Medicare Program; Withdrawal of Ambulance Fee Schedule Issued in Accordance With Federal District Court Order in Lifestar Ambulance, Inc., 52105-52108 [05-17278]
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[FR Doc. 05–17410 Filed 8–31–05; 8:45 am]
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52105
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1308–NC]
RIN 0938–AN94
Medicare Program; Withdrawal of
Ambulance Fee Schedule Issued in
Accordance With Federal District Court
Order in Lifestar Ambulance, Inc. v.
United States, No. 4:02-CV–127–1 (M.D.
Ga., Jan. 16, 2003)—Medicare Covered
Ambulance Services
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
AGENCY:
SUMMARY: This notice with comment
period withdraws the fee schedule that
was put in place in 2003 to effect
compliance with the Order in Lifestar
Ambulance, Inc. v. United States. [211
F.R.D. 688 (M.D. Ga. 2003)] That Order
was vacated on January 10, 2005 by the
U.S. Court of Appeals for the Eleventh
Circuit and is no longer in force.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on October 31, 2005.
ADDRESSES: In commenting, please refer
to file code CMS–1308–NC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (no duplicates, please):
1. Electronically. You may submit
electronic comments to https://
www.cms.hhs.gov/regulations/
ecomments or to https://
www.regulations.gov (attachments
should be in Microsoft Word,
WordPerfect, or Excel; however, we
prefer Microsoft Word).
2. By mail. You may mail written
comments (one original and two copies)
to the following address ONLY: Centers
for Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–1308–NC,
P.O. Box 8011, Baltimore, MD 21244–
1850.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments (one
original and two copies) to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–1308–NC, Mail Stop C4–26–05,
7500 Security Boulevard, Baltimore, MD
21244–1850.
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Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Notices
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments (one original
and two copies) before the close of the
comment period to one of the following
addresses. If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
7197 in advance to schedule your
arrival with one of our staff members.
Room 445–G, Hubert H. Humphrey
Building, 200 Independence Avenue,
SW., Washington, DC 20201; or
7500 Security Boulevard, Baltimore, MD
21244–1850.
(Because access to the interior of the
Humphrey Building is not readily
available to persons without Federal
Government identification, commenters
are encouraged to leave their comments
in the CMS drop slots located in the
main lobby of the building. A stamp-in
clock is available for persons wishing to
retain a proof of filing by stamping in
and retaining an extra copy of the
comments being filed.)
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
EFFECTIVE DATE: This notice is effective
on September 1, 2005.
FOR FURTHER INFORMATION CONTACT:
Anne Tayloe, (410) 786–4546.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome
comments from the public on all issues
set forth in this rule to assist us in fully
considering issues and developing
policies. You can assist us by
referencing the file code CMS–1308–NC
and the specific ‘‘issue identifier’’ that
precedes the section on which you
choose to comment.
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. CMS posts all electronic
comments received before the close of
the comment period on its public Web
site as soon as possible after they have
been received. Hard copy comments
received timely will be available for
public inspection as they are received,
generally beginning approximately 3
weeks after publication of a document,
at the headquarters of the Centers for
Medicare & Medicaid Services, 7500
Security Boulevard, Baltimore,
Maryland 21244, Monday through
Friday of each week from 8:30 a.m. to
VerDate Aug<18>2005
16:30 Aug 31, 2005
Jkt 205001
4 p.m. To schedule an appointment to
view public comments, phone 1–800–
743–3951.
I. Background
[If you choose to comment on issues
in this section, please include the
caption ‘‘BACKGROUND’’ at the
beginning of your comments.]
Section 4531 of the Balanced Budget
Act of 1997 (BBA) required the
Secretary of the Department of Health
and Human Services (HHS) (the
Secretary) to establish a national fee
schedule (FS) for payment of ambulance
services through a negotiated
rulemaking process. The statute
provides that the Secretary phase in the
application of payment rates under the
FS in a fair and efficient manner and
that the aggregate amount of payment
for the services under the new FS not
exceed the amount that would be paid
under the old system as stated in section
1834(l) of the Social Security Act (the
Act). The BBA provided that the FS
would apply to services furnished on or
after January 1, 2000.
