On August 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released over 200 pages of interim final regulations (the “Interim Final Regulations”) to clarify new enforcement requirements for nursing homes, add requirements for labs to report COVID-19 test results during the public health emergency and require nursing homes to test residents and staff for COVID-19.
Overview
CMS is revising regulations to enforce new nursing home requirements added to 42 CFR Part 483 published on May 8, 2020 to report nursing home data related to COVID-19 and infection control at least weekly. For this alert “nursing homes” refers to skilled nursing facilities (often known as “SNFs”) for Medicare and nursing facilities (often known as “NFs”) for Medicaid. Specifically, CMS is adding a regulation to specify the civil money penalty (“CMP”) amounts that may be imposed for the failure to electronically report COVID-19 data each week, which includes, suspected and confirmed COVID-19 infections among residents and staff, including residents previously treated for COVID-19, total deaths of COVID-19 deaths among residents and staff, and personal protective equipment and hand hygiene supplies in the nursing home.
CMS is also revising the nursing home infection control regulations at §483.80 to establish a new requirement for nursing homes to test their nursing home residents and staff, including individuals providing services under arrangement and volunteers. CMS is requiring that resident and staff testing in nursing homes for COVID-19 be conducted based on parameters set forth by HHS.
COVID-19 Reporting Enforcement Enhancement and Civil Money Penalties
CMS is immediately implementing a new enforcement regulation to enhance enforcement of the new CMS infection prevention and control reporting requirements at § 483.80(g)(1) and (2) that became effective on May 8, 2020, in the interim final regulations published that day.
- Prior to the Public Health Emergency
Prior to the public health emergency, Section 483.80(a)(2)(ii) required nursing homes to have written standards, policies and procedures regarding infection control, which must include when and to whom possible incidents of communicable disease or infections should be reported and which includes reporting to local/state health authorities.
- May 2020 Reporting Requirements
In May 2020, CMS added to the infection control requirements provisions to establish weekly nursing home reporting of suspected and/or confirmed COVID-19 cases, among other information, at new Section 483.80(g). At that time CMS revised the requirements to require nursing homes to electronically report information about COVID-19 in a standardized format and at a frequency specified by HHS but not less than weekly to the CDC NHSN.
Noncompliance with this requirement for each weekly reporting cycle will be cited at a scope of widespread, and a severity of no actual harm with potential for more than minimal harm that is not immediate jeopardy, which constitutes a level “F” deficiency.
- CMP Amounts
CMS is expanding its enforcement efforts of the recently issued requirements at Section 483.80(g)(1) and (2) that nursing homes report COVID-19 related information to the CDC’s NHSN by imposing CMPs for the failure to report. Specifically, CMS is adding Section 488.447 to impose a minimum CMP amount of $1,000 for the first occurrence of noncompliance with the reporting requirements at Section 483.80(g)(1) and (2) and will increase the CMP by $500 for each subsequent time the nursing home fails to report COVID-19 related data as required. If a nursing home fails to report the second time in the subsequent week that new noncompliance determination will lead to the imposition of another CMP but in the increased amount of $1,500 for that failure to report.
Since noncompliance with Section 483.80(g)(1) and (2) will be cited at a scope and severity of an “F,” CMS will not continue incrementally increasing the CMP amount after 12 occurrences of noncompliance. As a result, the maximum CMP amount imposed would not exceed $6,500 for each subsequent occurrence of noncompliance.
Nursing homes found out of compliance with Section 483.80(g)(1) and (2) are not required to submit a plan of correction as indicated in Section 488.408(f)(1).
New Infection Control Testing Requirement
Nursing homes, which include SNFs for Medicare and NFs for Medicaid, seeking to be Medicare and Medicaid providers of services must be certified as meeting federal participation requirements.
CMS revised the nursing home infection control regulations at Section 483.80 to establish a new requirement for nursing homes to test their nursing home residents and staff, including individuals providing services under arrangement and volunteers.
CMS amended the current infection control requirements for nursing homes at Section 483.80 by adding a paragraph (h) that requires a nursing home to test all of its residents and nursing home staff for COVID-19. Under this requirement, “staff” are considered any individuals employed by the nursing home, any individuals that have arrangements to provide services for the nursing home and any individuals volunteering at the nursing home.
An example of individuals providing services under arrangement includes a hospice that may have an agreement in accordance with the requirements for the use of outside resources under Section 483.70(g) and (o) to provide hospice care for residents in the nursing home.
