The impending end of the COVID-19 national and public health emergency will present a complicated landscape to navigate for hospital systems, which look to minimize the impact of the transition to post-pandemic normality.
The White House announced on January 23 that the COVID-19 national emergency and public health emergency (PHE) will simultaneously end on May 11, 2023. The end of the PHE will trigger the rollback of many COVID-19 programs and flexibilities, including blanket waivers issued by the Centers for Medicare & Medicaid Services (CMS) and the Drug Enforcement Agency (DEA), and statutory protections (commonly referred to collectively as “waivers”).
Both the nature of the waivers and the length of time they have been in place create potential operational and compliance complications for hospital organizations returning to the “normalcy” of their heavily regulated routine activities. In some instances, systems changes or employee turnover occurring during the PHE may have helped to engrain waiver-based policies and practices that now must unlearned under the soon-to-be-enforced rules.
Critically, the timing for the end of these waivers varies. While the majority will terminate on May 11 when the PHE ends, other waivers will remain in effect through December 31, 2023, or beyond. As a result, the end of the PHE will impact hospitals for the foreseeable future. In addition, the actions of Congress decoupled certain elements (such as Medicaid reenrollment) from the end of the PHE and bound them to a separate timeline. Moreover, it is possible that Congress could further act to make permanent changes based on successful Medicare experiences under the waivers.
This LawFlash highlights some key changes for hospitals but is not an exhaustive list of waivers expiring on May 11. Hospitals should review CMS guidance on waivers that will be ending on May 11 to further inform their preparation for upcoming changes.
1. Emergency Medical Treatment and Labor Act (EMTALA) Enforcement[1]
During the PHE, CMS waived the enforcement of EMTALA, allowing hospitals to screen patients at a location offsite, away from the hospital’s campus, to prevent the spread of COVID-19. Hospitals should plan to reimplement policies and procedures to ensure that EMTALA-required screening of patients occurs onsite.
2. Nursing Services and Other Conditions of Participation[2]
CMS waived the requirements that a hospital’s nursing staff must develop a nursing care plan for each patient and maintain policies and procedures in place establishing which outpatient departments need a registered nurse present. This was designed to present flexibility and opportunity to stretch nursing services, which were also subjected to many market and other pressures causing turnover, throughout the PHE. Hospitals should ensure that their nursing services policies have been reviewed and are consistent with the conditions of participation in 42 CFR § 482.23.
Likewise, hospitals should renew their commitment to the multiple other conditions of participation for which enforcement was waived during the PHE, including physical environment requirements[3] and medical record services[4] requirements established by Medicare conditions of participation.
3. Remote Prescription of Controlled Substances[5]
During the PHE, the DEA adopted policies allowing DEA-registered practitioners to prescribe controlled substances without having to interact in person with their patients.
4. Use of Temporary Expansion Sites[6]
CMS authorized use of temporary expansion sites (e.g., convention centers, tents, onsite hospital rooms, and surgical suites) for the duration of the PHE. CMS also permitted use of provider-based departments that were relocated to settings outside the hospital, including patients’ homes, after receipt of an extraordinary circumstances waiver, and that provide education and therapy services to hospital outpatients. When the PHE ends, hospitals will be required to provide services to patients within their hospital departments pursuant to Medicare conditions of participation.[7]
In addition, to retain any “exempted status” the provider-based department enjoyed prior to the PHE, CMS is taking the position that the relocated department must return to the same location from which it operated prior to the PHE. For hospital systems engaged in space management projects during the three-year PHE that may have rearranged departments, the end of the PHE could bring reduced reimbursement if the exempted provider-based department cannot return to its original location.
5. Return of the ‘Walls’ Between Excluded Units[8]
During the PHE, CMS waived certain requirements to allow hospitals to house acute care patients in excluded distinct part units (i.e., inpatient psychiatric units and inpatient rehabilitation units). The waiver permitted the hospital to bill for the care under the inpatient prospective payment system (IPPS) and required the hospital to document in the medical record that the patient is an acute care patient being housed in the excluded unit because of capacity issues related to the PHE.
Simultaneously, CMS allowed the opposite and permitted hospitals to relocate patients from the excluded distinct part units to an acute care unit, annotate the medical record accordingly, and bill for services under the inpatient psychiatric facility prospective payment system (IPF PPS) and the inpatient rehabilitation facility prospective payment system (IRF PPS), as applicable.
