Laboratories: CMS Flexibilities to Fight COVID-19
Summary
CMS fact sheet, Laboratories: CMS Flexibilities to Fight COVID-19, posted 05/10/2023. It states that CMS used emergency waiver authorities at the beginning of the COVID-19 Public Health Emergency and developed a cross-cutting initiative to reestablish certain health and safety standards and other requirements at the eventual end of the emergency, reviewed in three concurrent phases. It states that the sheet focuses on Medicare and Medicaid flexibilities only. Under Medicare COVID-19 Diagnostic Testing, it describes an Interim Final Rule with Comment Period issued October, 28, 2020 implementing the CARES Act requirement that providers of a COVID-19 diagnostic test make the cash price public, and states that noncompliance may result in civil monetary penalties up to $300 per day.
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Cite this document
“Laboratories: CMS Flexibilities to Fight COVID-19.”
Original at www.cms.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/ppr-int-239da0290df9f22f-laboratories-pdf-9e1e940b51/
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Laboratories: CMS Flexibilities to Fight COVID-19
At the beginning of the COVID-19 Public Health Emergency (PHE), CMS used emergency waiver
authorities and various regulatory authorities to enable flexibilities so providers could rapidly
respond to people impacted by COVID-19. CMS developed a cross-cutting initiative to use a
comprehensive, streamlined approach to reestablish certain health and safety standards and
other financial and program requirements at the eventual end of the COVID-19 public health
emergency.
This CMS cross-cutting initiative focused on evaluating CMS-issued PHE waivers and flexibilities
to prepare the health care system for operation after the PHE. This review happened in three
concurrent phases:
1. CMS assessed the need for continuing certain waivers based on the current phase of the
PHE. Since the beginning of the PHE, CMS has both added and terminated flexibilities and
waivers as needed. In doing so, CMS considered the impacts on communities — including
underserved communities — and the potential barriers and opportunities that the
flexibilities may address.
2. CMS assessed which flexibilities would be most useful in a future PHE, such as natural and
man-made disasters and other emergencies, to ensure a rapid response to future
emergencies, both locally and nationally, or to address the unique needs of communities
that may experience barriers to accessing health care.
3. CMS is continuing to collaborate with federal partners and the health care industry to
ensure that the health care system is holistically prepared for addressing future
emergencies.
As CMS identified barriers and opportunities for improvement, the needs of each person and
community served were considered and assessed with a health equity lens to ensure our
analysis, stakeholder engagement, and policy decisions account for health equity impacts on
members of underserved communities and health care professionals disproportionately serving
these communities.
Please note: This fact sheet focuses on Medicare and Medicaid flexibilities only.
Medicare COVID-19 Diagnostic Testing
• Price Transparency for COVID-19 Testing: In an Interim Final Rule with Comment Period
(IFC) issued October, 28, 2020, CMS implemented the CARES Act requirement that
providers of a diagnostic test for COVID-19 are to make public the cash price for such
tests on their websites. Providers without websites have been required to provide price
information in writing, within two business days upon request, and on a sign posted
05/10/2023 1
prominently at the location where the provider performs the COVID-19 diagnostic test,
if such location is accessible to the public. Noncompliance may result in civil monetary
penalties up to $300 per day. After the PHE, in accordance with the CARES Act, this
special price transparency requirement will terminate. Price transparency
requirements under other laws and regulations will continue to apply.
• Laboratory Specimen Collection from Patient’s Home: During the PHE, Medicare could
pay when laboratories send trained technicians to collect a sample from a homebound
beneficiary or a non-hospital inpatient for COVID-19 diagnostic testing. Medicare could
pay a specimen collection fee and for the travel. During the PHE, the nominal specimen
collection fee for COVID-19 testing for homebound and non-hospital inpatients
generally was $23.46 and for individuals in a non-covered stay in a SNF, or whose
samples are collected by a laboratory on behalf of an HHA, is $25.46. Effective for dates
of service on or after May 12, 2023, these payment amounts, billed with HCPCS codes
G2023 and G2024, are no longer payable under Medicare. Additionally, the HCPCS
codes will be terminated. Guidance on billing for specimen collection and travel can be
found at https://www.cms.gov/files/document/mm13071-travel-allowance-fees-
specimen-collection-2023-updates.pdf
• Physician or Practitioner Order for COVID-19 tests: In the COVID-19 Public Health
Emergency Interim Final Rule #3 (CMS-3401-IFC), we revised a previous policy that
covered multiple COVID-19 tests for an individual beneficiary without a physician or
other practitioner order. Medicare has been covering a beneficiary’s first COVID-19 test
without an order. Subsequent tests require a physician’s or other practitioner order.
