01-6310. Medicare Program; Expanded Coverage for Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements

AGENCY:

Health Care Financing Administration (HCFA), HHS.

ACTION:

Final rule; correction and confirmation of effective date.

SUMMARY:

In the December 29, 2000 issue of the Federal Register (65 FR 83130), we published a final rule that implements section 4105 of the Balanced Budget Act by expanding Medicare coverage for outpatient diabetes self-management training and establishes outcome measurements for evaluating the improvement of the health status of Medicare beneficiaries with diabetes. The final rule provided for a 60-day delay from the publication date in implementing the expanded coverage of the diabetes training; that is, February 27, 2001. We unknowingly delayed forwarding our report on the final rule to the Congress for review under 5 U.S.C. 801(a) at the time we published the final rule. This document reaffirms that the final rule, and its expansion of Medicare coverage for outpatient diabetes self-management training, went into effect on February 27, 2001, notwithstanding the delay in forwarding our report to the Congress. It also corrects cost assumptions that were overstated in the final rule.

DATES:

The effective date of the final rule published December 29, 2000 (65 FR 83130), is confirmed as February 27, 2001.

FOR FURTHER INFORMATION CONTACT:

Mary Stojak, [phone].

SUPPLEMENTARY INFORMATION:

In the December 29, 2000 issue of the Federal Register (65 FR 83130), we published a final rule that implements section 4105 of the Balanced Budget Act by expanding Medicare coverage for outpatient diabetes self-management training and establishes outcome measurements for evaluating the improvement of the health status of Medicare beneficiaries with diabetes. Under the congressional review provisions of 5 U.S.C. Chapter 8, the Administrator of the Office of Management and Budget's Office of Information and Regulatory Affairs determined that the final rule was a “major rule” as defined in 5 U.S.C. 804(2). In accordance with 5 U.S.C. 801(a)(3), we provided a 60-day delay period for the final rule's effective date, so that the final rule was effective on February 27, 2001.

We recently learned that we inadvertently overlooked forwarding our report to the Congress under 5 U.S.C. 801(a) at the time of the final rule's publication. The Congress subsequently received our report on February 13, 2001. Therefore, under 5 U.S.C. 801(a)(3), the general consequence of this delay would be that the effective date would no longer be February 27, 2001, but instead would be April 14, 2001, which is 60 days after the Congress received our report.

Under 5 U.S.C. 808(2), however, we find, for good cause, that a second, additional 60-day delay in the final rule's effective date would be contrary to the public interest. There has already been one 60-day effective-date delay period. As we have noted, our failure to submit the report to Congress on a timely basis was an inadvertent administrative oversight. We have reviewed and reinforced our administrative procedures to ensure that this does not occur again. An additional 60-day delay in the effective date would directly harm Medicare beneficiaries with diabetes who are eligible for the self-management training. Under the terms of the final rule, Medicare coverage for persons with diabetes was expanded on February 27, 2001. An additional 60-day delay in the effective date would therefore delay this expansion in coverage and preclude eligible beneficiaries with diabetes from receiving needed training for another 60 days. Medicare beneficiaries who have diabetes and are eligible for training should not be disadvantaged as a result of an administrative oversight. All interested parties have supported this expansion of Medicare coverage for beneficiaries with diabetes. Moreover, while the final rule was determined at its issuance to be a “major” economic rule (and thus subject to the 60-day minimum effective date), our actuaries have recently reviewed the impact analysis again. Based on this recent review, our actuaries believe that some of their cost assumptions overstated the likely costs of the rule. In particular, the actuaries believe that their previous analysis overstated the likely level of utilization by beneficiaries of the new benefit. The current estimate by our actuaries is that the final rule does not reach the $100 million threshold for a major economic rule. Indeed, it will have an annual impact of less than $100 million in any one year ($45 million in FY2001, $90 million in FY2002, $80 million in FY2003, $95 million in FY2004, and $95 million in FY2005).

The Office of Management and Budget (OMB) stated in its March 30, 1999 government-wide guidance to agencies on the Congressional Review Act (OMB Memorandum M-99-13), that use of the waiver authority in section 808(2) could be considered, on a case-by-case basis, in the case of final rules for which the rulemaking agency had previously requested public comment (as occurred in this case). Based on the OMB Memorandum, and for the reasons we have outlined above, we find that delaying the effective date for this major final rule for another 60 days would be contrary to the public interest, and therefore, find that there is good cause for invoking Section 808(2) and retaining the final rule's original effective date of February 27, 2001. In arriving at this decision, we have consulted with OMB, which concurs with this conclusion.

Authority: Section 1848 of the Social Security Act (42 U.S.C. 1395w-4).

(Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program)

Dated: March 8, 2001.

Brian P. Burns,

Deputy Assistant Secretary for Information Resources Management.