Medicare and Medicaid Programs; Contract Year 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-F2]

RIN 0938-AT97

Medicare and Medicaid Programs; Contract Year 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:

Final rule.

SUMMARY:

This final rule will 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 (PACE) to implement certain sections of the Bipartisan Budget Act of 2018 and the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment—(SUPPORT) for Patients and Communities Act (hereinafter referred to as the SUPPORT Act), enhance the Part C and D programs and the PACE program, codify several existing CMS policies, make required statutory changes, implement other technical changes, and make routine updates. As stated in the final rule that appeared in the

Federal Register

on June 2, 2020, CMS is fulfilling its intention to address the remaining proposals from the February 2020 proposed rule here. Although the provisions adopted in this second final rule will be in effect during 2021, most provisions will apply to coverage beginning January 1, 2022.

Notwithstanding the foregoing, for proposals from the February 2020 proposed rule that would codify statutory requirements that were already in effect prior to this rule's appearance in the

Federal Register

, CMS reminds organizations, plan sponsors, and other readers that the statutory provisions apply and will continue to be enforced. Similarly, for the proposals from the February 2020 proposed rule that would implement the statutory requirements in sections 2007 and 2008 of the SUPPORT Act, CMS intends to implement these statutory provisions consistent with their effective provisions.

DATES:

Effective Date:

These regulations are effective March 22, 2021.

Applicability Dates:

Most of the provisions in this rule will be applicable to coverage beginning January 1, 2022, except as noted below.

The

Part D Income Related Monthly Adjustment Amount (IRMAA) calculation update

in § 423.286(d)(4)(ii) is applicable March 22, 2021. The provision defining targeted beneficiaries for MTM at § 423.153(d)(2) is applicable March 22, 2021. The provisions on automatic escalation to the independent outside entity under a Medicare Part D drug management program (DMP) at §§ 423.590(i) and 423.600(b) and the related provisions on information on appeal rights in the beneficiary notices at §§ 423.153(f)(5)(ii)(C)(

3

), 423.153(f)(6)(ii)(C)(

4

), and 423.153(f)(8)(i) are applicable March 22, 2021. The provisions defining the term “parent organization” for MA and Part D plans at §§ 422.2 and 423.4 are applicable March 22, 2021. The General Requirements for Applicable Integrated Plans and Continuation of Benefits provisions at §§ 422.629 and 422.632 are applicable March 22, 2021.

In order to help ensure that Part D sponsors have sufficient implementation time, the beneficiary real time benefit tool (RTBT) (§ 423.128(d)(4)) requirement will not be applicable until January 1, 2023.

Due to operational considerations, revisions to the Special Needs Plan Model of Care requirements in § 422.101(f) are intended for implementation (that is, applicability) for models of care for contract year 2023. Plans that are required to submit models of care for contract year 2022 are due to submit MOCs by February 17, 2021; those submissions will be evaluated based on the regulations in effect at that time (that is, without the amendments adopted here) and SNPs must implement and comply with their approved MOCs in connection with coverage in 2022. Moving the applicable implementation of the SNP MOC provisions to contract year 2023 will allow SNPs and CMS to construct the necessary processes for full implementation and enforcement of the final rule. When MOCs for contract year 2023 are submitted for review and approval in early 2022, the regulations in this final rule will be used to evaluate those MOCs for approval.

SUPPLEMENTARY INFORMATION:

The Code of Federal Regulations (CFR) will be updated consistent with the respective effective date of each provision. The applicability and effective dates are discussed in the summary and preamble for each of these items. Because CMS is finalizing the call center, marketing, and communications requirements under §§ 422.111(h)(1), 422.2260 through 422.2274, §§ 423.128(d)(1), and 423.2260 through 423.2274 as applicable for the contract year and coverage beginning January 1, 2022, these requirements will apply to call center operations, marketing, and mandatory disclosures occurring in 2021 for enrollments made for contract year 2022.

FOR FURTHER INFORMATION CONTACT:

Cali Diehl, (410) 786-4053, Theresa Wachter, (410) 786-1157, or Christopher McClintick, (410) 786-4682—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.

Daniel Deisroth, (443) 431-4171—PACE Issues.

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

Tobey Oliver, (202) 260-1113—D-SNP Appeals and Grievances.

I. Executive Summary and Background

A. Executive Summary

1. Purpose

The primary purpose of this final 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), and

• 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 rule also includes a number of changes to: Strengthen and improve the Part C and D programs and the PACE program, codify in regulation several CMS interpretive policies previously adopted through the annual Call Letter and other guidance documents, make required statutory changes, implement other technical changes, and make routine updates.

In the June 2020 final rule (85 FR 33796), CMS addressed a selection of proposals from the February 2020 proposed rule (85 FR 9002). In this final rule, CMS is addressing the remaining proposals from the February 2020 proposed rule with two exceptions: (1)

Maximum Out-of-Pocket (MOOP) Limits for Medicare Parts A and B Services (§§ 422.100 and 422.101) and (2) Service Category Cost Sharing Limits for Medicare Parts A and B Services and per Member per Month Actuarial Equivalence Cost Sharing (§§ 422.100 and 422.113). Therefore, we may address the two remaining proposals from the February 18, 2020, proposed rule (85 FR 9002) not included in this final rule in subsequent rulemaking.

In so doing, the final rule addresses the following needs for federal regulatory action as set forth below:

• The regulations implementing the provisions of BBA of 2018 relating to Medicare Advantage Special Needs Plans address, as directed by law, care management requirements through the development and implementation of models of care. Given the context of these provisions is a federal program, Congress has mandated a federal regulatory approach with respect to these provisions.

• The provisions implementing the provisions of BBA of 2018 relating to the Coverage Gap Discount Program and the Part D Income Related Monthly Adjustment Amount (IRMAA) improve the operation of government programs by ensuring the regulations conform to the statute and the distribution of resources determined by Congress in statute. Given the context of these provisions is a federal program, Congress has mandated a federal regulatory approach with respect to these provisions.

• The provisions implementing the SUPPORT Act address the misuse and abuse of opioids in the manners directed by Congress. This includes the provisions related to Mandatory Drug Management Programs, Beneficiaries with History of Opioid-Related Overdose Included in Drug Management Programs, Automatic Escalation to External Review under a Medicare Part D Drug Management Program for At-Risk Beneficiaries, Suspension of Pharmacy Payments Pending Investigations of Credible Allegations of Fraud and Program Integrity Transparency Measures, Section 2008 of the SUPPORT Act, Section 6063 of the SUPPORT Act, Beneficiaries' Education on Opioid Alternatives, and Beneficiaries with Sickle Cell Disease. Given the context of these provisions is a federal program or impacts on several federal programs, Congress has mandated a federal regulatory approach with respect to these provisions.

• The provisions which strengthen and improve the PACE program with respect to Service Delivery Request Processes under PACE improve the operation of government programs by ensuring documentation is available for oversight required by statute. Given the context of these provisions is a federal program, a federal regulatory approach is appropriate with respect to these provisions.

• The provisions relating to Beneficiary Real Time Benefit Tools address inadequate and incomplete information available to Part D beneficiaries with regards to the choices they have for prescription drugs. Given the context of these provisions is a federal program, a federal regulatory approach is appropriate with respect to these provisions.

• The provisions relating to permitting a second, “preferred,” specialty tier in Part D address externalities caused by the current specialty tier regulation—specifically the absence of negotiation leverage and incentives within the Part D specialty tier. Given the context of these provisions as a federal program, a federal regulatory approach is appropriate with respect to these provisions.

• The provisions relating to the Medicare Advantage (MA) and Part D Prescription Drug Program Quality Rating System improve the operation of government programs by making updates to reflect changes in measures (thereby ensuring the government program does not use outdated methodologies) and clarifying existing regulations (thereby answering questions regulated parties may have). These and other provisions also codify sub-regulatory guidance, which is an improvement in that regulated parties and CMS have greater clarity regarding the application of these policies as a rule. Given the context of these provisions is a federal program, a federal regulatory approach is appropriate with respect to these provisions.

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 proposed regulations to implement section 2004 of the SUPPORT Act which require Part D sponsors to establish DMPs for plan years beginning on or after January 1, 2022.

CMS is finalizing the requirement for mandatory DMPs with an additional modification so that plans without a Pharmacy and Therapeutics (P&T) committee can comply with the DMP regulation.

b. Beneficiaries With History of Opioid-Related Overdose Included in Drug Management Programs (DMPs) (§ 423.153)

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, in lieu of modifying the definition of “potential at-risk beneficiary” at § 423.100 as proposed, CMS is finalizing the clinical guideline criteria at new paragraph § 423.153(f)(16)(ii)(2) to include a Part D eligible individual who is identified as having a history of opioid-related overdose, beginning January 1, 2022. 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. The clinical guideline criteria CMS is finalizing at § 423.153(f)(16)(ii)(2) specify that both a principal diagnosis of opioid-related overdose and a recent Part D opioid prescription are required components to meet the definition of a PARB based on the history of opioid-related overdose. Additionally, CMS is making some revisions to the terminology used in the clinical

guideline criteria at § 423.153(f)(16)(ii)(2) from what was initially proposed in the definition at § 423.100 to better characterize the data sources and opioid prescription criteria to be used to identify beneficiaries meeting the definition of a PARB based on a history of opioid-related overdose. The clinical guideline criteria mirror the definition of “potential at-risk beneficiary” that was initially proposed but relocated to § 423.153(f)(16)(ii)(2) to improve clarity of the regulation text.

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 U.S. Veterans Health Administration. Addiction. 2017 Jul;112(7):1193-1201. doi: 10.1111/add.13774.

c. 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. Section 6102 of the SUPPORT Act amended section 1860D-4(a)(1)(B) of the Act to require that Part D sponsors also must disclose to each enrollee 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 also amended section 1860D-4(a)(1)(C) to permit Part D sponsors to disclose this opioid risk and alternative treatment coverage information to only a subset of plan enrollees rather than disclosing the information to each plan enrollee. We are finalizing our proposal with only one modification to make the requirement applicable beginning January 1, 2022, rather than January 1, 2021 as proposed.

d. 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 proposed 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 by the expiration of the adjudication timeframe applicable to the plan level appeal. We also proposed conforming revisions to the notices that are sent to beneficiaries. In the February 2020 proposed rule, we solicited feedback on these proposals. As a result, we received several comments related to the timeframe in which a plan sponsor has to forward the case file to the IRE. Specifically, commenters requested that plan sponsors have additional time beyond the applicable adjudication timeframe in which to assemble and forward the administrative case file to the IRE. As a result of this feedback, we are finalizing the automatic escalation provision with a modification to reflect that plan sponsors must forward the case file to the independent outside entity no later than 24 hours following the expiration of the adjudication timeframe applicable to the plan level appeal. This approach is consistent with regulations applicable to cases that must be forwarded to the IRE if the plan sponsor is untimely in its decision making and, we believe, remains consistent with the enrollee protections set forth in the SUPPORT Act. We are also finalizing the provisions related to beneficiary notices. The following provisions of this final rule are applicable 60 days after the publication date of this final rule: §§ 423.590(i) and 423.600(b) related to auto-forwarding redeterminations made under a DMP to the IRE and the provisions related to information on appeal rights in the beneficiary notices at §§ 423.153(f)(5)(ii)(C)(

3

), 423.153(f)(6)(ii)(C)(

4

), and 423.153(f)(8)(i).

e. 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)

In the proposed rule, CMS proposed 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 unscrupulous 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 in FFS Medicare. 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. The statutory effective date for section 2008 is for plan years beginning on or after January 1, 2020.

(2) Section 6063 of the SUPPORT Act

Section 6063 requires, effective not later than 2 years after the date of enactment, 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.

The applicability date of the section 2008 and section 6063 provisions will be for plan years beginning on or after January 1, 2022 because of several factors. The first factor is the need to ensure that the web-based portal is complete and operational for plan sponsor's use. While the development of the web-based portal began when the legislation was enacted, CMS was unable to complete the development of the portal in time for its full implementation in plan year 2021. In addition, the portal has required several key updates to reflect the requirements in this regulation. Additional factors include the time needed for plan sponsors to determine internal procedures to meet the requirements outlined in this rule; the need for CMS to obtain feedback from plan sponsors to address any challenges encountered with the web-based portal; and the need to provide plan sponsors with the opportunity to address any other operational challenges with implementing these provisions, including potential changes that may be needed due to the COVID-19 public health emergency. Furthermore, the applicability date is later than the effective dates in the SUPPORT Act because the publication of this final rule is occurring after the bid deadline for plan year 2021. However, where the statute is self-implementing, the delay in applicability of these regulations is not a barrier to enforcement of the statutory provisions.

f. 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 have stated 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 we are codifying additional existing rules for calculating the ratings used for MA Quality Bonus Payments, implementing updates to the Health Outcomes Survey measures, adding new Part C measures, clarifying the rules around contract consolidations and application of the adjustment for extreme and uncontrollable circumstances when data are missing due to data integrity concerns, and making additional technical clarifications. Unless otherwise stated, data will be collected and performance measured using these rules and regulations for the 2022 measurement period and the 2024 Star Ratings.