The proposed and final FS rules both
provided for payment for ambulance
services to be made in two parts: (1) A
base rate; and (2) a payment for mileage.
Section 423 of the Medicare, Medicaid
and SCHIP Benefits Improvement and
Protection Act of 2000 (BIPA), which
was passed after the publication of the
proposed FS rule and prior to the
publication of the final rule, provided
that during the phase-in of the FS there
would be full payment of any national
mileage rate for ambulance services
furnished by suppliers in States where
the Medicare carrier did not previously
pay separately for all mileage within the
county from which the beneficiary is
transported (‘‘BIPA mileage provision’’).
Two States were identified as qualifying
under this provision: North Carolina
(NC) and Tennessee (TN). BIPA
specifies that this provision applies to
services furnished on or after July 1,
2001.
This FS was implemented on April 1,
2002 by a final rule published in the
Federal Register on February 27, 2002
(67 FR 9100). As stated in the final rule,
the phase-in is accomplished over five
years by blending a percentage of the
payment that is based on the old
payment system with a percentage of
the payment based on the FS according
to the following schedule:
Year
Old
(percent)
FS
(percent)
4/1/2002–12/
31/2002
2003
2004
80
20
60
40
40
60
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Year
Old
(percent)
FS
(percent)
2005
2006
20
0
80
100
The full national FS mileage rate in
those States that qualify for BIPA
provision section 423 (NC, TN) was paid
as of April 1, 2002.
In Lifestar Ambulance Service, Inc. v.
United States, 211 F.R.D. 688 (M.D. Ga.
2003), three ambulance suppliers
seeking to represent a nationwide class
of ambulance suppliers sued the
Secretary, arguing that he had no
discretion to give the FS an effective
date other than January 1, 2000. The
district court agreed with the plaintiff
suppliers and issued an order certifying
a nationwide class of ambulance
suppliers and requiring the Secretary to
adopt a FS for the January 1, 2000,
through March 31, 2002 period. The
court’s decision also required the
Secretary to pay full mileage under the
BIPA provision for the July 1, 2001
through March 31, 2002 period.
On April 16, 2003, the Secretary
issued a notice in compliance with the
district court’s order. (68 FR 18654) The
Secretary established a FS based on the
FS as described in the Federal Register
(67 FR 9100), with a modified phase-in
as follows:
Year
Old
(percent)
FS
(percent)
2000
2001
1/1/2002–3/31/
2002
95
90
80
5
10
20
Additionally, under the district
court’s order, the notice stated that the
Medicare program would pay full BIPA
mileage for services provided on or after
July 1, 2001. The notice stated that the
Secretary had appealed the decision in
Lifestar and that any FS or BIPA mileage
payment made under the notice for the
January 1, 2000 through March 31, 2002
period would be subject to recoupment
if the district court’s decision was
reversed on appeal. The Secretary has
not made any payments under this FS.
In addition, we are not aware of any
ambulance suppliers seeking payment
under this FS prior to the Eleventh
Circuit’s reversal of the district court
decision, although some were seeking
full mileage under the BIPA mileage
provision.
On appeal, the Eleventh Circuit found
that the district court had lacked
jurisdiction over the case because the
plaintiffs had not gone through the
administrative process before filing suit.
See Lifestar Ambulance Service, Inc. v.
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United States, 365 F.3d 1293 (11th Cir.
2004), cert. denied, -US-, 125 S.Ct. 866
(Jan 10, 2005). It reversed and vacated
the district court decision and
remanded the case with instructions to
dismiss for lack of subject-matter
jurisdiction. Plaintiffs unsuccessfully
sought rehearing en banc and Supreme
Court review. The district court
dismissed the complaint in accordance
with the Eleventh Circuit’s mandate on
February 2, 2005.
II. Provisions of the Notice With
Comment Period
[If you choose to comment on issues
in this section, please include the
caption ‘‘PROVISIONS’’ at the
beginning of your comments.]
