With the 1/30/23 announcement that the Biden administration plans to end the COVID-19 public health emergency declaration in May, what does this mean for the public, for state governments and health care providers? Answer: Much more than you probably realize.
The Trump administration issued the COVID-19 national emergency and the public health emergency (PHE) declarations in 2020. The PHE was declared on 1/31/20 by the Secretary of Health and Human Services. The national emergency was declared by President Trump on March 13, 2020.
The PHE declaration expires on its own after 90 days, unless renewed, and it has been repeatedly renewed (a total of 12 times) by both administrations since its initial implementation on 1/31/20. The COVID-19 national emergency declaration is currently set to expire on March 1, 2023 and the PHE declaration is set to expire on April 11, 2023 (its last renewal having occurred on 1/11/23).
The administration has indicated its plans to extend both declarations until May 11, 2023, and then terminate both on that date. https://www.whitehouse.gov/wp-content/uploads/2023 /01/SAP-H.R.-382-H.J.-Res.-7.pdf. It appears that this decision was made in response to proposed legislation that would terminate both declarations immediately if passed. Although passage would be uncertain in the current Congress, I suspect that the Biden White House weighed that against the certain chaos abrupt termination would pose for states, health care providers and the public, especially those who depend on Medicaid for their insurance coverage. In fact, the Biden administration has previously assured states and health care providers that it would provide at least 60 days of advance notice before terminating the PHE. Of course, one can also speculate that the administration may have been looking for an excuse to terminate the PHE, and perhaps understandably so given Congress’ repeated refusals to appropriate more funding for the PHE.
Implications and Impacts
It is quite daunting to consider all of the interim measures put in place during the pandemic that may now be terminated with the termination of the PHE declaration. It is all the more daunting because some measures have been given an extension following the termination of the PHE declaration and some measures have been made permanent through agency rule-making or by statute.
- FDA ability to grant Emergency Use Authorization (EUA) for vaccines, medications and medical devices.
It is of great concern to me that the contemplated ending of the PHE coincides with a time that:
- Evusheld has just had its EUA suspended;
- All previously authorized monoclonal antibody treatments have had their EUAs revoked or suspended;
- I anticipate that Molnupiravir will soon lose its EUA given studies showing little or no protection against severe disease and that treatment can promote the development of mutations;
- We need vaccines that provide better mucosal immunity and protection against infection and more therapeutic options, especially for the immunocompromised. Many new vaccines and therapeutics are currently in clinical trials;
- A surprisingly low percentage of the population has received a bivalent booster, especially in those who are over age 65;
- Our current vaccines have low effectiveness at preventing infection, transmission and PASC, with rapid waning of neutralizing antibody titers;
- A surprisingly low percentage of candidates for Paxlovid antiviral treatment are receiving the medication;
- We have a record number of new circulating variants with enhanced transmissibility and immune escape;
- We are learning much more about the potential detrimental long-term health consequences following even mild cases of COVID-19.
On February 4, 2020, the Secretary of Health & Human Services determined pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of SARS-CoV-2 pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. Federal Register :: Determination of Public Health Emergency.
On the basis of the Secretary’s determination that a public health emergency existed as of February 4, 2020, he also declared on March 27, 2020 that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. Federal Register :: Emergency Use Authorization Declaration
This concern about the ability of the FDA to continue to provide for EUAs was even greater in the past when the termination of the PHE could also result in the termination of the FDA’s authority to grant Emergency Use Authorizations to vaccines, biological products and medical devices. However, in 2013, the passage of The Pandemic and All Hazards Preparedness Reauthorization Act amended section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3, to provide more flexibility to the Health and Human Services Secretary to authorize the U.S. Food and Drug Administration (FDA) to issue Emergency Use Authorizations, not only during a declared public health emergency involving chemical, biological, radiological, and nuclear agents, but when there is an emerging threat and potential for the development of a public health emergency. The Secretary is no longer required to make a formal determination of a public health emergency under section 319 of the Public Health Service Act, 42 U.S.C. 247d before declaring that circumstances justify issuing an EUA.
Fortunately, this appears to give the Secretary the latitude to provide the FDA with continued authority to grant Emergency Use Authorizations, but unfortunately this depends upon the view of whether there are emerging threats or the threat of a potential public health emergency of a political appointee subject to political pressures.
- Commercialization of vaccines, tests and therapies.
