[Federal Register Volume 67, Number 56 (Friday, March 22, 2002)]
[Proposed Rules]
[Pages 13297-13300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6952]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Chapter IV

[CMS-6012-NOI]
RIN 0938-AL13


Medicare Program; Establishment of Special Payment Provisions and 
Standards for Suppliers of Prosthetics and Certain Custom-Fabricated 
Orthotics; Intent to Form Negotiated Rulemaking Committee

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Notice of intent.

-----------------------------------------------------------------------

SUMMARY: We are statutorily mandated under section 427 of the Medicare, 
Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 
(BIPA) to establish a negotiated rulemaking committee in accordance 
with the Negotiated Rulemaking Act and the Federal Advisory Committee 
Act (FACA). The committee's purpose would be to negotiate the 
development of a rule regarding the special payment provisions and 
requirements set forth in section 427 of BIPA for suppliers of 
prosthetics and certain custom-fabricated orthotics. The committee 
would consist of representatives who are likely to be significantly 
affected by the proposed rule. The committee would be assisted by a 
neutral facilitator.

DATES: Comments will be considered if we receive them at the 
appropriate address, as provided below, no later than 5 p.m. on April 
22, 2002.

ADDRESSES: Mail written comments (1 original and 3 copies) to the 
following address: Centers for Medicare & Medicaid Services, Department 
of Health and Human Services, Attention: CMS-6012-NOI, P.O. Box 8013, 
Baltimore, MD 21244-8013.
    Mail a separate copy of written comments to the following address: 
Kathryn Cox, Office of Financial Management, Mail Stop C3-02-16, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, MD 21244.
    Please allow sufficient time for mailed comments to be timely 
received in the event of delivery delays. If you prefer, you may 
deliver your written comments (1 original and 3 copies) by courier to 
one of the following addresses: Hubert H. Humphrey Building, Room 443-
G, 200 Independence Avenue, SW., Washington, DC, or Room C5-14-03, 7500 
Security Boulevard, Baltimore, MD 21244-1850.
    (Because access to the interior 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 
commenters wishing to retain 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 could be considered late. 
Because of staffing and resource limitations, we cannot accept comments 
by facsimile (FAX) transmission. In commenting, please refer to file 
code CMS-6012-NOI.

[[Page 13298]]

    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Kathryn Cox, (410)786-5954; Lynn 
Sylvester, (202) 606-9140 or Ira Lobel, (518) 431-0130.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments

    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 Blvd., 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 (410) 786-7197.

Background

I. Negotiated Rulemaking Act

    The Negotiated Rulemaking Act (Pub. L. 101-648, 5 U.S.C. 561-570) 
establishes a framework for the conduct of negotiated rulemaking and 
encourages agencies to use negotiated rulemaking to enhance the 
informal rulemaking process. Under the Negotiated Rulemaking Act, the 
head of an agency must consider whether--
     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 
those 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 policy as the basis for the rule 
proposed by the agency for notice and comment.
    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 proposed rule. If consensus is 
reached, the committee will transmit a report to the agency containing 
a proposed rule. The agency may use the report as the basis of the 
agency's proposed rule. The process does not affect otherwise 
applicable procedural requirements of FACA, the Administrative 
Procedure Act, and other statutes.

