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February 24, 2015

In This Issue:

The CAP testified at a Food and Drug Administration (FDA) public workshop regarding the FDA’s regulatory oversight of next generation sequencing (NGS) diagnostic tests.

During the February 20 meeting, the FDA gathered testimony on the appropriate approach to regulating diagnostic tests for human genetics and genomics using NGS technology. Karl V. Voelkerding, MD, FCAP, spoke on behalf of the CAP and provided comments on an FDA preliminary discussion paper addressing oversight of NGS. Dr. Voelkerding also participated in a panel discussion titled "Implementing analytical process standards" and spoke about laboratory accreditation and proficiency testing for NGS.

The CAP has several concerns with the FDA discussion paper. These concerns include the potential to use NGS to look at variants broadly and in an indication-blind manner. The College also is troubled with a focus on the interpretation and communication of test results in the discussion paper.

In practice, NGS is done on a patient for a particular purpose, whether to identify mutations in tumors or to identify a rare constitutional mutation in a patient with a serious but undiagnosed condition, Dr. Voelkerding said.

Regarding interpretation and communication of test results, the application of NGS to correctly identify a variant that is interpreted in the context of a patient's clinical presentation represents essential medical practice, Dr. Voelkerding said. Medical directors who review and interpret sequence variants generated by NGS use published interpretation guidelines developed initially for Sanger sequencing, but which are equally applicable to NGS.

"The FDA should not impede the research, innovation, and clinical translation of NGS that is already leading to advances in medical practice," Dr. Voelkerding stated in his testimony. "The College is concerned that the discussion paper espouses an expanded role of the FDA in the clinical translation of NGS. In portraying this role as one of facilitating innovation to benefit public health, the FDA is extending beyond its traditional role of ensuring safety and effectiveness of medical devices."

The CAP will report more on its engagement regarding this issue in future editions of STATLINE.

CAP Requests Reconsideration for Medicare NGS Payment

Following careful review of final determinations, the CAP requested the Centers for Medicare & Medicaid Services (CMS) reconsider the basis for payments of the new Tier 1 Molecular Pathology Current Procedural Terminology (CPT) Codes and the new Genomic Sequencing Procedures (GSP) and Other Molecular Multianalyte Assays (MAA) CPT Codes in the 2015 Clinical Laboratory Fee Schedule (CLFS). In December 2014, the CMS issued its final payment determinations for new codes in the 2015 CLFS. Additional input through the annual CLFS public meeting process would allow additional clarification regarding typical resources required to perform and the clinical uses for these services.

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The Arizona House of Representatives passed legislation to allow patients to directly order any laboratory test. If signed into law, the bill would give patients the right to order any laboratory test of their choosing without a physician's request or written authorization. The original bill was amended by the CAP and the Arizona Society of Pathologists (ASP) to make clear that the laboratory ultimately decides which tests, if any, patients may order.

The Arizona bill (HB 2645) would amend current statute limiting patient direct access to only certain laboratory tests designated by the state (see the current list of tests ).

On February 16, ASP President Richard Trepeta, MD, FCAP, wrote the state House Health Committee to request several amendments to the original bill. The Health Committee on February 17 took testimony on the bill and passed HB 2645 without amendment, but the CAP and ASP supported amendments on the state House floor that address several concerns on behalf of pathologists on February 19.

The House floor amendments also address potential pathologist liability concerns. Specifically, a health care provider would not be subject to liability or disciplinary actions for the failure to review or act on results of a laboratory test when the provider did not request or authorize the test. Test reports must state in bold type that the patient who was tested should arrange for a consultation and interpretation of the test results.

A House fact sheet offers more information about the bill.

The CAP will continue to monitor the Arizona legislation and keep pathologists informed in STATLINE of the bill's progress.

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The New Mexico State Legislature is considering legislation to correct defects in state law limiting access to genetic testing.

The "Informed Consent for Genetic Testing" bill (HB 369) would remedy state statute by specifically allowing laboratories to conduct genetic testing and retain DNA samples upon the orders of a health care practitioner. Prior law disallowed such actions without the patient's specific informed consent. The change would be consistent with CAP policy and has the support of the New Mexico Society of Pathologists (NMSP).

"Genetic testing has become an integral part of patient care, particularly in the diagnosis and treatment of cancer," wrote NMSP State Issue Advisor Scott Otteson, MD, FCAP in a February 20 letter in support of the legislation. "The requirement that laboratories obtain a separate informed consent for medically necessary genetic testing is often burdensome to the laboratory. Furthermore, the requirement can result in delays in diagnosis and treatment. Removing barriers to genetic testing is integral to providing quality patient care."

The CAP will keep members informed on the latest developments regarding this legislation in future editions of STATLINE.

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We apologize for the inconvenience, the webinar "Results from CAP's 2014 Practice Characteristics Survey" on February 26, 2015 has been canceled and will be rescheduled to a later date.

The CAP will notify members through STATLINE when a new date and time are scheduled for this webinar.

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