Under the PHE, most Americans have benefitted from the ability to obtain free COVID-19 testing and free vaccines and therapeutics without incurring out-of-pocket costs. With the termination of the PHE, vaccines, tests and therapeutics will move into the commercial market resulting in coverage determined by insurance plans, including deductibles and co-pays (other than vaccines, which should continue to be made available with no out-of-pocket costs pursuant to the Patient Protection and Affordable Care Act (ACA) of 2010 for those with ACA-covered health insurance. But, note that the ACA does not prevent insurers from imposing cost-sharing for tests and treatments). Of course, those who are uninsured will often be faced with paying full price for their vaccines (There may be limited opportunities to receive free vaccines through the Section 317 Immunization Program, but few are aware of it or how to access it and it does not appear that Congress intends to fund this program as it is not a “mandatory” program (in other words, Congress has discretion as to whether to fund it and if so, how much to fund it). Some uninsured can also access vaccines through safety net providers on a sliding scale fee schedule based upon income). It has been widely reported that Pfizer is projecting prices for its COVID-19 vaccines in the range of $110 – 130 per dose (the government currently pays approximately $30 per vaccine dose for both Pfizer and Moderna). Not that the pharmaceutical industry would ever engage in price fixing, but Moderna has also subsequently indicated that it will consider a price of $110 – 130 per vaccine dose.
Medicare beneficiaries will continue to have access to COVID-19 vaccines, including boosters, with no cost-sharing so long as they have Medicare Part B coverage. Providers will continue to use the government’s inventory of COVID-19 vaccines until they are depleted. Then, Medicare will determine a payment rate for the vaccines as well as continue to pay an administration fee.
The American Rescue Plan Act and the Inflation Reduction Act require Medicaid and CHIP programs to continue to provide all ACIP-recommended vaccines, including the COVID-19 vaccines and boosters with no cost sharing from beneficiaries even once the PHE ends and the federal supply of vaccines has been exhausted. Under the provisions of these laws, states will receive 100% FMAP payments for the costs associated with administering the COVID-19 vaccines and boosters through the last day of the first quarter that begins one year after the PHE is terminated. After that point in time, state costs are reimbursed at the regular FMAP rate for that particular state and at the enhanced FMAP rate for CHIP.
The Vaccines for Children Program (VFC) will continue to provide access to COVID-19 vaccines for Medicaid-eligible children once the federal supply is exhausted (by purchasing the vaccine and then distributing it to VFC-registered providers. The Medicaid program will pay providers administration fees. For other Medicaid and CHIP enrollees, states will pay providers for the vaccine and its administration.
On 8/18/22. CMS indicated that it will continue to pay approximately $40 per dose for administering COVID-19 vaccines in outpatient settings for Medicare beneficiaries through the calendar year in which the PHE ends (2023). As of 1/1/24, CMS will set the payment rate for administering COVID-19 vaccines to align with the payment rate for administering other vaccines under Part B. (There is also an additional payment amount of approximately $35.50 per dose for administering COVID-19 vaccines in the homes of certain Medicare beneficiaries. These payments will end at the end of the calendar year in which the PHE ends, i.e., 2023.)
Paxlovid, which has been shown to be nearly 90% effective in reducing the risk of severe COVID, (hospitalization and death), will also no longer be free once the PHE is terminated. The government reportedly pays $530 for a course of Paxlovid. Without a good alternative, and without bulk buying and committed orders from the government, one can only imagine what the retail price for Paxlovid will be (Pfizer has not yet announced their projected price). However, given the projected quadrupling of the vaccine price (when there is an alternative available), one can imagine that the price will likely exceed $2,000, and thus be unaffordable to the uninsured.
After the termination of the PHE, CMS will pay for monoclonal antibody treatments for COVID-19, if there are any, in the same manner in which they pay for biological products under Section 1847A of the Social Security Act. (CMS did note that this could change when the final rule is issued for the Calendar Year 2023 Physician Fee Schedule and OPPS/ASC proposed rule.)
The government did not purchase a supply of remdesivir. Since the FDA updated the approval of VEKLURY (remdesivir) for use in the outpatient setting, CMS will continue to provide payment for this drug and its administration under Medicare Part B even after the termination of the PHE. In most cases, this will subject Medicare beneficiaries to the annual Part B deductible and a 20% co-insurance fee.
