

[CMS-4190-P]

RIN 0938-AT97

Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly

AGENCY:

Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).

ACTION:

Proposed rule.

SUMMARY:

This proposed rule would revise regulations for the Medicare Advantage (Part C) program, Medicare Prescription Drug Benefit (Part D) program, Medicaid program, Medicare Cost Plan program, and Programs of All-Inclusive Care for the Elderly to implement certain sections of the Bipartisan Budget Act of 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, and the 21st Century Cures Act. This proposed rule would also enhance the Part C and D programs, codify several existing CMS policies, and implement other technical changes.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on April 6, 2020.

ADDRESSES:

In commenting, please refer to file code CMS-4190-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

1.

Electronically.

You may submit electronic comments on this regulation to

http://www.regulations.gov.

Follow the “Submit a comment” instructions.

2.

By regular mail.

You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4190-P, P.O. Box 8013, Baltimore, MD 21244-8013.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3.

By express or overnight mail.

You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4190-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

For information on viewing public comments, see the beginning of the

SUPPLEMENTARY INFORMATION

section.

FOR FURTHER INFORMATION CONTACT:

Theresa Wachter, (410) 786-1157, or Cali Diehl, (410) 786-4053—General Questions.

Kimberlee Levin, (410) 786-2549—Part C Issues.

Lucia Patrone, (410) 786-8621—Part D Issues.

Kristy Nishimoto, (206) 615-2367—Beneficiary Enrollment and Appeals Issues.

Stacy Davis, (410) 786-7813—Part C and D Payment Issues.

Sabrina Sparkman, (410) 786-3209—PACE Issues.

Debra Drew, (410) 786-6827—Program Integrity Issues.

Melissa Seeley, (212) 616-2329—D-SNP Issues.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments:

All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received:

http://www.regulations.gov.

Follow the search instructions on that website to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

Acronyms

AE Actuarial Equivalent

AEP Annual Coordinated Enrollment Period

AIC Amount in Controversy

ANOC Annual Notice of Change

ARB At-Risk Beneficiaries

BBA Bipartisan Budget Act

BBP Base Beneficiary Premium

BLS Bureau of Labor Statistics

CAHPS Consumer Assessment of Healthcare Providers and Systems

CARA Comprehensive Addiction and Recovery Act

CDC Centers for Disease Control and Prevention

CEAC Counties with Extreme Access Considerations

CMS Centers for Medicare & Medicaid Services

COI Collection of Information

CON Certificate of Need

COPD Chronic Obstructive Pulmonary Disease

C-SNP Chronic Condition Special Needs Plan

DME Durable Medical Equipment

DMP Drug Management Program

D-SNP Dual Eligible Special Needs Plan

ED Emergency Department

EGWP Employer Group Waiver Plan

EHR Electronic Health Record

EOC Evidence of Coverage

eRx E-Prescribing

ESRD End-Stage Renal Disease

FAD Frequently Abused Drug

FAQ Frequently Asked Question

FFS Fee-for-Service

FIDE SNP Fully Integrated Dual Eligible Special Needs Plan

FMV Fair Market Value

HEDIS Healthcare Effectiveness Data and Information Set

HHS Department of Health and Human Services

HIDE SNP Highly Integrated Dual Eligible Special Needs Plan

HIPAA Health Insurance Portability and Accountability Act of 1996

HOS Health Outcomes Survey

HPMS Health Plan Management System

HSD Health Service Delivery

ICD International Classification of Diseases

ICR Information Collection Requirement

IDR Integrated Data Repository

IDT Interdisciplinary Team

IMF Illicitly Manufactured Fentanyl

IRE Independent Review Entity

IRMAA Income-Related Monthly Adjustment Amount

I-SNP Institutional Special Needs Plan

IT Information Technology

LPPO Local Preferred Provider Organization

MA Medicare Advantage

MACPAC Medicaid and CHIP Payment and Access Commission

MAGI Modified Adjusted Gross Income

MA-PD Medicare Advantage Prescription Drug

MCO Managed Care Organization

MCMG Medicare Communications and Marketing Guidelines

MCS Improving or Maintaining Mental Health

MedPAC Medicare Payment Advisory Commission

MIPPA Medicare Improvements for Patients and Providers Act

MLR Medical Loss Ratio

MMA Medicare Prescription Drug, Improvement, and Modernization Act

MMCM Medicare Managed Care Manual

MME Morphine Milligram Equivalent

MMP Medicare-Medicaid Plan

MOC Model of Care

MOOP Maximum Out-of-Pocket

MPF Medicare Plan Finder

MSA Medical Savings Account

NAICS North American Industry Classification System

NBI MEDIC National Benefit Integrity Medicare Drug Integrity Contractor

NCQA National Committee for Quality Assurance

NMM Network Management Module

NPPES National Provider and Plan Enumeration System

NQF National Quality Forum

OACT Office of the Actuary

OEP Open Enrollment Period

OIG Office of Inspector General

OMB Office of Management and Budget

OMHA Office of Medicare Hearings and Appeals

OMS Overutilization Management System

OUD Opioid Use Disorder

PA Prior Authorization

PACE Programs of All-Inclusive Care for the Elderly

PAD Peripheral Artery Disease

PARB Potential At-Risk Beneficiary

PBP Plan Benefit Package

PCS Improving or Maintaining Physical Health

PDE Prescription Drug Event

PDP Prescription Drug Plan

PFFS Private Fee-for-Service

PIM Program Integrity Manual

PMPM Per Member Per Month

POS Point-of-Sale

PQA Pharmacy Quality Alliance

PRA Paperwork Reduction Act

QBP Quality Bonus Payment

QIA Quality Improvement Activity

RFA Regulatory Flexibility Act

RI Rewards and Incentives

RPPO Regional Preferred Provider Organization

RTBT Real Time Benefit Tool

SAE Service Area Expansion

SAR Service Area Reduction

SB Summary of Benefits

SBA Small Business Administration

SCD Sickle Cell Disease

SEP Special Election Period

SET Supervised Exercise Therapy

SIU Special Investigations Unit

SMID Standardized Material Identification

SNP Special Needs Plan

SOA Scope of Appointment

SPAP State Pharmaceutical Assistance Program

SSA Social Security Administration

SSBCI Special Supplemental Benefits for the Chronically Ill

SUPD Statin Use in Persons with Diabetes

SUPPORT Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment

TMP Timeliness Monitoring Project

UM Utilization Management

UMRA Unfunded Mandates Reform Act

I. Executive Summary

A. Executive Summary

1. Purpose

The primary purpose of this proposed rule is to implement certain sections of the following federal laws related to the Medicare Advantage (MA or Part C) and Prescription Drug Benefit (Part D) programs:

• The Bipartisan Budget Act of 2018 (hereinafter referred to as the BBA of 2018)

• The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (hereinafter referred to as the SUPPORT Act)

• The 21st Century Cures Act (hereinafter referred to as the Cures Act)

The rule would also include a number of changes to strengthen and improve the Part C and D programs, codify in regulation several CMS interpretive policies previously adopted through the annual Call Letter and other sub-regulatory guidance documents, and implement other technical changes for contract year 2021 and 2022. In the fall of 2017, CMS launched the Patients over Paperwork initiative. The key focus of this initiative is to reduce “red tape” that depletes resources from our healthcare system and wastes the time clinicians and other healthcare workers need to perform their primary mission—caring for patients.

In keeping with the success of this program, CMS continues to review its regulatory requirements and sub-regulatory policies to examine opportunities to prioritize the well-being of patients over the CMS requirements on the healthcare industry. In particular, the Patients over Paperwork initiative charges CMS to analyze the impact of existing requirements and remove unnecessary burdens. As part of this, CMS is streamlining and clarifying certain patient protections and codifying important sub-regulatory guidance in the Code of Federal Regulations. This provides an opportunity for the public to review and comment on proposed requirements and provides transparency into CMS's rules and guidance.

2. Summary of the Major Provisions

a. Mandatory Drug Management Programs (DMPs) (§ 423.153)

Section 704 of the Comprehensive Addiction and Recovery Act of 2016 (hereinafter referred to as CARA) included provisions permitting Part D sponsors to establish drug management programs (DMPs) for beneficiaries at-risk for misuse or abuse of frequently abused drugs (FADs). Under the DMPs in place today, Part D sponsors engage in case management of potential at-risk beneficiaries (PARBs) through contact with their prescribers to determine whether the beneficiary is at-risk for prescription drug misuse or abuse. If a beneficiary is determined to be at-risk, after notifying the beneficiary in writing, the sponsor may limit their access to coverage of opioids and/or benzodiazepines to a selected prescriber and/or network pharmacy(ies) and/or through a beneficiary-specific point-of-sale (POS) claim edit.

While the majority of Part D sponsors have already voluntarily implemented DMPs, CMS is proposing the requirement of mandatory implementation of DMPs by Part D sponsors, for plan years beginning on or after January 1, 2022, as required under section 2004 of the SUPPORT Act.

b. Beneficiaries With History of Opioid-Related Overdose Included in Drug Management Programs (DMPs) (§ 423.100)

A past overdose is the risk factor most predictive for another overdose or suicide-related event.

1

In light of this fact, in section 2006 of the SUPPORT Act, Congress required CMS to include Part D beneficiaries with a history of opioid-related overdose (as defined by the Secretary) as PARBs under a Part D plan's DMP. CMS is also required under this section to notify the sponsor of such identifications. In line with this requirement, we are proposing to modify the definition of “potential at-risk beneficiary” at § 423.100 to include a Part D eligible individual who is identified as having a history of opioid-related overdose, as we propose to define it. Inclusion of beneficiaries with a history of opioid-related overdose as PARBs in DMPs will allow Part D plan sponsors and providers to work together to closely assess these beneficiaries' opioid use and determine whether any additional action is warranted.

1

Bohnert KM, Ilgen MA, Louzon S, McCarthy JF, Katz IR. Substance use disorders and the risk of suicide mortality among men and women in the US Veterans Health Administration. Addiction. 2017 Jul;112(7):1193-1201. doi: 10.1111/add.13774.

c. Automatic Escalation to External Review Under a Medicare Part D Drug Management Program (DMP) for At-Risk Beneficiaries (§§ 423.153, 423.590, and 423.600)

CMS is proposing that, if on reconsideration a Part D sponsor affirms its denial of a DMP appeal, the case shall be automatically forwarded to the independent outside entity for review and resolution. We are proposing that a plan sponsor must forward the case to the independent outside entity by the expiration of the adjudication timeframe applicable to the plan level appeal. Finally, we are proposing conforming

revisions to the notices that are sent to beneficiaries.

d. Suspension of Pharmacy Payments Pending Investigations of Credible Allegations of Fraud and Program Integrity Transparency Measures (§§ 405.370, 422.500, 422.503, 423.4, 423.504, and 455.2)

CMS proposes to undertake rulemaking to implement the provisions outlined in sections 2008 and 6063 of the SUPPORT Act, which are summarized in the following sections (1) and (2). Implementing these provisions will allow CMS, MA organizations and Medicare Part D plan sponsors (including MA organizations offering MA-PD plans) to share data and information regarding bad actors, take swift action based on such data and information, and achieve enhanced outcomes in our efforts to fight the opioid crisis. In addition, this regulation will provide the means for more effective referrals to law enforcement based on plan sponsor reporting, ultimately resulting in reduced beneficiary harm and greater savings for the Medicare program.

(1) Section 2008 of the SUPPORT Act

Title XVIII of the Social Security Act (the Act) provides authority for CMS to suspend payments to Medicare fee-for-service (FFS) providers and suppliers pending an investigation of a credible allegation of fraud, unless a good cause exception applies. While Part D plan sponsors currently have the discretion to suspend payments to pharmacies in the plans' networks, section 2008 requires that plan sponsors' payment suspensions based on credible allegations of fraud be implemented in the same manner as CMS implements such payment suspensions. Under this provision, plan sponsors are required to notify the Secretary of the imposition of a payment suspension that is based on a credible allegation of fraud and may do so using a secure website portal. The reporting requirement applicable to plan sponsors will only apply to suspended payments based on credible allegations of fraud as required by section 2008 and will not extend to other payment suspensions for which plan sponsors already have authority. Section 2008 also clarifies that a fraud hotline tip, without further evidence, is not considered a credible fraud allegation for payment suspension purposes.

(2) Section 6063 of the SUPPORT Act

Section 6063 requires the Secretary to establish a secure internet website portal to enable the sharing of data among MA plans, prescription drug plans, and the Secretary, and referrals of “substantiated or suspicious activities” of a provider of services (including a prescriber) or a supplier related to fraud, waste, or abuse to initiate or assist with investigations conducted by eligible entities with a contract under section 1893 of the Act, such as a Medicare program integrity contractor. The Secretary is also required to use the portal to disseminate information to all MA plans and prescription drug plans on providers and suppliers that were referred to CMS for fraud, waste, and abuse in the last 12 months; were excluded or the subject of a payment suspension; are currently revoked from Medicare; or, for such plans that refer substantiated or suspicious activities to CMS, whether the related providers or suppliers were subject to administrative action for similar activities. The Secretary is required to define what constitutes substantiated or suspicious activities. Section 6063 specifies that a fraud hotline tip without further evidence shall not be treated as sufficient evidence for substantiated fraud, waste, or abuse.

Section 6063 also requires the Secretary to disseminate quarterly reports to MA plans and prescription drug plans on fraud, waste, and abuse schemes and suspicious activity trends reported through the portal. The Secretary's reports are to maintain the anonymity of information submitted by plans and to include administrative actions, opioid overprescribing information, and other data the Secretary, in consultation with stakeholders, determines important.

Beginning with plan year 2021, section 6063 also requires Part D plan sponsors to submit to the Secretary information on investigations, credible evidence of suspicious activities of providers or suppliers related to fraud, and other actions taken by the plans related to inappropriate opioid prescribing. The Secretary is required to issue regulations that define the term inappropriate prescribing with respect to opioids, identify a method to determine if providers are inappropriately prescribing, and identify the information plan sponsors are required to submit.

e. Medicare Advantage (MA) Plan Options for End-Stage Renal Disease (ESRD) Beneficiaries (§§ 422.50, 422.52, and 422.110)

The Cures Act (Pub. L. 114-255) amended sections 1851, 1852, and 1853 of the Act to expand enrollment options for individuals with end stage renal disease (ESRD) and make associated payment and coverage changes to the MA and original Medicare programs. Specifically, since the beginning of the MA program, individuals with ESRD have not been able to enroll in MA plans subject to limited exceptions. Section 17006(a) of the Cures Act removed this prohibition effective for plan years beginning on or after January 1, 2021. We are proposing to codify this change with revisions to §§ 422.50(a)(2), 422.52, and 422.110.

f. Medicare Fee-for-Service (FFS) Coverage of Costs for Kidney Acquisitions for Medicare Advantage (MA) Beneficiaries (§ 422.322)

With this new enrollment option, the Cures Act also made several payment changes in the MA and original Medicare FFS programs. Section 17006(c) of the Cures Act amended section 1852(a)(1)(B)(i) of the Act to exclude from the Medicare benefits an MA plan is required to cover for an MA enrollee coverage for organ acquisitions for kidney transplants, including as covered under section 1881(d) of the Act. Effective January 1, 2021, these costs will be covered under the original Medicare FFS program. Section 17006(c)(2) of the Cures Act also amended section 1851(i) of the Act, providing that CMS may pay an entity other than the MA organization that offers the plan in which the individual is enrolled for expenses for organ acquisitions for kidney transplants described in section 1852(a)(1)(B)(i) of the Act. We propose changes to our regulation at § 422.322 to align with these new statutory requirements.

g. Exclusion of Kidney Acquisition Costs From Medicare Advantage (MA) Benchmarks (§§ 422.258 and 422.306)

Since the original Medicare FFS program will cover costs of organ acquisitions for kidney transplants for individuals in an MA plan, section 17006(b) of the Cures Act also amended section 1853 of the Act to exclude these costs from the MA benchmarks used in determining payment to MA plans. Specifically, the Secretary, effective January 1, 2021, is required to exclude the estimate of standardized costs for payments for organ acquisitions for kidney transplants from MA benchmarks and capitation rates. We propose changes to our regulations at §§ 422.258(d) and 422.306 to align with these new statutory requirements.

h. Medicare Advantage (MA) and Part D Prescription Drug Program Quality Rating System (§§ 422.162, 422.164, 422.166, 422.252, 423.182, 423.184, and 423.186)

In the Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program Final Rule (hereinafter referred to as the April 2018 final rule), we codified the methodology for the Star Ratings system for the MA and Part D programs, respectively, at §§ 422.160 through 422.166 and §§ 423.180 through 423.186. We will propose through rulemaking any changes to the methodology for calculating the ratings, the addition of new measures, and substantive measure changes.

