Since early March 2020, the Centers for Medicare and Medicaid Services (CMS) has released a steady stream of guidance to Medicare Advantage Organizations (MAOs) and Part D sponsors in connection with the Coronavirus (COVID-19) outbreak. CMS recently compiled much of this guidance in a memorandum published on April 21, 2020, which revised prior guidance released on March 10, 2020. CMS also issued a new memorandum addressing the status of telehealth visits for risk adjustment, which was prompted by the expansion of telehealth but may extend beyond the COVID-19 emergency. This new guidance describes additional flexibilities CMS is granting MAOs and Part D sponsors, coverage requirements mandated by recent changes in law, and obligations MAOs and Part D sponsors have under existing program rules.

IN DEPTH

Medicare Advantage Organizations

Additional MAO Flexibilities

CMS identified numerous areas where it is exercising its enforcement discretion to permit MAOs to take actions that would otherwise be inconsistent with current program regulations, including certain benefit enhancements, lengthened member termination grace periods, and flexibilities specific to special needs plans (SNPs).

Benefit Enhancement and Telehealth. CMS will exercise its enforcement discretion to allow MAOs to:

• Make mid-year changes to their benefit packages (e.g., expanding covered benefits and reducing cost-sharing). The changes must (1) be provided in connection with the COVID-19 outbreak, (2) benefit members and (3) be provided uniformly to all similarly situated members. CMS cited meal delivery and medical transportation services to promote social distancing efforts as examples of accepted benefits.

• 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 MAO filed and CMS approved.

• Waive or reduce cost-sharing for members affected by the outbreak. The waiver or reduction must be consistently provided to all similarly situated enrollees and must be “tied to the outbreak.” As discussed below, separate legislation prohibits MAOs from charging cost-sharing for certain COVID-19-related services.

Risk Adjustment of Telehealth Visits. In separate guidance released on April 10, 2020, CMS stated that MAOs may submit diagnoses for risk adjustment that are from telehealth visits “when those visits meet all criteria for risk adjustment eligibility, which include being for an allowable inpatient, outpatient, or professional service, and from a face-to-face encounter.” CMS specified that diagnoses may meet the face-to-face requirement when provided using an interactive audio and video telecommunications system that permits real-time interactive communication. This policy is effective for both Risk Adjustment Processing System and Encounter Data System submissions. Although the memo initially references the expansion of telehealth due to COVID-19, CMS did not limit the application of its stated interpretation to any particular start or end date. As such, telehealth visits that occurred prior to the COVID-19 context may also be considered “face-to-face” visits for risk adjustment purposes. MAOs that provided coverage for telehealth prior to the COVID-19 emergency may wish to evaluate whether those visits qualify for risk adjustment.

Involuntary Disenrollment Timeframes. MAOs may delay involuntary disenrollment of enrollees who are temporarily absent from the service area for more than six months because of the COVID-19 emergency.

SNP Flexibilities. CMS is also exercising its enforcement discretion for SNPs, including:

• Permitting SNPs to delay disenrollment of enrollees who are losing special needs status and cannot recertify SNP eligibility because of the COVID-19 emergency

• Acknowledging that SNPs may need to deviate from their model of care to ensure that enrollees and providers are protected from COVID-19, and “considering” the special circumstances created by the outbreak when conducting model of care monitoring and oversight.

Other Enforcement Discretion. CMS also recognized that there might be other circumstances where an MAO may decide that it is “reasonable and necessary” to take actions that “do not fully comply with program requirements” in order to provide basic benefits while protecting enrollees from the spread of COVID-19. CMS stated that it will “consider the special circumstances presented by the COVID-19 outbreak when conducting monitoring or oversight activities.”

MAO Required Actions

In addition to providing guidance on new flexibilities, CMS advised MAOs of new requirements and reminded MAOs of their existing obligations triggered by declared emergencies.

COVID-19 Coverage Mandates. Pursuant to the Families First Coronavirus Response Act and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, MAOs cannot impose cost-sharing or utilization management requirements (such as prior authorization) on members receiving the following:

• Clinical laboratory tests for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19 and the administration of such tests

• COVID-19 testing-related services

• COVID-19 vaccines and the administration of such vaccines.

Section 1135 Waivers. The Secretary issued a Section 1135 waiver allowing CMS to authorize Medicare administrative contractors to pay for Part C covered services and seek reimbursement from MAOs for those services retrospectively. CMS noted, however, that to date it has not authorized Medicare administrative contractors to take this action.

