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Trump
Administration Acts to Ensure Coverage of Life-Saving COVID-19 Vaccines &
Therapeutics Under President Trump’s
leadership, the Centers for Medicare & Medicaid Services (CMS) is taking
steps to ensure all Americans, including the nation’s seniors, have access to
the coronavirus disease 2019 (COVID-19) vaccine at no cost when it becomes
available. Today, the agency released a comprehensive plan with proactive
measures to remove regulatory barriers and ensure consistent coverage and
payment for the administration of an eventual vaccine for millions of
Americans. CMS released a set of toolkits for providers, states and insurers
to help the health care system prepare to swiftly administer the vaccine once
it is available. These resources are designed to increase the number of
providers that can administer the vaccine, ensure adequate reimbursement for
administering the vaccine in Medicare, while making it clear to private
insurers and Medicaid programs their responsibility to cover the vaccine at
no charge to beneficiaries. In addition, CMS is taking action to increase
reimbursement for any new COVID-19 treatments that are approved or authorized
by the FDA. “Under President
Trump’s leadership, we have developed a comprehensive plan to support the
swift and successful distribution of a safe and effective vaccine for
COVID-19,” said CMS Administrator Seema Verma. “As Operation Warp Speed nears
its goal of delivering the vaccine in record time, CMS is acting now to
remove bureaucratic barriers while ensuring that states, providers and health
plans have the information and direction they need to ensure broad vaccine
access and coverage for all Americans.” To ensure broad access
to a vaccine for America’s seniors, CMS released an Interim Final Rule with
Comment Period (IFC) today that establishes that any vaccine that receives
Food and Drug Administration (FDA) authorization, either through an Emergency
Use Authorization (EUA) or licensed under a Biologics License Application
(BLA), will be covered under Medicare as a preventive vaccine at no cost to
beneficiaries. The IFC also implements provisions of the CARES Act that
ensure swift coverage of a COVID-19 vaccine by most private health insurance
plans without cost sharing from both in and out-of-network providers during
the course of the public health emergency (PHE). In anticipation of the
availability of new COVID-19 treatments, the IFC also establishes additional
Medicare hospital payment to support Medicare patients’ access to these
potentially life-saving COVID-19 therapies. In Medicare, hospitals are
generally reimbursed a fixed payment amount for the services they provide
during an inpatient stay, even if their costs exceed that amount. Under
current rules, hospitals may qualify for additional “outlier payments,” but
only when their costs for a particular patient exceed a certain threshold.
Under this IFC, hospitals would qualify for additional payments when they
treat patients with innovative new products approved or authorized to treat
COVID-19 to mitigate any losses they may experience from making these
therapies available, even if they do not reach the current outlier threshold.
The IFC also makes changes to reimbursement for outpatient hospital services
to ensure payment for certain innovative treatments for COVID-19 that occur
outside of bundled arrangements and are paid separately. In addition, CMS
released information to prepare hospitals to bill for the outpatient
administration of a monoclonal antibody product in the event one is approved
under an emergency use authorization (EUA). This rule also allows
states to employ a broad range of strategies - based on local needs - to
appropriately manage their Medicaid program costs. The guidance and
flexibility provided to states in the IFC will help them maintain Medicaid
beneficiary enrollment while receiving the temporary increase in federal
funding in the Families First Coronavirus Response Act (FFCRA). CMS is also taking
continued steps to ensure that price transparency extends to COVID-19 testing
during the PHE. Provisions in the IFC require that any provider who
performs a COVID-19 diagnostic test post their cash prices online. Providers
that are non-compliant may face civil monetary penalties. In addition to these
provisions, the IFC:
Along with these
regulatory changes, CMS is issuing three toolkits aimed at state Medicaid
agencies, providers who will administer the vaccine, and health insurance
plans. Together, these toolkits will help ensure the health care system is
prepared to successfully administer a safe and effective vaccine by
addressing issues related to access, billing and payment, and coverage. Increasing Access to Vaccines for Medicare & Medicaid
Beneficiaries The toolkits issued
today give health care providers not currently enrolled in Medicare the
information needed to administer and bill vaccines to Medicare patients. CMS
is working to increase the number of providers that will administer a
COVID-19 vaccine to Medicare beneficiaries when it becomes available, to make
it as convenient as possible for America’s seniors. New providers are now
able to enroll as a “Medicare mass immunizers” through an expedited 24-hour
process. The ability to easily enroll as a mass immunizer is important for
some pharmacies, schools, and other entities that may be non-traditional
providers or otherwise not eligible for Medicare enrollment. To further
