[Federal Register Volume 63, Number 106 (Wednesday, June 3, 1998)]
[Proposed Rules]
[Pages 30166-30173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14798]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Chapter IV
[HCFA-3250-NOI]
RIN 0938-AI92
Medicare Program; Coverage and Administrative Policies for
Clinical Diagnostic Laboratory Tests; 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 Meetings.
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SUMMARY: The Balanced Budget Act of 1997 requires the Secretary to
establish a Negotiated Rulemaking Committee under the Negotiated
Rulemaking Act and the Federal Advisory Committee Act. The Negotiated
Rulemaking Committee's (the Committee) purpose will be to negotiate
national coverage and administrative policies for clinical diagnostic
laboratory tests under Part B of the Medicare program as required by
the Balanced Budget Act of 1997 (BBA). The Committee will consist of
representatives of interested parties that are likely to be
significantly affected by the proposed rule. The Committee will be
assisted by a neutral facilitator.
The BBA outlines the scope of issues to be negotiated by the
Committee. We specifically request pubic comment as to whether we have
identified the interests that will be affected by key issues listed
below.
DATES: Comments and requests for representation or for membership on
the
[[Page 30167]]
Committee will be considered if we receive them at the appropriate
address provided below, no later than 5 p.m. on July 6, 1998.
The first meeting will be held at Turf Valley Hotel in Ellicott
City (Baltimore) at 9 a.m. on July 13, 14, and 15, 1998; (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-3250-N, P.O. Box 26688, Baltimore, MD
21207-5187.
Mail a separate copy of written comments to the following address:
Grant Bagley, M.D., Director, Coverage and Analysis Group, Office of
Clinical Standards and Quality, Mail Stop S3-02-01, Health Care
Financing Administration, 7500 Security Blvd., Baltimore, Maryland
21244-1850.
If you prefer, you may deliver your written comments, applications,
or nominations (1 original and 3 copies) to one of the following
addresses:
Room 309-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 information on electronic filing, see SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT:
Grant Bagley, M.D., (410) 786-7176, or Jackie Sheridan (410) 786-4635,
for general issues related to clinical diagnostic Laboratory tests.
Judy Ballard, (202) 690-7419, or Nancy Rubenstein, (202) 690-8246,
Conveners.
SUPPLEMENTARY INFORMATION: Comments may also be submitted
electronically to the following e-mail address: (filecode
hcfa3250noi)hcfa.gov. E-mail comments must include the full name and
address of the sender, and must be submitted to the referenced address
in order to be considered. All comments must be incorporated in the e-
mail message because we may not be able to access attachments.
Electronically submitted comment will be available for public
inspection at the Independence Avenue address, below. Because of
staffing and resource limitations, we cannot accept comments by
facsimile (FAX) transmission. In commenting, please refer to file code
HCFA-3250-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 309-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).
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I. Balanced Budget Act of 1997
Section 4554(b)(1) of the Balanced Budget Act of 1997 (BBA), Public
Law 105-33, mandates adoption, by January 1, 1999, of national coverage
and administrative policies for clinical diagnostic laboratory tests
under Part B of title XVIII of the Social Security Act using negotiated
rulemaking. Section 4554(b)(2) provides that these national policies
must be ``designed to promote program integrity and national uniformity
and simplify administrative requirements with respect to clinical
diagnostic laboratory tests'' payable under Part B in connection with
the following:
Beneficiary information required to be submitted with each
claim or order for laboratory tests;
The medical conditions for which a laboratory test is
reasonable and necessary;
The appropriate use of procedure codes in billing for a
laboratory test, including the unbundling of laboratory services;
The medical documentation that is required by a Medicare
contractor at the time a claim is submitted for a laboratory test;
Recordkeeping requirements in addition to any information
required to be submitted with a claim, including physicians'
obligations regarding such requirements;
Procedures for filing claims and for providing remittances
by electronic media; and
Limitation on frequency of coverage for the same tests
performed on the same individual.
