January 4, 2021
Centers for Medicare & Medicaid Services
Department of Health and Human Services
P.O. Box 8016,
Baltimore, MD 21244-8016 comports
RE: RIN 0938-AU35: Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency CMS-9912-IFC
To Whom It May Concern:
As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency. Our comments focus on the provisions aimed at ensuring every American has timely access to a COVID–19 vaccine without any out-of-pocket expenses, no matter their source of coverage, or whether they are covered at all.
- Supports the Centers for Medicare and Medicaid Services (CMS) interpretation that safe and effective COVID-19 vaccines that have been authorized by the Food and Drug Administration (FDA) during a public health emergency (PHE) should be made available to Medicare beneficiaries without deductibles or coinsurance.
- Urges CMS to value CPT codes for COVID-19 vaccine administration that reflect the relative value of the additional practice expenses specific to COVID-19 vaccines.
- Strongly urges CMS to use its authority to immediately increase vaccine administration reimbursement rates for routine Part B vaccines (influenza, pneumococcal, and hepatitis B for those at-risk).
- Urges CMS to allow providers to submit COVID-19 vaccine administration claims for Medicare Advantage beneficiaries to the plans instead of requiring submission to MACs.
- Recommends that CMS provide clear guidance that states must cover COVID-19 vaccines without cost sharing for all Medicaid beneficiaries, regardless of their benefit or waiver category, and regardless of whether the vaccine was authorized under an EUA or received full FDA approval.
- Encourages CMS to work with HRSA to streamline and expedite the reimbursement process for Provider Relief Funds to ensure that uninsured populations have timely and equitable access to COVID-19 vaccines.
AVAC consists of sixty organizational leaders in health and public health that are committed to addressing the range of barriers to adult immunization and to raising awareness of the importance of adult immunization. AVAC works towards common legislative and regulatory solutions that will strengthen and enhance access to adult immunization across the health care system. Our priorities and objectives are driven by a consensus process with the goal of enabling the range of stakeholders to have a voice in the effort to improve access to and utilization of adult immunizations.
II. Provisions of the Interim Final Rule—Department of Health and Human Services
A. Medicare Coding and Payment for COVID–19 Vaccine
The IFC provides a detailed explanation as to why it is imperative for Medicare beneficiaries to have access to a COVID-19 vaccine without cost sharing. It is consistent with the intent of Congress in the CARES Act and it comports with FDA authority and guidance around the use of a vaccine that is found to be safe and effective during a public health emergency (PHE) period.
Specifically, the IFR states, “That is, even though section 3713 of the CARES Act refers to a COVID–19 vaccine ‘‘licensed under section 351 of the PHS Act,’’ CMS could consider any vaccine for which FDA issued an EUA during the PHE, when furnished consistent with terms of the EUA, to be eligible for Medicare coverage and payment. We consider our interpretation of section 3713(d) of the CARES Act to be consistent with Congress’ intent to provide for Medicare coverage without deductible or coinsurance of any COVID–19 vaccine (and its administration) that FDA has authorized to be introduced into interstate commerce, which would be the case both for a vaccine for which emergency use is authorized under section 564 of the FD&C Act and for a vaccine that is licensed under section 351 of the PHS Act. Our interpretation also would be consistent with Congress’ general intent in the CARES Act and other recent legislation to provide for rapid coverage of COVID–19 vaccines.” AVAC strongly supports this interpretation and urges CMS to communicate instructions to Medicare providers and suppliers in order to ensure timely beneficiary access to COVID–19 vaccines.
Our coalition also strongly supports the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommendations in determining priority groups and phases for vaccine distribution and providing additional guidance to immunizing providers during this process.
4. Implementation and Methods of Coding and Payment for COVID–19 Vaccine and Administration
The IFR also addresses provider reimbursement rates for the cost of a COVID-19 vaccine and its administration. AVAC urges CMS to value CPT codes for administration that reflect the relative value of the additional practice expenses specific to COVID-19 vaccine administration. These new vaccines have varying storage, handling, and administration requirements that make them more expensive than routine immunizations, such as flu and pneumococcal. COVID-19 vaccines will also require that more time and resources are dedicated to patient and caregiver counseling and education. Adequate reimbursement that reflects these additional costs is essential to ensuring widespread access to COVID-19 vaccines across the immunization neighborhood. It is likely that current Medicare rates for vaccine administration will not sufficiently account for the resources required to successfully implement COVID-19 vaccination efforts in the provider setting.
AVAC is also concerned that immunizations received by Medicare Advantage beneficiaries will not be reported back to the plans due to the fact that providers are directed to submit claims for COVID-19 vaccines directly to the MAC. Requiring providers to report immunizations to the regional MAC not only presents an additional burden on the provider but also could result in gaps in data in terms of the patient health record. Medicare Advantage plans would not have access to claims data that they would process under ordinary circumstances, such as what vaccine the patient received and when. This data is important not only for ensuring beneficiary adherence to vaccine schedule completion (through the use of reminders and other direct beneficiary outreach) but can also be extremely valuable for vaccine safety monitoring. AVAC urges CMS to maintain the current provider claims process for vaccine administration for Medicare Advantage plan beneficiaries and to have the MA plans and the MACs manage the Medicare fee-for-service payment process on the back end. Doing so will ensure that plans have access to important patient data and that providers will be relieved of an additional burden that will complicate billing and timely reimbursement for Medicare Advantage beneficiaries.
