On October 30, 2020, the Centers for Medicare & Medicaid Services (CMS) released an interim final rule to create flexibility for the administration of an eventual COVID-19 vaccine and a mechanism for payment. The goal is to increase the number of providers that may administer a COVID-19 vaccine to persons covered by federal health care programs and group health plans. Under the rule, hospitals may also qualify for additional payments when they treat patients with new products approved or authorized to treat COVID-19, such as remdesivir and COVID-19 convalescent plasma.
Mass Immunizers
Under the interim final rule, providers such as hospitals, home health agencies, skilled nursing facilities, physician practices, and certain non-physician practitioners can enroll under Medicare as mass immunizers to offer COVID-19 vaccines to large groups of Medicare beneficiaries under roster billing, similar to flu and pneumococcal vaccines. In New York State, a non-physician practitioner may include a nurse practitioner, physician assistant, or pharmacist.
The mass immunizer rule was created for providers that otherwise would not be eligible for Medicare enrollment. In addition to satisfying all applicable enrollment requirements for establishing and maintaining Medicare billing privileges1, a party enrolled only as a mass immunization roster biller:
- May not bill Medicare for any services other than pneumococcal pneumonia vaccines (PPVs), influenza virus vaccines, COVID-19 vaccines (once approved), and their administration.
- Must submit claims through the roster biller or centralized biller process.
- Must meet all applicable state and local licensure or certification requirements.
Entities that are already enrolled Medicare providers and suppliers are directed by CMS to contact their Medicare administrative contractor if they plan to submit claims as a mass immunizer. An entity or individual that does not otherwise qualify as a Medicare provider or supplier but wishes to furnish mass immunization services may be eligible to enroll in Medicare as a “mass immunization roster biller.”
Coverage
Once the Food and Drug Administration (FDA) has authorized or approved a COVID-19 vaccine, the vaccine and its administration will be added to the list of preventive vaccines covered under Medicare Part B without coinsurance or deductible. In return for receiving free COVID-19 vaccines from the federal government, providers will be prohibited from charging consumers for the administration of the vaccine.
During the public health emergency and in exchange for receiving a 6.2 percent increase in the federal government’s contribution to a particular state’s Medicaid program, state Medicaid and CHIP agencies must cover COVID-19 testing services and treatments, including vaccines and the administration of vaccines, for enrollees without cost sharing. Such coverage is required during any quarter for which the state claims the temporary increase, which is available through the end of the quarter in which the public health emergency for COVID-19 ends. CMS is not aware of any states not currently claiming the temporary increase or any state that intends to cease claiming it.
In addition, private health insurance plans must cover COVID-19 immunizations recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, both in-network and out-of-network, without cost sharing. For individuals who are uninsured, providers will be able to be reimbursed for administering the COVID-19 vaccine through the Provider Relief Fund, which is administered by the Health Resources and Services Administration.
CMS ordinarily establishes Medicare payment rates for particular items and services through notice-and-comment rulemaking. Because of the unique circumstances of the COVID-19 pandemic, CMS intends to initially dispense with the rulemaking process in order to make Medicare payment quickly available to ensure widespread access to any new vaccine. Therefore, as soon as practicable after the authorization or licensure of each COVID-19 vaccine product by the FDA, CMS will announce the interim coding and a payment rate for its administration, taking into consideration any product-specific costs or considerations involved in furnishing the service. CMS will then address coding and payment rates as part of future notice-and-comment rulemaking, such as annual rulemaking under the Medicare physician fee schedule.
Price Transparency and Testing
The interim final rule will also require group health plans and issuers providing coverage for items and services to reimburse any provider of a COVID-19 diagnostic test an amount that equals the negotiated rate or, if the plan or issuer does not have a negotiated rate with the provider, the cash price for the service listed by the provider on a public website. Providers that perform a COVID-19 diagnostic test must post their cash prices online. Providers that do not comply with this mandate may face civil monetary penalties.2
As part of the interim final rule, CMS issued toolkits to provide health care providers not enrolled in Medicare with the information needed to administer and bill vaccines to Medicare beneficiaries as well as information related to coverage of the vaccine for a number of different programs and payers.
Comments to the interim final rule must be submitted by mail or e-mail within 60 days of the date the rule is published in the Federal Register.
Barclay Damon attorneys have consistently stayed up to date on changes proposed and implemented by CMS throughout the COVID-19 pandemic. We encourage providers that seek to enroll as mass immunizers to thoroughly document their eligibility as well as ensure they comply with the requirements outlined above, including submitting claims through a centralized biller process or roster biller. We also strongly recommend any provider that performs a COVID-19 diagnostic test prepare to post cash prices online in order to avoid the imposition of a civil monetary penalty.
1 See 42 CFR 424.500, et seq.
2 See 45 CFR Part 180
If you have any questions regarding the content of this alert, please contact Mary Connolly, associate, at mconnolly@barclaydamon.com, or another member of the firm’s Health Care Team.
We also have a specific team of Barclay Damon attorneys who are actively working on assessing regulatory, legislative, and other governmental updates related to COVID-19 and who are prepared to assist clients. You can reach our COVID-19 Response Team at COVID-19ResponseTeam@barclaydamon.com.