At the end of the PHE, hospitals will not be reimbursed for services provided to acute care patients housed in excluded distinct part units and vice versa. Hospitals must resume treating patients in their designated unit in order to receive payment for services.
6. Expanded Use of Swing Beds[9]
During the PHE, CMS waived the eligibility requirements to allow hospitals to apply for swing bed services that were needed to provide skilled nursing facilities (SNF) level care for non-acute care patients. During the COVID-19 PHE, hospitals could call the Medicare provider enrollment hotline to request swing bed approval instead of submitting a Form CMS-855A. With the end of the PHE, hospitals should consider whether submitting an application is required to maintain enrollment for swing beds approved through the waiver process.
7. Increased Critical Access Hospital (CAH) Beds and Lengths of Stay[10] and Other Rural Hospital Flexibilities
CMS waived the requirements that CAHs be located in a rural area for certain surge locations, limited to 25 beds, and that the length of stay be limited to 96 hours under the Medicare conditions of participation. The location, bed count, and length of stay requirements return with the end of the PHE, and CAHs should ensure that their operations comply.
Similarly, CMS will begin evaluating the eligibility requirements for sole community hospitals and Medicare-dependent hospitals under Sections 42 CFR § 412.92(a) and 42 CFR § 412.108(a), respectively, that have not been enforced during the PHE. Given the duration of the PHE, hospitals should ensure that the criteria for these special Medicare designations remain in effect.
8. Minimal Information for Discharge Planning[11]
CMS waived the requirements that hospitals (and other providers) engage in detailed information sharing for discharge. After May 11, hospitals must assist patients in selecting a post-acute care provider by collecting and sharing quality measures and resource use measures to ensure that a patient is discharged to an appropriate setting with the necessary medical information and goals of care.
9. Admission Requirements for SNFs[12]
CMS waived the requirement for a three-day prior hospitalization for coverage of a SNF stay. Once the waiver expires on May 11, hospitals must be cognizant of whether patients have been admitted long enough to be referred to SNFs for post-acute care.
10. Stark Law[13]
During the PHE, CMS issued blanket waivers of certain provisions of the Stark Law, permitting certain referrals and the submission of related claims that would otherwise violate the Stark Law, if all requirements of the waivers were met. When the PHE ends, the waivers will terminate and hospitals must immediately comply with all provisions of the Stark Law. For an in-depth analysis, see our prior LawFlash.
11. Telehealth
Numerous waivers related to services provided to Medicare and Medicaid beneficiaries through telehealth were authorized in response to the PHE. Most, but not all, waivers related to telehealth will remain in place after May 11. For an in-depth analysis, see our blog post on the topic.
12. Add-on Payments for COVID-19 Treatment[14]
The Coronavirus Aid, Relief, and Economic Security Act (CARES) Act expressly increased the weight of the assigned diagnosis-related group (DRG) by 20% for a patient diagnosed with COVID-19 who was discharged during the PHE (i.e., it was a congressional grant and not a CMS waiver). Nevertheless, by operation of the statute, Medicare’s 20% add on payments for patients diagnosed with COVID-19 to offset the cost of complex COVID-19 patient care will end on May 11.
13. Waived Cost of At-home COVID-19 Tests and Cost Sharing[15]
Medicare beneficiaries will no longer have access to free, over-the-counter (OTC) COVID-19 tests. However, Medicare beneficiaries will continue to have coverage for laboratory-conducted COVID-19 tests without cost sharing. Similarly, the requirement for private insurers to cover OTC and laboratory COVID-19 tests without cost sharing will end.
Notably, the requirement that state Medicaid programs cover OTC and laboratory-conducted COVID-19 tests without cost sharing continues until September 30, 2024, after which coverage of such tests will vary by state.[16]
14. Medicaid Coverage of COVID-19 Treatment[17]
During the PHE, some states expanded access to Medicaid coverage through a new, optional COVID-19 eligibility group to ensure that individuals who would otherwise be uninsured could access COVID-related services. The use of federal funding to cover these state-administered services will end on May 11. Thereafter, states may opt to use state-only funds to continue to provide coverage for the optional COVID-19 eligibility group.
