June 2, 2020

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June 01, 2020

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CMS Guidance and Waivers for MA and Part D Plans Response to COVID-19

Over the past week, the Centers for Medicare & Medicaid Services (CMS) has made a number of announcements related to Medicare coverage in connection with the Coronavirus (COVID-19) outbreak.  Several of those announcements have been specific to Medicare Advantage and Part D. 

IN DEPTH


Medicare Advantage Organizations

Regulations Disasters and Emergencies. Pursuant to 42 CFR § 422.100(m), “special requirements” go into effect for Part A/B and supplemental Part C benefit access during disasters and emergencies, including state declarations of emergency and a presidential declaration under the Stafford Act.

While in effect, these special requirements are that MA Plans must:

  • Cover Medicare Parts A and B services and supplemental Part C benefits at non-contracted facilities subject to § 422.204(b)(3)’s requirements that facilities have participation agreements with Medicare
  • Waive requirements for gatekeeper referrals
  • Provide the same cost-sharing for enrollees as if the service was furnished at a plan-contracted facility
  • Make changes that benefit enrollees effective immediately, without the 30-day notification requirement at § 422.111(d)(3).

Cost-Sharing Waivers and Telehealth. In a March 10 memo, CMS also advised Medicare Advantage Organizations (MAOs) of additional flexibilities for MAOs through the exercise of CMS’s enforcement discretion.

  • MAOs may waive or reduce enrollee cost-sharing for COVID-19-related services, such as laboratory tests, telehealth benefits or other services to address the outbreak, as long as they do so consistently for all affected enrollees.
  • MAOs may provide enrollees access to Medicare Part B services via telehealth in any geographic area and from beneficiaries’ homes. This flexibility is irrespective of the scope of the telehealth benefit the MA plan filed and CMS approved.
  • On March 17, 2020, CMS issued waivers and guidance to provide Medicare coverage of telehealth. These waivers appear to describe FFS Medicare coverage, and do not directly mention or address any requirements for Medicare Advantage plans.

CMS noted that it had consulted with the Office of Inspector General (OIG), and that plans that utilized these flexibilities would satisfy the safe harbor to the federal anti-kickback statute set forth at 42 CFR § 1001.952(l). Once the outbreak has subsided, CMS will notify MAOs and Part D sponsors through the Health Plan Management System that CMS is ending its enforcement discretion with respect to such measures.

Section 1135 Waivers. The Secretary issued a Section 1135 waiver providing that CMS may authorize Medicare administrative contractors to pay for Part C covered services and seek reimbursement from MAOs for those services retrospectively.

On March 13, CMS waived and modified requirements related to Medicare Advantage appeals and grievances.

Part D Sponsors

Expectations and Authorities. The March 10 memo also reminded Part D sponsors of provisions contained in the Prescription Drug Benefit Manual to ensure adequate emergency access for enrollees:

  • Part D sponsors are expected to relax their “refill-too-soon” edits if necessary to ensure access to covered Part D drugs.
  • If enrollees cannot reasonably be expected to obtain covered Part D drugs at a network pharmacy, sponsors must ensure that such enrollees have adequate access to covered Part D drugs dispensed at out-of-network pharmacies, although enrollees will remain responsible for any cost sharing and additional charges that exceed the plan allowance, as applicable.
  • For enrollees that cannot physically access a retail pharmacy (e.g., because of a quarantine), Part D sponsors may relax any plan-imposed policies that would discourage certain methods of delivery, such as mail or home delivery, for retail pharmacies that provide such services
  • In the event that Part D drugs are identified to treat or prevent COVID-19, Part D sponsors may waive prior authorization, as long as they do so consistently.
  • If a vaccine becomes available for COVID-19, Part D plans will be required to cover the vaccine if it is a Part D drug. Otherwise, it will be covered under Medicare Part B.
© 2020 McDermott Will & Emery

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About this Author

Jeremy Earl, Healthcare Attorney, complex regulatory counseling health insurers, McDermott Will Law Firm
Partner

Jeremy Earl is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C., office.  He is a member of the Health Industry Advisory Practice Group.

Jeremy focuses his practice on providing complex regulatory counseling and advice to a variety of health care organizations such as health insurers, health maintenance organizations, pharmacy benefit managers, pharmaceutical companies and other industry stakeholders on a variety of federal and state regulatory matters.  He has experience counseling clients on compliance with the health...

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Partner

Ankur J. Goel is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm's Washington, D.C. office. 

Ankur has experience in both government and the private sector, where he has assisted clients to successfully navigate significant litigation and enforcement matters.

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George Tzanetakos Healthcare Attorney Chicago
Associate

George Tzanetakos advises hospitals, health systems and other health industry clients on a variety of regulatory and transactional matters, including mergers, acquisitions, affiliations and joint ventures.

During law school, George served as a law clerk for the general counsel of a large Iowa health system, held a research assistantship at the University of Iowa Department of Health Management and Policy’s Rural Policy Research Institute, and was an intern for the United States Attorney’s Office for the Northern District of Iowa.

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