The Centers for Medicare & Medicaid Services (CMS) today proposed new requirements for Medicare-certified providers that are designed to expand access to seasonal influenza vaccination.  The notice of proposed rulemaking would update the conditions of participation and conditions for coverage for a number of provider types, in an effort to increase access to the vaccine, increase the number of patients receiving annual vaccination against seasonal influenza, and to decrease flu-linked morbidity and mortality.

"Today's proposed rule will expand Medicare beneficiaries' options for where to receive a flu shot during flu season," said CMS Administrator, Donald M. Berwick, M.D. "The new requirements would make flu shots available in more of the health care facilities that Medicare beneficiaries are most likely to visit, including hospitals and rural health clinics."

This proposed rule would require many Medicare providers and suppliers to offer all patients an annual influenza vaccination during flu season, unless medically contraindicated. As always, any patient would retain the right to decline any vaccination. This proposed requirement would extend to Medicare-certified:

  • Hospitals, including Short-term Acute Care, Psychiatric, Rehabilitation, Long-Term Care, Children's, and Cancer;
  • Critical Access Hospitals (CAHs);
  • Rural Health Clinics (RHCs);
  • Federally Qualified Health Centers (FQHCs) and;
  • End-Stage Renal Disease (ESRD) Facilities that offer dialysis services.

Today's proposed rule would update the conditions of participation and conditions for coverage for all of the provider types above. These rules apply to health care organizations that seek to begin and continue participating in the Medicare and Medicaid programs. The conditions are health and safety standards that are the foundation for improving quality and protecting the health and safety of beneficiaries.   CMS implements these standards through state departments of health and accrediting organizations recognized by CMS (through a process called "deeming"), which review provider practices to assure they meet or exceed the Medicare's condition standards.

In order to meet these proposed provisions, the providers and suppliers would need to develop and implement policies and procedures for offering and administering seasonal influenza vaccine. The proposed rule does allow for situations in which vaccine supplies may be unavailable or in short supply, and recognizes that providers and suppliers could not be held accountable for providing vaccine for all patients in such circumstances.

Additionally, the proposed rule would require the included providers and suppliers to develop policies and procedures that would allow them to offer vaccinations for pandemic influenza, in case of a future pandemic influenza event for which a vaccine is developed.

"This proposal will remove barriers for Medicare beneficiaries who want to receive annual flu shots as part of their preventive health routine," said Dr. Berwick. "While CMS believes that flu vaccination is the best way to keep beneficiaries and their families safe and healthy during flu season, our proposal respects the rights of beneficiaries and their families to choose whether the flu shot is best for them. However, we hope that by expanding the breadth of places where flu shots are offered, beneficiaries will make the choice about whether to vaccinate based on health needs rather than convenience or availability." 

CMS will accept public comments on the CMS proposed rule until July 5, 2011, and will respond to comments in a final rule to be published in the coming months. To submit comments, please visit http://www., and search for rule "CMS-3213-P." 

The proposed rule is available online from the Federal Register at