At this time, in addition to routine measure updates and technical clarifications, we are proposing to further increase the weight of patient experience/complaints and access measures from a weight of 2 to 4. We are also proposing to directly remove outliers prior to calculating the cut points to further increase the predictability and stability of the Star Ratings system. We are also proposing to clarify some of the current rules around assigning Quality Bonus Payment (QBP) ratings and to codify existing policy for assigning QBP ratings for new contracts under existing parent organizations. Unless otherwise stated, data would be collected and performance measured using these proposed rules and regulations for the 2021 measurement period and the 2023 Star Ratings.

i. Permitting a Second, “Preferred”, Specialty Tier in Part D (§§ 423.104, 423.560, and 423.578)

We are proposing to allow Part D sponsors to establish up to two specialty tiers and design an exceptions process that exempts drugs on these tiers from tiering exceptions to non-specialty tiers. We propose that Part D sponsors would have the flexibility to determine which Part D drugs are placed on either specialty tier, subject to the ingredient cost threshold established according to the methodology we are proposing and the requirements of the CMS formulary review and approval process under § 423.120(b)(2). To maintain Part D enrollee protections, we are proposing to codify a maximum allowable cost sharing that would apply to the higher cost-sharing specialty tier. Further, we propose to require that if there are two specialty tiers, one must be a “preferred” tier that offers lower cost sharing than the proposed maximum allowable specialty tier cost sharing.

We note that we are not proposing any revisions to § 423.578(c)(3)(ii), which requires Part D sponsors to provide coverage for a drug for which a tiering exception was approved at the cost sharing that applies to the preferred alternative. Because we propose that the exemption from tiering exceptions for specialty tier drugs would apply only to tiering exceptions to non-specialty tiers, our proposal would require Part D sponsors to permit tiering exception requests for drugs on the higher-cost specialty tier to the lower-cost specialty tier.

To improve transparency, we propose to codify current methodologies for cost sharing and calculations relative to the specialty tier, with some modifications. First, we propose to codify a maximum allowable cost sharing permitted for the specialty tiers of between 25 percent and 33 percent, depending on whether the plan includes a deductible, as described further in section V.F.4. of this proposed rule. We also propose to determine the specialty-tier cost threshold—meaning whether the drug has costs high enough to qualify for specialty tier placement—based on a 30-day equivalent supply. Additionally, we propose to base the determination of the specialty-tier cost threshold on the ingredient cost reported on the prescription drug event (PDE). We also propose to maintain a specialty-tier cost threshold for both specialty tiers that is set at level that, in general, reflects drugs with monthly ingredient costs that are in the top one percent, as described further in section V.F.6. of this proposed rule. Finally, we propose to adjust the threshold, in an increment of not less than ten percent, rounded to the nearest $10, when an annual analysis of PDE data shows that an adjustment is necessary to recalibrate the threshold so that it only reflects drugs with the top one percent of monthly ingredient costs. We propose to determine annually whether the adjustment would be triggered and announce the specialty-tier cost threshold annually.

j. Beneficiary Real Time Benefit Tool (RTBT) (§ 423.128)

This rule proposes to require that Part D plan sponsors implement, no later than January 1, 2022, a beneficiary real-time benefit tool (RTBT). This tool would allow enrollees to view a plan-defined subset of the information included in the prescriber RTBT system, which will include accurate, timely, and clinically appropriate patient-specific real-time formulary and benefit information (including cost, formulary alternatives and utilization management requirements). Plans would be permitted to use existing secure patient portals to fulfill this requirement, to develop a new portal, or use a computer application. Plans would be required to make this information available to enrollees who call the plans' customer service call center.

In order to encourage enrollees to use the beneficiary RTBT, we propose to allow plans to offer rewards and incentives (RI) to their enrollees who log onto the beneficiary RTBT or seek to access this information via the plan's customer service call center.

k. Medical Loss Ratio (MLR) (§§ 422.2420, 422.2440, and 423.2440)

We are proposing to amend the MA medical loss ratio (MLR) regulation at § 422.2420 so that the incurred claims portion of the MLR numerator includes all amounts that an MA organization pays (including under capitation contracts) for covered services. Currently, incurred claims in the MLR numerator include direct claims paid to providers for covered services furnished to all enrollees under an MA contract. This proposal would include in the incurred claims portion of the MLR numerator amounts paid for covered services to individuals or entities that do not meet the definition of “provider” as defined at § 422.2.

We are also proposing to codify in the regulations at §§ 422.2440 and 423.2440 the definitions of partial, full, and non-credibility and the credibility factors that CMS published in the Medicare Program; Medical Loss Ratio Requirements for the Medicare Advantage and the Medicare Prescription Drug Benefit Programs Final Rule (78 FR 31284) (hereinafter referred to as the May 2013 Medicare MLR final rule). We believe that it is more consistent with the policy and principles articulated in Executive Order 13892 on Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication (October 9, 2019) that we define and publish the definitions of partial, full, and non-credibility and the credibility factors in the

Federal Register

, and that we codify these definitions and factors in the Code of Federal Regulations, as opposed to using the annual Advance Notice and Rate Announcement process, as specified in current §§ 422.2440 and 423.2440.

Additionally, we are proposing to amend § 422.2440 to provide for the application of a deductible factor to the

MLR calculation for MA medical savings account (MSA) contracts that receive a credibility adjustment. The proposed deductible factor would serve as a multiplier on the applicable credibility adjustment. This additional adjustment for MA MSAs is intended to recognize that the variability of claims experience is greater under health insurance policies with higher deductibles than under policies with lower deductibles, with high cost or outlier claims representing a larger portion of the overall claims experience of plans with high deductibles. The proposed deductible factor would reduce the risk that an MSA contract will fail to meet the MLR requirement as a result of random variations in claims experience. We are proposing to adopt the same deductible factors that apply under the commercial MLR regulations at 45 CFR part 158.

l. Medicare Advantage (MA) and Cost Plan Network Adequacy (§§ 417.416 and 422.116)

We are proposing to strengthen network adequacy rules for MA plans by codifying our existing network adequacy methodology and standards (with some modifications); we are also seeking comment on refining standards related to telehealth, maximum time and distance standards, and whether there are additional changes we should consider to improve MA plan access in all county types, such as to address the effect of Certificate of Need (CON) requirements, or whether there more specific changes we should consider to increase plan choice in more rural counties. The authorization of additional telehealth benefits pursuant to the BBA of 2018 incentivizes new ways for beneficiaries to access health care beginning in 2020. As a result, CMS has been examining its network adequacy standards overall to determine how contracted telehealth providers should be considered when evaluating the adequacy of an MA plan network. We propose to allow MA plans to receive a 10 percent credit towards the percentage of beneficiaries residing within published time and distance standards when they contract with telehealth providers in the following provider specialty types: dermatology, psychiatry, cardiology, otolaryngology and neurology. We also are soliciting comment regarding whether we should expand this credit to other specialty provider types, such as nephrology for home dialysis and if this percentage “credit” should vary by county type.

Additionally, in order to expand access to MA plans where network development can be challenging, we propose to modify the current network adequacy standards by codifying a reduced standard for the percentage of beneficiaries that must reside within the maximum time and distance standards in non-urban counties (Micro, Rural, and Counties with Extreme Access Considerations (CEAC) county type designations) for an MA plan to comply with the network adequacy standards. We also solicit comment about whether and how much of a percentage reduction would likely be required to incentivize MA penetration and whether the reduction should apply to all county types, or just non-urban counties.

m. Special Election Periods (SEPs) for Exceptional Conditions (§§ 422.62 and 423.38)

Sections 1851(e)(4) and 1860D-1(b)(3) of the Act establish special election periods (SEPs) during which, if certain circumstances exist, an individual may request enrollment in, or disenrollment from, MA and Part D plans. The Secretary also has the authority to create SEPs for individuals who meet other exceptional conditions. We are proposing to codify a number of SEPs that we have adopted and implemented through subregulatory guidance as exceptional circumstances SEPs. Codifying our current policy for these SEPs will provide transparency and stability to the MA and Part D programs by ensuring that the SEPs are known and changed only through additional rulemaking. Among the proposed SEPs are the SEP for Individuals Affected by a FEMA-Declared Weather-Related Emergency or Major Disaster, the SEP for Employer/Union Group Health Plan (EGHP) elections, and the SEP for Individuals Who Disenroll in Connection with a CMS Sanction. We are also proposing to establish two additional SEPs for exceptional circumstances: the SEP for Individuals Enrolled in a Plan Placed in Receivership and the SEP for Individuals Enrolled in a Plan that has been identified by CMS as a Consistent Poor Performer.

n. Service Delivery Request Processes Under PACE (§§ 460.104 and 460.121)

Currently, PACE participants or their designated representatives may request to initiate, eliminate or continue a service, and in response, the PACE organization must process this request under the requirements at § 460.104(d)(2). These requests are commonly referred to by CMS and the industry as “service delivery requests.” In response to feedback from PACE organizations and advocacy groups, and based on our experience monitoring PACE organizations' compliance with our current requirements, we are proposing to move the requirements for processing service delivery requests from § 460.104(d)(2) and add them to a new § 460.121 in order to increase transparency for participants and reduce confusion for PACE organizations. We are also proposing to modify these provisions in order to reduce unnecessary burden on PACE organizations and eliminate unnecessary barriers for participants who have requested services that a PACE organization would be able to immediately approve. Specifically, we are proposing to more clearly define what constitutes a service delivery request, and provide transparent requirements for how those requests would be processed by the PACE organization, including who can make a request, how a request can be made, and the timeframe for processing a service delivery request. We are also proposing to allow the interdisciplinary team (IDT) to bypass the full processing of a service delivery request under the new proposed requirements under § 460.121 when the request can be approved in full by an IDT member at the time it is made. For all other service delivery requests that are brought to the IDT, we are proposing to maintain the requirement that an in-person reassessment must be conducted prior to a service delivery request being denied, but we are proposing to eliminate the requirement that a reassessment (either in-person or through remote technology) be conducted when a service delivery request can be approved. Lastly, we are proposing to add participant protections; specifically, we are proposing to increase notification requirements in order to ensure participants understand why their request was denied, and we are proposing to add reassessment criteria in order to ensure reassessments are meaningful to the service delivery request, and that the IDT takes them into consideration when rendering a decision.

o. Beneficiaries With Sickle Cell Disease (SCD) (§ 423.100)

Beneficiaries with active cancer-related pain, residing in a long-term care facility, or receiving hospice, palliative, or end-of-life care currently meet the definition of “exempt individuals” with respect to DMPs in § 423.100. Section 1860D-4(c)(5)(C)(ii)(III) of the Act provides the Secretary with the authority to elect to treat other beneficiaries as exempted from DMPs.

Due to concerns of misapplication of opioid restrictions in the sickle cell disease (SCD) patient population, CMS is proposing that, starting in plan year 2021, beneficiaries with SCD are classified as exempt individuals.

3. Summary of Costs and Benefits

BILLING CODE 4120-01-P

EP18FE20.000

EP18FE20.001

EP18FE20.002

EP18FE20.003

EP18FE20.004

BILLING CODE 4120-01-C

II. Implementation of Certain Provisions of the Bipartisan Budget Act of 2018

A. Special Supplemental Benefits for the Chronically Ill (SSBCI) (§ 422.102)

The BBA of 2018 (Pub. L. 115-123) was signed into law on February 9, 2018. The law included new authorities concerning supplemental benefits that may be offered to chronically ill enrollees in Medicare Advantage (MA) plans, specifically amending section 1852(a)(3) of the Act to add a new subparagraph (D) authorizing a new category of supplemental benefits that may be offered by MA plans. We discussed this new authority in the April 2018 final rule (83 FR 16481 through 16483).

2

We propose to codify the existing guidance (April 2019 Health Plan Management System (HPMS) Memo

3

and the 2020 Call Letter)

4

and parameters for these special supplemental benefits for chronically ill enrollees at § 422.102(f) to implement section 1852(a)(3)(D) of the Act.

2

https://www.govinfo.gov/content/pkg/FR-2018-04-16/pdf/2018-07179.pdf.

3

https://www.cms.gov/Medicare/Health-Plans/HealthPlansGenInfo/Downloads/Supplemental_Benefits_Chronically_Ill_HPMS_042419.pdf.

4

https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2020.pdf.

Specifically, the BBA of 2018 amended section 1852(a)(3) of the Act to: (1) Authorize MA plans to provide additional supplemental benefits that have a reasonable expectation of improving or maintaining the health or overall function of the chronically ill enrollee to chronically ill enrollees; (2) permit those additional supplemental benefits to be not primarily health related; (3) define “chronically ill enrollee” to limit eligibility for these additional supplemental benefits; and (4) authorize CMS to waive uniformity requirements in connection with this for eligible chronically ill enrollees. We refer to these benefits hereafter as Special Supplemental Benefits for the Chronically Ill (SSBCI). The heading for new subparagraph (D) of section 1852(a)(3) of the Act, as added by the BBA, states, “Expanding supplemental benefits to meet the needs of chronically ill enrollees.” Consistent with this text, this new category of supplemental benefits is intended to enable MA plans to better tailor benefit offerings, address gaps in care, and improve health outcomes for the chronically ill population. Section 1852(a)(3)(D)(ii) of the Act, as amended, defines a chronically ill enrollee as an individual who—

• Has one or more comorbid and medically complex chronic conditions that is life threatening or significantly limits the overall health or function of the enrollee;

• Has a high risk of hospitalization or other adverse health outcomes; and

• Requires intensive care coordination.

Thus, with respect to SSBCI benefits, we propose at § 422.102(f)(1)(i), to codify this definition of a chronically ill enrollee. Section 1859(f)(9) of the Act requires us to convene a panel of

clinical advisors to establish and update a list of conditions that meet the definition of a severe or disabling chronic condition under section 1859(b)(6)(B)(iii) of the Act, which provides how having such a condition is an eligibility criterion for a chronic care special needs plan. The standard for severe or disabling chronic condition under section 1859(b)(6)(B)(iii) of the Act is substantially similar to the criterion used in defining “chronically ill enrollee” for purposes of SSBCI eligibility. Under our proposal, MA plans may consider any enrollee with a condition identified on this list to meet the statutory criterion of having one or more comorbid and medically complex chronic conditions that is life threatening or significantly limits the overall health or function of the enrollee. Further, an MA plan may consider any chronic condition not identified on this list if that condition is life threatening or significantly limits the overall health or function of the enrollee. CMS wishes to allow plans the flexibility to continue to innovate around providing care for their specific plan populations. This includes targeted chronic conditions. We recognize that there may be some conditions and/or a subset of conditions in a plan population that may meet the statutory definition of a chronic condition, but may not be present on the list. We encourage plans to identify needs within their unique plan population and do not wish to prevent a plan from addressing a condition or need in their population that may not be on the list. To reflect this policy, we are proposing at § 422.102(f)(1)(i)(B), regulation text indicating our intent to publish a non-exhaustive list of medically complex chronic conditions as determined by the panel as described in section 1859(b)(6)(B)(iii) to be life threatening or significantly limit the overall health or function of an individual.

