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

Federal RegisterApr 16, 2019

Ask Donna

What actually matters in this document.

Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 422, 423, 438, and 498

[CMS-4185-F]

RIN 0938-AT59

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

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Final rule.

SUMMARY:

This final rule will revise the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Bipartisan Budget Act of 2018; improve quality and accessibility; clarify certain program integrity policies for MA, Part D, and cost plans and PACE organizations; reduce burden on providers, MA plans, and Part D sponsors through providing additional policy clarification; and implement other technical changes regarding quality improvement. This final rule will also revise the appeals and grievances requirements for certain Medicaid managed care and MA special needs plans for dual eligible individuals to implement certain provisions of the Bipartisan Budget Act of 2018.

DATES:

Effective Dates:

These regulations are effective on January 1, 2020, except for the amendments to §§ 422.107(c)(9), (d), (e)(2), 422.560(a)(4) and (b)(5), 422.566(a), 422.629 through 422.634, 422.752(d), 438.210, 438.400, and 438.402, which are effective January 1, 2021, and for the amendments to §§ 422.222(a)(2), 423.120(c)(6)(iv), and 498.5(n)(1), which are effective June 17, 2019.

FOR FURTHER INFORMATION CONTACT:

Theresa Wachter, (410) 786-1157, or Cali Diehl, (410) 786-4053, MA/Part C Issues. Elizabeth Goldstein, (410) 786-6665, Parts C and D Quality Ratings Issues. Kari Gaare, (410) 786-8612, Prescription Drug Plan Access to Parts A and B Data Issues. Vanessa Duran, (410) 786-8697, D-SNP Issues. Frank Whelan, (410) 786-1302, Preclusion List Issues.

SUPPLEMENTARY INFORMATION:

I. Executive Summary and Background

A. Executive Summary

1. Purpose

The primary purpose of this final rule is to revise the Medicare Advantage (MA) program (Part C) and Prescription Drug Benefit Program (Part D) regulations based on our continued experience in the administration of the Part C and Part D programs and to implement certain provisions of the Bipartisan Budget Act of 2018. The changes are necessary to—

• Implement the Bipartisan Budget Act of 2018 provisions;

• Improve program quality and accessibility;

• Clarify program integrity policies; and

• Implement other changes.

This final rule will meet the Administration's priorities to reduce burden across the Medicare program by reducing unnecessary regulatory complexity, and improve the regulatory framework to facilitate development of Part C and Part D products that better meet the individual beneficiary's healthcare needs. Because the Bipartisan Budget Act of 2018 requires the Secretary to establish procedures, to the extent feasible, for integration and unification of the appeals and grievance processes for dual eligible individuals who are enrolled in Medicaid and in MA special needs plans for dual eligible individuals (D-SNPs), this final rule also includes provisions to revise the appeals and grievances requirements for Medicaid managed care and MA D-SNPs. While the Part C and Part D programs have high satisfaction among beneficiaries, we continually evaluate program policies and regulations to remain responsive to current trends and newer technologies, and provide increased flexibility to serve patients. Specifically, this final rule meets the Secretary's priorities to: (1) Reform health insurance by increasing access to personalized health care, (2) transform our healthcare system to be value-based and innovative by promoting health information technology, and (3) support boosting transparency around price and quality. These changes being finalized will promote more convenient, cost-effective access to care within Part C and D plans, improve accountability and bolster program integrity, allow plans to innovate in response to patients' needs, and promote coordination within MA D-SNPs.

2. Summary of the Major Provisions

a. Requirements for Medicare Advantage Plans Offering Additional Telehealth Benefits (§§ 422.100, 422.135, 422.252, 422.254, and 422.264)

Section 50323 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123) created a new section 1852(m) of the Social Security Act (the Act), which allows MA plans the ability to provide “additional telehealth benefits” (referred to as “MA additional telehealth benefits” in this rule) to enrollees starting in plan year 2020 and treat them as basic benefits. The statute limits these authorized MA additional telehealth benefits to services for which benefits are available under Medicare Part B, but that are not payable under section 1834(m) of the Act and have been identified for the applicable year as clinically appropriate to furnish through electronic information and telecommunications technology (referred to as “electronic exchange” in this rule). Under this final rule, MA plans will be permitted to offer—as part of the basic benefit package—MA additional telehealth benefits beyond what is currently allowable under the original Medicare telehealth benefit (referred to as “Medicare telehealth services” in this rule). In addition, MA plans will continue to be able to offer MA supplemental benefits (that is, benefits not covered by original Medicare) via remote access technologies and/or telemonitoring (referred to as “MA supplemental telehealth benefits” in this rule) for those services that do not meet the requirements for coverage under original Medicare or the requirements for MA additional telehealth benefits.

In this final rule, we establish regulatory requirements that will allow MA plans to cover Part B benefits furnished through electronic exchange but not payable under section 1834(m) of the Act as MA additional telehealth

benefits—and as part of the basic benefits defined in § 422.101 instead of separate MA supplemental benefits. We believe MA additional telehealth benefits will increase access to patient-centered care by giving enrollees more control to determine when, where, and how they access benefits. We solicited comments from stakeholders on various aspects of our proposal, which informed how we are implementing the MA additional telehealth benefits in this final rule.

b. Dual Eligible Special Needs Plans Provisions (§§ 422.2, 422.60, 422.102, 422.107, 422.111, 422.560 Through 422.562, 422.566, 422.629 Through 422.634, 422.752, 438.210, 438.400, and 438.402)

Section 50311(b) of the Bipartisan Budget Act of 2018 amends section 1859 of the Act to require integration of the Medicare and Medicaid benefits provided to enrollees in Dual Eligible Special Needs Plans (D-SNPs). In particular, the statute requires: (1) Development of unified grievance and appeals processes for D-SNPs; and (2) establishment of new standards for integration of Medicare and Medicaid benefits for D-SNPs.

The statute specifies a number of key elements for unified D-SNP grievance and appeals processes and grants the Secretary discretion to determine the extent to which unification of these processes is feasible. In particular, the unified processes must adopt the provisions from section 1852(f) and (g) of the Act (MA grievances and appeals) and sections 1902(a)(3) and (5), and 1932(b)(4) of the Act (Medicaid grievances and appeals, including managed care) that are most protective to the enrollee, take into account differences in state Medicaid plans to the extent necessary, easily navigable by an enrollee, include a single written notification of all applicable grievance and appeal rights, provide a single pathway for resolution of a grievance or appeal, provide clear notices, employ unified timeframes for grievances and appeals, establish requirements for how the plan must process, track, and resolve grievances and appeals, and with respect to benefits covered under Medicare Parts A and B and Medicaid, incorporate existing law that provides continuation of benefits pending appeal for items and services covered under Medicare and Medicaid. The statute requires the Secretary to establish unified grievance and appeals procedures by April 1, 2020 and requires D-SNP contracts with state Medicaid agencies to use the unified procedures for 2021 and subsequent years.

Regarding the establishment of new standards for integration of Medicare and Medicaid benefits, the statute requires that all D-SNPs meet certain new minimum criteria for such integration for 2021 and subsequent years, either by covering Medicaid benefits through a capitated payment from a state Medicaid agency or meeting a minimum set of requirements as determined by the Secretary. The law also stipulates that for the years 2021 through 2025, if the Secretary determines that a D-SNP failed to meet one of these integration standards, the Secretary may impose an enrollment sanction, which would prevent the D-SNP from enrolling new members. In describing the “additional minimum set of requirements” established by the Secretary, the statute directs the Federally Coordinated Health Care Office in CMS to base such standards on input from stakeholders. We implement these new statutory provisions and clarify definitions and operating requirements for D-SNPs in this final rule.

c. Medicare Advantage and Part D Prescription Drug Plan Quality Rating System (§§ 422.162(a) and 423.182(a), §§ 422.166(a) and 423.186(a), §§ 422.164 and 423.184, and §§ 422.166(i) and 423.186(i))

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 (hereafter referred to as the April 2018 final rule), CMS codified at §§ 422.160, 422.162, 422.164, and 422.166 (83 FR 16725 through 16731) and §§ 423.180, 423.182, 423.184, and 423.186 (83 FR 16743 through 16749) the methodology for the Star Ratings system for the MA and Part D programs, respectively. This was part of the Administration's effort to increase transparency and advance notice regarding enhancements to the Part C and D Star Ratings program.

At this time, we are finalizing enhancements to the cut point methodology for non-Consumer Assessment of Healthcare Providers and Systems (CAHPS) measures. We are also making substantive updates to the specifications for a few measures for the 2022 and 2023 Star Ratings, and finalizing rules for calculating Star Ratings in the case of extreme and uncontrollable circumstances. Data would be collected and performance measured using these final rules and regulations for the 2020 measurement period and the 2022 Star Ratings, except for the Plan All-Cause Readmission measure where the applicability date is the 2021 measurement period as described in section II.B.1.d.(1).(c) of this final rule.

d. Preclusion List Requirements for Prescribers in Part D and Individuals and Entities in MA, Cost Plans, and PACE (§§ 422.222 and 423.120(c)(6))

In the April 2018 final rule, CMS removed several requirements pertaining to MA and Part D provider and prescriber enrollment that were to become effective on January 1, 2019. We stated in that final rule our belief that the best means of reducing the burden of the MA and Part D provider and prescriber enrollment requirements without compromising our payment safeguard objectives would be to focus on providers and prescribers that pose an elevated risk to Medicare beneficiaries and the Trust Funds. That is, rather than require the enrollment of MA providers and Part D prescribers regardless of the level of risk they might pose, we would prevent payment for MA items or services and Part D drugs that are, as applicable, furnished or prescribed by demonstrably problematic providers and prescribers. We therefore established in the April 2018 final rule a policy under which: (1) Such problematic parties would be placed on a “preclusion list”; and (2) payment for MA services and items and Part D drugs furnished or prescribed by these individuals and entities would be rejected or denied, as applicable. The MA and Part D enrollment requirements, in short, were replaced with the payment-oriented approach of the preclusion list.

This final rule will make several revisions and additions to the preclusion list provisions we finalized in the April 2018 final rule. We believe these changes will help clarify for stakeholders CMS' expectations regarding the preclusion list.

3. Summary of Costs and Benefits

Provision

Description

Impact

Requirements for Medicare Advantage Plans Offering Additional Telehealth Benefits (§§ 422.100, 422.135, 422.252, 422.254, and 422.264)

Consistent with section 50323 of the Bipartisan Budget Act of 2018, MA plans have the ability to provide “additional telehealth benefits” to enrollees starting in plan year 2020 and treat them as basic benefits.

MA additional telehealth benefits are expected to produce $557 million in savings for enrollees over 10 years from reduced travel time to and from providers. The impact of paying for MA additional telehealth benefits out of the Medicare Trust Fund (as basic benefits) versus out of the rebates (as supplemental benefits) results in a transfer of $80 million from the Medicare Trust Fund to enrollees over 10 years.

Integration Requirements for Dual Eligible Special Needs Plans (§§ 422.2, 422.60, 422.102, 422.107, 422.111, and 422.752)

Consistent with section 50311(b) of the Bipartisan Budget Act of 2018, we are establishing, effective 2021, Medicare and Medicaid integration standards D-SNPs. Effective 2021 through 2025, we will require the imposition of an intermediate sanction of prohibiting new enrollment into a D-SNP if CMS determines that the D-SNP is failing to comply with these integration standards. Finally, we are creating new and modifying existing regulatory definitions that relate to D-SNPs.

For the initial year of implementation, we estimate a $3.4 million cost to MA plans and a $0.5 million cost to state Medicaid agencies, half of which is transferred to the federal government, in order to transition to the new requirements. After that, we estimate that impact will be negligible.

Unified Grievances and Appeals Procedures for Dual Eligible Special Needs Plans and Medicaid Managed Care Plans at the Plan Level (§§ 422.560-562, 422.566, 422.629-422.634, 438.210, 438.400, and 438.402)

Consistent with section 50311(b) of the Bipartisan Budget Act of 2018, we are unifying Medicare and Medicaid grievance and appeals procedures for certain D-SNPs that enroll individuals who receive Medicare and Medicaid benefits from the D-SNP and a Medicaid managed care organization offered by the D-SNP's MA organization, the parent organization, or subsidiary owned by the parent organization. Medicare and Medicaid grievance and appeals processes differ in several key ways, which in effect creates unnecessary administrative complexity for health issuers participating across product lines. This will allow enrollees to follow one resolution pathway at the plan level when filing a complaint or contesting an adverse coverage determination with their plan regardless of whether the matter involves a Medicare or Medicaid covered service.

The provision gives rise to both savings, from the increased efficiency of a unified process, and costs from the requirement to provide benefits while appeals are pending. Over 10 years there are three anticipated effects: (1) Plans will save $0.7 million from the increased efficiency of unified appeals and grievance processes; this savings is passed to the Medicare Trust Fund; (2) the Medicare Trust Fund will incur a $4.2 million expense for providing benefits while appeals are pending; and (3) enrollees will incur an extra $0.7 million in cost sharing for benefits while appeals are pending.

MA and Part D Prescription Drug Plan Quality Rating System (§§ 422.162(a) and 423.182(a), 422.166(a) and 423.186(a), 422.164 and 423.184, and 422.166(i)(1) and 423.186(i)(1))

We are finalizing several measure specification updates, adjustments due to extreme and uncontrollable circumstances, and an enhanced cut point methodology. The measure changes are routine and do not have a significant impact on the ratings of contracts. The policy for disasters will hold contracts harmless from decreases in ratings from the prior year when there are extreme and uncontrollable circumstances affecting them. The methodology to set Star Ratings cut points will help increase the stability and predictability of cut points from year to year.

Negligible impact.

Preclusion List Requirements for Prescribers in Part D and Individuals and Entities in MA, Cost Plans, and PACE (§§ 422.222 and 423.120(c)(6))

We are making several revisions to the MA and Part D preclusion list policies that we finalized in the April 2018 final rule.

Negligible impact.

B. Background

We received approximately 180 timely pieces of correspondence containing multiple comments on the proposed rule titled “Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-for-Service, and Medicaid Managed Care Programs for Years 2020 and 2021” which published November 1, 2018, in the

Federal Register

(83 FR 54982). While we intend to address the Risk Adjustment Data Validation (RADV) proposals in subsequent rulemaking (due to an extended comment period for these proposals until April 30, 2019, per 83 FR 66661), we are finalizing all other provisions with changes varying from minor clarifications to more significant modifications based on comments received. We also note that some of the public comments received were outside of the scope of the proposed rule. These

out-of-scope public comments are not addressed in this final rule. Summaries of the public comments that are within the scope of the proposed rule and our responses to those public comments are set forth in the various sections of this final rule under the appropriate headings. However, we note that in this final rule we are not addressing comments received with respect to the RADV provision of the proposed rule that we are not finalizing at this time. Rather, we will address these comments in subsequent rulemaking, as appropriate.

