[Federal Register Volume 64, Number 14 (Friday, January 22, 1999)]
[Proposed Rules]
[Pages 3474-3478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1615]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Part 405
[HCFA-1002-NOI]
RIN 0938-AI72
Medicare Program: Ambulance Fee Schedule; Intent To Form
Negotiated Rulemaking Committee
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Notice of Intent to form negotiated rulemaking committee and
notice of meeting
-----------------------------------------------------------------------
SUMMARY: Section 4531(b) of the Balanced Budget Act (BBA) of 1997
requires that the Secretary establish a fee schedule for the payment of
ambulance services under the Medicare program by negotiated rulemaking.
We are required to establish a Negotiated Rulemaking Committee under
the Federal Advisory Committee Act (FACA). The Committee's purpose will
be to negotiate this fee schedule for ambulance services. The Committee
will consist of representatives of interests that are likely to be
significantly affected by the proposed rule. The Committee will be
assisted by a neutral facilitator.
This notice announces our intent to establish a Negotiated
Rulemaking Committee and outlines the scope of issues to be negotiated
by the Committee as specified by section 4531(b)(2) of the BBA. We
request public comment on whether we have properly identified the key
issues to be negotiated by the committee as well as the interests that
will be affected by those issues.
DATES: Comments: Comments and requests for representation or for
membership on the Committee will be considered if we receive them at
the appropriate address provided below, no later than 5 p.m. on
February 22, 1999.
Meetings: The first meeting will be held at Turf Valley Hotel in
Ellicott City, Maryland at 9 a.m. on February 22, 23, and 24, 1999
(410) 465-1500.
ADDRESSES: Mail written comments and requests for representation or for
membership on the Committee, or nominations of another person for
membership on the Committee (1 original and 3 copies) to the following
address: Health Care Financing Administration, Department of Health and
Human Services, Attention: HCFA-1002-NOI, P.O. Box 7517, Baltimore, MD
21207-5187.
If you prefer, you may deliver your written comments, applications,
or nominations (1 original and 3 copies) to one of the following
addresses:
Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue,
SW, Washington, DC 20201; or Room C5-09-26, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
FOR FURTHER INFORMATION CONTACT:
Bob Niemann (410) 786-4569 or Margot Blige (410) 786-4642 for general
issues related to ambulance services.
Lynn Sylvester (202) 606-9140 or Elayne Tempel (207) 780-3408,
Conveners.
SUPPLEMENTARY INFORMATION:
Comments, Procedures, Availability of Copies, and Electronic Access
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code HCFA-1002-NOI. Comments received timely will be available
for public inspection as they are received, generally beginning
approximately 3 weeks after publication of a document, in Room 445-G of
the Department's offices at 300 Independence Avenue, SW, Washington,
DC., on Monday through Friday of each week from 8:30 a.m. to 5 p.m.
(phone: (202) 690-7890).
Copies: To order copies of the Federal Register containing this
document, send your request to: New Orders, Superintendent of
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date
of the issue requested and enclose a check or money order payable to
the Superintendent of Documents, or enclose your Visa or Master Card
number and expiration date. Credit card orders can also be placed by
calling the order desk at (202) 512-1800 or by faxing to (202) 512-
2250. The cost for each copy is $8. As an alternative, you can view and
photocopy the Federal Register document at most libraries designated as
Federal Depository Libraries and at many other public and academic
libraries throughout the country that receive the Federal Register.
This Federal Register document is also available from the Federal
Register online database through GPO Access, a service of the U.S.
Government Printing Office. Free public access is available on a Wide
Area Information Server (WAIS) through the Internet and via
asynchronous dial-in. Internet users can access the database by using
the World Wide Web; the Superintendent of Document home page address is
http://www.access.gpo.gov/su__docs/, by using local WAIS client
software, or by telnet to swais.access.gpo.gov, then log in as guest
(no password required). Dial-in users should use communications
software and modem to call (202) 512-1661; type swais, then log in as
guest (no password required).
