Legal Intelligencer article by Lamb McErlane Health Law Chair Vasilios J. (Bill) Kalogredis, Esq.

On August 18, 2022, more than two years since the beginning of the COVID-19 outbreak, the Centers for Medicare & Medicaid Services (CMS), the federal agency within the US Department of Health and Human Services (HHS) that administers the Medicare program as well as works with states to administer Medicaid, the Children’s Health Insurance Program (CHIP), and health insurance portability standards, announced a cross-cutting initiative aimed at evaluating CMS-issued Public Health Emergency blanket waivers and flexibilities to prepare Providers for post pandemic operations[1].  It may be found at CMS.gov.  It is worth the read.

A Public Health Emergency (PHE) declaration by the federal government releases resources meant to handle a public health crisis. In 2020, the President issued an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (Stafford Act)[2]. The Secretary of the HHS is authorized to waive certain Medicare, Medicaid and CHIP program requirements and conditions of participation under Section 1135 of the Social Security Act once the President has declared an emergency through the Stafford Act. As a result, effective March 1, 2020, under Section 1135, as well as, where applicable, under Section 1812(f) of the Social Security Act in the effort to help healthcare providers to contain the spread of 2019 Novel Coronavirus Disease (COVID-19), the CMS enacted certain PHE waivers and flexibilities[3]. They were designed to enable healthcare providers of various levels to rapidly respond to COVID-19 impacted patients by modifying, and in some cases relaxing, certain requirements in a wide range of areas within the public assistance programs, as well as relative to private carriers to allow for less stringent regulation aimed at streamlining patient services, providing much needed improved access to care, reducing administrative burdens, and providing certain liability immunities to practitioners who administer these services, among other things.

Some of these modifications and relaxations included flexibility for telehealth services and reporting requirements, expanding ability for hospitals to offer long-term care services for patients who do not require acute care but meet certain other criteria, waiving certain minimum personnel qualifications for particular clinical professionals, suspending mandatory training requirements for programs unrelated to the public health emergencies, deferring staff licensure, certification, or registration to state law, including temporarily waiving requirements that out-of-state practitioners be licensed in the state where they are providing services when they are licensed in another state. Additionally, CMS implemented waivers and flexibilities to temporarily suspend certain provider enrollment and revalidation requirements to increase access to care, as well as temporarily suspend requirements for certain pre-admission and annual screenings for nursing home residents. CMS also relaxed certain Home Health Agency (HHA) requirements, such as onsite visits and reporting deadlines, among others.

A number of these flexibilities, however, are scheduled to be lifted as the pandemic declines and the PHE declarations expire. Consequently, CMS has developed a cross-cutting initiative to use a comprehensive, streamlined approach to reestablish certain health and safety standards as well as other program requirements to prepare the health care system for operations after the PHE. This cross-cutting initiative aims to evaluate CMS-issued PHE blanket waivers and is being done in three concurrent phases[4]:

1. CMS is assessing the need for continuing certain blanket waivers based on the current phase of the PHE. During the PHE period, CMS has both added and terminated flexibilities and waivers as they became necessary. Doing so, impacts on communities, as well as the potential barriers and opportunities that the flexibilities could address, were considered.

2. CMS is assessing which flexibilities would be most useful in a future PHE, such as natural and man-made disasters and other emergencies, to help ensure a rapid response to them. This includes addressing the unique needs of communities that may experience barriers in accessing health care.

3. CMS is collaborating with other federal agencies and health care industry players to ensure the system’s ability to address future emergencies.

Extended Waivers and Waivers Made Permanent

During the PHE period, the HHS gained valuable experience and input from various members of the healthcare community, including providers, insurers and other stakeholders using the enacted waivers and flexibilities. Those proven especially useful were determined to remain in place even following the PHE expiration date to keep and/or improve healthcare quality, promote equity and access to health, as well as to advance innovation.

