As HHS Secretary Xavier Becerra announced in the letter to U.S. Governors, the COVID-19 PHE expired at the end of May 11, 2023. Department of Health and Human Services also released a fact sheet to clarify what will or will not change as the healthcare industry transitions out of the pandemic. Here is a breakdown of some of the changes occurring after May 11, 2023, that BlueStone Services’ Medical Business Advisory group thinks you should be aware of:

What Happens to COVID-19 Vaccine Coverage and Payments After PHE Ends?

• Medicare will continue to provide access to vaccinations “without cost sharing” after PHE ends.
• States must provide Medicaid and CHIP coverage without cost sharing for COVID-19 vaccinations through September 30, 2024. After that date, many Medicaid and CHIP enrollees will continue to have coverage for COVID-19 vaccinations due to the American Rescue Plan Act (ARPA). In states that have opted to amend their policies, Medicaid coverage for the uninsured may continue beyond September 30, 2024. As per federal law, Medicaid coverage of COVID-19 vaccinations, testing, and treatment for this group will end when the PHE ends.
• Private Health Insurers will continue to offer cost-free coverage for COVID-19 immunizations administered by in-network providers. Patients who choose to receive vaccines from an out-of-network provider might have to cover a portion of the cost.
• CMS states that they will continue to pay approximately $40 per dose for administering vaccines “in most outpatient settings through the end of the calendar year in which the Secretary ends the EUA declaration for drugs and biologicals with respect to COVID-19. The EUA declaration is distinct from, and not dependent on, the PHE for COVID-19.”(1) Medicare will also pay $40 per dose or booster for multi-dose vaccinations (1).
• “Effective January 1 of the year following the year in which the EUA declaration ends, payments for administering COVID-19 vaccines will align to rates associated with preventive vaccines, which is approximately $30 per dose”(1).
  For Vaccines administered in a patient’s home for certain Medicare patients, CMS will pay approximately $36 in addition to the standard administration fee of $40 per dose, including multi-dose vaccines and booster vaccinations. Geographical adjustments will also be paid but rates are contingent upon where services are administered. Starting January 1, 2023, CMS annually updates “the additional in-home payment rate for administering the COVID-19 vaccine to reflect changes in costs related to administering preventive vaccines.” (1) The $76 total payment for in-home vaccination will continue through 2023 and will not be affected by the end of PHE (1).

What Happens to COVID-19 Testing and Reporting After PHE Ends?

• Traditional Medicare plans will cover COVID-19 PCR and antigen tests with no cost sharing when the test is ordered by a physician, physician assistant, or certain registered nurses, and performed by a laboratory. For Medicare Advantage (MA) plans, COVID-19 PCR and antigen tests are covered when the test is covered by Medicare, but cost-sharing may change when the PHE ends.
• States must provide Medicaid and CHIP coverage without cost sharing for COVID-19 testing. After the ARPA coverage requirements expire, Medicaid and CHIP coverage of COVID-19 testing may vary by state. Medicaid coverage for the uninsured may continue beyond September 30, 2024, in states that have opted to amend their policies. As per federal law, Medicaid coverage of COVID-19 testing for this group will end when the PHE ends.
• Private Health Insurers mandated coverage for over-the-counter and laboratory-based COVID-19 PCR and antigen tests will expire on May 11, 2023, “though coverage will vary depending on the health plan.”(1) If coverage is available, cost sharing, prior authorization, or other forms of medical management may be required.
• According to CMS, “Consistent and regular reporting of all testing results to local officials is critical to public health management of the pandemic, so we would expect any clinician or laboratory receiving results to report those results promptly, consistent with state and local public health requirements, typically within 24 hours.”(1) Indicating that providers will need to follow state and local reporting guidelines after May 11, 2023. In addition, “Medicare will require all COVID-19 and related testing that is performed by a laboratory to be ordered by a physician or non-physician practitioner.”(1).
• After the PHE ends, the usual requirements for billing the level 1 E/M visit (CPT code 99211) for established patients will apply.
  Therapeutics
• There are no changes to Medicare coverage of treatments once PHE ends. Even after the PHE has ended, all applicable cost-sharing and deductibles will still apply. There will be no change in access to oral antivirals, such as Paxlovid and Lagevrio, after May 11, 2023.
• States must provide Medicaid and CHIP coverage without cost sharing for COVID-19 therapeutics. After the ARPA coverage requirements expire, Medicaid and CHIP coverage of COVID-19 therapeutics may vary by state. In states that have opted to amend their policies, Medicaid coverage for the uninsured may continue beyond September 30, 2024. As per federal law, Medicaid coverage of COVID-19 treatments for this group will end when the PHE ends.
• The expiration of PHE will not affect how insurers opt to cover COVID-19 therapeutics, and all applicable cost-sharing and deductibles will still apply.
  Telehealth Services
• Patients with Medicare coverage can access telehealth services in any geographic area in the United States until December 31, 2024. If a patient cannot use audio and video, such as a smartphone or computer, some telehealth visits may be carried out via audio-only/telephone. Additional coverage may be offered through some Medicare Advantage plans and some participating ACOs may cover primary care telehealth services after telehealth flexibilities expire on December 31, 2024.
• Telehealth service coverage will vary by state for Medicaid and CHIP. Providers should review their state Medicaid and CHIP coverage to ensure compliance.
• Providers should be aware that coverage for telehealth services as well as other “remote care services,” will vary according to private health insurers. Providers need to be aware that co-pays, deductibles, prior authorizations, or other forms of medical management may apply if coverage is offered.
• It is important to note that licensing requirements for providing Telehealth in all states will fall under State Rules and Regulations and the incident to “virtually” will end with the PHE.
• Remote evaluations, virtual check-ins and E-visits coverage will only apply to established patients when the PHE ends.

