The Health Law Ticker

May 11, 2023 marked a milestone in the pandemic response with the expiration of the federal COVID-19 Public Health Emergency (PHE). The expiration of the PHE marks an end to the wide-reaching efforts undertaken by the federal government through emergency declarations, congressional and regulatory actions that provided flexibilities for the healthcare industry to ensure continuous delivery of health services during the PHE. As the Centers for Medicare & Medicaid Services (CMS) explained, while some of these changes are extended or made permanent, others are not. Medicare Advantage (MA) plans as well as private managed care plans (PMCPs) should be mindful of these changes and consult legal counsel as necessary.

FEDERAL CHANGES

COVID-19 Vaccines, Testing, and Treatments

Going forward, when Medicare covers COVID-19 PCR and antigen tests, MA enrollees may continue to receive these tests. However, with the end of the PHE, MA enrollees’ cost-sharing obligations may change. For example, historically, Medicare did not pay for over-the-counter (OTC) services and tests but did so during the PHE. With the end of the PHE, Medicare will no longer cover these, though MA plans may continue providing coverage as a supplemental benefit. Oral antivirals like Paxlovid and Lagevrio will continue to be covered as well.

Most PMCPs must still cover—without cost sharing—COVID-19 vaccines provided in-network, though there may still be cost sharing when administered out-of-network. Similarly to MA plans, PMCPs may choose to continue covering OTC and laboratory-based COVID-19 PCR and antigen tests and potentially require cost sharing or prior authorizations. After the PHE, coverage for COVID-19 treatment itself remains unchanged, though cost sharing and deductibles may kick back in likely leading so some increased costs to enrollees.

Telehealth

A hallmark of the changes in healthcare delivery during the PHE was the extension of Medicare coverage to many telehealth services. With this flexibility, many Medicare patients did not need to travel physically to their appointments but were still covered by Medicare. As the Consolidated Appropriations Act of 2023 has extended many telehealth flexibilities through December 31, 2024, MA plans may also offer additional telehealth benefits.

Also, during the PHE, CMS temporarily changed the definition of “direct supervision” to allow supervising healthcare professionals to be virtually, but not physically, available via real-time audio/video technology. CMS also temporarily permitted provision of telehealth services by clinical staff “incident to” the professional services of physicians and other practitioners. These flexibilities will expire December 31, 2023. Furthermore, the federal government has also temporarily extended telehealth flexibilities for the prescribing of controlled medications and is considering making this change permanent.

Unlike MA plans, PMCPs retained discretion whether to cover telehealth services during the PHE. Going forward, this will not change. If they cover telehealth, PMCPs may still impose cost-sharing or prior authorization.

Other Managed Care Considerations

The end of the PHE also presents some indirect considerations for managed care plans. For example, the U.S. Department of Health and Human Services (HHS) no longer has express authority to require COVID-19 surveillance data from labs, potentially impacting statistics for COVID-19 incidence; states are still encouraged to provide HHS with this data. Although coverage for COVID-19 testing may change (see above), the federal government may continue to distribute free COVID-19 tests from the Strategic National Stockpile through the Postal Service, states, and other community partners.

During the PHE, the Food and Drug Administration (FDA) had authority to authorize products like tests, treatments, and vaccines for emergency use through Emergency Use Authorizations (EUAs). The FDA’s pre-existing EUAs for COVID-19 products will remain intact, and FDA may still issue new EUAs. During the PHE, the federal government had permitted patients to begin receiving buprenorphine in an Opioid Treatment Program (OTP) via telehealth without undergoing the mandatory in-person physical examination beforehand. This flexibility should remain intact. The federal government had also permitted an increased number of take-home doses to patients taking methadone in an OTP and has extended this flexibility until May 11, 2024, with the eventual goal of making it permanent.

Medicaid Considerations

While many of the flexibilities noted on the foregoing were also available within the Medicaid program, none was more important at increasing access to care and reducing the overall uninsured rate than the continuous coverage provision enacted as part of the Families First Coronavirus Response Act (FFCRA). FFCRA included the requirement that Medicaid programs keep beneficiaries continuously enrolled through the end of the COVID-19 public health emergency (PHE), in exchange for enhanced federal funding. However, as part of the Consolidated Appropriations Act, 2023, Congress severed the continuous enrollment provision from the PHE thereby ending continuous enrollment effective March 31, 2023. CMS required states to submit plans describing how Medicaid enrollment renewals will be prioritized. The potential adverse impact on the number of beneficiaries covered by Medicaid is significant. The Kaiser Family Foundation estimates that between 8 million to 24 million current Medicaid beneficiaries could lose coverage during the 12 month unwinding period. States may work with their Medicaid managed care plan partners, however, to perform outreach and assistance for current beneficiaries in order to prevent disenrollment from occurring. Medicaid managed care plans should follow these developments and consult with legal counsel to ensure opportunities are not missed to retain and grow enrollment.