Medicare beneficiaries will likely have cost-sharing requirements for most COVID-19 treatments once the PHE ends. I am researching, but not yet clear, as to whether commercial health plans must offer and cover drugs and services that are only available under an Emergency Use Authorization. The Consolidated Appropriations Act of 2023 does require Medicare Part D plans to cover certain COVID-19 therapies (antivirals) that only have EUA, but these remain subject to cost-sharing.
The American Rescue Plan Act requires Medicaid and CHIP programs to cover all drugs and biological products for the treatment or prevention of COVID-19 with no cost sharing for enrollees through the last day of the first quarter that begins one year after the termination of the PHE. However, once that coverage period ends, Medicaid and CHIP must continue to cover FDA-approved COVID treatments, but these can then be subject to cost-sharing and utilization review. The law would not require coverage of treatments that are still under EUA, but states may choose to do so (so, for Idaho, that is likely a “no.”)
It remains to be seen whether the shift of costs from the government to commercial health plans and employer-sponsored health plans will result in premium increases, but it would not be surprising, especially when you add in the costs of providing care to those with PASC or Long COVID.
This commercialization of vaccines, tests and therapeutics will widen already well-documented health care disparities that occurred prior to, and were amplified during, the pandemic. I fear that we have not yet learned the lesson that controlling the community spread of a contagious disease requires ensuring availability of vaccinations, testing, and treatments to those in the community who are uninsured and underinsured.
In addition, given that there will not be large advance guaranteed purchase agreements with the government, one can be justified in worrying that if the near future will continue to be characterized by waves of COVID-19 and under-prescribing/underuse of Paxlovid, we could then see shortages of Paxlovid were we to experience a new large wave with a new variant that was causing more severe disease suddenly and significantly increasing demand, similar to what we have recently seen with children’s cold medicines and certain antibiotics, especially if that wave was world-wide or occurring simultaneously in many countries.
As far as at-home COVID tests, Medicare beneficiaries will bear the full cost once the PHE is terminated. During the PHE, Medicare implemented a demonstration program to allow Medicare beneficiaries to receive up to eight at-home COVID-19 tests per calendar month at no cost. However, this program expires with the termination of the PHE.
Provider COVID testing will be covered under Medicare Part B, but beneficiaries will still be responsible for the associated out-of-pocket costs. Medicare Advantage plans (Part C) may allow at-home COVID tests to be covered under any over-the-counter benefit they offer and they may choose through their plan design whether to require cost-sharing or not for provider COVID testing.
Medicaid and CHIP must cover COVID-19 at-home tests and provider testing for enrollees at no cost through the last day of the first quarter that begins one year after the PHE is terminated. After that point in time, states may decide whether to cover at-home tests and whether cost-sharing will be required, but there is no requirement to do so. Nevertheless, states must continue to cover provider-ordered COVID testing in a medical facility.
For commercial and employer sponsored health plans that are subject to the ACA, COVID-19 testing would fall under essential health benefits and therefore must be covered following the termination of the PHE. However, any essential health benefits that do not receive an A or B rating from the US Preventive Services Task Force (which COVID-19 testing has not) can be subject to cost-sharing by the health plan. Insurers can also require the testing be pursuant to a provider order, they can limit the number of tests per plan year, they can restrict testing to in-network facilities, and they can impose cost-sharing.
- Telehealth coverage/access
Throughout the COVID-19 public health emergency (PHE), CMS has used a combination of emergency authority waivers, regulations, enforcement discretion, and sub-regulatory guidance to ensure access to care and give health care providers the flexibilities needed to respond to COVID-19 and help keep people safer. Many of these waivers and broad flexibilities will terminate at the eventual end of the PHE.
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) of 2020 broadened CMS’ section 1135 (Social Security Act) waiver authority. Telehealth access and coverage was extended during the pandemic initially under CMS 1135 waivers that were retroactive to March 1, 2020 and in effect until the expiration of the PHE declaration. CMS then waived the restrictions on who can provide distant site telehealth services so as to allow any provider who is eligible to bill the Medicare program to provide these services (e.g., this would allow physical therapists, occupational therapists and speech language therapists to provide distant site telehealth services). That waiver was specified to end 151 days following the termination of the PHE declaration.