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

We are finalizing regulations 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. Under this final rule, Part D sponsors will 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 proposed and the requirements of the CMS formulary review and approval process under § 423.120(b)(2). To maintain Part D enrollee protections, we will codify a maximum allowable cost sharing that would apply to the higher cost-sharing specialty tier. Further, we will require that if there are two specialty tiers, one must be a “preferred” tier that offers lower cost sharing than the proposed maximum allowable cost sharing.

We note that we did not propose to revise and are not revising § 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 the exemption from tiering exceptions for specialty tier drugs under § 423.578(a)(6)(iii) as proposed would apply only to tiering exceptions to non-specialty tiers, the existing requirement at § 423.578(c)(3)(ii) will require Part D sponsors to permit tiering exception requests for drugs on the higher cost-sharing specialty tier to the lower cost-sharing, specialty tier.

To improve transparency, we will codify current methodologies for cost sharing and calculations relative to the specialty tier, with some modifications. First, we will 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 IV.E.4. of this final rule. We 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 base the determination of the specialty-tier cost threshold on the ingredient cost reported on the prescription drug event (PDE). We will also maintain a specialty-tier cost threshold for both specialty tiers that is set at a level that, in general, reflects drugs with monthly ingredient costs that are in the top 1 percent, as described further in section IV.E.6. of this final rule. Finally, we will adjust the specialty-tier cost threshold, in an increment of not less than 10 percent, when an annual analysis of PDE data shows that an adjustment is necessary to recalibrate the specialty-tier cost threshold so that it only reflects Part D drugs with the top one percent of monthly ingredient costs. We will determine annually whether the adjustment would be triggered and announce the specialty-tier cost threshold annually via an HPMS memorandum or a comparable guidance document.

We are finalizing these provisions as proposed, except that we are not finalizing our proposal to specify a specialty-tier cost threshold of $780. Additionally, in response to comments, we are finalizing new paragraph § 423.104(d)(2)(iv)(A)(

6

), which describes the eligibility for placement on the specialty tier of newly-FDA-

approved Part D drugs. These provisions will apply for coverage year 2022.

To retain the policies in effect before coverage year 2022, we are amending the definition of specialty tier at § 423.560 by adding paragraph (i) to clarify that the existing definition will be in effect before coverage year 2022, and paragraph (ii) to cross reference the definition which appears in § 423.104(d)(2)(iv), which will apply beginning coverage year 2022. Additionally, as discussed in section IV.E.2. of this final rule, we are amending § 423.578(a)(6)(iii) by adding paragraph (A) to cross reference the definition of specialty tier which will apply before coverage year 2022, and paragraph (B) to cross reference placement of the definition of specialty tier at § 423.104(d)(2)(iv) which will apply beginning coverage year 2022. Additionally, paragraph (A) will remove the phrase “and biological products,” and paragraph (B) will (1) reflect the possibility of a second specialty tier, and (2) clarify that Part D sponsors may design their exception processes so that Part D drugs on the specialty tier(s) are not eligible for a tiering exception to non-specialty tiers.

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

This rule finalizes regulations to require that Part D plan sponsors implement a beneficiary real-time benefit tool (RTBT) by January 1, 2023. The RTBT must allow enrollees to view 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). This rule permits plans to use existing secure patient portals to fulfill this requirement, to develop a new portal, or use a computer application. Plans are required to make this information available to enrollees who call the plan's customer service call center.

In order to encourage enrollees to use the beneficiary RTBT, plans are permitted 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, provided the value of the RI offered is a reasonable amount.

i. 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 proposed moving the requirements for processing service delivery requests from § 460.104(d)(2) and adding them to a new § 460.121 in order to increase transparency for participants and reduce confusion for PACE organizations. We also proposed modifying 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 proposed 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 also proposed allowing the interdisciplinary team (IDT) to bypass the full processing of a service delivery request under the new proposed requirements in § 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 proposed maintaining the requirement that an in-person reassessment must be conducted prior to a service delivery request being denied, but we proposed eliminating the requirement that a reassessment (either in-person or through remote technology) be conducted when a service delivery request can be approved. Lastly, we proposed adding participant protections; specifically, we proposed increasing notification requirements in order to ensure participants understand why their request was denied, and we proposed adding 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.

We are finalizing these provisions as proposed, with some minor modifications. For example, all references to “service delivery requests” in §§ 460.104, 460.121 and 460.122 have been replaced with the term “service determination request.” In addition, we have modified § 460.121(d)(2) to limit service determination requests to requests that are received by PACE organization employees and contractors who provide direct care in the participant's residence, the PACE center, or while transporting participants.

j. 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 beneficiary” 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 proposed that beneficiaries with SCD be classified as exempt beneficiaries. CMS is finalizing the definition of an exempted beneficiary to include beneficiaries with SCD as proposed with one modification to clarify that this definition is applicable starting in plan year 2022.

3. Summary of Costs and Benefits

Provision

Description

Primary impact to plans and sponsors, enrollees,

and medicare trust fund as applicable

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

This provision will codify the SUPPORT Act requirement making it mandatory that Part D sponsors implement DMPs, starting in plan year 2022.

There is a 10 year cost of $4.0 million. Part D sponsors will incur s a special first year cost of 3.2 million with ongoing costs of $0.1 million in later years.

b. Beneficiaries with History of Opioid-Related Overdose Included in Drug Management Programs (DMPs) (§ 423.153)

As finalized, this provision will require that, starting in plan year 2022, CMS identify beneficiaries enrolled in Medicare Part D with a history of opioid-related overdose (as defined by the Secretary) and include such individuals as PARBs for prescription drug abuse or misuse under sponsors' DMPs.

Part D beneficiaries with a history of opioid-related overdose have higher than average drug costs. CMS estimates that as a result of reduced utilization of drugs for beneficiaries participating in DMPs, there will be a savings of 5 percent of the current annual drug costs for enrollees with a history of opioid overuse. After the first year, the reduction in drug utilization may result in an annual savings of $7.7 million to the Medicare Trust Fund resulting from reduced drug spending by beneficiaries. The costs for case management and related paperwork is estimated at $10.1 million annually.

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

CMS is finalizing requirements that Part D sponsors and MA-PDs must provide information on the risks of opioids and alternative therapies to all Part D beneficiaries with modification starting in plan year 2022.

The requirements set forth under 1860D-4(a)(1)(B) will cost approximately $0.5 million in the first year to account for one-time programming costs and $0.4 million in the following years.

d. 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)

Under this final rule, if a Part D sponsor denies a DMP appeal, the case shall be automatically forwarded to the independent outside entity for review and resolution. A plan sponsor must forward the case to the independent outside entity no later than 24 hours following the expiration of the adjudication timeframe applicable to the plan level appeal. Finally, this final rule establishes conforming revisions to the notices that are sent to beneficiaries.

We estimate there will be about 28,600 appeals per year, of which 0.08 percent will be denied and automatically escalated to the independent review entity (IRE). Therefore, there are approximately 23 cases (0.08 percent * 28,600) annually affected by this provision. Since most IRE cases are judged by a physician at a wage of $202.46, and typically an IRE will take at most 1 hour to review, the total burden is about $4,656.58 (23 cases * $202.46 * 1 hour).

e. 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 is finalizing policies to implement two sections of the SUPPORT Act, which will—(1) require Part D plan sponsors to notify the Secretary of the imposition of a payment suspension on pharmacies that is based on a credible allegation of fraud, impose such payment suspensions consistent with the manner in which CMS implements payment suspensions in fee-for service Medicare, and report such information using a secure website portal; (2) define inappropriate prescribing with respect to opioids; (3) require plan sponsors to submit to the Secretary information on investigations and other actions related to inappropriate opioid prescribing; (4) define “substantiated or suspicious activities” related to fraud, waste, or abuse; and (5) establish a secure portal which would enable the sharing of data and referrals of “substantiated or suspicious activities” related to fraud, waste, or abuse among plan sponsors, CMS, and CMS's program integrity contractors.

While we believe there may be savings generated through actions taken by plans that will conduct their own due diligence from the reporting and sharing of administrative actions between CMS and plans sponsors, as well as additional law enforcement actions, we cannot estimate the impact at this time. The Part C and Part D sponsors will incur an initial aggregate cost of $15.2 million with level subsequent year aggregate costs of $9.6 million.

f. 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)

We are codifying additional existing rules for calculating MA Quality Bonus Payments ratings, implementing updates to the Health Outcomes Survey measures, adding new Part C measures, clarifying the rules around contract consolidations and application of the adjustment for extreme and uncontrollable circumstances when data are missing due to data integrity concerns, and making additional technical clarifications.

There will be no, or negligible, impact on the Medicare Trust Fund from these provisions.

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

CMS is finalizing regulations to (1) allow Part D sponsors to establish a second, “preferred,” specialty tier at a lower cost-sharing threshold than the current specialty tier; (2) codify the existing maximum cost sharing for the highest specialty tier; (3) codify a methodology to determine annually the specialty-tier cost threshold using ingredient cost and increase the threshold when certain conditions are met; (4) require sponsors to permit tiering exceptions between the two specialty tiers; and (5) permit sponsors to determine which drugs go on either specialty tier.

Permitting Part D sponsors to establish a second, “preferred,” specialty tier is unlikely to have a material impact on Part D costs to either the government or Part D enrollees.

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

CMS is finalizing regulations to require that each Part D plan implement a beneficiary real time benefit tool by January 1, 2023. he RTBTl must enable enrollees to have the information included in the prescriber RTBT system which includes accurate, timely, and clinically appropriate patient-specific real-time formulary and benefit information (including cost, formulary alternatives and utilization management requirements).

Adoption of a beneficiary RTBT will be an additional cost and burden on Part D sponsors. Based on our estimates, we believe this will cost Part D plans about $4.0 million for all plans in the first year based on the costs for them to reprogram their computer systems.

Additionally, the voluntary provision of rewards by Part D sponsors to enrollees using RTBT will have an impact of $0.7 million in the first year, in order to implement the program, and $0.4 million in subsequent years in order to maintain the program. These are maximum impacts assuming all Part D sponsors choose to implement the rewards and incentives, and it remains to be seen whether or not this will be the case.

i. Service Delivery Request Processes under PACE (§§ 460.104 and 460.121)

CMS is finalizing the process by which PACE organizations address service determination requests. Currently the IDT must determine the appropriate member(s) of the IDT to conduct a reassessment, perform a reassessment, and render a decision on each service determination request. However, our experience shows that approximately 40 percent of all requests could be immediately approved in full by an IDT member. We are therefore removing the obligation for a request to be brought to the IDT or for a reassessment to be conducted when a member of the IDT receives and can approve a service determination request in full at the time it is made. We are also removing the requirement to conduct a reassessment in response to a service determination request except when a request would be partially or fully denied.

The proposed revisions create efficiencies which are estimated to create cost savings of $16.8 million in the first year and gradually increase to $ 21.3 million in 2031. The net savings over 10 years is $193.8 million. The savings are true savings to PACE organizations as a result of reduced administrative burden.

j. Beneficiaries with Sickle Cell Disease (SCD) (§ 423.100)

CMS is finalizing that beneficiaries with SCD are classified as exempted from DMPs starting in plan year 2022.

We estimate that the impact of this provision is negligible because it will result in under 70 beneficiaries (

i.e.,

beneficiaries with SCD who meet DMP inclusion criteria by meeting the definition of a PARB) being exempted from DMPs.

B. Background

We received approximately 667 timely pieces of correspondence containing multiple comments for the provisions implemented within this final rule from the proposed rule titled “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” which appeared in the

Federal Register

on February 18, 2020 (85 FR 9002) (February 2020 proposed rule). Comments were submitted by MA health plans, Part D sponsors, MA enrollee and beneficiary advocacy groups, trade associations, providers, pharmacies and drug companies, states, telehealth and health technology organizations, policy research organizations, actuarial and law firms, MACPAC, MedPAC, and other vendor and professional associations. As mentioned previously, we are finalizing the policies from the February 2020 proposed rule in more than one final rule. The first part titled “Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program” appeared in the

Federal Register

on June 2, 2020 (85 FR 33796), and contained a subset of regulatory changes that impacted MA organizations and Part D sponsors more immediately, including information needed to submit their bids by the statutory deadline (the first Monday in June). The majority of the remaining provisions are addressed here in this final rule.