I. Balanced Budget Act of 1997
Section 4531(b)(2) of the Balanced Budget Act of 1997 (BBA), Public
Law 105-33, added a new section 1834(l) to the Social Security Act (the
Act). Section 1834(l) of the Act mandates implementation, by January 1,
2000, of a national fee schedule for payment of ambulance services
furnished under Medicare Part B. The fee schedule is to be established
through negotiated rulemaking. Section 4531(b)(2) also provides that in
establishing such fee schedule, the Secretary will--
Establish mechanisms to control increases in expenditures
for ambulance services under Part B of the program;
Establish definitions for ambulance services that link
payments to the type of services furnished;
Consider appropriate regional and operational differences;
Consider adjustments to payment rates to account for
inflation and other relevant factors; and
Phase in the fee schedule in an efficient and fair manner.
II. Negotiated Rulemaking Process
Section 1834(l)(1) of the Act provides that these negotiations take
place within the framework of the Negotiated Rulemaking Act of 1990
(Public Law 101-648, 5 U.S.C. 561-570). Under the Negotiated Rulemaking
Act, the head of an agency generally must consider whether--
[[Page 3475]]
There is a need for a rule;
There are a limited number of identifiable interests that
will be significantly affected by the rule;
There is a reasonable likelihood that a committee can be
convened with a balanced representation of persons who--
Can adequately represent the interests identified; and
Are willing to negotiate in good faith to reach a
consensus on the proposed rule;
There is a reasonable likelihood that a committee will
reach a consensus on the proposed rule within a fixed period of time;
The negotiated rulemaking procedure will not unreasonably
delay the notice of proposed rulemaking and the issuance of a final
rule;
The agency has adequate resources and is willing to commit
such resources, including technical assistance, to the committee; and
The agency, to the maximum extent possible consistent with
the legal obligations of the agency, will use the consensus of the
committee with respect to the proposed rule as the basis for the rule
proposed by the agency for notice and comment.
We note that the Congress has determined that the above conditions
have been met and has mandated that the negotiated rulemaking process
is appropriate.
Negotiations are conducted by a committee chartered under the
Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2). The committee
includes an agency representative and is assisted by a neutral
facilitator. The goal of the Committee is to reach consensus on the
language or issues involved in a rule. If consensus is reached, it is
used as the basis of the agency's proposal. The process does not affect
otherwise applicable procedural requirements of the FACA, the
Administrative Procedure Act, and other statutes.
The Negotiated Rulemaking Act permits (but does not require) an
agency to use the services of an impartial convener to assist the
agency in identifying interests that will be significantly affected by
the proposed rule, including residents of rural areas, and in
conducting discussions with persons representing the identified
interests to ascertain whether the establishment of a negotiated
rulemaking committee is feasible and appropriate in the particular
rulemaking. At the agency's request, the convener also ascertains the
names of persons who are willing and qualified to represent interests
that will be significantly affected by the rule. The agency may also
ask the convener to recommend a process for the negotiations. The
convener submits a written report, which is available to the public.
Pursuant to this procedure authorized by the Negotiated Rulemaking Act,
Lynn Sylvester and Elayne Temple of the Federal Mediation and
Conciliation Service (FMCS) will act as conveners for the negotiated
rulemaking on the ambulance fee schedule. Over the last several months,
they have interviewed a wide range of organizations that were
identified as having a possible interest in this negotiated rulemaking.
They submitted a report to HCFA based on those convening interviews,
which serves as a basis for this notice. The report lists the proposed
representatives on the Committee. The convening report is a public
document and is available upon request from the HCFA contacts listed
above.
III. Interaction With the Proposed Rule Published on June 17, 1997
On June 17, 1997, we published a proposed rule in the Federal
Register to revise and update the Medicare ambulance regulations at 42
CFR 410.40 (62 FR 32715). Specifically, we proposed to base Medicare
payment on the level of service required to treat the beneficiary's
condition; to clarify and revise policy on coverage of nonemergency
ambulance services; and to set national vehicle, staff, and billing and
reporting requirements. As noted above, section 1834(l)(2) of the Act
provides, in part, that in establishing the ambulance fee schedule, the
Secretary will establish definitions for ambulance services that link
payments to the types of services provided. One of the provisions of
the June 17, 1997 proposed rule would have defined ambulance services
as either advanced life support (ALS) or basic life support (BLS)
services and linked Medicare payment to the type of service required by
the beneficiary's condition. We received an extremely large number of
comments on this issue and, in general, commenters were very concerned
about our proposal. In light of that concern, and because service
definition is a required element of the negotiated rulemaking, we have
decided not to proceed with a final rule on the definition of ALS and
BLS services. We will include this issue as a matter for the
negotiating committee.