CMS expects that only those individuals that are physically working on-site at the nursing home be required to be tested for COVID-19. The nursing home may have staff, including individuals providing services under arrangement and volunteers, who provide services for the nursing home from an off-site location that is not physically located within the nursing home, and such staff would not be required to be tested for COVID-19.
At Section 483.80(h)(1), CMS requires that resident and staff testing for COVID-19 be conducted based on parameters set forth by HHS. These parameters may include, but are not limited to:
- Testing frequency;
- The identification of any nursing home resident or staff diagnosed with COVID-19 in the nursing home;
- The identification of any nursing home resident or staff with symptoms consistent with COVID-19 or with known or suspected exposure to COVID-19;
- The criteria for conducting testing of asymptomatic individuals specified in this paragraph, such as the positivity rate of COVID-19 in a county;
- The response time for test results; and
- Other factors specified by HHS that help identify and prevent the transmission of COVID-19.
We expect these parameters to be disclosed in an upcoming CMS memo.
CMS requires at Section 483.80(h)(2) that all resident and staff testing be conducted in a manner that is consistent with current professional standards of practice for conducting COVID-19 tests. Current “professional standards of practice” refers to those professional standards that apply at the time that the care or service is delivered.
CMS is requiring at Section 483.80(h)(3)(i) that for each instance of resident or staff COVID-19 testing, which includes testing of individuals providing services under arrangement and volunteers, the nursing home document that testing was completed and the results of each staff test.
CMS expects this documentation would be located in the staff personnel record for all staff. In the case of individuals who are providing services under arrangement at the nursing home, we expect that this documentation is located in the record or file that the nursing home maintains for the individual. In the event that no such record or file is maintained, CMS expects that the agreement for the services provided under arrangement includes a process for documenting these results.
Similar to the documentation requirements for nursing home staff, CMS requires at Section 483.80(h)(3)(ii) that the nursing home document in the resident’s medical record that testing was offered and completed (as appropriate to the resident’s testing status) and the results of each test.
In Section 483.80(h)(4) CMS calls for a nursing home to take action to prevent the transmission of COVID-19 when a resident or staff member, including individuals providing services under arrangement and volunteers, presents with symptoms consistent with COVID-19 or who test positive for COVID-19.
For nursing home staff, CMS expects nursing homes to restrict the access to the nursing home for any staff member, including individuals providing services under arrangement and volunteers, who presents with symptoms consistent with COVID-19 or who tests positive for COVID-19 until he or she is deemed to be safe to return to work.
For nursing home residents who present with symptoms consistent with COVID-19 or who test positive for COVID-19, CMS expects the nursing home to take measures to mitigate the transmission of the virus within the nursing home that may include resident cohorting, consistent with CDC’s guidance.
Under Section 483.10(c)(6), residents have the right to refuse and/or discontinue treatment. In addition, staff retains the right to refuse COVID-19 testing. There may also be instances in which nursing home residents or staff are not able to be tested, such as the presence of anatomical or other medical contraindications. In Section 483.80(h)(5), CMS requires that the nursing home have procedures for addressing residents and staff, including individuals providing services under arrangement and volunteers, who refuse or are unable to be tested. In these instances, CMS calls for nursing homes to take steps to maintain the health and safety of its staff and residents who have not been diagnosed with COVID-19 that may include limiting the staff’s access to the nursing home and cohorting residents.
New Section 483.80(h)(6) requires that the nursing home must coordinate with state and local health departments on the availability of testing supplies, obtaining testing supplies and processing test results when necessary.
Practical Takeaways
- Nursing homes should be ready to restrict from work any staff showing symptoms consistent with COVID-19, even without a positive test result.
- Nursing homes need to work with contractors, volunteers and others entering the nursing home for work to test them.
- Nursing homes need to adopt policies and procedures for reporting, testing and addressing when residents and staff refuse to be tested.
- Nursing homes should ensure they have a reliable and documented procedure for reporting COVID-19 test results.
If you have questions or would like additional information about this topic, please contact:
- Sean Fahey at (317) 977-1472 or sfahey@hallrender.com;
- Todd Selby at (317) 977-1440 or tselby@hallrender.com;
- Brian Jent at (317) 977-1402 or bjent@hallrender.com; or
- Your regular Hall Render attorney.
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