| CMS Final Rule Removes COVID-19 Testing and Staff Vaccination Requirements | https://www.ahcancal.org/News-and-Communications/Blog/Pages/CMS-Final-Rule-Removes-COVID-19-Testing-and-Staff-Vaccination-Requirements.aspx | CMS Final Rule Removes COVID-19 Testing and Staff Vaccination Requirements | | | | | 5/31/2023 4:00:00 AM | | <div>On May 31, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a <a href="https://public-inspection.federalregister.gov/2023-11449.pdf?utm_source=federalregister.gov" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank">final rule</a>, <em>“Medicare and Medicaid Programs; Policy and Regulatory Changes to the Omnibus COVID-19 Health Care Staff Vaccination Requirements; Additional Policy and Regulatory Changes to the Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) to Provide COVID-19 Vaccine Education and Offer Vaccinations to Residents, Clients, and Staff; Policy and Regulatory Changes to the Long Term Care Facility COVID-19 Testing Requirements.”</em></div><div> <br></div><div><strong>This rule will be effective 60 days after it is published in the federal register, which is scheduled to happen on June 5, 2023. </strong><br></div><div><br></div><div>This rule makes three key changes:<br></div><div><ul><li>Removes expired language addressing staff and resident COVID-19 testing requirements issued in the interim final rule (IFR) <a href="https://www.federalregister.gov/documents/2020/09/02/2020-19150/medicare-and-medicaid-programs-clinical-laboratory-improvement-amendments-clia-and-patient" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank">“LTC Facility Testing”</a> on September 2, 2020. </li><li>Withdraws the regulations published the IFR <em><a href="https://www.federalregister.gov/documents/2021/11/05/2021-23831/medicare-and-medicaid-programs-omnibus-covid-19-health-care-staff-vaccination" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank">"COVID-19 Health Care Staff Vaccination"</a></em> on November 5, 2021.</li><li>Finalizes certain provisions published in the IFR <em><a href="https://www.federalregister.gov/documents/2021/05/13/2021-10122/medicare-and-medicaid-programs-covid-19-vaccine-requirements-for-long-term-care-ltc-facilities-and" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank">“COVID-19 Vaccine Educate and Offer”</a></em> on May 13, 2021.<br></li></ul></div><div>CMS will not be enforcing the staff vaccination provisions between now and the effective date of this final rule. </div><div><span style="font-size:11pt;"><br></span></div><div><span style="font-size:11pt;">More details are shared below. Please contact </span><a href="mailto:regulatory@ahca.org" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank" style="font-size:11pt;">regulatory@ahca.org</a><span style="font-size:11pt;"> with questions. </span></div><div><br></div><div><div><strong>CMS COVID-19 Vaccine Regulatory Changes</strong></div><div><ul><li>CMS is withdrawing all requirements to vaccinate staff for COVID-19 issued in the <a href="https://www.federalregister.gov/documents/2021/11/05/2021-23831/medicare-and-medicaid-programs-omnibus-covid-19-health-care-staff-vaccination" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank">staff vaccination IFC</a>. </li><li>This removes section 483.80(i) of the SNF requirements of participation and 483.430(f) of the ICF/IID conditions of participation. </li><ul><li>This means that the requirement to have all staff vaccinated for COVID-19 or receive a medical exemption will be removed. </li><li>Note, COVID-19 vaccination of health care staff and residents will be reported through the SNF Quality Reporting Program (QRP).</li></ul><li><span style="font-size:11pt;">CMS is finalizing the requirement from the <a href="https://www.federalregister.gov/documents/2021/05/13/2021-10122/medicare-and-medicaid-programs-covid-19-vaccine-requirements-for-long-term-care-ltc-facilities-and" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank">“COVID-19 Vaccine Educate and Offer rule”</a> which maintains requirements for LTC facilities to educate staff and residents about, and offer, the COVID-19 vaccine. </span></li><ul><li>Guidance on this rule is available in <a href="https://www.cms.gov/files/document/qso-21-19-nh.pdf" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank">QSO-21-19-NH</a>. </li><li>All elements of this rule are being finalized except for the language referring to LTC facility staff refusing the COVID-19 vaccine originally set forth at § 483.80(d)(3)(v).</li><li>Note that this rule maintains the requirement to report COVID-19 vaccine status for residents and staff to NHSN.