September 14, 2020. This article highlights the importance of long-term care (LTC) assisted living and skilled nursing facilities having a documented CMS Emergency Preparedness Rule plan in place as a Medicare Conditions of Participation survey and certification framework that is linked to the CMS Testing and Reporting Requirements published in the Federal Register earlier this month.
Emergency Rules. The Secretary of Health and Human Services (HHS) declared a public health emergency (PHE) on January 31, 2020, under section 319 of the Public Health Service Act (42 U.S.C.); and President Trump issued two national emergency declarations under the Stafford Act and the National Emergencies Act (NEA) on March 13, invoked emergency powers via Executive Order under the Defense Production Act on March 18, and named the Federal Emergency Management Agency (FEMA) as the lead agency in the COVID-19 emergency response, all of which actions in an effort to reduce the spread of the COVID-19 virus and protect the economy against its mounting impact.
The Secretary of HHS, on behalf of the Centers for Medicare & Medicaid Services (CMS), published an Interim Final Rule (IFR) in the Federal Register on September 2, 2020, effective that date, that:
- Revises regulations to strengthen the CMS’ ability to enforce compliance with Medicare and Medicaid long-term care (LTC) facility requirements for reporting information related to COVID-19;
- Establishes a new requirement for LTC facilities for COVID-19 testing of facility residents and staff;
- Establishes requirements for all CLIA laboratories to report COVID-19 test results to the Secretary of HHS in such form and manner, and at such timing and frequency as the Secretary may prescribe during the PHE.
The Secretary of HHS, on behalf of CMS, in compliance with the Emergency Preparedness Final Rules of 2016 and 2019, requires LTCs, at 42 CFR 483.73, to evaluate infectious disease hazards and implement and document policies and procedures to mitigate such hazards as a condition of participation (CoP) as part of the annual survey and certification process.
Linkage. The IFR testing and reporting provisions not only require compliance with the IFR on their own, but also require compliance under the Emergency Preparedness Rules as mitigation policies and procedures from an “all hazards” risk assessment requirement of an infectious disease risk of a PHE declaration. The direct link is through the IFR survey and certification process of the Emergency Preparedness policy and procedure at 42 CFR 483.73(b)(6):
(b) Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following: …
(6) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
CMS published on August 26, 2020, a document that outlined Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements and Revised COVID-19 Focused Survey Tool. The addendum to that document, dated August 25, 2020, and entitled: COVID-19 Focused Survey for Nursing Homes, has a section, #9, entitled: Emergency Preparedness—Staffing in Emergencies, for which the surveyor is to ask the following questions pertaining to compliance:
- Policy development: Does the facility have a policy and procedures for ensuring staffing to meet the needs of the residents when needed during an emergency, such as COVID-19 outbreak?
- Policy implementation: In an emergency, did the facility implement its planned strategy for ensuring staffing to meet the needs of the residents?
- Did the facility develop and implement policies and procedures for staffing strategies during an emergency? If no, the survey refers to E-0024, which is the Emergency Preparedness survey instructions pertaining to the Emergency Preparedness Rule at 42 CFR 483.73(b)(6):
E-0024 is from CMS’s State Operations Manual: Appendix Z—Emergency Preparedness for All Provider and Certified Supplier Types, Interpretive Guidance. The content pertaining to LTCs is the following:
- During an emergency, a facility may need to accept volunteer support from individuals with varying levels of skills and training. The facility must have policies and procedures in place to facilitate this support. In order for volunteering healthcare professionals to be able to perform services within their scope of practice and training, facilities must include any necessary privileging and credentialing processes in its emergency preparedness plan policies and procedures. Non-medical volunteers would perform non-medical tasks.
- Facilities have flexibility in determining how best to utilize volunteers during an emergency as long as such utilization is in accordance with State law, State scope of practice rules, and facility policy. These may also include federally designated health care professionals, such as Public Health Service (PHS) staff, National Disaster Medical System (NDMS) medical teams, Department of Defense (DOD) Nurse Corps, Medical Reserve Corps (MRC), or personnel such as those identified in federally designated Health Professional Shortage Areas (HPSAs) to include licensed primary care medical, dental, and mental/behavioral health professionals. Facilities are also encouraged to collaborate with State-established volunteer registries, and where possible, State-based Emergency System for Advanced Registration of Volunteer Health Professionals (ESAR- VHP).
