Fourth COVID-19 Interim Final Rule with Comment Period (IFC-4)
The Trump Administration has taken historic and unprecedented steps to equip the American healthcare system with maximum flexibility to respond to the Public Health Emergency (PHE) for COVID-19, and to ensure consumers have affordable access to testing and treatment for COVID-19. In anticipation of when a vaccine becomes available, the Trump Administration and the Centers for Medicare & Medicaid Services (CMS) are taking actions to ensure the participants in our programs have access to a Food and Drug Administration (FDA)-authorized or approved COVID-19 vaccine at no cost. With a vaccine expected before the end of the year, CMS, along with the Departments of Labor and the Treasury, is laying the groundwork now to ensure immediate coverage and payment for preventive COVID-19 vaccination for individuals covered by group health plans and health insurance issuers.
In an Interim Final Rule with Comment Period (IFC) issued on October 28 2020, CMS removes administrative barriers to eliminate potential delays to patient access to a lifesaving vaccine. In addition, the rule:
- Creates flexibilities for states maintaining Medicaid enrollment during the COVID‑19 PHE;
- Establishes enhanced Medicare payments for new COVID-19 treatments;
- Takes steps to ensure price transparency for COVID-19 tests, and
- 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.
COVID-19 Vaccines for Medicare Beneficiaries
Pursuant to Section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), once the FDA has authorized or approved a COVID-19 vaccine, the vaccine, and its administration, will be added to the list of preventive vaccines that are covered under Medicare Part B without coinsurance or deductible. The CARES Act provision amended Section 1861(s)(10)(A) of the Social Security Act (SSA).
CMS will also announce coding and payment for FDA authorized or approved vaccines and administration as expediently as possible through program memoranda.
COVID-19 Vaccine Coverage Requirements for Private Health Plans
The IFC includes provisions for implementing the requirement in section 3203 of the CARES Act that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage provide coverage, without cost sharing, for qualifying coronavirus preventive services, which includes COVID-19 immunizations.
In this IFC, the Departments of Health and Human Services (HHS), Labor, and the Treasury amend existing regulations to implement the unique requirements related to rapid coverage of qualifying coronavirus preventive services. This coverage is required to be provided within 15 business days after the date on which the United States Preventive Services Task Force or the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) makes an applicable recommendation relating to a qualifying coronavirus preventive service.
Specifically, plans and issuers must cover COVID-19 immunizations that have in effect a recommendation of ACIP with respect to the individual involved, even if not listed for routine use on the Immunization Schedules of the CDC. This IFC also provides that during the public health emergency for COVID-19, plans and issuers must cover without cost sharing qualifying coronavirus preventive services, regardless of whether an in-network or out-of-network provider delivers such services. The IFC also affirms that plans and issuers subject to section 2713 of the Public Health Service Act must cover without cost sharing items and services that are integral to the furnishing of recommended preventive services, including the administration of COVID-19 immunizations.
COVID-19 Vaccine Coverage for Medicaid, CHIP, and Basic Health Program (BHP) Beneficiaries
Under Section 6008 of the Families First Coronavirus Response Act (FFCRA), states’ and territories’ Medicaid programs may receive a temporary 6.2 percentage point increase in the Federal Medical Assistance Percentage (FMAP). The FMAP increase is available through the end of the quarter in which the COVID-19 PHE ends. To receive that increase, section 6008(4) of the FFCRA establishes a condition that a state must cover COVID-19 vaccines and their administration for Medicaid enrollees without cost sharing. However, CMS has not interpreted section 6008(b)(4) of the FFCRA to require that state Medicaid programs cover the services described in that provision for individuals whose Medicaid eligibility is limited by statute or under existing section 1115 demonstration authority to only a narrow range of benefits that would not otherwise include these services (e.g., groups that receive Medicaid coverage only for COVID-19 testing, family planning or Tuberculosis-related treatment services).
The condition at section 6008(b)(4) of the FFCRA does not apply to the Children’s Health Insurance Program (CHIP). In CHIP, separate CHIPs cover Advisory Committee on Immunization Practices (ACIP)-recommended vaccines and their administration for all children under age 19 with no cost sharing. Coverage of uninsured pregnant women in a separate CHIP program is optional. Currently, the states that cover pregnant women in a separate CHIP program include all ACIP-recommended vaccines with no cost sharing in this coverage. However, current CMS interpretation is that this vaccine coverage is not required.