</li></ul></ul></div><div><span style="font-size:11pt;"><br></span></div><div><span style="font-size:11pt;"><strong>CMS COVID-19 Testing Changes</strong></span><br></div><div><ul><li>CMS is removing all testing requirements issued in the interim final rule (IFR) <a href="https://www.federalregister.gov/documents/2020/09/02/2020-19150/medicare-and-medicaid-programs-clinical-laboratory-improvement-amendments-clia-and-patient" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank">“LTC Facility Testing”</a> on September 2, 2020. </li><li>This removes section 483.80(h) of the Requirements of Participation.</li></ul></div></div> | CMS announced a final rule removing COVID-19 testing and staff vaccination requirements | |
| COVID-19 Provider Vaccine Mandate Still in Effect | https://www.ahcancal.org/News-and-Communications/Blog/Pages/COVID-19-Provider-Vaccine-Mandate-Still-in-Effect.aspx | COVID-19 Provider Vaccine Mandate Still in Effect | | | | | 5/22/2023 4:00:00 AM | | <p><span style="font-size:11pt;">Earlier this month, AHCA/NCAL released a </span><a href="/News-and-Communications/Blog/Pages/CMS-Announces-Ending-of-COVID-Staff-Vaccine-Requirement,-Other-Protocols.aspx" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank" style="font-size:11pt;">member update</a><span style="font-size:11pt;"> regarding the release of </span><a href="https://www.cms.gov/files/document/qso-23-13-all.pdf" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank" style="font-size:11pt;">QSO-23-14-ALL</a><span style="font-size:11pt;"> which addressed that the COVID-19 Health Care Provider Vaccine Mandate would “soon end.” The release of this memo has raised many questions as to when the COVID-19 Health Care Provider Vaccine Mandate will end. <br></span><span style="font-size:11pt;"><br>There is a formal and lengthy process the Centers for Medicare & Medicaid Services is required to take to end any rule. Therefore, the COVID-19 vaccine mandate remains in place until further rulemaking occurs. AHCA/NCAL will notify members once more information is available. <br></span><span style="font-size:11pt;"><br>Please send any questions to </span><a href="mailto:regulatory@ahca.org" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank" style="font-size:11pt;">regulatory@ahca.org</a><span style="font-size:11pt;">.</span></p> | The COVID-19 vaccine mandate remains in place until further rulemaking occurs. | |
| COVID-19 PHE Policies for Therapy and Physician Telehealth Remain in Place for SNF and AL Residents | https://www.ahcancal.org/News-and-Communications/Blog/Pages/COVID-19-PHE-Policies-for-Therapy-and-Physician-Telehealth-Remain-in-Place-for-SNF-and-AL-Residents.aspx | COVID-19 PHE Policies for Therapy and Physician Telehealth Remain in Place for SNF and AL Residents | | | | | 5/22/2023 4:00:00 AM | | <p></p><div>Last week, the Centers for Medicare and Medicaid Services (CMS) responded to stakeholder concerns about the uncertain status of certain important Medicare Part B telehealth waivers impacting residents of nursing facilities and assisted living residences. Specifically, in the <a href="https://www.cms.gov/files/document/frequently-asked-questions-cms-waivers-flexibilities-and-end-covid-19-public-health-emergency.pdf" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank">CMS Waivers, Flexibilities, and the End of the COVID-19 Public Health Emergency FAQs</a>, the Agency updated FAQs #22 and #23: </div><div><br></div><div><ul><li>FAQ #22 - Confirmed that the recently enacted Consolidated Appropriations Act of 2023 provisions recognize physical therapists (PT), occupational therapists (OT), and speech-language pathologists (SLP), working in office- or facility-based settings, remain as distant site practitioners under Medicare law. </li></ul></div><div><br></div><div><ul><li>FAQ #23 - CMS indicated that physicians could continue to furnish telehealth services to nursing facility residents for visits, other than the required 30 or 60 day in-person visits required under 42 CFR 483.30, until at least December 31, 2023. </li></ul></div><div><br></div><div>These decisions extend the flexibilities for Medicare beneficiaries residing in SNF and AL settings, particularly those in rural and underserved areas. This allows for ongoing access to therapy and physician telehealth services under Medicare Part B, as they experienced during the COVID-19 PHE. Providers, including SNFs, will continue to submit claims for these telehealth services as they have done so during the PHE. <br></div> | Last week, CMS responded to stakeholder concerns about the uncertain status of certain important Medicare Part B telehealth waivers impacting residents of nursing facilities and assisted living residences. | |