This change has ensured that beneficiaries receive appropriate medical attention if they
feel they need multiple tests and has reduced the risk of fraud. FDA requirements for an
order and state requirements around ordering diagnostic tests still applied. CMS also
removed certain documentation and recordkeeping requirements associated with
orders for COVID-19 diagnostic tests as these requirements would not be relevant in the
absence of an order. CMS still requires laboratories to furnish the results of COVID-19
tests to the beneficiary. Consistent and regular reporting of all testing results to local
officials is critical to public health management of the pandemic, so we would expect
any clinician or laboratory receiving results to report those results promptly, consistent
with state and local public health requirements, typically within 24 hours. After the PHE,
Medicare will require all COVID-19 and related testing that is performed by a
laboratory to be ordered by a physician or non-physician practitioner.
• Pharmacists: A pharmacy that acquires a CLIA certificate can enroll with Medicare as a
clinical diagnostic laboratory to conduct and bill for clinical diagnostic laboratory tests
authorized under their certificate, and many pharmacies have done this to furnish and
bill for COVID-19 clinical diagnostic laboratory tests during the PHE. This is permissible
under current permanent Medicare policies and remains after the end of the PHE as
long as the pharmacy retains its CLIA certification and is enrolled in Medicare as a
05/10/2023 2
clinical diagnostic laboratory. In addition, to help ensure that beneficiaries can get the
tests they need, CMS covers laboratory-performed COVID-19 and related testing when
ordered by a pharmacist or other health care professional permitted by their state to
order diagnostic laboratory tests. The interim final rule, in revising previous policy for
the PHE, allowed laboratories to be paid when pharmacists ordered these tests. This
ordering flexibility ends with the end of the PHE. Diagnostic laboratory tests must be
ordered by a physician or nonphysician practitioner.
• Antibody (serology) tests: FDA-authorized COVID-19 serology testing is a Medicare-
covered diagnostic test for patients with known current or known prior COVID-19
infection or suspected current or suspected past COVID-19 infection. The outcome of
the serology test may change the health care decisions made by a patient and their
practitioner. At the end of the PHE, coverage is at the Medicare Administrative
contractor’s discretion.
• Increased payment for COVID-19 laboratory tests performed using high throughput
technologies: Medicare has paid a higher payment for COVID-19 clinical diagnostic lab
tests making use of high-throughput technologies developed by the private sector that
allows for increased testing capacity, faster results, and more effective means of
combating the spread of the virus. High-throughput lab tests can process more than two
hundred specimens a day using highly sophisticated equipment that requires specially
trained technicians and more time-intensive processes to assure quality. These
increased payments are effective through the end of the PHE. When the COVID-19 PHE
ends, payment rates will revert to those rates under the Clinical Laboratory Fee
Schedule. HCPCS codes U0003, U0004, and U0005 created for this policy will no longer
be payable for dates of service on or after May 12, 2023, and the HCPCS codes will be
terminated. A number of CPT© codes were created to address the laboratory testing
environment throughout the PHE and these codes are reflected on Medicare’s Clinical
Lab Fee Schedule. Providers and suppliers should select the most appropriate code that
describes their test.
Reducing Administrative Burden
• “Stark Law” Waivers: The physician self-referral law (also known as the “Stark Law”) 1)
prohibits a physician from making referrals for certain designated health services
payable by Medicare to an entity with which he or she (or an immediate family
member) has a financial relationship, unless the requirements of an applicable
exception are satisfied; and 2) prohibits the entity from filing claims with Medicare (or
billing another individual, entity, or third party payer) for any improperly referred
designated health services. On March 30, 2020, CMS issued blanket waivers of certain
provisions of the Stark Law. These blanket waivers applied to financial relationships and
referrals that are related to the COVID-19 emergency. The remuneration and referrals
described in the blanket waivers must be solely related to COVID-19 purposes, as
defined in the blanket waiver document. During the PHE, CMS permitted certain
05/10/2023 3
referrals and the submission of related claims that would otherwise violate the Stark
Law, if all requirements of the waivers were met. When the COVID-19 PHE ends, the
waivers will terminate and physicians and entities must immediately comply with all
provisions of the Stark Law.