The proposals we are finalizing in this final rule range from minor clarifications to more significant modifications based on the comments received. Summaries of the public comments received and our responses to those public comments are set forth in the various sections of this final rule under the appropriate headings.

We also note that some of the public comments received for the provisions implemented in this final rule were outside of the scope of the proposed rule. CMS did not make any proposals in the February 2020 proposed rule on these topics, and as such, these out-of-scope public comments are not addressed in this final rule. The following paragraphs summarize the out-of-scope public comments.

We received comments about how CMS will assess compliance with PACE regulatory requirements, recommendations for changes to PACE grievance requirements, and a recommendation to require plan sponsors to automatically escalate all adverse Part D benefit appeals to the independent review entity. Related to Star Ratings, we received comments that CMS should only apply the Categorical Adjustment Index if it positively impacts a contract's Star Rating, and that we adopt completely new Star Ratings measures or change HEDIS measures during the COVID-19 pandemic. Related to establishing pharmacy performance measure reporting requirements, we received comments in favor of abolishing Direct and Indirect Remunerations, applying 100 percent of direct pharmacy price concessions at the point-of sale, prohibiting use of a scoring method that

solely uses contractual pay-for-performance metrics, and the inclusion of clinical data as part of any standardized performance measures.

With regard to our proposals to permit Part D sponsors to maintain up to two specialty tiers, several commenters expressed that, in general, tiered-formulary structures have misaligned incentives, and that specialty tiers (particularly a second specialty tier), exacerbate the impact of such misaligned incentives. These commenters expressed concerns over the transparency of Part D rebate mechanisms and suggested that Part D sponsors have incentives to grant more expensive products with preferred status even when preferred products are not always the least expensive products, which the commenters posited increases costs for both Part D enrollees and the government. Some commenters suggested that CMS should eliminate the specialty tier, reasoning that elimination of the specialty tier would only produce modest increases in premiums and cost sharing in other tiers. Some commenters also suggested that the tiers should be relabeled and reordered in the hierarchy relative to Part D enrollee cost sharing to be more consistent with current industry practices. Some commenters suggested that CMS should mandate that denials at the pharmacy counter trigger the appeals process. Other commenters suggested that Part D enrollees stabilized on a specialty drug be exempt from unfavorable coverage changes (for example, increased cost sharing) resulting from a secondary specialty tier. Some commenters suggested that CMS should adjust the Part D rebate sharing formulas to remove plan incentives for high-cost, high-rebate brand drugs. Some commenters encouraged CMS to investigate alternative catastrophic reinsurance models to incent the most savings for health plans implementing a preferred specialty tier. Some commenters suggested that, like private insurance plans with more than one specialty tier, CMS should establish an out-of-pocket max in Part D. Some commenters suggested a comprehensive reform of the Part D program. Some commenters suggested that transitioning to a biosimilar biological product on a lower specialty tier may have negative clinical implications for a patient stabilized on a reference product. (We refer readers to the Food and Drug Administration (FDA) regarding the safety and efficacy of biosimilar biological products, and their use in patients who have previously been treated with the reference product, as well as in patients who have not previously received the reference product.) Some commenters took the opportunity to suggest that CMS should expand the scope of our mid-year formulary change policy to include biosimilar biological products, reasoning that they are “equivalent” to the reference biological products. Some commenters suggested that CMS should improve the exceptions and appeal process. Some commenters suggested that CMS should ensure independent pharmacies cannot be excluded from providing non-preferred specialty tier drugs. Finally, some commenters suggested that CMS should institute conflict of interest provisions for pharmacy chains owned by PBMs. (We note that this rule, as we are finalizing it, would not provide Part D sponsors with any additional basis to exclude independent pharmacies from their networks.)

In response to proposed changes to the Coverage Gap Discount Program (CGDP), two commenters offered suggestions about how the Part D program could be more cost effective. One of these commenters urged CMS to prohibit Part D plans from using utilization management tools to steer utilization away from lower cost biosimilar products. The other commenter suggested that Congress change the CGDP in a way that would result in greater use of lower cost drugs throughout the program and suggested that the program's existence shifts the lower net cost determinations of generic and biosimilar products.

With regard to Medication Therapy Management (MTM), one commenter expressed concern about how pharmacists are paid for providing services, while another questioned the overall cost benefit of the MTM program.

A commenter recommended that CMS align exemption criteria for the Pharmacy Quality Alliance's Initial Opioid Prescribing Measures with DMP exemption criteria; however, these measures are not developed by CMS and are outside the scope of the proposed rule. We also received a number of comments that did not refer specifically to our Part D opioid proposals but more generally (1) referenced the opioid epidemic, (2) cited concerns that existing restrictions on opioid access may drive chronic pain patients to illicit markets and/or reduce their quality of life and functional status, (3) raised questions about Drug Enforcement Agency (DEA) actions against opioid prescribers and whether they address the root cause of the opioid epidemic, and (4) opined that interventions should be focused on illegal drugs.

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

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

Congress authorized special needs plans (SNPs) as a type of Medicare Advantage (MA) plan designed to enroll individuals with special needs. The three types of SNPs are those designed for: (1) Institutionalized individuals (defined in § 422.2 as an individual continuously residing, or expecting to continuously reside, for 90 days or longer in specified facility) or institutionalized-equivalent (defined in § 422.2 as living in the community but requiring an institutional level of care, which is determined using a specified assessment instrument and conducted consistent with specified standards); (2) individuals entitled to medical assistance under a State Plan under title XIX of the Act; or (3) other individuals with severe or disabling chronic conditions that would benefit from enrollment in a SNP. As noted in the proposed rule (85 FR 9013 through 9014), there have been a number of changes to the requirements for MA SNPs since their initial authorization. We proposed changes to § 422.101(f) to implement and extend the latest of those statutory changes, made by the Bipartisan Budget Act of 2018 (BBA).

As of July 2019, there were 321 SNP contracts with 734 SNP plans that had at least 11 members. 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).

2

The proposed rule summarized current processes and requirements for the models of care that all SNPs must use and follow under current law. (85 FR 9014)

2

For more information pertaining to chapter 16b of the Medicare Managed Care Manual, please see:

https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/mc86c16b.pdf.

The Bipartisan Budget Act of 2018 (BBA), enacted into law on February 9, 2018, amended section 1859(f) of the Act to include new care management requirements for C-SNPs. We proposed, and are finalizing here, regulations to

implement the provisions of the BBA of 2018 and establishes new care management requirements at § 422.101(f) for all SNPs, including minimum benchmarks for SNP models of care. Due to operational considerations, the requirements we are finalizing at § 422.101(f) are intended for implementation for coverage beginning contract year 2023. Plans that are required to submit MOCs for contract year 2022 are due to submit MOCs by February 17, 2021; those submissions will be evaluated based on the regulations in effect at that time (that is, without the amendments adopted here) and SNPs must implement and comply with their approved MOCs in connection with coverage in 2022. Moving the applicable implementation of the SNP MOC provisions to contract year 2023 will allow SNPs and CMS to construct the necessary processes for the full implementation and enforcement of this final rule. When MOCs for contract year 2023 are submitted for review and approval in early 2022, the regulations in this final rule will be used to evaluate those MOCs for approval.

Specifically, we proposed the following:

• First, we proposed to implement the requirement in section 1859(f)(5)(B)(i) of the Act regarding the interdisciplinary team, or sometimes called the interdisciplinary care team (ICT), in an amendment to § 422.101(f)(1)(iii) that would require the team to include providers with demonstrated expertise, including training in an applicable specialty, in treating individuals similar to the targeted population of the plan, and in addition to implementing the statutory requirement for C-SNPs, extend the requirement to all SNPs.

• Second, we proposed 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 in a new paragraph (f)(1)(iv) of § 422.101 that would extend the requirement to all SNPs. Under our proposal, face-to-face encounters would have to be between each enrollee and a member of the enrollee's ICT 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; we also proposed that a face-for-face encounter must be either in-person or through a visual, real-time, interactive telehealth encounter.

• Third, we proposed 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 proposed to extend this requirement to the model of care for all SNPs, in revisions to § 422.101(f)(1)(i).

• Fourth, we proposed 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 proposed a new provision at § 422.101(f)(3)(ii) to require that, as part of the evaluation and approval of the SNP model of care, National Committee for Quality Assurance (NCQA) must evaluate whether goals were fulfilled from the previous model of care. We also proposed, in new paragraphs (f)(3)(ii)(A) through (C) that: (A) 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; (B) plans submitting a new model of care must provide relevant information pertaining to the MOC's goals for review and approval; and (C) 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 also proposed 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)(i), using the same language.

• Lastly, we proposed to implement 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. The proposed regulation in § 422.101(f)(3)(iii) would extend these benchmarks for all SNP models of care.

We proposed to extend the new requirements enacted by the BBA of 2018 to all SNP plan types for several reasons. We explained that 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. Finally, we stated 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. Our proposal would streamline operational and administrative obligations by making the different SNPs have similar requirements as well as establish minimum standards to benefit all special needs individuals in these plans.

In the proposed rule, we solicited comment on the extension of the new care management and MOC requirements for C-SNPs to the care management and MOC requirements for all SNP types and then discussed each of the specific proposed policies in turn. We address comments about the extension of the requirements to all SNP types first, followed by a review of each proposed policy and the relevant comments and the response to such comments. 1. Extension of the C-SNP requirements to all SNP types

Comment:

CMS received a number of comments in support of or in opposition to the extension of C-SNP requirements, added to section 1859(f)(5) of the Act by the BBA of 2018, to apply to all SNP types, instead of limiting the applicability of these requirement to just C-SNPs. A handful of commenters were concerned about the applicability of several of the proposed regulations to I-SNP and D-SNP care management protocols with some arguing that the proposed rule would result in requirements that are duplicative of the current MOC approval process requirements. Several commenters specifically noted that SNPs of all types have existing processes and practices that cover the areas discussed in the proposed rule. They contend that the NCQA Model of Care, review, and scoring guidelines comprehensively cover the coordination of care, provider, and quality requirements outlined in the proposed rule. In addition, commenters noted that CMS audits include review of

performance by SNPs on these processes.

Response:

Regarding the extension of section 1859(f)(5) of the Act to include all SNP types, we agree this rule is consistent with current CMS policy, including several current regulations implementing section 1859; the statute and several regulations establish similar requirements for all SNPs regardless of type. Specifically, section 1859(f)(5)(A) of the Act requires that MA organizations offering a SNP implement an evidence-based model of care. The MOC and other SNP-specific requirements have been incorporated into the MA application for MAOs that wish to offer a SNP so that these MAOs can demonstrate that they meet CMS' SNP specific requirements and are capable of serving the vulnerable special needs individuals who enroll in SNPs. In the Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs: Negotiated Pricing and Remaining Revisions (74 FR 1493), known hereafter as the January 2009 final rule, CMS outlined the overarching purpose of section 422.101(f) and noted that SNPs, regardless of type, are required to meet the same requirements including that each plan must 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 people with disabilities, frail older adults, and those near the end of life based on appropriate protocols. (74 FR 1498 through 1450) CMS's belief that these measures are critical to providing care to the types of special needs populations served by SNPs has not changed in the intervening years since finalizing § 422.101(f) in 2009. As noted in this section of this rule, for each specific provision we proposed and are finalizing at § 422.101(f), CMS is codifying certain requirements that are part of the current SNP MOC approval process. Rather than forcing a duplication of processes, we believe that SNPs have already implemented many of these new requirements into their MOC. Understanding this, we proposed and are finalizing these provisions in line with current MOC review and scoring guidelines, covering all facets of the MOC including care coordination, provider, and quality requirements.

As discussed in the proposed rule, extending the statutory requirements for C-SNPs to all SNPs will provide improvements to the care coordination model in all SNPs. For example, section 1859(f)(5)(B)(ii), as added by the BBA of 2018, requires C-SNPs to provide face-to-face encounters with each enrollee on an annual basis, consistent with standards adopted by CMS. We proposed and are finalizing, at § 422.101(f)(1)(iv), that all SNPs provide for face-to-face encounters 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 month of enrollment, as feasible and with the individual's consent. Face-to-face encounters are appropriate to require for all SNP enrollees because these SNP enrollees have similar healthcare needs, including the need for treatment of multiple chronic conditions and for services such as care coordination.

Comment:

Another comment supported the proposal, but added that CMS should explore the application of a more rigorous set of requirements focused on person-centered care to strengthen the MOC and meet the needs of SNP enrollees.