MA plans are not required to submit to CMS the processes used to identify chronically ill enrollees that meet the three pronged definition of chronically ill enrollee. However, all three criteria must be met for an enrollee to be eligible for the SSBCI authorized under section 1852(a)(3)(D) of the Act. In subregulatory guidance (April 2019 HPMS Memo and the 2020 Call Letter), CMS noted that we expect MA plans to document their determinations about an enrollee's eligibility for SSBCI based on the statutory definition. We propose to codify this as a requirement at § 422.102(f)(3)(ii). In addition, we are also proposing at § 422.102(f)(3)(ii) to require plans to make information and documentation (for example, copies of the internal policies used to make the determinations, etc.) related to determining enrollee eligibility as a chronically ill enrollee available to CMS upon request.

We are proposing at paragraph (f)(1)(ii) the definition of SSBCI. In addition to limiting the class of enrollees who may be eligible to receive the new SSBCI benefits to the chronically ill, section 1852(a)(3)(D) of the Act requires that the specific supplemental benefit provided under this authority have a reasonable expectation of improving or maintaining the health or overall function of the enrollee. We propose to codify this statutory requirement as part of the definition of SSBCI at § 422.102(f)(1)(ii). Because SSBCI are supplemental benefits, they must also comply with the criteria for supplemental benefits that we are proposing to codify at § 422.100(c)(2)(ii), which is discussed in detail in section VI.F. of this proposed rule. We considered whether the regulation for SSBCI should explicitly reference the requirements in § 422.100(c)(2)(ii) to make this clear and solicit comment on this point. Traditionally, CMS has defined supplemental benefits as benefits that: (1) Are primarily health related; (2) require the MA plan to incur a non-zero medical cost; and (3) are not covered under Medicare Parts A, B or D. In light of the authority in section 1852(a)(3)(D) of the Act for SSBCI, we are proposing to modify some aspects of this longstanding policy in this context. First, as the statute provides that SSBCI may be not primarily health related, we are proposing specific text on this point in both §§ 422.100(c)(2)(ii) and 422.102(f)(1)(ii). Second, we are proposing to clarify in § 422.100(c)(2)(ii)(B) that the MA organization incur a non-zero direct medical cost for all supplemental benefits applies in the context of SSBCI that are not primarily health related; in such cases, the MA organization must incur a non-zero direct non-administrative cost for the SSBCI. MA rules require plans to incur a non-zero direct medical cost for supplemental benefits. In the case of SSBCI, we are clarifying that such incurred cost should be a non-administrative cost for providing the benefit even if it is not necessarily a cost paid to a medical provider or facility because SSBCI benefits are not necessarily primarily health related. In all other respects not specifically addressed as part of our proposal, SSBCI would be treated like other supplemental benefits.

Under section 1852(a)(3)(D)(ii)(I) of the Act, SSBCI benefits may include items or services that are not primarily health related. As discussed in detail in section VI.F. of this proposed rule, a primarily health related benefit is an item or service that is used to diagnose, compensate for physical impairments, acts to ameliorate the functional/psychological impact of injuries or health conditions, or reduces avoidable emergency and healthcare utilization. Therefore, at § 422.102(f)(1)(ii), we propose to codify as part of the definition of SSBCI that these benefits may be non-primarily health related SSBCI benefits, including a cross-reference to where we propose to codify the definition of primarily health related; however, in all cases, an SSBCI must have, with respect to a chronically ill enrollee, a reasonable expectation of improving or maintaining the health or overall function of the enrollee. By including it in the definition, we are implementing the statutory authority for MA plans to offer both primarily health and non-primarily health related SSBCI. In the 2019 HPMS memo, we provided examples of non-primarily health related SSBCI benefits. Those examples included: Meals (beyond a limited basis), food and produce, transportation for non-medical needs, pest control, indoor air quality and equipment and services, access to community or plan-sponsored programs and events to address enrollee social needs, (such as non-fitness club memberships, community or social clubs, park passes, etc.), complementary therapies (offered alongside traditional medical treatment), services supporting self-direction (for example. financial literacy classes, technology education, and language classes), structural home modifications, and general supports for living (for example. plan-sponsored housing consultations and/or subsidies for rent or assisted living communities or subsidies for utilities such as gas, electric, and water). We intend this guidance to be equally applicable to our proposed regulation.

Another provision of our proposed rule flows from the statutory authority for SSBCI to be not primarily health related. Unlike with traditional supplemental benefits, MA plans might not incur direct medical costs in furnishing or covering SSBCI. In the 2020 Call Letter, we issued guidance that so long as an MA plan incurs a non-zero non-administrative cost in connection with SSBCI, the benefits would be considered to meet this standard. As supplemental benefits, SSBCI may also take the same form as

traditional supplemental benefits. For example, reductions in cost sharing for benefits under the original Medicare fee-for-service program are an allowable supplemental benefit, as reflected in the definitions of mandatory supplemental benefit in § 422.2. Thus, SSBCI can be in the form of—

• Reduced cost sharing for Medicare covered benefits (such as to improve utilization of high-value services that meet the definition of SSBCI);

• Reduced cost sharing for primarily health related supplemental benefits;

• Additional primarily health related supplemental benefits; or

• Additional non-primarily health related supplemental benefits.

Eligibility for SSBCI must be determined based on identifying the enrollee as a chronically ill enrollee, using the statutory definition, and if the item or service has a reasonable expectation of improving or maintaining the health or overall function of the enrollee. In the April 2019 HPMS memo CMS clarified that MA plans can provide non-primarily health related supplemental benefits that address chronically ill enrollees' social determinants of health so long as the benefits maintain or improve the health or function of that chronically ill enrollee. MA plans may consider social determinants when determining eligibility for an SSBCI of health as a factor to help identify chronically ill enrollees whose health could be improved or maintained with SSBCI. However, MA plans may not use social determinants of health as the sole basis for determining eligibility for SSBCI. We propose to codify the ability of an MA plan to consider social determinants (for example, food and housing insecurity) when determining whether an SSBCI benefit is likely to improve or maintain the health of a chronically ill enrollee as described at § 422.102(f)(2)(iii).

Generally, § 422.100(d) and other regulations require all MA plan benefits to be offered uniformly to all enrollees residing in the service area of the plan. As explained in the April 2018 final rule (83 FR 16480 through 16485), MA plans may also provide access to services (or specific cost sharing or deductibles for specific benefits) that are tied to a disease state in a manner that ensures that similarly situated individuals are treated uniformly. Section 1852(a)(3)(D)(ii)(II) of the Act authorizes CMS to waive the uniformity requirements generally applicable to benefits covered by MA plans with respect to SSBCI, effective in CY 2020. As discussed in the April 2018 final rule (83 FR 16481 and 16482), this gives CMS the authority to allow MA plans to offer chronically ill enrollees supplemental benefits that are not uniform across the entire population of chronically ill enrollees in the MA plan and may vary SSBCI offered to the chronically ill as a specific SSBCI relates to the individual enrollee's specific medical condition and needs. We are proposing to codify the authority for this waiver at § 422.102(f)(2)(ii) such that upon approval by CMS, an MA plan may offer non-uniform SSBCI. In both the CY 2020 call letter and the April 2019 HPMS memo, we explained how we expect MA plans to have written policies based on objective criteria (for example, health risk assessments, review of claims data, etc.) for determining SSBCI eligibility to receive a particular SSBCI benefit, to document these criteria, and to make this information available to CMS upon request. We are also proposing to codify requirements at § 422.102(f)(3)(iii) and (iv) for MA plans that offer SSBCI to have written policies based on objective criteria, document those criteria, to document each determination that an enrollee is eligible to receive an SSBCI and make this information available to CMS upon request. We believe that objective criteria are necessary to address potential beneficiary appeals, complaints, and/or general oversight activities performed by CMS. We are also proposing, at § 422.102(f)(3)(i), to require plans to have written policies for determining enrollee eligibility and must document its determination that an enrollee is a chronically ill enrollee based on the statutory definition codified in paragraph (f)(1)(i) of this section. And we are proposing to require plans to make information and documentation related to determining enrollee eligibility available to CMS upon request at § 422.102(f)(3)(ii). We also clarify here that the determination on the benefits an enrollee is entitled to receive under an MA plan's SSBCI is an organization determination that is subject to the requirements of part 422, subpart M, including the issuance of denial notices to enrollees.

This provision codifies already existing guidance and practices and therefore is not expected to have additional impact above current operating expenses. Additionally, this provision amends definitions and therefore does not impose any collection of information requirements.

B. Improvements to Care Management Requirements for Special Needs Plans (SNPs) (§ 422.101)

Special needs plans (SNPs) are MA plans that are specifically designed to provide targeted care and limit enrollment to special needs individuals. Section 50311 of the BBA of 2018 modified the requirements for C-SNPs in section 1859(f)(5) of the Act. Specifically, the amendments included the following:

• That the interdisciplinary team include a team of providers with demonstrated expertise, including training in an applicable specialty, in treating individuals similar to the targeted population of the C-SNP.

• That the C-SNP comply with requirements developed by CMS to provide face-to-face encounters with enrollees not less frequently than on an annual basis.

• That, as part of the mandatory model of care (MOC), the results of the initial assessment and annual reassessment required for each enrollee be addressed in the individual's individualized care plan.

• That, as part of the annual evaluation and approval of the MOC, CMS take into account whether the plan fulfilled the previous year's goals (as required under the model of care).

• That CMS establish a minimum benchmark for each element of the MOC and only approve a C-SNP's MOC if each element of the model of care meets such minimum benchmark applicable under the preceding sentence.

We are proposing to amend and add new regulations at § 422.101(f) to implement the BBA of 2018 amendments to section 1859(f) of the Act and extend them to all SNP types. Specifically, we propose to add new regulations, to be codified at § 422.101(f), to account for two new requirements governing SNP enrollee care management and three new requirements governing SNP model of care submissions.

The history of special needs plans in the MA program is nearly as long as the program itself. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (hereinafter referred to as the MMA) (Pub. L. 108-173) authorized CMS to contract with MA coordinated care plans that are specifically designed to provide targeted care to individuals with special needs. Originally SNPs were statutorily authorized for a limited period, but after several extensions of that authority, section 50311(a) of the BBA of 2018 permanently authorized SNPs. Under section 1859(f)(1) of the Act, SNPs are able to restrict enrollment to Medicare beneficiaries who are: (1) Institutionalized individuals, who are currently defined in § 422.2 as those residing or expecting to reside for 90 days or longer in a long-term care facility; (2) individuals entitled to

medical assistance under a state plan under Title XIX; or (3) other individuals with certain severe or disabling chronic conditions who would benefit from enrollment in a SNP. As of July 2019, 321 SNP contracts with 734 SNP plans have at least 11 members.

5

These figures included 208 Dual Eligible SNP contracts (D-SNPs) with 480 D-SNP plans with at least 11 members, 57 Institutional SNP contracts (I-SNPs) with 125 I-SNP plans with at least 11 members, and 56 Chronic or Disabling Condition SNP contracts (C-SNPs) with 129 C-SNP plans with at least 11 members. For more discussion of the history of SNPs, please see Chapter 16b of the Medicare Managed Care Manual (MMCM).

6

This proposed rule would implement the provisions of the BBA of 2018 and establish new care management requirements at § 422.101(f) for all SNPs, including minimum benchmarks for SNP models of care.

5

See the following link for SNP plan and enrollment data:

https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data-Items/SNP-Comprehensive-Report-2019-07.html?DLPage=1&DLEntries=10&DLSort=1&DLSortDir=descending.

6

Chapter 16b of the Medicare Managed Care Manual can be found at:

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/mc86c16b.pdf.

Section 1859(f) of the Act and the current implementing regulations specify several requirements for SNPs. MA organizations that would like to offer a SNP are required to engage in an application process to demonstrate that they meet SNP specific requirements, including the requirement in §  422.101(f) that MA organizations offering a SNP implement an evidence based model of care (MOC) to be evaluated by the National Committee for Quality Assurance (NCQA); the requirement in §  422.107 that D-SNPs have a contract with the state Medicaid agencies in the states in which they operate; and the requirement in §  422.152(g) that SNPs conduct quality improvement programs. SNP applicants follow the same process in accordance with the same timeline as applicants seeking to contract to offer other MA plans.

Section 164 of the Medicare Improvements for Patients and Providers Act (hereinafter referred to as MIPPA) (Pub. L. 110-275) added care management requirements for all SNPs effective January 1, 2010, as set forth in section 1859(f)(5) of the Act (42 U.S.C. 1395w-28(f)). The new mandate required dual-eligible, institutional, and chronic condition SNPs to implement care management requirements which have two explicit components: An evidence-based model of care and a series of care management services. While the revisions made in the Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs interim final rule with comment (73 FR 54226), hereinafter referred to as the September 2008 final rule, simply reflected the substance of the new MIPPA provisions, the Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs proposed rule, hereinafter referred to as the May 2008 proposed rule (73 FR 28555), proposed other, related provisions which were finalized in the Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs: Negotiated Pricing and Remaining Revisions final rule (hereinafter referred to as the January 2009 final rule) (74 FR 1493).

CMS had previously provided guidance and instructions in the 2008 and 2009 Call Letters,

7 8

“Special Needs Plan Solicitation,” in order to more clearly establish and clarify delivery of care standards for SNPs and to codify standards. In the May 2008 proposed rule, CMS proposed that SNPs have networks with clinical expertise specific to the special needs population of the plan; use performance measures to evaluate models of care; and be able to coordinate and deliver care targeted to the frail/disabled, and those near the end of life based on appropriate protocols. Section 164 of the MIPPA subsequently added care management requirements for all SNPs as directed in section 1859(f)(5) of the Act (42 U.S.C. 1395w-28(f)), outlining new model of care requirements that include—(1) an appropriate network of providers and specialists to meet the specialized needs of the SNP target population; (2) a comprehensive initial health risk assessment and annual reassessments; (3) an individualized plan of care having goals and measurable outcomes; and (4) an interdisciplinary team to manage care. The MIPPA laid a statutory foundation for much of our regulatory standards for the model of care.

7

Announcement of Calendar Year (CY) 2008 Medicare Advantage Capitation Rates and Payment Policies can be found at:

https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/announcement2008.pdf.

8

Announcement of Calendar Year (CY) 2009 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies can be found at:

https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2009.pdf.

MOCs are a vital quality improvement tool and integral component for ensuring that the unique needs of each beneficiary enrolled in a SNP are identified and addressed. Section 3205 of the Patient Protection and Affordable Care Act of 2010 (hereinafter referred to as the Affordable Care Act) (Pub. L. 111-148) amended section 1859(f) of the Act to require that, starting in 2012, all SNPs be approved by NCQA based on standards developed by the Secretary. As provided under §§ 422.4(a)(iv), 422.101(f), and 422.152(g), the NCQA approval process is based on evaluation and approval of the SNP MOC, as per CMS guidance. Therefore, all SNPs must submit their MOCs to CMS for NCQA evaluation.

The MOC is organized to promote clarity and enhance the focus on care coordination, care transition, care needs and activities. The NCQA scoring approval process is based on scoring each of the clinical and non-clinical elements of the MOC as part of the SNP application.

The MOC narrative must include the following four elements:

• Description of the SNP Population.

• Care Coordination.

• SNP Provider Network.

• MOC Quality Measurement & Performance Improvement.

Each of the four elements is comprised of a set of required subcomponents, or factors, such as an identification and comprehensive description of the SNP-specific population. These subcomponents are reviewed and scored by NCQA and contribute to the overall score for that element. A full list of elements and factors, as well as CMS subregulatory guidance pertaining to MOC submission requirements and structure, can be found in Chapter 5 of the MMCM.