We note that section 1834(1)(3) of the Act provides that, in
establishing the fee schedule, the Secretary must ensure that the
aggregate payment amount made for ambulance services in calendar year
(CY) 2000 does not exceed the aggregate payment amount that would have
been made absent the fee schedule. Although we are foregoing final
agency action on the ALS/BLS definition proposal and including the
issue as a part of the negotiations, we believe that the savings that
would have been realized through implementation of that policy should
not be lost to the Medicare program. We have estimated that $65 million
would have been realized if the ALS/BLS proposal had been published as
a final rule. Therefore, we intend to set the spending target for CY
2000 (the first year that the fee schedule will be in effect) $65
million lower than budget neutrality to reflect these savings. We
intend to proceed with a final rule for those provisions of the June
17, 1997 proposed rule that are unrelated to the ALS/BLS issue. In
addition, that rule will implement the provisions of section 4531(c) of
the BBA, which authorizes the Secretary to include, under certain
specified conditions, ALS services provided by a paramedic intercept
service in a rural area as a covered ambulance service.
IV. Subject and Scope of the Rule
A. General
Currently, the Medicare program pays for ambulance services on a
reasonable cost basis when they are provided by a hospital, skilled
nursing facility, or home health agency and on a reasonable charge
basis when provided by an outside supplier. Section 4531(b)(1) of the
BBA requires that ambulance services covered under the Medicare program
be paid based on the lower of the actual charge or the fee schedule
amount. The fee schedule is limited in that payments may not exceed
what would have been paid if the fee schedule were not put into effect.
As discussed above, we intend to set spending for the first year at $65
million less than budget neutrality.
The effective date for the fee schedule is January 1, 2000, but the
Secretary has the authority under section 1834(l)(2)(E) of the Act to
provide for a phase-in period. In addition, section 1834(l)(2) requires
that in developing the fee schedule the Secretary:
Establish mechanisms to control increases in expenditures
for ambulance services under Part B of the program;
Establish definitions for ambulance services that link
payments to the type of services furnished;
Consider appropriate regional and operational differences;
and
Consider adjustments to payment rates to account for
inflation and other relevant factors.
[[Page 3476]]
While we recognize that it is difficult to predict the end product
of negotiated rulemaking on the ambulance fee schedule, we anticipate
that the proposed rule resulting from negotiations will include a
specific recommended schedule of relative values for ambulance
services, any adjustments or add-on amounts for particular types of
services, and possibly a mechanism for controlling expenditures and a
phase-in schedule. While section 1834(l)(2)(D) of the Act requires that
we include an inflation adjustment in the considerations, section
1834(l)(3)of the Act prescribes the inflation factor to be used for
future years. Therefore, we are not including the inflation factor as
part of the negotiation process. Medicare billing data will be
available for use in the negotiations and we will share that
information with Committee participants.
B. Issues and Questions To Be Resolved
Issues that we anticipate being resolved are outlined below. We
also invite public comment on other issues not identified that may be
within the scope of this rule.
We believe the issues to be the following:
1. The type of services furnished. That is, how services are
grouped for payment purposes and the minimum services that must be
furnished in order to meet the definition of each payment group. For
example, what is an ALS versus BLS service? How many gradations of
service are required? For example, should there be three levels of
care: BLS, ALS and critical care transport? What are the relative
values of each level of care and what are the projected utilizations of
each?
2. Definition(s) of type of provider and how that affects the
payment rate. For example, should volunteer, municipal and private
ambulance services be treated differently?
3. Definition(s) of appropriate regional differences and how they
affect the payment rate. For example, the use of a geographic wage
adjustment.
4. Definition(s) of appropriate operational differences and how
they affect the payment rate. For example:
--ALS versus BLS;
--Ground versus air;
--Fixed wing versus helicopter;
--Hospital-based versus independent;
--For-profit versus volunteer;
--Rural versus urban; or
--Isolated essential ambulance source (that is, only one ambulance
source in a given geographical area)
5. Whether mileage should be paid separately from the base rate,
and if so, what components of the ambulance service should be included
in the base rate and what should be included in mileage.
6. Phase-in methodology of the fee schedule from the existing
payment method, both method and time period.
7. Mechanism to control expenditures, for example, a volume
performance measure such as the number of trips per beneficiary or the
ratio of ALS to BLS that is used to adjust the conversion factor for
the following year.