II. Subject and Scope of the Rule

A. Need for the Rule
    Section 427 of the Medicare, Medicaid, and SCHIP Benefits 
Improvement and Protection Act of 2000 (BIPA), enacted on December 21, 
2000, requires the Secretary of Health and Human Services to establish 
the following using negotiated rulemaking procedures:
     Standards for those who bill Medicare for prosthetics and 
certain custom-fabricated orthotics.
     A list of custom-fabricated orthotics that are subject to 
the supplier qualification set forth in section 427 of BIPA.
B. Subject and Scope of the Rule
    Section 1834(h) of the Social Security Act (the Act) provides for 
payment of ``orthotics and prosthetics,'' that are described in section 
1861(s)(9) of the Act and in our regulations (see 42 CFR 414.202). 
Orthotics are leg, arm, back, and neck braces. Prosthetics are defined 
as artificial legs, arms, and eyes, including replacements if required 
because of a change in the beneficiary's physical condition.
    Prosthetics and orthotics which are mainly covered under Medicare 
Part B, must be reasonable and necessary for the diagnosis or treatment 
of an illness or injury or to improve a malformed body member. 
Historically, there has been no Medicare requirement that a supplier of 
prosthetics or orthotics be certified or meet educational requirements 
other than what a State may require. Presently, fewer than 10 States 
have licensing requirements for suppliers of prosthetics and orthotics.
    In an OIG report, ``Medicare Orthotics,'' by Inspector General June 
Gibbs Brown, October 1997 (0EI-02-95-00380), the OIG recommended that 
we take action to improve Medicare billing for orthotics. Specifically, 
they recommended that we require standards for suppliers of custom-
molded and custom-fabricated orthotics.
    According to the Congress' mandate under section 427 of BIPA, 
Medicare will cover prosthetics and certain custom-fabricated orthotics 
only if furnished by a ``qualified practitioner'' and fabricated by a 
``qualified practitioner'' or ``qualified supplier.'' A ``qualified 
practitioner'' is defined as--
     A physician, a qualified physical or occupational 
therapist, and a State-licensed orthotist or prosthetist; or
     In States that do not issue those licenses, a trained 
individual who is either: (1) Certified by either the American Board of 
Certification in Orthotics and Prosthetics, Inc. (ABC) or the Board for 
Orthotist/Prosthetist Certification (BOC), or (2) who is credentialed 
by a program that the Secretary determines, in conjunction with 
appropriate experts, has sufficient training and education standards.
    A ``qualified supplier'' is defined as any entity that is 
accredited by--
     ABC or BOC; or
     A program that the Secretary determines has equivalent 
accreditation and approval standards.
    We are required to use a negotiated rulemaking procedure to 
establish (1) a list of prosthetics and custom-fabricated orthotics 
subject to this provision, and (2) criteria for acceptable 
accreditation and credentialing programs for qualified practitioners 
and suppliers.
C. Issues and Questions To Be Resolved
    We anticipate discussion on the issues outlined below. We invite 
public comment on other issues not identified that would be within the 
scope of the rule.
1. What/who will be covered by the rule?
    a. Custom-fabricated orthotics.
    b. Practitioners (who does that include?).
    c. The definition of a ``positive model'' as set forth in the 
statute.
    d. Interface among practitioners, facilities, and manufacturers.
2. How will practitioners obtain certification and/or credentialing?
    a. Provisions for grandfathering.
    b. Education and experience requirements.
    c. Provisions for loss of certification.
    d. State requirements.
    e. Should there be different certifications for practitioners, 
manufacturers, and facilities?
    f. Rural areas.
3. Who will certify?
    a. States.
    b. Professional organizations.
    c. Other (for example, educational institutions).
4. Management of the program
    a. CMS's role.
    b. Interface among CMS, the certifying bodies, and the State 
licensing

[[Page 13299]]

boards.
    With regard to matters outside the scope of the rule, we do not 
plan to negotiate the process or procedures for updating the list of 
codes for custom-fabricated orthotics subject to the rule.

III. Affected Interests and Potential Participants

    The convener interviewed numerous organizations to identify 
potential participants whose interests would be affected by the 
proposed rule. The description of those organizations, together with 
the convener's finding can be viewed at www.hcfa.gov/medicare/enrollment/CONVRPT.htm. The convener has proposed and we agree to 
accept the following organizations as negotiation participants. We 
believe these organizations represent an appropriate mix of interests 
and backgrounds:
     ABC.
     BOC.
     National Community Pharmacy (NCP).
     National Commission of Orthotic and Prosthetic Education 
(NCOPE).
     American Academy of Orthotists and Prosthetists.
     National Association for the Advancement of Orthotists and 
Prosthetists (NAAOP).
     American Physical Therapy Association (APTA).
     American Orthotic and Prosthetic Association (AOPA).
     National Orthotic Manufacturers Association (NOMA).
     International Association of Orthotics and Prosthetics 
(IAOP).
     Hanger Prosthetics.
     Point Health Centers.
     Coalition of Illinois and Florida certification boards.
     Coalition of State associations representing orthotists 
and prothetists.
     Paralyzed Veterans of America (PVA).
     National Association for Long Term Care (NALTC).
    We invite comment on this list of negotiation participants. The 
intent in establishing the negotiating committee is that all interests 
are represented, not necessarily all parties. We believe this proposed 
list of participants represent all interests associated with the rule 
to be negotiated.
    Groups or individuals who wish to apply for a seat on the committee 
should respond to this notice within 30 days of its publication. They 
should provide detailed information regarding the following:
     A description of the interest they represent.
     Evidence that they are authorized to represent parties 
related to the interests they propose to represent.
     A written commitment that they will actively participate 
in good faith in the development of the regulation.
     Reasons why the proposed committee could not adequately 
represent their interest.