The purpose of this notice is to
withdraw the FS covering the period of
January 1, 2000 through March 31, 2002
that was published in the April 16, 2003
notice. As we stated explicitly in the
April 16, 2003 notice, we only issued
this ambulance fee schedule to comply
with the Lifestar district court order and
that order was vacated and the Lifestar
case dismissed. Although the April 16,
2003 notice clearly states that payment
under the FS for the January 1, 2000
through March 31, 2002 period is
dependent on the district court opinion
not being reversed by the Eleventh
Circuit Court of Appeals, refraining
from formally withdrawing the FS for
this period could create unnecessary
confusion.
In light of our inability to issue a fee
schedule by January 1, 2000, we
continue to believe that giving the fee
schedule prospective application clearly
meets the intent of the Congress. The
Congress made no indication that it
wanted us to apply the base rate or the
mileage provisions of the FS
retroactively in the event that we were
unable to issue the final FS by January
1, 2000. Also, given ample opportunity,
the Congress did not provide specific
direction regarding this issue after the
January 1, 2000 date passed. The
Congress itself took no further action on
the issue (such as directing the
implementation of its own version of an
ambulance fee schedule).
Furthermore, the BBA directed the
Secretary to phase in the application of
the payment rates under the fee
schedule in an efficient and fair manner
and required that payments under the
schedule in the year 2000 not exceed
the inflation-adjusted expenditures that
were made under the prior statute as
stated in section 1834(l) of the Act. The
FS was to reallocate expenditures
among ambulance providers and
suppliers in a manner that did not result
in an increase in aggregate payments for
VerDate Aug<18>2005
16:30 Aug 31, 2005
Jkt 205001
ambulance services (for example, some
providers and suppliers would have
received higher payments, others would
have received lower payments, and the
changes would have offset each other.)
Only additional payments made under
the BIPA mileage provision were not
required to meet this criteria. Applying
the FS to the January 1, 2000 through
March 31, 2002 period would violate
this principle unless the FS applied to
all ambulance providers and suppliers,
not just those seeking additional
payment under it. Accordingly, we may
have to recoup monies paid to those
providers and suppliers whose
payments were greater under the preexisting ‘‘reasonable charge’’ and
‘‘reasonable cost’’ system when
compared to what they would have
received under the FS for the January 1,
2000 through March 31, 2002 period.
Applying the FS retroactively to the
providers and suppliers would arguably
not constitute a fair phase-in of the FS
provisions.
III. Waiver of Proposed Rulemaking
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register and invite public comment on
the proposed rule. The notice of
proposed rulemaking includes a
reference to the legal authority under
which the rule is proposed, and the
terms and substance of the proposed
rule or a description of the subjects and
issues involved. This procedure can be
waived, however, if an agency finds
good cause that a notice-and-comment
procedure is impracticable,
unnecessary, or contrary to the public
interest and incorporates a statement of
the finding and its reasons in the rule
issued.
The FS being withdrawn by this
notice was only put in place pursuant
to the court’s order in Lifestar, and
explicitly provided that it would not be
effective in the event the Lifestar
decision was overturned on appeal. The
Lifestar decision has been vacated, and
the case in district court dismissed. To
our knowledge no payments have been
made under the FS to date and, had they
been, such payments would be subject
to recoupment pursuant to the
provisions of the April 16, 2003, notice.
Accordingly, there is no reason to keep
a FS in place that CMS is no longer
required to promulgate, and under
which it would make no payments in
light of the appellate court decision. To
leave the FS in place while awaiting
comments would only generate
confusion on the part of ambulance
providers and suppliers.
Therefore, we find good cause to
waive the notice of proposed
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52107
rulemaking with respect to the issuance
of this notice.
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 (44
U.S.C. 35).
V. Regulatory Impact Statement or
Analysis
We have examined the impact of this
notice 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.
Because the FS for the January 1, 2000
through March 31, 2002 is not one
under which we are required to make
payments in light of the Eleventh
Circuit reversal of the district court
decision, withdrawing the FS will have
no financial impact on providers and
suppliers, or on government spending.
Executive Order 12866 directs
agencies to assess all costs and benefits
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). Because the FS being
withdrawn is not one under which we
are required to make payments, in light
of the Eleventh Circuit decision,
withdrawing it will have no financial
impact on program spending. Therefore,
this notice is not a major notice as
defined in Title 5, United States Code,
section 804(2) and is not an
economically significant notice under
Executive Order 12866.