15. Reimbursement for Out-of-Network Providers for COVID-19 Testing[18]
The CARES Act required health plans to reimburse out-of-network COVID-19 test claims at up to the cash price that the provider has posted on a public web site. Providers without websites have been required to provide price information in writing, within two business days upon request, and on a prominent sign where COVID-19 tests are performed. After May 11, in accordance with the CARES Act, this price transparency requirement will terminate. Price transparency requirements under other laws and regulations will continue to apply.
In addition to preparation for the waivers described above, hospitals should anticipate further changes to hospital operations and reimbursement when the next set of waivers expires on December 31, 2023 and still more waivers expire over the course of 2024.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following:
[1] Ctrs. for Medicare and Medicaid Servs., COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers at 2, 43, CMS (Oct. 13, 2022) (citing “Emergency Medical Treatment and Labor Act (EMTALA)” and “Special Waivers EMTALA”) [hereinafter CMS Blanket Waivers].
[2] CMS Blanket Waivers at 6 (citing “Nursing Services”).
[3] CMS Blanket Waivers at 4-5 (citing “Physical Environment”).
[4] CMS Hospital Blanket Waivers at 17 (citing “Verbal Orders”).
[5] See Drug Enforcement Admin., How to Prescribe Controlled Substances to Patients During the COVID-19 Public Health Emergency, DOJ (last accessed April 13, 2023); see also Drug Enforcement Admin., COVID-19 Information Page, DOJ (last accessed April 13, 2023).
[6] CMS Blanket Waivers at 9 (citing “Temporary Expansion Locations”).
[7] Ctrs. for Medicare and Medicaid Servs., Hospitals and CAHs (including Swing Beds, DPUs), ASCs and CMHCs: CMS Flexibilities to Fight COVID-19 at 4, CMS (last accessed April 13, 2023) [hereafter CMS Hospital Blanket Waivers].
[8] CMS Hospital Blanket Waivers at 13-14 (citing “Housing Acute Care Patients in Excluded Distinct Part Units”, “Care for Excluded Inpatient Psychiatric Unit Patients in the Acute Care Unit of a Hospital”, and “Care for Excluded Inpatient Rehabilitation Unit Patients in the Acute Care Unit of a Hospital”).
[9] See CMS Blanket Waivers at 7 (citing “Expanded Ability for Hospitals to Offer Long-term Care Services (“Swing Beds”) for Patients Who Do Not Require Acute Care but Do Meet the Skilled Nursing Facility (SNF) Level of Care Criteria as Set Forth at 42 CFR 409.31.”); see also Ctrs. for Medicare and Medicaid Servs., MLN Matters - COVID-19 Blanket Swing Bed Waiver for Addressing Barriers, CMS (May 20, 2020).
[10] CMS Blanket Waivers at 3 (citing “CAH Length of Stay”).
[11] See CMS Blanket Waivers at 3 (citing “Detailed Information Sharing for Discharge Planning for Hospitals and CAHs”); see also CMS Hospital Blanket Waivers at 18.
[12] CMS Blanket Waivers at 16 (citing “3-Day Prior Hospitalization”).
[13] CMS Hospital Blanket Waivers at 16.
[14] Section 3710 of the CARES Act; see also Ctrs. for Medicare and Medicaid Servs., New Waivers for Inpatient Prospective Payment System, CMS (Sep. 11, 2020).
[15] See Dep’t of Labor, FAQs About Affordable Care Act Implementation Part 51, Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation, DOL (Jan. 10, 2022) (discussing the Families First Coronavirus Response Act (FFCRA)); see also U.S. Dep’t of Health and Human Servs., Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap, HHS (Feb. 9, 2023).
[16] Ctrs. for Medicare and Medicaid Servs., Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap, CMS (Feb. 9, 2023).
[17] See Ctrs. for Medicare and Medicaid Servs., SHO# 21-006, RE: Mandatory Medicaid and CHIP Coverage of COVID-19-Related Treatment under the American Rescue Plan Act of 2021, CMS (Oct. 22, 2021) (discussing the American Rescue Plan Act of 2021 (ARP)).
[18] See Dep’t of Labor, FAQs About Affordable Care Act Implementation Part 51, Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation, DOL (Jan. 10, 2022) (discussing the FFCRA); see also CMS Hospital Blanket Waivers at 15.