C. Issues That Are Outside the Scope of This Negotiation
Based on the convening report, several issues were identified that
we have determined are outside the scope of this rule. The following is
a list of some, although not necessarily all, of the issues that we
have determined are outside the scope of this negotiation.
1. Program policies with respect to the coverage, as distinguished
from payment, of ambulance services. For example, the definition of
``bed-ridden'' and ``medically necessary,'' physician certification for
the use of ambulance, coverage of paramedic intercept services, and
ambulance waiting time (which is not covered by Medicare).
2. The aggregate amount of Trust Fund dollars available for payment
during the first year. This amount will be based on the amount the
program would have paid in the year 2000 absent the fee schedule,
reduced by the $65 million dollar savings that would have been realized
through publication of a final rule on the ALS/BLS definition.
3. The way items and services are grouped in terms of the Billing
Codes used to bill Medicare.
4. The base year, which will be the latest year for which complete
HCFA ambulance claims data exist.
5. Local or State ordinances requiring certain ambulance staffing
or all ALS ambulance.
6. The choice of an appropriate coding system to implement the fee
schedule; section 1834(l)(7) of the Act gives HCFA the authority to
specify the coding system.
V. Affected Interests and Potential Participants
In addition to our participation on the Committee, the Conveners
have proposed and we agree to accept representatives from the following
organizations as negotiation participants:
American Health Care Association (AHCA).
American Ambulance Association (AAA).
Association of Air Medical Services (AAMS).
International Association of Fire Chiefs (IAFC).
International Association of Fire Fighters (IAFF).
National Association of State Emergency Medical Services
Directors (NASEMSD).
American Hospital Association (AHA).
National Volunteer Fire Council (NVFC).
In addition to this list, we note that we have requested that the
American College of Emergency Physicians (ACEP) and the National
Association of EMS Physicians (NAEMSP) form a coalition and send one
representative to be a negotiation participant. We invite public
comment on this list of Committee participants.
We note that Medicare contractors, which are those entities that
adjudicate claims in local regions, will provide technical information
to the negotiator representing HCFA. Since we consider the contractors
to be agents of HCFA, we believe that they are most efficiently and
effectively utilized in this manner rather than as negotiators in the
process.
This document gives notice of this process to other potential
participants and affords them the opportunity to request that they be
considered for membership on the Committee. Persons who will be
significantly affected by this rule may apply for or nominate another
person for membership on the Committee to represent such interests by
submitting comments on this notice. Any application or nomination must
include:
The name of the applicant or nominee and a description of
the interests such person represents;
Evidence that the applicant or nominee is authorized to
represent parties related to the interests the person proposes to
represent;
A written commitment that the applicant or nominee will
actively participate in the negotiations in good faith; and
The reasons that the applicant or nominee believes its
interests are sufficiently different from the persons or entities
listed above so that those interested would not be adequately
represented on the Committee as currently proposed.
Individuals representing the proposed organizations and health
industry sectors should have practical experience, be recognized in
their particular community, have the ability to engage in negotiations
that lead to consensus, and be able to fully represent the views of the
interests they represent.
[[Page 3477]]
We reserve the right to refuse representatives who do not possess these
characteristics. Given the limited time frame for the development of
this rule, we expect that the negotiations will be intensive.
Representatives must be prepared and committed to fully participate in
the negotiations in an attempt to reach consensus on the issues
discussed.
The intent in establishing the Committee is that all interests are
represented, not necessarily all parties. We believe the proposed list
of participants represents all interests associated with adoption of a
national fee schedule for ambulance services. In determining whether a
party had a significant interest and was represented, we considered
groups who have and will continue to actively represent the main
interest groups. Lastly, while we are obligated to ensure that all
interests that are significantly affected are adequately represented,
it is critical to the Committee's success that it be kept to a
manageable size, particularly because of the short time frame in which
the Committee must complete its task.
Groups or individuals who wish to apply for a seat on the Committee
should respond to this notice and provide the detailed information
described above.
VI. Schedule for the Negotiations
We have set a deadline of 5-6 months beginning with the date of the
first meeting for the negotiated rulemaking Committee to complete work
on the proposed rule. We anticipate 4 or 5 additional meetings, to be
scheduled by the Committee, with the final meeting no later than the
end of June 1999. The first meeting of the Committee is scheduled for
February 22, 23, and 24, 1999 at the Turf Valley Hotel in Ellicott
City, Maryland beginning at 9 a.m. The purpose of this meeting is to
discuss in detail how the negotiations will proceed, the schedule for
subsequent meetings, and how the Committee will function. The Committee
will agree to ground rules for Committee operations, will determine how
best to address the principal issues, and, if time permits, will begin
to address those issues.