We propose to revise § 422.101(f) to implement certain new requirements added to section 1859(f)(5)(B) of the Act by the BBA of 2018 and to extend them to all SNP types. Specifically, we propose to revise § 422.101(f) to impose the new requirements governing SNP enrollee care management and SNP MOC submissions. Section 50311(c) of the BBA of 2018 amends section 1859(f)(5) of the Act to explicitly require improvements in care management and the establishment of a minimum benchmark for each element of the SNP model of care of a plan specific to C-SNP MOC submissions. We are proposing that these requirements be extended to all SNP plan types for several reasons. First, these additional requirements are consistent with current regulations and sub-regulatory guidance CMS provides to all SNPs regarding care management and MOC compliance. Second, we believe that these proposed

regulations are important safeguards to preserve the quality of care for all special needs individuals, including those enrolled in D-SNPs and I-SNPs and not just those enrolled in C-SNPs. Given the prevalence of medically complex chronic conditions among I-SNP and D-SNP enrollees, we believe the proper application of these new care improvement requirements would improve care for enrollees with complex chronic conditions. Further, we believe that the application of multiple, different MOC standards would be operationally complex and burdensome for MA organizations that sponsor multiple SNP plan types, for instance, a D-SNP and a C-SNP. We welcome comment of the extension of the new care management and MOC requirements for C-SNPs to the care management and MOC requirements for all SNP types.

1. The Interdisciplinary Team in the Management of Care

First, we propose to implement the requirement in section 1859(f)(5)(B)(i) of the Act addressing the interdisciplinary team in an amendment to § 422.101(f)(1)(iii) that would, in addition to implementing the statutory requirement for C-SNPs, extend the requirement to all SNPs. Currently, § 422.101(f)(1)(iii) requires each SNP to use an interdisciplinary team in the management of care but does not include much detail about that requirement. We propose to amend paragraph (f)(1)(iii) to require that each MA organization offering a SNP plan must provide each enrollee with an interdisciplinary team in the management of care that includes a team of providers with demonstrated expertise and training, and, as applicable, training in a defined role appropriate to their licensure in treating individuals similar to the targeted population of the plan.

As we noted in the January 2009 final rule, MIPPA required SNPs to conduct initial and annual comprehensive health risk assessments, develop and implement an individualized plan of care, and implement an interdisciplinary team for each beneficiary. We believe that combination of MIPPA's statutory elements and our regulatory prescription for the SNP model of care establishes the standardized architecture for effective care management while giving plans the flexibility to design the unique services and benefits that enable them to meet the identified needs of their target population. We believe this proposal, which amends paragraph (f)(1)(iii) and applies additional requirements pertaining to demonstrated expertise and training of interdisciplinary team providers to all SNPs, is consistent with the MIPPA requirements and the January 2009 final rule that provided the original authority regarding the use of interdisciplinary teams. All SNPs must have an interdisciplinary team to coordinate the delivery of services and benefits. However, one SNP may choose to contract with an interdisciplinary team to deliver care in community health clinics and another SNP may hire its team to deliver care in the home setting. Under the current rule, and our proposal, all SNPs must coordinate the delivery of services and benefits through integrated systems of communication among plan personnel, providers, and beneficiaries. However, one SNP may coordinate care through a telephonic connection among all stakeholders and a second SNP may coordinate care through an electronic system using Web-based records and electronic mail accessed exclusively by the plan, network providers, and beneficiaries. All SNPs must coordinate the delivery of specialized benefits and services that meet the needs of their most vulnerable beneficiaries. However, D-SNPs may need to coordinate Medicaid services while an institutional SNP may need to facilitate hospice care for its beneficiaries near the end of life. These examples demonstrate the variety of ways SNPs currently implement their systems of care, and we believe plans can and should provide enrollees with a team of providers with expertise and training that are appropriate for each individual enrollee.

Ultimately, we believe plans are in the best position to identify an interdisciplinary team with the appropriate expertise and training necessary to meet the clinical needs for each enrollee based on the medical and behavioral health conditions of their member population. We solicit comment on this proposed implementation of section 1859(f)(5)(B)(i) of the Act. We welcome feedback on how plans can meet the requirements for both demonstrated expertise and training in an applicable specialty.

2. Face-to-Face Annual Encounters

Second, we propose to implement the requirement in section 1859(f)(5)(B)(ii) of the Act requiring compliance with requirements (developed by CMS) to provide a face-to-face encounter with each enrollee. We are proposing that the face-to-face encounter be between each enrollee and a member of the enrollee's interdisciplinary team or the plan's case management and coordination staff on at least an annual basis, beginning within the first 12 months of enrollment, as feasible and with the individual's consent. A face-for-face encounter must be either in person or through a visual, real-time, interactive telehealth encounter. We propose to implement this requirement in a new paragraph (f)(1)(iv) of § 422.101 that would extend the requirement to all SNPs. We propose to require the MA organization to provide an annual face-to-face visit, that is in-person or by remote technology, to occur starting within the first 12 months of enrollment within the plan. For instance, a plan enrolling a beneficiary on October 1 would need to facilitate an in-person meeting by September 30th of the following year. Under our proposal, a visit to or by a member of an individual's interdisciplinary team or the plan's case management and coordination staff that perform clinical functions, such as direct beneficiary care, would meet this requirement. Examples of what these encounters may entail, though not limited to, include a member of an individual's interdisciplinary team or the plan's case management and coordination staff engaging with the enrollee to manage, treat and oversee (or coordinate) their health care, including preventive care included in the individualized care plan (ICP). Additional examples of such activities may include annual wellness visits and/or physicals, health risk assessment (HRA) completion, care plan review, health related education, and care coordination activities, but these are not the only activities that satisfy the proposed regulatory requirement. Encounters may also address any concerns related to physical, mental/behavioral health, and overall health status, including functional status. We anticipate that, consistent with good clinical practice, concerns are addressed and any appropriate referrals, follow-up, and care coordination activities provided or scheduled as necessary as a result of these face-to-face encounters. Plans should implement this requirement in a manner that honors any enrollee's decision not to participate in any qualifying encounter as noted previously.

Consistent with the authority for MA plans to offer additional telehealth benefits, under § 422.135 as finalized in the Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and

Medicaid Managed Care Programs for Years 2020 and 2021 Final Rule (hereinafter referred to as the April 2019 final rule), we are proposing that the face-to-face encounters required for all SNPs under this new rule may include visual, real-time, interactive telehealth encounters. As we noted in the April 2019 final rule, we believe MA additional telehealth benefits will increase access to patient-centered care by giving enrollees more control to determine when, where, and how they access benefits. We are seeking comment on proposed § 422.101(f)(1)(iv) and the suggested criteria for what constitutes a face-to-face encounter.

3. Health Risk Assessments and the SNP Enrollee's Individualized Care Plan

Third, we are proposing to codify the requirement in section 1859(f)(5)(B)(iii) of the Act that, as part of the C-SNP model of care, the results of the initial assessment and annual reassessment required for each enrollee be addressed in the individual's individualized care plan. As with the other provisions in section 1859(f)(5)(B) of the Act, we are proposing to extend this requirement to the model of care for all SNPs in revisions to § 422.101(f)(1)(i). Currently, MA organizations offering SNPs must conduct a comprehensive initial health risk assessment of the individual's physical, psychosocial, and functional needs as well as annual HRA, using a comprehensive risk assessment tool that CMS may review during oversight activities. We propose to revise § 422.101(f)(1)(i) by adding that the MA organization must ensure that results from the initial assessment and annual reassessment conducted for each individual enrolled in the plan are addressed in the individual's individualized care plan required under § 422.101(f)(1)(ii) are addressed in the individual's individualized care plan required under § 422.101(f)(1)(ii).

We believe that the HRA plays a critical role in coordinating the care of SNP enrollees. Section 1859(f)(5)(A) of the Act requires SNPs to conduct initial and annual comprehensive HRA, develop and implement an individualized plan of care, and implement an interdisciplinary team for each beneficiary. As noted in the January 2009 final rule, we believe that the combination of these statutory elements and our regulatory prescription for the SNP model of care establishes the standardized architecture for effective care management. We believe extending the requirement for the individualized care plan to address the results of the initial assessment and annual reassessment care to I-SNPs and D-SNPs, instead of limiting the requirement to C-SNPs, would further increase the effectiveness of the ICP and increase quality outcomes. We welcome comment concerning the amended regulation at § 422.101(f)(1)(i).

4. SNP Fulfillment of the Previous Year's MOC Goals

Fourth, we are proposing to codify the requirement in section 1859(f)(5)(B)(iv) of the Act that the evaluation and approval of the model of care take into account whether the plan fulfilled the previous MOC's goals and to extend this evaluation component to all SNP models of care, rather than limiting it to C-SNPs. We propose a new regulation at § 422.101(f)(3)(ii) that as part of the evaluation and approval of the SNP model of care, NCQA must evaluate whether goals were fulfilled from the previous model of care and plans must provide relevant information pertaining to the MOC's goals as well as appropriate data pertaining to the fulfillment of the previous MOC's goals. If the SNP model of care did not fulfill the previous MOC's goals, the plan must indicate in the MOC submission how it will achieve or revise the goals for the plan's next MOC. We are also proposing to move an existing regulation at § 422.101(f)(2)(vi) that requires all SNPs must submit their MOC to CMS for NCQA evaluation and approval in accordance with CMS guidance to a new paragraph at § 422.101(f)(3). The proposed paragraph at (f)(3)(i) would contain the same language as § 422.101(f)(2)(vi).

We intend that NCQA would determine whether each SNP, as part of the evaluation and MOC approval process, provided adequate information to evaluate the regulation under § 422.101(f)(3)(ii) as well as whether the SNP met goals from the previous MOC submission. It is implicit in the evaluation of the MOC and the requirement for the SNP to submit relevant information that the information submitted by the SNP must be adequate for NCQA to use to evaluate whether the goals from the prior MOC have been fulfilled. We solicit comment whether more explicit requirements on this point should be part of the regulation text.

The proposed regulation at § 422.101(f)(3)(ii) aligns with our current guidance on the MOC submission and review process regarding SNP fulfillment of goals. Currently, all SNPs are required to identify and clearly define measureable goals and health outcomes as part of their model of care under MOC 4, Element B: Measureable Goals and Health Outcomes for the MOC as defined in Chapter 5 of the MMCM. CMS believes that it is critical for all SNPs to use the results of the quality performance indicators and measures to support ongoing improvement of the MOC, and that all SNPs should continuously assess and evaluate plan quality outcomes. MOC 4, Element B currently contains the following parameters:

• Identify and define the measurable goals and health outcomes used to improve the health care needs of SNP beneficiaries.

• Identify specific beneficiary health outcome measures used to measure overall SNP population health outcomes at the plan level.

• Describe how the SNP establishes methods to assess and track the MOC's impact on SNP beneficiaries' health outcomes.

• Describe the processes and procedures the SNP will use to determine if health outcome goals are met.

• Describe the steps the SNP will take if goals are not met in the expected timeframe.

For SNPs submitting their initial MOC, NCQA will evaluate the information under MOC 4 Element B as the setting of clearly definable and measurable goals and health outcomes in their MOC for the upcoming MOC period of performance. For the following submission year, the plan will be evaluated on whether the measurable goals and health outcomes set in the initial MOC were achieved.

Plans submitting an initial model of care must provide relevant information pertaining to the MOC's goals for review and approval under this paragraph. We propose specific regulation text on this point at § 422.101(f)(3)(ii)(B). We seek comment on the new regulation at § 422.101(f)(3)(ii).

5. Establishing a Minimum Benchmark for Each Element of the SNP Model of Care

Finally, we propose new regulation text at § 422.101(f)(3)(iii) to impose the requirement for benchmarks to be met for a MOC to be approved. Section 1859(f)(5)(B)(v) of the Act requires that the Secretary establish a minimum benchmark for each element of the C-SNP model of care, and that the MOC can only be approved if each element meets a minimum benchmark. We propose in § 422.101(f)(3)(iii) to implement these benchmarks for all SNP models of care. Given that medically complex conditions are found in enrollees across all SNP types and

that implementation to C-SNPs alone would be operationally challenging for plans offering multiple SNP types, we believe it is appropriate to extend this requirement to all SNPs. Each SNP model of care would be evaluated based on a minimum benchmark for each of the four elements. Currently, each subfactor of a MOC element is valued at 0-4 points with the score of each element based on the number of factors met for that specific element; the aggregate total of all possible points across all elements equals 60, which is then converted to percentage scores based on the number of total points received. We propose that each element of the MOC must meet a minimum benchmark of 50 percent of total points as allotted, and a plan's MOC would only be approved if each element of the model of care meets the applicable minimum benchmark.

We welcome comment on the proposed § 422.101(f)(3)(iii). Specifically, we are seeking comment to our proposed benchmark and scoring criteria as they impact the evaluation of SNP models of care.

C. Coverage Gap Discount Program Updates (§§ 423.100 and 423.2305)

We propose to amend our regulations at §§ 423.100 (definition of applicable drug) and 423.2305 (determination of coverage gap discount) to reflect recent changes to the relevant statutory provisions. Sections 53113 and 53116 of the BBA of 2018 amended section 1860D-14A of the Act to (a) increase the coverage gap discount for applicable drugs from 50 to 70 percent of the negotiated price beginning in plan year 2019, and (b) revise the definition of an applicable drug to include biosimilar biological products, also beginning in plan year 2019.

Specifically, section 53116 of the BBA of 2018 revised the definition of “discounted price,” meaning the price provided to the beneficiary, in section 1860D-14A(g)(4)(A) of the Act to mean, for a plan year after 2018, 30 percent of the negotiated price. This means that the coverage gap discount is 70 percent, rather than 50 percent. To make our regulations consistent with this change, we propose to amend the definition of “applicable discount” in § 423.2305 to provide that, with respect to a plan year after plan year 2018, the applicable discount is 70 percent of the portion of the negotiated price (as defined in § 423.2305) of the applicable drug of a manufacturer that falls within the coverage gap and that remains after such negotiated price is reduced by any supplemental benefits that are available.

Section 53113 of the BBA of 2018 amended section 1860D-14A(g)(2)(A) of the Act to specify that biologic products licensed under subsection (k) (that is, biosimilar and interchangeable biological products) are excluded from the coverage gap discount program only with respect to plan years before 2019. Therefore, we are proposing to revise the definition of applicable drug at § 423.100 to specify that such biological products are excluded only for plan years before 2019. Accordingly, biosimilar products are included in the Discount Program beginning for plan year 2019.

D. Part D Income Related Monthly Adjustment Amount (IRMAA) Calculation Update for Part D Premium Amounts (§ 423.286)

Section 3308 of the Affordable Care Act amended section 1860D-13(a) of the Act and imposed an income-related monthly adjustment amount for Medicare Part D (hereinafter referred to as Part D-IRMAA) for beneficiaries whose modified adjusted gross income (MAGI) exceeds the same income threshold amount tiers established under section 1839(i) of the Act with respect to the Medicare Part B income-related monthly adjustment amount (Part B-IRMAA). The Part D-IRMAA is an amount that a beneficiary pays in addition to the monthly plan premium for Medicare prescription drug coverage under the Part D plan in which the beneficiary is enrolled when the beneficiary's MAGI is above the specified threshold.

The Part D-IRMAA income tiers mirror those established for the Part B-IRMAA. As specified in section 1839(i) of the Act, when the Part B-IRMAA went into effect in 2007, individuals and joint tax filers enrolled in Medicare Part B whose modified adjusted gross income exceeded $80,000 and $160,000, respectively, were assessed the Part B-IRMAA on a sliding scale. As specified in section 1839(i)(5) of the Act, each dollar amount within the income threshold tiers shall be adjusted annually based on the Consumer Price Index (CPI). As a result of the annual adjustment, for calendar year 2010, the income threshold amounts had increased to reflect the four income threshold amount tiers for individuals and joint tax filers whose modified adjusted gross income exceeded $85,000 and $170,000, respectively. (We note that section 3402 of the Affordable Care Act froze the income thresholds for 2011 through 2019 at the level established for 2010.)

Consistent with section 3308 of the Affordable Care Act, the Part D-IRMAA is calculated using the Part D national base beneficiary premium (BBP) and the applicable premium percentage (P) as follows: BBP × [(P − 25.5 percent)/25.5 percent]. The premium percentage used in the calculation will depend on the level of the Part D enrollee's modified adjusted gross income.

Section 3308 of the Affordable Care Act requires CMS to provide the Social Security Administration (SSA) with the national base beneficiary premium amount used to calculate the Part D-IRMAA no later than September 15 of each year, starting in 2010. Also effective in 2010, CMS must provide SSA no later than October 15 of each year, with: (1) The modified adjusted gross income threshold ranges; (2) the applicable percentages established for Part D-IRMAA in accordance with section 1839 of the Act; (3) the corresponding monthly adjustment amounts; and (4) any other information SSA deems necessary to carry out Part D-IRMAA.

