[Federal Register Volume 71, Number 129 (Thursday, July 6, 2006)]
[Rules and Regulations]
[Pages 38264-38266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-6029]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 413
[CMS-1531-F]
RIN 0938-AO35
Medicare Program; Revision of the Deadline for Submission of
Emergency Graduate Medical Education Affiliation Agreements
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This final rule responds to comments on and revises the
deadline for submission of the 2006 emergency Medicare graduate medical
education (GME) affiliation agreements. The deadlines to submit the
emergency Medicare GME affiliation agreements for the 2005 through 2006
and 2006 through 2007 academic years are changed from on or before June
30, 2006 and July 1, 2006, respectively, to on or before October 9,
2006.
DATES: These regulations are effective on June 30, 2006.
FOR FURTHER INFORMATION CONTACT: Elizabeth Truong, (410) 786-6005.
SUPPLEMENTARY INFORMATION:
I. Background
A. Legislative and Regulatory History
The stated purpose of section 1135 of the Social Security Act (the
Act) is to enable the Secretary to ensure, to the maximum extent
feasible, in any emergency area and during an emergency period, that
sufficient health care items and services are available to meet the
needs of enrollees in Medicare, Medicaid, and the State Children's
Health Insurance Program (SCHIP). Section 1135 of the Act authorizes
the Secretary, to the extent necessary to accomplish the statutory
purpose, to temporarily waive or modify the application of certain
types of statutory and regulatory provisions (such as conditions of
participation or other certification requirements, program
participation or similar requirements, or pre-approval requirements)
with respect to health care items and services furnished by health care
provider(s) in an emergency area during an emergency period.
The Secretary's authority under section 1135 of the Act arises in
the event there is an ``emergency area'' and continues during an
``emergency period'' as those terms are defined in the statute. Under
section 1135(g) of the Act, an emergency area is a geographic area in
which there exists an emergency or disaster that is declared by the
President according to the National Emergencies Act or the Robert T.
Stafford Disaster Relief and Emergency Assistance Act, and a public
health emergency declared by the Secretary according to section 319 of
the Public Health Service Act. (Section 319 of the Public Health
Service Act authorizes the Secretary to declare a public health
emergency and take the appropriate action to respond to the emergency,
consistent with existing authorities.) Throughout the remainder of this
discussion, we will refer to such emergency areas and emergency periods
as ``section 1135'' emergency areas and emergency periods.
When Hurricane Katrina occurred on August 29, 2005, disrupting
health care operations and medical residency training programs at
teaching hospitals in New Orleans and the surrounding area, the
conditions were met for an emergency area and emergency period under
section 1135(g) of the Act. Under section 1135 of the Act, the
Secretary was then authorized to waive a number of provisions to ensure
that sufficient services would be available in the section 1135
emergency area to meet the needs of Medicare, Medicaid, and SCHIP
patients. Shortly after Hurricane Katrina occurred, we were informed by
hospitals in New Orleans that the training programs at many teaching
hospitals in the city were closed or partially closed as a result of
the disaster and that the displaced residents were being transferred to
training programs at host hospitals in other parts of the country. For
purposes of discussion in this rule, a host hospital is a hospital that
trains residents displaced from a training program in a section 1135
emergency area. A home hospital is a hospital that meets all of the
following: (1) Is located in a section 1135 emergency area, (2) had its
inpatient bed occupancy decreased by 20 percent or more due to the
disaster so that it is unable to train the number of residents it
originally intended to train in that academic year, and (3) needs to
send the displaced residents to train at a host hospital.
In the April 12, 2006 Federal Register (71 FR 18654), we published
an interim final rule with comment period to modify the Graduate
Medical Education (GME) regulations as they apply to Medicare GME
affiliations to provide for greater flexibility during times of
disaster. Specifically, the interim final rule implemented the
emergency Medicare GME affiliated group provisions to address issues
that may be faced by certain teaching hospitals in the event that
residents who would otherwise have trained at a hospital in an
emergency area (as that term is defined in section 1135(g) of the
Social Security Act (the Act)) are relocated to alternate training
sites. To provide home hospitals with more flexibility to train
displaced residents at various sites, and to allow host hospitals to
count displaced residents for IME and direct GME, home hospitals may
enter into emergency Medicare GME affiliation agreements effective
retroactive to the date of the first day of the section 1135 emergency
period.