VII. Formation of the Negotiating Committee
A. Procedure for Establishing an Advisory Committee
As a general rule, an agency of the Federal Government is required
to comply with the requirements of FACA when it establishes or uses a
group that includes non-Federal members as a source of advice. Under
FACA, an advisory committee begins negotiations only after it is
chartered. This process is underway.
B. Participants
The number of participants in the group is estimated to be 10 and
should not exceed 15 participants. A number larger than this could make
it difficult to conduct effective negotiations within the time frame
required by the statute. One purpose of this notice is to determine
whether the proposed rule would significantly affect interests not
adequately represented by the proposed participants. We do not believe
that each potentially affected organization or individual must
necessarily have its own representative. However, each interest must be
adequately represented. Moreover, the group as a whole should reflect a
proper balance or mix of interests.
C. Requests for Representation
If, in response to this notice, an additional individual or
representative of an interest requests membership or representation on
the Committee, we will determine, in consultation with the conveners,
whether that individual or representative should be added to the
Committee. We will make that decision based on whether the individual
or interest--
Would be significantly affected by the rule, and
Is already adequately represented in the negotiating
group.
D. Establishing the Committee
After reviewing any comments on this Notice and any requests,
applications or nominations for representation, we will take the final
steps to form the Committee.
VIII. Negotiation Procedures
The following procedures and guidelines will apply to the
Committee, unless they are modified as a result of comments received on
this notice or during the negotiating process.
A. Facilitators
We will use neutral facilitators to conduct the negotiations. The
facilitators will not be involved with the substantive development or
enforcement of the regulation. The facilitators' role will be to--
Chair negotiating sessions in an impartial manner;
Help the negotiation process run smoothly;
Help participants define issues and reach consensus; and
Manage the keeping of the Committee's minutes and records.
Lynn Sylvester and Elayne Tempel of the Federal Mediation and
Conciliation Service (FMCS) will serve as facilitators.
B. Good Faith Negotiations
Participants must be willing to negotiate in good faith and be
authorized to do so. We believe this may best be accomplished by
selecting senior officials as participants. We believe senior officials
are best suited to represent the interests and viewpoints of their
organizations. This applies to us as well, and we are designating Nancy
Edwards, Deputy Director of the Division of Acute Care, in our Center
for Health Plans and Providers, to represent us.
C. Administrative Support
We will supply logistical, administrative, and management support.
We will provide technical support to the Committee in gathering and
analyzing additional data or information as needed.
D. Meetings
Meetings will be held in the Baltimore/Washington area. Unless
announced otherwise, meetings are open to the public.
E. Committee Procedures
Under the general guidance and direction of the facilitators, and
subject to any applicable legal requirements, the members will
establish the detailed procedures for Committee meetings that they
consider most appropriate.
F. Defining Consensus
The goal of the negotiating process is consensus. Under the
Negotiated Rulemaking Act, consensus generally means that each interest
concurs in the result unless the term is defined otherwise by the
Committee. We expect the participants to fashion their working
definition of this term.
G. Failure of Advisory Committee To Reach Consensus
If the Committee fails to reach consensus, the Committee may
transmit a report specifying any areas on which consensus was reached
and may include in the report any information, recommendations, or
other materials that it considers appropriate. Additionally, any
Committee member may include such information in an addendum to a
report.
If any Committee member withdraws, the remaining Committee members
will evaluate whether the Committee should continue.
[[Page 3478]]
H. Record of Meetings
In accordance with FACA's requirements, minutes of all committee
meetings will be kept. The minutes will be placed in the public
rulemaking record and Internet site on our home page.
I. Other Information
In accordance with the provisions of Executive Order 12866 this
notice was reviewed by the Office of Management and Budget.
Authority: Section 1834(l)(1) of the Social Security Act (42
U.S.C. 1395m).
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: December 17, 1998.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
Dated: December 23, 1998.
Donna E. Shalala,
Secretary.
[FR Doc. 99-1615 Filed 1-21-99; 8:45 am]
BILLING CODE 4120-01-P