[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Notices]
[Pages 17085-17086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6614]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Secretary's Advisory Committee on Genetics, Health, and Society; 
Office of the Secretary, HHS; Request for Public Comment

ACTION: Request for public comment on a draft report on coverage and 
reimbursement of genetic tests and services.

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SUMMARY: The Secretary's Advisory Committee on Genetics, Health, and 
Society (SACGHS) is requesting public comment on a draft report on 
coverage and reimbursement of genetic tests and services.

DATES: Written or electronic comments should be submitted by May 6, 
2005.

ADDRESSES: Comments can be sent by mail to the following address: 
Secretary's Advisory Committee on Genetics, Health, and Society, attn: 
Suzanne Goodwin, NIH Office of Biotechnology Activities, 6705 Rockledge 
Drive, Suite 750, Bethesda, MD, 20892. Comments also can be sent via e-
mail to Suzanne Goodwin at [email protected] or via facsimile to 301-
496-9839.

FOR FURTHER INFORMATION CONTACT: Suzanne Goodwin, NIH Office of 
Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, MD 
20892, 301-496-9838, [email protected].

SUPPLEMENTARY INFORMATION: The Department of Health and Human Services 
(HHS) established SACGHS to serve as a public forum for deliberations 
on the broad range of human health and societal issues raised by the 
development and use of genetic technologies and, as warranted, to 
provide advice on these issues. For more information about the 
Committee, please visit its Web site: http://www4.od.nih.gov/oba/sacghs.htm.
    In its first year, SACHGS identified coverage and reimbursement of 
genetic tests and services as a high priority because there are 
significant barriers to coverage and reimbursement as well as unmet 
data needs that are currently limiting appropriate access and clinical 
integration.
    Its report, Coverage and Reimbursement of Genetic Tests and 
Services, describes the current state of, and problems associated with, 
coverage and reimbursement for genetic tests and services and offers 
recommendations on how current mechanisms for coverage and 
reimbursement for genetic tests and services might be improved. Once 
finalized, the report and recommendations will be transmitted to the 
Secretary of Health and Human Services.
    SACGHS proposing to make the following recommendations in its 
report to the Secretary:
    1. The Secretary should task an appropriate group or body to 
develop a set of principles to guide coverage decision making for 
genetic tests. The principles should identify criteria to help 
determine which types or categories of genetic tests should be covered, 
which should not be covered, and which fall into an uncertain gray 
zone. The group's guiding principles should address the issues of 
economic evaluation/cost-effectiveness, prevention, rare disease tests, 
and therapeutic versus informational benefit. The Committee also 
recommends that the existing evidence for specific tests be assessed in 
order to determine whether the evidence is adequate in type, quality, 
and quantity to establish analytical validity, clinical validity and 
clinical utility as well as to identify any gaps in evidence.
    This body should include both relevant HHS agencies and private 
organizations and utilize resources of models in the public and private 
sector. The Evaluation of Genomic Applications in Practice and 
Prevention Work Group organized by the Centers for Disease Control and 
Prevention involves such a diverse range of stakeholders and is 
performing similar work and, thus, is an example of such a body to be 
tasked to develop these principles and address these issues.
    The Committee also recommends a mechanism be established that would 
specifically promote and fund studies to address any identified gaps in 
the evidence base.
    2. Genetic tests and services in pediatrics and those with a 
prevention component should be considered specifically with respect to 
the benefits they can offer the populations they serve. Although 
standardization of coverage decisions using best scientific evidence 
across public and private payers is ideal (see Recommendation 1), 
private payers should be supported with necessary information to make 
their own coverage determinations about these tests and services 
relative to the populations they serve.
    3. Although a mixed national-local coverage decision-making process 
is a reasonable approach to making Medicare coverage decision for 
genetic tests and services, there are several aspects of the current 
national-local decision-making process that limit its utility. While 
not suggesting changes to the current system, SACGHS recommends that 
the Secretary encourage the Centers for Medicare & Medicaid Services 
(CMS) to move forward with the implementation of Section 731 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 
which requires the development of a plan to evaluate new local coverage 
decisions to determine which should be adopted nationally and to what 
extent greater consistency in Medicare coverage policy can be achieved.
    4. Medicare beneficiaries who lack current signs, symptoms, or 
personal histories of illness stand to clinically benefit from 
predictive and predispositional genetic tests and services. As such, 
SACGHS recommends that preventive services, including predispositional 
genetic tests and services, meeting evidence standards should be 
covered under Medicare.
    The Secretary should urge Congress to add a benefit category for 
preventive services that would enable CMS to determine through its 
national coverage decision-making process, which includes an assessment 
of existing evidence, whether an item or service is reasonable and 
necessary for the prevention or early detection of an illness or 
disability and, thus, ought to be covered. Such action would allow CMS 
to consider covering many more genetic tests and services that are used 
for preventive purposes.
    More immediately, the Secretary should direct CMS to clarify, 
through appropriate guidance, that in certain circumstances and where 
scientific evidence warrants, ``personal history'' may include family 
history of a particular disease for purposes of establishing that a 
genetic test is ``reasonable and necessary'' and, therefore, covered 
under Medicare. CMS should specify the circumstances and criteria 
required to make such a determination.
    5. The Secretary should broadly disseminate to all states 
information about the existing evidence base and other supporting 
information, such as guiding principles that serve as the basis for 
coverage decision-making, on genetic tests and services. This 
information could be utilized by the