Under this same authority, CMS waived the requirement for certain services for the use of interactive telecommunications systems to furnish telehealth services to the extent video was otherwise required. CMS established “audio-only” E&M codes for those services covered by this waiver. This waiver was also declared to expire 151 days following the termination of the PHE declaration.
Subsequently, some of these measures were codified under the Consolidated Appropriations Act of 2021. Some of these benefits were further extended or enhanced under the Consolidated Appropriations Acts of 2022 and 2023. For example, the Consolidated Appropriations Act of 2023 extended many of the telehealth flexibility waivers that were passed under Consolidated Appropriations Act of 2022, including geographic and originating site restrictions so that Medicare patients can continue to use telehealth services from their home and allowing audio-only telehealth services through December 31, 2024. In addition, the removal of restrictions on which providers can provide distant site telehealth services is extended through December 31, 2024 so that physical therapists, occupational therapists and speech language therapists can continue sessions via telehealth through that date.
In addition, the Consolidated Appropriations Act of 2023 further extended the date for which telehealth can be used to conduct recertification of eligibility for hospice services through December 31, 2024. That same statute extends the Acute Hospital Care at Home Program through the end of calendar year 2024.
Telehealth services for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) are also extended until December 31, 2024 under the Consolidated Appropriations Act of 2023.
Under the Consolidated Appropriations Act of 2021, Medicare patients were able to receive telehealth services for behavioral health care in their homes in any part of the country, including most behavioral health services, such as counseling, psychotherapy, and psychiatric evaluations. The patient must have had at least one in-person visit with the provider in the six months before the telehealth visit in order to be eligible. This provision was extended through the end of calendar year 2024 by the Consolidated Appropriations Act of 2023.
Passed by Congress in March 2020, the Families First Coronavirus Response Act was intended, in part, to shore up state finances by temporarily increasing the federal share of Medicaid funding for states. To protect health coverage during the pandemic, states were prohibited from disenrolling individuals from Medicaid for the duration of the federal PHE as a condition of accessing the enhanced funding. This “continuous coverage” requirement extends from March 18, 2020, through the end of the month in which the PHE ends. FFCRA § 6008.
Under the Families First Coronavirus Response Act, state Medicaid programs were eligible to receive an additional 6.2 percent federal funding match provided they met specific Maintenance of Effort requirements, including providing continuous eligibility to those enrolled as of March 18, 2020 or at any time thereafter during the PHE. When the PHE ends, states will need to redetermine the eligibility of over 80 million Medicaid enrollees, including an estimated 37.3 million children.
In a typical annual redetermination process, some number of enrollees lose Medicaid coverage due to changes in circumstances that impact eligibility (e.g., new employment or income increases). More commonly, Medicaid eligible people lose coverage (referred to as “churn”) as a result of administrative barriers like a lack of online options for renewing coverage, complicated paperwork and documentation processes, and personal circumstances that prevent individuals from responding to a renewal request on time (these challenges are particularly acute for individuals with significant health needs). Evidence suggests that churn – and not external factors like an improving economy driving income ineligibility for Medicaid – have been the primary sources of Medicaid enrollment decreases in recent years. https://familiesusa.org/wp-content/uploads/2019/09/Return_of_Churn_Analysis.pdf https://familiesusa.org/wp-content/uploads/2019/09/Return_of_Churn_Analysis.pdf The FFCRA continuous coverage requirement effectively eliminates churn in Medicaid for the duration of the PHE.
The Centers for Medicare & Medicaid Services (CMS) released guidance that describes timelines and obligations for states to restart eligibility and enrollment activities following the end of the PHE. This guidance attempts to help mitigate coverage disruptions by giving states 12 months to complete the “PHE unwinding” process and requiring robust consumer communication, among other strategies. https://www.medicaid.gov/federal-policy-guidance/downloads/sho-21-002.pdf
The Urban Institute and Robert Wood Johnson Foundation estimated prior to the Biden administration announcement that if the PHE were to expire in April 2023, 18.0 million people will lose Medicaid coverage in the following 14 months. Of those, about 3.2 million children are estimated to transition from Medicaid to separate Children’s Health Insurance Programs, about 3.8 million people will become uninsured, about 9.5 million people will either newly enroll in employer-sponsored insurance after losing Medicaid or transition to employer-sponsored insurance as their only source of coverage after being enrolled in both employer-sponsored insurance and Medicaid sometime during the PHE, and more than 1 million people will enroll in the nongroup market, most of whom will be eligible for premium tax credits in the Marketplace. The Impact of the COVID-19 Public Health Emergency Expiration on All Types of Health Coverage (urban.org)
The end of the PHE will also mean the end of the Title 42 border policy, which allowed border officials to expel foreign nationals and ignore asylum claims for the sake of public health protections. Title 42 restrictions were ordered to be terminated at the end of December, however, the U.S. Supreme Court overturned that decision and Title 42 remains in effect by subsequent order of the U.S. District Court. Five things to know about the end of Title 42 | The Hill.