The legislative history of BBA suggests that section 4554
was enacted in response to variations among carriers' requirements for
laboratories filing claims for payment.
II. Negotiated Rulemaking Process
Section 4554 of the BBA provides that these negotiations take place
within the framework of the Negotiated Rulemaking Act (Pub. L. 101-648,
5 U.S.C. 561-570). Under the Negotiated Rulemaking Act, the head of an
agency generally 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
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.
Negotiations are conducted by a Committee chartered under the
Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2). The Committee
includes
[[Page 30168]]
an agency representative and is assisted by a neutral facilitator. The
goal of the Committee is to reach consensus on the language or content
of 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 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, we asked
Judy Ballard and Nancy Rubenstein, who are with the Departmental
Appeals Board (DAB) to act as convener for the negotiated rulemaking on
laboratory policies. Over the last several months, they met with a wide
range of organizations that were identified as having a possible
interest in this negotiated rulemaking. They submitted to HCFA a report
based on those convening interviews, which serves as a basis for this
notice. This report lists the proposed representatives on the
Committee. The convening report is a public document and may be found
on the HCFA Internet website at http://www.hcfa.gov/quality/qlty-8a.
III. Subject and Scope of the Rule
A. General
During the convening process, a number of issues were presented by
the interested parties for negotiations as described below. We believe
it is important to have an opportunity to engage in discussions with
the interested parties on the issues that were presented. Many of these
issues need clarification and a common understanding before regulations
can be developed. We believe it is important that the Committee
meetings include ample opportunity for such clarifications.
Many of the issues raised by identified interested parties were
based on the current laboratory coverage policies and claims processing
systems. It is important to take into consideration how these current
processes have been affected by the changes mandated by other
subsections of section 4554 of the BBA. This provision of the law
likely will mitigate some of the problems identified. For example, the
law permits a carrier to develop and implement interim policies for
laboratory services when there is a demonstrated need for a policy due
to aberrant utilization or provision of unnecessary tests. The law
provides that interim national policies developed by carriers are
effective for no more than two years when no national policies exist,
and provides an opportunity for public participation in the biennial
review of national policies.
As outlined in section 4554(b) of the BBA, the scope of the rule
will be the development of coverage and administrative policies for
clinical laboratory services that are designed to promote program
integrity and national uniformity while simplifying administrative
requirements. Consensus related to administrative simplification for
laboratory services must comply with the limitations imposed by the
administrative simplification provisions in section 261 of the Health
Insurance Portability and Accountability Act of 1996 (HIPAA). HIPAA
requires the Secretary to establish standards and requirements for the
electronic transmission of claims and other information that will be
used throughout the health insurance industry.
Given that there are limited time and resources for these
negotiations, it is critical that a process for coverage policy
concerning laboratory tests be developed. Clearly, time constraints may
prevent the development of test-specific policies for all laboratory
tests. HCFA, therefore, proposes that the Committee negotiate a process
for coverage and administration capable of uniform application
throughout the country that takes into account the statutory boundaries
within which HCFA must administer the Medicare program.
Many of the issues identified during the convening interviews
related to administrative policies associated with claims submission,
documentation, and recordkeeping. These administrative issues will be
negotiated to the extent that they are within the framework of section
4554(b) of the BBA as discussed below.
B. Issues and Questions to be Resolved
1. Beneficiary Information on Claims
Under current Medicare policy, laboratory tests furnished in
physicians' offices and by independent laboratories are reported on a
HCFA-1500, while hospital laboratory services are reported on a UB-92
form. Virtually all claims from independent clinical laboratories,
hospital laboratories, and a substantial number of claims for
laboratory services performed in physician office laboratories are
submitted using electronic versions of these forms.
During the convening process, interested parties raised issues
regarding application of general Medicare coverage and administrative
policies to the laboratory industry. Two specific issues interviewees
wished to negotiate concerned the documentation necessary to
substantiate that skilled nursing care patients were in beds certified
as skilled nursing facilities for Medicare purposes (and consequently,
subject to rebundling), and the use of the standard form HCFA-1500 for
submitting Medicare claims for laboratory services. To the extent that
these issues are directly related to the categories of items delineated
in section 4554(b)(2) of the BBA, they are within the scope of the
negotiations. Thus, the applicability of general Medicare policies
regarding beneficiary information required on claims for laboratory
services is within the framework of these negotiations.