II. Provisions of the Proposed Rule and Analysis of and Responses to Public Comments

A. Implementing the Bipartisan Budget Act of 2018 Provisions

1. Requirements for Medicare Advantage Plans Offering Additional Telehealth Benefits (§§ 422.100, 422.135, 422.252, 422.254, and 422.264)

Technologies that enable healthcare providers to deliver care to patients in locations remote from the providers (hereinafter referred to as “telehealth”) are increasingly being used to complement face-to-face patient-provider encounters. Telehealth visits among rural Medicare beneficiaries participating in original Medicare have increased more than 25 percent a year from 2004 to 2013.

In Medicare Advantage (MA), about 81 percent of MA plans offered supplemental telehealth benefits in the form of remote access technologies in 2018, an increase from 77 percent in 2017.

This shows that the healthcare industry has made significant advances in technology that enable secure, reliable, real-time, interactive communication and data transfer that were not possible in the past. Moreover, the use of telehealth as a care delivery option for MA enrollees may improve access to and timeliness of needed care, increase convenience for patients, increase communication between providers and patients, enhance care coordination, improve quality, and reduce costs related to in-person care.

Mehrotra, A., Jena, A., Busch, A., Souza, J., Uscher-Pines, L., Landon, B. (2016). “Utilization of Telemedicine Among Rural Medicare Beneficiaries.”

JAMA,

315(18): 2015-2016.

https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/index.html

Medicare Payment Advisory Commission (MedPAC),

Report to the Congress: Medicare Payment Policy,

March 2018.

MA basic benefits are structured and financed based on what is covered under Medicare Parts A and B (paid through the capitation rate by the government) with coverage of additional items and services and more generous cost sharing provisions financed as MA supplemental benefits (paid using rebate dollars or supplemental premiums paid by enrollees). Traditionally, MA plans have been limited in how they may deliver telehealth services outside of the original Medicare telehealth benefit under section 1834(m) of the Act (hereinafter referred to as “Medicare telehealth services”) because of this financing structure; only services covered by original Medicare under Parts A and B, with actuarially equivalent cost sharing, are in the basic benefit bid paid by the capitation rate. Section 1834(m) of the Act and § 410.78 generally limit payment for Medicare telehealth services by authorizing payment only for specified services provided using an interactive audio and video telecommunications system that permits real-time communication between a Medicare beneficiary and either a physician or specified other type of practitioner, and by specifying where the beneficiary may receive telehealth services (eligible originating sites). Eligible originating sites are limited as to the type of geographic location (generally rural) and the type of care setting. The statute grants the Secretary the authority to add to the list of Medicare telehealth services based on an established annual process but does not allow for exceptions to the restrictions on types of practitioners that can furnish those services or on the eligible originating sites. Because sections 1852(a), 1853, and 1854 of the Act limit the basic benefits covered by the government's capitation payment to only Parts A and B services covered under original Medicare with actuarially equivalent cost sharing, telehealth benefits offered by MA plans in addition to those covered by original Medicare are currently offered as MA supplemental benefits and funded through the use of rebate dollars or supplemental premiums paid by enrollees.

On February 9, 2018, President Trump signed the Bipartisan Budget Act of 2018 (Pub. L. 115-123) into law. Section 50323 of the Bipartisan Budget Act of 2018 created a new section 1852(m) of the Act, which allows MA plans the ability to provide “additional telehealth benefits” (hereinafter referred to as “MA additional telehealth benefits”) to enrollees starting in plan year 2020 and treat them as basic benefits (also known as “original Medicare benefits” or “benefits under the original Medicare fee-for-service program option”). The statute limits these authorized MA additional telehealth benefits to services for which benefits are available under Medicare Part B but that are not payable under section 1834(m) of the Act and have been identified for the applicable year as clinically appropriate to furnish through electronic information and telecommunications technology (hereinafter referred to as “electronic exchange”). While MA plans have always been able to offer more telehealth services than are currently payable under original Medicare through MA supplemental benefits, this change in how such MA additional telehealth benefits are financed (that is, accounted for in the capitated payment) makes it more likely that MA plans would offer them and that more enrollees would use the benefit.

We are adding a new regulation at § 422.135 to implement the new section 1852(m) of the Act and amending existing regulations at §§ 422.100, 422.252, 422.254, and 422.264. Specifically, we are codifying a new regulation at § 422.135 to allow MA plans to offer MA additional telehealth benefits, to establish definitions applicable to this new classification of benefits, and to enact requirements and limitations on them. Further, we are amending § 422.100(a) and (c)(1) to include MA additional telehealth benefits in the definition of basic benefits and adding a cross-reference to new § 422.135 to reflect how these benefits may be provided as part of basic benefits. Finally, we are amending the bidding regulations at §§ 422.252, 422.254, and 422.264 to account for MA additional telehealth benefits in the basic benefit bid.

We proposed that, beginning in contract year 2020, MA plans will be permitted to offer—as part of the basic benefit package—MA additional telehealth benefits beyond what is currently allowable under Medicare telehealth services. Pursuant to section 1852 of the Act and the regulation at § 422.100(a), MA plans are able to offer Medicare telehealth services including those described in existing authority at section 1834(m) of the Act and §§ 410.78 and 414.65 of the regulations. We proposed that in addition to Medicare telehealth services, MA plans will be able (but not required) to offer MA additional telehealth benefits described in this final rule and at section 1852(m) of the Act. In addition, we proposed to continue authority for MA plans to offer MA supplemental benefits (that is, benefits not covered by original Medicare) via remote access technologies and telemonitoring (as

currently named in the plan benefit package (PBP) software; hereinafter referred to as “MA supplemental telehealth benefits”) for those services that do not meet the requirements for coverage under original Medicare (for example, for Medicare telehealth services under section 1834(m)) or the requirements for MA additional telehealth benefits, such as the requirement of being covered by Part B when provided in-person. For instance, an MA plan may offer, as an MA supplemental telehealth benefit, a videoconference dental visit to assess dental needs because services primarily provided for the care, treatment, removal, or replacement of teeth or structures directly supporting teeth are not currently covered Part B benefits and thus would not be allowable as MA additional telehealth benefits.

We proposed to establish regulatory requirements that will allow MA plans to cover Part B benefits furnished through electronic exchange but not payable under section 1834(m) of the Act as MA additional telehealth benefits—and as part of the basic benefits defined in § 422.101 instead of separate MA supplemental benefits. 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.

Section 1852(m)(2)(A)(i) of the Act, as added by the Bipartisan Budget Act of 2018, defines “additional telehealth benefits” as services—(1) for which benefits are available under Part B, including services for which payment is not made under section 1834(m) of the Act due to the conditions for payment under such section; and (2) that are identified for the applicable year as clinically appropriate to furnish using electronic information and telecommunications technology (which we refer to as “through electronic exchange”) when a physician (as defined in section 1861(r) of the Act) or practitioner (described in section 1842(b)(18)(C) of the Act) providing the service is not at the same location as the plan enrollee. In addition, section 1852(m)(2)(A)(ii) of the Act excludes from “additional telehealth benefits” capital and infrastructure costs and investments relating to such benefits. This statutory definition of “additional telehealth benefits” guided our proposal.

We proposed a new regulation at § 422.135 to authorize and govern the provision of MA additional telehealth benefits by MA plans, consistent with our interpretation of the new statutory provision. First, we proposed definitions for the terms “additional telehealth benefits” and “electronic exchange” in § 422.135(a). We proposed to define “additional telehealth benefits” as services that meet the following: (1) Are furnished by an MA plan for which benefits are available under Medicare Part B but which are not payable under section 1834(m) of the Act; and (2) have been identified by the MA plan for the applicable year as clinically appropriate to furnish through electronic exchange. For purposes of this specific regulation and addressing the requirements and limitations on MA additional telehealth benefits, we proposed to define “electronic exchange” as “electronic information and telecommunications technology” as this is a concise term for the statutory description of the means used to provide the MA additional telehealth benefits. We did not propose specific regulation text that defines or provides examples of electronic information and telecommunications technology because the technology needed and used to provide MA additional telehealth benefits would vary based on the service being offered. Examples of electronic information and telecommunications technology (or “electronic exchange”) may include, but are not limited to, the following: Secure messaging, store and forward technologies, telephone, videoconferencing, other internet-enabled technologies, and other evolving technologies as appropriate for non-face-to-face communication. We believe this broad and encompassing approach will allow for technological advances that may develop in the future and avoid tying the authority in the regulation to specific information formats or technologies that permit non-face-to-face interactions for furnishing clinically appropriate services.

We did not propose specific regulation text defining “clinically appropriate;” rather, we proposed to implement the statutory requirement for MA additional telehealth benefits to be provided only when “clinically appropriate” to align with our existing regulations for contract provisions at § 422.504(a)(3)(iii), which requires each MA organization to agree to provide all benefits covered by Medicare “in a manner consistent with professionally recognized standards of health care.” We proposed to apply the same principle to MA additional telehealth benefits, as MA additional telehealth benefits must be treated as if they were benefits under original Medicare per section 1852(m)(5) of the Act.

The statute limits MA additional telehealth benefits to those services that are identified for the applicable year as clinically appropriate to furnish through electronic exchange. The statute does not specify who or what entity identifies the services for the year. Therefore, we proposed to interpret this provision broadly by not specifying the Part B services that an MA plan may offer as MA additional telehealth benefits for the applicable year, but instead allowing MA plans to independently determine each year which services are clinically appropriate to furnish in this manner. Thus, our definition of MA additional telehealth benefits at § 422.135(a) provides that it is the MA plan (not CMS) that identifies the appropriate services for the applicable year. We believe that MA plans are in the best position to identify each year whether MA additional telehealth benefits are clinically appropriate to furnish through electronic exchange. MA plans have a vested interest in and responsibility for staying abreast of the current professionally recognized standards of health care, as these standards are continuously developing with new advancements in modern medicine. As professionally recognized standards of health care change over time and differ from practice area to practice area, our approach is flexible enough to take those changes and differences into account.

Furthermore, § 422.111(b)(2) requires the MA plan to annually disclose the benefits offered under a plan, including applicable conditions and limitations, premiums and cost sharing (such as copayments, deductibles, and coinsurance) and any other conditions associated with receipt or use of benefits. MA plans satisfy this requirement through the Evidence of Coverage, or EOC, document provided to all enrollees. This disclosure requirement would have to include applicable MA additional telehealth benefit limitations. That is, any MA plan offering MA additional telehealth benefits must identify the services that can be covered as MA additional telehealth benefits when provided through electronic exchange. We believe that it is through this mechanism (the EOC) that the MA plan would identify each year which services are clinically appropriate to furnish through electronic exchange as MA additional telehealth benefits.

We solicited comment on this proposed implementation of the statute and our reasoning. We noted in the proposed rule how we had considered whether CMS should use the list of Medicare telehealth services payable by original Medicare under section 1834(m) of the Act as the list of services that are clinically appropriate to be

provided through electronic exchange for MA additional telehealth benefits. In that circumstance, services on the list could be considered as clinically appropriate to be provided through electronic exchange for MA additional telehealth benefits without application of the location limitations of section 1834(m) of the Act. However, we do not believe that is the best means to take full advantage of the flexibility that Congress has authorized for the MA program. The list of Medicare telehealth services for which payment can be made under section 1834(m) of the Act under the original Medicare program includes services specifically identified by section 1834(m) of the Act as well as other services added to the Medicare telehealth list using criteria and an annual process established by CMS. We stated in the proposed rule that we believe these limitations and criteria should not apply to MA additional telehealth benefits under new section 1852(m) of the Act for MA plans.

The statute requires the Secretary to solicit comment on what types of items and services should be considered to be MA additional telehealth benefits. Therefore, we also solicited comments on whether we should place any limitations on what types of Part B items and services (for example, primary care visits, routine and/or specialty consultations, dermatological examinations, behavior health counseling, etc.) can be MA additional telehealth benefits provided under this authority.

An enrollee has the right to request MA additional telehealth benefits through the organization determination process. If an enrollee is dissatisfied with the organization determination, then the enrollee has the right to appeal the decision. We believe these rights help ensure access to medically necessary services, including MA additional telehealth benefits offered by an MA plan as described in this rule. In addition, CMS audits plan performance with respect to timeliness and clinical appropriateness of organization determinations and appeals.

While the MA plan would make the “clinically appropriate” decision in terms of coverage of an MA additional telehealth benefit, we note that each healthcare provider must also provide services that are clinically appropriate. We acknowledge that not all Part B items and services would be suitable for MA additional telehealth benefits because a provider must be physically present in order to properly deliver care in some cases (for example, hands-on examination, administering certain medications). As stated earlier, we proposed that MA plans would independently determine each year which services are clinically appropriate to furnish in this manner. Behavioral health, in particular, is a prime example of a service that could be provided remotely through MA plans' offering of MA additional telehealth benefits under this rule. The President's Commission on Combating Drug Addiction and the Opioid Crisis recommends telehealth as useful in the effort to combat the opioid crisis when clinically appropriate, especially in geographically isolated regions and underserved areas where people with opioid use disorders and other substance use disorders may benefit from remote access to needed treatment.

Retrieved at:

https://www.whitehouse.gov/sites/whitehouse.gov/files/images/Meeting%20Draft%20of%20Final%20Report%20-%20November%201%2C%202017.pdf.

We proposed in paragraph (b) the general rule to govern how an MA plan may offer MA additional telehealth benefits. Specifically, we proposed that if an MA plan chooses to furnish MA additional telehealth benefits, the MA plan may treat these benefits as basic benefits covered under the original Medicare fee-for-service program as long as the requirements of proposed § 422.135 are met. We also proposed in § 422.135(b) that if the MA plan fails to comply with the requirements of § 422.135, then the MA plan may not treat the benefits provided through electronic exchange as MA additional telehealth benefits, but may treat them as MA supplemental telehealth benefits, subject to CMS approval of the MA supplemental telehealth benefits. For example, a non-Medicare covered service provided through electronic exchange cannot be offered as an MA additional telehealth benefit because it does not comply with § 422.135, which is limited to furnishing through electronic exchange otherwise covered Part B covered services, but it may be offered it as an MA supplemental telehealth benefit.

Section 1852(m)(4) of the Act mandates that enrollee choice is a priority. If an MA plan covers a Part B service as an MA additional telehealth benefit, then the MA plan must also provide access to such service through an in-person visit and not only through electronic exchange. We proposed to codify this statutory mandate preserving enrollee choice in regulation text at § 422.135(c)(1), which requires that the enrollee must have the option to receive a service that the MA plan covers as an MA additional telehealth benefit either through an in-person visit or through electronic exchange. Section 1852(m)(5) of the Act mandates that MA additional telehealth benefits shall be treated as if they were benefits under the original Medicare fee-for-service program option. In proposed regulation text at § 422.135(f), we proposed to allow MA plans to maintain different cost sharing for the specified Part B service(s) furnished through an in-person visit and the specified Part B service(s) furnished through electronic exchange.