Response:

We thank the commenter for their comment and suggestions. As proposed and finalized, the new provisions in § 422.101(f) provide both a structure for creating a care management process specifically designed to provide targeted care to individuals with special needs and allow flexibilities enabling plans to create innovative approaches to person-centered care. As noted in the Interim Final Rule with comment, titled “Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs” (CMS-4138-IFC), issued in September 2008 (“September 2008 IFC”) (73 FR 54225, 54228), we expect the MA organizations that have the commitment and resources to serve vulnerable special needs beneficiaries through SNPs will perpetually evaluate their own model of care by collecting and analyzing performance data to continually improve their model of care. We also noted in the September 2008 IFC that CMS would continue to evaluate models of care through the analysis of SNP performance data and monitoring visits, the review of scientific research on the efficacy of other care models, and feedback from beneficiaries, advocacy groups, and healthcare professionals (73 FR 54228). The revisions to § 422.101(f) adopted in this final rule represent a continuation of this process to evaluate and refine SNP care management.

This final rule establishes and clarifies delivery of care standards for SNPs and codifies standards which we have included in other CMS guidance and instructions. As such, we are finalizing the revisions to paragraph (f) to § 422.101 generally as proposed to extend certain statutory requirements to all SNPs.

1. The Interdisciplinary Team (ICT) in the Management of Care

As amended by the BBA of 2018, section 1859(f)(5)(B)(i) of the Act requires the interdisciplinary team (ICT) of each C-SNP to include providers with specified expertise and training. We proposed to implement this through an amendment to § 422.101(f)(1)(iii) that would apply the requirement to all SNPs. We proposed to require that each MA organization offering a SNP plan must provide each enrollee with an ICT that includes 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.

We explained in the proposed rule that MIPPA required SNPs to conduct initial and annual comprehensive health risk assessments, develop and implement an individualized plan of care, and implement an ICT for each beneficiary. Specifically, Section 1859(f)(5)(A)(ii)(III) of the Act requires all SNPs to use ICTs as part of offering a specialized MA plan for special needs individuals. As stated in the proposed rule, we believe that the combination of MIPPA's statutory elements and our regulatory prescription for the SNP model of care establishes a standardized architecture for effective care management while giving plans the flexibility to design the unique services and benefits that enable them to meet the needs and preferences of their target population. We believe our proposal, which amends paragraph (f)(1)(iii) and applies the additional requirements pertaining to demonstrated expertise and training of interdisciplinary team providers to all SNPs, is consistent with the MIPPA requirements and the rulemakings that first adopted requirements for the use of interdisciplinary teams (73 FR 54228, 74 FR 1498).

All SNPs must have an ICT to coordinate the delivery of services and benefits, but the current regulation provides flexibility as necessary for each SNP: One SNP may choose to contract with an ICT 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, as we explained in the proposed rule, one SNP may coordinate care through a

telephonic connection among all stakeholders and another 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. We provided these examples in the proposed rule to demonstrate the variety of ways SNPs currently implement their systems of care and how we believe all SNP enrollees should have access to a team of providers with expertise and training that are appropriate for each individual enrollee.

We received the following comments and our responses follow:

Comment:

A commenter recommended that CMS clarify that “providers,” as used in this section, follows the definition of “provider” in 42 CFR 422.2, and also recommended that CMS provide additional details about what constitutes “demonstrated expertise and training.” Specifically, the commenter requested that CMS clarify whether there are minimal expertise or training requirements that the provider must meet or whether each special needs plan would have discretion to make this determination.

Response:

As proposed and finalized, § 422.101(f)(1)(iii) requires SNPs to use an interdisciplinary team 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. Our current guidance for the MOC approval process provides that a SNP's MOC describe the composition of the ICT, including how the SNP determines ICT membership and the roles and responsibilities of each member. Additional information can be found in Chapter 5 of the MMCM, section 20.2.2, specifically guidance on MOC 2, Element D.

3

A compliant and well-developed MOC includes a description that specifies how the expertise and capabilities of the ICT members align with the identified clinical and social needs of the SNP beneficiaries. As proposed and as finalized, the requirement in § 422.101(f)(1)(iii) to have training in a defined role appropriate to their licensure in treating individuals similar to the targeted population of the plan means that individual providers and providers in one type of SNP (compared to other SNPs) may have training and expertise that differ based on the SNP-type or each individual enrollee's needs. For example, a C-SNP that targets diabetes mellitus may seek to establish an ICT for each enrollee that has a specialist with training and expertise in endocrinology while a D-SNP may want to establish ICTs for individual enrollees that focus on a particular set of chronic conditions or focus on specific service delivery needs for an enrollee, such as long-term services and supports. This is consistent with our current guidance and we believe that any additional burden here for SNPs will be minimal.

3

Please see Chapter 5 of the MMCM, which can be found at:

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/mc86c05.pdf

.

As defined in § 422.2, a provider is: (1) An individual who is engaged in the delivery of health care services in a State and is licensed or certified by the State to engage in that activity in the State; or (2) an entity that is engaged in the delivery of health care services in a State and is licensed or certified to deliver those services if such licensing or certification is required by State law or regulation. Therefore, the providers in the ICT must be licensed or certified to furnish the health care services they deliver. Under this new regulation, providers in an ICT must also be trained in a defined role appropriate to their licensure in treating individuals similar to the targeted population of the plan, when applicable. We expect that plans are already meeting this requirement that members of the ICT have training and expertise specific to the SNP's target population based on MOC scoring guidelines provided to all SNPs by NCQA; for example, MOC submissions specify how the expertise and capabilities of the ICT members align with the identified clinical and social needs of the SNP enrollees and describe how specific care plans for enrollees are used to determine the composition of the ICT.

4

In conclusion, under the amendment to paragraph (f)(1)(iii) that we are finalizing here, all members of the ICT must be licensed or certified to deliver the applicable health care furnished to enrollees of the SNP in compliance with § 422.2 and all of the members of the ICT must have 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. The revisions at § 422.101(f)(1)(iii) are being finalized as applicable beginning with 2023 so MOCs for that period will be reviewed and approved based on demonstrated compliance with this final rule. The specifics of the expertise and necessary training will vary with the SNP and the covered population, and we are not adopting specific, uniform minimum requirements for all providers in all SNPs ICTs.

4

The scoring guidelines can be found at:

https://snpmoc.ncqa.org/wp-content/uploads/MOC-Scoring-Guidelines_CY-2021-1.pdf.

See section MOC 2, Element D.

The revisions at § 422.101(f)(1)(iii) are being finalized as applicable beginning 2023 so MOCs for that period and subsequent years will be reviewed and approved based on demonstrated compliance with the amendments to the regulation that we are finalizing here.

Comment:

CMS received several comments regarding the extension of the new statutory interdisciplinary team requirements to D-SNPs and I-SNPs. Some commenters believed that plan implementation of additional ICT requirements would be unnecessarily burdensome because some D-SNPs have difficulty contracting with and requiring specialists to take part in the ICT process. Other commenters noted that the new rule would be redundant, given existing regulations and policies are already in place, including regulations applying to the institutional settings in which I-SNP beneficiaries reside. Some of these commenters noted that adding ICT requirements will increase the burden on long-term care facilities and may require some patients to be managed to different standards than others. Others noted that this provision could interfere with plans' current practices that promote the identification of providers from disciplines that are most relevant to the beneficiary's needs. Another commenter noted that for D-SNPs, there are credentialing and network adequacy standards already in place to ensure appropriate access for D-SNP enrollees to high-quality providers. Lastly, CMS received a comment stating that the ICT should include the enrollee's managed care long term services and supports (MLTSS) care manager in cases where the enrollee receives those services.

Response:

We believe the revisions we proposed and are finalizing at § 422.101(f)(1)(iii) are consistent with the current review and approval process for each MOC submission under MOC 2, Element D. While there might be overlap and redundancies for § 422.101(f)(1)(iii) and existing standards either for SNPs and SNP MOCs or for institutional providers that furnish services to SNP enrollees, that only reinforces that finalizing

§ 422.101(f)(1)(iii) as proposed is appropriate. As SNPs are designed to furnish services and coordinate care based on the needs of its target population, ensuring that the providers and ICT that deliver that care have expertise that is specific to the target population is consistent with the overall goals of SNPs.

As noted in Chapter 5 of the MMCM, section 20.2.2, the role and conditions of MOC approval for the ICT are described in MOC 2 Element D. All SNPs are required in §  422.101(f) to implement an evidence based model of care (MOC) that has been evaluated and approved by the NCQA. As part of the approval process, SNPs are also required to meet ICT requirements under Element D. Each SNP must describe how its organization determines the composition of ICT membership. Under factor 1 of MOC 2, Element D, all SNPs must explain how the SNP facilitates the participation of beneficiaries and their caregiver(s) as members of the ICT. In addition, each SNP must describe how the beneficiary's Health Risk Assessment Tool (HRAT) and ICP are used to determine the composition of the ICT for each enrollee, including where additional team members are needed to meet the unique needs of a beneficiary. Lastly, SNPs must explain how the ICT uses health care outcomes to evaluate processes established to manage changes or adjustments to the beneficiary's health care needs on a continuous basis. The new regulation text concerning the ICT and the need to include providers with certain expertise and training are similar to these existing requirements and standards for the MOC, so any additional burden should be minimal. To the extent that a SNP is already using the needs and assessments of each enrollee to identify ICT members that are qualified and trained to meet that individual enrollee's unique needs (and does this for each enrollee), this new standard may require some additional documentation from the SNP about the demonstrated expertise, licensure and training of the ICT. CMS believes plans will be able to implement the new ICT provisions without significant changes to current processes based on two critical factors: (1) All SNPs are already required under §  422.101(f)(1)(iii) to establish an ICT for each enrollee, and thus, plans have in place steps for reviewing ICT composition and qualification; and (2) more importantly, SNPs are currently employing a process similar to the new provision for establishing an ICT as part of the MOC application approval process. Again, the new ICT provision is a natural extension of and generally codifies elements of the current MOC approval process covering the ICT, which should facilitate a seamless transition for SNPs as they implement the necessary processes to comply with new ICT requirements. These changes to the MOC, and the others contained in the amendments to §  422.101(f) will apply to MOCs and SNP performance for 2023. This means that SNPs submitting MOCs for 2023 will need to develop and implement their MOCs for 2023 based on the amendments in this final rule. However, CMS will not require SNPs that currently employ MOCs that have been approved by NCQA and are not due for review and approval in 2023 to resubmit their MOCs to demonstrate compliance with § 422.101(f)(1)(iii) as amended in this rule; so long as the SNP and its MOC meets all other requirements, the SNP may continue to operate under its current MOC based on how similar the ICT provision of this final rule is to current law and policy. We strongly encourage D-SNPs and I-SNPs that do not have MOCs up for review and approval for 2023 to review their MOCs and implement changes as necessary to ensure the interdisciplinary team for each enrollee 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.

While the commenter states that some SNPs may face obstacles when seeking ICT participation from some providers (including certain types of specialists), CMS has not seen evidence suggesting such difficulties. Due to the similarity of § 422.101(f)(1)(iii) as revised in this rule to CMS's current policy and the standards used in NCQA reviews, it is likely that any difficulty that would lead to an inability to comply with this provision would have been apparent in past reviews of MOCs.

As we noted in the preamble of the proposed rule, SNPs are in the best position to identify an ICT 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 and the SNP's developed expertise. We expect that an MA organization that offers a SNP for a particular population based on a chronic condition, on residence in an institution or needing a similar level of care as those who reside in an institution, or on eligibility for both Medicare and Medicaid, will have considered the needs of such populations in designing the plan and the network of providers. MA organizations are not required to offer SNPs and those that choose to do so must be capable of meeting the unique needs of the targeted population, including gaining the participation of specialists and other health care providers that have the most or best expertise for serving these vulnerable populations, consistent with the regulatory requirements. With respect to the inclusion of the enrollee's MLTSS care manager, we again defer to SNPs to determine the appropriate composition of the beneficiary's ICT in compliance with the MOC standards, which includes consultation with the beneficiary. This final rule is based on and reflects a policy that while all SNPs must develop and use an ICT to coordinate the delivery of services and benefits for each enrollee, the construction of the ICT must recognize and be built to address the needs and wishes of each individual enrollee.

After consideration of the comments and for the reasons outlined in the response to comments and in the proposed rule, we are finalizing the amendment to § 422.101(f)(1)(iii) regarding ICT expertise and training as proposed without modification.

