Over the past three years, the federal Public Health Emergency (PHE) declared in response to the COVID-19 pandemic facilitated the dismantling of various legal and regulatory barriers to obtaining healthcare in a time of lockdowns and social distancing. A parade of both federal and state regulatory waivers and flexibilities have supported, among other initiatives, the rollout of COVID-19 testing and vaccines, a tremendous growth in the utilization of telehealth services, maintenance of Medicaid enrollments without interruption, and flexibility for healthcare facilities in admitting and treating the sick.
Based on current COVID-19 trends, the Biden Administration has announced that the federal PHE will end on May 11, 2023. Legislation has extended some of the pandemic-era changes beyond the end of the PHE and pending legislative and regulatory changes may extend some of the lessons of the pandemic farther into the future. However, healthcare providers should review the flexibilities that will be rolled back as of May 11, 2023.
Highlights of the changes are included below, but every type of healthcare provider should review the available guidance to determine how the expiration of the PHE will impact their specific organization.
During the PHE, Medicare beneficiaries enjoyed a broad expansion of access to telehealth services, all from the comfort of their homes. As a result of federal waivers, facilitated by congressional action, Medicare beneficiaries could access telehealth without the narrow geographic limits that had applied pre-pandemic.
Although the broad waivers in place during the PHE are now coming to a close, the Consolidated Appropriations Act of 2023 has extended many select telehealth flexibilities through December 31, 2024, such as:
- Medicare beneficiaries can access telehealth services in any geographic area in the United States, rather than only those in rural areas
- People with Medicare can stay in their homes for telehealth visits that Medicare pays for rather than traveling to a health care facility
- Certain telehealth visits can be delivered audio-only (such as a telephone)
- An in-person visit within six months of an initial behavioral or mental health telehealth service and annually thereafter is not required
- The expanded list of healthcare providers who can deliver telehealth include, among others, physicians, nurse practitioners and certain physician extenders, physical therapists, clinical psychologists, clinical social workers, speech language pathologists, and occupational therapists
- Federally Qualified Health Centers and Rural Health Clinics may serve as distant site providers for telehealth services and receive reimbursement
- The CMS Acute Hospital Care at Home program will be extended to allow for hospitals to provide care outside their walls and still receive hospital reimbursement rates for that care
The extension of the above flexibilities (and others) is only temporary and will run through December 31, 2024, without further congressional action. Healthcare providers should remain informed and prepared should the above flexibilities change with future legislation.
During the PHE, the Drug Enforcement Administration (DEA) permitted practitioners to prescribe schedule II-IV controlled substances to patients without an in-person medical evaluation, provided a telehealth visit was conducted and other conditions met. The DEA also allowed qualifying practitioners to prescribe buprenorphine to new and existing patients with opioid use disorder based on a telephone evaluation.
Upon conclusion of the PHE, the above flexibilities will expire. On February 24, 2023 the DEA announced proposed rules for prescribing controlled substances via telemedicine after the PHE expires. The DEA’s proposed rule would create two limited options for telemedicine prescribing of controlled substances without a prior in-person exam, but it would remain more complex and restrictive than the waivers in place during the PHE. The proposed rule has garnered over 35,000 comments for the DEA to consider in crafting the final regulations, expected sometime in 2023.
Until new DEA regulations are finalized, telemedicine prescribing of Schedule II-IV medications will revert to pre-PHE restrictions. Thus, practitioners prescribing schedule II-IV drugs after the expiration of the PHE should be aware of and follow the in-person exam requirements of the federal Ryan Haight Act in place prior to the PHE. In general, the Ryan Haight Act requires a practitioner to conduct at least one in-person medical evaluation of a patient before prescribing a controlled substance by means of the “internet” – including telemedicine. Where state prescribing rules are more restrictive than the federal law, the more restrictive provision will apply. Practitioners accustomed to prescribing Schedule II-IV medications via telemedicine will need to ensure that in-person examination requirements are met.
Vaccines and Testing
Despite the expiration of the PHE, Medicare, Medicaid, and private health insurance must continue to provide COVID-19 vaccines without cost sharing. Medicare and Medicaid will continue to cover COVID-19 testing, but cost sharing obligations may vary. In addition, private health insurers will be able to determine whether to cover testing and at what level.
Expiring Facility Flexibilities
Medicare-certified facilities should be aware of additional flexibilities that will expire. For example, waivers will end that previously allowed hospitals to temporarily expand capacity by housing acute care patients in other facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories. Instead, hospitals must now provide services in accordance with pre-pandemic site and facility rules. Various waivers intended to reduce administrative burdens related to Hospital Conditions of Participation (i.e., equipment inspections, medical records, etc) will be removed.
For skilled nursing facilities, waivers of the requirement for a three-day prior inpatient hospitalization and prior Medicare coverage of a skilled nursing facility stay will expire, along with other pandemic-era changes to requirements for testing, room assignments, etc.
Medicare rules require physician or other practitioner supervision of certain services provided by non-physician staff. To encourage distancing and maintain access to care during the PHE, CMS temporarily changed the definition of “direct supervision” to allow the supervising health care professional to be immediately available through real-time audio and video technology instead of requiring their physical presence. CMS also clarified during the PHE that the temporary exception to allow immediate availability for direct supervision through virtual presence also facilitates the provision of telehealth services by clinical staff “incident to” the professional services of physicians and other practitioners. This flexibility will expire on December 31, 2023. Thus, any Medicare provider offering services that require physician or other practitioner supervision will need to update their processes to ensure that appropriate supervision is in place and documented.
Medicaid Provider Flexibilities
In conjunction with the end of the PHE, a number of flexibilities available to Medicaid-enrolled providers will end on May 11, 2023, while some will last for six months after the end of the PHE. Virginia has extended some provider flexibilities permanently, including expanded access to telehealth, the availability of take-home doses of medications through opioid treatment programs, and the removal of-copayments for Medicaid and FAMIS members. Virginia Medicaid providers should review updated guidance from the Department of Medical Assistance Services.
Medicaid providers may also face challenges as an estimated 5 to 14 million people are expected to lose Medicaid coverage during the unwinding of the continuous enrollment provision of the Families First Coronavirus Response Act. For general information about Medicaid unwinding, see “10 Things to Know About the Unwinding of the Medicaid Continuous Enrollment Provision,” Kaiser Family Foundation (April 5, 2023).
As the PHE reaches an official sunset and some flexibilities born during the pandemic live on in some ways, action is required. Most healthcare providers will need to modify their operations, procedures, and processes in some way to address the end of the PHE and the end of substantial flexibilities that have become entrenched over the past three years. In addition to changes in flexibilities granted by the federal government in treating Medicare and Medicaid beneficiaries, providers should also stay abreast of changes in requirements imposed by health insurance carriers and state regulatory agencies. This article is only a broad overview of the changes ahead and healthcare providers should consult with experienced legal counsel as needed to understand how the end of the PHE affects them.