It is known that some waivers or flexibilities will continue for at least some time after the PHE is lifted. During the PHE, the HHS Secretary, Xavier Becerra, has been using the waiver authority under Section 1135 of the Act to create flexibilities in the requirements of Section 1834(m)(1) of the Act and 42 CFR § 410.78 for use of interactive telecommunications systems to furnish telehealth services. This permitted physicians to provide more services to beneficiaries via telehealth by allowing them to take care of their patients without the need for in-person visits thereby mitigating the risk of the spread of the virus. During the PHE, such telehealth services were provided to new as well as established patients across the country. The Consolidated Appropriations Act, 2022 provides for a 151-day extension for some of these flexibilities beyond the PHE expiration date[5].

Also, during the PHE, direct supervision has not been required at the initiation of non-surgical extended duration therapeutic services provided in hospital outpatient departments and critical access hospitals. Instead, a general level of supervision may be provided for the entire duration of these services, so the supervising physician or practitioner is not required to be immediately available. CMS made this provision permanent. So this policy will stay in effect even after the PHE expiration.

Additionally, CMS adopted simplified medical record documentation requirements for physicians and certain non-physician practitioners to allow the billing clinician to review and verify, rather than re-document, information added to the medical record by any member of the healthcare team. These simplified medical record documentation requirement policies were finalized and will continue to be in effect after the PHE ends.

Terminated Waivers and Waivers Scheduled to be Terminated upon PHE Expiration.

As CMS analyzes the impact and effect of the enacted waivers and flexibilities it is deciding whether to terminate such modification upon PHE expiration or during the PHE active period. Examples of terminated waivers are waiver for provider enrollment site visits for moderate and high-risk providers and suppliers (waiver terminated on July 6, 2020); waiver for fingerprint-based criminal background checks for 5% or greater owners of newly enrolling high-risk categories of providers and suppliers (waiver terminated on October 31, 2021), waiver for collection of application fees for institutional providers who are initially enrolling, revalidating, or adding a new practice location (waiver terminated on October 31, 2021), as well as postponing of all revalidation actions (waiver terminated on October 31, 2021).

The vast majority of waivers and flexibilities, however, are set to expire at the eventual end of PHE period, as they were intended to address the extraordinary circumstances of COVID-19 pandemic and not replace existing requirements. One such example is CMS waiver of requirements at § 482.12(c)(1)-(2) and (4) under which Medicare patients in the hospital must be under the care of a licensed physician. This has allowed hospitals to use other practitioners, such as physician assistants (PA) and nurse practitioners (CRNP) to a fuller extent. This waiver is ends upon the conclusion of the PHE. Another example is a Medicare demonstration program to allow people with Medicare coverage to receive up to eight over-the-counter self-administered tests per calendar month at no cost. This program will also end at the end of the COVID19 public health emergency.

Conclusion

The PHE is originally set to expire in mid-October of this year and the HHS Secretary has previously committed to giving states and the healthcare community a sixty days’ notice before ending the PHE. In the meantime, CMS advises providers to prepare for the conclusion of these waivers and flexibilities as soon as possible to mitigate potential post-PHE disruptions and to begin reestablishing pre-pandemic health and safety standards as well as billing practices. Since no such notice has been provided by Secretary Becerra yet, it can be reasonably expected that either the PHE will be extended, or the waivers will be extended beyond the predetermined expiration date.

The aforementioned August 18 CMS Guidance should be reviewed.  It provides links to a “roadmap” for the eventual end of the Medicare PHE waivers and flexibilities; to fact sheets summarizing the current status of Medicare Blanket waivers and flexibilities by provider type as well as flexibilities applicable to the Medicaid community; and a list of COVID-19 waivers.  Unless otherwise specified, these waivers will end with the PHE.  Keep your eyes and ears open for further updates from CMS.

Vasilios J. (Bill) Kalogredis, Esq. has been exclusively advising physicians, dentists, and other health care professionals and their businesses as to contractual, regulatory and transactional matters for over 45 years. He is Chairman of Lamb McErlane PC’s Health Law Department. bkalogredis@lambmcerlane.com. 610-701-4402.

*Artyom Sharbatyan contributed to this article.

[1] https://www.cms.gov/blog/creating-roadmap-end-covid-19-public-health-emergency

[2] https://www.fema.gov/fr/news-release/20200514/president-donald-j-trump-directs-fema-support-under-emergency-declaration

[3] https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx

[4] https://www.cms.gov/files/document/physicians-and-other-clinicians-cms-flexibilities-fight-covid-19.pdf

[5] https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf

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