2. Face-to-Face Annual Encounters

We proposed to implement 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 proposed 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. We also proposed to codify that a face-for-face encounter must be either in-person or through a visual, real-time, interactive telehealth encounter. We proposed to adopt this in a new paragraph (f)(1)(iv) in § 422.101 that would extend the requirement to all SNPs. Under our proposal, SNPs would be required to provide an annual face-to-face visit that is in-person or by remote technology and occurs 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 a face-to-face encounter with that enrollee by September 30th of the following year. We indicated in the proposed rule that SNPs should implement this requirement in a manner that honors

any enrollee's decision not to participate in any qualifying encounter.

We received the following comments and our responses follow:

Comment:

CMS received a number of comments both supporting and opposing the requirement for SNPs to provide a face-to-face encounter with each enrollee. Some plans noted that this is already part of their program. Some commenters, however, were concerned that implementation could be a burden for enrollees, while others were concerned that the requirements would be particularly difficult for SNP types with larger enrollments, such as D-SNPs. Still others believed that the new regulation would be hard for plans to track encounters between enrollees and providers. Others suggested that CMS allow SNPs to use encounters with non-ICT plan contracted providers to meet this requirement.

Response:

We are finalizing the proposal to add § 422.101(f)(1)(iv) to require each SNP to provide an annual face-to-face encounter with each enrollee, with some modifications to address concerns raised by the commenters. As proposed and finalized, the required face-for-face encounter must be either in-person or through a visual, real-time, interactive telehealth encounter. The final rule requires, as proposed, that the MA organization provide for face-to-face encounters between each enrollee and a member of the enrollee's interdisciplinary team or the plan's case management and coordination staff. And finally, we are also finalizing that the face-to-face encounter occur on at least an annual basis, beginning within the first 12 month of enrollment, as feasible and with the individual's consent. However, we are finalizing additional flexibility as well for SNPs in connection with § 422.101(f)(1)(iv) by including that the required face-to-face encounter may also be with a contracted health plan provider and clarification as to the type of encounter that is required.

As we noted in the proposed rule, we intend for this requirement to be met in a number of different ways. In the proposed rule, we provided examples of encounters that would meet the requirement, including 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. We agree with commenters that have requested that encounters with health care providers contracted with the enrollee's SNP qualify under the implementation of the final rule. This would include the enrollee's regular primary care physician, a specialist related to the enrollee's chronic condition, a behavioral health provider, health educator, social worker, and MLTSS plan staff or related MLTSS health care providers provided that such providers are (i) a member of the enrollee's interdisciplinary team; (ii) part of the plan's case management and coordination staff; or (iii) contracted plan healthcare providers. Requiring at a minimum that a healthcare provider with a contractual relationship with the SNP be part of the annual face-to-face encounter in this way will ensure that the annual encounter is a meaningful one from the perspective of the enrollee's overall health and wellbeing. We also believe that a healthcare provider with a contractual relationship will facilitate the sharing of critical health information among the plan, the ICT, and other key healthcare providers, and thus ensure coordination of care for the enrollee under § 422.112(b), and result in increased care coordination and facilitate any necessary follow-up care or referrals. Therefore, we are finalizing the new regulation at § 422.101(f)(1)(iv) with additional text to list contracted plan healthcare providers as well as members of the ICT and the plan's care coordination team. We defer to each SNP to identify which providers are part of the plan's case management and coordination staff or contracted plan healthcare providers so long as the SNP's policies are reasonable and not a means to evade compliance with the rule.

We intend for this mandatory face-to-face encounter to serve a clinical or care coordination/care management purpose. Ensuring that a special needs individual has been contacted by the SNP at least once a year and that there has been a face-to-face encounter that pertains to the individual's health care is a way of ensuring that the goals of a SNP are met. Examples of the necessary services or engagement happening during the required encounter include: (i) Engaging with the enrollee to manage, treat and oversee (or coordinate) their health care (such as furnishing preventive care included in the individualized care plan (ICP)); (ii) annual wellness visits and/or physicals; (iii) completion of a health risk assessment (HRA), such as the one annually required for all SNPs under the current regulation at § 422.101(f)(1); (iv) care plan review or other similar care coordination activities; or (v) health related education whereby the enrollee receives information or instructions critical to the maintenance of their health or implementing processes for maintaining the enrollee's health, such as the administration of a medication. These examples are not the only activities that satisfy the new regulatory requirement. Encounters may also address any concerns related to the enrollee's physical, mental/behavioral health, or overall health status, including functional status. Plans may also use qualifying encounters—those that meet qualifications as stipulated in this final rule—that are the result of plan efforts to satisfy state-mandated Medicaid or MTLSS requirements. We believe many SNPs would already meet this standard in current practice and have sufficient encounters on at least an annual basis with each enrollee that this new regulation will not be burdensome. Encounters that are sufficient to meet the regulatory requirement we are finalizing could occur either through regular visits by the enrollee to a member of the beneficiary's interdisciplinary team or through the care coordination process established by the plan's staff or contracted plan healthcare providers. 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.

We are cognizant that enrollees should have the final authority over their health care and our proposed regulation text reflected this by requiring that these face-to-face encounters be as feasible and with the enrollee's consent. A SNP must comply with this requirement in a manner that honors any enrollee's decision not to participate in a face-to-face (either in-person or virtual) encounter. If an enrollee does not consent to the encounter required by § 422.101(f)(1)(iv), the plan should document that in order to demonstrate compliance with the regulation. The rule addresses feasibility barriers to a SNP providing for the required annual encounter, such as where a SNP enrollee may be non-responsive to plan outreach or the state of the member's health (such as if the member is dealing with a hospitalization) prohibits a face-to-face encounter with the type of provider or staff that are described in the final regulation. In these circumstances, CMS recognizes that a SNP may not be able to comply with the rule's mandate of an annual face-to-face encounter and we intend the “as feasible” standard in the regulation to address such situations. Since the enrollee has refused or because the SNP could not reach the enrollee after reasonable attempts, the plan has

complied with the requirement despite the lack of a qualified encounter. However, plans should document the basis or reason that a face-to-face encounter is not feasible in order to demonstrate that where there are no face-to-face encounters in the year, that failure is not a violation of the regulation. Note that a feasibility barrier does not include a SNP having to provide a reasonable accommodation, such as interpreter services, in order for the enrollee to participate in the encounter.

Lastly, restricting the manner of face-to-face encounters to those that are in-person or as a visual, real-time, interactive telehealth encounter is consistent with section 1859(f)(5)(B)(ii) of the Act as amended by section 50311 of the Bipartisan Budget Act of 2018. The statute requires CMS to set requirements for face-to-face encounters that must happen on an annual basis for C-SNPs; and in extending that requirement to I-SNPs and D-SNPs, we do not believe there is reason to develop different standards. For this specific requirement, we believe that a real-time, interactive, visual telehealth encounter permits face-to-face interaction even though electronic or telecommunications technology is used to facilitate the encounter. The real-time, interactive, visual encounter serves the same function and permits sufficiently similar engagement between the enrollee and the required member of the ICT, the SNP's case management or care coordination staff, or other contracted provider of the SNP as an in-person encounter for purposes of this specific requirement; our regulation here does not address when or how telehealth encounters may be clinically appropriate or sufficient but only specifically addresses the need for SNPs to ensure there is one annual encounter of a certain type for each enrollee. While not all covered services are necessarily appropriate to furnish through electronic means, MA plans (including SNPs) have broader flexibility in this regard under § 422.135. Therefore, 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 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 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.

Comment:

A few commenters suggested that in the implementation of the face-to-face encounter requirement that SNPs should be allowed to develop their own technical specifications for capturing compliance with this requirement. For example, An MAO recommended that SNPs be allowed to capture verbal confirmation from members or providers of completed face-to-face encounters from external parties and/or telehealth encounters as evidence of compliance.

Response:

CMS believes plans are in the best position to develop the processes and technical specifications for documenting how they meet this requirement and that a face-to-face encounter for purpose of satisfying this regulation has taken place. While § 422.101(f)(1)(iv) imposes some parameters for these encounters, there is a broad range of flexibility for how SNPs may meet the requirement. However, we clarify that our guidance here is specific to § 422.101(f)(1)(iv) and does not address any other Medicare program requirements. Because an encounter must pertain to the delivery of health care to the enrollee, we encourage SNPs to take the information from these encounters into account and to document them consistent with how other health care visits are documented. Lastly, CMS will monitor compliance with the requirement and consider additional rulemaking if necessary.

Comment:

Several commenters suggested the addition of the face-to-face requirement would create additional reporting burden for plans associated with capturing compliance to the rule.

Response:

We are also cognizant that new regulations sometimes include additional reporting or record keeping requirements. The final rule does not create any additional, explicit reporting requirements. However, SNPs are required under § 422.503(b)(4)(vi) to adopt and implement an effective compliance program, which must include measures that prevent, detect, and correct non-compliance with CMS' program requirements as well as measures that prevent, detect, and correct fraud, waste, and abuse. CMS will be monitoring compliance by SNPs with this requirement. In addition, SNPs should have information about all health care encounters and deliveries of covered services for many purposes, including: Payment to providers for furnishing services; complying with the existing data submission requirements in § 422.310; and meeting the requirements of § 422.112(b)(4), which requires procedures for plans and their provider networks to have the information necessary for effective and continuous patient care and quality review.

Comment:

Several commenters stated that some enrollees lack access to technology that would provide visual, real-time, interactive telehealth encounter, which may create a barrier to beneficiary participation in such encounters. Others requested that CMS allow telephonic encounters to count towards the annual face-to-face requirement under the new regulation.

Response:

We are cognizant that enrollees should have the final authority over their health care and our proposed regulation text reflected this by requiring that these face-to-face encounters be as feasible and with the enrollee's consent. First, SNPs have the flexibility to meet the requirement for a face-to-face encounter, either in-person or virtually. We believe that many beneficiaries are already meeting the requirement through in-person face-to-face encounters with qualified healthcare providers, which we believe will create minimal additional burden for plans implementing this final rule. The final rule does not mandate that SNPs utilize a visual, real-time, interactive telehealth encounter, though it is a permissible option when appropriate. Second, the SNP must comply with this requirement in a manner that honors any enrollee's decision not to participate in a face-to-face (either in-person or virtual) encounter. If an enrollee does not consent to the encounter required by § 422.101(f)(1)(iv), the plan should document that in order to demonstrate compliance with the regulation. The rule addresses feasibility barriers to a SNP providing for the required annual encounter, such as where a SNP enrollee may be non-responsive to plan outreach or the state of the member's health (such as if the member is dealing with a hospitalization in an out-of-network facility) prohibits a face-to-face encounter. In these circumstances, CMS recognizes that a SNP may not be able to comply with the rule's mandate of an annual face-to-face encounter and we intend the “as feasible” standard in the regulation to address such situations. By clarifying that a face-to-face encounter for delivery of health care services by a contracted provider will satisfy this requirement, it seems likely that most SNPs will be able to meet this requirement for most enrollees, as most enrollees in SNPs receive health care

services at some point each year. If the enrollee has refused or because the SNP could not reach the enrollee after reasonable attempts, the plan would be considered to have complied with the requirement despite the lack of a qualified encounter.

This final rule allows many types of face-to-face encounters, including visual, real-time, interactive telehealth encounters, to suffice for meeting the requirement. We do not believe that telephonic encounters should count towards the fulfilling the requirements of § 422.101(f)(1)(iv) for several reasons. First, the statute at section 1859(f)(5)(B)(ii) of the Act is specific in requiring that the encounters provided annually must be face-to-face with individuals enrolled in the plan. An audio-only encounter does not meet the statutory requirement that the encounter be face-to-face. Even though the statutory requirement is for C-SNPs, we believe that requiring all SNPs to meet this standard is appropriate in light of the health care needs and characteristics of the other populations of special needs individuals. Second, an audio-only encounter does not permit the provider to see the patient to use visual clues (for example, bruising, physical symptoms, or lack of focus) that could indicate something is wrong with the patient. This is a requirement for only one visit of this type a year and does not prohibit the use of audio-only encounters when those are appropriate for addressing other health care needs or visits. Further, for enrollees who do not use telehealth or lack the technological resources for such encounters, in-person delivery of health care services from one of the types of providers described in the regulation satisfies this requirement; there is no requirement for telehealth-based encounters to be used instead of in-person encounters. However, we will continue to monitor the ability of beneficiaries to take part in virtual encounters, the applicability of non-telephonic face-to-face encounters, and to assess the adequacy of substituting telephonic encounters in addition to the set of qualifying face-to-face encounters for I-SNPs and D-SNPs through future rulemaking.

