So, what exactly happens to those regulatory flexibilities and emergency measures when the pandemic ends? On April 15, the Department of Health and Human Services (HHS) extended the PHE for a 90-day period beginning on April 21 and ending on July 19. HHS won’t keep doing this forever – so what happens when the PHE is no longer renewed?
The PHE So Far
HHS first declared the COVID-19 PHE on January 27, 2020, and HHS has since renewed the PHE four times, each for 90 days. When Acting Health and Human Services Secretary Norris Cochran sent a letter to state governors on January 21, 2021 estimating the PHE will likely remain in place for the entirety of 2021,” many thought the current extension would run through the calendar year, but Secretary Xavier Becerra extended the PHE through July 19, following the pattern of 90-day renewals as stipulated by the Public Health Service Act. The January 2021 letter indicated that when HHS decides to terminate the declaration and/or let the PHE expire, the Department will provide states with 60 days’ notice.
When Will the PHE End?
Do you remember when President George W. Bush relayed the message that the war in Iraq was over during his famed aircraft carrier speech on May 1, 2003, and then the war continued for many years? Is that what will happen with the PHE?
As it goes, there isn’t a requirement that HHS outline any specific criteria to be met for the PHE to end. The Health and Human Services Secretary has the option of declaring the PHE over, or he may simply not extend the current emergency. For their part, the American Health Care Association offered one suggestion – that the PHE be lifted if roughly 70% of the population has been vaccinated, or less than 500 COVID-19 deaths have occurred for 14 consecutive days .
Key Measures Linked to the PHE
Both Congress and the Administration have advanced key COVID-19 relief measures whose expiration dates are linked to the termination of the PHE. Below is a list of pivotal relief measures and their central provisions.
- Certain measures included in COVID-19 relief legislation. Many policies tied to the PHE are included in the Families First Coronavirus Response Act, enacted March 18, 2020, the CARES Act, enacted March 27, 2020, and the American Rescue Plan Act, enacted March 11, 2021. Some of these measures expire at the conclusion of the PHE, while others have a specific end date beyond the PHE, such as the one year or one calendar quarter after the termination of the PHE. Key provisions include:
- Enhanced coverage and no cost-sharing for COVID-19 testing and vaccines under Medicare, Medicare Advantage, Medicaid, CHIP, and TRICARE.
- Waived or modified Medicare requirements for telehealth, such as the restriction on use of a telephone and the requirement for face-to-face visits between home dialysis patients and physicians.
- Increased Medicaid federal match rate to 6.2%.
- Waived site-neutral payment rate provisions for long-term care hospitals.
- Continued payments to providers via the Medicare Hospital Accelerated Payment Program.
- Recalculated Medicaid disproportionate share hospital allotment.
- Temporary regulatory flexibilities under CMS. In interim final rules published on March 31, May 8, September 2, and November 2, 2020, the Centers for Medicare and Medicaid Services (CMS) has relaxed numerous Medicare and Medicaid rules for the duration of the PHE. Examples include testing and reporting requirements for long-term care facilities, enhanced Medicare reimbursement for certain COVID-19 treatments, and price transparency requirements for COVID-19 tests. The interim final rules also include a number of telehealth provisions, with notable examples including:
- Waived requirements on the types of practitioners that can furnish Medicare telehealth services to include all practitioners eligible for Medicare reimbursement, including physical therapists, occupational therapists, and speech language pathologists.
- Modified reporting requirements for remote physiological monitoring services.
- Payment parity for audio-only telephone services.
- Allowing hospitals to bill for services provided remotely by hospital-based practitioners to Medicare beneficiaries registered as outpatients.
- Allowing teaching physicians to review services provided by resident physicians remotely via audio-visual communications technology.
- Section 1135 Waivers. Since the start of the pandemic, CMS has invoked Section 1135 waiver authority to issue a blanket waiver and a series of state-specific waivers that expand telehealth coverage, allow clinicians to practice across state lines, and suspend some reporting requirements. All of these waivers are set to expire at the conclusion of the PHE.
- HIPAA Enforcement. The HHS Office of Civil Rights has relaxed certain HIPAA privacy rules for the duration of the PHE that apply to telehealth technologies, testing sites, and web-based scheduling platforms for COVID-19 vaccination appointments.
- Stark and Anti-Kickback Statute. The HHS Office of the Inspector General has issued guidance discouraging enforcement of pandemic response activities until the end of the PHE that could be viewed as problematic under the anti-kickback statute and the Stark Laws.
- Controlled Substances. Both the Substance Abuse and Mental Health Services Administration and the Drug Enforcement Administration have issued guidance allowing more flexibility for providers and opioid treatment programs to prescribe controlled substances during the PHE.
Previewing a Post-PHE World
As vaccinations increase and jurisdictions gradually reopen, the fate of temporary policies that expire at the end of the PHE remains unclear. Fortunately, recent actions by federal officials offer clues as to how some of temporary policies may be retained, particularly those relating to telehealth. As expressed by then-CMS Administrator Seema Verma in December 2020, congressional action will be essential to ensuring expanded telehealth coverage and other flexibilities can be made permanent. Since then, policymakers have been providing suggestions to lawmakers on what to do with telehealth after the PHE ends. In its March 15, 2021 report to Congress, for example, the Medicare Payment Advisory Commission recommended continuing some telehealth flexibilities one to two years following the end of the PHE to evaluate whether the temporary policies should be adopted permanently. The report also provided the following recommendations to Congress:
- Continue Medicare coverage for telehealth services, regardless of a beneficiary’s location.
- Discontinue allowing providers to reduce or waive cost-sharing for telehealth.
- Continue coverage of audio-only services if there is a clinical benefit.
Additionally, members of Congress have put forth their own proposals to permanently expand telehealth. Key legislation introduced so far includes:
- H.R. 366, the “Protecting Access to Post-COVID–19 Telehealth Act of 2021,” introduced by Rep. Mike Thompson (D-CA), which would eliminate most geographic and originating site restrictions on the use of telehealth in Medicare and authorize CMS to continue reimbursement for telehealth for 90 days beyond the end of the PHE.
- H.R. 787, the “Expanding Student Access to Mental Health Services Act,” introduced by Rep. Rick Allen (R-GA), which would permanently expand telehealth services for students.
- H.R. 937, the “Tech to Save Moms Act,” introduced by Rep. Eddie Bernie Johnson (D-TX), which would integrate telehealth models into maternity care services.
While the federal government may not yet have a specific plan on how it intends to handle temporary regulatory flexibilities once the pandemic expires, recent action from legislators and policymakers suggest a desire to keep at least some policies around permanently.