AVAC also encourages CMS to take corrective action on disparities in vaccine administration rates for routinely recommended vaccines, such as influenza, pneumococcal, and hepatitis B (for at risk patients) through the IFR. Over the past several years, AVAC has noted the decline in Medicare Part B vaccine administration rates, commenting on the 2019 and 2020 proposed physician fee schedule (PFS) rules and during a telephone conference with members of the HAPG on May 26, 2020. The 2019 final PFS rule stated, “We recognize that it is in the public interest to ensure appropriate payments to physicians and other practitioners for provision of the immunization administration services that are used to deliver vaccines and plan to review the valuations for these services to ensure appropriate payment.” However, the final 2020 PFS rule abandoned a proposal to decouple the practice expense RVU for vaccine administration from therapeutic injection (96372) to crosswalk the valuation of vaccine administration CPT codes 90460, 90471, and 90473 and HCPCS codes G0008, G0009, and G0010 to CPT code 36000 (Introduction of needle or intracatheter, vein). It is important that providers are adequately compensated for their efforts to implement vaccination strategies to immunize patients safely during this pandemic and that will remain as providers work to restore immunization coverage rates for other routinely recommended vaccines to pre-pandemic levels, or better. AVAC urges CMS to use existing emergency authority under the PHE to immediately increase the values of HCPCS codes G0008, G0009, and G0010. The pandemic has placed a significant financial burden on many immunizing providers and we cannot afford to undermine their ability to offer access to immunization services, especially the COVID-19 vaccine. Patients rely on their health care providers for advice and their trusted voices and leadership in this effort will be essential.
B. COVID–19 Vaccine Coverage for Medicaid, CHIP, and BHP Beneficiaries
The IFR also notes that states receiving a temporary 6.2 percent increase in the Federal Medical Assistance Percentage (FMAP) rate are required to cover COVID–19 testing services and treatments, including the vaccines and the administration, for Medicaid enrollees without cost sharing. The IFR also indicates that states must compensate Medicaid providers with a vaccine administration fee or reimbursement for a provider visit. According to the Families First COVID Relief Act (FFCRA), the increase, and the requirements associated with it, is available through the end of the quarter in which the PHE for COVID–19 ends.
We regret that the IFR does not apply to all Medicaid beneficiaries. Specifically, “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 to only a narrow range of benefits that would not otherwise include these services. FFCRA section 6008(b)(4) did not amend the varying benefits packages that are required for different Medicaid eligibility groups under section 1902(a)(10) of the Act.” We are concerned that these patients will not have access to the COVID-19 vaccine and believe that it was Congress’ intent to guarantee that all Medicaid beneficiaries have access. AVAC strongly recommends that CMS correct this interpretation and provide clear guidance that states must cover COVID-19 vaccines without cost sharing for all Medicaid beneficiaries, regardless of their benefit or waiver category, and regardless of whether the vaccine was authorized under an EUA or received full FDA approval.
Lastly, we appreciate that Provider Relief Funds have been made available to compensate providers for COVID-19 vaccine administration costs for uninsured populations. However, we would note that, to date, providers have found the process for seeking reimbursement for other COVID related diagnostic and treatment services to be slow and burdensome. AVAC urges CMS to work with HRSA to streamline and expedite this program so uninsured populations, many of whom are at higher risk of COVID-19 disease, complications, and death, have timely and equitable access to the vaccine.
Now more than ever, immunizations are a public health imperative and ensuring that immunization providers are properly reimbursed is key to fostering a sustained environment of timely immunization now and in the future. Vaccine administration by health care providers at the point of care is an opportunity that needs to be maintained and encouraged during the COVID-19 pandemic and beyond. It is imperative that we work across all segments of government and the health care system to build and support a better system for immunization services that is not only safe and effective but is also accessible and equitable for everyone.
We appreciate this opportunity to share our perspective on the proposed rule and are grateful for your work to update and streamline the quality measurement tools available to providers. Please contact an AVAC Coalition Manager at (202) 540-1070 or email@example.com if you wish to further discuss our comments. To learn more about the work of AVAC, visit www.adultvaccinesnow.org.
Alliance for Aging Research
American Academy of Family Physicians
Asian & Pacific Islander American Health Forum
Association of Asian Pacific Community Health Organizations (AAPCHO)
Association of Immunization Managers
Biotechnology Innovation Organization (BIO)
Families Fighting Flu
Hep B United
Hepatitis B Foundation
Immunization Action Coalition
Infectious Diseases Society of America
Kimberly Coffey Foundation
National Association of Nutrition and Aging Services Programs
National Consumers League
National Viral Hepatitis Roundtable
The AIDS Institute
Trust for America’s Health
Vaccinate Your Family