On March 13, 2020, CMS exercised its authority under section 1135 to waive and modify requirements related to Medicare Advantage appeals and grievances:

• Timeframes for filing appeals and requests for additional information are extended.

• Appeals must be processed even with incomplete Appointment of Representation forms, but communicated only to the beneficiary.

• Requests for appeals that do not meet the required elements will be processed using the information available.

Disaster and Emergency Regulations. CMS reminded MAOs that pursuant to 42 CFR § 422.100(m), they have certain obligations during disasters and emergencies to ensure access to benefits. Qualifying emergencies are currently in effect for all 50 states, the District of Columbia and the Territories. For the duration of the emergency declaration, an MAO must:

• Cover Medicare Parts A and B services and supplemental Part C benefits rendered 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 contracted facility

• Make changes that benefit enrollees effective immediately, without the 30-day notification requirement at § 422.111(d)(3).

Part D Sponsors

CMS also noted several new flexibilities for Part D sponsors, summarized new statutory requirements to ensure access to drugs during the emergency, and reiterated existing requirements triggered by the outbreak.

New Flexibilities. CMS encouraged Part D sponsors to take actions they “deem reasonable and necessary” to keep members and employees safe, while also ensuring access to drugs. CMS acknowledged that some such actions may not “fully comply with program requirements” and stated that the agency will “consider the special circumstances presented by the COVID-19 outbreak when conducting monitoring or oversight activities.” To that end, CMS announced that it is exercising its enforcement discretion during the COVID-19 emergency to permit Part D sponsors to:

• Dispense solid oral doses of brand-name drugs to enrollees residing in long-term care facilities for more than 14-day increments at a time

• Waive Part D medication delivery documentation and signature log requirements, including in the case of opioids

• Relax “to the greatest extent possible” prior authorization requirements, where appropriate

• Suspend plan-coordinated pharmacy audits.

Extended Drug Access During the Emergency. CMS summarized several requirements intended to ensure drug access. Specifically, Part D sponsors must:

• Relax their “refill-too-soon” edits if necessary to ensure access to covered Part D drugs except as limited by safety edits. CMS notes that relaxed refill-too-soon edits are safety edits for the purpose of § 3714 of the CARES Act.

• Allow members to obtain the total day supply prescribed (up to 90 days) if requested by the enrollee, subject to applicable safety edits and utilization management requirements.

Despite the emphasis on expanded access, CMS explicitly noted that Part D sponsors may continue or begin to implement safety edits. With respect to opioid safety edits, CMS stated that Part D sponsors “are expected” to apply existing point-of-sale safety edits but are “encouraged” to waive requirements for pharmacist consultation with the prescriber to confirm intent.

Existing Requirements and Flexibilities for Emergency Access. CMS reminded Part D sponsors of Prescription Drug Benefit Manual provisions intended to ensure adequate emergency access for enrollees. Specifically, Part D sponsors:

• Must ensure that enrollees who cannot reasonably be expected to obtain covered Part D drugs at a network pharmacy have adequate access to covered Part D drugs dispensed at out-of-network pharmacies (subject to normal cost sharing and charges)

• Must follow existing CMS guidance should a drug shortage arise

• May relax any plan-imposed policies that would discourage certain methods of delivery, such as mail or home delivery, for enrollees who cannot physically access a retail pharmacy (e.g., because of a quarantine) and retail pharmacies that provide such services

• May waive prior authorization, as long as they do so consistently, in the event that Part D drugs are identified to treat or prevent COVID-19.

MAOs and Part D Sponsors

Involuntary Disenrollment. CMS encouraged MAOs and Part D sponsors to eliminate or relax any existing policies regarding enrollee disenrollment for non-payment of premiums. CMS encouraged plans to lengthen the mandatory grace period, at a minimum.

Marketing and Communications. CMS indicated that COVID-19 messages to members regarding information on precautions and the public health emergency “would almost invariably be communications” and thus would not require Health Plan Management System (HPMS) submission and review prior to dissemination.

Discontinuation of Enforcement Discretion. Once the outbreak has subsided, CMS will notify MAOs and Part D sponsors through HPMS that CMS is ending its enforcement discretion.

Business Continuity Plans. CMS reminded MAOs and Part D sponsors that existing regulations require them to have business continuity plans to minimize disruptions during emergencies.