We proposed § 422.135(c)(2) to require MA plans to use their EOC (at a minimum) to advise enrollees that they may receive the specified Part B service(s) either through an in-person visit or through electronic exchange. We proposed, at § 422.135(c)(3), that MA plans would have to use their provider directory to identify any providers offering services for MA additional telehealth benefits and in-person visits or offering services exclusively for MA additional telehealth benefits. We stated in the proposed rule that these notifications in the EOC and the provider directory are important to ensure choice, transparency, and clarity for enrollees who might be interested in taking advantage of MA additional telehealth benefits. We requested comments on what impact, if any, MA additional telehealth benefits should have on MA network adequacy policies. Specifically, we were looking for the degree to which MA additional telehealth benefit providers should be considered in the assessment of network adequacy (including for certain provider types and/or services in areas with access concerns) and any potential impact on rural MA plans, providers, and/or enrollees.

Section 1852(m)(3) of the Act requires the Secretary to specify limitations or additional requirements for the provision or furnishing of MA additional telehealth benefits, including requirements with respect to physician or practitioner qualifications, factors necessary for the coordination of MA additional telehealth benefits with other items and services (including those furnished in-person), and other areas identified by the Secretary. We recognize the potential for MA additional telehealth benefits to support coordinated health care and increase access to care in both rural and urban areas. We stated in the proposed rule how we expect MA plans would use these types of benefits to support an effective, ongoing doctor-patient relationship and the efficient delivery of needed care.

We proposed in regulation text at § 422.135(c)(4) to require an MA plan

offering MA additional telehealth benefits to comply with the provider selection and credentialing requirements provided in § 422.204. An MA plan must have written policies and procedures for the selection and evaluation of providers and must follow a documented process with respect to providers and suppliers, as described in § 422.204. Further, we proposed that the MA plan, when providing MA additional telehealth benefits, must ensure through its contract with the provider that the provider meet and comply with applicable state licensing requirements and other applicable laws for the state in which the enrollee is located and receiving the service. We recognize, however, that it is possible for a state to have specific provisions regarding the practice of medicine using electronic exchange; our proposal reflected our intent to ensure that MA network providers comply with these laws and that MA plans ensure compliance with such laws and only cover MA additional telehealth benefits provided in compliance with such laws. We solicited comment on whether to impose additional requirements for qualifications of providers of MA additional telehealth benefits, and if so, what those requirements should be.

In order to monitor the impact of the MA additional telehealth benefits on MA plans, providers, enrollees, and the MA program as a whole, we also proposed to require MA plans to make information about coverage of MA additional telehealth benefits available to CMS upon request, per proposed § 422.135(c)(5). We proposed that this information may include, but is not limited to, statistics on use or cost of MA additional telehealth benefits, manner(s) or method(s) of electronic exchange, evaluations of effectiveness, and demonstration of compliance with the requirements in § 422.135. We explained in our proposed rule that the purpose of requiring MA plans to make such information available to CMS upon request would be to determine whether CMS should make improvements to the regulation and/or guidance regarding MA additional telehealth benefits.

In § 422.135(d), we proposed to require that MA plans furnishing MA additional telehealth benefits may only do so using contracted (that is, network) providers. We believe limiting service delivery of MA additional telehealth benefits to contracted providers offers MA enrollees access to these covered services in a manner more consistent with the statute because plans would have more control over how and when such services are furnished. The regulation at § 422.204 requires MA plans to have written policies and procedures for the selection and evaluation of providers and that such policies conform with MA specific credentialing requirements outlined in § 422.204. We explained in the proposed rule that these policies would also be a means to ensure additional oversight of providers' performance, thereby increasing plans' ability to provide covered services such as MA additional telehealth benefits. We also proposed to specify that if an MA plan covers benefits furnished by a non-contracted provider through electronic exchange, then those benefits may only be covered as MA supplemental telehealth benefits. These benefits are not MA additional telehealth or basic benefits if furnished by a non-contracted provider through electronic exchange. We requested comment on whether the contracted providers' restriction should be placed on all MA plan types or limited only to certain plan types, such as local/regional preferred provider organization (PPO) plans, medical savings account (MSA) plans, and/or private fee-for-service (PFFS) plans. Currently, pursuant to § 422.4(a)(1)(v), PPO plans must provide reimbursement for all plan-covered medically necessary services received from non-contracted providers without prior authorization requirements. We explained in the proposed rule our view that without an opportunity to review the qualifications of the non-contracted provider and to impose limits on how only clinically appropriate services are provided as MA additional telehealth benefits, PPO plans would not be able to meet the proposed requirements. Therefore, we solicited comment on whether to require just PPOs (or MSA plans, PFFS plans, etc.), instead of all MA plan types, to use only contracted providers for MA additional telehealth benefits.

Per section 1852(m)(2)(A)(ii) of the Act, the term “additional telehealth benefits” does not include capital and infrastructure costs and investments relating to such benefits. We proposed to codify this requirement in § 422.254(b)(3)(i) as a restriction on how MA plans include MA additional telehealth benefits in their bid submission. We stated that we believe that the statutory limit is tied only to the cost to the government, which is tied to how MA additional telehealth benefits may be included in the bid as basic benefits. Therefore, our proposal was to eliminate from the basic benefit bid those capital and infrastructure costs and investments that are required or used to enable the provision of MA additional telehealth benefits. We did not propose specific definitions of capital and infrastructure costs or investments related to such benefits because the costs and investments needed and used to provide MA additional telehealth benefits would vary based on the individual MA plan's approach to furnishing the benefits. In the proposed rule, we provided some examples of capital and infrastructure costs, including, but not limited to, high-speed internet installation and service, communication platforms and software, and video conferencing equipment. We also solicited comment on what other types of capital and infrastructure costs and investments should be excluded from the bid and how CMS should operationalize this statutory requirement in the annual bid process. We proposed to provide a more detailed list of examples in this final rule, based on feedback received from stakeholders.

We explained in the proposed rule that our proposal at § 422.254(b)(3)(i) meant that MA plans must exclude any capital and infrastructure costs and investments specifically relating to MA additional telehealth benefits from their bid submission for MA additional telehealth services offered directly by the plan sponsor and by a third party provider. Accordingly, we explained our proposal meant that the projected expenditures in the MA bid for services provided via MA additional telehealth benefits must not include the corresponding capital and infrastructure costs and that any items provided to the enrollee in the administration of MA additional telehealth benefits must be directly related to the care and treatment of the enrollee for the Part B benefit. In the proposed rule, we provided an example of this provision, noting that MA plans would not be able to provide enrollees with internet service or permanently install telecommunication systems in an enrollee's home as part of administration of MA additional telehealth benefits.

In addition to our proposal at § 422.135, we also proposed to amend paragraphs (a) and (c)(1) of § 422.100 to explicitly address how MA additional telehealth benefits may be offered by an MA plan. Section 1852(a)(1)(A) of the Act requires that each MA plan shall provide enrollees benefits under the original Medicare fee-for-service program option. As amended by the Bipartisan Budget Act of 2018, section 1852(a)(1)(B) of the Act defines “benefits under the original Medicare fee-for-service program option” to mean—subject to subsection (m) (regarding provision of MA additional

telehealth benefits)—those items and services (other than hospice care or coverage for organ acquisitions for kidney transplants) for which benefits are available under Parts A and B to individuals entitled to benefits under Part A and enrolled under Part B. Since this definition is subject to the statutory provision for MA additional telehealth benefits, this means that all of the same coverage and access requirements that apply with respect to basic benefits also apply to any MA additional telehealth benefits an MA plan may choose to offer. Therefore, we proposed to amend § 422.100(c)(1) to include MA additional telehealth benefits in the definition of basic benefits and to cross-reference § 422.135, which provides the rules governing MA additional telehealth benefits. We proposed to further clarify the regulation text in § 422.100(c)(1) to track the statutory language described earlier more closely in addressing both kidney acquisition and hospice in the definition of basic benefits. Finally, we proposed to make corresponding technical revisions to § 422.100(a) to reference the new paragraph (c)(1) for basic benefits (clarifying that MA additional telehealth benefits are voluntary benefits for MA plans to offer but are not required) and paragraph (c)(2) for MA supplemental benefits (instead of § 422.102 because MA supplemental benefits are listed as a benefit type in (c)(2)). We also proposed a small technical correction in the last sentence of § 422.100(a) to replace the reference to § 422.100(g) with “this section” because there are a number of provisions in § 422.100—not just paragraph (g)—that are applicable to the benefits CMS reviews.

Additionally, we proposed amendments to the bidding regulations at §§ 422.252, 422.254, and 422.264 to account for MA additional telehealth benefits and to correct the inconsistent phrasing of references to basic benefits (for example, these regulations variously use the terms “original Medicare benefits,” “benefits under the original Medicare program,” “benefits under the original Medicare FFS program option,” etc.). In order to make the MA additional telehealth benefits part of the basic benefit bid and included in the “monthly aggregate bid amount” as part of the original Medicare benefits that are the scope of the basic benefit bid, we proposed to update these various phrases to consistently use the phrase “basic benefits as defined in § 422.100(c)(1).” We also proposed a few minor technical corrections to the bidding regulations. Finally, we proposed a paragraph (e) in new § 422.135 to state that an MA plan that fully complies with § 422.135 may include MA additional telehealth benefits in its bid for basic benefits in accordance with § 422.254. This provision means that inclusion in the bid is subject to the bidding regulations we proposed to amend.

In offering MA additional telehealth benefits, MA plans must comply with existing MA rules, including, but not limited to: Access to services at § 422.112; recordkeeping requirements at § 422.118 (for example, confidentiality, accuracy, timeliness); standards for communications and marketing at § 422.2268 (for example, inducement prohibition); and non-discrimination at §§ 422.100(f)(2) and 422.110(a). Further, in addition to §§ 422.112, 422.118, 422.2268, 422.100(f)(2), and 422.110(a), MA plans must also ensure compliance with other federal non-discrimination laws, such as Title VI of the Civil Rights Act of 1964, section 504 of the Rehabilitation Act of 1973, and section 1557 of the Affordable Care Act. We did not propose specific reference to these existing requirements in new § 422.135 because we do not believe that to be necessary. Compliance with these existing laws is already required; we merely note, as an aid to MA plans, how provision of MA additional telehealth benefits must be consistent with these regulations. We solicited comment on this policy choice, specifically whether there were other existing regulations that CMS should revise to address their application in the context of MA additional telehealth benefits.

Finally, section 1852(m)(2)(B) of the Act instructed the Secretary to solicit comments on the implementation of these MA additional telehealth benefits by November 30, 2018; in addition to the proposed regulations to implement section 1852(m) of the Act, we used the proposed rule and the associated comment period to satisfy this statutory requirement. We thank commenters for their input to help inform CMS's next steps related to implementing the MA additional telehealth benefits. We received the following comments on this proposal, and our response follows:

Comment:

Many commenters suggested that CMS's approach to MA additional telehealth benefits align with CMS's existing approaches to what is currently available via telehealth under original Medicare. These commenters referenced the “Medicare telehealth services” definition in section 1834(m) of the Act, payment for remote patient monitoring (RPM) services outside of section 1834(m) of the Act, as well as the new communication technology-based services not subject to section 1834(m) restrictions, described in the Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019 (83 FR 59452, Nov. 23, 2018; hereinafter referred to as the Calendar Year 2019 Physician Fee Schedule final rule). Commenters also requested that CMS clarify the distinction between MA additional telehealth benefits and the various services in original Medicare that use communications technology (including Medicare telehealth services under section 1834(m) of the Act). Specifically, some commenters recommended that CMS state in the final rule that MA additional telehealth benefits are subject to the technological specifications for Medicare telehealth services furnished under section 1834(m) of the Act, that is, two-way audio and visual real-time and interactive services. Further, commenters requested that CMS explicitly state that under current original Medicare rules, MA plans may already include other clinically appropriate virtual services that are not subject to the location limitations of section 1834(m) of the Act—such as RPM technology—as part of basic benefits because such services are payable under Part B for original Medicare.

Response:

We understand commenters' concerns that differences between telehealth services under original Medicare and MA additional telehealth benefits be clearly distinguished and explained. We appreciate the input offered by commenters and provide a thorough and clear discussion here.

First, we must emphasize that the term “additional telehealth benefits” is a term of art with a specific meaning in the MA program; it is defined in section 1852(m)(A) of the Act and in the regulation we finalize here at § 422.135(a). We are finalizing the regulatory definition with changes from the proposed rule to delete “are furnished by an MA plan” and to include the statutory provisions that MA additional telehealth benefits are services for which benefits are available under Part B and are provided when specific healthcare providers and enrollees are in different locations. As finalized, the definition reads that additional telehealth benefits means services:

(1) For which benefits are available under Medicare Part B but which are not payable under section 1834(m) of the Act; and

(2) That have been identified by the MA plan for the applicable year as clinically appropriate to furnish through electronic exchange when the physician (as defined in section 1861(r) of the Act) or practitioner (described in section 1842(b)(18)(C) of the Act) providing the service is not in the same location as the enrollee. We are focused here on the first part of this definition.

Second, determining whether a service may be offered by an MA plan as part of basic benefits requires addressing two questions: (1) Is the service covered and payable under Part A or Part B?; and (2) if not, is the reason it is not payable under Part B solely because of the limits in section 1834(m) of the Act? If the answer to the first question is yes, then the service is already a benefit under the original Medicare fee-for-service program option and, unless it is hospice care or coverage for organ acquisitions for kidney transplants, must be provided under current law at section 1852(a) of the Act and the MA regulations in 42 CFR part 422. If the answer to the second question is yes, then provision of the service through electronic exchange may be covered as an MA basic benefit under section 1852(m) of the Act, as added by the Bipartisan Budget Act of 2018, and the regulations (at §§ 422.100, 422.135, 422.252, 422.254, and 422.264) we are finalizing in this rule. We note that these regulations include other conditions that must also be satisfied in order for the service to be MA additional telehealth benefits that may be included as basic benefits, but our focus for this specific discussion is on the relationship to Part B coverage. We turn now to Part B coverage of telehealth services.

Under original Medicare, Part B provides for coverage and payment of services (and items, which are not relevant for purposes of this discussion), including services furnished in an in-person encounter between a physician or other practitioner, services furnished as Medicare telehealth services as specified under section 1834(m) of the Act, and certain other services that can be furnished in full without the patient being present. “Medicare telehealth services,” as defined in section 1834(m) of the Act and the implementing regulations at §§ 410.78 and 414.65 include professional consultations, office visits, office psychiatry services, and other similar services that must ordinarily be furnished in-person but instead may be furnished using interactive, real-time telecommunication technology subject to the restrictions on Medicare telehealth services specified under section 1834(m) of the Act. Also under section 1834 of the Act, synchronous “store and forward” telehealth services may be furnished as part of federal telemedicine demonstration projects in Alaska and Hawaii. Medicare telehealth services under section 1834(m) of the Act are limited in that they must only be furnished by physicians and other specified types of practitioners, and can be furnished and paid only when the beneficiary is located at an eligible originating site.