To determine a beneficiary's IRMAA, SSA considers the beneficiary's MAGI, together with their tax filing status, to determine the percentage of the: (1) Unsubsidized Medicare Part B premium the beneficiary must pay; and (2) cost of basic Medicare prescription drug coverage that the beneficiary must pay.

Since the implementation of the Part D-IRMAA in 2011, subsequent revisions to the statute have modified the associated income tiers used in IRMAA calculations:

• Section 402 of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015, revised the income thresholds for the Part B- and Part D-IRMAA income groups such that beneficiaries with incomes greater than $85,000 but not more than $107,000 were required to pay 35 percent of Part B and Part D program costs; beneficiaries with incomes greater than $107,000 but not more than $133,500 would pay 50 percent of Part B and Part D program costs; beneficiaries with incomes greater than $133,500 but not more than $160,000 would pay 65 percent of Part B and Part D program costs; while beneficiaries with incomes greater than $160,000 were required to pay 80 percent of Part B and Part D program costs.

• Section 53114 of the BBA of 2018 revised the MAGI ranges again such that, beginning in 2019, beneficiaries with incomes greater than $500,000 ($750,000 for joint tax filers) are required to pay 85 percent of program costs (an increase from 80 percent).

We are proposing to revise § 423.286(d)(4)(ii) for consistency with the changes made by section 53114 of

the BBA of 2018 and to make other technical changes to ensure that the calculations used in the methodology for updating Part D-IRMAA are described correctly. We propose to remove the language “the product of the quotient obtained by dividing the applicable premium percentage specified in § 418.2120 (35, 50, 65, or 80 percent) that is based on the level of the Part D enrollee's modified adjusted gross income for the calendar year reduced by 25.5 percent and the base beneficiary premium as determined under paragraph (c) of this section” and replace it with the product of the standard base beneficiary premium, as determined under paragraph (c) of this section, and the ratio of the applicable premium percentage specified in 20 CFR 418.2120, reduced by 25.5 percent; divided by 25.5 percent (that is, premium percentage −25.5)/25.5).

We are not scoring this provision in the Regulatory Impact Analysis section since it codifies existing guidance. We believe all stakeholders are already following the current guidance. We are also not scoring this provision in the Collection of Information section since we believe all information impacts of this provision have already been accounted for under OMB control number 0938-0964 (CMS-10141), but seek comment on this assumption.

E. Contracting Standards for Dual Eligible Special Needs Plan (D-SNP) Look-Alikes (§ 422.514)

Special needs plans (SNPs) are MA plans created by the MMA that are specifically designed to provide targeted care and limit enrollment to special needs individuals. Under section 1859 of the Act, SNPs are able to restrict enrollment to: (1) Institutionalized individuals, who are currently defined in § 422.2 as those residing or expecting to reside for 90 days or longer in a long term care facility; (2) individuals entitled to medical assistance under a State Plan under Title XIX; or (3) other individuals with certain severe or disabling chronic conditions who would benefit from enrollment in a SNP. As of July 2019, there are 321 SNP contracts with 734 SNP plans that have at least 11 members, including all of the following:

• 480 dual eligible SNPs (D-SNPs).

• 125 institutional SNPs (I-SNPs).

• 129 chronic or disabling condition SNPs (C-SNPs).

9

9

Centers for Medicare & Medicaid Services.

SNP Comprehensive Report.

(July 2019) Retrieved from

https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data.html.

Beneficiaries who are dually eligible for both Medicare and Medicaid can face significant challenges in navigating the two programs, which include separate or overlapping benefits and administrative processes. Fragmentation between the two programs can result in a lack of coordination for care delivery, potentially resulting in—(1) missed opportunities to provide appropriate, high-quality care and improve health outcomes; and (2) undesirable outcomes, such as avoidable hospitalizations and poor beneficiary experiences. Advancing policies and programs that integrate care for dually eligible individuals is one way in which we seek to address such fragmentation. Under plans that offer integrated care, dually eligible individuals receive the full array of Medicaid and Medicare benefits through a single delivery system, thereby improving care coordination, quality of care, and beneficiary satisfaction, and reducing administrative burden. Some studies have shown that highly integrated managed care programs perform well on quality of care indicators and enrollee satisfaction.

10

10

See Kim, H., Charlesworth, C.J., McConnell, K.J., Valentine, J.B., and Grabowski, D.C. “Comparing Care for Dual-Eligibles Across Coverage Models: Empirical Evidence From Oregon”,

Medical Care Research and Review,

(November 15, 2017) 1-17. Retrieved from

http://journals.sagepub.com/doi/abs/10.1177/1077558717740206;

Anderson, W.L., Feng, Z., & Long, S.K.

Minnesota Managed Care Longitudinal Data Analysis,

prepared for the U.S. Department of Health and Human Services Assistant Secretary for Planning and Evaluation (ASPE) (March 31, 2016). Retrieved from

https://aspe.hhs.gov/report/minnesota-managed-care-longitudinal-data-analysis;

Health Management Associates.

Value Assessment of the Senior Care Options (SCO) Program

(July 21, 2015). Retrieved from

http://www.mahp.com/wp-content/uploads/2017/04/SCO-White-Paper-HMA-2015_07_20-Final.pdf;

and Medicare Payment Advisory Committee. “Chapter 2, Care coordination programs for dual-eligible beneficiaries.” In

June 2012 Report to Congress: Medicare and Health Care Delivery System

(June 16, 2012). Retrieved from

http://www.medpac.gov/docs/default-source/reports/jun12_entirereport.pdf?sfvrsn=0.

D-SNPs are intended to integrate or coordinate care for this population more effectively than standard MA plans or the original Medicare fee-for-service program by focusing enrollment and care management on dually eligible individuals. As of July 2019, approximately 2.6 million dually eligible individuals (1 of every 5 dually eligible individuals) were enrolled in 480 D-SNPs.

Federal statute and implementing regulations have established several requirements for D-SNPs in addition to those that apply to all MA plans, including all of the following:

•

Health risk assessment.

Section 164 of MIPPA amended section 1859(f) of the Act to require all SNPs to conduct an initial assessment and an annual reassessment of an enrollee's physical, psychosocial, and functional needs. Implementing regulations are codified at § 422.101(f)(1)(i).

•

Model of care.

Section 164 of MIPPA amended section 1859(f) of the Act to require all SNPs to have in place an evidence-based model of care with appropriate networks of providers and specialists. Implementing regulations are codified at § 422.101(f).

•

Comprehensive written statement.

Section 164 of MIPPA amended section 1859(f) of the Act to require D-SNPs to provide each prospective enrollee, prior to enrollment, with a comprehensive written statement that describes the benefits and cost-sharing protections to which the beneficiary is entitled under Medicaid and which of those Medicaid benefits are covered by the D-SNP. Implementing regulations are codified at § 422.111(b)(2)(iii).

•

State Medicaid agency contract.

Section 164 of MIPPA also amended section 1859(f) of the Act to require that D-SNPs contract with the state Medicaid agency to provide benefits, or arrange for the provision of Medicaid benefits, which may include long-term care services consistent with state policy, to which an individual is entitled. Notwithstanding this requirement for D-SNPs, section 164(c)(4) of MIPPA stipulated that a state is in no way obligated to contract with a D-SNP, which therefore provides states with significant control over the availability of D-SNPs. Implementing regulations are codified at § 422.107.

These requirements promote coordination of care. Additionally, the state Medicaid agency contracting requirement allows states the flexibility to require greater integration of Medicare and Medicaid benefits from the D-SNPs in their markets. For example, to develop products that integrate Medicare and Medicaid coverage, several states—including Arizona, Hawaii, Idaho, Massachusetts, Minnesota, New Jersey, and Tennessee—operate Medicaid managed care programs for dually eligible individuals in which the state requires that the Medicaid managed care organizations (MCOs) serving dually eligible individuals offer a companion D-SNP product. These states also require specific care coordination or data sharing activities in their contracts with D-SNPs.

11

11

See Verdier, J., Kruse, A., Sweetland Lester, R., Philip, A.M., and Chelminsky, D.

State Contracting

with Medicare Advantage Dual Eligible Special Needs Plans: Issues and Options

(November 2016). Retrieved from

https://www.integratedcareresourcecenter.com/sites/default/files/ICRC_DSNP_Issues_Options.pdf.

More recently, section 50311(b) of the BBA of 2018 amended section 1859 of the Act to add new requirements for D-SNPs, beginning in 2021. These requirements, along with clarifications to existing regulations, were codified in the April 2019 final rule (84 FR 15680 through 15844).

•

Minimum integration standards.

As required under section 1859(f)(8)(D)(i) of the Act, as added by the BBA of 2018, all D-SNPs must meet certain new minimum criteria for integration of Medicare and Medicaid benefits for 2021 and subsequent years. To achieve the minimum integration standards, we codified in the April 2019 final rule that a D-SNP must: (1) Be a fully integrated dual eligible (FIDE) SNP; (2) be a highly integrated dual eligible (HIDE) SNP; or (3) have a contract with the state to notify the state, or the state's designee, of high-risk individuals' hospital and skilled nursing facility admissions. Section 1859(f)(8)(D)(ii) of the Act provides that for the years 2021 through 2025, if the Secretary determines that a D-SNP fails to meet one of these integration standards, the Secretary may prevent the D-SNP from enrolling new members. These provisions are codified in amendments to §§ 422.2, 422.107(d), and 422.752(d) that are effective January 1, 2021.

•

Medicaid coordination:

We interpreted the meaning of the requirement in section 1859(f)(3)(D) of the Act, originally codified at § 422.107(b), that the MA organization has responsibility under the contract for providing benefits or arranging for benefits to be provided for individuals entitled to Medicaid as requiring aD-SNP, at a minimum, to coordinate the delivery of Medicare and Medicaid benefits. This requirement is reflected in an amendment to the D-SNP definition at § 422.2, effective January 1, 2020. In addition, an amendment to § 422.562(a)(5), also effective January 1, 2020, requires all D-SNPs to make assistance available to individuals filing a grievance or appeal for Medicaid services.

•

Unified appeals and grievances.

Sections 1859(f)(8)(B) and (C) of the Act require development of unified grievance and appeals processes forD-SNPs, to the extent feasible, to be applicable beginning 2021. We finalized definitions at § 422.561 and implementing regulations, effective January 1, 2021, at §§ 422.560, 422.562, 422.566, 422.629 through 422.634, 438.210, 438.400, and 438.402 in the April 2019 final rule. For 2021 and subsequent years, integrated D-SNPs with exclusively aligned enrollment, termed “applicable integrated plans,” must establish integrated grievance and appeals systems using integrated timeframes, notices, and processes. New rules under § 422.632, also effective January 1, 2021, require continuation of benefits pending appeal for enrollees in applicable integrated plans.

The pattern of federal legislation, CMS rulemaking, and state use ofD-SNP contracting requirements has incrementally created new requirements for D-SNPs that have generally promoted additional beneficiary protections, coordination of care, and integration of Medicare and Medicaid coverage for dually eligible individuals. While many of these requirements impose additional burdens for D-SNPs, they have not impeded enrollment growth in these plans. Total D-SNP enrollment has more than doubled from one million in 2010 to 2.6 million in 2019.

12

Participation of MA organizations is robust, and most markets are stable and competitive.

12

Centers for Medicare & Medicaid Services.

SNP Comprehensive Report

(July 2010 & July 2019). Retrieved from

https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data.html.

In its June 2018 and 2019 reports to Congress, the Medicare Payment Advisory Commission (MedPAC) describes the emergence of “D-SNP look-alike” plans that have similar levels of dual eligible enrollment asD-SNPs. For example, MedPAC analysis of 2016 data in select California counties found that, as a percentage of total enrollment, dually eligible individuals accounted for 97 percent of enrollment in D-SNPs and 95 percent in D-SNP look-alikes—compared to 10 percent in other MA plans. Analysis of 2017 enrollment nationally showed multiple D-SNP look-alikes in which dually eligible individuals account for more than 95 percent of total enrollment.

13

Although section 1859(b)(6) of the Act establishes D-SNPs as the only type of MA plan that can exclusively enroll dually eligible individuals, the data show that D-SNP look-alikes have levels of dual eligible enrollment that are virtually indistinguishable from those of D-SNPs and far above those of the typical MA plan.

13

See

June 2018 MedPAC Report to Congress, Chapter 9

at

http://medpac.gov/docs/default-source/reports/jun18_ch9_medpacreport_sec.pdf?sfvrsn=0

and

June 2019 MedPAC Report to Congress, Chapter 12

at

http://www.medpac.gov/docs/default-source/reports/jun19_ch12_medpac_reporttocongress_sec.pdf?sfvrsn=0.

We believe the low enrollment of non-dually eligible individuals in D-SNP look-alikes results from benefits and cost-sharing that, like the benefits and cost-sharing offered by D-SNPs, are designed to attract only dually eligible individuals. In contrast to non-SNP MA plans, both D-SNPs and D-SNP look-alikes allocate a lower percentage of MA rebate dollars received under the bidding process at § 422.266 to reducing Medicare cost-sharing and a higher percentage of rebate dollars to supplemental medical benefits such as dental, hearing, and vision services. With such a benefit design, manyD-SNP look-alikes technically require members to pay higher cost sharing on Parts A and B services than most MA plans require, which we believe dissuades most non-dually eligible Medicare beneficiaries from enrolling. However, because most dually eligible individuals are Qualified Medicare Beneficiaries (QMBs) who are not required to pay Medicare cost sharing, we believe they are not dissuaded from enrolling in these non-D-SNPs by the relatively higher cost sharing. A similar dynamic exists for Part D premiums and high deductibles, both of which are covered by the Part D low-income subsidy that dually eligible individuals receive. We believe that such benefit designs are unattractive for Medicare beneficiaries who are not dually eligible individuals because they would need to cover these costs out-of-pocket. Despite the similarities with D-SNPs in terms of levels of dual eligible enrollment and benefits and cost-sharing design, D-SNP look-alikes are regulated as non-SNP MA plans and are not subject to the federal regulatory and state contracting requirements applicable to D-SNPs.

D-SNP look-alikes first emerged in certain California markets in 2013, after the state placed enrollment restrictions on D-SNPs in areas served by Medicare-Medicaid Plans (MMPs) participating in the Financial Alignment Initiative. Enrollment in D-SNP look-alikes has increased substantially since that time. In these California markets, MedPAC found that D-SNP look-alike enrollment grew from around 5,000 in 2013 to over 95,000 in 2017.

14

MedPAC also explored enrollment trends more broadly, identifying 31 non-SNP

plans

15

operating in 2017 in which dually eligible individuals comprised 80 percent or more of total plan enrollment. These 31 plans, which operated in 10 states (mostly in California and Florida), included approximately 151,000 enrollees. MedPAC estimated that in 2019 enrollment would increase to 193,000 beneficiaries in 54 D-SNP look-alikes across 13 states.

16

14

See

June 2018 MedPAC Report to Congress, Chapter 9

at

http://medpac.gov/docs/default-source/reports/jun18_ch9_medpacreport_sec.pdf?sfvrsn=0.

15

MedPAC also excluded employer group waiver plans (EGWPs) and a select group of medical savings account (MSA) plans.

16

See

June 2018 MedPAC Report to Congress, Chapter 9

at

http://medpac.gov/docs/default-source/reports/jun18_ch9_medpacreport_sec.pdf?sfvrsn=0

and

June 2019 MedPAC Report to Congress, Chapter 12

at

http://www.medpac.gov/docs/default-source/reports/jun19_ch12_medpac_reporttocongress_sec.pdf?sfvrsn=0.