- Facilities are expected to include in its emergency plan a method for contacting off-duty staff during an emergency and procedures to address other contingencies in the event staff are not able to report to duty which may include, but are not limited to, utilizing staff from other facilities and state or federally-designated health professionals.
- Survey Procedures
- Verify the facility has included policies and procedures for the use of volunteers and other staffing strategies in its emergency plan.
Penalties for Noncompliance with the Emergency Preparedness and IFR Testing and Reporting Rules. Chapter 7 of the State Operations Manual provides the Survey and Enforcement Process for Skilled Nursing Facilities and Nursing Facilities. Section 7301 provides “action when facility is not in substantial compliance,” including substantial civil monetary penalties (CMP). Below are excerpts of provisions:
- 7301.1- Immediate Jeopardy Exists
- The Medicare regional office or State Medicaid Agency will impose termination and/or temporary management in as few as 2 calendar days after the survey which determined immediate jeopardy.
- The Medicare regional office or State Medicaid Agency may impose a civil money penalty between $3,050 and $10,000 per day of immediate jeopardy or a “per instance” civil money penalty from $1,000 to $10,000 for each deficiency.
- The State will require an acceptable plan of correction for all deficiencies cited after it conducts the revisit to confirm removal of the immediate jeopardy.
- 7301.2 – Immediate Jeopardy Does Not Exist
- CMS or the State must determine whether the facility will be given an opportunity to correct its deficiencies before remedies are imposed.
- The regional office or State Medicaid Agency should impose another remedy in addition to termination for a facility not being given an opportunity to correct.
- The regional office or State Medicaid Agency terminates the Medicare and/or Medicaid provider agreements that are in effect no later than 6 months from the date of the survey that determined noncompliance if noncompliance still exists.
- When there is an opportunity to correct before remedies are imposed, the State will request an acceptable plan of correction.
- The regional office or State Medicaid Agency may impose either a per day civil money penalty between $50 and $3,000 per day or a “per instance” civil money penalty between $1,000 and $10,000 for each deficiency.
Summary. As stated earlier and demonstrated above, the IFR testing and reporting protocols not only require compliance with the IFR on their own, but also require compliance under the Emergency Preparedness Rules as mitigation policies and procedures from an “all hazards” risk assessment requirement of an infectious disease risk of a public health emergency (PHE) declaration. The direct link is through the IFR survey and certification process of the Emergency Preparedness policy and procedure at 42 CFR 483.73(b)(6). Consequently, a facility would be subject to the civil money penalties (CMP) above should a survey find the facility noncompliant for the Emergency Preparedness Rule or IFR testing and reporting protocols, or both; and subject to non-certification as a participant in Medicare or Medicaid programs, or both.
CAIPHI has designed its mobile, cloud-based platform, CyPHIprepare®, as a data and documentation management tool for demonstrating compliance with the CMS Emergency Preparedness Rule and for tracking COVID-19 test reporting as required by the IFR. You can see a short 3-minute demonstration of the functionality of CyPHIprepare® at: WATCH.
1) This document is available online at: https://www.govinfo.gov/content/pkg/FR-2020-09-02/pdf/2020-19150.pdf.
2) The November 16, 2016, CMS Emergency Preparedness Final Rule is available online at: https://www.govinfo.gov/content/pkg/FR-2016-11-16/pdf/2016-27478.pdf. The September 30, 2019, CMS Final Rule that modified Emergency Preparedness provisions for Medicare providers and suppliers is available online at: https://www.govinfo.gov/content/pkg/FR-2019-09-30/pdf/2019-20736.pdf.
3) From Director, Survey and Certification Group to: State Survey Agency Directors, Ref. QSO-20-38-NH, which is available online at: https://www.cms.gov/files/document/qso-20-38-nh.pdf.
4) Rev. 186 was effective and implemented on March 4, 2019, and is available online at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Downloads/Appendix-Z-EP-SOM-February-2019.pdf.
5) Rev. 185 was effective and implemented on November 16, 2018, and is available online at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c07pdf.pdf.