However, if provided under a state’s separate CHIP program include all ACIP-recommended vaccines with no cost sharing in this coverage; however, this vaccine coverage is not required. The condition at section 6008(b)(4) of the FFCRA also does not apply to the BHP. Minnesota and New York are the only states that currently operate a BHP. BHP coverage includes benefits in at least the ten essential health benefits described in section 1302(b) of the PPACA and must comply with the Exchange’s cost-sharing protections, which includes providing all ACIP-recommended vaccines without cost sharing.
After the conditions in FFCRA section 6008 are no longer in effect in a state, the state Medicaid program must cover administration of COVID-19 vaccines recommended by the ACIP for several populations:
- All Medicaid-enrolled children under the age of 21 eligible for the Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit;
- Any adult populations who receive coverage through Alternative Benefit Plans (ABPs), including the PPACA adult expansion population; and
- Adults in states electing to receive a one percentage point FMAP increase for offering such vaccines and their administration under the preventive services benefit pursuant to section 1905(b) of the Social Security Act.
Other adult beneficiaries may be covered at state option for the COVID-19 vaccine administration after the requirements in FFCRA section 6008 are no longer in effect in a state. In separate CHIPs, vaccine coverage is the same during and after the PHE.
In BHP, vaccine coverage is largely the same during and outside of the public health emergency. However, during the COVID-19 public health emergency, plans must provide coverage for and must not impose any cost-sharing for “qualifying coronavirus preventive services,” including a COVID vaccine, regardless of whether the vaccine is delivered by an in-network or out-of-network provider.
The COVID-19 Claims Reimbursement program administered by HRSA may cover COVID-19 treatment, including the administration of vaccines, for limited-benefit beneficiaries. In addition, a state might have the option, subject to federal approval, to propose or amend a section 1115 demonstration to include this coverage for a group that would not otherwise be entitled to receive it under the statute or under current section 1115 authority.
Section 1332 State Innovation Waivers
This IFC creates flexibilities in the public notice requirements and post-award public participation requirements for State Innovation Waivers during the PHE for COVID-19. Specifically, this IFC gives the HHS Secretary and the Treasury Secretary authority to modify, in part, the public participation requirements to expedite a decision on a proposed waiver request that is submitted during the PHE for COVID-19. This IFC also gives the Secretaries the authority to modify, in part, the post-award public notice requirements for an approved waiver that would otherwise take place or become due during the PHE for COVID-19. If a modification is approved through this process, the HHS and the Department of the Treasury or the state, if applicable, will publish any modification determinations within approximately 15 calendar days of approval. HHS and the Department of Treasury are of the view that section 1332 waivers are a critical tool for states to ensure patients have stable access to healthcare coverage, including during the PHE for COVID-19. These final provisions are effective immediately and apply for the duration of the PHE for COVID-19.
Updated Policy for Maintaining Medicaid Enrollment during the COVID‑19 Public Health Emergency
Section 6008 of the FFCRA authorizes states to claim a temporary 6.2 percentage point increase in the federal medical assistance percentage (FMAP) if they satisfy certain conditions laid out in section 6008(b). CMS’s original interpretation of the condition in section 6008(b)(3) of the FFCRA prevented states from implementing certain changes to effectively manage their programs. This IFC reinterprets the condition in section 6008(b)(3) of the FFCRA under which states claiming the temporary FMAP increase must maintain beneficiary enrollment through the end of the month in which the PHE for COVID-19 ends, and includes additional safeguards to protect beneficiaries.
Under this rule, in order to claim the temporary FMAP increase, states must continue to maintain the Medicaid enrollment of “validly enrolled beneficiaries” in one of three tiers of coverage (or a more robust tier of coverage). Such coverage must be maintained, with certain exceptions, through the end of the month in which the PHE for COVID-19 ends. States may terminate individuals not validly enrolled, after providing advance notice and fair hearing rights per 42 C.F.R. Part 431 Subpart E, and still claim the temporary FMAP increase. States may make changes to beneficiary coverage, cost sharing and post-eligibility treatment of income, including both individual changes and changes to the state plan and a section 1115 demonstration and/or a waiver authorized under section 1915 of the Act, and not violate the section 6008(b)(3) of FFCRA condition , or other applicable Medicaid requirements.