2. Medical Conditions for Which a Laboratory Test is Covered
Section 4554 of the BBA mandates that HCFA use the negotiated
rulemaking process to develop national coverage and administrative
policies for clinical diagnostic laboratory tests under Medicare Part
B. While HCFA and the clinical laboratory industry understand and
support the need for national uniformity in terms of policy, both
recognize the practical difficulty of addressing and developing
coverage policies for all laboratory tests within the time provided in
the negotiated rulemaking process. As a result, the Committee will
focus on negotiating the medical conditions for which specific tests
are covered for a subset of tests that have been identified as
priorities by the Committee members after the process for making this
determination has been negotiated.
In the interest of expediting this phase in the negotiation
process, HCFA proposes that the facilitator work with Committee members
prior to the first meeting to develop a recommended list of tests that
will be specifically discussed during the negotiations. We
[[Page 30169]]
expect that those tests designated as priorities by the Committee will
likely fulfill at least one of the following criteria:
It is subject to wide divergence in coverage among local
Medicare carriers,
It is a high-volume test, or
Its medical utility or clinical effectiveness is
considered controversial.
The Committee will negotiate and reach consensus on a list of
priority tests. Using a process developed by the Committee, the
Committee will then negotiate and attempt to reach consensus on the
medical condition for which these specific tests will be covered.
3. Use of Appropriate Procedure Codes in Billing
Laboratory services are reported to HCFA using the HCFA Common
Procedure Coding System (HCPCS). A major component of this system is
the American Medical Association's Current Procedural Terminology
(CPT). In addition, HCFA requires diagnosis reporting on all claims.
Diagnosis is coded using the International Classification of Diseases,
Ninth Edition, Clinical Modification (ICD-9-CM).
Medicare contractors that process claims are charged with the
development of local medical review policies to apply safeguards
against inappropriate expenditures of program funds. Local policies are
a means of applying local coverage decisions where national policies do
not exist. Unlike most national coverage policies, which are generally
narrative statements, nearly all local medical review policies are at
the code-specific level.
We recognize that the level of understanding of coding conventions
is not uniform among the laboratory industry, community physicians
ordering clinical diagnostic testing, and our contractors. Clearly,
there is some confusion and misunderstanding among the parties with
regard to application of the coding guidelines to specific
circumstances. For example, during convening, interviewees reported
that historically there have been problems with coding multichannel
automated testing.
This is an issue of application of general Medicare policies to the
laboratory industry. HCFA believes that it is appropriate for the
Committee to discuss specific coding guidelines to seek clarification
as part of the development of specific national coverage and
administrative policies for laboratory tests identified as priorities.
Thus, for example, it may be appropriate for the Committee to negotiate
policies for automated multichannel testing, including clarification of
coding guidelines. To the extent that coding issues are related to the
coverage policies under discussion, they are within the scope of the
negotiations.
4. Medical Documentation Required with Claim
During the convening interviews, interested parties identified
issues with respect to the medical documentation required on a claim.
One issue dealt with the documentation the physician should submit to
the laboratory in order for the laboratory to submit the claim. Another
issue concerned assuring consistent action by the contractors when the
documentation submitted with the claims is insufficient.
We believe the first issue of medical documentation requirements
would be an inherent part of the negotiations of individual coverage
policies. That is, if the Committee determines that coverage policy for
a given tests should be developed on a diagnosis code-specific level,
then reporting of the diagnosis code would be required for that policy.
In other situations, the Committee could determine that a code was not
satisfactorily specific for the coverage policy, so alternative
documentation may be required. The Committee may also determine that
coverage policy should be established more broadly using a narrative
format rather than a detailed policy developed on a code-specific
level. Clearly, this issue will be discussed in depth as part of the
negotiations on the national coverage policies.
