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Statement of Need: The Health Care Financing Administration (HCFA) received over 20,000 comments on this issue after publication of the notice of proposed rulemaking (NPRM), December 19, 1997. Since that time, interested parties (CRNAs vs. anesthesiologists) have urged congressional action in support of their respective positions, and public debate has been heavy on either side of the issue. In addition, the public has urged HCFA to publish a final rule.

Summary of the Legal Basis: Sections 1861(e)(1) through (e)(8) of the Social Security Act (the Act) provide that a hospital participating in the Medicare program must meet certain specified requirements. Section 1861 (e)(9) of the Act specified that a hospital also must meet such other requirements as the Secretary finds necessary in the interests of the health and safety of the hospital's patients. Section 1820 of the Act contains criteria for application for States establishing a Critical Access Hospital. Sections 1832(a)(2)(f)(I) and 1833(I) provide coverage requirements for ASCs. Section 1861 (bb) of the Act provides definitions for CRNAs and their services.

Alternatives: The only alternative available at this time would be to not publish the final rule and maintain the existing requirement. However, in consideration of public comments on the NPRM and available scientific research studies, we believe it is necessary to publish a final rule allowing flexibility by referring to State law on the issue of CRNA practice. Sound evidence does not exist to necessitate maintaining the current requirement of physician supervision of CRNAs during anesthesia delivery in every situation. Nor is there evidence that States have been negligent in their duty to regulate health professional practice or have failed to protect the safety of their citizens.

Anticipated Costs and Benefits: There is negligible budget impact on the Medicare and Medicaid programs associated with the implementation of this final rule. This rule does not change the Medicare payment policies or fee schedules for anesthesia services provided by anesthesiologist or CRNAs. Anesthesiologists will continue to be paid as they currently are, for independent practice or for medical direction of CRNAs. CRNAs will continue to be paid on the current fee schedule that allows for independent practice. The flexibility resulting from this rule could provide increased access to anesthesia services in some areas in hospitals, critical access hospitals (CAHs), and ASCs. It removes the burden of implementing a Federal requirement for physician supervision of CRNAs in all cases. It will allow hospitals, CAHs, and ASCs the flexibility within the authority of State licensing laws to implement best practice protocols in providing anesthesia services most associated with positive patient outcomes. Moreover, hospitals are free to exercise stricter practice standards. This provision does not lend itself to a quantitative impact estimate and we do not anticipate a substantial economic impact either in cost or savings.

Risks: If we do not publish the final rule, we anticipate Congress may pass legislation in response to pressure from public interest groups.