As we explained in the Calendar Year 2019 Physician Fee Schedule final rule, we have generally regarded the Medicare telehealth services for which payment can be made under section 1834(m) of the Act as being limited to services that must ordinarily be furnished in-person during an encounter between a clinician and the patient, but are instead furnished using telecommunication technology as a substitute for that in-person encounter (83 FR 59482-59483). There are other services under original Medicare that use telecommunication technology, but are not considered Medicare telehealth services as defined under section 1834(m) of the Act, for example, RPM and remote interpretation of diagnostic tests, chronic care management services, transitional care management services (other than the included evaluation and management service), and behavioral health integration services.

Additionally, as established in the Calendar Year 2019 Physician Fee Schedule final rule, effective January 1, 2019, original Medicare now makes separate payment for new “communication technology-based services.” These services are not subject to the limitations of section 1834(m) of the Act because they are not a substitute for an in-person, face-to-face encounter between a clinician and a patient. As such, these services are inherently non-face-to-face, are paid under the Physician Fee Schedule like other physicians' services, and are not subject to the restrictions on Medicare telehealth services specified under section 1834(m) of the Act. The communication technology-based services include brief communication technology-based service (virtual check-in), remote evaluation of pre-recorded patient information, and interprofessional internet consultation. These three services and their corresponding Healthcare Common Procedure Coding System (HCPCS) codes are described in detail in the Calendar Year 2019 Physician Fee Schedule final rule at 83 FR 59482 through 59491. That rule also finalized separate payment under the Physician Fee Schedule for chronic care remote physiologic monitoring services.

In the Calendar Year 2019 Physician Fee Schedule final rule, CMS also implemented sections 50302 and 50325 of the Bipartisan Budget Act of 2018 to remove certain section 1834(m) limitations on geography and originating site (patient setting) for certain services. Specifically, the policies under section 50302 of the Bipartisan Budget Act of 2018 added renal dialysis facilities and the homes of beneficiaries as allowable originating sites and removed the geographic restrictions for hospital-based or critical access hospital-based renal dialysis centers, renal dialysis facilities, and beneficiary homes, for purposes of monthly ESRD-related clinical assessments for patients receiving home dialysis. The policies under section 50325 of the Bipartisan Budget Act of 2018 added mobile stroke units as allowable originating sites and removed the originating site type and geographic restrictions, for acute stroke-related telehealth services. Both are effective January 1, 2019.

Additionally, CMS revised the Medicare telehealth regulations to reflect the amendments made to section 1834(m) of the Act by section 2001(a) of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) (Pub. L. 115-271) to remove the originating site geographic requirements for all originating sites described in section 1834(m)(4)(C)(ii) of the Act, except for renal dialysis facilities that are only permissible originating sites for purposes of monthly ESRD-related clinical assessments for patients receiving home dialysis, and to add the home of an individual as a permissible originating site, with respect to telehealth services furnished for purposes of the treatment of an individual with a substance use disorder diagnosis or co-occurring mental health disorder, effective July 1, 2019 (83 FR 59494 through 59496).

All of the telehealth services and other non-face-to-face services furnished via communication technology described earlier are covered and paid under original Medicare. Therefore, MA plans must cover these services because they are required basic benefits. Any services falling outside the scope of these services that an MA plan wishes to offer may potentially be covered as MA additional telehealth benefits, effective January 1, 2020, assuming they meet the requirements under section 1852(m) of the Act. In other words, MA additional telehealth benefits can

include an even broader range of telehealth services for enrollees in an MA plan offering MA additional telehealth benefits, beyond original Medicare benefits. An examination conducted using videoconferencing and/or other telecommunications systems to relay information (such as images and vital signs) may be covered as a primary care visit when the physician (as defined in section 1861(r) of the Act) or practitioner (described in section 1842(b)(18)(C) of the Act) and enrollee are in different locations that do not meet the requirements under section 1834(m) of the Act. As a practical matter, we do not expect MA plans to find implementation and compliance difficult because, if a service provided by the physician or practitioner is a Part B covered service for which payment could be made, but for the limitations in section 1834(m) of the Act, it may be an MA additional telehealth benefit if the MA plan complies with § 422.135 as finalized. If a service or item provided by a physician or practitioner is covered under Part B by the original Medicare program and payment is not prohibited based on the limitations in section 1834(m) of the Act, then the service or item is a basic benefit without consideration of whether § 422.135 could apply. Finally, if a service is not covered under Part B, even if the limitations in section 1834(m) of the Act are taken into account, then the service may only be covered by an MA plan as an MA supplemental telehealth benefit, and not offered as an MA additional telehealth benefit. In addition, we clarify in this final rule that if a service is covered under Part B and provided through electronic exchange but otherwise does not comply with § 422.135 (for example, if it is provided by an out-of-network healthcare provider), then the service may be covered only as an MA supplemental telehealth benefit per § 422.135(b). For example, a nursing hotline staffed by nurses, that are not practitioners specified in section 1842(b)(18)(C)

of the Act, that provides assistance in identifying when to seek additional medical help would not be covered under Part B even if the assistance were provided in person. We discuss these issues in more detail in our responses to comments below.

Such practitioners include: (i) A physician assistant, nurse practitioner, or clinical nurse specialist (as defined in section 1861(aa)(5)) of the Act; (ii) A certified registered nurse anesthetist (as defined in section 1861(bb)(2)); (iii) A certified nurse-midwife (as defined in section 1861(gg)(2)); (iv) A clinical social worker (as defined in section 1861(hh)(1)); (v) A clinical psychologist (as defined by the Secretary for purposes of section 1861(ii)) and (vi) A registered dietitian or nutrition professional.

We thank commenters for their feedback on how to reconcile the telehealth differences between MA and original Medicare, and we hope our response provides adequate clarification and removes any misinterpretation. Please note, CMS intends to release more detailed sub-regulatory guidance relating to telehealth for both the original Medicare and MA programs.

Comment:

Several commenters supported CMS's explicit recognition that MA plans may continue to offer other telehealth services through MA supplemental telehealth benefits. A commenter questioned whether non-contracted providers will be allowed to provide MA additional telehealth benefits as supplemental benefits.

Response:

We thank commenters for their support for continuing to allow MA plans to offer MA supplemental telehealth benefits for those services that do not meet the requirements for coverage under original Medicare or as MA additional telehealth benefits. We are finalizing our proposal, at § 422.135(d), to require that MA additional telehealth benefits only be furnished using contracted providers. As discussed in the preamble of the proposed rule, an MA plan may still cover out-of-network services that would be considered MA additional telehealth benefits (and thus offered as MA basic benefits) when provided by a contracted provider, but these out-of-network services may only be covered as MA supplemental telehealth benefits because the MA plan has not complied with § 422.135(d). These services are not MA additional telehealth benefits if furnished by a non-contracted provider through electronic exchange.

Comment:

Many commenters supported CMS's proposed definition for the term “electronic exchange” in proposed regulation text at § 422.135(a). The commenters stated that CMS's broad definition, which defines electronic exchange as “electronic information and telecommunications technology,” is reasonable as it allows MA plans to use evolving technology to provide MA additional telehealth benefits. Further, some commenters strongly urged CMS to rescind the electronic exchange examples listed in the proposed rule preamble, but finalize as proposed the definition of “electronic exchange” in the regulation text at § 422.135(a). Commenters stated CMS could not provide a list of electronic exchange examples that adequately takes in to account future technological innovation. Commenters also explained that a limited list of electronic exchange examples would cause confusion in the marketplace because plans and providers would be uncertain about permissible forms of electronic exchange technology.

Response:

We appreciate all of the comments received on the proposed definition for the term “electronic exchange.” Our definition is based on how section 1852(m)(2) of the Act uses the phrase “electronic information and telecommunications technology” to describe how the services are provided when the physician or practitioner and the patient are not in the same location. In § 422.135(a) as finalized, we define “electronic exchange” as “electronic information and telecommunications technology.” We agree that this definition of “electronic exchange” allows MA plans the use of various forms of technology to provide MA additional telehealth benefits to enrollees. Our purpose in defining “electronic exchange” in this manner is to allow modernization in the MA program and the provision of evidence-based, effective health care. As noted in the proposed rule, we did not propose specific regulation text that defines or provides examples of electronic information and telecommunications technology. We stated that we believe this broad and encompassing approach will allow for technological advances that may develop in the future.

While our list of electronic exchange examples in the proposed rule preamble was not intended to be a comprehensive list for purposes of the final rule, we acknowledge that the list of electronic exchange examples does not take into account future technological innovation, and we seek to allow plans the flexibility to develop forms of electronic exchange without unnecessary burden. We are finalizing as proposed the definition of “electronic exchange” in the regulation text at § 422.135(a). We believe this more general approach allows for MA plan flexibility and innovation, does not inadvertently restrict MA plans to certain forms of electronic exchange, and avoids the possibility of overlap with original Medicare telehealth coverage. We explicitly clarify here that future technology that is within the scope of the phrase “electronic information and telecommunications technology” as used in the statute may be used for purposes of providing MA additional telehealth benefits.

Comment:

Many commenters supported CMS's decision not to propose specific regulation text that defines or provides examples of electronic information and telecommunications technology because

the technology needed and used to provide MA additional telehealth benefits will vary based on the service being offered. A commenter suggested there be a governing body to review and certify the telehealth technology used and to ensure proper telehealth provider training.

Response:

We agree with commenters' position that specific regulation text that defines or provides examples of electronic information and telecommunications technology should not be included in the final rule. We do not include this specific regulation text in the final rule because technology will vary based on user and over time. As discussed earlier, we believe this broad and encompassing approach will allow for technological advances that may develop in the future and avoid tying the authority in the new regulation to specific information formats or technologies.

We appreciate the commenter's suggestion that there be a governing body to review and certify the telehealth technology used and to ensure proper telehealth provider training. We are not requiring a governing body to conduct oversight of telehealth technology and providers at this time, but we will use authority codified in this final rule at § 422.135(c)(4) to review information about coverage of MA additional telehealth benefits, which may include, but is not limited to, statistics on use or cost, manner(s) or method of electronic exchange, evaluations of effectiveness, and demonstration of compliance with the requirements of this final rule.

Comment:

Many commenters supported CMS allowing MA plans to independently determine each year which services are clinically appropriate to furnish through electronic exchange as MA additional telehealth benefits. These commenters stated that MA plans should have authority to make these determinations because plans and healthcare providers work directly with enrollees and are more aware of evolving methods of delivering care. A few commenters recommended that CMS authorize healthcare providers, rather than or in addition to MA plans, to make the annual determination of which services are clinically appropriate to furnish through MA additional telehealth benefits.

Response:

We are finalizing our proposal that MA plans have the discretion to determine which Part B services are clinically appropriate to provide through electronic exchange and to make that determination for each applicable plan year. Such services, when the other requirements in § 422.135 are met, would be permissible MA additional telehealth benefits. As professionally recognized standards of health care change over time, we believe MA plans have an interest in working with providers to develop and use the methods of modern medicine necessary to provide MA additional telehealth benefits to enrollees who choose to have their health benefits delivered in this manner. MA plans are required, per § 422.202(b), to consult with their contracted network providers regarding the MA plan's medical policy; this would include any applicable MA additional telehealth benefits policy, and we believe that is sufficient for establishing the required involvement of healthcare providers. We encourage MA plans to involve their contracted providers when making determinations about which services are clinically appropriate to furnish through MA additional telehealth benefits beyond the consultation required under that regulation, but we are not adopting such a requirement in this final rule.

Furthermore, we note that in accordance with § 422.112(b)(3), all MA coordinated care plans are required to coordinate MA benefits with community and social services generally available in the plan service area. Therefore, we expect MA coordinated care plans offering MA additional telehealth benefits to coordinate care for enrollees receiving the specified Part B service(s) through electronic exchange in the same manner as for enrollees receiving the service in-person.

Comment:

Many commenters opposed CMS placing limitations on the types of Part B items and services that can be MA additional telehealth benefits. Specifically, commenters urged CMS to use only the MA plan annual determination and medical review to define the types of items and services to be included as MA additional telehealth benefits. They explained that any definition of items or services will lock CMS into an approach supported by today's evidence, which will hinder CMS's ability to update its policies for future evidence-based innovation.

Response:

We agree with the commenters that adopting a specific list of services that could be MA additional telehealth benefits when provided through electronic exchange creates a risk of not being sufficiently flexible in the future. We proposed and are finalizing regulation text that allows MA plans flexibility to determine which services are clinically appropriate to furnish through MA additional telehealth benefits on an annual basis consistent with the limits in the statute and § 422.135.

Comment:

Some commenters supported CMS's proposal to allow MA plans offering MA additional telehealth benefits to maintain different cost sharing for in-person visits and visits through electronic exchange, while several commenters opposed differential cost sharing. Commenters expressed concerns that low-income enrollees living in rural, underserved areas without internet access may be disadvantaged because they would have to choose the in-person option, which may have higher cost sharing as compared to the alternative visit through electronic exchange. A few commenters, including the Medicare Payment Advisory Commission, recommended CMS ensure access to in-person services is not made prohibitively expensive by differential cost sharing as it could be discriminatory if undue financial burden is imposed on enrollees who choose in-person services instead of accessing services through electronic exchange. Further, commenters requested that CMS actively monitor differential cost sharing amounts to ensure they fairly reflect actual cost differentials and are not used to steer enrollees away from preferred methods of care. Commenters stated that enrollees lacking internet access should be able to get in-person services without facing an increase in out-of-pocket costs. Some commenters also requested that CMS clarify that a Qualified Medicare Beneficiary (QMB) would be protected from billing for cost sharing for all Part A/B services delivered via telehealth.

Response:

As discussed in the proposed rule, section 1852(m)(5) of the Act mandates that MA additional telehealth benefits shall be treated as if they were benefits under the original Medicare fee-for-service program option. We acknowledged in the proposed rule that CMS has traditionally interpreted section 1852(a)(1)(B)(i) and (iii)-(v) of the Act to mean that, subject to certain exceptions, MA plans must cover basic benefits using cost sharing that is actuarially equivalent to the Part A and B cost sharing from a plan-level (not enrollee-level) perspective. MA plans are not required, in most cases, to have the exact same cost sharing as in original Medicare. Subject to certain beneficiary protections and limits on cost sharing for certain specific services,

MA plans have great flexibility in setting the cost sharing for specific benefits. Further, for in-network services, CMS has limited authority to set the payment structure, including the payment amount, an MA

plan uses to pay its contracted providers; to some extent, the amount the MA plan has negotiated to pay its contracted providers may influence the cost sharing amount that the MA plan sets for the associated services. In addition, MA plans must have uniform cost sharing per § 422.100(d)(2). CMS has taken a broad and flexible approach to the uniformity requirement, including permitting MA plans to set up “preferred” networks that carry lower cost sharing for specific services.

In response to comments on this topic, we are clarifying the rationale for § 422.135(f).