The second issue concerning contractor actions in response to
insufficient documentation was suggested as an issue for negotiation. A
broad view of the language of section 4554(b) of the BBA places this
issue within the scope of the negotiations. Therefore, we are willing
to have this matter brought before the Committee for discussion.
5. Recordkeeping Requirements in Addition to Claims Information
During the convening interviews, the issue of recordkeeping and
retention by laboratories and physicians who order laboratory tests was
raised. We believe that it is appropriate to negotiate with respect to
the types of records that should be maintained, who bears
responsibility for maintaining documentation, and the period of time
that records should be stored. In this regard, we are currently working
under an initiative to reduce paperwork burden on the public, including
clinical laboratories. We share the sentiment expressed by many
interested parties that the recordkeeping requirements should be
nationally uniform, simple, consistent with patient confidentiality
requirements, and that a balance should be developed between program
integrity concerns and the burden placed on the provider.
6. Procedures for Filing Claims and Providing Remittances
Electronically
Electronic claims submission is within the scope of these
negotiations as outlined by section 4554(b)(2) of the BBA. Consensus
related to administrative simplification must comply with section 261
of HIPAA. Two specific issues were presented in regard to this topic.
First, interested parties have voiced concern about the lack of
uniformity among the carriers in the way claims are reviewed. For
example, there is variation in how many and in what order the ICD-9-CM
diagnosis codes are reviewed to determine if they justify medical
necessity. Second, there is a concern that there may be a future
requirement for electronic filing of claims. While cost laboratories
already file claims electronically, small laboratories, including
physician office laboratories, are concerned that such electronic
filing may become mandatory in the future and would be burdensome.
With regard to the lack of uniformity in the way in which carrier
systems review claims, we acknowledge that differences exist in the way
contractor systems analyze claims and that these differences do result
in inconsistencies that are particularly problematic for the Laboratory
industry. We note that the two events will significantly improve this
situation over the next several years. First, under section 4554(b), we
will be implementing new national laboratory coverage and
administrative policies that will be negotiated by this Committee.
Second, Medicare contractors will be moving to a single standard
carrier claims processing system and a single standard fiscal
intermediary claims processing system over the next several years. It
is our intention that modifications to the local standard systems will
be minimal and based on need. Use of uniform claims processing systems
will significantly increase the uniformity in claims review.
Labroatories within a carrier jurisdiction will be informed of the
transition as it becomes imminent in the area so that they can prepare
for the change. HCFA believes that it is important for the interested
parties to be well informed about the transition. We
[[Page 30170]]
appreciate the opportunity to discuss this further with the interested
parties.
It should be noted that there have been several legislative
proposals over recent years that would require electronic claims filing
or provide for a service fee for processing of paper claims. However,
we are not adverse to discussing the possibility of administrative
policies related to mandatory electronic claims filing.
7. Limitations on Frequency of Coverage
Several of the interested parties raised the issue of disclosure of
utilization parameters used as a trigger to perform medical review as a
topic for negotiation. They believe that some contractors are using
utilization parameters as a frequency limit on coverage, which makes
them de facto coverage policies and subject to negotiations. They noted
the lack of uniformity among the contractors complicates this issue
further because providers may be submitting claims to more than one
contractor and have no assurances that these claims will be similarly
reviewed. A test that may be paid by one contractor may not be paid by
another.
We recognize that differences among Medicare contractors in
frequency limits on coverage pose difficulties, especially for large
national laboratories that deal with a variety of Medicare contractors.
We expect that frequency limits as they apply to coverage policies will
be negotiated by the interested parties as part of the discussions.
It should be noted that the Department of Health and Human
Services, which includes HCFA and the Office of the Inspector General
(OIG), has concerns related to disclosure of utilization parameters and
its impact on our ability to assure program integrity and manage
program expenditures. Nonetheless, we acknowledge that section
4554(b)(2) of the BBA does require negotiations related to frequency
limitations. We appreciate the opportunity to discuss alternatives for
meeting the needs of the program to assure program integrity while also
addressing the industry's concerns.