Flexibilities under the “Stark Law” waivers have included:
o Hospitals and other health care providers could pay above or below fair market
value for the personal services of a physician (or an immediate family member of a
physician), and parties could pay below fair market value to rent equipment or
purchase items or services. For example, a physician practice could rent or sell
needed equipment to a hospital at a price below what the practice could charge
another party. Or, a hospital could provide space on hospital grounds at no charge
to a physician who is willing to treat patients who sought care at the hospital but
were not appropriate for emergency department or inpatient care.
o Health care providers could support each other financially to ensure continuity of
health care operations. For example, a physician owner of a hospital could make a
personal loan to the hospital without charging interest at a fair market rate so that
the hospital could make payroll or pay its vendors.
o Hospitals could provide benefits to their medical staff, such as multiple daily meals,
laundry service to launder soiled personal clothing, or child care services while the
physicians were at the hospital and engaging in activities that benefited the hospital
and its patients.
o Health care providers could offer certain items and services that were solely related
to COVID-19 purposes (as defined in the waivers), even when the provision of the
items or services would exceed the annual non-monetary compensation cap. For
example, a home health agency could provide continuing medical education to
physicians in the community on the latest care protocols for homebound patients
with COVID-19, or a hospital could provide isolation shelter or meals to the family of
a physician who was exposed to the novel coronavirus while working in the
hospital’s emergency department.
o Physician-owned hospitals could temporarily increase the number of their licensed
beds, operating rooms, and procedure rooms, even though such expansion would
otherwise be prohibited under the Stark Law. For example, a physician-owned
hospital could temporarily convert observation beds to inpatient beds to
accommodate patient surge during the COVID-19 pandemic in the United States.
o Some of the restrictions regarding when a group practice could furnish medically
necessary designated health services (DHS) in a patient’s home were loosened. For
example, any physician in the group could order medically necessary DHS that were
furnished to a patient by one of the group’s technicians or nurses in the patient’s
home contemporaneously with a physician service that was furnished via telehealth
by the physician who ordered the DHS.
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o Group practices could furnish medically necessary MRIs, CT scans, or clinical
laboratory services from locations like mobile vans in parking lots that the group
practice rented on a part-time basis.
COVID-19 Accelerated and Advance Payments (CAAP): For the most up to date information
related to the CAAP Program, please visit https://www.cms.gov/medicare/covid-19-
accelerated-and-advance-payments
• Provider Enrollment: During the PHE, CMS has established toll-free hotlines for
physicians, non-physician practitioners, and Part A certified providers and suppliers who
have established isolation facilities to enroll and receive temporary Medicare billing
privileges. When the PHE ends, the hotlines will be shut down. Additionally, CMS has
provided the following flexibilities for provider enrollment:
o Screening requirements:
• Site Visits: CMS waived provider enrollment site visits for moderate and high-
risk providers/suppliers. (This waiver terminated on 07-06-2020, and CMS,
in accordance with 42 CFR §§ 424.517 and 424.518, resumed all provider
enrollment site visits.)
• Fingerprint-based criminal background checks: CMS waived the requirement
for fingerprint-based criminal background checks for 5% or greater owners of
newly enrolling high-risk categories of providers and suppliers (e.g., newly-
enrolling Home Health Agencies, DMEPOS suppliers, Medicare Diabetes
Prevention Programs, Opioid Treatment Programs). (This waiver terminated
on 10/31/2021, and CMS, in accordance with 42 CFR § 424.518, resumed
requesting fingerprints for all newly enrolling high-risk providers and
suppliers.)
o Application Fees: CMS waived the collection of application fees for institutional
providers who are initially enrolling, revalidating, or adding a new practice location.
(This waiver terminated on 10/31/2021 and CMS, in accordance with 42 CFR §
424.514, resumed collecting application fees.)
o Revalidation: CMS postponed all revalidation actions. This did not prevent a provider
who wanted to submit a revalidation application from doing so; MACs processed
revalidation applications. (This waiver terminated on 10/31/2021 and CMS
resumed a phased-in approach to revalidation activities; revalidation letters began
being mailed again in November 2021 with due dates in early 2022.)
o Expedited Enrollment: CMS expedited any pending or new applications from
providers and suppliers, including physicians and non-physician practitioners
05/10/2023 5
received on or after March 1, 2020. When the PHE ends, CMS will resume normal
application processing times.
Medicare appeals in Traditional Medicare, Medicare Advantage (MA) and Part D
• During the PHE, CMS has been allowing Medicare Administrative Contractors (MACs)
and Qualified Independent Contractors (QICs) in the FFS program (42 CFR 405.942 and
42 CFR 405.962) and MA and Part D plans, as well as the Part C and Part D Independent
Review Entity (IREs) (42 CFR 422.582 and 42 CFR 423.582) to allow extensions to file an
appeal. Specifically, 42 CFR 422.582(c) and 42 CFR 423.582(c) allow a Part C or Part D
plan to extend the timeframe for filing a request if there is good cause for the late filing.
In addition, the Part D IRE may find good cause for late filing of a request for
reconsideration. When the COVID-19 PHE ends, these flexibilities will continue to apply
consistent with existing authority and requests for appeals must meet the existing
regulatory requirements.
• During the PHE, CMS has been allowing MACs and QICs in the FFS program (42 CFR 405.
