Letter from HHS Secretary on COVID-19 Vaccine Coverage

To the health care payer community:

We appreciate the strong partnership on transitioning COVID-19 vaccines from government distribution to traditional health care distribution channels.  Unfortunately, some consumers are experiencing insurance coverage denials when seeking the updated COVID-19 vaccines, and I am writing to ask for continued partnership and also want to remind you of legal obligations for coverage of the vaccines.

As you know, this is the first season where COVID-19 vaccines are being distributed in the traditional health care distribution channels. We began preparing for this over a year ago to ensure a smooth transition for the updated COVID-19 vaccines. I spoke with many of you about this transition on an August 30, 2022 webinar that kicked off a series of webinars and meetings held by my Department with plans, issuers, pharmacy benefit managers, pharmacists, and providers. And the Administrator of the Centers for Medicare & Medicaid Services (CMS) wrote to you on July 13, 2023, reminding you of coverage requirements and requesting that you begin working on getting your systems ready.¹

Upon the first reports of these problems late last week, CMS reached out to all of you, and again reminded you on September 20, 2023, that the requirement for most plans and issuers to cover the updated COVID-19 vaccines from Pfizer and Moderna without cost sharing became effective immediately upon FDA authorization or approval of these vaccines on September 11, 2023.²

Since that time, I know my team—including CMS—has been in close contact with you, now on a daily basis.  I also know that parts of these challenges are beyond your control.  We will continue to be in daily communication with pharmacies and pharmacy benefit managers until these problems get resolved.

Because some of these issues appear to be beyond your direct control, you may share our frustration with these problems.  But some of these issues may be within your control, or the control of your partners.  I want to underscore that my team stands ready to partner and problem solve wherever possible under our existing authorities.  And most importantly, whether the problems are directly within your organization’s control or the control of your partners, your obligation as a plan or issuer to ensure that your members have coverage for COVID-19 vaccines without cost sharing is not conditional upon other parties’ compliance with applicable requirements.

I also know that, with the end of the public health emergency, the requirement to cover COVID-19 vaccinations furnished by out-of-network providers generally has ended.³  However, if a plan or issuer does not have a provider in its network who can provide a qualifying coronavirus preventive service, the plan or issuer must cover the item or service when furnished by an out-of-network provider and may not impose cost sharing with respect to the item or service.⁴  We want to underscore the public health importance of reducing barriers to coverage however possible and urge you to consider any and all ways to reduce these barriers. It is critical to help your members navigate your network, particularly to help people understand the differences between your medical and pharmacy network as appropriate.  We know you are already looking for ways to smooth these issues and hope that will continue. In the meantime, we will do our part to urge consumers to seek in-network providers when possible.

In closing, I would remind you that we should be completely aligned in our goals of getting everyone the updated COVID-19 vaccine.  According to CDC, for every 10,000 vaccinations given to people 65 and over last winter, about 40 hospitalizations are prevented.  With claims rejections in the thousands each day, we are missing opportunities to save lives together. 

I stand ready to partner with you however we can and urge you to act as quickly as possible.  In the meantime, I am urging consumers to reach out to their plans or issuers so that you can meet your obligations as easily as possible.

Endnotes

¹  https://www.hhs.gov/about/news/2023/07/13/cms-administrator-brooks-lasure-letter-to-payors-regarding-coverage-covid-19-vaccines-post-commercialization.html.

²  See FAQs about Affordable Care Act Implementation Part 50, Health Insurance Portability and Accountability Act and Coronavirus Aid, Relief, and Economic Security Act Implementation (Oct. 4, 2021), Q1, available at https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-50.pdf and https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-50.pdf. See also FAQs about Families First Coronavirus Response Act, Coronavirus Aid, Relief, and Economic Security Act, and Health Insurance Portability and Accountability Act Implementation Part 58 (Mar. 29, 2023), Q4, available at https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-58.pdf and https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-58.pdf.

³  See 26 CFR 54.9815-2713(a)(3)(ii), 29 CFR 2590.715-2713(a)(3)(ii), 45 CFR 147.130(a)(3)(ii).

⁴  FAQs about Families First Coronavirus Response Act, Coronavirus Aid, Relief, and Economic Security Act, and Health Insurance Portability and Accountability Act Implementation Part 58 (Mar. 29, 2023), Q4, available at https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-58.pdf and https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-58.pdf.