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Legal Insights and Perspectives for the Healthcare Industry

In the face of the coronavirus (COVID-19) pandemic, the US president’s National Emergency Declaration, issued on March 13, set in motion several actions required of other agencies to provide the regulatory relief needed to ensure that healthcare providers have flexibility in responding quickly to the growing need in the United States.

First, the secretary of the US Department of Health and Human Services (HHS) issued a Waiver or Modification of Requirements under Section 1135 of the Social Security Act on March 13, with a retroactive effective date of March 1, 2020 (1135 Waiver). The 1135 Waiver suspends certain Medicare, Medicaid, and Children’s Health Insurance Program requirements “only to the extent necessary, as determined by the Centers for Medicare & Medicaid Services” to meet the needs of those programs’ participants and to assure that providers furnishing care to such participants in good faith are reimbursed.

The 1135 Waiver enumerates waivers that may modify or suspend Medicare/Medicaid conditions of participation and certification requirements, program participation requirements for physicians and other healthcare practitioners, certain preapproval or preauthorization requirements, certain EMTALA requirements, Stark Law requirements, and other statutory and regulatory provisions.

Concurrent with the 1135 Waiver, the Centers for Medicare & Medicaid Services (CMS) issued a COVID-19 Emergency Declaration Health Care Providers Fact Sheet (CMS Fact Sheet) that lists a number of blanket waivers applicable to the provider community concerning stabilization and screening of patients coming to the emergency room and flexibility that can be initiated during the COVID-19 pandemic including, for example:

  • Skilled Nursing Facilities – waiving the legal requirement for a three-day prior hospitalization for coverage of a SNF benefit
  • Critical Access Hospitals – waiving the requirements that CAHs limit the number of beds to 25 and that the length of stay be limited to 96 hours
  • Housing acute care patients in excluded distinct part units, allowing acute care hospitals to house acute care patients in excluded distinct part units
  • Durable Medical Equipment – allowing DME suppliers to waive the face-to-face requirements to replace damaged or lost DME without a new medical necessity form, or physician’s order
  • Waiving out-of-state licensing requirements applicable to Medicare and Medicaid
  • Creating an expedited enrollment process for provider enrollment in Medicare
  • Extension and waivers of timelines for Medicare appeals

HHS also issued a Finding on the same day that permits CMS to waive the three-day inpatient stay requirement for the skilled nursing facility (SNF) benefit. This allows hospitals and entities to discharge SNF patients and transfer them in relation to the “spell of illness” benefit and should provide for the ability of facilities to make room in distinct part units for surge capacity while appropriately assuring care for SNF patients without delay.

Additionally, HHS/CMS has issued a number of waivers implementing the Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSAA) with regard to the Medicare telehealth waiver. For more information including links to important resources, please see our March 17, 2020, LawFlash - HHS and States Relax Telehealth Licensing Rules for Healthcare Professionals Amid COVID-19 Emergency and March 16, 2020, blog post - CMS Issues Program Instructions for Medicare Telehealth Waiver.

We have received questions and are aware that not all issues have been addressed by CMS in its 1135 Waiver. If the activities for which a provider seeks a waiver from regulatory restraint are listed on the CMS Fact Sheet or explicitly described in an agency finding, there is no need to pursue an individual waiver as CMS has pre-emptively made the “determination” necessary under the 1135 Waiver authority.

However, if there is a regulatory burden/issue that falls within the enumerated authority of the 1135 Waiver that has not been addressed by the CMS Fact Sheet or agency finding, providers should consider seeking an individual waiver request by making application to their CMS regional office. CMS has posted guidance on the waiver process to its website, although there is no particular form.

New issuances, waivers, guidelines, and directives are being issued daily during this pandemic. To obtain the most updated information, please subscribe to our COVID-19 resource page as we are compiling and updating resources daily in an effort to capture and synthesize this data for clients.

We welcome questions and input during this time, and seek to provide as much help and support for our healthcare clients to allow them to treat patients and address the needs of their healthcare workforce.