Moreover, section 4554(b)(4) provides: ``the Secretary shall permit
any carrier to develop and implement interim policies of the type
described in paragraph (1) [coverage and administrative polices under
negotiation], in accordance with guidelines established by the
Secretary, in cases in which a uniform national policy has not been
established under this subsection and there is a need for a policy to
respond to aberrant utilization or provision of unnecessary tests.''
C. Other Issues and Questions
Section 4554(b)(2) of the BBA and the Negotiated Rulemaking Act
provide the framework for determining the scope of issues to be
negotiated. Issues that are not included within the seven issues
directly specified in section 4554(b)(2), such as Food and Drug
Administration (FDA) approval of laboratory tests, Medicare payment
policies, and Clinical Laboratory Improvement Act (CLIA) matters are
not within the scope of these negotiations. Based on a review of the
BBA and the Negotiated Rulemaking Act, we have concluded that the
following issues specifically raised in the convening report are not
within the scope of the negotiated rulemaking mandated by Congress, and
thus will not be subject to negotiations by the Committee.
1. Use of Requisition Forms
During the convening interviews, some of the interested parties
raised the issue of a standard requisition form for ordering laboratory
services as a means of standardizing information exchange. If the
laboratory community believes that standardized requisition forms are
needed, HCFA would appreciate the opportunity to provide input in
developing these forms to assure that the information collected on the
standard requisitions meets all the Medicare claim requirements.
However, we believe that the Medicare program's interest is limited
to information necessary to allow a determination regarding Medicare
benefits and does not extend to how information is exchanged among
providers, physicians and suppliers.
2. Enforcement of Physician Reporting
The interested parties suggested discussing sanctions or other
enforcement mechanisms for physicians who do not provide the required
documentation to the laboratory. We do not believe this is within the
areas authorized for rulemaking outlined under section 4554 (b)(2) of
the BBA. Moreover, we do not believe the law authorizes such
enforcement. That is, section 4317 of the BBA requires physicians and
other practitioners to include diagnostic information with their
laboratory orders when such information is required by HCFA or a
contractor in order for the laboratory performing the test to get paid.
However, the statute does not expressly authorize sanctions for
violations of this requirements. Further, HCFA does not have the
resources to monitor and develop the necessary record to pursue
sanctions or other disciplinary mechanisms.
3. Advance Beneficiary Notice
When a determination is made under section 1862(a)(1) that a
service is not reasonable or necessary, a beneficiary may have
liability waived under section 1879 of the Social Security Act. The
beneficiary will be liable, however, if he or she has received written
notice of noncoverage in advance of receiving the service. These
provisions are already in regulations at 42 CFR 411.404. The written
notice is called advance beneficiary notice (ABN).
Interested parties to these negotiations told the convener that
there is a wide divergence in practices regarding when ABNs are
obtained for noncovered laboratory services. Moreover, since
laboratories seldom have direct patient contact, they have little to no
control over the information that is provided to the beneficiary.
Although we are also concerned about this issue, we do not believe
that the policies related to ABNs are within the scope of these
negotiations. It does not appear related to the provisions identified
in Section 4554(b)(2) of the BBA. However, we understand there appears
to be significant confusion related to the ABN policies. We agree that
it would be beneficial to the negotiations to provide time for
clarification of these policies and discuss their applicability to the
laboratory industry. As a result, we would be agreeable to a discussion
on ABNs if the Committee requests it.
4. Elimination of Local Coverage Policy
Most of the interested parties contacted raised the issue of
consistency in local coverage policies for laboratory services as an
area for negotiation. Some strongly believe that local policies should
not be permitted as they are inconsistent with the goal of promoting
national uniformity. Other interested parties believe there may be
local practice patterns or other conditions that would justify
differences in evaluating medical necessity.