See 42 CFR 422.100(f), (j) and (k).

See Announcement of Calendar Year 2019 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter.

In the context of original Medicare Part B, services furnished in an in-person encounter between a clinician and a patient are subject to different rules than those delivered through electronic exchange; in effect, the statutory provisions governing payment for original Medicare telehealth services treat services furnished through electronic exchange as different services than the in-person services, rather than as the same services delivered through different modalities. Section 1834(m) of the Act limits Part B payment for services furnished through electronic exchange to only certain healthcare services delivered through certain technology by specified types of clinicians to beneficiaries located in originating sites that meet specific conditions. Under the statutory scheme of section 1834(m) of the Act, services furnished through electronic exchange, where the physician or practitioner is not in the same location as the patient, are distinct and different services from those furnished in-person and in the same location.

We interpret the current law regulating the cost sharing in the MA context to mean that MA plans must charge enrollees the same cost sharing for the same item or service delivered by the same provider, and we view a service delivered in-person versus a service delivered via electronic exchange as different services because they are delivered differently. In order words, delivering a Part B service via electronic exchange is inherently different (for example, in modality and required infrastructure) than delivering the Part B service in-person under Medicare coverage rules; therefore, we consider these to be sufficiently different services for purposes of the MA requirement that cost sharing be uniform, and thus the services can be treated differently from a cost sharing perspective. Further, the cost of providing the service via electronic exchange might be lower, so having lower cost sharing is acceptable. For example, an MA plan may offer a dermatology exam using store-and-forward technology as an MA additional telehealth benefit, and the cost of this electronic exchange would likely be lower than the cost of an in-person dermatology exam. Thus, differential cost sharing for the electronic exchange versus the in-person visit would be appropriate in this scenario. This overall reasoning is consistent with our traditional interpretation of the Medicare statute and the applicable provisions in Part C, therefore we are finalizing the regulation text at § 422.135(f) as proposed.

We understand commenters' apprehensions about enrollee discrimination and enrollee access to MA additional telehealth benefits. The anti-discrimination requirements in current CMS regulations at § 422.100(f)(2) and § 422.110(a) are traditionally related to discrimination based on health status. Other federal non-discrimination laws, such as Title VI of the Civil Rights Act of 1964, focus on specific protected classes (such as race and age). Economic status or geographic location (rural/urban) are not protected classes under those laws, nor under current CMS regulations. Consequently, we do not have clear authority to enforce anti-discrimination rules based solely on an enrollee's economic status or geographic location.

However, the statutory requirement (section 1852(m)(4) of the Act) and our corresponding regulatory requirement in this final rule (§ 422.135(c)(1)) protecting the enrollee's choice to receive covered services in-person control how an MA plan offers MA additional telehealth benefits. An MA plan offering MA additional telehealth benefits must preserve the enrollee's right to choose whether to access the service in-person or, if offered by the MA plan, through electronic exchange. MA plans may not circumvent or limit enrollee choice by using differential cost sharing to steer beneficiaries or inhibit access to services. We view such steering and inhibiting access as violations of § 422.100(f)(2) because of how those activities would inhibit an enrollee from exercising his or her rights under section 1852(m)(4) of the Act and § 422.135(c). If an MA plan chooses to maintain differential cost sharing for MA additional telehealth benefits, we expect the primary purpose would be to parallel the actual cost of administering the service and not to steer beneficiaries or inhibit access. We will actively monitor complaints regarding differential cost sharing for MA additional telehealth benefits. If we identify a problem with enrollee access or steering, we may take compliance or enforcement actions, as necessary, and we may modify our policy to address the issue.

As discussed previously, MA plans have great flexibility in setting cost sharing for specific benefits. We believe that restricting this flexibility for certain plans that offer MA additional telehealth benefits, for example in cases where an MA plan operates in a rural or underserved area, could result in MA plans choosing not to offer MA additional telehealth benefits in rural service areas. Given this, and given the existing beneficiary cost sharing protections described previously, we do not believe it is appropriate to limit MA plans' existing flexibility to set cost sharing for MA additional telehealth benefits. However, we encourage MA plans to take issues like this into consideration in establishing cost sharing for MA additional telehealth benefits.

Finally, we appreciate the comments regarding QMB cost sharing protections. However, we believe that the current requirements at § 422.504(g)(1)(iii) requiring MA plans to take steps to ensure that QMBs are protected from providers billing cost sharing are adequate. This regulation prohibits MA plans from imposing cost sharing on dual eligible individuals when the state is responsible for paying for the cost sharing and from imposing cost sharing on such enrollees that is higher than the cost sharing permitted by the state Medicaid plan. For more information on cost sharing protections provided under the Act for QMBs and other dual eligible individuals, we refer readers to the CMS website for the QMB program at:

https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/QMB.html.

Comment:

In accordance with section 1852(m)(4) of the Act, if an MA plan covers a Part B service as an MA additional telehealth benefit, then the MA plan must also provide access to such service through an in-person visit and not only through electronic exchange. We proposed § 422.135(c)(2) to require MA plans to use their EOC (at a minimum) to advise enrollees that they may receive the specified Part B service(s) either through an in-person visit or through electronic exchange. We also proposed, at § 422.135(c)(3), that MA plans would have to use their provider directory to identify any

providers offering services for MA additional telehealth benefits and in-person visits or offering services exclusively for MA additional telehealth benefits. While we received some support for our proposed disclosure (that is, EOC and provider directory) requirements for MA additional telehealth benefits, other commenters believed that these requirements would be overly restrictive, burdensome, and/or time consuming.

Several commenters recommended that CMS provide more flexibility in how MA plans can disclose information about MA additional telehealth benefits to enrollees. For example, commenters suggested that CMS allow plans to use more general terminology instead of explicitly listing each service in the EOC, and allow plans to describe in the EOC how enrollees can obtain information on telehealth services. In terms of the provider directory, a commenter believed CMS should let plans make the determination regarding inclusion of telehealth providers in a way the plan believes optimizes clarity for enrollees, especially since the common industry approach is for telehealth vendors to contract with licensed providers, and the list of providers is not static. Another commenter requested that CMS require only an indication of which providers are exclusively available via telehealth in directories, and allow sufficient lead-time for plans to implement any new directory requirements. A commenter suggested CMS work with plans on alternative ways to responsibly share information on MA additional telehealth benefits with enrollees. A few commenters requested clear guidance (for example, model language) on the proposed disclosure requirements and clarification, such as whether provider directory updates would need to be made for all providers or only a specific subset.

Response:

We appreciate commenters' concerns about the proposed disclosure requirements being too restrictive and onerous on plans, and we thank those who offered alternative solutions and ideas for more flexibility. As discussed in the proposed rule, we believe that choice, transparency, and clarity are vital when it comes to disclosing MA additional telehealth benefits to enrollees. However, we also recognize that there are various ways to effectively communicate with enrollees consistent with the mandatory disclosure and information requirements in § 422.111. CMS has traditionally discussed specific required elements for mandatory disclosures (for example, the provider directory and EOC) and marketing materials in sub-regulatory guidance to explain and interpret the applicable regulations as well as describe best practices for MA plans and Part D sponsors.

We agree with commenters that more flexibility may be needed, and sub-regulatory guidance provides an opportunity for flexibility in applying the applicable regulations where possible and for regular updates as necessary to account for changes in technology or evolving methods of compliance. Therefore, we are not finalizing our proposed regulation text for the provider directory requirement at proposed § 422.135(c)(3). Instead, we will address any provider directory elements pertaining to plans offering MA additional telehealth benefits in future sub-regulatory guidance. We note that the provider directory requirements in § 422.111 are not being amended and continue to apply. Therefore, provider directories must be complete, accurate, and updated timely to identify the healthcare providers currently under contract with the MA plan to furnish covered services to enrollees. In response to comments claiming that the common industry approach is for telehealth vendors to contract with licensed providers and that the list of providers is not static, we remind MA plans of the requirement to issue provider directories and notify enrollees of network changes per § 422.111. As the providers of MA additional telehealth services must be contracted providers, we expect that they will be identified as contracted providers in provider directories.

We intend to be as clear as possible in our sub-regulatory guidance to assist plans with their enrollee communications and to address how the existing provider directory requirements apply in the context of MA plan obligations in connection with furnishing MA additional telehealth benefits. We note that, as discussed in more detail below, we are finalizing our proposal that only contracted (that is, in-network) providers may be used by an MA plan to furnish MA additional telehealth benefits.

For similar reasons, we are also not finalizing our reference to the EOC at proposed regulation text § 422.135(c)(2). The regulation at § 422.111 establishing what information must be provided to enrollees (and when) regarding benefits covered by the MA plan is sufficient. We have historically used sub-regulatory guidance to address the specific level of detail required by that regulation and will issue guidance specific to how MA additional telehealth benefits must be addressed in mandatory communication materials such as the EOC and the Annual Notice of Change. None of our other regulations about specific benefits require specific content in the EOC. We believe that it is appropriate to follow that practice for addressing how information about MA additional telehealth benefits must be disclosed and provided to enrollees.

However, we are finalizing the remaining text at (c)(2), which requires an MA plan furnishing MA additional telehealth benefits to advise enrollees that they may receive the specified Part B service(s) either through an in-person visit or through electronic exchange. We have decided to maintain this general enrollee disclosure requirement (without reference to the EOC) because of the statutory requirement at section 1852(m)(4)(B) of the Act that the enrollee must have that choice. We believe the MA plan must disclose this right of choice to enrollees in a transparent manner in order to ensure that the right is meaningfully provided. We plan to issue sub-regulatory guidance specifically for § 422.135(c)(2) regarding the requirement that an MA plan advise enrollees that they may receive the specified Part B service(s) through an in-person visit or through electronic exchange; we will also issue guidance on disclosure requirements of MA plans, including model language for both the EOC and the provider directory, in the context of MA additional telehealth benefits.

Comment:

In the proposed rule, we sought comment on what impact, if any, MA additional telehealth benefits should have on MA network adequacy policies, and the comments we received were mixed. Commenters who were supportive of a change to network adequacy policies for MA additional telehealth benefits stated that CMS should allow telehealth providers to be considered in the network adequacy assessment, either in the network criteria itself or through the exceptions process. Some suggested CMS update the network criteria to account for how MA plans may offer MA additional telehealth benefits (for example, allow telehealth providers to count in the network review or comprise a certain percentage of a plan's providers per specialty) or eliminate the time and distance standard and maintain just the minimum number per enrollee standard for telehealth providers. Others believed the current exceptions process was sufficient, that is, commenters expressed that through the current exceptions process, CMS could potentially allow plans to substitute telehealth providers for in-person providers only where there is a shortage

of specialty providers. A commenter suggested CMS consider telehealth exceptions for network adequacy when a plan can demonstrate that access to certain specialties would otherwise be problematic without permitting the MA plan to use telehealth providers to meet the network adequacy requirements; the commenter believed such policy would allow for more competition and more attractive MA plan options. Some commenters indicated that incorporating telehealth into network adequacy would improve enrollee choice and access in MA, particularly in rural/underserved areas, for certain specialties like behavioral health, and through an increase in after-hours and weekend care. A few commenters further encouraged CMS to provide flexibility regarding time and distance standards and allow telehealth to fill in network gaps, which might in turn streamline the network review process.

Other commenters asserted that a telehealth provider should not carry the same weight as an in-person provider and should only be used as a supplement, not a replacement, for in-person services. A few commenters suggested CMS continue basing network adequacy only on in-person services given the disparity in internet access.

Still others suggested CMS do a complete study to assess data in light of increased telehealth utilization, which could inform future changes to network adequacy policies and measurement options. A commenter recommended that, minimally, CMS should wait to reevaluate network criteria until there is a higher market saturation of telehealth providers for Part B services. Another commenter believed CMS should collect specific feedback on current plan-provider telehealth arrangements and current enrollee experience and satisfaction with telehealth providers, both within and outside MA.

Response:

We thank the commenters for their feedback on MA additional telehealth benefits' potential impact on network adequacy. We will consider these comments as we perform further research on the issue and update sub-regulatory guidance to reflect any applicable changes in policy. We are not using this final rule to announce or adopt changes in current policies for evaluating MA network adequacy under § 422.112 because CMS interprets the requirements at § 422.112 through the MA network adequacy criteria, which have traditionally been addressed in sub-regulatory guidance.

Comment:

Many commenters supported CMS's proposal to require MA plans to ensure through their provider contracts that providers meet and comply with applicable state licensing requirements and other applicable laws for the state in which the enrollee is located and receiving the service. Specifically, the commenters suggested CMS allow plan providers to utilize state-based credentialing standards for telehealth services as opposed to federal standards for MA provider participants authorized in § 422.204(b). A commenter believed that plans should be allowed to apply additional provider requirements.

Response:

We support requiring the MA plan to ensure through its contract with the provider that the provider meet and comply with applicable state licensing requirements and other applicable laws for the state in which the enrollee is located and receiving the service. This standard is codified in the final rule at § 422.135(c)(3). We believe creating additional provider licensing requirements is unnecessary, but we acknowledge that states may have specific provisions regarding the practice of medicine using electronic exchange. We remind readers and MA plans that existing provider credentialing and network participation requirements, specifically in §§ 422.200 through 422.224, continue to apply. As this final rule requires MA plans to use only contracted (that is, in-network) physicians and practitioners to furnish MA additional telehealth benefits, those existing regulations will apply.

Comment:

Several commenters expressed an openness to CMS occasionally collecting data on MA additional telehealth benefits, per the proposal to require MA plans to make information about coverage of MA additional telehealth benefits available to CMS upon request. However, these commenters were leery of the potential for administrative burden on MA plans. Some voiced concern about CMS collecting confidential or sensitive information and specifically requested that CMS exclude information that could be held under contractual consideration. For example, a commenter stated that specific information on use or cost of MA additional telehealth benefits is proprietary and commercially sensitive, and revealing contract-specific details would be anti-competitive. Another commenter concurred with CMS collecting data on the costs and benefits of MA plans' MA additional telehealth benefits as long as it was not overly onerous on plans.

Response:

We understand commenters' concerns about burden and confidentiality when it comes to CMS data collection. However, we note that the regulation text at proposed § 422.135(c)(5)—finalized at § 422.135(c)(4)—includes the language “upon request,” which implies that CMS does not intend to establish uniform data collection at this time, but instead reserves the right to ask for this information from MA plans. We encourage readers to refer to section III.B.1. of this final rule, which provides additional detail and explicitly states that the information collection provision at § 422.135(c)(4) is exempt from the requirements of the Paperwork Reduction Act (PRA) since we estimate fewer than 10 respondents. Thus, we do not anticipate a significant increase in plan burden due to § 422.135(c)(4). We also remind readers that any uniform request to more than nine MA plans would require further review and would be subject to public comment under the PRA requirements.