- Nursing Home COVID-19 reporting
On May 8, 2020, pursuant to an interim final rule with comment posted by CMS, nursing homes were required to report resident and staff infections and deaths related to COVID-19. The rule was set to expire with the termination of the PHE, however, in the 2023 Home Health rule, CMS revised the infection control requirements that Long-term Care (LTC) Facilities must meet to participate in the Medicare and Medicaid programs so that these facilities continue the COVID-19 reporting requirements until December 2024.
- Loss of limited immunity for the administration of COVID-19 counter-measures by licensed health care professionals and hospitals
The Public Readiness and Emergency Preparedness Act (PREP), subsequently amended as the Public Health Service Act, which added Section 319F-3 that contains the limited immunity provisions, affords some limited liability to various to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct.” These legal protections expire 12 months following the termination of the PHE pursuant to the Secretary’s declaration.
- Reduction in payments to health care providers
Unless Congress intervenes, a 4% reduction in Medicare payments is scheduled for this year under the PAYGO (pay-as-you-go) budget rules that was supposed to take place in 2022, but was delayed.
Congress waived automatic 2% Medicare payment reductions under sequestration between May 1, 2020 and March 31, 2022. It is not clear whether Congress will further delay these cuts or accelerate given the current budget negotiations between Republicans and the White House attempting to significantly reduce spending and the national debt.
Congress increased payments to hospitals for inpatient COVID-19 admissions by 20% to account for the increase intensity of care, increased supply costs and the loss of revenue due to deferring elective procedures. These payments will end with the termination of the PHE.
- Reduction in SNAP (Supplemental Nutrition Assistance Program)
The largest effects for SNAP would arise from ending the pause on participation limitations for students and for able-bodied adults without dependents and from lengthening certification periods.
- Ending of CMS emergency waiver authorities as well as other various regulatory authorities used to create flexibility for providers
It is expected that the following waivers or other flexibilities will end when the PHE is terminated:
- Hospitals without walls (temporary expansion sites) – this allowed hospitals to provide hospital services in other hospitals and at sites that otherwise would not have been considered part of a healthcare facility, including the ability to set up temporary expansion sites that could accommodate increased capacity needs. CMS subsequently allowed additional flexibility for a hospital to utilize a hotel or other community facility. This flexibility end with the termination of the PHE.
- CMS did allow for ASCs or free-standing emergency departments to temporarily enroll as a hospital during the PHE. The ability to enroll as a hospital was suspended on December 1, 2021 and those facilities that did enroll prior to 12/1/21 will have to meet the certification standards for hospitals or return to their ASC or free standing emergency room status when the PHE is terminated. Independent, freestanding emergency departments also will no longer be able to participate in Medicare as the temporary Medicare certification granted during the PHE will end.
- Waiver of some EMTALA requirements. Under the PHE, CMS waived EMTALA requirements to allow hospitals to screen patients for emergency medical conditions at locations off the hospital’s campus in order to assist with controlling the spread of COVID. This waiver will terminate with the ending of the PHE.
- CMS also waived certain paperwork requirements for hospitals that were considered to be impacted by a widespread outbreak of COVID-19 as determined by CDC guidelines, including relief from the timelines to provide copies of medical records and requirements to have written polices and procedures regarding visitation for patients in COVID-19 isolation. This waiver ends with the PHE termination.
- CMS waived certain restrictions on placement of alcohol-based hand sanitizers to allow for increased availability for infection control measures. This waiver will terminate with the ending of the PHE.
- CMS waived the requirement for quarterly fire drills at certain health care facilities, allowing a documented orientation and training program instead. This waiver will end with the PHE termination, but has already been terminated in June of 2022 for inpatient hospices and skilled nursing facilities.
