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Statement of Need: Section 4105 of the BBA provided for coverage of diabetes self-management training to include services provided in non-hospital-based-programs. This proposed rule would expand Medicare coverage for diabetes outpatient self-management training; define who may be a certified provider of services that may provide diabetes outpatient management training services; explain that the physician managing the patient's diabetes must certify that the services are needed under a comprehensive plan of care; and sets standards for certified providers that have been established in consultation with appropriate diabetes organizations.

Summary of the Legal Basis: Section 4105(a) of the BBA provides coverage for diabetes outpatient self-management training. Under this coverage training would include educational and training services furnished in an outpatient setting (according to frequency standards established by the Secretary) to a beneficiary with diabetes by a "certified provider" that meets certain quality standards.

Alternatives: Coverage is provided for in section 4105(a) of the BBA, therefore, no alternatives to issuing this regulation exist.

Anticipated Costs and Benefits: rojected Budget Impact of New Benefit ($ in millions): FY 1998 -- $60 FY 1999 -- $560 FY 2000 -- $230 FY 2001 -- $80 FY 2002 -- $80 An estimate of benefits has not been established.

Risks: If the diabetes self-management training is not implemented, our diabetic beneficiaries will not receive information for improving their long term health that would result from this rule.