Comment:

A few commenters questioned whether CMS will allow MA plans (including PPO plans) to use only contracted providers for MA additional telehealth benefits. Some commenters believed that the contracted providers' restriction should apply to all MA plan types. Some commenters rejected CMS's proposal that all plan types be required to use only contracted providers. A few commenters recommended CMS limit this requirement to HMOs, thus allowing PPOs to use both contracted and non-contracted providers for MA additional telehealth benefits. Other commenters recommended that CMS extend the allowable providers beyond just contracted, in-network providers, stating that the issue of no oversight of out-of-network providers exists whether or not telehealth is involved.

Response:

We are finalizing the proposal at § 422.135(d) to require that all MA plan types, including PPO plans, use only contracted providers to provide MA additional telehealth benefits. We are clarifying that if a PPO plan furnishes MA additional telehealth benefits consistent with the requirements at § 422.135, then the PPO plan requirement at § 422.4(a)(1)(v) (that the PPO must furnish all services both in-network and out-of-network) will not apply to the MA additional telehealth benefits; all other benefits covered by the PPO must be covered on both an in-network and out-of-network basis. In other words, a PPO plan is not required to furnish its MA additional telehealth benefits out-of-network, as is the case for all other plan-covered services. However, if a PPO plan would like to cover a service delivered through electronic exchange on an out-of-network basis, then the PPO plan has that option but may only cover the service as an MA supplemental

telehealth benefit, consistent with the regulation text at § 422.135(d).

In response to comments that recommended CMS extend the allowable providers beyond contracted providers because the issue of no oversight for non-contracted providers exists whether or not telehealth is involved, we note that MA plans must be able to review and pre-certify the qualifications and compliance of contracted providers to ensure that telehealth services are furnished consistent with clinically appropriate standards of care for the MA additional telehealth benefits offered by the MA plan and that all state licensure and credentialing requirements are met. We are therefore finalizing the proposed regulation text at paragraph (d), that an MA plan must furnish MA additional telehealth benefits only using contracted providers. Therefore the regulation will require that all MA plans, including PPOs that cover benefits provided by non-contracted providers, use only contracted providers for MA additional telehealth benefits.

Comment:

Commenters recommended that CMS remain flexible in the ultimate determination of what will be considered capital and infrastructure costs and investments to be excluded from their bid submissions relative to MA additional telehealth benefits. Some commenters offered ideas to operationalize the exclusions. One suggestion was for CMS to stipulate a percentage that represents the industry average of allowed fees as representative of the capital and infrastructure costs, which could be trended over time. Another commenter suggested that CMS align the definition of capital and infrastructure costs and investments with a traditional understanding, such that those items that would add permanent or depreciable value to the plan or enrollee would be excluded, thus allowing the cost of necessary support items or services for telehealth delivery. A few commenters mentioned the 15 percent used in the Regulatory Impact Analysis of the proposed rule as a proxy for these costs. A commenter stated that the percentage was too high while another stressed that it was too low.

Commenters also raised concerns about the difficulty of identifying with specificity (for bid purposes) the capital and infrastructure components of MA additional telehealth benefits for services offered directly by the plan or through downstream entities such as providers and third party vendors. Specifically, a few commenters were concerned with the difficulty in excluding these costs from their claims capture and data reporting and in obtaining this information from contracted providers and vendors absent an additional contractual provision. Commenters also stated that capital and infrastructure costs would vary significantly from provider to provider. These commenters pointed out that currently there is no incentive for providers or vendors to accurately identify these costs, and plans would not be able to verify if the costs were reasonably stated. Consequently, commenters expressed, this lack of standardization and reliability could lead to challenges of plans' actuarial attestations and potential inequitable reporting in the bid. Another commenter also opposed the exclusion of capital and infrastructure costs from MA plans' basic benefit bid.

Response:

We appreciate the comments concerning the exclusion of capital and infrastructure costs relating to MA additional telehealth benefits from the basic benefit bid submission. Section 1852(m)(2)(A)(ii) of the Act excludes from MA additional telehealth benefits capital and infrastructure costs and investments related to MA additional telehealth benefits. We are codifying this requirement in § 422.254(b)(3)(i) as a restriction on how MA plans include MA additional telehealth benefits in their bid submission. We believe the statutory limit is tied only to the cost to the government, which is tied to how MA additional telehealth benefits may be included in the bid as basic benefits. Therefore, our proposal was to eliminate from the basic benefit bid those capital and infrastructure costs and investments that are required or used to enable the provision of MA additional telehealth benefits.

We appreciate the concerns raised by commenters about broad interpretations of the statutory exclusion of capital and infrastructure costs and investments. In recognition of these challenges, we are clarifying in regulation text that the exclusion from the bid of capital and infrastructure costs and investments relating to MA additional telehealth benefits, codified at § 422.254(b)(3)(i), applies to capital and infrastructure costs and investments “directly incurred or paid by the MA plan.” The bid for basic benefits submitted by an MA plan cannot include such capital and infrastructure costs or investments for MA additional telehealth benefits.

We do not propose a specific definition of capital and infrastructure costs or investments related to such benefits here because the costs and investments needed and used to provide MA additional telehealth benefits would vary based on the individual MA plan's approach to furnishing the benefits.

We also thank the commenters for providing lists of capital and infrastructure examples. Although we stated in the proposed rule that we would provide a more detailed list of examples in this final rule based on stakeholder feedback, after further consideration we have chosen not to do so. We made this decision in acknowledgment of the variety of potential capital and infrastructure models, for which a given MA plan could incur or pay costs, related to MA additional telehealth benefits.

Comment:

Many commenters requested clarification on how the annual bid submission process will work for MA additional telehealth benefits. Specifically, commenters questioned how plans will be expected to file MA additional telehealth benefits in the PBP.

Response:

We appreciate this request for greater clarity concerning how the annual bid submission process will be impacted by MA additional telehealth benefits. We will take these comments into consideration when developing the annual bid guidance, which we consider to be a more appropriate place to provide instruction for completing the bid.

Comment:

Several commenters supported CMS's proposal to allow MA plans to provide MA additional telehealth benefits because the proposal does not include geographic and originating site limitations. A few commenters believed CMS should extend authority for MA additional telehealth benefits to original Medicare, specifically to eliminate geographic and originating site limitations applicable in original Medicare. Some commenters requested that CMS make efforts to ensure parity for original Medicare beneficiaries, claiming they would be disadvantaged since they cannot access MA additional telehealth benefits as MA enrollees can. Some commenters urged CMS to reference and ensure alignment with the Part B definition of telecommunications systems and note that the section 1834(m) originating site and geographic restrictions do not apply to MA additional telehealth benefits.

Response:

This final rule will allow MA plans the ability to offer—as part of the basic benefit package—MA additional telehealth benefits beyond what is currently allowable under Medicare telehealth services; this is authorized by section 1852(m) of the Act, which was added by section 50323 of the Bipartisan Budget Act of 2018. Neither the statute nor this final rule includes geographic or originating site

limitations as part of defining or authorizing MA additional telehealth benefits. With regard to comments regarding coverage and payment under the original Medicare program, we note that we are constrained by the statutory requirements and that the original Medicare program is not within the scope of this final rule.

Comment:

A commenter requested that CMS provide permissible MA additional telehealth benefit designs to ensure MA plan compliance with CMS's final rule.

Response:

We appreciate the commenter's request for permissible MA additional telehealth benefit designs. However, we do not provide any specific MA additional telehealth benefit designs in the final rule in order to provide MA plans with the discretion to develop their plan benefit offerings.

Comment:

A commenter requested information regarding whether MA additional telehealth benefits can be used to furnish the Medicare Diabetes Prevention Program (MDPP) services. A few commenters referenced CMS previously declining to test online MDPP diabetes self-management training.

Response:

As discussed above, we are finalizing this rule to define “additional telehealth benefits” as services that: (1) Are furnished by an MA plan for which benefits are available under Medicare Part B but which are not payable under section 1834(m) of the Act; and (2) have been identified by the MA plan for the applicable year as clinically appropriate to furnish through electronic exchange when the physician (as defined in section 1861(r) of the Act) or practitioner (described in section 1842(b)(18)(C) of the Act) providing the service is not in the same location as the enrollee. Because this definition requires MA additional telehealth benefits to be services provided by a physician or practitioner, and MDPP services, pursuant to § 410.79, must be provided by an MDPP supplier, MDPP services cannot be offered as MA additional telehealth benefits. Existing guidance about how MDPP services may be provided on a virtual basis or through electronic exchange still applies and can be covered as a supplemental benefit.

Comment:

Some commenters requested that CMS include in the definition of a telehealth provider specific specialty types such as pharmacists, audiologists, speech-language pathologists, home health care aides, and telerehabilitation providers.

Response:

We appreciate comments requesting additional specificity in identifying permissible telehealth provider types. However, we did not define a telehealth provider in the proposed rule and will not finalize such a definition here. Section 1852(m)(2)(A)(i)(2) uses the term “physician” as defined in section 1861(r) of the Act and the term “practitioner” described in section 1842(b)(18)(C) of the Act. We have codified these statutory requirements in our final definition of “additional telehealth benefits” at § 422.135(a)(2), described previously. Both the statute and this final rule limit MA additional telehealth benefits to services furnished by physicians and practitioners as so defined. Further, the statute and regulation require that the service be clinically appropriate to furnish through electronic exchange, which in some cases may prohibit certain services from being covered as MA additional telehealth benefits. Finally, in § 422.135(d), we are codifying the requirement that MA plans furnishing MA additional telehealth benefits only do so using contracted providers.

Comment:

A few commenters questioned how MA additional telehealth benefits will interact with encounter data and risk adjustment. For example, commenters recommended CMS establish rules or clarify the criteria under which diagnoses obtained through telehealth encounters can be considered and submitted for risk adjustment purposes. A commenter specifically requested that CMS allow telehealth encounters to be included for MA risk adjustment, while other requestors requested future guidance on telehealth encounter data submissions.

Response:

We appreciate commenters raising this particular issue. This regulation does not change the existing obligation to submit encounters. Consistent with the requirements under § 422.310, MA plans must submit risk adjustment data that characterize the context and purpose of each item and service provided to an MA enrollee, and must also conform to CMS's requirements for submitting these data. We will be releasing guidance regarding MA additional telehealth benefits and encounter data and risk adjustment in the future.

Summary of Regulatory Changes

We received a range of comments pertaining to this proposal, the majority of which reflected support for the regulations. After careful consideration of all comments received, and for the reasons set forth in the proposed rule and in our responses to the related comments summarized earlier, we are finalizing the proposed changes to §§ 422.100, 422.252, 422.254, and 422.264 and new regulation at § 422.135, with the following modifications:

• In proposed regulation text § 422.135(a), we are removing the phrase “that meet the following.” Thus, we are revising § 422.135(a) to read as follows: “

Definitions.

For purposes of this section, the following definitions apply:

Additional telehealth benefits

means services:”

• In proposed regulation text § 422.135(a)(1), we are removing the phrase “are furnished by an MA plan” but finalizing the remaining text in (a)(1). Thus, we are revising (a)(1) to read as follows: “For which benefits are available under Medicare Part B but which are not payable under section 1834(m) of the Act; and”

• In proposed regulation text § 422.135(a)(2), we are adding the word “That” and adding the phrase “when the physician (as defined in section 1861(r) of the Act) or practitioner (described in section 1842(b)(18)(C)) of the Act) providing the service is not in the same location as the enrollee.” Thus, we are revising (a)(2) to read as follows: “That have been identified by the MA plan for the applicable year as clinically appropriate to furnish through electronic exchange when the physician (as defined in section 1861(r) of the Act) or practitioner (described in section 1842(b)(18)(C)) of the Act) providing the service is not in the same location as the enrollee.”

• In proposed regulation text § 422.135(c)(2), we are removing the phrase “at a minimum in the MA plan's Evidence of Coverage required at § 422.111(b)” but finalizing the remaining text in (c)(2). Thus, we are revising (c)(2) to read as follows: “Advise each enrollee that the enrollee may receive the specified Part B service(s) through an in-person visit or through electronic exchange.”

• We are not finalizing our proposed regulation text for the provider directory requirement at proposed § 422.135(c)(3). Thus, we are removing proposed (c)(3) in its entirety, redesignating proposed (c)(4) as (c)(3), and redesignating proposed (c)(5) as (c)(4).

• In proposed regulation text § 422.254(b)(3)(i), we are adding the phrases “directly incurred or paid by the MA plan” and “for the unadjusted MA statutory non-drug monthly bid amount.” Thus, we are revising (b)(3)(i) to read as follows: “MA plans offering additional telehealth benefits as defined in § 422.135(a) must exclude any capital and infrastructure costs and investments directly incurred or paid by the MA plan relating to such benefits from their bid submission for the unadjusted MA

statutory non-drug monthly bid amount.”

2. Dual Eligible Special Needs Plans

Special needs plans (SNPs) are MA plans created by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) that are specifically designed to provide targeted care and limit enrollment to special needs individuals. Under the law, SNPs are able to restrict enrollment to: (1) Institutionalized individuals, who are defined in § 422.2 as those residing or expecting to reside for 90 days or longer in a long term care facility; (2) individuals entitled to medical assistance under a state plan under Title XIX; or (3) other individuals with certain severe or disabling chronic conditions who would benefit from enrollment in a SNP. As of June 2018, the CMS website listed 297 SNP contracts with 641 SNP plans that have at least 11 members.

These figures included 190 Dual Eligible SNP contracts (D-SNPs) with 412 D-SNP plans with at least 11 members, 49 Institutional SNP contracts (I-SNPs) with 97 I-SNP plans with at least 11 members, and 58 Chronic or Disabling Condition SNP contracts (C-SNPs) with 132 C-SNP plans with at least 11 members. This final rule implements the provisions of the Bipartisan Budget Act of 2018 that establish new requirements for D-SNPs for the integration of Medicare and Medicaid benefits and unification of Medicare and Medicaid grievance and appeals procedures that are effective in 2021. This final rule also clarifies definitions and operating requirements for D-SNPs that will be applicable to D-SNPs starting January 1, 2020, as specified earlier in this final rule.

Centers for Medicare & Medicaid Services (2018, June). SNP Comprehensive Report. Retrieved from

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

a. Integration Requirements for Dual Eligible Special Needs Plans (§§ 422.2, 422.60, 422.102, 422.107, 422.111, and 422.752)

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

See:

Kim, H., Charlesworth, C.J., McConnell, K.J., Valentine, J.B., and Grabowski, D.C. (2017, November 15).

Comparing Care for Dual-Eligibles Across Coverage Models: Empirical Evidence From Oregon.

Retrieved from

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

Anderson, W.L., Feng, Z., & Long, S.K. (2016, March 31).

Minnesota Managed Care Longitudinal Data Analysis,

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

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

Health Management Associates (2015, July 21).

Value Assessment of the Senior Care Options (SCO) Program.

Retrieved from

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

and Medicare Payment Advisory Committee (2012, June 16). “

Care coordination programs for dual-eligible beneficiaries.”