Read a Medicaid.gov fact sheet for more information here: https://www.medicaid.gov/state-resource-center/downloads/covid-19-tech-factsheet-ifc-433400.pdf
Enhanced Medicare Payments for New COVID-19 Treatments
Hospital Inpatient Stays
In order to mitigate potential financial disincentives for hospitals to provide new COVID-19 treatments hospital during the COVID-19 PHE, the Medicare program will provide an enhanced payment for eligible inpatient cases that involve use of certain new products authorized or approved to treat COVID-19. The enhanced payment will be equal to the lesser of: (1) 65 percent of the operating outlier threshold for the claim; or (2) 65 percent of the cost of a COVID-19 stay beyond the operating Medicare payment (including the 20 percent add-on payment under section 3710 of the CARES Act) for eligible cases.
Outpatient Hospital Department
CMS wants to mitigate potential financial disincentives for hospitals to provide new COVID-19 treatments provided in a hospital outpatient setting during the COVID-19 PHE. Therefore, in this IFC, CMS has excluded FDA-authorized or approved drugs and biologicals (including blood products) authorized or approved to treat or prevent COVID-19 from being packaged into Comprehensive Ambulatory Payment Classification (C-APC) payment when these treatments are billed on the same claim as a primary C-APC service. Instead, Medicare will pay for these drugs and biologicals separately throughout the course of the PHE.
Price Transparency for COVID-19 Diagnostic Tests
Section 3202(b) of the CARES Act establishes a requirement for providers to publicize cash prices for COVID-19 diagnostic tests during the PHE. For purposes of implementing section 3202(b) of the CARES Act, this IFC adds a new 45 CFR part 182 to our regulations. This new requirement applies to every “provider of a COVID-19 diagnostic test” (or “provider”), which is defined as any facility that performs one or more COVID-19 diagnostic tests. Additionally, it requires that each provider of a COVID-19 diagnostic test make public the cash price, defined as the charge that applies to an individual who pays cash (or cash equivalent) for a COVID-19 diagnostic test, for such tests on the internet. If the provider does not have its own website, the provider must make the cash price available in writing within two business days upon request and through signage (if applicable). Additionally, this IFC gives CMS discretion to take any of the following actions, which generally, but not necessarily, will occur in the following order if CMS determines the provider is noncompliant with these requirements:
- Provide a written warning notice to the provider of the specific violation(s).
- Request that a provider submit and comply with a corrective action plan (CAP) if its noncompliance is not corrected after a warning notice.
- Impose a civil monetary penalty (CMP) on the provider if the provider fails to respond to CMS’ request to submit a CAP or to comply with the requirements of a CAP approved by CMS.
Questions about compliance can be submitted via email at COVID19CashPrice@cms.hhs.gov.
Extension of End Date for the Comprehensive Care for Joint Replacement (CJR) model
In this Interim Final Rule, certain Comprehensive Care for Joint Replacement (CJR) model policies are revised and technical changes made to accommodate these policy changes. Specifically, CMS extends Performance Year (PY) 5 of the model an additional 6 months, so PY 5 now ends September 30, 2021. To accommodate this additional extension of PY 5, CMS will bifurcate PY 5 and perform two reconciliations—one for the first 12 months of PY 5 and one for the remaining 9 months of PY 5. This rule also ends the current COVID-19 extreme and uncontrollable circumstances policy on March 31, 2021 or the end of the PHE, whichever occurs first. After that, to address ongoing effects of the pandemic, actual episode payments will be capped at the quality adjusted target price for any episode with actual episode payments that include a claim with a COVID-19 diagnosis code. Lastly, to ensure that the model continues to include the same inpatient Lower Extremity Joint Replacement (LEJR) procedures, despite the adoption of new MS-DRGs 521 and 522 to describe those procedures, CMS makes a technical change, as of October 1, 2020, to include these new DRGs in the model.
Questions about the CJR model can be submitted via email at CJRSupport@cms.hhs.gov