B. Requirements for Issuance of Regulations
Section 902 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) amended section 1871(a)(3) of the Act
and requires the Secretary, in consultation with the Director of the
Office of Management and Budget, to establish and publish timelines for
the publication of Medicare final regulations based on the previous
publication of a Medicare proposed or interim final regulation. Section
902 of the MMA also states that the timelines for these regulations may
vary but shall not exceed 3 years after publication of the preceding
proposed or interim final
[[Page 38265]]
regulation except under exceptional circumstances.
This final rule finalizes one provision set forth in the April 12,
2006 interim final rule with comment period. In addition, this final
rule has been published within the 3-year time limit imposed by section
902 of the MMA. Therefore, we believe that the final rule is in
accordance with the Congress' intent to ensure timely publication of
final regulations.
II. Provisions of the Final Rule
In this final rule we are responding to comments regarding the
deadline for submission of emergency Medicare GME affiliation
agreements and finalizing the provision from the April 12, 2006 interim
final rule with comment period, specified at Sec. 413.79(f)(6)(ii),
regarding this deadline. We will issue a separate Federal Register
document to respond to comments received and finalize the other
provisions of the April 12, 2006 interim final rule with comment
period.
In the April 12 interim final rule with comment period, we
specified that for the year during which the section 1135 emergency was
declared, each hospital participating in the emergency affiliation must
submit a copy of the emergency Medicare GME affiliation agreement, as
specified under Sec. 413.79(f)(6), to CMS and the CMS FI servicing
each hospital by the later of 180 days after the section 1135 emergency
period begins or by June 30 of the relevant training year. The interim
final rule also specified that emergency Medicare GME affiliation
agreements for the subsequent 2 academic years must be submitted by the
later of 180 days after the section 1135 emergency period begins or by
July 1 of each of the years. Furthermore, amendments to the emergency
Medicare GME affiliation agreement to adjust the distribution of the
number of full-time equivalent (FTE) residents in the original
emergency Medicare GME affiliation among the hospitals that are part of
the emergency Medicare GME affiliated group can be made through June 30
of the academic year for which they are effective.
We received a number of written comments to the interim final rule
provision regarding the timely submission of the emergency Medicare GME
affiliation agreements. A summary of the comments received on this
provision and our responses are as follows:
Comment: Commenters expressed concern that the year 2006 deadlines
for submission of the emergency Medicare GME affiliation agreements
(that is, June 30, 2006 and July 1, 2006 for the first and second
effective years, respectively) are too restrictive and impose a
hardship on hospitals that are coping with the destructive effects of
Hurricanes Katrina and Rita, which have made even basic daily
operations difficult. A commenter noted that the interim final rule
with comment period was posted for public display on April 7, 2006,
thereby giving hospitals only 84 days to negotiate and finalize
agreements that often involve multiple parties and complex calculations
to sort out the various cap transfers before the June 30, 2006
deadline.
Response: The June 30 and July 1 dates were selected at the time
the interim final rule with comment period was published based on--(1)
the current requirements for signing Medicare GME affiliation
agreements; (2) the beginning of the academic year for residency
programs, and (3) the belief that hospitals training residents were
likely to want signed affiliation agreements in effect prior to the
beginning of the residency training year. We had drafted the interim
final rule with comment period to apply, not only to hospitals affected
by the 2005 hurricanes, but to any similarly catastrophic event
affecting hospitals in the future. Accordingly, the provision was
drafted to allow hospitals until the later of 180 days after the
section 1135 emergency period begins or June 30 to submit the emergency
affiliation agreement for the academic year during the which the
emergency occurs, and until the later of 180 days after the section
1135 emergency period begins or July 1 of the relevant training year to
submit the emergency agreement for the subsequent 2 academic years. We
now recognize that the hospitals affected by Hurricanes Katrina and
Rita had only 79 days from April 12, 2006, the date that the interim
final rule with comment period appeared in the Federal Register, to
finalize their written agreements. This is a far shorter period than
180 days after the section 1135 emergency period began, which is the
period allowed by our regulations in the event of future emergencies.
We recognize and appreciate that it may not be administratively
possible for all home and host hospitals to submit to the appropriate
FIs and CMS all emergency Medicare GME affiliation agreements resulting
from Hurricanes Katrina and Rita, due on or before June 30, 2006 (for
the 2005 through 2006 academic year) and July 1, 2006 (for the 2006
through 2007 academic year) because of the limited timeframe in which
the affected hospitals had to negotiate and finalize these agreements.
Therefore, in response to the many requests for an extension on the
year 2006 deadlines, in this final rule we are revising Sec.