IV. Schedule for the Negotiation

    We have set a deadline of 6 months beginning with the date of the 
first meeting for the committee to complete work on the proposed rule. 
We intend to terminate the activities of the committee if it does not 
appear likely to reach consensus on a schedule that is consistent with 
our rulemaking needs.
    The first and second meeting dates and times will be published in 
the Federal Register. The purpose of the first meeting will be to 
discuss in detail how the negotiations will proceed and how the 
committee will function. The committee will agree to ground rules for 
committee operation, determine how best to address the principal 
issues, and, if time permits, begin to address those issues.
    We expect that by the second meeting, the committee can complete 
action on any procedural matters outstanding from the organizational 
meeting and either begin or continue to address the issues.

V. 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 is established only after both 
consultations with the General Services Administration and receipt of a 
charter. We have prepared a charter and initiated the requisite 
consultation process. Only upon successful completion of this process 
and the receipt of the approved charter will we form the committee and 
begin negotiations.
B. Participants
    The number of participants on the committee is estimated to be 16 
and should not exceed 25 participants. A number larger than this could 
make it difficult to conduct effective negotiations. One purpose of 
this notice is to help 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, we must be satisfied that the committee as a whole reflects a 
proper balance and 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 negotiating committee, we will determine, in consultation with the 
facilitator, 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 
committee.
D. Establishing the Committee
    After reviewing any comments on this notice and any requests for 
representation, we will take the final steps to form the committee.

VI. Negotiation Procedures

    When the committee is formed, the following procedures and 
guidelines will apply, unless they are modified as a result of comments 
received on this notice or during the negotiating process.
A. Facilitator
    We will use a neutral facilitator. The facilitator will not be 
involved with the substantive development or enforcement of the 
regulation. The facilitator's role is to--
     Chair negotiating sessions;
     Help the negotiation process run smoothly; and
     Help participants define and reach consensus.
B. Good Faith Negotiations
    Participants must be willing to negotiate in good faith and be 
authorized to do so. We believe this may be best accomplished by 
selection of senior officials as participants. We believe senior 
officials are best suited to represent the interests and viewpoint of 
their organizations. This applies to us, and we are designating Hugh H. 
Hill III, M.D., J.D., Medical Officer, Program Integrity Group, Office 
of Financial Management.
C. Administrative Support
    We will supply logistical, administrative, and management

[[Page 13300]]

support. If it is deemed necessary and appropriate, we will provide 
technical support to the committee in gathering and analyzing 
additional data or information.
D. Meetings
    Meetings will be held in the Baltimore/Washington area (or in 
another location) at the convenience of the committee. We will announce 
committee meetings and agendas in the Federal Register. Unless 
announced otherwise, meetings are open to the public.
E. Committee Procedures
    Under the general guidance and direction of the facilitator, and 
subject to any applicable legal requirements, the members will 
establish the detailed procedures for committee meetings, which 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 committee defines the term otherwise. 
We expect the participants to fashion the committee's working 
definition of this term.
G. Failure of Advisory Committee to Reach Consensus
    If the committee is unable to reach consensus, we will proceed to 
develop a proposed rule. Parties to the negotiation may withdraw at any 
time. If this happens, we and the remaining committee members will 
evaluate whether the committee should continue.
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.
I. Other Information
    In accordance with the provisions of Executive Order 12866, this 
notice was reviewed by the Office of Management and Budget.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: January 9, 2002.
Thomas A. Scully,
Administrator, Center for Medicare and Medicaid Services.

    Dated: February 22, 2002.
Tommy G. Thompson,
Secretary.
[FR Doc. 02-6952 Filed 3-21-02; 8:45 am]
BILLING CODE 4120-01-P