[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]
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