After consideration of the comments and for the reasons outlined in the response to comments and in the proposed rule, we are finalizing § 422.101(f)(1)(iv) regarding face-to-face encounters substantially as proposed, but with modifications to clarify that the required face-to-face encounters pertain to the delivery of certain kinds of services (health care or care coordination services or care management) and must be with a contracted health care provider or certain SNP staff (a member of the enrollee's interdisciplinary team or the plan's case management and coordination staff). In addition, our final regulation text at paragraph (f)(1)(iv) is somewhat reorganized from the proposed rule to improve the readability of the provision.

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

We proposed 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. We also proposed 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 an annual HRA, using a comprehensive risk assessment tool that CMS may review during oversight activities. The proposed revision to paragraph (f)(1)(i) would also require the MA organization to 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).

We received the following comments and our responses follow:

Comment:

Several commenters sought clarification concerning what type of information must be included in the ICP from the HRA. In addition, a few commenters wanted to know what information plans could omit from the ICP while adhering to the regulation. Another commenter asked if D-SNPs would be permitted to align the HRA with other beneficiary assessments that some D-SNPs are required to submit for a state's requirement that enrollees be assessed as to Medicaid managed long-term services and supports (MLTSS) needs.

Response:

Existing CMS guidance addresses the first part of these comments—pertaining to the information from the HRA that must be incorporated into the ICP—and that guidance is consistent with the regulatory provision being finalized at § 422.101(f)(1)(i). Chapter 5 of the Medicare Managed Care Manual, section 20.2.2, addresses how each SNP's MOC includes a clear and detailed description of the policies and procedures for completing the health risk assessment tool (HRAT).

5

Because this existing guidance adequately describes how information from the annual HRA is incorporated into the enrollee's ICP, the guidance remains applicable. Part of NCQA's review of SNP MOCs is an evaluation of MOC 2, Element B, which includes the following subfactors:

5

Please see Chapter 5 of the MMCM, which can be found at:

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/mc86c05.pdf

.

• How the organization uses the HRAT to develop and update the Individualized Care Plan (ICP) for each beneficiary (Element 2C).

• How the organization disseminates the HRAT information to the Interdisciplinary Care Team (ICT) and how the ICT uses that information (Element 2D).

• How the organization conducts the initial HRAT and annual reassessment for each beneficiary.

• The detailed plan and rationale for reviewing, analyzing and stratifying (if applicable), the HRA results.

Under Element B, the content of and methods used to conduct the HRAT have a direct effect on the development of the ICP and ongoing coordination of ICT activities. The HRAT must assess the medical, functional, cognitive, psychosocial and mental health needs of each SNP beneficiary, as noted in Chapter 5 of the MMCM, section 20.2.2.

To meet the requirements of the first 2 factors of MOC 2, Element B, the SNP's MOC must include a description of how the HRAT is used to develop and update, in a timely manner, the ICP for each beneficiary and how the HRAT information is disseminated to and used by the ICT. Under factor 3, the description must include the methodology used to coordinate the initial and annual HRAT for each beneficiary (for example, mailed questionnaire, in-person assessment, phone interview) and the timing of the assessments. There must be a provision in the MOC for reassessing beneficiaries if and when warranted by a health status change or care transition (for example, hospitalization or a change in medication). The SNP must describe in the MOC the SNP's process for attempting to contact beneficiaries and have them complete the HRAT, including provisions for beneficiaries that cannot or do not want to be contacted or complete the HRAT. This approach in our current guidance provides plans the flexibility to develop an ICP that is appropriate for each beneficiary based on and using HRA information; the requirement added to

§ 422.101(f)(1)(i) that each SNP ensure that results from the initial assessment and annual reassessment conducted for each enrollee are addressed in the individual's individualized care plan would be met by a SNP that does these things in its development of the MOC and the ICP. CMS intends to implement and enforce the revisions to § 422.101(f)(1)(i) consistent with existing CMS guidance regarding the information from the HRA and HRAT that must be incorporated into the ICP.

We understand that some D-SNPs may be required to complete and use other assessments related to the Medicaid program. Integrated D-SNPs may choose to combine Medicaid and Medicare assessments as long as the assessment includes a review of the medical, functional, cognitive, psychosocial and mental health needs of each SNP beneficiary and is described in the MOC. Other assessments may (or may not) require the same elements or scope as the HRA required of MA SNPs so alignment and overlap of the assessments and how they are used depends on the specifics of each situation. As we implement § 422.101(f)(1)(i), we will continue to monitor the alignment of multiple assessments on SNP enrollees to determine whether further rulemaking is necessary. However, plans have created an HRA process as part of their approved MOC in the past, so we do not anticipate that SNPs will have difficulty complying with the changes we are finalizing to § 422.101(f)(1)(i). To the extent that there is overlap and the HRA required by § 422.101(f)(1)(ii) can be aligned with other assessments conducted by the SNP, the MOC should include a description of that alignment, consistent with the standards in MOC 2, Element B of Chapter 5, § 20.2.2.

We believe the current factors outlined in MOC 2, Element B allows SNPs the flexibility to align a MOC-approved HRAT with other assessment tools (as noted above), and is consistent with the intent of the changes being finalized here in § 422.101(f)(1)(i). Current guidance will be the basis for how CMS will implement and enforce § 422.101(f)(1)(i) to ensure that SNPs incorporate and address the results from the initial assessment and annual reassessment conducted for each individual enrolled in the individual's individualized care plan.

After consideration of the comments and for the reasons outlined in the response to comments and in the proposed rule, we are finalizing the amendment to § 422.101(f)(1)(i) as proposed without modification.

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

We also proposed 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 proposed new regulation text at § 422.101(f)(3)(ii) to provide 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. Under our proposal, if the SNP MOC did not fulfill the previous MOC's goals, the plan must indicate in its MOC submission how it will achieve or revise those goals for the plan's next MOC. We also proposed to move an existing regulation at § 422.101(f)(2)(vi) that requires all SNPs to submit their MOC to CMS for NCQA evaluation and approval in accordance with CMS guidance to a new paragraph at § 422.101(f)(3); our proposed paragraph (f)(3)(i) contains the same language as current § 422.101(f)(2)(vi).

We also proposed at paragraph (f)(3)(ii)(A) through (C) specific provisions regarding how NCQA would evaluate the MOC in terms of achievement of goals from the prior MOC. We explained how we intended that NCQA would determine whether each SNP, as part of NCQA's process for evaluation and approval of MOCs, provided adequate information to perform the evaluation required by § 422.101(f)(3)(ii) as well as whether the SNP met goals from the previous MOC submission. After stating that 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 the MOC, we solicited comment whether more explicit requirements on this point should be part of the regulation text.

We received the following comments on the proposal regarding evaluation of outlining and fulfillment of the MOC's goals and our responses follow:

Comment:

CMS received several suggestions related to providing information for evaluation whether the SNP achieved the goals from the prior MOC. One commenter proposed CMS look to the Healthcare Effectiveness Data and Information Set (HEDIS) reporting and measures for direction. Another commenter suggested that CMS evaluate plan performance monitoring and evaluation metrics included in the MOC, and not goals included in the Individual Care Plan.

Response:

We appreciate these suggestions as to the type and scope of information that should be used to evaluate whether a SNP has fulfilled the goals of its prior MOC. We clarify that it is the goals of the MOC (and whether those goals have been met) and not the goals of the ICP that are to be evaluated by NCQA under § 422.101(f)(3)(ii) as proposed and finalized.

We explained in the proposed rule that proposed § 422.101(f)(3)(ii) would align with our current guidance on the MOC submission and review process regarding SNP fulfillment of goals and summarized the current review process. (85 FR 9016) This includes the type of information submitted by SNPs and used by NCQA in evaluating whether the goals of a prior MOC have been fulfilled. Currently, all SNPs are required to identify and clearly define measurable goals and health outcomes as part of their model of care under MOC 4, Element B: Measurable Goals and Health Outcomes for the MOC, as addressed in Chapter 5 of the MMCM. 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 all SNPs should continuously assess and evaluate plan quality outcomes. This is reflected in current guidance in Chapter 5, § 20.2.2 of the Medicare Managed Care Manual. MOC 4, Element B currently contains the following subfactors:

• 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.

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

The measures identified in the MOC as part of addressing these subfactors are the measures that should be used in evaluating whether the goals of the prior MOC have been fulfilled. Current CMS guidance permits the SNP to identify

and describe the measures and data used by the SNP and does not require specific quality measures, such as HEDIS, be used. SNPs may use data and quality performance that CMS measures for the Star Ratings program or through the HEDIS surveys (or other surveys and required quality performance data) but are not limited to those measures and data sources. Subfactors 3 and 4 of Element B provide for descriptions of how the SNP assesses and tracks the impact of the MOC and determines if health outcome goals are met. As proposed and finalized, paragraph (f)(3)(ii)(A) does not list specific types of data or information but requires submission of relevant information pertaining to the MOC's goals and whether those goals were fulfilled. For example, a SNP may submit plan-level health or clinical goals such as controlling diabetes or improving mental health screening access, and provide data showing progress towards these goals. This means that the type and scope of data required are tied to what the MOC's goals are and how the previous MOC addressed MOC 4, Element B. At a minimum, the data and measures described in the previous MOC should be submitted under § 422.101(f)(3)(ii)(A) for determining whether the MOC's goals have been fulfilled but other data may be relevant and pertinent. We expect SNPs to make reasonable determinations about what other data could be submitted as relevant and pertinent for the NCQA evaluation that is required under § 422.101(f)(3)(ii).

For SNPs submitting their initial MOC, NCQA will evaluate the information under MOC 4 Element B as whether the SNP has set clearly definable and measurable goals and health outcomes in the MOC for the upcoming MOC period of performance. For the following submission year, the SNP MOC will be evaluated on whether the measurable goals and health outcomes set in the initial MOC were achieved. We proposed specific regulation text at § 422.101(f)(3)(ii)(B) that plans submitting an initial model of care must provide relevant information pertaining to the MOC's goals for review and approval and are finalizing that provision. This new regulation is consistent with our existing regulation and we intend that similar standards will be used going forward as those that are used now regarding the amount of information required from SNPs.

Comment:

CMS received several comments expressing concern regarding the incorporation of MOC performance information and data from the previous MOC into the next submission. Commenters noted that plans would need to have complete information on the achievement of goals from the previous year before submission of the next year's MOC in order to meet the new requirement 42 CFR 422.101(f)(3)(ii), and that this short timeframe may prevent plans from being able to provide a complete representation of their performance from the previous year. Others sought further clarification regarding how plans should operationalize the regulation or specific metrics to be evaluated by NCQA.

Response:

While we understand the commenters' concern about sufficient information being available each year about the previous year's MOC and performance, we believe that SNPs and NCQA can meet the requirements of the regulation. For SNPs submitting a MOC renewal after one year (because an annual review and approval is necessary), preliminary data from the immediately prior year can provide evidence to the level of fulfillment of the previous MOC's goals. For many I-SNPs and D-SNPs, they will be able to share findings from multiple years of data as part of this requirement because their MOCs will not necessarily need to be reviewed and approved on an annual basis. C-SNPs, which must submit annually under section 1859(f)(5)(B)(iv) of the Act, will be able to select preliminary findings each year from measures that provide evidence of progress on the MOC's goals. Further, for goals that are tied to building on prior performance or making incremental progress in the same or similar area each year, information about performance in more than one prior year may be relevant and pertinent to show how the SNP is fulfilling the MOC's goals. Under MOC 4, Element B of the MOC, SNPs must currently provide a description of the processes and procedures the plan will use to determine if health outcome goals are met. By sharing the findings from these processes, SNPs can outline achievable steps toward long term goals so that small steps using limited data year to year can be evaluated. Therefore, we believe that SNPs can effectively demonstrate progress to meet the requirements of § 422.101(f)(3)(ii).

As proposed and finalized, § 422.101(f)(3)(ii) requires, as part of the evaluation and approval of the SNP model of care, that NCQA evaluate whether goals were fulfilled from the previous model of care. To serve this purpose, the regulation also requires that:

• Plans must provide relevant information pertaining to the MOC's goals as well as appropriate data pertaining to the fulfillment the previous MOC's goals.

• Plans submitting an initial model of care must provide relevant information pertaining to the MOC's goals for review and approval.

• 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.

In each MOC submission and evaluation of the MOC, the SNP must be able to demonstrate that it is continuing to work towards achieving the MOC goals even if the SNP requires additional time or metrics to evaluate the progress. Each MOC should reflect modification of the SNP's strategies to meet the goals of the MOC as needed. Again, under MOC 4 Element B, SNPs are currently submitting health outcome measures used to measure overall SNP population health outcomes at the plan level. SNPs may submit final or preliminary findings from these measures in order to provide evidence of progress as part of each MOC submission.