The RFA requires agencies to analyze
options for regulatory relief of small
entities. 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
considered to be small entities. We have
determined that this notice will not
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Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Notices
have a significant economic impact on
a substantial number of small entities.
Therefore, we are not preparing an
analysis for the RFA.
In addition, section 1102(b) of the
Social Security Act (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 have determined that this
notice will not have a significant effect
on the operations of a substantial
number of small rural hospitals.
Therefore, we are not preparing an
analysis for section 1102(b) of the Act.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule that may result in expenditures in
any 1 year by State, local, or tribal
governments, in the aggregate, or by the
private sector, of $110 million. This
notice has 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 publishes a rule that
imposes substantial direct requirement
costs on State and local governments,
preempts State law, or otherwise has
Federalism implications. This notice
will not have a substantial effect on
State or local governments. There are no
other alternatives at this time.
In accordance with the provisions of
Executive Order 12866, this notice was
reviewed by the Office of Management
and Budget.
Authority: Sections 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
(Catalog of Federal Domestic Assistance
Program No. 93.774, Medicare—
Supplementary Medical Insurance Program)
Dated: May 17, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: August 25, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05–17278 Filed 8–26–05; 9:46 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Food and Drug Administration
Family and Youth Services Bureau;
Positive Youth Development State and
Local Collaboration Demonstration
Projects
Agency Emergency Processing Under
Office of Management and Budget
Review; Guidance for Requesting an
Extension to Use Existing Label Stock
After the Trans Fat Labeling Effective
Date of January 1, 2006
Family and Youth Services
Bureau, Administration for Children
and Families (ACF), Department of
Health and Human Services (HHS).
ACTION: Award announcement.
AGENCY:
CFDA#: The Catalog of Federal
Domestic Assistance (CFDA) number for
this program is 93.623. The title is the
Positive Youth Development State and
Local Collaboration Demonstration
Projects.
Legislative Authority: Grants for
Runaway and Homeless Youth programs
are authorized by the Runaway and
Homeless Youth Act (title III of the
Juvenile Justice and Delinquency
Prevention Act of 1974), as amended by
the Missing, Exploited, and Runaway
Children Protection Act of 1999, (Pub.
L. 106–71).
Amount of Award: $100,000 per
grantee.
Project Period: 9/30/04–9/29/05.
SUMMARY: Notice is hereby given that a
noncompetitive grant supplement is
being made to the following state
agencies: State of Nebraska Health &
Human Services, University of
Kentucky Research Foundation, State of
Oregon, New York Office of Children &
Family Services, State of Louisiana,
Iowa Dept. of Human Rights Criminal &
Juvenile Justice, Commonwealth of
Massachusetts, Illinois Department of
Human Services, Governor’s Office for
Children Youth & Families. The purpose
of this supplement is to support
collaborations between state-level
agencies and local community
jurisdictions regarding positive
development opportunities available to
young people as approved in their
original planning grant.
FOR FURTHER INFORMATION CONTACT:
Administration for Children and
Families, Family and Youth Services
Bureau, 330 C Street, SW., Washington,
DC 20447, Courtney Workman—(202)
205–8657, cworkman@acf.hhs.gov.
Dated: August 22, 2005.
Joan E. Ohl,
Commissioner, Administration on Children,
Youth and Families.
[FR Doc. 05–17371 Filed 8–31–05; 8:45 am]
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[Docket No. 2005N–0343]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for emergency processing under
the Paperwork Reduction Act of 1995
(the PRA). FDA is preparing a guidance
document to notify the public of
procedures being implemented by the
agency to assist firms that wish to
request, on a case-by-case basis upon an
appropriate showing, an extension to
use existing label stock after the
effective date of the trans fat labeling
final rule. This notice solicits comments
on the proposed collection of
information associated with the
guidance document entitled ‘‘Guidance
for Requesting an Extension to Use
Existing Label Stock After the Trans Fat
Labeling Effective Date of January 1,
2006.’’