[[Page 17086]]

states to inform their Medicaid coverage decisions.
    HHS should continue to provide states with grants that encourage 
the coverage, adoption and provision of genetic services that have a 
sound evidence base.
    6. In many cases, payment rates for genetic tests are lower than 
the actual cost of performing the test. Until the fee schedule can be 
reconsidered in a comprehensive way, the Secretary should direct CMS to 
address variations in payment rates for the genetic test Current 
Procedural Terminology (CPT) codes through its inherent reasonableness 
authority.
    7. Genetic counseling is a critically important component of the 
appropriate use and integration of genetic tests and services. As such, 
SACGHS recommends the following:
     Qualified health providers should be allowed to bill 
directly for genetic counseling services. The Secretary should 
expeditiously identify an appropriate mechanism for determining the 
credentials and criteria needed for a health provider to be deemed 
qualified to provide genetic counseling services and eligible to bill 
directly for them.
     The Secretary should direct government programs to 
reimburse prolonged service codes when determined to be reasonable and 
necessary.
     HHS, with input from the various providers of genetic 
counseling services, should assess the adequacy of existing CPT 
Evaluation & Management (E&M) codes and their associated relative 
values with respect to genetic counseling services. Any inadequacies 
identified should be addressed as deemed appropriate.
     CMS should deem all non-physician health providers who are 
currently permitted to bill directly any health plan--public or 
private--eligible for a National Provider Identifier.
     The Secretary should direct CMS to allow non-physician 
health professionals who are qualified to provide genetic counseling 
services and who currently bill incident to a physician to utilize the 
full range of CPT E&M codes available for genetic counseling services.
    8. Since providers act as intermediaries between health plans and 
plan members and thus have an important role in ensuring genetic tests 
and services are provided appropriately, there is a need to support the 
ongoing training and continued education of health providers in 
genetics and genomics. SACGHS's recommendations to the Secretary in 
2004 included the following: the Secretary should develop a plan for 
HHS agencies to work collaboratively with state, federal and private 
organizations to support the development, cataloguing and dissemination 
of case studies and practice models that demonstrate the current 
relevance of genetics and genomics; and the Secretary should strive to 
incorporate genetics and genomics into relevant initiatives of HHS, 
including the National Health Information Infrastructure.
    9. Reliable and trustworthy information about family history, 
genetics and genetic technologies should be developed and made more 
widely available through the internet and other mechanisms that allow 
patients and consumers to evaluate health plan benefits and health 
providers so that they may make the most appropriate and most 
financially responsible decisions for themselves and their families.
    The Secretary should leverage HHS resources to develop and make 
widely available reliable and trustworthy information about genetics 
and genetic technologies to guide and promote informed decision making 
by healthcare consumers and providers. Such information should be made 
available though federal government Web sites and other appropriate 
mechanisms.
    The full report is available electronically at http://www4.od.nih.gov/oba/sacghs/public_comments.htm. A paper or electronic 
copy also can be requested by calling the NIH Office of Biotechnology 
Activities at 301-496-9838- or by e-mailing Suzanne Goodwin at 
[email protected].
    SACGHS is requesting comments on these recommendations and the 
overall content of the draft report. Public comments received by May 6, 
2005, will be considered by SACGHS in preparing the final report. The 
report and the public comments will be discussed at SACGHS's next 
meeting on June 15-16, 2005, in Bethesda, MD. Comments also will be 
available for public inspection at the NIH Office of Biotechnology 
Activities Monday through Friday between the hours of 8:30 a.m. and 5 
p.m.

    Dated: March 28, 2005.
Anna Snouffer,
Acting Director, Office of Federal Advisory Committee Policy.
[FR Doc. 05-6614 Filed 4-1-05; 8:45 am]
BILLING CODE 4140-01-M