Fitzgibbon Hospital Issues Public Comment on Centers for Medicare & Medicaid Services Rule

WASHINGTON, Oct. 31 -- Angela P. Littrell, president and CEO, and Amy R. Weber, manager of business development and government relations, at Fitzgibbon Hospital, Marshall, Missouri, have issued a public comment on the Centers for Medicare and Medicaid Services rule entitled "Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments, and Patient Protection and Affordable Care Act: Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency". The comment was written on Oct. 6, 2020, and posted on Oct. 29, 2020:

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Please allow this writing to address Interim Final Rule (IFC), CMS-3401-IFC, 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 COVID19 Focused Survey Tool, which was issued on Aug. 26 and implemented immediately, pending comments and final rule.

We are specifically addressing the Long Term Care Facility Testing Requirements as established by HHS. Fitzgibbon Hospital in Marshall, Mo., is a rurally located, disproportionate share, sole-community acute care hospital that also operates a Medicare Certified Long Term Care Facility, licensed for 99 beds.

We believe several flawed assumptions were made in developing CMS-3401-IFC which meaningfully and negatively impact the testing selection standards, frequency standards and outcomes.

Nowhere in the guidance is the type of PPE worn by staff mentioned nor considered. PPE type, PPE availability and PPE donning policies vary broadly across long-term care facilities. Those facilities which utilize N-95's should be exempt to much of the rule, or at minimum, the standards for testing frequency should be altered. At our facility, for example, all staff are universally equipped with N-95 respirator masks, and our staff don an N-95 for the duration of their shift. The universal use of N-95 affords caregivers a superior level of protection against droplet spread. Therefore, testing frequency and selection of those to be tested after a single employee tests covid-19 positive must take this into account.

Perhaps an additional focus in preventing the spread of Covid-19 in long-term care facilities should be the provision of N-95 masks rather than the sole emphasis on increased testing.

As we interpret the guidance, we would be required to test all staff twice a week, if the county's positivity rate in greater than 10 percent. This frequency places an undue resource burden on already financially struggling health care facilities and is simply unsustainable. As of this writing, we have tested all employees 16 times either after a single employee admitted to exposure away from work or as a result of our county positivity rate. Contact tracing indicated in every instance those single employees contracted the virus away from work. Because all staff wear N-95's during their shift, virus spread to fellow employees and residents was avoided, and subsequent testing resulted in -0- positive cases identified among our residents. However, the testing cost for 16 rounds of tests exceeds $300,000, not to mention the drain on testing supplies, which have been reserved for those displaying Covid-19 symptoms. It is still unclear which entity will bear the financial burden for all of this testing, as regulations around Covid-19 coverage, funding and reimbursement remains in flux.

In addition, subjecting employees to the invasive manner of Covid-19 testing twice weekly - despite the fact that they are required to wear N-95's during their shift - will negatively impact our facility's success in recruiting employees. As a rurally located Skilled Nursing Facility, we compete for employees amongst larger, metropolitan or suburban facilities, both on a salary basis and a "lifestyle" basis. We currently have 17 open positions at The Living Center, and many of our employees travel some distance to work from outside the county.

This fact, that employees travel from outside the county, is not taken into consideration in the development of the guidance's Table 2, which specifies testing based on "Community Covid-19 Activity Level." Additionally, the community activity level is erroneously expressed as a positivity percentage rate. This, too, is a flaw. In a sparsely populated or rural area, using a percentage rate as a decision metric provides a skewed picture of community activity. Any discussion of "community activity" should be expressed as cases per 1,000 or cases per 10,000. The entire population of our county is Just 25,000 people. To date, our facility has functioned as a regional testing site and has identified approximately 600 positive cases among county residents since the beginning of the pandemic. A large number of cases can be traced to a meat-processing plant and a major employer in our community. But as the pandemic wears on, only those individuals displaying symptoms and who have a physician's order are now presenting for Covid-19 testing. Therefore, the positive percentage rate will skew upward because fewer asymptomatic individuals are presenting for testing. Establishing testing intervals as detailed in Table 2 based on "community activity level" is flawed and assumes that all employees come only from your community and that the community is somehow engaged in broad-based population testing. Neither, in fact, is the case.

Finally, adherence to the regulation requires an additional administrative burden in order to facilitate, track and report the repeated testing activities. We estimate that it takes two full-time equivalents to perform the associated tasks, and this further exacerbates the cost structure for our facility.

In summary, we object to the flawed methodologies and assumptions used to establish testing frequency rules in the Interim Final Rule (IFC), CMS-3401-IFC issued by CMS on Aug. 26 as well as the financial burden that such a rigorous testing protocol would create.

Sincerely,

Angela P. Littrell, MBA, CPA President & CEO

Amy R. Weber Manager, Business Development and Government Relations

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The rule can be viewed at: https://www.regulations.gov/document?D=CMS-2020-0097-0001

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