413.79(f)(6)(ii) to extend the deadline for emergency Medicare GME
affiliation agreements that would otherwise by required to be submitted
by June 30, 2006 or July 1, 2006 to October 9, 2006, which is 180 days
after the April 12, 2006 interim final rule with comment period.
III. Waiver of the Delay in the Effective Date
The Administrative Procedure Act (APA) normally requires a 30-day
delay in the effective date of a final rule. This delay may be waived,
however, if an agency finds for good cause that the delay is
impracticable, unnecessary or contrary to the public interest, and
incorporates a statement of the finding and the reasons for it in the
rule issued. The Secretary is subject to a similar requirement pursuant
to section 1871(e)(1)(B) of the Act.
We find that good cause exists to waive the 30-day delay in
effective date because it would be contrary to the public interest to
delay the effective date of this final rule. We believe that there is
an urgent need for the regulation changes provided in this final rule
to ensure that hospitals affected by Hurricanes Katrina and Rita do not
face dramatic disruptions in their Medicare GME funding, with possible
dire effects on their GME programs and financial stability. The
existing regulations do not provide adequate time for hospitals to
submit their emergency Medicare GME affiliation agreements for the 2005
through 2006 and the 2006 through 2007 academic years.
IV. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995.
V. Regulatory Impact Statement
We have examined the impact of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 directs agencies to assess all costs and
benefits
[[Page 38266]]
of available regulatory alternatives and, if regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety effects,
distributive impacts, and equity). A regulatory impact analysis (RIA)
must be prepared for major rules with economically significant effects
($100 million or more in any 1 year). This final rule does not reach
the economic threshold and thus is not considered a major rule. In
addition, we expect that there will not be an additional cost to the
Medicare program due to our extension of the deadline to submit 2006
emergency Medicare GME affiliation agreements to October 9, 2006.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, either by nonprofit status or by having revenues of
$6 million to $29 million in any 1 year. Individuals and States are not
included in the definition of a small entity. We are not preparing an
analysis for the RFA because we have determined that this rule will not
have a significant economic impact on a substantial number of small
entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds. We are not preparing an
analysis for section 1102(b) of the Act because we have determined that
this rule will not have a significant impact on the operations of a
substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. That threshold
level is currently approximately $120 million. This rule will have no
consequential effect on State, local, or tribal governments or on the
private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. Since this regulation does not impose any costs on State
or local governments, the requirements of E.O. 13132 are not
applicable.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 413
Health facilities, Kidney disease, Medicare, Puerto Rico, Reporting
and recordkeeping requirements.
0
For the reasons set forth in the preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR chapter IV part 413 as set forth below:
PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR
ENDSTAGE RENAL DISEASE SERVICES: PROSPECTIVELY DETERMINED PAYMENT
RATES FOR SKILLED NURSING FACILITIES
0
1. The authority citation for part 413 continues to read as follows:
Authority: Secs. 1102, 1812(d), 1814(b), 1815, 1833(a), (i), and
(n), 1861 (v), 1871, 1881, 1883, and 1886 of the Social Security Act
(42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n),
1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww) Sec. 124 of Pub. L.
106-113, 113 Stat. 1515.
Subpart F--Specific Categories of Costs
0
2. Section 413.79 is amended by revising paragraph (f)(6)(ii) to read
as follows:
Sec. 413.79 Direct GME payments: Determination of the weighted number
of FTE residents.
* * * * *
(f) * * *
(6) * * *
(ii) Deadline for submission of the emergency Medicare GME
affiliation agreement. (A) Except for emergency Medicare GME
affiliation agreements that meet the requirements of paragraph
(f)(6)(ii)(B) of this section, each participating hospital must submit
an emergency Medicare GME affiliation agreement to CMS and submit a
copy to its CMS fiscal intermediary by--
(1) First year. The later of 180 days after the section 1135
emergency period begins or by June 30 of the academic year in which the
section 1135 emergency was declared; or
(2) Two subsequent academic years. The later of 180 days after the
section 1135 emergency period begins, or by July 1 of each academic
year for the 2 subsequent academic years.
(B) For emergency Medicare GME affiliation agreements that would
otherwise be required to be submitted by June 30, 2006 or July 1, 2006,
each participating hospital must submit an emergency Medicare GME
affiliation agreement to CMS and submit a copy to its CMS fiscal
intermediary on or before October 9, 2006.
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: June 30, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: June 30, 2006.
Michael O. Leavitt,
Secretary.
[FR Doc. 06-6029 Filed 6-30-06; 4:00 pm]
BILLING CODE 4120-01-P