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This document is scheduled to be published in the
Federal Register on 04/16/2019 and available online at
https://federalregister.gov/d/2019-06822, and on govinfo.gov


[Billing Code 4120-01-P]

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 [Insert Date 60 Days after date of publication in the Federal Register].



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 (Public Law 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.

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. The enrollee must have the option whether to receive such service through an in-

person visit or, if offered by the MA plan, through electronic exchange. In addition, section

1852(m)(2)(A)(ii) of the Act excludes from MA additional telehealth benefits capital and

infrastructure costs and investments relating to such benefits. These statutory provisions have

guided our rule.

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