| Clinical Laboratory Improvement Amendment Changes Post-PHE | https://www.ahcancal.org/News-and-Communications/Blog/Pages/Clinical-Laboratory-Improvement-Amendment-Changes-Post-PHE.aspx | Clinical Laboratory Improvement Amendment Changes Post-PHE | | | | | 5/15/2023 4:00:00 AM | | <p><br></p>The Centers for Medicare and Medicaid Services (CMS) recently published memo <a href="https://www.cms.gov/files/document/qso-23-15-clia.pdf" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank">QSO-23-15 CLIA</a>, outlining the impact of the ending of the Public Health Emergency (PHE) on the Clinical Laboratory Improvement Amendments (CLIA) requirements and flexibilities implemented during the COVID-19 pandemic.<div><br></div><div>The key changes impacting long term care providers operating under CLIA Certificates of Waivers (COW) are identified below.<br></div><div><br></div><div><ul><li><span style="font-size:11pt;"><strong>COVID-19 Test Result Reporting Requirements: </strong>During the PHE, all providers operating under a CLIA waiver that performed a COVID-19 test were required to report the results of each test. Because CMS only has authority to require reporting during the PHE, the CLIA requirement to report COVID-19 results will end when the PHE is terminated on May 11, 2023. Two important caveats regarding the ending of this requirement are as follows:</span></li><ul><li>Facilities are still required to report COVID-19 information, including positive test results, to NHSN under <a href="https://www.govinfo.gov/content/pkg/FR-2020-05-08/pdf/2020-09608.pdf" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank">CMS-5531-IFC</a>. </li><li>Individual states may have reporting requirements in place, so providers should verify any state reporting requirements before discontinuing the reporting of test results.<br></li></ul><li><strong>Molecular and Antigen Point of Care Test Asymptomatic Testing: </strong>Many FDA-approved COVID-19 molecular and antigen point of care (POC) tests are authorized only for use on symptomatic individuals. During the PHE, CMS allowed laboratories to use these tests on asymptomatic individuals. This flexibility was important for skilled nursing facilities and assisted living communities, as they commonly used these POC tests on asymptomatic individuals to meet CMS and state requirements to conduct screening testing of staff, regardless of symptoms. This flexibility has been phased out with the end of the PHE. <strong><em>All CLIA-certified settings are now required to follow the manufacturer’s Instructions for Use (IFU) for testing.</em></strong> CLIA will not consider it a modification, however, if the IFU states, “individuals suspected of COVID-19 by their health care provider”, and the test is ordered by the health care provider for asymptomatic patients. The decision if an individual is suspected of COVID-19 is made by the health care provider. <br></li><li><strong>Use of Expired Reagents During the PHE:</strong> CMS allowed laboratories to use expired reagents due to COVID-19 reagent supply problems. CMS has determined that at the end of the PHE, laboratories will no longer be able to continue using expired reagents.<br></li></ul></div><div><br>Finally, in the FAQ section at the end of the memo, CMS provides clarification regarding use of tests that are Emergency Use Authorized for use under a CLIA Certificate of Waiver. CMS states, <em>“Laboratories with a Certificate of Waiver (CoW) will continue to be eligible to perform testing for as long as the test’s Emergency Use Authorization remains in effect. Once the assay has gone through the FDA’s full traditional marketing authorization, it will receive CLIA complexity categorization. If the test remains categorized as waived, no further action would be necessary.” </em><br><br></div><div>All changes are effective immediately. Members are encouraged to review <a href="https://www.cms.gov/files/document/qso-23-15-clia.pdf" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank">QSO-23-15 CLIA</a> for a complete list of changes. </div><div> <br>Please contact <a href="mailto:COVID19@ahca.org" data-feathr-click-track="true" data-feathr-link-aids="["60b7cbf17788425491b2d083"]" target="_blank">COVID19@ahca.org</a> with any questions. <span style="font-size:11pt;"></span></div> | CMS recently published memo QSO-23-15 CLIA, outlining the impact of the ending of the PHE on the Clinical Laboratory Improvement Amendments requirements and flexibilities implemented during the COVID-19 pandemic. | |