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

Retrieved from

http://www.medpac.gov/docs/default-source/reports/chapter-3-appendixes-care-coordination-programs-for-dual-eligible-beneficiaries-june-2012-report-.pdf?sfvrsn=0.

D-SNPs are a type of MA plan that is intended to integrate or coordinate care for this population more effectively than standard MA plans or original Medicare by focusing enrollment and care management on dual eligible individuals. As of June 2018, approximately 2.3 million dual eligible individuals (1 out of every 6 dual eligible individuals) were enrolled in 412 D-SNPs. About 170,000 dual eligible individuals are enrolled in fully integrated dual eligible special needs plans, or FIDE SNPs (that is, where the same organization receives capitation to cover both Medicare and Medicaid services).

A number of states, including Arizona, Idaho, Hawaii, Massachusetts, Minnesota, New Jersey, New Mexico, New York, Pennsylvania, Tennessee, Texas, Virginia, and Wisconsin, operate Medicaid managed care programs for dual eligible individuals in which the state requires that the Medicaid managed care organizations serving dual eligible individuals offer a companion D-SNP product.

Centers for Medicare & Medicaid Services (2018, June).

SNP Comprehensive Report.

Retrieved from

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

As summarized in our proposed rule, since the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) first authorized D-SNPs' creation, subsequent legislation has been enacted that has extended their authority to operate and set forth additional programmatic requirements, including sections 164 and 165 of the Medicare Improvements for Patients and Providers Act (MIPPA) (Pub. L. 110-275), which amended sections 1859(f) and 1852(a) of the Act, and section 3205 of the Patient Protection and Affordable Care Act (Pub. L. 111-148), which revised section 1853(a)(1)(B) of the Act. Regulations promulgated following the enactment of these laws implemented these statutory provisions.

Using the contract that D-SNPs are required to have with states under section 1859(f)(3)(D) of the Act, implemented in the regulation at § 422.107, state Medicaid agencies are able to establish requirements that surpass the minimum standards set in federal regulations for D-SNPs with regard to integration and coordination of Medicare and Medicaid benefits. To that end, we have seen states leverage their contracts with D-SNPs to limit D-SNP enrollment to individuals who also receive Medicaid benefits through the same organization, collect certain data from the D-SNP, and integrate beneficiary communication materials and care management processes to provide D-SNP enrollees a more seamless, coordinated experience of care.

CMS supports states that have an interest in pursuing integrated care models for dual eligible individuals, including through the use of their contracts with MA organizations offering D-SNPs, and provides technical assistance to states seeking to develop solutions tailored to their local market conditions, beneficiary characteristics, and policy environment.

Verdier, J, Kruse, A., Sweetland Lester, R., Philip, A.M., & Chelminsky, D. (2016, November). “State Contracting with Medicare Advantage Dual Eligible Special Needs Plans: Issues and Options.” Retrieved from

http://www.integratedcareresourcecenter.com/PDFs/ICRC_DSNP_Issues__Options.pdf.

Through this final rule, we are adopting new requirements in accordance with section 50311(b) of the Bipartisan Budget Act of 2018, which amended section 1859 of the Act to require that all D-SNPs meet certain new minimum criteria for Medicare and Medicaid integration for 2021 and subsequent years. Beyond the newly enacted amendments to the Act, we are

also using this final rule to add requirements and clarifications to existing regulations to codify guidance and policy since D-SNPs were established nearly 15 years ago and to update certain aspects of the regulations. Under the newly enacted section 1859(f)(8)(D)(i) of the Act, the statute calls for D-SNPs, for 2021 and subsequent years, to meet one or more of three specified requirements, to the extent permitted under state law, for integration of benefits:

• A D-SNP must, in addition to meeting the existing requirement of contracting with the state Medicaid agency under section 1859(f)(3)(D) of the Act, coordinate long-term services and supports (LTSS), behavioral health services, or both, by meeting an additional minimum set of requirements for integration established by the Secretary based on input from stakeholders. Such requirements for integration could include: (1) Notifying the state in a timely manner of hospitalizations, emergency room visits, and hospital or nursing home discharges of enrollees; (2) assigning one primary care provider for each enrollee; or (3) data sharing that benefits the coordination of items and services under Medicare and Medicaid.

• A D-SNP must either: (1) Meet the requirements of a fully integrated dual eligible special needs plan described in section 1853(a)(1)(B)(iv)(II) of the Act (other than the requirement that the plan have similar average levels of frailty as the PACE program); or (2) enter into a capitated contract with the state Medicaid agency to provide LTSS, behavioral health services, or both.

• The parent organization of a D-SNP that is also the parent organization of a Medicaid managed care organization providing LTSS or behavioral services must assume “clinical and financial responsibility” for benefits provided to beneficiaries enrolled in both the D-SNP and Medicaid managed care organization.

Section 50311(b) of the Bipartisan Budget Act of 2018 also authorizes the Secretary, in section 1859(f)(8)(D)(ii) of the Act, to impose an enrollment sanction on an MA organization offering a D-SNP that has failed to meet at least one of these integration standards in plan years 2021 through 2025. In the event that the Secretary imposes such a sanction, the MA organization must submit to the Secretary a plan describing how it will come into compliance with the integration standards.

We received a number of comments on our proposals to implement these new integration requirements, both in general and with regard to specific proposals. We summarize and respond to the comments below.

Comment:

We received numerous comments in support of our integration proposal, with many commenters citing the proposal's fulfillment of statutory intent and expressing appreciation for the flexibility afforded to states to define what integrated care looks like in their state. For example, some of these commenters noted the diversity of state policies, which impact what the D-SNP market looks like in each state, and cautioned against any proposal that upon implementation would disrupt existing integrated care models and beneficiaries' coverage. A subset of commenters, while supportive of our proposal, also encouraged CMS to raise the bar of integration even further. One commenter encouraged CMS to help states move toward integration and not penalize plans and states that are not yet able to integrate further, advising that focus should also remain on minimizing administrative burden and reducing complexity for beneficiaries. The Medicare Payment Advisory Commission (MedPAC) stated its belief that the proposed rule will do little to promote greater integration, citing in particular the first of the proposed new standards for integration—requiring D-SNPs to share information on inpatient and SNF admissions—as having a very limited impact on improving care coordination, as discussed in more detail in the comments we received on proposed § 422.107(d). Another commenter objected to our integration proposal and recommended that CMS leave all decision-making to the states, including granting them the ability to opt out of any of the D-SNP integration requirements.

Response:

We appreciate the widespread support we received for our proposal. We believe that the requirements we are finalizing in this rule strike an appropriate balance between increasing integrated care in D-SNPs for dual eligible individuals and preserving state flexibility, within the framework established by the amendments to section 1859(f)(8) of the Act made by section 50311(b) of the Bipartisan Budget Act of 2018. While our aim is to support states that are operating successful programs and assist those seeking to establish more integrated programs, we also recognize that our proposal must account for the current state of integrated care and the need to meet states where they are by setting reasonable and achievable integration benchmarks. As the D-SNP landscape evolves, we will continue to consider ways to advance integrated care, including further rulemaking. Finally, we note that the statute does not authorize CMS or states to disregard a D-SNP's obligation to meet one or more of the integration requirements, and imposes consequences for non-compliance, as discussed in response to comments on proposed § 422.752(d).

Comment:

One commenter expressed concern about D-SNPs' ability to meet the integration requirements by 2021 due to the potential for delayed decision-making on the part of states. Another commenter requested a one-year delay in the effective date in consideration of the time required to negotiate and execute contracts between states and D-SNPs and to develop new processes, which will vary depending on each state's capabilities. Conversely, another commenter stated that 2021 is an achievable date for meeting one of the three integration requirements.

Response:

The statute requires that D-SNPs comply with the integration requirements by 2021. As discussed throughout this preamble, the Medicare-Medicaid Coordination Office provides technical assistance to states on integration issues, and we expect to continue to engage states, plans, and other stakeholders as we implement the requirements in this final rule.

Comment:

One commenter observed that CMS does not make any additional funding available for the coordination activities that D-SNPs perform today and that adding to these requirements could create burdens on plans and CMS or cause D-SNPs to exit the market. Another commenter urged CMS to establish nationwide standards to ensure plans can scale best practices and that beneficiaries receive the same high quality service no matter where they live.

Response:

While we believe that states are well positioned to drive innovation in care delivery for dual eligible individuals, we also recognize that the Bipartisan Budget Act of 2018 set forth a minimum level of integration for all D-SNPs to meet. We believe that the proposal we set forth is a reasonable one that preserves state flexibility while fulfilling our statutory obligation. While we recognize the desirability of having national standards, particularly for MA organizations that operate D-SNPs in multiple markets across the country, we have to balance this desire with the differences that exist in states' capabilities, ranging from states where some or all dual eligible individuals may be precluded from enrolling in any capitated plan for their Medicaid services to states with highly integrated D-SNP models. Notwithstanding our reluctance to mandate the use of

national standards, we are committed to cataloguing and disseminating best practice information as part of the final rule's implementation and our ongoing administrative alignment efforts, discussed later in the preamble to this final rule.

Comment:

Several commenters supported our D-SNP integration proposals but considered them only a starting point for ensuring better alignment and encouraged CMS to build upon these requirements in the future. Several commenters also recommended that CMS provide strong oversight to ensure that integration requirements are being met and that dual eligible individuals enrolled in D-SNPs are actually benefiting from increased integration. One commenter urged CMS to go further in recognizing states' authority and options to implement even more robustly integrated programs.

Response:

We appreciate these commenters' perspectives on our proposal. We acknowledge the importance of working in close partnership with states to advance integration within each state-specific context. CMS will monitor the implementation of these provisions to determine market and beneficiary impacts and assess the need for additional rulemaking to modify or expand upon the integration standards we are finalizing in this rule.

Comment:

One commenter recommended that CMS conduct a comprehensive review of basic operational processes to determine where Medicare and Medicaid could be further aligned to enhance care delivery and quality and to reduce burdens on plans, providers, and beneficiaries and to facilitate plans' moving along the integration continuum toward a FIDE SNP or HIDE SNP status. This commenter further suggested that CMS advance integration using all available statutory authorities, including seeking clarification from Congress regarding its intent in enacting provisions in the Bipartisan Budget Act of 2018 related to the Medicare-Medicaid Coordination Office.

Several commenters recommended that CMS extend to D-SNPs processes and flexibilities developed under the Financial Alignment Initiative for MMPs and under the Minnesota Demonstration to Align Administrative Functions for Improvements in Medicare-Medicaid Beneficiary Experience, including use of the contract management team structure for joint oversight of plans, integrated beneficiary communications materials, joint CMS-state marketing reviews, coordinated enrollment processes and timelines, integrated MOCs, dual eligible-specific network adequacy requirements, and streamlined and plan-level reporting processes. Several commenters suggested other areas in which CMS could create additional administrative and policy incentives to reward states for moving toward further Medicare-Medicaid alignment, including year-round marketing to dual eligible individuals; expansion of current passive enrollment and default enrollment authorities; establishment of a Special Election Period for enrollment in integrated plans; plan payment reforms, including changes to the frailty adjustment for FIDE SNPs; an increase of the enhanced Medicaid match for care coordination and IT activities; and alignment of state and federal contracting cycles. A commenter recommended that CMS improve its messaging about D-SNPs in its beneficiary-centered materials and tools.

Response:

We thank commenters for their robust feedback about additional alignment opportunities for D-SNPs. Since 2013, the Financial Alignment Initiative and Minnesota demonstration have provided us with opportunities to test a number of programmatic and administrative flexibilities for MMPs and some D-SNPs, and many of these flexibilities have been positively received by beneficiaries, states, and health plans. We will continue to consider additional ways to promote better outcomes and experiences for dual eligible individuals.

As we have indicated in the CY 2016 Draft and Final Call Letters, the CY 2019 Draft and Final Call Letters, and the CY 2020 Draft Call Letter,

CMS remains committed to providing administrative flexibility that facilitates efforts by state Medicaid agencies and MA organizations to use D-SNPs to integrate coverage of Medicare and Medicaid benefits, including in the areas of integrated beneficiary communications, D-SNP models of care, and enrollment processes. That commitment is also evidenced by our recent CY 2019 final rule (CMS-4182-F, 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) codifying our authority to permit default enrollment of newly Medicare-eligible individuals into integrated D-SNPs at § 422.66(c)(2) and, at § 422.60(g)(1)(iii), to allow passive enrollment to preserve continuity of care and integrated care related to D-SNP non-renewals or state Medicaid managed care organization procurements. We have also worked with states and integrated D-SNPs to develop integrated beneficiary communications materials, integrate model of care requirements and reviews with states, and provide state Medicaid agencies with technical assistance and information on plan performance and audit results of their contracted D-SNPs so that the quality of Medicare services delivered by those D-SNPs can inform state contracting strategies. We look forward to continuing our work in this area with additional states and plans.

https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Advance2020Part2.pdf.

Comment:

A number of commenters recommended CMS consideration of additional regulatory and operational policies on a number of issues related to dual eligible individuals that were not related to the D-SNP integration requirements in the proposed rule. One commenter urged CMS to make funds available for ombudsman programs to serve dual eligible individuals in integrated D-SNPs. Several commenters recommended that CMS continue to work with plans on identifying a long-term solution impacting dual eligibility status and socioeconomic factors in Medicare Advantage Star Ratings. One commenter reiterated the need for CMS to develop a risk adjustment model that adequately accounts for the costs of serving beneficiaries with functional limitations. Another commenter urged CMS to consider how D-SNPs should be designed to minimize cost-sharing obligations that are ultimately unpaid and to consider a more holistic approach to coverage for dual eligible individuals that does not simply transfer cost-sharing liability to providers. Another commenter noted the critical importance of home and community-based service (HCBS) eligibility barriers when determining how the D-SNP-to-Medicaid transition should occur and recommended that the federal government ease this transition through reform of the Medicaid HCBS eligibility requirements. One commenter requested that CMS consider recognizing Part B premium buy-downs in Puerto Rico D-SNPs as part of plans' bids to provide Parts A and B benefits, rather than requiring plans to use rebate dollars to buy down the Part B premium as a supplemental benefit. Another commenter recommended cost-sharing integration processes for dual eligible individuals at the pharmacy counter or, in the shorter-term, implementation of real time beneficiary eligibility solutions for use within the NCPDP Telecommunication standard.

Response:

These recommendations are not within the scope of our final rule

provisions establishing integration criteria for D-SNPs effective in 2021, and some of them are beyond our programmatic authority. We do, however, appreciate the many comments and suggestions related to programmatic improvements for dual eligible individuals, including those enrolled in D-SNPs.

Comment:

A range of commenters, including the Medicaid and CHIP Payment and Access Commission (MACPAC), expressed concern that the market entry of non-D-SNP MA plans designed and marketed exclusively to dual eligible individuals—so-called “D-SNP look-alike plans”—threatens to undermine efforts by CMS, states, and D-SNPs to increase integration and coordination of Medicare and Medicaid services. Some of these commenters recommended that CMS address this issue including by requiring MA plans with a minimum percentage of dual eligible members to meet all D-SNP requirements, including the obligation to contract with the states in which the plans operate.