Comment:

Several commenters questioned the applicability of the proposed regulation to D-SNPs and stated that dual eligible enrollees experience changes in eligibility based on their Medicaid status, which the commenters stated impacts the plan's ability to implement and operationalize the MOC.

Response:

First, we believe that the process for setting health outcome goals and choosing a set of measures to determine progress permits all SNPs, including D-SNPs, to select measures that make sense for the population that the plan serves in so far as those measures speak to benchmarks, specific time frames, and how achieving those goals will be determined. A SNP that believes it suffers from disproportionate rates of disenrollment can seek to align outcome measures in a way that recognizes these perceived challenges; however, any measures that the plan selects must be approved by NCQA as part of the MOC approval process. Second, we also believe that the extension of the provision in this rule requiring fulfillment of the previous MOC's goals is consistent with current MOC approval requirements as outlined in Chapter 5, section 20.2.2 (Model of Care Scoring Criteria), as applied currently to all MOC types. The goal of performance improvement and quality measurement is to improve the SNP's ability to deliver high-quality health care services and benefits to its SNP enrollees; our commitment to this is

reflected in how it is explicitly stated in section 20.2.2 under MOC 4: MOC Quality Measurement and Performance Improvement, Element B: Measurable Goals and Health Outcomes for the MOC. This goal may be achieved as a result of increased organizational effectiveness and efficiency through incorporation of quality measurement and performance improvement concepts that drive organizational change. The leadership, managers and governing body of a SNP must have a comprehensive quality improvement program in place to measure its current level of performance and determine if organizational systems and processes must be modified, based on performance results.

In addition, section 20.2.2 of Chapter 5 of the Medicare Managed Care Manual provides additional information for plans to identify and clearly define measurable goals and health outcomes for the MOC in listing the five subfactors for Element B of MOC 4. Under factor 1, the SNP's description of measurable goals must include benchmarks, specific time frames, and how achieving goals will be determined. For factor 2, the SNP must include the specific data sources it will use for measurement for the stated health outcome measures. SNPs have flexibility in setting health outcome goals, particularly flexibility to align those goals with the population being served by the plan, but such measures must be approved by NCQA in its review of the MOC. The rule we are finalizing at §§ 422.101(f)(3)(ii) maintains the current level of flexibility for different SNP types in setting goals and the measures and data used to determine if the goals are met. By allowing such flexibilities, the regulation permits SNPs to take into account unique challenges facing their plan (such as potential changes in enrollment due to changes in eligibility for enrollees) and to set goals that allow SNPs to measure progress against these challenges.

For factor 2, the SNP must identify in the MOC the specific data sources it will use for measurement for the stated health outcome measures. We believe that the process for setting health outcome goals and choosing a set of measures to determine progress permits D-SNPs, and all SNPs, to select measures that makes sense for the population of beneficiaries that the plan serves in so far as those measures speak to benchmarks, specific time frames, and how achieving goals will be determined. The regulation we are finalizing at § 422.101(f)(3)(ii) maintains the level of flexibility for different SNP types as it is currently constructed through NCQA's MOC approval process. By allowing such flexibilities, plans can take into account unique challenges facing their plan and to set goals that allow SNPs to measure progress against these challenges.

After consideration of the comments and for the reasons outlined in the response to comments and in the proposed rule, we are finalizing the amendment to § 422.101(f)(3)(ii) as proposed without modification.

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

Finally, we proposed a new regulation at § 422.101(f)(3)(iii) imposing the requirement that benchmarks for each MOC element set by CMS must 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 proposed to implement this requirement and a minimum 50% benchmark for all SNP models of care because medically complex conditions are found in enrollees across all SNP types and implementation of the benchmark requirement only for C-SNPs would be operationally challenging for MA organizations that operate more than one SNP. In the proposed rule, we stated that each SNP model of care would be evaluated based on a minimum benchmark for each of the four elements and how that was consistent with our current policy. 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 proposed 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 received the following comments and our responses follow:

Comment:

CMS received several comments that, while receptive to the establishment of the minimum benchmark as proposed, were concerned about the timing of the implementation of the rule. Commenters sought implementation to begin in Contract Year 2022.

Response:

We are finalizing the changes to § 422.101(f) as being applicable for contract year 2023 and subsequent years. While this final rule will have an earlier effective date, making these provisions applicable for the period beginning January 1, 2023 provides time for MA organizations to plan and time for NCQA to implement these new standards for use in evaluating MOCs developed and submitted for 2023. Plans that are required to submit MOCs for contract year 2022 are due to submit MOCs by February 17, 2021; those submissions will be evaluated based on the regulations in effect at that time (that is, without the amendments adopted here) and SNPs must implement and comply with their approved MOCs in connection with coverage in 2022. Moving the applicable implementation of the SNP MOC provisions to contract year 2023 will allow SNPs and CMS to construct the necessary processes for the full implementation and enforcement of this final rule. When MOCs for contract year 2023 are submitted for review and approval in early 2022, the regulations in this final rule will be used to evaluate those MOCs for approval.

Comment:

A number of commenters asked for additional clarity regarding how CMS will implement the scoring of each MOC sub-element.

Response:

First, we clarify that NCQA evaluates and scores the MOCs, as part of the NCQA approval requirement that has been in place since 2012 and that will be codified at § 422.101(f)(3) under this final rule. Second, we intend that scoring using the 50 percent benchmarks will be consistent with how MOCs are evaluated and scored now with the addition that the MOC submitted by the SNP must score at least 50% on each element; the scope, content and number of elements and the points available for each element remain the same as outlined in Chapter 5 of the Medicare Managed Care Manual, section 20.2.2.

Currently, the MOC narrative in Chapter 5 addresses four overarching categories: (1) Description of the SNP Population, (2) Care Coordination, (3) SNP Provider Network, and (4) MOC Quality Measurement & Performance Improvement. Each of the four categories is then comprised of a set of required elements, such as Element B: Subpopulation—Most Vulnerable Beneficiaries under the MOC 1 category. These elements and their various factors are reviewed and scored by NCQA and contribute to the overall score for that element. All total, there are 15 elements among the 4 MOC categories. A full list of categories, elements, and factors, as

well as additional guidance pertaining to MOC submission requirements and structure, can be found in Chapter 5 of the MMCM. As we explained in the proposed rule, there are a total of 60 points available, across all categories and elements. Each element is scored by NCQA on a range of 0 to 4. To meet the new standard at § 422.101(f)(3)(iii), each MOC must earn at least 2 points for each element.

As proposed and finalized, § 422.101(f)(3)(iii) does not alter the current characteristics or the number of categories, elements, and factors and the mandatory benchmarks will be applied at the element level. For example, the category MOC 2: Care Coordination is made up of five elements:

• Element A: SNP Staff Structure;

• Element B: Health Risk Assessment Tool (HRAT);

• Element C: Individualized Care Plan (ICP);

• Element D: Interdisciplinary Care Team (ICT); and

• Element E: Care Transition Protocols.

A SNP will need to meet a minimum benchmark score of 50 percent for each of Elements A-E. Failing to meet the minimum score in any one element would result in disapproval of the MOC by NCQA during the first round of evaluation. The current process and procedures for the evaluation is not changing under this final rule, so the SNP would be able to resubmit a revised MOC during the cure period after having an opportunity to address the failures identified by NQCA and to revise how the MOC addresses the applicable element(s).

Starting with the MOC for contract year 2023, each SNP will need to meet a minimum benchmark score of 50 percent for each element, and a plan's model of care will only be approved if each element of the model of care meets the minimum benchmark. CMS and NCQA will provide an overview of any category and/or element deficiencies in our correspondence to plans at the completion of NCQA's MOC evaluation. In addition, each SNP MOC will need to meet an overall score in order to meet NCQA approval, as is the case now.

Comment:

CMS received one comment concerned that the introduction of this new scoring process at the element level would potentially derail an otherwise worthy MOC submission.

Response:

We believe the final rule is largely consistent with existing regulations and guidance regarding review of SNP MOC standards as plans already receive scores at the element level, though under our current policy approval is based only on the aggregate score. However, use of minimum benchmarks for each element serves important policy goals by ensuring that each MOC is minimally compliant and that each MOC addresses all of the elements. We also have concerns that the current system potentially allows a MOC to pass while containing a significant deficiency in a specific element. We believe continued guidance and training by CMS and NCQA will mitigate disruption that may stem from the changes associated with the new scoring process under § 422.101(f)(3)(iii).

As we noted in the proposed rule, we anticipate that there will be some impact to the number of MOC submissions that will not pass NCQA's initial MOC review. Looking at MOC score data for contract year 2020, our proposed element benchmark of 50 percent would have impacted 20 of the 273 MOCs submitted, or 7.3 percent. Meaning 20 of the 273 MOCs in 2020 would have been required to resubmit during the cure period of the approval process. For comparison, for contract year 2020, under our current aggregate scoring system, seven plans were required to submit revised MOCs based on the current scoring system and an additional seven plans decided to withdraw their MOCs before the revision process, for a total of 14 MOCs. CMS intends to work with NCQA to ensure that the transition for SNPs to using the new scoring benchmarks for each element is as seamless as possible. Further, the cure period will provide an opportunity to make revisions to address deficiencies identified by NCQA for SNPs that must submit their MOCs for review and approval by NCQA for 2023.

Comment:

A commenter expressed concerns that the amended scoring process would be particularly problematic for D-SNPs that enroll beneficiaries with significant and complex medical and social needs.

Response:

We believe the MOC review and approval processes are structured to provide a uniform apparatus that already takes into account differences among SNP types and the populations that they serve. As a quality improvement tool, the MOC acts as an important roadmap for ensuring that the unique needs of SNP enrollees are addressed and is a fundamental component of SNP quality improvement. NCQA uses a review process that scores a MOC based on how well a plan has addressed process details and narrative descriptions. Each MOC renewal is an opportunity for a SNP to plan for, lay out, and implement improvements to its processes for each specific element and factor. Even when the MOC guidelines focus on quality improvement and enrollee health outcomes, the MOC review is centered on the SNP's processes and procedures used to determine if those health outcome goals are met. Under the MOC rubric, CMS does not intend for SNPs to meet specific metric thresholds denoting quality. For example, under MOC, Element B, factor 4, the MOC must describe how it determines if the goals described in factor 1 are met rather than address performance on a specific metric set by CMS. Regardless of SNP type, NCQA applies the review standards uniformly across each MOC submission under this regulation.

Comment:

A commenter noted concern that the MOC benchmark was duplicative of the reporting and tracking of plan performance under the Star Rating system.

Response:

The MOC requirement is distinct from the goals and purpose of the Star Ratings system so even though there may be some overlap in MA organization and SNP processes in order to successfully implement the MOC and achieve high Star Ratings, we do not believe that these are duplicative or that one should be eliminated in favor of the other.

Section 1859(f)(5)(A)(i) of the Act requires that all SNPs be approved by NCQA based on standards developed by the Secretary; this requirement was added by section 164 of the Medicare Improvements for Patients and Providers Act (hereinafter referred to as MIPPA) (Pub. L. 110-275) and became effective with the 2012 contract year. As provided in §§ 422.4(a)(1)(iv), 422.101(f), and 422.152(g), the NCQA approval process is based on evaluation and approval of the SNP MOC. Therefore, all SNPs must submit their MOCs to CMS for NCQA evaluation, and an MA organization must develop separate MOCs to meet the needs of the targeted population for each SNP type it offers. NCQA, based on guidance from CMS, has applied scoring standards applicable to all SNP types. The MOC is a forward-looking tool used by SNPs to design processes to perform and improve their performance over a set time period. The Star Ratings system, on the other hand, is used to measure and provide comparative information about the performance of MA organizations on defined measures. Under sections 1853(o) and 1854(b) of the Act, Star Ratings are used in determining payment and beneficiary rebates for MA plans; CMS has adopted provisions, at §§ 422.504(a)(17) and 423.505(a)(26), to use historical, sustained poor

performance on the Star Ratings to evaluate compliance with MA and Part D program requirements and, thus, whether an MA contract should be terminated. In this way, the Star Ratings are retrospective and provide information about past performance, not the MA organization's intentions or plans for improvement and to address enrollee needs in the coming year. Even if past performance can sometimes predict future performance, the Star Ratings program is not the duplicative of a quality improvement program like the MOC. There are other differences between the Star Ratings program and the MOC review and approval process, but these differences in purpose are fundamental and sufficient to conclude that it is appropriate to use a minimum benchmark for approval of all SNP MOCs. Therefore, we are finalizing § 422.101(f)(3)(iii) as proposed to require use of a 50 percent minimum benchmark for each MOC element.