Section 4554(b) clearly authorizes local coverage policies as
necessary to assure program integrity. Specifically, section 4554(b)(4)
states: ``After the date the Secretary first implements such national
policies, the Secretary shall permit any carrier to develop and
implement interim policies * * *, in cases in which a uniform national
policy has not been established under this subsection and there is a
demonstrated need for a policy to
[[Page 30171]]
respond to aberrant utilization or provision of unnecessary tests.''
Since the statute clearly authorizes local policies when there is a
demonstrated need to respond to aberrant utilization or the provision
of unnecessary tests, we believe it would be inappropriate to open the
issue of eliminating local policies to negotiation.
We are confident that the policies resulting from these
negotiations and the provisions in section 4554(b) of the BBA will be
extremely beneficial in mitigating the inconsistencies in laboratory
coverage policies throughout the country. Since one of the likely
criteria for prioritization of laboratory tests for discussion is the
extent of national inconsistency, we believe that the negotiation on
specific laboratory tests will likely address tests where there is
currently the greatest variation in coverage among local carriers.
However, we also believe the statute is clear in its intent to provide
the authority for carriers to institute local policies in areas where
there is demonstrated need to respond to potential abuse.
5. Screening Tests
Section 1862(a)(7) of the Act prohibits payment for routine
physical checkups. In addition, section 1862(a)(1)(A) of the Act
prohibits payment for services that are not reasonable and necessary
for the treatment of illness or injury. HCFA has interpreted these
provisions as supporting the exclusion of coverage for general
screening services under the Medicare program. Historically, HCFA has
interpreted ``screening'' as those services furnished in the absence of
signs or symptoms indicating potential illness or injury. We believe
the Congress' actions in adding coverage of specific screening
services, such as pap smears, mammography, colorectal screening,
through legislation rather than extending coverage to all screening
services, supports its continuing intent to exclude other screening
services from Medicare coverage.
Several of the interested parties reported during the convening
process that HCFA's policy on what constitutes screening is unclear and
misunderstood. For example, one representative suggested distinguishing
screening tests from those tests used to establish a baseline value,
tests for a population that is susceptible to a particular condition,
tests used to rule out a condition, and tests used to monitor
medication. Other representatives cited coding conventions and testing
results as complicating issues.
HCFA acknowledges that there has been confusion and inconsistency
among the contractors in interpreting the policy regarding screening
testing. For example, baseline testing is not considered screening
where an illness or injury is identified and baseline testing is
necessary prior to initiation of therapy to monitor the effectiveness
of the treatment. Similarly, testing used for monitoring the
effectiveness of a medication that the patient is taking would not be
considered screening.
The issue of interpretive guidelines for screening services
involves a broader consistency of the medical community than the
interested parties identified for this clinical laboratory negotiated
rulemaking. For example, radiologists may be affected by any provision
that would be negotiated regarding screening tests, yet not have a
sufficient interest in this rulemaking proceeding to be included on
this Committee. We believe that it would be inappropriate to engage in
negotiation without the participation of all parties that would be
significantly affected. Given that the Committee for this negotiated
rulemaking does not include the full complement of interested parties
for development of a rule related to screening services and that this
item is not within the guidelines explicit in section 4554(b)(2) of the
BBA, we do not believe that screening services should be included
within the scope of the negotiations.
In determining that the general interpretation of screening
services is not within the scope of these negotiations, we do not
intend to preclude the development of individual laboratory coverage
policies related to specific screening testing. If the Committee
decides to develop laboratory coverage policy that distinguishes
between screening and diagnostic uses of a specific test, that action
would be within the scope of these negotiations.
IV. 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, some of which are coalitions
of two or more groups:
American Association of Bioanalysts
American Association for Clinical Chemistry
American Association of Retired Persons
American Clinical Laboratory Association
American Health Information Management Association
American Medical Association
American Medical Group Association
American Society of Clinical Pathologists
American Society of Internal Medicine
College of American Pathologists
Clinical Laboratory Management Association
Health Industry Manufacturers Association
Medical Group Management Association
National Medical Association
We have determined that various types of laboratories, laboratory
managers, physicians, and Medicare beneficiaries are likely to be
significantly affected by the rule. These groups would be significantly
and directly affected by coverage policies for clinical diagnostic
laboratory tests, as well as by documentation and administrative
policies for such tests. Group practices would be affected both because
they operate laboratories and because they would be subject to any
physician documentation or recordkeeping requirements imposed. Coding
and recordkeeping issues also affect medical record specialists.