It is not clear that D-SNP look-alikes are essential to the implementation of the Medicare Advantage program or to access to coverage or care for Medicare beneficiaries. Unlike the non-SNP MA plans in which many dually eligible individuals enroll, D-SNP look-alikes do, however, have the near-exclusive levels of dual eligible enrollment that the statute envisions only for D-SNPs that must meet additional Medicare and Medicaid coordination and integration requirements. Most D-SNP look-like enrollment is in markets that feature numerous other plan choices for beneficiaries. Only about 1.2 percent of dually eligible enrollees in traditional MA plans (that is, non-SNP MA plans) are in plans with 80 percent or higher dually eligible enrollment. The data also show that traditional MA plans that are not D-SNP look-alikes can attract dually eligible enrollment; 97 percent of dually eligible individuals enrolled in non-SNP MA plans are in a plan with dual eligible enrollment of 30 percent or less.

17

17

Ibid.

The proliferation and growth ofD-SNP look-alikes raises multiple areas of concern as follows:

•

Effective implementation of BBA of 2018 requirements.

As discussed earlier in this proposed rule, beginning in contract year 2021, all D-SNPs must meet new minimum criteria for Medicare and Medicaid integration.D-SNP look-alikes hinder meaningful implementation of these statutory requirements. By creating and offering these D-SNP look-alikes that target the same dually eligible individuals who are intended to benefit from integrated D-SNPs, MA organizations are circumventing the new integration requirements.

•

Meaningful integration.

Several states use the state Medicaid agency contracting requirements for D-SNPs at § 422.107 to promote greater Medicare-Medicaid integration. In such states, the state and D-SNP establish specific care coordination protocols, data sharing processes, and other activities to promote better beneficiary experiences. Proliferation of D-SNP look-alikes, for which the same state contracting requirement does not apply, impedes states from using their contracting authority under section 1859 of the Act to ensure that plans predominantly serving dually eligible individuals are working toward those goals. In its comments to CMS for the April 2019 final rule, the Medicaid and CHIP Payment and Access Commission (MACPAC) expressed concern that the growth of D-SNP look-alikes may undermine efforts to promote increased integration through D-SNPs and urged CMS to continue to monitor the growth of look-alikes and determine if further action is needed.

18

As we noted earlier, studies have shown that highly integrated managed care programs perform well on quality of care indicators and enrollee satisfaction.

18

Available at

https://www.macpac.gov/wp-content/uploads/2018/12/Comments-on-Changes-to-MA-the-Medicare-prescription-drug-benefit-PACE-Medicaid-fee-for-service-and-managed-care.pdf.

•

Care coordination requirements.

To better serve the dually eligible population, MIPPA and implementing regulations require D-SNPs to provide periodic health risk assessments, develop individualized care plans for their members, and develop and seek CMS approval for their models of care. These requirements do not apply toD-SNP look-alikes. As a result, nothing requires the D-SNP look-alikes to deliver the types of care coordination that Congress established as statutory requirements for plans that are designed for dually eligible individuals.

•

Beneficiary confusion.

The prevalence of the D-SNP look-alikes has led to instances of misleading marketing by brokers and agents that misrepresent to dually eligible individuals the characteristics of such look-alike plans, especially where the plans have marketed themselves as being special Medicaid-focused plans. We continue to learn of these marketing practices from our own review of broker materials, investigating complaints we have received, and reports from advocacy organizations.

19

Confusing and misleading marketing efforts may violate § 422.2268(a)(1) and (2) which this proposed rule proposes to redesignate as § 422.2262(a)(1)(i) and (iii) which prohibits MA organizations from providing information that is inaccurate or misleading and from engaging in activities that could mislead or confuse Medicare beneficiaries or misrepresent the MA organization. For that reason, and as discussed elsewhere in this proposed rule, we propose at § 422.2262(a)(1)(xvi) to codify previous subregulatory guidance from the Medicare Communications and Marketing Guidelines prohibiting MA organizations, with respect to their non-D-SNP plans, from marketing their plan as if it were a D-SNP, implying that their plan is designed for dually eligible individuals, targeting their marketing efforts exclusively to dually eligible individuals, or claiming a relationship with the state Medicaid agency, unless a contract to coordinate Medicaid services for that plan is in place.

19

Justice in Aging,

Dual Eligible Special Needs Plan (D-SNP) Look-Alikes: A Primer

(July 2019) at

https://www.justiceinaging.org/wp-content/uploads/2019/07/D-SNP-Look-Alikes-A-Primer.pdf.

We sought comments on the impact of D-SNP look-alikes in Medicare and Medicaid in the 2020 Draft Call Letter.

20

Specifically, we sought comment on topics related to the extent to which D-SNP look-alikes impact informed consumer choice; competition and innovation; the provision of high-quality coordinated care that addresses the full spectrum of dually eligible individuals' care and service needs; state Medicaid policy and operations; financial incentives; provider burden; and development and sustainability of products for dually eligible individuals through which an enrollee can receive all Medicare and Medicaid services from one organization.

20

Available at

https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Announcements-and-Documents.html.

As discussed in the 2020 Final Call Letter, we received comments from a range of stakeholders, including states, beneficiary advocates, and MA organizations and Medicaid MCOs.

21

Overall, the comments reinforced our concern that the proliferation of D-SNP look-alikes impedes progress toward developing products that meaningfully integrate Medicare and Medicaid benefits for dually eligible individuals. Commenters believed that D-SNP look-alikes allow MA organizations to circumvent enrollment restrictions and federal regulatory and state contracting requirements for D-SNPs and MMPs, undercutting efforts to lower costs and improve the quality of care.

21

Ibid.

As we noted in the 2020 Final Call Letter, commenters highlighted three areas that warranted further investigation and analysis and potential rulemaking: Benefit design and

nondiscrimination; beneficiary education, marketing, and broker compensation; and enhanced requirements for MA plans with high proportions of dually eligible enrollees. Some stakeholders suggested that benefit design used by D-SNP look-alikes appears to violate the prohibition at § 422.100(f)(2) against benefit designs that are discriminatory and against steering subsets of beneficiaries to specific plans, since their design targets dually eligible individuals.

We also received broad support for efforts to ensure that MA organizations do not market D-SNP look-alikes as plans that coordinate Medicaid benefits, as particularly suited to dually eligible individuals, or as uniquely subject to rules that protect dually eligible individuals from cost sharing or for which Medicaid pays the full amount of plan cost sharing. Lastly, several commenters recommended that CMS require MA plans with high proportions of dually eligible individuals to meet D-SNP regulatory requirements, including the requirement to contract with the state Medicaid agency.

To address these concerns, we are proposing at § 422.514(d) that CMS not enter into or renew a contract for a D-SNP look-alike in any state where there is a D-SNP or any other plan authorized by CMS to exclusively enroll dually eligible individuals. We also propose to establish procedures for transitioning enrollees from D-SNP look-likes to other MA plans in new regulation text at § 422.514(e). The proposed new contracting standards would effectively ensure all MA plans that predominantly serve dually eligible individuals integrate delivery of Medicare and Medicaid services and coordinate care consistent with the statutory and regulatory requirements for D-SNPs wherever it is feasible to do so.

Under our authority to adopt standards implementing the Part C statute and to add contract terms in sections 1856(b) and 1857(e)(1) of the Act, we are proposing to establish contracting standards for MA organizations based on their projected dually eligible enrollment in plan bids or on the proportion of dually eligible enrollees actually enrolled in the plan. A high rate of enrollment by dually eligible individuals in a non-D-SNP would allow us to identify non-SNP MA plans that are intended to predominantly enroll dually eligible individuals (that is, D-SNP look-alikes). We propose exceptions to these contracting standards for all SNPs. We believe that our proposal is an effective way to ensure that MA organizations do not undermine the statutory requirements established for D-SNPs by designing non-SNP MA plans to predominantly enroll dually eligible individuals. We believe that failure to adopt these exceptions could compromise the statutory and regulatory framework for D-SNPs. Any MA organization, by designing its benefits and outreach strategy to target dually eligible enrollment, practices that the enrollment patterns of D-SNP look-alikes show MA organizations are readily adopting, can offer an MA plan with high rates—in some cases almost 100 percent—of dually eligible enrollment without implementing any of the care management or Medicaid coordination activities that federal law requires of D-SNPs. States' ability to set contract terms for D-SNPs, including terms that limit contracted D-SNPs to entities that deliver integrated Medicare and Medicaid benefits, as provided under section 1859 of the Act, is likewise subverted by D-SNP look-alikes. Our proposal is especially critical as we approach implementation of new D-SNP requirements included in the BBA of 2018.

To prevent the undermining of the statutory and regulatory framework for D-SNPs, we therefore propose to establish a new regulation precluding CMS from entering into or renewing a contract for an MA plan that an MA organization offers, or proposes to offer, with enrollment of dually eligible individuals that exceeds specific enrollment thresholds. This proposed regulation would apply in any state where there is a D-SNP or any other plan authorized by CMS to exclusively enroll dually eligible individuals. Section 1856(b)(1) of the Act provides the Secretary with the authority to establish in regulation other standards not otherwise specified in statute that are both consistent with Part C statutory requirements and necessary to carry out the MA program. Our proposed regulations would ensure applicability and compliance with the statutory framework for D-SNPs. Additionally, section 1857(e)(1) of the Act authorizes the Secretary to establish MA organization contract terms and conditions that are necessary and appropriate and not inconsistent with other Part C statutory requirements. We believe that our proposed contract terms prohibiting the offering of D-SNP look-alikes is not inconsistent with the Part C statute and is necessary and appropriate to retain the integrity of the D-SNP statutory framework. Under the statute, only D-SNPs can primarily enroll dually eligible individuals, and D-SNPs must meet certain requirements. Our proposal would ensure that a non-SNP MA plan that, in practice, enrolls primarily dually eligible individuals under the conditions outlined in our proposal does not skirt the specific statutory and regulatory requirements designed to meet the specific needs of dually eligible individuals.

We propose not to enter into or renew MA contracts for an MA plan for an upcoming plan year when that MA plan is identified as exceeding specific enrollment thresholds for dually eligible individuals. However, MA organizations with plans identified as exceeding the enrollment threshold that also have approved D-SNPs for the following plan year would be permitted to transition dually eligible enrollees from D-SNP look-alikes to D-SNPs for which the individuals are eligible. We would permit this transition process to minimize disruptions to beneficiary coverage and allow enrollees in these D-SNP look-alikes to benefit from the statutory and regulatory care coordination and Medicaid integration requirements. We describe the specific changes we are proposing to § 422.514 as follows.

We propose changing the title of § 422.514 by removing the word “minimum” because the changes we propose to § 422.514 reflect an additional type of enrollment requirement beyond the minimum enrollment requirements currently articulated in § 422.514. We also propose to change the title of paragraph (a) from “Basic rule” to “Minimum enrollment rules” for clarity due to the proposed change to the scope of § 422.514.

We propose a new paragraph (d) to establish new contract requirements related to dual eligible enrollment. The proposed requirement at paragraph (d) would apply for an MA plan that is not a special needs plan for special needs individuals as defined in § 422.2. We propose applying this requirement only to non-SNP plans to allow for the predominant dually eligible enrollment that characterizes D-SNPs, I-SNPs, and some C-SNPs by virtue of the populations that the statute expressly permits each type of SNP to exclusively enroll. For D-SNPs, the rationale for the exception is obvious—these MA plans enroll dually eligible individuals by statute. I-SNPs, by virtue of enrolling institutionalized individuals, or community-residing individuals who, but for the long-term services and supports they receive, otherwise reside in a long-term care institution, typically have high proportions of dually eligible individuals who qualify to receive

Medicaid long-term care benefits. In July 2017, 92 percent of I-SNP enrollees were dually eligible individuals.

22

Certain C-SNPs also have a relatively high proportion of dually eligible individuals because the chronic conditions these plans target are more prevalent among dually eligible individuals. For example, in July 2017, dually eligible individual enrollment in one end-stage renal disease (ESRD) C-SNP was 49 percent of total enrollment, in one HIV/AIDS C-SNP was 68 percent of total enrollment, and in one chronic and disabling mental health conditions C-SNP was 83 percent of total enrollment.

23

We would not want our proposed requirements to limit C-SNP enrollment by dually eligible individuals who could benefit from a plan that employs a specialized model of care, periodic health risk assessments, and other techniques that result in specialized, comprehensive care for individuals with certain chronic conditions.

22

CMS, Chronic Conditions Data Warehouse, Part D Plan Characteristics File and Master Beneficiary Summary File, Final 2017 MBSF created in January 2019.

23

Ibid.

The proposed requirement at paragraph (d) would be limited to states where there is a D-SNP or any other plan authorized by CMS to exclusively enroll dually eligible individuals, such as MMPs. We propose this limitation because it is only in such states that the implementation of D-SNP requirements necessitates our proposed new contracting requirements. That is, in a state with no D-SNPs or comparable managed care plans like MMPs, the D-SNP requirements have not had any relevance historically. There are no plans contracted with the state to implement the D-SNP requirements or otherwise integrate Medicare and Medicaid services, and therefore the operation of a D-SNP look-alike would not have any material impact on the full implementation of federal D-SNP requirements. In such states, the existence of D-SNP look-alikes is not impeding state or federal implementation of any requirements for enhanced care coordination and Medicaid integration by providing a vehicle for MA organizations to avoid compliance with those requirements that are imposed on D-SNPs or comparable managed care plans like MMPs. Therefore, we do not believe it is critical for our proposed requirements in paragraph (d) to apply in such states.

As of July 2019, eight states do not have any D-SNPs. We believe there are two main reasons for the absence of D-SNPs in these states. First, the rural nature of some states makes it challenging for any MA plan, including a D-SNP, to operate because of the sparse Medicare population and the difficulty in establishing networks. Second, some state Medicaid agencies have decided not to contract with any D-SNPs, either because the agency is not pursuing integration of Medicare and Medicaid through managed care, or is pursuing integrated care through MMPs.

We believe the proposed limitation on the states where the proposed dual eligible enrollment requirement would apply would continue to protect states' ability to contract with plans—including for Medicaid behavioral health services and long-term supports and services—in a manner that promotes integration and coordination of benefits and a more seamless experience for dually eligible individuals in such plans. Based on the type of plan, states use different contracting mechanisms to establish such requirements. In particular, states establish three-way contracts with MMPs, state Medicaid agency contracts with D-SNPs, and other contracts with Medicaid MCOs affiliated with D-SNPs for the delivery of Medicaid benefits. Each type of contract between the state and plan can effectively establish integration and coordination of benefits requirements.

However, we recognize that the limitation would allow, in certain states, D-SNP look-alikes that do not meet the minimum D-SNP requirements for data sharing or care coordination. We seek comment on whether the absence of these data sharing and care coordination requirements for D-SNP look-alikes in states where they could continue to operate under our proposed rule disadvantages the dually eligible individuals in D-SNP look-alikes and whether we should extend the proposed requirement at paragraph (d) to all states.

We propose to add new paragraphs (d)(1) and (2) that would require that CMS not enter into or renew a contract, for plan year 2022 or subsequent years, for an MA plan that is a non-SNP plan that either:

• Projects in its bid submitted under § 422.254 that 80 percent or more of the plan's total enrollment are enrollees entitled to medical assistance under a state plan under Title XIX, or

• Has actual enrollment, as determined by CMS using the January enrollment of the current year, consisting of 80 percent or more of enrollees who are entitled to medical assistance under a state plan under Title XIX, unless the MA plan has been active for less than one year and has enrollment of 200 or fewer individuals at the time of such determination.

We believe that using either enrollment scenario is necessary to ensure that both new D-SNP look-alikes are not offered and that current, or existing, D-SNP look-alikes are not continued.

Proposed paragraph (d)(2), which would allow us to identify D-SNP look-alikes based on actual enrollment, would limit the prohibition to MA plans that have been active for one or more years and with enrollment equal to or greater than 200 individuals at the time of CMS' determination under proposed paragraph (d)(2). This limitation on our proposed contract requirement during a plan's first year is important because an early enrollment pattern may not be representative of the enrollment profile the plan will experience at a point of greater maturity.