- CMS issued a waiver to allow hospitals to offer long-term care services (swing beds) without meeting all of the usual criteria for patients who no longer require acute care, but for whom the hospital and family have not been able to find a skilled nursing facility bed available. This waiver ends with the termination of the PHE.
- CMS waived the limitations on number of beds and length of stay for patients at critical access hospitals. This waiver will end with the ending of the PHE.
- CMS issued a waiver relating to the rural location for critical access hospitals to allow them flexibility in creating surge site locations that may not be in a qualifying rural area or at the distance required relative to other hospitals. This waiver will also end with the termination of the PHE. CMS issued a similar waiver for sole community hospitals and that waiver also expires at the end of the PHE.
- In order to mitigate potential financial disincentives for hospitals to provide new COVID-19 treatments and to minimize any potential payment disruption following the end of the PHE, effective for discharges occurring on or after November 2, 2020 and through the end of the fiscal year in which the PHE ends, the Medicare program will make an enhanced payment for eligible inpatient cases that involve treatment with these new therapies (this would be a payment in addition to the DRG payment to avoid the costs for these treatments having to come out of the hospital’s bundled payment). There is a similar enhanced payments for new treatments available to hospital outpatient departments in addition to the APC fees. These enhance payments will also end with the termination of the PHE.
- CMS issued a special price transparency requirement mandating that providers of a diagnostic test for COVID-19 were to make public the cash price for such tests on their websites. This special rule will terminate with the end of the PHE.
- During the PHE, CMS paid hospital outpatient departments a symptom assessment and specimen collection fee of approximately $23 under new code C9803 (when not billed with a separately payable hospital outpatient service) to encourage hospitals to set up COVID-19 testing sites. After the ending of the PHE, this fee will no longer be paid separately. The payment for COVID-19 testing specimen collection will be packaged into the payment rate for COVID testing.
- CMS issued limited waivers of the Stark Law relating to financial relationships with physicians for services solely related to COVID-19, including some that might otherwise violate the personal services and non-monetary compensation restrictions, as well as allowing for some additional benefits to the medical staff such as meals, laundry and child-care services. These waivers expire with the termination of the PHE.
- CMS waived the requirement for verbal orders to be signed within 48 hours, but this waiver will end with the termination of the PHE.
- CMS also waived some reporting requirements (e.g., deaths of patients who were in soft restraints at the time of their death) and some of the discharge planning requirements relating to the provision of data on quality measures and certain other information (e.g., a comprehensive list of facilities) about prospective facilities to which the patient may be transferred. These waivers also expire with the ending of the PHE.
- CMS also waived some of the requirements relating to medical records, in particular the timeline for completion of the medical records by physicians and the requirement to provide patients with information about advance directive policies. These waivers end with the termination of the PHE.
- CMS also waived the requirements for ongoing utilization review in hospitals. This too expires at the end of the PHE.
- CMS waived some of the requirements relating to the Quality Assessment and Performance Improvement Plan, though it did not waive the obligation to maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. This waiver similarly expires with the ending of the PHE.
- CMS waived some of the requirements as to nursing services, particularly relating to the requirement for a current nursing plan of care for each patient in order to increase nursing time available for direct patient care. This waiver expires with the ending of the PHE.
- CMS also waived the requirement for hospitals to maintain a current therapeutic diet manual at surge capacity sites. This waiver will terminate with the ending of the PHE.
- CMS also indicated that it would not enforce the requirement for signature and proof of delivery for Part B drugs and DME when a signature cannot be obtained because of COVID disruptions. This will expire with the PHE ending.
- During the PHE, CMS has allowed licensed physicians and other practitioners to bill Medicare for services provided outside of their state of enrollment. Once the PHE ends, the requirements for providing services out of state will defer to state laws.
- CMS waived the hospital sterile compounding requirements to allow used face masks to be removed and retained in the compounding area to be re-donned and reused during the same work shift in the compounding area only in order to conserve scarce PPE supplies. This waiver ends with the termination of the PHE.
- CMS also waived the time limits imposed under the Medical Staff requirements for those physicians whose privileges would otherwise expire before the medical staff and governing board can reconvene due to the impacts of COVID-19. This waiver also ends with the PHE.
- CMS waived the requirements for physician supervision of CRNAs during the PHE. This will end with the PHE termination.
it is possible CMS could extend some of these waivers or use other authorities in some cases to continue programmatic changes. Further, CMS is evaluating which of the waivers were most effective and useful in order to prepare them for immediate roll-out with a future PHE.