Finally, to the extent that coverage of new tests will be affected by
this rule to be negotiated, manufacturers of clinical diagnostic
laboratory tests are like to be significantly affected.
We would also like to 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 to 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 believe that
their interests are
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sufficiently different from the persons or entities listed above so as
not to 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. We reserve the right to refuse
representatives who do no 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. We are establishing an
Internet site on our home page (http://www.hcfa.gov/quality), which
will carry the names of Committee members as well as other meeting
information. We invite public comment on this list of negotiation
participants.
The intent in establishing the Committee is that all interests are
represented, not necessarily all parties. We believe this proposed list
of participants represents all interests associated with adoption of
national coverage and administrative policies for clinical diagnostic
laboratory tests. 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 provider groups, Lastly, while
we are obligated to assure 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.
V. Schedule for the Negotiations
We have set a deadline of six months beginning with the date of the
first meeting for the Committee to complete work on the proposed rule.
The first meeting of the negotiated rulemaking Committee is
scheduled for July 13, 14, and 15, 1998, at Turf Valley Hotel in
Ellicott City (Baltimore) beginning at 9 a.m. The purpose of this
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 operations, will determine how best to address the
principal issues, and, if time permits, will begin to address those
issues.
A second meeting is scheduled for July 28, 29, and 30, 1998 at the
Turf Valley Hotel in Ellicott City (Baltimore). Again, the meetings
will begin at 9 a.m. We expect that by this meeting the Committee can
complete action on any procedural matters remaining from the
organizational meeting and either begin or continue to address the
issues. Six subsequent meetings will be held as follows: August 25, 26,
and 27 at the Phoenix Park Hotel in Washington, DC (1-800-824-5419);
September 14, 15, and 16 in Washington, DC; October 6, 7, and 8 at the
Turf Valley Hotel in Ellicott City (Baltimore); October 26, 27, and 28
at the Turf Valley Hotel in Ellicott City; November 18, 19, and 20 at
the Phoenix Park Hotel in Washington, DC and December 8, 9, and 10 at
the Phoenix Part Hotel in Washington, DC.
All meetings will begin at 9 a.m. and end at approximately 5 p.m.
During these meetings, the Committee will continue to address the
issues within the scope of the negotiations as described in this
document. More detailed agenda for each meeting will be available on
the HCFA Internet Home Page (http://www.hcfa.gov/quality/qlty-8a)
preceding each meeting date.
VI. 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 15 and
should not exceed 25 participants. A number larger than this could make
it difficult to conduct effective negotiations within the timeframe
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 of 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.
VII. 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. 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 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.
We propose to use Judy Ballard and Nancy Rubenstein of the HHS
Departmental Appeals Board as the 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 Grant
Bagley, M.D., Director of the Coverage and Analysis Group, in our
Office of Clinical Standards and Quality to represent HCFA.
C. Administrative Support
We will supply logistical, administrative, and management support.
We will provide technical support to the Committee in gathering
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and analyzing additional data or information as needed.
D. Meetings
Meetings will be held in the Baltimore/Washington area at either
the Phoenix Park Hotel in Washington, DC, or at the Turf Valley Hotel
in Ellicott City (Baltimore area) on the dates noted above. More
detailed agenda for each meeting will be publicly available on the HCFA
Home Page of the Internet (http://www.HCFA.gov/quality/qlty-8a). 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 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.
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.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance)
Dated: May 1, 1998.
Nancy-Ann Min DeParle,
Deputy Administrator, Health Care Financing Administration.
Approved: May 28, 1998.
Donna E. Shalala,
Secretary.
[FR Doc. 98-14798 Filed 6-2-98; 8:45 am]
BILLING CODE 4120-01-M