DATES: Fax written comments on the
collection of information by October 3,
2005. FDA is requesting approval of this
emergency processing by September 8,
2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
SUPPLEMENTARY INFORMATION: FDA has
requested emergency processing of this
proposed collection of information
under section 3507(j) of the PRA (44
U.S.C. 3507(j)) and 5 CFR 1320.13. FDA
issued a final rule (the trans fat final
rule) on July 11, 2003 (68 FR 41434) to
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]]>Agencies
[Federal Register Volume 70, Number 169 (Thursday, September 1, 2005)]
[Notices]
[Pages 52105-52108]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17278]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1308-NC]
RIN 0938-AN94
Medicare Program; Withdrawal of Ambulance Fee Schedule Issued in
Accordance With Federal District Court Order in Lifestar Ambulance,
Inc. v. United States, No. 4:02-CV-127-1 (M.D. Ga., Jan. 16, 2003)--
Medicare Covered Ambulance Services
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: This notice with comment period withdraws the fee schedule
that was put in place in 2003 to effect compliance with the Order in
Lifestar Ambulance, Inc. v. United States. [211 F.R.D. 688 (M.D. Ga.
2003)] That Order was vacated on January 10, 2005 by the U.S. Court of
Appeals for the Eleventh Circuit and is no longer in force.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on October 31, 2005.
ADDRESSES: In commenting, please refer to file code CMS-1308-NC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates,
please):
1. Electronically. You may submit electronic comments to https://
www.cms.hhs.gov/regulations/ecomments or to https://www.regulations.gov
(attachments should be in Microsoft Word, WordPerfect, or Excel;
however, we prefer Microsoft Word).
2. By mail. You may mail written comments (one original and two
copies) to the following address ONLY: Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Attention: CMS-1308-
NC, P.O. Box 8011, Baltimore, MD 21244-1850.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments (one
original and two copies) to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-1308-NC, Mail Stop C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
[[Page 52106]]
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-7197 in advance to schedule your arrival
with one of our staff members.
Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201; or
7500 Security Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the Humphrey Building is not
readily available to persons without Federal Government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
EFFECTIVE DATE: This notice is effective on September 1, 2005.
FOR FURTHER INFORMATION CONTACT: Anne Tayloe, (410) 786-4546.
SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments
from the public on all issues set forth in this rule to assist us in
fully considering issues and developing policies. You can assist us by
referencing the file code CMS-1308-NC and the specific ``issue
identifier'' that precedes the section on which you choose to comment.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. CMS posts all electronic
comments received before the close of the comment period on its public
Web site as soon as possible after they have been received. Hard copy
comments received timely will be available for public inspection as
they are received, generally beginning approximately 3 weeks after
publication of a document, at the headquarters of the Centers for
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore,
Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4
p.m. To schedule an appointment to view public comments, phone 1-800-
743-3951.
I. Background
[If you choose to comment on issues in this section, please include
the caption ``BACKGROUND'' at the beginning of your comments.]
Section 4531 of the Balanced Budget Act of 1997 (BBA) required the
Secretary of the Department of Health and Human Services (HHS) (the
Secretary) to establish a national fee schedule (FS) for payment of
ambulance services through a negotiated rulemaking process. The statute
provides that the Secretary phase in the application of payment rates
under the FS in a fair and efficient manner and that the aggregate
amount of payment for the services under the new FS not exceed the
amount that would be paid under the old system as stated in section
1834(l) of the Social Security Act (the Act). The BBA provided that the
FS would apply to services furnished on or after January 1, 2000.
The proposed and final FS rules both provided for payment for
ambulance services to be made in two parts: (1) A base rate; and (2) a
payment for mileage. Section 423 of the Medicare, Medicaid and SCHIP
Benefits Improvement and Protection Act of 2000 (BIPA), which was
passed after the publication of the proposed FS rule and prior to the
publication of the final rule, provided that during the phase-in of the
FS there would be full payment of any national mileage rate for
ambulance services furnished by suppliers in States where the Medicare
carrier did not previously pay separately for all mileage within the
county from which the beneficiary is transported (``BIPA mileage
provision''). Two States were identified as qualifying under this
provision: North Carolina (NC) and Tennessee (TN). BIPA specifies that
this provision applies to services furnished on or after July 1, 2001.