To provide an example of how CMS would implement proposed paragraph (d)(2) in the first year, CMS would review MA plan enrollment data for January 2021 to determine if actual enrollment consists of 80 percent or more of enrollees who are entitled to medical assistance under a state plan under Title XIX. CMS would not enter into or renew the contract for contract year 2022 for an MA plan that exceeds the 80 percent threshold unless the MA plan has been active for less than one year and has January 2021 enrollment of 200 or fewer individuals.

We believe focusing on the proportion of dually eligible enrollment, both in bids and actual enrollment, is the best way to identify D-SNP look-alikes because it is the net result of benefit design and marketing strategies and less subject to gaming by plans than other alternatives, as discussed later in this preamble. We propose a threshold for dually eligible enrollment at 80 percent of a non-SNP MA plan's enrollment because it far exceeds the share of dually eligible individuals in any given market and, therefore, would not be the result for any plan that had not intended to achieve high dually eligible enrollment. MedPAC analysis shows that in most MA markets, the proportion of dually eligible individuals as a percentage of total enrollment is clustered in the 10 to 25 percent range and in no county exceeds 50 percent.

24

We believe the proportion of dually eligible enrollment as a percentage of

total plan enrollment is therefore a reliable indicator or proxy for identifying a non-SNP MA plan that the MA organization intends to have exclusive or predominantly dually eligible enrollment in without being subject to the D-SNP integration and care coordination requirements. MedPAC data show that our proposed threshold would have minimal impact on total dually eligible enrollment in non-SNP MA plans. Among dually eligible enrollees in traditional MA plans, only about 1.2 percent are in plans in which dually eligible individuals make up 80 percent or more of total plan enrollment. Also, 97 percent of dually eligible individuals enrolled in traditional MA plans are enrolled in a plan with 30 percent or less dually eligible enrollment, which indicates that traditional MA plans do not have to create D-SNP look-alikes to attract dually eligible individuals.

25

24

June 2019 MedPAC Report to Congress, Chapter 12

at

http://www.medpac.gov/docs/default-source/reports/jun19_ch12_medpac_reporttocongress_sec.pdf?sfvrsn=0.

25

See

June 2018 MedPAC Report to Congress, Chapter 9

at

http://medpac.gov/docs/default-source/reports/jun18_ch9_medpacreport_sec.pdf?sfvrsn=0

and

June 2019 MedPAC Report to Congress, Chapter 12

at

http://www.medpac.gov/docs/default-source/reports/jun19_ch12_medpac_reporttocongress_sec.pdf?sfvrsn=0.

We considered an alternative discussed by MedPAC in its June 2019 report to Congress for identifying traditional MA plans with predominantly dually eligible enrollment: Setting the bar at the higher of 50 percent dually eligible enrollment or the proportion of dually eligible MA-eligible individuals in the plan service area plus 15 percentage points. We also considered setting a lower threshold for dually eligible enrollment at a point between 50 percent and our proposed 80 percent threshold. However, we opted to propose an enrollment threshold of 80 percent or higher as an indicator that the plan is designed to attract disproportionate dually eligible enrollment because it aligns with MedPAC's 2019 research findings, provides a threshold that would be easier for MA organizations to determine prospectively, and would be easier for CMS to implement. We seek comment on whether these alternative enrollment thresholds are preferable.

Under our proposal for paragraph (d)(2), we would annually make the determination whether an MA organization has a non-SNP MA plan with actual enrollment exceeding the established threshold using the plan's enrollment in January of the current year. We intend to make such evaluations and issue the necessary information to affected MA organizations early in the coverage year. Even without a notice from CMS, we expect that each MA organization would be able to independently determine the level of dually eligible enrollment in its MA plan. Upon receiving the notice from CMS that this proposed prohibition on contracting with D-SNP look-alikes is triggered, the MA organization would then have the opportunity to make an informed business decision to: (1) As necessary, apply and contract for a new D-SNP for the forthcoming contract year; (2) create a new MA plan or plans through the annual bid submission process; or (3) terminate the D-SNP look-alike plan and not submit a bid for the following contract year.

In proposed paragraph (e), we propose a process and procedures for transitioning individuals who are enrolled in a D-SNP look-alike to another MA-PD plan (or plans) offered by the MA organization to minimize disruption as a result of the prohibition on contract renewal for existing D-SNP look-alikes. Enrollees in MA plans that an MA organization cannot continue to operate as a result of our proposal may choose new forms of coverage for the following plan year, including a new MA or MA-PD plan or through the original Medicare fee-for-service program. Under our proposal, an MA organization with a non-SNP MA plan determined to meet the enrollment threshold in proposed paragraph (d)(2) could transition enrollees into another MA-PD plan (or plans) offered by the same MA organization, as long as any such MA-PD plan meets certain proposed criteria described in this section. As stated in paragraph (e)(2), this proposed transition process would allow MA enrollees to be transitioned from one MA plan offered by an MA organization to another MA-PD plan (or plans) without having to fill out an election form or otherwise indicate their enrollment choice as typically required, but it would also permit the enrollee to make an affirmative choice for another MA plan of his or her choosing. Enrollees would still have the opportunity to choose their own plan during this transition process because of how the proposed transition process would overlap with the annual coordinated election period.

Proposed paragraph (e)(1) specifies that, for coverage effective January 1 of the next year, the MA organization could only transition individuals from the D-SNP look-alike that is not being renewed into one or more MA plans (including a D-SNP) if such individuals are eligible to enroll in the receiving plan(s) in accordance with §§ 422.50 through 422.53. Thus, the individual would have to reside in the service area of the new plan and otherwise meet eligibility requirements for it. The proposed process would allow, but not require, the MA organization to transition dually eligible enrollees from a D-SNP look-alike into one or more D-SNPs offered under the MA organization, or another MA organization that shares the same parent organization as the MA organization, and therefore allow enrollees to benefit not only from continued coverage under the same parent organization but also from the care coordination and Medicaid benefit integration offered by a D-SNP.

We also propose at paragraphs (e)(1)(i) through (iii) specific criteria for any MA plan to receive enrollment through this transition process. Our policy goal for this process is to ensure that enrollees receive coverage under their new MA plan that is similarly affordable as the plan that would not be permitted for the next year. Under paragraph (e)(1)(i), we propose to allow a terminating D-SNP look-alike to transition enrollment to another non-SNP plan (or plans) only if the resulting total enrollment in each of the MA plans receiving enrollment consists of less than 80 percent dually eligible individuals. SNPs receiving transitioned enrollment would not be subject to the proposed dual eligible enrollment requirement. The percent of dually eligible individuals in the resulting total enrollment would have to be determined prospectively in order for us to make a timely decision on whether to allow for an MA organization to transition enrollment into a non-SNP MA plan or plans. As described at proposed paragraph (e)(3), we would make such determination by adding the cohort of enrollees that the MA organization proposes to enroll into a different non-SNP plan to the April enrollment of the receiving plan and calculating the resulting percent of dually eligible enrollment. We would make this calculation for each non-SNP plan into which the MA organization proposes to transition enrollment. This proposed criterion would ensure that the enrollment transitions under this regulation do not result in another non-SNP MA plan being treated as a D-SNP look-alike under proposed paragraph (d). Proposed paragraph (e)(1)(ii) would require that any plan receiving transitioned enrollment be an MA-PD plan as defined in § 422.2. Proposed paragraph (e)(1)(iii) would require that any MA plan receiving transitioned enrollment from a D-SNP look-alike have a combined Part C and D beneficiary premium of $0 after application of the premium subsidy for

full subsidy eligible individuals described at § 423.780(a).

As proposed in paragraph (e)(2)(ii), the MA organization would be required to describe changes to MA-PD benefits and provide information about the MA-PD plan into which the individual is enrolled in the Annual Notice of Change that the MA organization must send, consistent with § 422.111(a), (d), and (e) and proposed § 422.2267(e)(3). Consistent with § 422.111(d)(2), enrollees would receive this Annual Notice of Change (ANOC) describing the change in plan enrollment and any differences in plan enrollment at least 15 days prior to the first day of the annual election period. By proposing that this information is provided before the annual election period through this reference to the ANOC, we believe that we are ensuring that each enrollee affected by a transition under this proposal would have the information necessary to decide if they wish to change plans rather than be transitioned to the MA organization's other plan. By timing the notice with the annual open enrollment period, our proposal ensures that affected enrollees retain the opportunity to choose another MA plan or the original Medicare fee-for-service program and a Prescription Drug Plan.

As proposed in paragraph (e)(4), in cases where an MA organization does not transition some or all current enrollees from a D-SNP look-alike plan to one or more of the MA organization's other plans as provided in proposed paragraph (e)(1), it would be required to send affected enrollees a written notice consistent with the non-renewal notice requirements at § 422.506(a)(2). This proposal ensures that affected enrollees who would otherwise be disenrolled to the original Medicare fee-for-service program have an opportunity during the annual open enrollment period to make a different enrollment election.

This proposed transition process is conceptually similar to “crosswalk exception” procedures historically allowed by CMS and proposed at § 422.530, as described in section VI.C. of this proposed rule. However, in contrast to the proposed crosswalk exceptions, our proposal would allow the transition process to apply across legal entities offered by MA organizations under the same parent organization, as well as different plan types (for example, non-SNP to SNP). Allowing this type of enrollment transition process would minimize disruptions in coverage for dually eligible individuals enrolled in a D-SNP look-alike (who could be transitioned to a D-SNP or a non-D-SNP) and the small number of Medicare-only individuals enrolled in a D-SNP look-alike plan (who could be transitioned into a non-SNP MA plan operated by the same MA organization). Because this transition process is not the same as the crosswalk process, our proposal codifies it as part of § 422.514.

We considered an alternative that would require transitioning any dually eligible individuals into a D-SNP for which they were eligible if such a plan is offered by the MA organization. We opted for proposing a less prescriptive set of transition rules, recognizing a potentially wide array of transition scenarios, but seek comment on this alternative. In addition, we seek comment on whether additional criteria for the receiving plan are necessary to protect beneficiaries who are affected by this proposed prohibition on renewing MA plans that meet the criteria in proposed § 422.514(d).

We intend for the transition process to take effect in time for D-SNP look-alikes operating in 2020 to utilize the transition process for enrollments to be effective January 1, 2021. This will allow current MA-PD plans that expect to meet the enrollment threshold in proposed paragraph (d)(2) to retain some or all of their current enrollment by transitioning these individuals to other MA-PD plans offered by the same MA organization a year before CMS implements any plan terminations under this proposal. Contract terminations for plans that are specified in proposed paragraph (d)(2) would take effect no earlier than December 31, 2021, because, as specified in the proposed regulation text, such terminations would apply only beginning for plan year 2022. However, the proposed provision at paragraph (e)(1) allowing an MA organization to transition enrollees from a D-SNP look-alike plan into one or more MA-PD plans offered by that MA organization would be effective after the publication of a final rule in 2020. That is, if our proposal is finalized, we would work with plans that expect to have enrollment of dually eligible individuals that exceeds the enrollment threshold in proposed paragraph (d)(2) for Contract Year 2021 to confirm eligibility for the transition process and take necessary operational steps in 2020 to allow transition of enrollees from those plans into new MA-PD plans offered by the same MA organization on January 1, 2021, because CMS would not renew those contracts for 2022.

Overall, our proposal focuses on dually eligible beneficiaries as a percentage of a plan's total enrollment. We considered using alternative criteria instead of, or in addition to, the percentage of projected or actual dually eligible enrollment, to identify non-SNP MA plans designed to exclusively or predominantly enroll dually eligible individuals. In particular, we considered identifying D-SNP look-alikes by the benefit design these plans typically offer—relatively high Parts A and B cost sharing and a high Part D deductible that make the plans unattractive to Medicare-only beneficiaries, supplemental benefits like dental and hearing services and over-the-counter drugs that mimic typical D-SNP offerings, and a premium for Part D coverage that is fully covered by the Part D low-income subsidy. We also considered using the percentage of MA rebate dollars allocated to buy down Parts A and B cost sharing compared to other supplemental benefits—D-SNP look-alikes typically allocate a greater percentage to the latter—as a way to identify D-SNP look-alikes. However, we chose our proposal over these alternatives for multiple reasons. First, we are concerned that further regulating benefit design in this way could inadvertently diminish benefit flexibility that genuinely improves competition and choice, without necessarily being designed to undermine rules applicable to D-SNPs. For example, it is conceivable that future benefit designs would be precluded by any benefit and cost sharing criteria we established to eliminate D-SNP look-alikes, even if those benefit designs would not have drawn a high percentage of dually eligible individuals based on factors that we cannot currently foresee. Second, we determined that MA organizations could likely avoid any new limitations on benefit design through small tweaks to their benefit design or allocation of MA rebate dollars. Most importantly, we determined that the best indicator that a MA organization intends a plan to have exclusive or predominantly dually eligible enrollment is in the enrollment it projects in the bid and in the enrollment it actually achieves. Finally, we believe the criteria to identify D-SNP look-alikes should mirror the principal criterion that distinguishes D-SNPs from other MA plans in statute the ability to have enrollment that exclusively, or predominantly, consists of dual eligible individuals—which enables a D-SNP to integrate and coordinate the delivery of Medicaid services and necessitates the additional care coordination to meet the needs of this vulnerable population. We seek comment on whether these alternative criteria should be used instead of, or in addition to, the criteria we are

proposing for identifying D-SNP look-alikes and applying contracting prohibition.

III. Implementation of Several Opioid Provisions of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

A. Mandatory Drug Management Programs (DMPs) (§ 423.153)

1. Summary and Background of DMPs

The SUPPORT Act made changes to the requirements for Part D DMPs to enhance Part D sponsors' ability to reduce the abuse or misuse of opioid medications in their prescription drug benefit plans. CMS is proposing two corresponding changes to the Part D DMP provisions codified in § 423.153(f): (1) Requiring Part D sponsors to adopt DMPs with respect to a plan year on or after January 1, 2022, as required under section 2004 of the SUPPORT Act; and (2) requiring inclusion of Part D beneficiaries with a history of opioid-related overdose in sponsors' DMPs beginning January 1, 2021, as required under section 2006 of the SUPPORT Act. In addition, CMS is proposing an additional category of exempt beneficiaries, for example, those with sickle cell disease, from DMPs and proposing several technical clarifications to the DMP regulations, which are described in subsequent paragraphs.

CARA amended the Act and included new authority for the establishment of DMPs in Medicare Part D, effective on or after January 1, 2019. CMS established through notice and comment rulemaking a framework at § 423.153(f) under which Part D plan sponsors may establish a DMP for beneficiaries at-risk for prescription drug abuse, or “at-risk beneficiaries” (ARBs) (defined in § 423.100).

Under the DMPs in place today, CMS identifies “potential at-risk beneficiaries” (PARBs) (defined in § 423.100) who meet the clinical guidelines described in § 423.153(f)(16), which we refer to as the minimum Overutilization Management System (OMS) criteria. The OMS reports such beneficiaries to their Part D plans for case management under their DMP. There are also supplemental clinical guidelines, or supplemental OMS criteria, which Part D sponsors can apply themselves to identify additional potential at-risk beneficiaries.

The OMS criteria used to identify PARBs are based on a history of filling opioids from multiple doctors and/or multiple pharmacies. Once PARBs are identified, plan sponsors engage in case management of these beneficiaries through contact with their prescribers to determine whether the beneficiary is at-risk for prescription drug misuse or abuse. If a sponsor determines through case management that a PARB is at-risk, after notifying the beneficiary in writing, the sponsor may limit their access to coverage of opioids and/or benzodiazepines to a selected prescriber and/or network pharmacy(ies) and/or through a beneficiary-specific point-of-sale (POS) claim edit. This process does not apply to “exempted beneficiaries” (defined at § 423.100). Exempted beneficiaries currently include those being treated for active cancer-related pain, residing in a long-term care facility, receiving hospice care or receiving palliative or end-of-life care, but we are proposing, in section VIII.N. of this proposed rule, to exempt beneficiaries with sickle cell disease beginning with plan year 2021.

