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:
- Provides an
extension of Performance Year 5 for the Comprehensive Care for
Joint Replacement (CJR) model; and
- Creates
flexibilities in the public notice requirements and post-award
public participation requirements for a State Innovation
Waiver under Section 1332 of the Patient Protection and
Affordable Care Act during the COVID-19 PHE.
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
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
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