May 11, 2005 - ASM Comments to SACGHS on Coverage and Reimbursement of Genetic Tests and Services

Secretary’s Advisory Committee on
Genetics, Health, and Society
Department of Health and Human Services
Attn: Suzanne Goodwin
NIH Office of Biotechnology Activities
6705 Rockledge Drive, Suite 750
Bethesda, MD 20892

To Whom It May Concern:

The American Society for Microbiology (ASM) would like to take the opportunity to provide comments in response to the Request for Public Comment on the Draft Report on Coverage and Reimbursement of Genetic Tests and Services that was developed by the Department of Health and Human Services Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) and published in the Federal Register on April 4, 2005 (Volume 70, Number 63, Pages 17085-6).

The ASM is the largest educational, professional, and scientific society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents more than 43,000 microbiologists, including scientists and science administrators working in a variety of areas, including biomedical, environmental, and clinical laboratory medicine. Many of ASM’s members are individuals responsible for directing clinical microbiology, clinical immunology and molecular diagnostic laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing products for use, and researchers involved in developing and evaluating the performance of new technologies. Thus, our Society has a significant interest in the process of establishing reasonable coverage and reimbursement for medically necessary genetic tests and services to ensure quality patient care for Medicare beneficiaries and for individuals insured by other third party payers.

The discipline of clinical microbiology also represents the initial area in which molecular genetic testing services has gained widespread acceptance and utilization based on both positive clinical and financial performance data; thus, our members have substantial experience with the processes and obstacles associated with coverage and reimbursement for infectious disease molecular testing. In addition, as the scope of the SACGHS includes “exploration of the use of genetics in bioterrorism,” the ASM has a significant interest in ensuring that reasonable coverage and reimbursement decisions are made with regard to new genetic technologies used in Sentinel and Laboratory Response Network laboratories for both agents of bioterrorism as well as for naturally occurring emerging infectious diseases of significant concern. Further, it is expected that genetic technologies will continue to play an expanding role in laboratory evaluation of infectious diseases, and coverage and reimbursement in this area is of equal importance.

With regard to the specific potential recommendations described in the draft report:

Recommendation #1: ASM concurs that a set of principles should be developed to guide coverage decision making for genetic tests. The Negotiated Rulemaking Committee for Clinical Laboratory Diagnostic Tests that was convened in 1998 as mandated by the Balanced Budget Act of 1997, provides an excellent model for such a process. Under Negotiated Rulemaking, 23 National Coverage Decisions (NCDs) were developed through a consensus process involving 18 professional group “stakeholders” who were charged to systematically evaluate available evidence for or against the medical necessity of coverage under certain medical conditions for specific laboratory procedures. While many genetic tests are inherently more complex than those evaluated for NCD development, a similar consensus process requiring evaluation of evidence is strongly recommended. However, it is of note that ASM co-chaired the Infectious Disease Workgroup which developed two NCDs that described coverage conditions for HIV molecular testing for both diagnosis and prognosis.

In particular, there should be a clarification of the relationship, if any, between FDA clearance or approval status and eligibility for coverage reimbursement for in vitro diagnostics designated as Research Use Only or Investigational Use Only. In addition, for those genetic tests that are described as “homebrew” or that use “Analyte Specific Reagents” and therefore are subject only to the Clinical Laboratory Improvement Amendments (CLIA) to determine eligibility for reimbursement, it is strongly recommended that criteria be established for the validation of assays to ensure both analytical and clinical validity, such as those found in the guidelines for molecular testing published by the Clinical and Laboratory Standards Institute (CLSI/formerly NCCLS).

Recommendation #2: ASM concurs that genetic tests and services must be considered specifically with respect to the benefits and clinical utility they can offer the populations for which they are intended. Further, validation of test performance must occur in the population the test is intended for use, as described above.

Recommendation #3: ASM concurs with SACGHS’s recommendation that the Secretary encourage the Centers for Medicare and Medicaid Services (CMS) to implement Section 731 of the Medicare Modernization Act of 2003, which requires the development of a plan to evaluate Local Coverage Decisions (LCD) for national adoption and to evaluate Local Coverage Decisions with the intent of achieving greater standardization and consistency. For example, TrailBlazer Health Enterprises, LLC developed a molecular infectious disease LCD in 2004 with significant input from professional societies including ASM, which provided documentation of evidence-based studies. The LCD has been very well received by the medical and scientific community, and a streamlined process by which this LCD could be adopted nationally would guarantee beneficiary access to these genetic testing services when medically necessary in a shorter timeframe.

Recommendation #4: It is clear that many genetic tests and services providing predictive or predispositional data will ultimately prove to be cost effective in managing healthcare resources. It will be essential that federally funded programs like Medicare allow for payment of these services that under current statutory interpretation would be considered “screening” and therefore “not reasonable or necessary” for coverage. This is currently an issue with regard to infectious disease testing as both the American College of Obstetrics and Gynecology and the American Cancer Society have endorsed the “DNA with PAP” (i.e. a Papanicolaou stain performed on a liquid cervical cytology sample concurrently with a Human papillomavirus DNA virus high risk type molecular test) as an alternative to potentially reduce the frequency of testing required in women who have negative results with both tests. To realize the financial benefits of genetic tests, coverage of such services will be necessary and we concur that in select situations, Medicare coverage should be considered.