This FS was implemented on April 1, 2002 by a final rule published
in the Federal Register on February 27, 2002 (67 FR 9100). As stated in
the final rule, the phase-in is accomplished over five years by
blending a percentage of the payment that is based on the old payment
system with a percentage of the payment based on the FS according to
the following schedule:
------------------------------------------------------------------------
Year Old (percent) FS (percent)
------------------------------------------------------------------------
4/1/2002-12/31/2002 80 20
2003 60 40
2004 40 60
2005 20 80
2006 0 100
------------------------------------------------------------------------
The full national FS mileage rate in those States that qualify for
BIPA provision section 423 (NC, TN) was paid as of April 1, 2002.
In Lifestar Ambulance Service, Inc. v. United States, 211 F.R.D.
688 (M.D. Ga. 2003), three ambulance suppliers seeking to represent a
nationwide class of ambulance suppliers sued the Secretary, arguing
that he had no discretion to give the FS an effective date other than
January 1, 2000. The district court agreed with the plaintiff suppliers
and issued an order certifying a nationwide class of ambulance
suppliers and requiring the Secretary to adopt a FS for the January 1,
2000, through March 31, 2002 period. The court's decision also required
the Secretary to pay full mileage under the BIPA provision for the July
1, 2001 through March 31, 2002 period.
On April 16, 2003, the Secretary issued a notice in compliance with
the district court's order. (68 FR 18654) The Secretary established a
FS based on the FS as described in the Federal Register (67 FR 9100),
with a modified phase-in as follows:
------------------------------------------------------------------------
Year Old (percent) FS (percent)
------------------------------------------------------------------------
2000 95 5
2001 90 10
1/1/2002-3/31/2002 80 20
------------------------------------------------------------------------
Additionally, under the district court's order, the notice stated
that the Medicare program would pay full BIPA mileage for services
provided on or after July 1, 2001. The notice stated that the Secretary
had appealed the decision in Lifestar and that any FS or BIPA mileage
payment made under the notice for the January 1, 2000 through March 31,
2002 period would be subject to recoupment if the district court's
decision was reversed on appeal. The Secretary has not made any
payments under this FS. In addition, we are not aware of any ambulance
suppliers seeking payment under this FS prior to the Eleventh Circuit's
reversal of the district court decision, although some were seeking
full mileage under the BIPA mileage provision.
On appeal, the Eleventh Circuit found that the district court had
lacked jurisdiction over the case because the plaintiffs had not gone
through the administrative process before filing suit. See Lifestar
Ambulance Service, Inc. v.
[[Page 52107]]
United States, 365 F.3d 1293 (11th Cir. 2004), cert. denied, -US-, 125
S.Ct. 866 (Jan 10, 2005). It reversed and vacated the district court
decision and remanded the case with instructions to dismiss for lack of
subject-matter jurisdiction. Plaintiffs unsuccessfully sought rehearing
en banc and Supreme Court review. The district court dismissed the
complaint in accordance with the Eleventh Circuit's mandate on February
2, 2005.
II. Provisions of the Notice With Comment Period
[If you choose to comment on issues in this section, please include
the caption ``PROVISIONS'' at the beginning of your comments.]
The purpose of this notice is to withdraw the FS covering the
period of January 1, 2000 through March 31, 2002 that was published in
the April 16, 2003 notice. As we stated explicitly in the April 16,
2003 notice, we only issued this ambulance fee schedule to comply with
the Lifestar district court order and that order was vacated and the
Lifestar case dismissed. Although the April 16, 2003 notice clearly
states that payment under the FS for the January 1, 2000 through March
31, 2002 period is dependent on the district court opinion not being
reversed by the Eleventh Circuit Court of Appeals, refraining from
formally withdrawing the FS for this period could create unnecessary
confusion.
In light of our inability to issue a fee schedule by January 1,
2000, we continue to believe that giving the fee schedule prospective
application clearly meets the intent of the Congress. The Congress made
no indication that it wanted us to apply the base rate or the mileage
provisions of the FS retroactively in the event that we were unable to
issue the final FS by January 1, 2000. Also, given ample opportunity,
the Congress did not provide specific direction regarding this issue
after the January 1, 2000 date passed. The Congress itself took no
further action on the issue (such as directing the implementation of
its own version of an ambulance fee schedule).