After consideration of the comments and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing amendments to § 422.101(f)(1) introductory text, (f)(1)(i), (f)(1)(iii), and (f)(2) introductory text and adding § 422.101(f)(1)(iv) and (f)(3). These provisions are finalized substantially as proposed with a modification in paragraph (f)(1)(iv) to set standards for the required face-to-face encounter.

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

We proposed to amend our regulations at §§ 423.100 (definition of applicable drug) and 423.2305 (determination of coverage gap discount) to reflect changes to the relevant statutory provisions made by the BBA of 2018. 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 proposed 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 biological products licensed under subsection (k) of section 351 of the Public Health Service Act (that is, biosimilar and interchangeable biological products) are excluded from the coverage gap discount program only with respect to plan years prior to 2019. Accordingly, CMS has treated biosimilar biological products as applicable drugs under the Discount Program since 2019. Therefore, we proposed to revise the definition of applicable drug at § 423.100 to specify that such biological products are excluded only for plan years prior to 2019.

6

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Unless our policy specifically distinguishes biosimilar biological products from interchangeable biological products, we use the term “biosimilar biological product(s)” in this preamble to reference biosimilar or interchangeable (when such products become available) biological products.

We received four comments on our proposal. The two comments that were within the scope of the rule were supportive of the proposed changes. Therefore, we are finalizing the regulatory change as proposed to amend the definition of “applicable discount” in § 423.2305 to increase the applicable discount from 50 to 70 percent of the negotiated price beginning in 2019, and to revise the definition of applicable drug at § 423.100 such that biosimilar biological products are excluded only for plan years before 2019. As previously noted, these changes are being made to update the regulations to reflect statutory and operational changes that became effective in 2019.

C. 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 established 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 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 required 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 Bipartisan Budget Agreement (BBA) of 2018 revised the income thresholds 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 proposed 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 proposed 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 received no comments on this proposal and are finalizing the proposed revisions to § 423.286(d)(4)(ii) without modification. Although we are finalizing this provision as applicable 60 days after publication, it codifies current policies so we anticipate that there will be no change in operations or administration of the MA and Part D programs and encourage MA organizations and Part D sponsors to take this final rule into account immediately. We note that the revisions to this provision that we are finalizing in this final rule simply codify the Part D-IMRAA calculation that is currently used by SSA.

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)

Section 2004 of the SUPPORT Act requires that all Part D sponsors must have established DMPs no later than January 1, 2022. We proposed to amend regulatory language at § 423.153(f) to reflect this requirement. As discussed in the proposed rule preamble, the Overutilization Monitoring System (OMS) criteria used to identify “potential at-risk beneficiaries” (PARBs) (defined in § 423.100) are based on a history of filling opioids from multiple doctors and/or multiple pharmacies. While implementation of DMPs has been optional since codified for 2019, 85.9 percent of Part D contracts in calendar year 2019 and 87.2 percent in calendar year 2020 have established 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) are covered under Part D contracts that offer a DMP already. We received the following comments on this proposal and our responses follow:

Comment:

CMS received numerous comments that were generally supportive of our proposal to codify the statutory requirement that all Part D plans implement a DMP.

Response:

We thank commenters for their support.

Comment:

Several commenters expressed concerns that enrollees being treated for pain would be forced, through mandatory DMPs, to see a new doctor or use a new pharmacy and that the proposed regulation would undermine the doctor-patient relationship.

Response:

The concerns expressed in some of these comments appeared to reflect a misunderstanding of the requirements in section 2004 of the SUPPORT Act. Although section 2004 mandates the establishment of DMPs for all Part D sponsors beginning January 1, 2022, section 2004 did not expand DMPs' scope. Thus, it is not the case that a “mandatory” DMP would now require all Part D beneficiaries taking opioids to be subject to coverage limitations or quantity limits. Rather, the statute and the regulations we are finalizing in this rule will now require the few Part D sponsors who have not already established a DMP to do so. DMPs identify a subset of opioid users in the Part D program who may be at the highest risk of an adverse health event, for example, due to uncoordinated care. As mentioned in the proposed rule, CMS' internal analysis estimated that only 158 additional PARBs will be identified per year by applying the current minimum OMS criteria across all Part D contracts that do not already have DMPs in place. CMS expects that only a few of these additional beneficiaries will be subject to a coverage limitation after case management with their opioid prescribers.

CMS does not agree that DMP activities undermine the doctor-patient relationship. In fact, the goal of case management under a DMP is for Part D sponsors to assist prescribers in coordinating care for PARBs to ensure their opioid use is appropriate and medically necessary. The case management process increases safety and accountability within the doctor-patient relationship, as prescribers may or may not be aware that there are other prescribers of opioids or benzodiazepines for their patients. Any potential coverage limitation under a DMP is put in place only after the plan conducts case management, solicits the views of the enrollee's prescriber(s), and provides advance written notice to the enrollee. If a Part D sponsor implements a prescriber and/or a pharmacy limitation, the affected beneficiary is provided opportunities to select their preferred pharmacy and prescriber when they receive an Initial Notice of their PARB status and a Second Notice of their at-risk beneficiary (ARB) status, as described in regulation at § 423.153(f)(5)(ii)(4) and § 423.153(f)(6)(ii)(5). The sponsor is required to consider the beneficiary's preferences consistent with § 423.153(f)(9). These aspects of DMPs safeguard beneficiary's access to coverage of opioids, prescriber and pharmacy choice, and the integrity of the doctor/patient relationship.

Comment:

Several commenters requested that PACE organizations be exempt from the requirement to establish a DMP. These commenters noted that drug utilization management programs, quality assurance measures, and medication therapy management (MTM) program requirements

(§ 423.153(a) through (d)) are currently waived for PACE under § 423.458(d). Commenters also stated that the PACE model of care already addresses opioid overutilization through use of a closed provider network; care coordination through primary care providers and the interdisciplinary team; proactive drug utilization review; and in-person health assessments already required for PACE enrollees.

Some of these commenters noted that, while the majority of PACE participants do not reside in an LTC facility, PACE participants are required to meet their state's eligibility criteria for nursing home care and therefore share characteristics with beneficiaries who are exempt from DMPs because they are residents of LTC facilities. They also state that PACE organizations typically contract with a single pharmacy which inherently coordinates access and achieves the goals of a DMP. One commenter noted that many PACE organizations do not have formularies and therefore no Pharmacy and Therapeutic (P&T) committee to develop and carry out DMP policies and procedures.

Response:

CMS thanks these commenters for their feedback, but disagrees that PACE organizations should be exempt from the statutory requirement to establish a DMP. While the DMP statute does outline certain exempted beneficiaries, such as individuals with cancer or who reside in a LTC facility, it does not specify or contemplate exemptions based on Part D plan type. CMS notes that MA-PDs that require enrollees to access routine care from contracted and/or employed prescribers through an HMO or integrated care model are similarly required under Part 422 to provide coordinated care, but are not exempt from the DMP requirement. As commenters noted, PACE participants are an especially vulnerable Medicare population, and for those who live in the community, additional monitoring will serve as a valuable safeguard to help prevent misuse of opioids. Depending on the frequency of engagement between the participant and PACE organization, as well as participant preferences, the in-person assessments required under §§ 460.104 and 460.121 may not always coincide with identification through the OMS, and may present missed opportunities to intervene.

Under the existing regulatory framework where DMPs are voluntary, approximately 40 percent of PACE contracts have reported to CMS that they already have a DMP in place. In 2019, PACE enrollees accounted for 0.03 percent of all Part D enrollees belonging to a plan with a DMP, and 0.07 percent of Part D enrollees identified in OMS as PARBs because they met the minimum OMS criteria. Based on CMS' analysis used in the proposed rule, PACE enrollees account for 0.14 percent of total Part D enrollees identified as PARBs because they meet the criteria for history of opioid overdose (see discussion in this section of this rule), which is proportional to the number of PACE enrollees in Part D (for January 2020, 0.1 percent of all Part D enrollment). In other words, the likelihood of a PACE participant being identified as a PARB, either based on OMS criteria or history of opioid overdose, is at least as high as the likelihood of any Part D enrollee to meet those criteria. Therefore, a PACE participant is as likely as any other Part D enrollee to benefit from case management and should not be deprived of this aspect of the Part D program. As discussed in the proposed rule preamble, Part D sponsors with DMPs infrequently implement coverage limitations after case management. This reflects the goals of case management as a means through which Part D sponsors engage prescribers, gather relevant patient-specific information not available to CMS, such as more recent medical or prescription claims data, and seek to coordinate care tailored to the unique needs of the beneficiary. CMS expects the volume of PARBs identified through minimum OMS criteria in the PACE organizations that have not yet implemented a DMP will continue to be minimal and present a low overall burden for these organizations. As with other Part D plans, such burden includes conducting case management, implementing any needed coverage limitations, and reporting of case management outcomes and coverage limitations back to CMS via OMS. Reporting outcomes of case management provides CMS with valuable information to help track the safe use of opioids and benzodiazepines in the Part D program and serves as a means to document that case management occurred.

CMS agrees with commenters that a PACE organization, or for that matter, any Part D plan sponsor, that does not have a P&T committee would not be in compliance with existing § 423.153(f)(1), which requires approval of DMP policies and procedures by the “applicable P&T committee.” As specified in § 423.120(b), only Part D sponsors that use formularies must have a P&T committee, and CMS did not propose to broaden that requirement to apply to Part D sponsors that do not use formularies. For this reason, after consideration of the comments, CMS is amending the language at § 423.153(f)(1) to account for Part D sponsors, including PACE organizations, that do not have their own or a contracted P&T committee (for example, through their PBM) because they do not use a formulary. Such sponsors can comply with this requirement by having written DMP policies and procedures that are approved by the Part D sponsor's medical director and applicable clinical and other staff or contractors, as determined appropriate by the medical director. We have also added cross references to the existing regulations requiring that Part D sponsors have a medical director at § 423.562(a)(5), and for PACE organizations, at § 460.60(b).

Comment:

Several commenters stated general concerns or recommendations regarding DMPs. Commenters expressed concerns regarding the misapplication of the CDC Guideline for Prescribing Opioids for Chronic Pain

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and recommended that CMS direct sponsors towards appropriate disease-specific pain management guidelines. Additional recommendations included facilitating or encouraging providers to refer patients to non-pharmacologic therapies for pain; ensuring provider education about overdose and naloxone prescribing, including evaluation for substance use disorder; ensuring shared decision-making between beneficiaries and prescribers such that access to medically necessary opioids is not impeded; ensuring beneficiaries with a coverage limitation are not forced to use a pharmacy in which the sponsor has a financial interest; and generally ensuring DMP activities are non-punitive or stigmatizing.

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Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016. MMWR Recomm Rep 2016;65(No. RR-1):1-49. DOI:

http://dx.doi.org/10.15585/mmwr.rr6501e1.

Response:

CMS appreciates the concerns and recommendations commenters shared regarding case management activities. We note that the recommendations are not inconsistent with the current DMP requirements.

In finalizing the regulatory framework for DMPs (83 FR 16440), CMS made a conscious effort that DMP activities would not be punitive or stigmatizing and would not inappropriately limit access or result in abrupt opioid tapering. This is consistent with the CDC's commentary

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published in 2019,

which advised against the misapplication of the Guideline for Prescribing Opioids for Chronic Pain, including the inflexible application of the Guideline's dosage recommendations and policies that encourage abrupt tapering, sudden discontinuation, or dismissal of the patient from their physician.

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https://www.cdc.gov/media/releases/2019/s0424-advises-misapplication-guideline-prescribing-opioids.html.

CMS agrees that many of the suggestions proposed could be of value in many cases, and encourages sponsors to incorporate them, as appropriate, into their DMP policies and procedures, as well as protect against the unintended consequences identified by the CDC. Finally, CMS notes that beneficiaries are provided opportunities to select their preferred pharmacies and prescribers, if their plan intends to apply a pharmacy or prescriber limitation under the DMP. See § 423.153(f)(5)(ii)(4) and § 423.153(f)(6)(ii)(5).

Comment:

A few commenters stated that mandatory DMPs are redundant with existing prescription drug monitoring programs (PDMPs).

Response:

CMS disagrees that DMPs are redundant with PDMPs. PDMPs are state-level electronic databases that are used to collect information on all controlled substance prescriptions in a state. While PDMPs, which allow providers to access their patients' prescription history, are one tool to combat the opioid epidemic, PDMPs do not exist in all states, and health plans may not have access to them. Also, while CMS encourages providers to use PDMPs prior to issuing prescriptions for con

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