Response:

Although the issue of D-SNP look-alike plans is beyond the scope of this rule, we share the commenters' concern with the impact of such plans on our efforts to increase Medicare-Medicaid integration. We call attention to the CY 2020 Draft Call Letter

in which we sought comment on the impact of D-SNP look-alike plans in order to inform future policy development.

https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Advance2020Part2.pdf.

Comment:

A commenter recommended that CMS continue and expand efforts to help states adopt policies and incentives that assist D-SNPs in moving toward higher levels of integration (including FIDE SNP or HIDE SNP status with better aligned enrollments) for dual eligible individuals.

Response:

States and CMS both play important roles in implementing more integrated care delivery systems for dual eligible individuals. The Medicare-Medicaid Coordination Office facilitates this technical assistance and dialogue with states, including through its Integrated Care Resource Center (see

https://www.integratedcareresourcecenter.com/

). We are committed to continuing our work with states based on their specific policy priorities following the implementation of this final rule.

Comment:

One commenter reaffirmed their support for Medicare-Medicaid Plans (MMPs) offered under the Financial Alignment Initiative and urged CMS to make them permanent. The same commenter urged CMS to develop a common statutory and regulatory framework for all forms of integrated plans, including MMPs, PACE organizations, and FIDE SNPs, that would include uniform rules on marketing, enrollment processes, claims reporting, rate-setting, and risk adjustment.

Response:

We appreciate the commenter's support for our work with states and MMPs in the Financial Alignment Initiative. CMS will continue to explore ways within our programmatic authority to improve the current regulatory framework for integrated care as we gain experience and gather data about the impacts of the FAI capitated model and other demonstrations, our administrative alignment efforts, streamlining of the PACE program, and the implementation of new D-SNP integration requirements finalized in this rule.

Comment:

We received comments from one organization expressing concerns about CMS' sole reliance on the D-SNP delivery model and urging us to consider other plan types (including Institutional SNPs (I-SNPs) and fee-for-service Medicare) that can help achieve integrated care goals. This commenter expressed concern that sole reliance on D-SNPs would result in unnecessary disruptions to care.

Response:

We support beneficiary choice in selecting the health care delivery system that best meets each individual's needs. The final rule focuses on the specific requirements added to section 1859(f) of the Act for D-SNPs by section 50311 of the Bipartisan Budget Act. Comments related to fee-for-service Medicare and I-SNPs are therefore outside the scope of this final rule.

Comment:

A few commenters requested that CMS consider providing guidance on how the integration requirements will affect the operations of MMPs.

Response:

We clarify that there is no direct impact on MMPs as a result of this final rule. The D-SNP requirements in this final rule are not applicable to MMPs, and MMP policy and operations will continue to be established in three-way contract agreements among CMS, health plans, and states.

(1) Definitions of a “Dual Eligible Special Needs Plan”, “Fully Integrated Dual Eligible Special Needs Plan”, “Highly Integrated Dual Eligible Special Needs Plan”, and “Aligned Enrollment” (§ 422.2)

D-SNPs are described in various sections of 42 CFR part 422, including provisions governing the definition of specialized MA plans for special needs individuals in § 422.2, the supplemental benefit authority for D-SNPs that meet a high standard of integration and minimum performance and quality-based standards in § 422.102(e), state Medicaid agency contracting requirements in § 422.107, and specific benefit disclosure requirements in § 422.111(b)(2)(iii). In the proposed rule, we proposed to consolidate statutory and regulatory references to D-SNPs; we also proposed to establish a definition for such a plan in § 422.2. In addition to proposing a new definition for the term “dual eligible special needs plan,” we also proposed a revised definition of the term “fully integrated dual eligible special needs plan,” and new definitions of the terms “highly integrated dual eligible special needs plan” and “aligned enrollment,” for purposes of part 422 (that is, the rules applicable to the MA program) and the proposed rule.

In our proposed definition at § 422.2, we described a dual eligible special needs plan as a type of specialized MA plan for individuals who are eligible for Medicaid under Title XIX of the Act that provides, as applicable, and coordinates the delivery of Medicare and Medicaid services, including LTSS and behavioral health services, for individuals who are eligible for such services; has a contract with the state Medicaid agency consistent with § 422.107 that meets the minimum requirements in paragraph (c) of such section; and satisfies at least one of following integration requirements:

• It meets the additional state Medicaid agency contracting requirement we proposed at § 422.107(d) (described in section II.A.2.a.(2) of the proposed rule) that surpasses the minimum requirements in current regulations at § 422.107(c);

• It is a highly integrated dual eligible special needs plan (HIDE SNP), as described in further detail later in this section; or

• It is FIDE SNP.

In addition, we proposed additional performance requirements for D-SNPs that we did not incorporate into the definition; for example, a D-SNP would provide assistance to individuals filing a grievance or appeal for a Medicaid services in accordance with proposed

§ 422.562(a)(5) (described in section II.A.2.b.(1) of the proposed rule). As discussed in the proposed rule, we believed this proposed definition identified the minimum requirements for an MA plan to be a D-SNP under section 1859 of the Act as amended by the Bipartisan Budget Act of 2018. We also explained that the proposed definition would clarify the applicability of the separate regulatory provisions that establish the minimum standards for D-SNPs. We solicited comment on whether our proposed definition met these goals or should be revised to include other regulatory provisions that establish requirements for D-SNPs.

We discussed in the proposed rule and reiterate here that it is important to clarify through this final rule the meaning of the requirement in section 1859(f)(3)(D) of the Act, which is currently codified at § 422.107(b), that the MA organization have responsibility under the contract for providing benefits or arranging for benefits to be provided for individuals entitled to Medicaid. Prior to our proposed rule, we had not adopted a specific interpretation of this statutory language, “arranging for benefits,” in previous rulemaking or in subregulatory guidance. We proposed to interpret “arranging for benefits” as requiring a D-SNP, at a minimum, to coordinate the delivery of Medicare and Medicaid benefits. We proposed to relocate this requirement to our proposed D-SNP definition. As stated in the proposed rule, while our interpretation is consistent with the new statutory integration standards, the proposed clarification was based on requirements for D-SNPs that existed prior to the enactment of the Bipartisan Budget Act of 2018 that we believe should be strengthened. We believe coordination would encompass a wide range of activities that a D-SNP may engage in for their dual eligible members and provided some examples of such coordination in the preamble to the proposed rule. If a D-SNP identifies through an enrollee's health risk assessment and/or individualized care plan, as required by § 422.101(f), functional limitations or mental health needs, the D-SNP could: (1) Verify the enrollee's eligibility for LTSS and/or behavioral health services under Medicaid; (2) determine how the enrollee receives such services (through FFS Medicaid or through another Medicaid managed care product); or (3) make arrangements with the applicable Medicaid program (state Medicaid agency or managed care plan) for the provision of such services by the appropriate payer or provider. We solicited comment on whether our proposed definition should be more prescriptive in identifying which plan activities constitute coordination or whether it should remain broadly defined as proposed.

We proposed revising the definition of fully integrated dual eligible special needs plan (FIDE SNP) at § 422.2 to align with the proposed definition of a D-SNP and to codify current policy. Specifically, we proposed the following:

• Striking the reference to a “CMS approved MA-PD” plan in the current FIDE SNP definition and paragraph (1), which refers to the individuals eligible for enrollment in a FIDE SNP, because those provisions duplicate elements of the new proposed definition of a D-SNP at § 422.2;

• Replacing the reference to “dual eligible beneficiaries” with “dual eligible individuals” in newly redesignated paragraph (1) to align with the terminology used in section 1935(c) of the Act;

• Adding to newly redesignated paragraph (2) that a FIDE SNP's capitated contract with a state Medicaid agency may include specified behavioral health services, as well as replacing the term “long-term care” benefits with “long-term services and supports” to better describe the range of such services FIDE SNPs cover in capitated contracts with states. We also proposed codifying in paragraph (2) the current policy that the FIDE SNP's capitated contract with the state provide coverage of nursing facility services for at least 180 days during the plan year;

Following the April 2, 2012 issuance of the “Announcement of Calendar Year (CY) 2013 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter,” Chapter 16b of the Medicare Managed Care Manual was revised to include this policy.

• Striking references to coordination of covered Medicare and Medicaid “health and long-term care” and referring more broadly to Medicare and Medicaid services in in newly redesignated paragraph (3); and

• Replacing the reference to “member” materials with “beneficiary communication materials,” consistent with the definition of “communication materials” at § 422.2260.

We proposed to codify a definition of highly integrated dual eligible special needs plan (HIDE SNP) at § 422.2. Under the proposed definition, a HIDE SNP would be a type of D-SNP offered by an MA organization that has—or whose parent organization or another entity that is owned and controlled by its parent organization has—a capitated contract with the Medicaid agency in the state in which the D-SNP operates that includes coverage of LTSS, behavioral health services, or both, consistent with state policy. We solicited comment on this proposed definition, including on whether additional requirements for HIDE SNPs should be addressed in the definition.

We also proposed to establish at § 422.2 a definition for the term aligned enrollment, as many of the other D-SNP proposals in the proposed rule were based on this concept. Under our proposal, aligned enrollment is when a full-benefit dual eligible individual is a member of a D-SNP and receives coverage of Medicaid benefits from the D-SNP or from a Medicaid managed care organization, as defined in section 1903(m) of the Act, that is: (1) The same organization as the MA organization offering the D-SNP; (2) its parent organization; or (3) another entity that is owned and controlled by the D-SNP's parent organization. Aligned enrollment, as we proposed to define it, would not arise where the MA organization or its parent organization solely has a contract with the applicable state to offer a prepaid inpatient health plan (PIHP) or prepaid ambulatory health plan (PAHP) in the state's Medicaid program. Unlike a Medicaid MCO, these other Medicaid managed care plans cover only a specific and non-comprehensive set of services. In the event that it is the policy of the state Medicaid agency to limit a D-SNP's membership to individuals with aligned enrollment, we proposed describing this practice as “exclusively aligned enrollment,” which was embedded in the proposed definition of “aligned enrollment.” As noted in the proposed rule, some states limit D-SNP enrollment to full-benefit dual eligible individuals who also choose to receive Medicaid benefits through the D-SNP or a Medicaid MCO operated by the same entity (that is, by the MA organization) or by the MA organization's parent organization. Such a limitation would be included in the state Medicaid agency contract with the D-SNP. Exclusively aligned enrollment is relevant to how we proposed to apply the integrated grievance and appeals requirements described in section II.A.2.b. of the proposed rule. We solicited comment on our proposed definition of aligned enrollment given its relevance to the category of D-SNPs to which the integrated grievance and appeals procedures apply. We also solicited comment on whether we should consider other types of Medicaid managed care arrangements beyond companion Medicaid MCOs, as defined

in section 1903(m) of the Act and codified at § 438.2, operated by a HIDE SNP's parent organization.

Finally, we proposed in our definition of a D-SNP at § 422.2 to codify that an MA organization seeking to offer a D-SNP must satisfy any one (or more) of the three integration requirements in section 1859(f)(3)(D)(i) of the Act. We noted that the statutory language requires that plans meet one or more statutorily identified integration requirements to the extent permitted under state law. We explained in the proposed rule how we interpreted the integration standard in section 1859(f)(8)(D)(i)(II) of the Act (that the D-SNP be a FIDE SNP or have a capitated contract with the state Medicaid agency to provide LTSS or behavioral health services, or both) to mean that the D-SNP is a FIDE SNP or HIDE SNP; we also explained how we interpreted the integration standard in section 1859(f)(8)(D)(i)(III) of the Act (that clinical and financial responsibility for Medicare and Medicaid benefits for enrollees of the D-SNP be borne by an entity that is both the parent organization of the D-SNP and of the Medicaid managed care organization providing LTSS or behavioral health services under a contract under section 1903(m) of the Act) means that the D-SNP is a HIDE SNP or FIDE SNP with exclusively aligned enrollment. We interpreted the phrase “to the extent permitted under state law” as acknowledging and respecting the flexibility provided to states under the Medicaid program while imposing on D-SNPs integration requirements that Congress has deemed necessary. Given this flexibility, we proposed to interpret this statutory provision in a way that provides multiple avenues for a MA plan to qualify as a D-SNP. However, we considered other interpretations of this particular provision. For example, we considered whether “to the extent permitted under state law” should mean that in states that have Medicaid managed care programs for dual eligible individuals, all MA organizations seeking to offer a D-SNP could do so only if they were under contract with the state to offer a companion Medicaid managed care plan in that state, on the grounds that such an opportunity is permitted under state law. We solicited comments on our proposed interpretation as well as alternatives. We also requested comment on whether and how our proposed definition could or should be revised consistent with our statutory interpretation.

As discussed in the proposed rule, our intent was for the proposed definitions to describe different types of D-SNPs based on the degree to which they integrate Medicaid benefits at the plan level. Under section 1859(f)(8)(D)(i) of the Act, those D-SNPs that are neither FIDE SNPs nor HIDE SNPs must meet an additional state Medicaid contracting requirement beginning in 2021. Our proposed definition of a D-SNP addressed this in paragraph (1), cross-referencing the new requirement proposed to be codified in paragraph (d) of § 422.107. This proposed new requirement, which involves the provision of notice when an individual who belongs to a group of high-risk dual eligible individuals has a hospital and skilled nursing facility admission, is discussed in section II.A.2.a.(2) of this final rule in greater detail. We solicited comments on this proposal and, in particular, on alternative approaches to classifying D-SNPs consistent with requirements of section 1859(f)(8)(D)(i) of the Act.

We received the following comments on these proposed definitions and respond to them below:

Comment:

Many commenters expressed support for CMS' proposed regulatory framework for defining D-SNPs, whereby a D-SNP could satisfy any one or more of three integration requirements: (1) As a D-SNP subject to the hospital and skilled nursing facility admission notification requirement in proposed § 422.107(d); (2) as a HIDE SNP; or (3) as a FIDE SNP. In justifying their support, several of these commenters cited one or more of the following:

• The benefits that accrue to beneficiaries and taxpayers when there is a market that permits an array of D-SNPs to compete with each other, rather than one that limits the types of D-SNPs that can compete in that market;

• The need for state flexibility in promoting integration in a manner that is incremental and minimizes market disruption;

• The importance of preserving a pathway for D-SNPs that do not hold a Medicaid managed care contract in the state or operate in states where no such Medicaid managed care market exists; or

• The opportunity for D-SNPs to make the transition on a gradual basis to greater, and eventually full, integration. Another commenter indicated that this proposal would create a spectrum of integration and give states and plans clear starting points from which to better define their goals and objectives.

Response:

We appreciate the commenters' support of our proposal to create multiple pathways for an MA plan to qualify as a D-SNP, which—as discussed later in this preamble—we are fi

This text is long and has been trimmed here. Open the source document for the complete record.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.