Furthermore, the BBA directed the Secretary to phase in the
application of the payment rates under the fee schedule in an efficient
and fair manner and required that payments under the schedule in the
year 2000 not exceed the inflation-adjusted expenditures that were made
under the prior statute as stated in section 1834(l) of the Act. The FS
was to reallocate expenditures among ambulance providers and suppliers
in a manner that did not result in an increase in aggregate payments
for ambulance services (for example, some providers and suppliers would
have received higher payments, others would have received lower
payments, and the changes would have offset each other.) Only
additional payments made under the BIPA mileage provision were not
required to meet this criteria. Applying the FS to the January 1, 2000
through March 31, 2002 period would violate this principle unless the
FS applied to all ambulance providers and suppliers, not just those
seeking additional payment under it. Accordingly, we may have to recoup
monies paid to those providers and suppliers whose payments were
greater under the pre-existing ``reasonable charge'' and ``reasonable
cost'' system when compared to what they would have received under the
FS for the January 1, 2000 through March 31, 2002 period. Applying the
FS retroactively to the providers and suppliers would arguably not
constitute a fair phase-in of the FS provisions.
III. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposed rule. The
notice of proposed rulemaking includes a reference to the legal
authority under which the rule is proposed, and the terms and substance
of the proposed rule or a description of the subjects and issues
involved. This procedure can be waived, however, if an agency finds
good cause that a notice-and-comment procedure is impracticable,
unnecessary, or contrary to the public interest and incorporates a
statement of the finding and its reasons in the rule issued.
The FS being withdrawn by this notice was only put in place
pursuant to the court's order in Lifestar, and explicitly provided that
it would not be effective in the event the Lifestar decision was
overturned on appeal. The Lifestar decision has been vacated, and the
case in district court dismissed. To our knowledge no payments have
been made under the FS to date and, had they been, such payments would
be subject to recoupment pursuant to the provisions of the April 16,
2003, notice. Accordingly, there is no reason to keep a FS in place
that CMS is no longer required to promulgate, and under which it would
make no payments in light of the appellate court decision. To leave the
FS in place while awaiting comments would only generate confusion on
the part of ambulance providers and suppliers.
Therefore, we find good cause to waive the notice of proposed
rulemaking with respect to the issuance of this notice.
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 (44 U.S.C. 35).
V. Regulatory Impact Statement or Analysis
We have examined the impact of this notice 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.
Because the FS for the January 1, 2000 through March 31, 2002 is
not one under which we are required to make payments in light of the
Eleventh Circuit reversal of the district court decision, withdrawing
the FS will have no financial impact on providers and suppliers, or on
government spending.
Executive Order 12866 directs agencies to assess all costs and
benefits 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). Because the
FS being withdrawn is not one under which we are required to make
payments, in light of the Eleventh Circuit decision, withdrawing it
will have no financial impact on program spending. Therefore, this
notice is not a major notice as defined in Title 5, United States Code,
section 804(2) and is not an economically significant notice under
Executive Order 12866.
The RFA requires agencies to analyze options for regulatory relief
of small entities. 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
considered to be small entities. We have determined that this notice
will not
[[Page 52108]]
have a significant economic impact on a substantial number of small
entities. Therefore, we are not preparing an analysis for the RFA.
In addition, section 1102(b) of the Social Security Act (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 have
determined that this notice will not have a significant effect on the
operations of a substantial number of small rural hospitals. Therefore,
we are not preparing an analysis for section 1102(b) of the Act.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditures in any 1 year by
State, local, or tribal governments, in the aggregate, or by the
private sector, of $110 million. This notice has 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 publishes a rule that imposes substantial
direct requirement costs on State and local governments, preempts State
law, or otherwise has Federalism implications. This notice will not
have a substantial effect on State or local governments. There are no
other alternatives at this time.
In accordance with the provisions of Executive Order 12866, this
notice was reviewed by the Office of Management and Budget.
Authority: Sections 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: May 17, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: August 25, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05-17278 Filed 8-26-05; 9:46 am]
BILLING CODE 4120-01-P