U.S. Department of Health and Human Services Public Health Emergency Declarations site: https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx
Medicaid.gov. Unwinding and Returning to Regular Operations after COVID-19.
Centers for Medicare & Medicaid Services (CMS). October 2022. COVID-19 Public Health Emergency Unwinding Frequently Asked Questions for State Medicaid and CHIP Agencies.
Centers for Medicare & Medicaid Services (CMS). October 2022. Ex Parte Renewal: Strategies to Maximize Automation, Increase Renewal Rates, and Support Unwinding Efforts.
Centers for Medicare & Medicaid Services (CMS). September 2022. Resources to Support System and Logic Testing for Unwinding.
Centers for Medicare & Medicaid Services (CMS). June 2022. Top 10 Fundamental Actions to Prepare for Unwinding and Resources to Support State Efforts.
Centers for Medicare & Medicaid Services (CMS). June 2022. Renew Your Medicaid or CHIP Coverage.
Centers for Medicare & Medicaid Services (CMS). May 2022. Eligibility & Enrollment Processing for Medicaid, CHIP, and BHP During COVID-19 Public Health Emergency Unwinding Key Requirements for Compliance.
Centers for Medicare & Medicaid Services (CMS). March 2022. State Health Official Letter # 22-001. RE: Promoting Continuity of Coverage and Distributing Eligibility and Enrollment Workload on Medicaid, CHIP, and Basic Health Program Upon Conclusion of the COVID-19 Public Health Emergency.
Centers for Medicare & Medicaid Services (CMS). March 2022. Medicaid and CHIP Continuous Enrollment Unwinding: A Communications Toolkit.
Centers for Medicare & Medicaid Services (CMS). March 2022. Medicaid and Children’s Health Insurance Program Eligibility and Enrollment Data Specifications for Reporting During Unwinding.
Centers for Medicare & Medicaid Services (CMS). Medicaid and CHIP Continuous Enrollment Unwinding Speaking Request Form
Center on Budget and Policy Priorities. May 2022. Time to Get it Right: State Actions Now Can Preserve Medicaid Coverage When Public Health Emergency Ends.
Center on Budget and Policy Priorities. March 2022. Unwinding the Medicaid Continuous Coverage Requirement. Frequently Asked Questions.
National Academy for State Health Policy. September 2022. Unwinding Medicaid’s Continuous Coverage Requirement: State Communication Strategies.
National Academy for State Health Policy. March 2022. How States Are Getting Ready to Unwind Medicaid’s Continuous Coverage Requirement.
National Academy for State Health Policy. December 2021. States Plan for the End of the Medicaid Continuous Coverage Requirement.
Kaiser Family Foundation. Implications for Ending the COVID-19 Public Health Emergency.
Kaiser Family Foundation. August 2022. A 50-State Review of Access to State Medicaid Program Information for People with Limited English Proficiency and/or Disabilities Ahead of the PHE Unwinding.
Kaiser Family Foundation. March 2022. Unwinding of the PHE: Maintaining Medicaid for People with Limited English Proficiency.
Kaiser Family Foundation and Georgetown Center for Children and Families. March 2022. Medicaid and CHIP Eligibility and Enrollment Policies as of January 2022: Findings from a 50-State Survey.
Georgetown Center for Children and Families. September 2022. 50-State Unwinding Tracker.
Georgetown Center for Children and Families. September 2022. Tips and Best Practices for Unwinding the Medicaid Continuous Coverage Protection.Funding for Health Care Providers During the Pandemic: An Update | KFF
Interim Final Rules and waivers: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.
 Renewals on April 21, 2020; July 23, 2020; October 2, 2020; January 7, 2021; April 15, 2021; July 19, 2021; October 15, 2021; January 14, 2022; April 12, 2022; July 15, 2022; October 13, 2022; and January 11, 2023.
 One monoclonal antibody (Actemra/Tocilizumab) retains its EUA only for a certain subgroup of patients (those hospitalized for COVID-19, who are receiving systemic corticosteroids and requiring supplemental oxygen, mechanical ventilation or ECMO).
 Examples of health plans that are not subject to the ACA include grandfathered plans; healthcare sharing ministry plans; and short-term, limited duration plans.