CMS data has shown value from plan sponsors engaging in case management. From 2011

26

through 2017, there was a 76 percent decrease in the number of Part D potential at-risk beneficiaries (almost 22,500 beneficiaries) who met the applicable OMS criteria under the prior opioid overutilization policy. Part D sponsors also implemented 4,375 beneficiary-specific POS opioid claim edits through 2017. Early analysis of the coverage limitations (for example, pharmacy and prescriber limitations and beneficiary-specific POS claim edits) implemented under DMPs through the second quarter of 2019 continues to show a relatively low application of coverage limitations by Part D sponsors. However, this is not unexpected,

27

as the design of the DMP process is for Part D sponsors to engage in beneficiary-specific casework with the PARB's prescribing physicians to address the unique needs of the beneficiary and coordinate care. Nevertheless, the availability and use of coverage limitations by sponsors remains important, necessary, and appropriate in certain clinical situations.

26

In developing the Medicare Part D opioid overutilization policy and OMS which began in 2013, we conducted pilots and testing in 2012. Therefore, we use 2011 as the pre-pilot/pre-policy measurement period. DMPs incorporated the OMS criteria and case management approach established in the opioid overutilization policy.

27

See discussion p. 16690: ICRs Regarding the Implementation of the Comprehensive Addictions and Recovery Act of 2018 (CARA) Provisions (§ 423.153) in the April 2018 final rule (83 FR 16440).

2. Mandatory Drug Management Programs (DMPs)

Section 2004 of the SUPPORT Act requires that, no later than January 1, 2022, Part D sponsors must have established DMPs. We are proposing to amend regulatory language at § 423.153(f) to reflect this requirement. We note that while implementation of DMPs has been optional since 2019, when Part D sponsors could first adopt them, 85.9 percent of Part D contracts in calendar year 2019 and 87.2 percent for calendar year 2020 adopted DMPs to address opioid overutilization among their enrollees. Thus, of about 49 million beneficiaries who were enrolled in the Medicare Part D program in 2019, about 48.5 million enrollees (99 percent) were covered under Part D contracts that offered a DMP already. Our internal analysis estimates that only 158 additional PARBs will be identified due to making DMPs mandatory by meeting the current minimum OMS criteria.

B. Beneficiaries With History of Opioid-Related Overdose Included in Drug Management Programs (DMPs) (§ 423.100)

Under section 2006 of the SUPPORT Act, CMS is required to identify Part D beneficiaries with a history of opioid-related overdose (as defined by the Secretary), and such individuals must be included as PARBs for prescription drug abuse under a Part D plan's DMP. CMS is also required under this section to notify the sponsor of such identifications. In line with this requirement, we are proposing to modify the definition of “potential at-risk beneficiary” at § 423.100 to include a Part D eligible individual who is identified as having a history of opioid-related overdose, as we propose to define it.

We propose to define “history of opioid-related overdose” to mean that for the Part D beneficiary, a recent claim has been submitted

28

that contains a principal diagnosis code reflecting an opioid overdose, regardless of the type of opioid and at least one recent PDE for an opioid dispensed to such beneficiary has been submitted.

28

Claim date for meeting lookback period criteria based on the claim dates of service, admission date or date the claim was loaded into CMS's data warehouse.

We propose to operationalize this proposed definition by: (1) Using diagnoses that include both prescription and illicit opioid overdoses; (2) using a 12-month lookback period from the end of each OMS reporting quarter, for record of opioid-related overdose within Medicare fee-for-service (FFS) claims

and Medicare Advantage Encounter data (excluding those not enrolled in a Part D plan, whether an MA-PD or standalone PDP plan); and (3) using a 6-month lookback period from the end of each OMS reporting quarter, for record of a recent Part D opioid PDE. The number of unique beneficiaries identified under this proposal is approximately 18,268.

Our rationale for this proposal is that a past overdose is the risk factor most predictive for another overdose or suicide-related event.

29

We propose using diagnoses that include both prescription and illicit opioid overdoses because an opioid overdose may result from prescription or illicit opioids alone or in combination, and the statute does not distinguish based on type of opioid. Further, in the case of prescription opioids, the diagnosis code does not indicate if the prescription was legally obtained and used by the intended patient. Lastly, we propose to define history of opioid-related overdose to include only those instances where the enrollee also recently filled an opioid prescription under their Part D benefit, because the existence of an opioid PDE means sponsors would have an opioid prescriber with whom to conduct case management, which is an integral part of the DMP process.

29

Bohnert KM, Ilgen MA, Louzon S, McCarthy JF, Katz IR. Substance use disorders and the risk of suicide mortality among men and women in the US Veterans Health Administration. Addiction. 2017 Jul;112(7):1193-1201. doi: 10.1111/add.13774.

Other factors we took into consideration for our proposal: First, as to including both prescription and illicit opioid overdose diagnoses, we considered that the Part D program is a prescription drug benefit program and, therefore, considered defining a history of opioid-related overdose as only including those overdoses involving validly prescribed and taken prescription opioids. However, given the risks associated with opioid-related overdose, we believe the best policy is to include both types of overdoses. Also, we cannot accurately identify whether an illicit or prescription opioid drug or drugs contributed to an overdose, and even if we could, we cannot determine whether a prescription opioid that contributed to the overdose was legally obtained and taken. Thus, our approach also overcomes limitations in the diagnosis data available (described further in this section of this proposed rule). The Alternatives Considered section of the Regulatory Impact Analysis (section X.D.1. of this proposed rule) provides a more in-depth review of the various other approaches considered and the projected numbers of affected enrollees.

Second, we note that the proposed 12-month lookback period of Medicare FFS claims and Medicare Advantage Encounter data to identify enrollees with a history of opioid-related overdose, which aligns with the measurement period used for active cancer diagnosis data in the current OMS criteria, takes into account program size and factors in patterns of beneficiaries who overdose more than once. We think 12 months is the appropriate lookback period to identify the beneficiaries who are at the most risk. When using Medicare fee-for-service inpatient data, we noted that a two-year lookback period (between July 2016 and June 2018) for Medicare beneficiaries who overdosed more than once almost proportionately doubles the number of overdoses compared to a one-year lookback (July 2017 to June 2018); however, 90 percent of the beneficiaries who had more than one opioid-related overdose episode, had a subsequent overdose episode on average within 12 months. In our methodology, we used the calendar month and year of opioid-related overdose events to identify each episode and also found that 95 percent of the beneficiaries had a subsequent overdose episode on average within 14 months and 99 percent of the beneficiaries had a subsequent overdose episode on average within 19 months. Thus, a 12-month lookback period strikes a better balance in identifying beneficiaries who would be at risk of having another opioid-related overdose taking into consideration the drug management program size.

Third, while we considered reporting any enrollees who have a history of opioid-related overdose during the 12-month lookback period, regardless of whether there is an opioid PDE, we believe our proposal to report only those enrollees who also recently filled a Part D opioid prescription should increase the likelihood for the sponsor to conduct successful provider outreach for case management. This aligns with the 6-month measurement period used for opioid PDE records in the current OMS criteria. We solicit feedback on the proposed 12-month lookback period for identifying claims for opioid-related overdose and the proposal to report only those enrollees with at least one Part D opioid PDE within the prior 6 months.

To derive an estimated population of PARBs identified under this proposal, we identified beneficiaries with inpatient, outpatient or professional FFS or encounter data opioid overdose claims based on the principal International Classification of Disease (ICD)-10 diagnosis codes (see Table 1) during the 12-month measurement period from 07/01/2017 to 06/30/2018 and at least one recent Part D opioid PDE from 01/01/2018 to 06/30/2018. We excluded beneficiaries if they were identified as having elected hospice, in a resident facility, had palliative care diagnosis, and/or had a death date during the last 6 months (01/01/2018-06/30/2018). We also excluded beneficiaries if they had active cancer during the 12-month lookback period (07/01/2017-06/30/2018). This is consistent with the measurement period used to identify these attributes in the current OMS criteria. Finally, we excluded beneficiaries who were not Part D enrolled during the last month of the OMS measurement period. Again, the number of unique beneficiaries identified under this proposal is 18,268. To align with our current OMS quarterly reporting frequency, we ran additional simulations using 2018 data and estimated that about 4,500 new beneficiaries with an opioid related overdose would be identified every quarter.

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ICD-10 diagnosis codes related to underdosing, adverse effects and assault are excluded.

Table 1—List of Opioid-Related Overdose Codes Included in Analysis

Overdose type

ICD-10 diagnosis codes

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Any Opioid

T40.0 (opium), T40.1 (heroin), T40.2 (natural/semisynthetic opioids including hydrocodone and oxycodone), T40.3 (methadone), T40.4 (synthetic opioids other methadone including fentanyl and tramadol) and T40.6 (other and unspecified narcotics).

Prescription Opioid

T40.2 (natural/semisynthetic opioids including hydrocodone and oxycodone), T40.3 (methadone), and T40.6 (other and unspecified narcotics).

Illicit Opioid

T40.1 (heroin) and T40.4 (synthetic opioids other methadone likely illicitly manufactured fentanyl).

Table 1 categorizes the diagnoses codes we used to derive our estimate, as well as the other options in section X.D.1. of this proposed rule. As previously noted, there are limitations when using diagnosis data to identify opioid-related overdoses. An additional limitation is that there is an unspecified opioid overdose code, which requires that assumptions be made in order to classify an overdose code as prescription or illicit. We classified code 40.2 (other opioids), as a prescription opioid overdose, but in some cases oxycodone may have been obtained illegally. We classified code 40.4 (other synthetic opioids) as illicit opioid overdose but in some cases fentanyl may have been obtained by prescription. We made these designations in order for our proposal to align with Centers for Disease Control and Prevention's (CDC) practice of defining all fentanyl overdoses (synthetic opioids other than methadone) as likely illicit.

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Current information reported about overdose deaths in NVSS does not distinguish pharmaceutical fentanyl from illicitly manufactured fentanyl (IMF). Opioid Data Analysis and Resources. Available from:

https://www.cdc.gov/drugoverdose/data/analysis.html.

As noted earlier in this proposed rule, Part D sponsors with DMPs must conduct case management for each PARB identified by CMS through OMS which includes sending written information to the beneficiary's prescribers that the beneficiary met the clinical guidelines/OMS criteria and is a PARB. Currently, case management under DMPs generally addresses safety concerns related to opioid prescriptions for Part D beneficiaries involving multiple prescribers/pharmacies. We continue to encourage providers to consult state-based prescription drug monitoring programs before prescribing opioids to reduce the number of beneficiaries meeting the current OMS criteria. However, under this proposal, the nature of the safety concern for the Part D beneficiaries who must be identified and reported to sponsors by OMS is different. Sponsors will communicate with providers about potential safety concerns due to the beneficiary's history of opioid-related overdose, and the provider may or may not already be aware of this history and the beneficiary may or may not be using multiple opioid prescribers/pharmacies. Thus, our proposal is similar to PARBs who are reported by OMS with a benzodiazepine flag, as a particular provider may or may not be aware that a beneficiary is taking benzodiazepines in addition to opioids.

Such communication is an opportunity for sponsors, through their DMPs, to offer information to, and/or discuss with, providers the risk factors relevant to opioid use and a prior overdose history, and to make prescribers aware of the tools available under a DMP to assist them in managing their patient's care, as they consider prescription opioid use of their patient. The provider should also consider prescribing the beneficiary an opioid-reversal agent if they are newly aware of the beneficiary's history of opioid-related overdose and DMPs should notify providers and patients of the coverage of naloxone and its availability through their plan. As with any beneficiary in a DMP, the goal is the best-possible, coordinated, and safe care for each unique patient as determined by their provider(s), and not to stigmatize the patient; nor abruptly taper or discontinue their medications, nor unnecessarily or abruptly remove the patient from a provider's practice.

We solicit comments on whether our proposal needs any additional features to facilitate the case management process for PARBs with a history of opioid related overdose, such as written sponsor-provider communication and/or to address the anticipated effects of this type of sponsor-provider collaboration. We recognize that the model beneficiary notices

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provided by CMS may need to be revised to incorporate a PARB having a history of opioid-related overdose (noted in section IX.B.3. of this proposed rule).

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Notice documents available at

https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Part-D-Drug-Management-Program-Notices-.zip.

C. Information on the Safe Disposal of Prescription Drugs (§ 422.111)

Section 6103 of the SUPPORT Act amends section 1852 of the Act by adding a new subsection (n). Section 1852(n)(1) requires MA plans to provide information on the safe disposal of prescription drugs when furnishing an in-home health risk assessment. Section 1852(n)(2) requires us to establish, through rulemaking, criteria that we determine appropriate with respect to information provided to an individual during an in-home health risk assessment to ensure that he or she is sufficiently educated on the safe disposal of prescription drugs that are controlled substances.

In order to implement the requirements of section 1852(n)(1) for MA plans, CMS proposes to revise the § 422.111, Disclosure Requirements, to add a paragraph (j), which would require MA plans that furnish an in-home health risk assessment on or after January 1, 2021, to include both verbal (when possible) and written information on the safe disposal of prescription drugs that are controlled substances in such assessment. Consistent with section 1852(n)(1), we propose that information must include details on drug takeback programs and safe in-home disposal methods.

In educating beneficiaries about the safe disposal of medications that are controlled substances, we propose MA plans would communicate to beneficiaries in writing and, when feasible, verbally. We propose that MA plans must do the following to ensure that the individual is sufficiently educated on the safe disposal of controlled substances: (1) Advise the enrollee that unused medications should be disposed of as soon as possible; (2) advise the enrollee that the US Drug Enforcement Administration allows unused prescription medications to be mailed back to pharmacies or other authorized sites using packages made available at such pharmacies or other authorized sites; (3) advise the enrollee that the preferred method of disposing of controlled substances is to bring them to a drug take back site; (4) identify drug take back sites that are within the enrollee's MA plan service area or that are nearest to the enrollee's residence; and (5) instruct the enrollee on the safe disposal of medications that can be discarded in the household trash or safely flushed. Although we are not proposing to require MA plans to provide more specific instructions with respect to drug disposal, we are proposing that the communication to enrollees provide the following additional guidance: If a drug can be safely disposed of in the enrollee's home, the enrollee should conceal or remove any personal information, including Rx number, on any empty medication containers. If a drug can be discarded in the trash, the enrollee should mix the drugs with an undesirable substance such as dirt or used coffee grounds, place the mixture in a sealed container such as an empty margarine tub, and discard in the trash.

We also propose that the written communication include a web link to the information available on the United States Department of Health and Human Services website identifying methods for the safe disposal of drugs available at the following address:

https://www.hhs.gov/opioids/prevention/safely-dispose-drugs/index.html

. We note that the safe disposal of drugs guidance at this website can be used for all medications not just medications that

are controlled substances. We believe that plan communications consistent with the standard on this website provides enrollees with sufficient information for proper disposal of controlled substances in their community.

D. Beneficiaries' Education on Opioid Risks and Alternative Treatments (§ 423.128)

Sponsors of Part D prescription drug plans, including MA-PDs and standalone PDPs, must disclose certain information about their Part D plans to each enrollee in a clear, accurate, and standardized form at the time of enrollment and at least annually thereafter under section 1860D-4(a)(1)(a) of the Act. Among the drug specific information that sponsors must provide pursuant to section 1860D-4(a)(1)(B) of the Act is information about the plan formulary, pharmacy networks, beneficiary cost-sharing requirements, and the availability of medication therapy management (MTM) and DMPs.

Section 6102 of the SUPPORT Act amended section 1860D-4(a)(1)(B) of the Act to require that, for plan year 2021 and each subsequent plan year, Part D sponsors also must disclose to each enrollee, with respect to the treatment of pain, information about the risks of prolonged opioid use. In addition to this information, with respect to the treatment of pain, MA-PD sponsors must disclose coverage of non-pharmacological therapies, devices, and non-opioid medications under their plans. Sponsors of standalone PDPs must disclose coverage of non-pharmacological therapies, devices, and non-opioid medications under their plans and under Medicare Parts A and B.

Section 6102 of the SUPPORT Act also amended section 1860D-4(a)(1)(C) of the Act to permit Part D sponsors to disclose this opioid risk and alternative treatment coverage information to only a subset of plan enrollees, such as enrollees who have been prescribe

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