increase the number of providers who can administer the COVID -19 vaccine,
CMS will continue to share approved Medicare provider information with states
to assist with Medicaid provider enrollment efforts. CMS is also making it
easier for newly enrolled Medicare providers to also enroll in state Medicaid
programs to support state administration of vaccines for Medicaid recipients. Coverage As a condition of
receiving free COVID-19 vaccines from the federal government, providers will
be prohibited from charging consumers for administration of the vaccine. To
ensure broad and consistent coverage across programs and payers, the toolkits
have specific information for several programs, including: Medicare: Beneficiaries with Medicare pay nothing for
COVID-19 vaccines and their copayment/coinsurance and deductible are waived. Medicare Advantage (MA): For calendar years 2020
and 2021, Medicare will pay directly for the COVID-19 vaccine and its
administration for beneficiaries enrolled in MA plans. MA plans would not be
responsible for reimbursing providers to administer the vaccine during this
time. Medicare Advantage beneficiaries also pay nothing for
COVID-19 vaccines and their copayment/coinsurance and deductible are waived. Medicaid: State Medicaid and CHIP agencies must provide
vaccine administration with no cost sharing for most beneficiaries during the
public health emergency. Following the public health emergency,
depending on the population, states may have to evaluate cost sharing
policies and may have to submit state plan amendments if updates are needed. Private Plans: CMS, along with the Departments
of Labor and the Treasury, is requiring that most private health plans and
issuers cover a recommended COVID-19 vaccine and its administration, both
in-network and out-of-network, with no cost sharing. The rule also provides
that out-of-network rates cannot be unreasonably low, and references CMS’s
reimbursement rates as a potential guideline for insurance companies. Uninsured: For individuals who are uninsured, providers
will be able to be reimbursed for administering the COVID-19 vaccine to individuals
without insurance through the Provider Relief Fund, administered by the
Health Resources and Services Administration (HRSA). Billing and Payment The toolkits also
address issues related to billing and payment. After the FDA either approves
or authorizes a vaccine for COVID-19, CMS will identify the specific vaccine
codes, by dose if necessary, and specific vaccine administration codes for
each dose for Medicare payment. CMS and the American Medical
Association (AMA) are working collaboratively on finalizing a new
approach to report use of COVID-19 vaccines, which include separate
vaccine-specific codes. Providers and insurance companies will be able
to use these to bill for and track vaccinations for the different vaccines
that are provided to their enrollees. Medicare Payment CMS also released new
Medicare payment rates for COVID-19 vaccine administration. The Medicare
payment rates will be $28.39 to administer single-dose vaccines. For a
COVID-19 vaccine requiring a series of two or more doses, the initial dose(s)
administration payment rate will be $16.94, and $28.39 for the administration
of the final dose in the series. These rates will be geographically
adjusted and recognize the costs involved in administering the vaccine,
including the additional resources involved with required public health
reporting, conducting important outreach and patient education, and spending
additional time with patients answering any questions they may have about the
vaccine. Medicare beneficiaries, those in Original Medicare or enrolled in
Medicare Advantage, will be able to get the vaccine at no cost. CMS is encouraging
state policymakers and other private insurance agencies to utilize the
information on the Medicare reimbursement strategy to develop their vaccine
administration payment plan in the Medicaid program, CHIP, the Basic Health
Program (BHP), and private plans. Using the Medicare strategy as a model
would allow states to match federal efforts in successfully administering the
full vaccine to the most vulnerable populations. The IFC (CMS-9912-IFC)
is scheduled to display at the Federal Register as soon as possible with an
immediate effective date, and a 30-day comment period. It can be downloaded
from the Federal Register at: https://www.cms.gov/files/document/covid-vax-ifc-4.pdf Additional information
on this IFC can be found in the fact sheet here: https://www.cms.gov/newsroom/fact-sheets/fourth-covid-19-interim-final-rule-comment-period-ifc-4 Additional Information
on the Updated Policy for Maintaining Medicaid Enrollment during the COVID‑19
Public Health Emergency can be found here: https://www.medicaid.gov/state-resource-center/downloads/covid-19-tech-factsheet-ifc-433400.pdf The COVID-19 vaccine
resources for providers, health plans and State Medicaid programs can be
found here: https://www.cms.gov/covidvax The FAQs on billing for
therapeutics can be found here: https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf ### Contact: CMS Media Relations: CMS
Media Inquiries Get CMS news at cms.gov/newsroom,
sign up for CMS news via
email and follow CMS on Twitter CMS Administrator @SeemaCMS and @CMSgov |
Wednesday, October 28, 2020
Trump Administration Acts to Ensure Coverage of Life-Saving COVID-19 Vaccines & Therapeutics
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