What Happens to Virtual Supervision After COVID-19 PHE Ends?

• The CMS flexibility of virtual supervision will also expire on December 31, 2023. This flexibility allowed “more people to receive care during the PHE, CMS temporarily changed the definition of “direct supervision” to allow the supervising health care professional to be immediately available through virtual presence using real-time audio/video technology instead of requiring their physical presence. CMS also clarified 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.” (4)

What Happens to Stark Law After COVID-19 PHE Ends?

• “Stark Law” waivers granted during the PHE to ease administrative burdens will end on May 11, 2023. Providers and all healthcare entities must comply with all the provisions of the law after May 11th.
• During a virtual meeting in October 2022, CMS’s Jean Moody-Wilkes stated, CMS is “encouraging health care providers to prepare for the end of the flexibilities and begin to move forward if you don’t need that particular waiver and flexibility so that we can ensure that health and safety standards are in place.” (3)

What’s Next?

While CMS has stated that “certain services” will continue to be covered after May 11th, it is critical that medical practices do not assume that all services are still covered. On April 14, 2023, HHS Secretary Xavier Becerra also announced the intention of amending “the PREP Act declaration to extend certain important protections that will continue to facilitate such access.”  BlueStone’s Medical Business Advisory group will provide future updates as they become available to ensure your practice is prepared for future changes and complies with regulatory agencies. If you are not already a client, to be notified on future matters like this, please sign-up to receive our email alerts.

To view the full Department of Health and Human Services fact sheet, please visit their website, click here.

How Can BlueStone Services’ Medical Business Advisory Help?

Is your practice needing further guidance in navigating these DHHS PHE updates? Your partners at BlueStone Services’ Medical Business Advisory group are here to help answer your questions and guide you through these changes. Our healthcare consultants can be valuable resources for medical practices as either interim or permanent solutions. Learn more about our medical practice management consulting services by clicking here.

This update is brought to you by, Your trusted advisors at BlueStone Services

(1) https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19
(2) Medicare COVID-19 Vaccine Shot Payment | CMS
(3) https://skillednursingnews.com/2022/10/cms-to-nursing-home-providers-its-time-to-move-forward-as-covid-waivers-sunset
(4) U.S. Department of Health & Human Services. (2023). Fact sheet: COVID-19 public health emergency transition roadmap.
(5) U.S. Department of Health & Human Services, Administration for Strategic Preparedness and Response (ASPR). (2023). COVID-19 (February 9, 2023).
(6) https://www.hhs.gov/about/news/2023/02/09/letter-us-governors-hhs-secretary-xavier-becerra-renewing-covid-19-public-health-emergency.html