As FDA Holds Emergency Use Authorization Meetings, Spanberger, Johnson Push for Guaranteed Access to Free COVID-19 Vaccine for Medicare Beneficiaries, Passage of SAVE for Seniors Act

Dec 08, 2020
Healthcare
Press

 WASHINGTON, D.C. – U.S. Representatives Abigail Spanberger (D-VA-07) and Dusty Johnson (R-SD-AL) today pushed congressional leadership to pass their bipartisan Securing Affordable Vaccines Equally (SAVE) for Seniors Act to make sure seniors on traditional Medicare have access to a future COVID-19 vaccine without cost-sharing.

The SAVE for Seniors Act would clarify that Medicare must cover – without cost-sharing – a COVID-19 vaccine authorized for emergency use, just as it would do for one licensed under the Public Health Service Act. By closing this loophole, the legislation ensures that seniors are not the only group who must pay out-of-pocket for a COVID-19 vaccine. Nearly all private insurers have committed to covering a COVID-19 vaccination for free, and Medicaid is required to do so at no cost.

“Seniors, individuals with disabilities, and those with chronic and complex health conditions are more at risk of suffering severe illness from COVID-19, and many of these individuals receive health coverage through Medicare,” said Spanberger and Johnson. “According to data from the Centers for Disease Control and Prevention (CDC), 8 out of 10 deaths reported in the U.S. from COVID-19 have been in adults 65 years of age or older. Residents and employees of long-term care facilities are especially vulnerable to the virus, and have accounted for 40% of deaths nationwide. On December 1st, the CDC announced that long-term care residents – many of whom are Medicare beneficiaries – will be the highest priority to receive the vaccine, with seniors and those with underlying conditions next on the list.

Their letter continues, “Congress must act to clarify that Medicare beneficiaries will not face out-of-pocket costs for a vaccine, regardless of its pathway to market. There is an abundance of research showing that cost sharing causes patients to delay or forgo care. Since both vaccine candidates require two doses and two visits to a provider, removing financial barriers is especially important to ensure individuals complete the full course of immunization.”

The CARES Act, which became law in March 2020, requires Medicare to cover a COVID-19 vaccine without any cost-sharing for the beneficiary, beginning on the date that said vaccine is licensed under Section 351 of the Public Health Service Act. However, due to the urgency of the ongoing pandemic, the most likely pathway to market for a COVID-19 vaccine is through an Emergency Use Authorization, under Section 564 of the Federal Food Drug and Cosmetic Act. In September 2020, the U.S. Department of Health and Human Services (HHS) raised concerns that due to language in the CARES Act, traditional Medicare beneficiaries might face cost-sharing for a COVID-19 vaccine that is authorized for emergency use under the Federal Food Drug and Cosmetic Act.

Spanberger and Johnsons introduced the SAVE for Seniors Act in October 2020. The bipartisan bill is cosponsored by U.S. Representatives Chrissy Houlahan (D-PA-06), Elissa Slotkin (D-MI-08), and Brian Fitzpatrick (R-PA-08).

Click here to read the letter, and the full letter text is also below.

Dear Speaker Pelosi and Leader McCarthy,

We urge you to pass the Secure Affordable Vaccines Equally (SAVE) for Seniors Act (H.R. 8623) ahead of any decision by the Food and Drug Administration (FDA) to authorize a COVID-19 vaccine for emergency use. The SAVE for Seniors Act fixes a loophole in the CARES Act that could cause Medicare beneficiaries to face cost sharing for a vaccine authorized for emergency use rather than licensed under the Public Health Service Act.

Seniors, individuals with disabilities, and those with chronic and complex health conditions are more at risk of suffering severe illness from COVID-19, and many of these individuals receive health coverage through Medicare. According to data from the Centers for Disease Control and Prevention (CDC), 8 out of 10 deaths reported in the U.S. from COVID-19 have been in adults 65 years of age or older. Residents and employees of long-term care facilities are especially vulnerable to the virus, and have accounted for 40% of deaths nationwide. On December 1st, the CDC announced that long-term care residents – many of whom are Medicare beneficiaries – will be the highest priority to receive the vaccine, with seniors and those with underlying conditions next on the list.

Congress must act to clarify that Medicare beneficiaries will not face out-of-pocket costs for a vaccine, regardless of its pathway to market. There is an abundance of research showing that cost sharing causes patients to delay or forgo care. Since both vaccine candidates require two doses and two visits to a provider, removing financial barriers is especially important to ensure individuals complete the full course of immunization.

There is no time to waste. The FDA has scheduled meetings to discuss Emergency Use Authorizations (EUAs) for Pfizer’s and Moderna’s vaccine candidates on December 10th and 17th respectively. Once the EUAs are granted, vaccines will start being shipped to providers within hours and administered to priority patients shortly thereafter.

Again, we urge you to act quickly to ensure Medicare beneficiaries do not face barriers to receiving any eventual COVID-19 vaccine by passing SAVE for Seniors as soon as possible.

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