950 and 42 CFR 405.966), and the Part C and Part D IREs to waive requirements for
timeliness for requests for additional information to adjudicate appeals. In addition,
under applicable regulations, MA plans may extend the timeframe to adjudicate
organization determinations and reconsiderations for medical items and services (but
not Part B drugs) by up to 14 calendar days if: the enrollee requests the extension; the
extension is justified and in the enrollee's interest due to the need for additional
medical evidence from a noncontract provider that may change an MA organization's
decision to deny an item or service; or, the extension is justified due to extraordinary,
exigent, or other non-routine circumstances and is in the enrollee's interest (42 CFR
422.568(b)(1)(i), 42 CFR 422.572(b)(1) and 42 CFR 422.590(f)(1)). When the COVID-19
PHE ends, these flexibilities will continue to apply consistent with existing authority
and requests for appeals must meet the existing regulatory requirements.
• During the PHE, CMS has been allowing MACs and QICs in the FFS program (42 CFR
405.910) and MA and Part D plans, as well as the Part C and Part D IREs, to process an
appeal, even with incomplete Appointment of Representation forms (see 42 CFR
422.561 and 42 CFR 423.560 for definitions of “representative”). However, any
communication was sent only to the beneficiary. When the COVID-19 PHE ends, this
flexibility will continue to apply, consistent with existing guidance for the MACs and
QIC in the FFS program. For MA and Part D plans, as well as the Part C and Part D IREs,
this flexibility will no longer apply. The MA and Part D plans, as well as the Part C and
D IREs, must process the appeals based on regulatory requirements (42 CFR
422.582(f)-(g), 42 CFR 423.582(e)-(f), 42 CFR 422.592(d)-(e), and 42 CFR 423.600(g)-(h)).
• During the PHE, CMS has been allowing MACs and QICs in the FFS program (42 CFR 405.
950 and 42 CFR 405.966) and MA and Part D plans, as well as the Part C and Part D IREs,
to process requests for appeal that don’t meet the required elements, but instead use
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information that is available (42 CFR 422.562 and 42 CFR 423.562). When the COVID-19
PHE ends, requests for appeals must meet the existing regulatory requirements.
• During the PHE, CMS has been allowing MACs and QICs in the FFS program (42 CFR 405.
950 and 42 CFR 405.966) and MA and Part D plans, as well as the Part C and Part D IREs,
to utilize all flexibilities available in the appeal process as if good cause requirements are
satisfied. When the PHE ends, these flexibilities may only be provided consistent with
existing regulatory authority.
Clinical Laboratory Improvement Act (CLIA) Guidance
• CMS has exercised enforcement discretion to facilitate pathologists’ ability to review
pathology slides remotely without the need for a separate CLIA certificate for the
remote location. Enforcement discretion is not contingent on PHE authority; CMS will
continue to exercise enforcement discretion that allows pathologists to examine digital
images and laboratory data at remote locations.
• CMS has expedited CLIA certificate application review and processing to ensure that
laboratories located in the United States wishing to perform COVID-19 testing are able
to begin testing as quickly as possible during the public health emergency. CMS has
determined that at the end of the PHE, regulations will allow CMS to continue to allow
for expedited lab certification by allowing a Laboratory to begin testing as soon as
they receive a CLIA number and pay the laboratory fee.
• CMS has allowed laboratories within a hospital/university hospital campus to hold a
single certificate for the laboratory sites within the same physical location or street
address. CMS has determined that at the end of the PHE, regulations will allow CMS to
continue to allow for labs within a hospital to hold a single certificate for the
laboratory sites within the same physical location or street address. This requirement
is expressly authorized under the CFR (See 42 CFR 493.35(b), 43(b), 55(b).
• CMS has clarified that alternate specimen collection devices and media may be used to
collect and transport COVID-19 samples. CLIA regulations are not prescriptive about the
type of transport device; for example, specimen collection swabs and viral transport
media that laboratories use to collect the specimens needed to perform a test. CLIA only
requires that the laboratory follow the manufacturer’s instructions. If a laboratory
modifies the manufacturer’s instructions, the laboratory must establish performance
specifications and validate the assay prior to performing patient testing. CLIA is not
prescriptive as to how the study is performed; the Laboratory Director is responsible for
defining the validation parameters. CMS has determined that at the end of the PHE,
regulations will allow CMS to continue to use alternate specimen collection devices
and media. Under existing regulations, Laboratories must either follow manufacturer’s
instructions or establish performance specifications for a modified procedure, as is
reflected in 42 CFR 493.1253(b)(2).
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Additional Guidance
• The Interim Final Rules and waivers can be found at https://www.cms.gov/about-
cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-
waivers.
• Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During
COVID-19 Public Health Emergency can be found at:
https://www.cms.gov/files/document/qso-20-21-clia.pdf-0.
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