Elevating the Post-Acute and
Long Term Care Profession

April 19, 2021

HHS Extends PHE through July 20, 2021. Late last week, US Health and Human Services (HHS) Secretary Xavier Becerra renewed the determination that a Public Health Emergency (PHE) exists, extending the COVID-19 PHE through July 20, 2021. The Biden Administration stated early on that they would give a 60-day notice to states before the end of the PHE and they intended to renew the PHE throughout calendar year 2021. The PHE declaration can be extended only for 90 days at a time, hence Secretary Becerra's action. The emergency blanket waivers impacting health care providers, such as the waivers allowing decreased aide supervision in home health and hospice, modifying the active treatment regulations in ICFs/IID, and removing the 3-day hospital stay requirement for Medicare SNF coverage, are tied to the PHE but can be terminated sooner. For instance, in the Federal Fiscal Year 2022 SNF Payment Rule released earlier this month, the Centers for Medicare and Medicaid Services (CMS) requested feedback on continued use of the 3-day stay waiver, indicating that they are considering an early termination of the waiver. Another example is QSO 21-17-NH, in which CMS announced that three specific waivers of SNF regulations will end May 10, 2021. For a full catalog of blanket waivers in effect and impacted by the PHE extension, please see the current list for your provider type.

More on PPE During Outbreaks. In a meeting today, AHCA/NCAL's Courtney Bishnoi discussed Centers for Disease Control and Prevention (CDC) recommendations for personal protective equipment (PPE) during an outbreak in a SNF. These recommendations appear in the recent, consolidated guidance for SNFs (see section entitled, "New Infection in Healthcare Personnel or Resident"). Ms. Bishnoi said CDC's intent is to recommend full PPE when providing care throughout a SNF that has had an outbreak, still defined as a single resident or staff case, but CDC does not view this a change. In their view, the guidelines previously recommended full PPE in patient care areas throughout the building, and the recent reorganization of the guidance merely made it more clear. This recommendation would continue until the outbreak ends (14 days with no new positives), unlike suspension of visitation. Ms. Bishnoi suggested that CDC does not expect staff to use full PPE everywhere in the building, but mainly in patients' rooms or other areas where care is provided routinely. They are looking for good-faith compliance with the guidelines.

We would note that despite CDC's reorganization of the guidelines, we are unaware of Department of Health (ODH) surveyors issuing any citations to facilities that used full PPE only in the area of the building affected by the outbreak. Members may wish to weigh the risks and benefits in deciding how far to go with using full PPE.

ANCOR Survey on Vaccines for People with ID/DD. The American Network of Community Options and Resources (ANCOR) is asking OHCA ID/DD members to complete a brief survey related to the experiences of the people they support and their access to the COVID-19 vaccines. Please take a few minutes to share your thoughts with ANCOR.

Ohio Gray Again for SNFs. As anticipated, today's CMS county positivity table for Ohio shows all counties as gray, meaning CMS could not calculate valid positivity numbers for any of them. Please disregard the percentages on the table. Our COVID-19 Update on Saturday and the linked letter from the Directors of Health and Aging explained this situation and directed SNFs to use the positivity rates for the period ending March 30, 2021.

ODH to Begin CLIA Certificate of Waiver Surveys. On January 8, 2021, CMS issued QSO-21-10-CLIA, which provided extensive surveyor guidance for the Clinical Laboratory Improvement Amendments (CLIA) regulations requiring all laboratories to report SARS-CoV-2 test results in a standardized format and at a frequency specified by the HHS Secretary. The survey guidance followed up on previous QSOs (QSO-20-37-CLIA, NH and QSO-20-38-NH) that described the regulatory test result reporting requirements. Failure to report SARS-CoV-2 test results is considered a Condition-level violation of the CLIA regulations and may result in a civil money penalty (CMP) as outlined in QSO-20-37.

According to ODH, on-site surveys of CLIA Certificate of Waiver laboratories under these guidelines will begin within the next few weeks. ODH provided a CLIA SARS CoV-2 Pre-Survey Form that will be used to guide these surveys. Before the survey, ODH will send a letter to the CLIA-waived lab announcing the date of the survey. In addition, the letter also likely will outline the following documentation to be available for review by the ODH surveyor:

  • Copy of the laboratory’s policy/procedure for reporting SARS-CoV-2 test results in accordance with the regulation.
  • Documentation of SARS-CoV-2 test results.
  • Evidence that demonstrates reporting of all (including negative and positive) test results in accordance with the regulations. 

Please remember, SARS-CoV-2 test results must be reported in aggregate each day by 11:00 a.m. via the State of Ohio COVID-19 Laboratory Testing Portal. In addition, line-level reporting of all positive and negative point-of-care test results is required within 24 hours of conducting the test either through the National Healthcare Safety Network (NHSN) Point of Care Reporting Tool or directly to ODH via Electronic Lab Reporting

Vaccine News. Last week, two bits of news came out relative to the two messenger RNA vaccines, Moderna and Pfizer/BioNTech. First, Moderna announced that like Pfizer's, its vaccine is 90% effective for at least 6 months (the maximum time tracked so far). Second, in the same release, Moderna discussed the development of booster shots to protect against COVID-19 variants. Recent media coverage (for example, this story) also quoted Pfizer's Chief Executive Officer as saying that a third shot may be necessary within 12 months, with variants again being the key factor. This question is under study, with results not expected for some time. Meanwhile, CDC's Advisory Committee on Immunization Practices (ACIP) is scheduled to meet Friday for further discussion of the Johnson & Johnson vaccine, use of which remains paused.

Reminder: Free April 20 Webinar Highlights Pandemic-Related Regulatory Risks for Skilled Nursing Providers (from HealthCap and AHCA).

HealthCap® and the American Health Care Association are hosting a webinar on Tuesday, April 20 from 2 p.m. EDT highlighting the most significant regulatory and enforcement changes implemented by the federal authorities throughout the pandemic that impact skilled nursing facility providers. The one-hour session is titled As the World Recovers, Regulatory & Enforcement Environment.

Following this session, attendees will be better equipped to identify regulatory risk areas based on current government initiatives and, in turn, proactively implement processes aimed at reducing the pandemic-related risks skilled nursing providers will likely continue to sustain into the future.

Speakers include Angie Szumlinski, director of HealthCap’s Risk Management Services, and John Hessburg and Andrea DeLand, attorneys with the Kitch Firm. They will emphasize the most significant regulatory changes and the consequences of those changes, which oftentimes are not readily apparent until after they are applied to a set of facts.r