Separate genetic and molecular test registries proposed by the National Institutes of Health and by Palmetto GBA draw detailed public comments from medical lab groups
Registries for genetic tests and molecular diagnostic assays don’t seem to be going over well with clinical laboratories and pathology groups. Two different genetic test registries are drawing criticisms from pathologists and laboratory medicine professionals.
One molecular test registry was proposed last year by the National Institutes of Health (NIH). For different purposes, this fall, Palmetto GBA, the Medicare Carrier based in Columbia, South Carolina, proposed a molecular test registry that would be used by laboratories billing for molecular testing services provided in the Medicare J1 region, which includes California, Hawaii, and Nevada.
This second registry is part of what Palmetto GBA has named the “Molecular Diagnostic Program” (MolDx). Palmetto expects this registry will help resolve problems created by code stacking claims for genetic and molecular tests. (See Dark Daily “Palmetto GBA Execs Explain MolDx, Its New “Molecular Diagnostic Services” Program for Clinical Pathology Laboratories,” November 15, 2011.) The MolDx program has already attracted public comments, both positive and negative.
Over at the National Institutes of Health, its proposed “Genetic Testing Registry” (GTR), continues to draw criticism from the medical laboratory testing profession. For example, the Association for Molecular Pathology (AMP) has voiced its concerns about the NIH’s proposed genetic testing registry.
It is not a coincidence that, in just the space of 24 months, two major healthcare organizations have announced proposals to create a genetic testing registry. The National Institutes of Health (NIH) and Palmetto GBA, the Medicare carrier, both point out the need for a database of genetic tests and molecular diagnostic assays. Each proposed genetic test registry has generated public comments by clinical laboratory and pathology associations that express concerns over the design and function of these two separate proposed genetic test registries. (Photo copyright by MayLabs.com.)
AMP responded to the NIH Request for Information (RFI) with a two-page letter this fall. In this letter, AMP stated that the proposed GTR lacks clarity and understates costs. These developments were reported by Medical Express in a story it published on October 28, 2011.
“AMP continues to have concerns regarding the format and the data elements proposed for the Genetic Test Registry,” noted Mary Steele Williams, MNA, MT (ASCP)SM, AMP’s Executive Director in the AMP press release.
AMP’s letter to the NIH included the following general concerns:
- The NIH genetic test registry should differentiate between the data elements that are appropriate for manufacturers, researchers, and clinical laboratories.
- Some data elements to be collected by the registry address detailed issues of laboratory policy that are inappropriate for inclusion in the GTR. There are also legal and liability concerns associated with these data elements.
- Some data fields request information that is not relevant or useful for the stated purposes of the genetic test registry.
“The [GTR] format, as proposed, includes levels of details that may result in confusing information,” stated Elaine Lyon, Ph.D., Chair of AMP’s Professional Relations Committee. It was Lyon who authored the comment letter that was sent by AMP to the NIH.
Further, according to AMP, the NIH significantly underestimated the time and costs involved in creating and maintaining the GTR. Med Express quoted Lyon, who said “Because many of the genetic tests are complex, those [individuals] entering the data will most likely need to be genetic counselors, laboratory supervisors, or laboratory directors—all of whom are paid more than the mean hourly wage of $22.85 listed by NIH for laboratory technicians.”
“Additionally,” continued Lyon, “contrary to the current design of the GTR, laboratory tests do not necessarily fall into neat discrete categories. The rigid inclusion requirements may create unintended consequences and vague categories.”
Explosion In Genetic Testing Drives Need For Accessible Database
It was in a March 2010, press release that NIH announced it was creating a public database to provide information that would be submitted on a voluntary basis by genetic test providers. NIH officials stated that the purpose was to enhance access to information about the availability, validity, and usefulness of genetic tests.
In its May 2010 RFI, the NIH stated its expectation that inclusion of information on the validity and utility of genetic tests will make this genetic test registry most useful to healthcare providers, patients and consumers, pathologists, clinical laboratory professionals, policy makers, and researchers.
“Although more than 2,000 genetic tests are available,” noted the NIH RIF, “there is no single public resource that provides information about the validity and usefulness of these tests. The NIH believes that transparent access to such information is vital to facilitate research and to enable informed decision making by patients, caregivers, health care providers, clinical laboratory professionals, payers, and policy makers.”
It is not surprising that clinical laboratories, anatomic pathology groups, and independent medical lab companies have concerns about efforts to create registries of genetic tests and molecular diagnostic assays. Significant amounts of the data assembled into these registries would represent proprietary and/or confidential information, for example.
On the other hand, within the United States, there is no master database or single catalog of the genetic tests and molecular diagnostic assays that are offered for clinical use. This creates problems across all sectors of the healthcare system. Whether it is employers and health insurers looking for the clinical utility of individual genetic tests, or physicians seeking appropriate tests for their patients, all stakeholders bemoan the lack of a central information resource about genetic tests and molecular assays.
—Pamela Scherer McLeod
Related Information:
Proposed NIH genetic testing registry lacks clarity, understates costs
Request for Information (RFI) on the NIH Plan to Develop the Genetic Testing Registry
Proposed NIH Genetic Testing Registry Lacks Clarity, Understates Costs
Developing the Blueprint for a Genetic Testing Registry
Jurisdiction 1 Part B: Palmetto GBA Laboratory and Molecular Diagnostic Services Program: MolDx
THE DARK REPORT: Genetic Testing Genie Is Now Out of the Bottle
