By Alex Spanko
The federal government on Tuesday issued stricter requirements for
COVID-19 testing in nursing homes, making routine staff testing a
requirement for participation in Medicare and Medicaid and rolling out
fines as high as $8,000 per instance of non-compliance.
The Centers for Medicare & Medicaid Services (CMS) established
the new rules as part of a larger package of data reporting requirements for hospitals and laboratories.
“These new rules represent a dramatic acceleration of our efforts to
track and control the spread of COVID-19,” CMS administrator Seema Verma
said in a statement announcing the requirements. “Reporting of test
results and other data are vitally important tools for controlling the
spread of the virus and give providers on the front lines what they need
to fight it.”
The exact frequency of the required employee testing will depend on
the level of COVID-19 infections in a facility’s surrounding community,
according to CMS.
“CMS recommendations for the frequency of staff testing will be based
on the degree of community spread, to be announced shortly through
guidance, that indicate the facility may be at increased risk for
COVID-19 transmission,” the agency noted.
Nursing homes must now also provide tests to residents during all
outbreaks, as well as when residents show any symptoms of the viral
infection.
CMS has directed state surveyors to perform inspections ensuring that
providers comply with the new regulations, with fines exceeding $400
per day or $8,000 per individual infraction.
Finally, all nursing facilities that receive a point-of-care testing
unit from the Department of Health and Human Services (HHS) will be
required to report diagnostic results as mandated under the CARES Act,
CMS announced.
The rule, which will also apply to hospital labs and other sites that
perform COVID-19 tests, will be enforced with fines of $1,000 per day
for the initial infraction, with $500-per-day fines thereafter.
Nursing homes and other lab sites will be given a one-time grace period, lasting three weeks, to begin reporting the data.
“This requirement complements existing HHS guidance requiring
laboratories to report test results and additional information, such as
demographic data,” CMS noted. “This change allows CMS to take
enforcement action against laboratories that fail to provide the
required data, which is needed by federal, state, and local officials to
conduct effective surveillance of the COVID-19 pandemic.”
CMS explicitly framed the rulemaking decision as a directive from President Trump.
“The provisions in today’s rule on nursing homes represent his
expectation that CMS pull every available regulatory lever to maximize
nursing home residents’ safety and quality of life,” Verma said in the
statement. “These Americans and their families, who have already gone
through so much, deserve nothing less.”
The move to beef up rules and enforcement around testing was largely
expected in the wake of the HHS program, under which most of the
nation’s 15,000 nursing facilities are slated to receive a point-of-care
antigen testing unit by the end of September.
The antigen testing units are generally less sensitive than the
gold-standard polymerase chain reaction (PCR) tests, with a higher
chance of false negatives, though industry leaders and health care
experts have largely welcomed the ability for quicker test results in a
landscape marked by overwhelmed third-party labs and long turnaround
times.
The federal government will provide an initial shipment of testing
assays as part of those device deliveries, but facilities will be on
their own to cover the costs of subsequent tests — as well as any
follow-up PCR tests, which are typically recommended to confirm negative
antigen results.
CMS pointed to the most recent round of $5 billion in federal CARES
Act relief set aside for nursing homes — on top of billions in other aid
available to post-acute and long-term care providers — as a key source
of funding to cover testing expenses under the new rules.
The new requirements will take effect under an interim final rule with comment period,
published in the Federal Register for inspection.
Previous federal testing requirements have largely taken the form of
recommendations, such as specific benchmarks included in CMS’s
guidelines for reopening nursing homes to visitors; CMS in July also
announced its intention to
require weekly staff testing in states with an overall infection rate of 5% or higher.
The American Health Care Association, which represents primarily
for-profit nursing facilities, expressed general support for wider
mandatory testing rules, while also raising concerns about how
third-party testing delays could potentially result in fines.
“When CMS clarifies the frequency of testing required, it must factor
in the delays that continue to be a reality,” AHCA president and CEO
Mark Parkinson said in a statement. “Otherwise facilities could face
fines for circumstances beyond their control and be conducting tests
that are so delayed that they have little clinical value. CMS can solve
these concerns by being reasonable in its implementation of the rule.”
LeadingAge, a trade organization of non-profit senior care and
housing providers, called for more direct assistance on top of the
requirements, noting that some providers have serious questions about
the logistics of using the point-of-care machines.
“The fight against this virus is far from over, and our members need
continued support,” CEO Katie Smith Sloan said in a statement. “The
antigen testing machines HHS is delivering to nursing homes will help,
but members who already have the machines report that they are still
waiting for instructions and test kits to make them usable. What’s more,
this HHS program addresses just one segment of the care continuum, and
even nursing homes still face high costs for testing supplies and staff
resources.”
Full Article & Source:
CMS Implements Stricter COVID-19 Testing Requirements, Fines for Nursing Homes
