[Federal Register Volume 66, Number 50 (Wednesday, March 14, 2001)]
[Rules and Regulations]
[Pages 14861-14862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6310]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 410, 414, 424, 480, and 498

[HCFA-3002-CN]
RIN 0938-AI96


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.

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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, (410) 786-6939.

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.


[[Page 14862]]


    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.
[FR Doc. 01-6310 Filed 3-13-01; 8:45 am]
BILLING CODE 4120-01-P