Recommendation #5: ASM concurs that HHS should broadly disseminate information serving as the basis for coverage decision making. The process already in place since 2001 for the development of new NCDs, including review by the Medicare Coverage Advisory Committee (MCAC) as well as other existing technology assessment groups, provides a useful resource for obtaining such information for dissemination. In addition, during the process of establishing new CPT-4 codes, documentation is generally submitted to the American Medical Association and to the Pathology Coding Caucus which would not only describe the technology for a new genetic test or service, but would also provide data on the clinical utility and utilization of the assay which, with permission of the AMA, could also be disseminated for use in coverage decision making. In short, much data currently exists that should be more openly shared in development of Medicare and other payer decisions.

Recommendation #6: The Institute of Medicine Report on Medicare Laboratory Payment Policy clearly established that the current National Limitation Amount (NLA) is not relevant to present day laboratory practice, particularly for many emerging technologies. Not only are reimbursement amounts lower than the actual costs of performing the tests, but the current coding system fails to take into account methodological differences that may relate to costs (e.g. “real-time PCR” is not separately distinguished) and in fact, these differences may relate to clinical and financial performance as more data are obtained and evaluated. In addition, there are illogical differences in reimbursement for tests costing roughly an equivalent amount to perform. For example, the NLA for the HIV viral load assay is priced at 2X that of the HCV viral load assay, when in fact, the higher amount is inadequate to cover costs for either. Inherent reasonable authority, when activated, is one avenue to adjust reimbursement to be more reasonable; however, a complete re-evaluation may be necessary to introduce ration and logic into the reimbursement process for genetic services.

Recommendation #7: ASM strongly endorses the recognition of qualified, Board-certified, non-physician providers as valuable and critical members of the healthcare team by allowing coding for and direct billing for services provided directly by those providers using an assigned National Provider Identifier.

In the case of genetic counselors, ASM endorses the draft recommendation for direct billing of genetic counseling services using an appropriate set of well-defined CPT-4 codes. However, ASM also strongly recommends that the SACGHS consider that other Board-certified clinical laboratory scientists make invaluable contributions in the interpretation of genetic tests and services for which CPT-4 codes currently exist, and for which they are currently unable to directly bill. For example, CPT-4 code 83912 for interpretation of molecular diagnostic tests is reimbursed as a physician fee schedule item when an interpretation is performed by a pathologist, but when interpreted by a doctoral level Board-certified clinical laboratory scientist, no reimbursement for the same service is allowable. For interpretation of complex infectious disease molecular diagnostics other than simple qualitative or quantitative assays (e.g. genotyping assays), no interpretation codes exist. In fact, this concept extends far beyond the genetic test arena, but the disparity is readily apparent here. It should be noted that CLIA regulations recognize individuals holding board certification by the American Board of Medical Microbiology (ABMM) and the American Board of Medical Laboratory Immunology (ABMLI) in the categories of Laboratory Director and Clinical Consultant.

Recommendation #8: ASM strongly concurs that HHS should partner with other agencies and organizations to develop case studies and practice models to demonstrate the relevance of genetic tests and services. In fact, ASM has many active educational programs that use a case study design to demonstrate the relevance of infectious disease diagnostics, diagnostic immunology, and molecular diagnostics. ASM would be pleased to partner with HHS to support such educational objectives.

Recommendation #9: ASM strongly supports the use of HHS resources to increase availability of reliable information for informed decision making by healthcare providers and healthcare consumers. Direct-to-consumer marketing as a trend will likely continue and it is of paramount importance that reliable sources of information be promoted. Again, HPV provides an example from infectious diseases where the sole manufacturer of the HPV molecular test kit has taken a very aggressive approach to advertising its product in a number of popular venues, emphasizing the endorsement in ACOG and ACS practice guidelines. In response, HHS has recently (March 2005) issued a “Dear Colleague” letter clarifying potential points of confusion. In the future, it will be increasingly necessary to remain aware of such marketing campaigns and both reassure and educate consumers and healthcare providers when conflicting information is available. ASM stands ready to serve as a resource in any matters of mutual interest.

In summary, ASM appreciates the opportunity to provide comments on the SACGHS Draft Report on Coverage and Reimbursement of Genetic Tests and Services. While our members have significant interest in current matters pertaining to coverage and reimbursement for molecular diagnostics for infectious diseases and a number of other applications including cancer diagnostics and pharmacogenomics, we anticipate an even greater interest in future years. Not only is there a greater appreciation of the role of the host in the susceptibility to infectious diseases and in determination of the ultimate outcome in the internal battle in an infection, but there is increasing recognition of the role of microorganisms as triggers of many illnesses here-to-fore considered chronic for which genetic tests may play a vital role in analysis (Microbial Triggers of Chronic Human Illness, American Academy of Microbiology, 2005). Further, advances in microarray technology will yield information on the presence of both known and previously unrecognized microbial agents which will not only be diagnostically useful, but may also raise ethical concerns regarding long term implications for medical and economic well-being of individual patients. This will be particularly true for viruses, which are etiologically associated with malignancy. Therefore, coverage and reimbursement will continue to present challenges in provision of laboratory services, and ASM stands ready to assist SACGHS in any way possible.