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The CAP strongly encouraged the House Energy and Commerce Committee to use the CAP's approach for laboratory-developed test (LDT) oversight when legislating to ensure quality testing and innovations continue in laboratories.

The CAP released a statement advocating for its legislative proposal for LDT oversight to the Energy and Commerce Health Subcommittee during a hearing on November 17. The subcommittee gathered testimony from officials at the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) regarding each agency's responsibilities and areas of expertise in the regulation of diagnostic tests. The hearing was held after the Energy and Commerce Committee released a second discussion draft of legislation to reform and provide oversight on in vitro diagnostic testing, including LDTs.

In the statement, the CAP advocated for its legislative approach to the oversight of LDTs and provided initial feedback on the committee's discussion draft. In particular, the CAP expressed concern to the committee regarding new provisions in the draft. The CAP stated that the second discussion draft has increased the regulatory burden on laboratories by adding unnecessary regulatory provisions to the LDT issue. The CAP expressed strong concern with the broader construct and regulatory approach taken by the committee to regulate LDTs—and believes the discussion draft is unnecessarily complex and would be burdensome to laboratories.

"We believe any proposal that enhances CLIA should pertain to the oversight of LDTs, and not as an opportunity to unnecessarily add provisions extraneous to LDTs that only adds another layer of regulation and potentially imposes unintended consequences for some laboratories depending on their business model," the CAP stated. "These provisions include expanding requirements for waived testing, requiring implementation of quality systems standards throughout the testing process, and modifying improper referral requirements, and expanding specialties and subspecialties within CLIA (eg, molecular pathology, genetics)."

As was the case with the committee's initial draft, the CAP disagreed with the discussion draft's regulatory framework since laboratories could no longer develop low or moderate-risk LDTs outside of the purview of FDA's regulatory authority. The CAP believes for most LDTs, in particular moderate and low-risk, laboratories can provide innovative and quality laboratory testing under the current CLIA program where pathologists perform laboratory operations and develop LDTs.

The CAP advocated for the committee to look to the CAP's legislative proposal for an approach that is less burdensome and ensures quality laboratory testing.

"At a time when the Congress is considering several approaches to the oversight of LDTs, the CAP strongly believes the best approach is to enhance the existing CLIA structure to include analytical and clinical validity, to ensure the validation of LDTs, and to establish a targeted role for the FDA to review tests with the least transparency and greatest risk to patients," the CAP said. "We respectfully encourage the committee to consider the CAP's legislative approach, which we believe strikes the right regulatory balance to ensure innovation and quality testing without overburdening laboratories."

Read the CAP's full statement to the Energy and Commerce Health Subcommittee.

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The CAP is urging the CMS to ensure pathologists have opportunities to participate and receive incentives under the new Medicare value-based payment models. The CAP responded to the Medicare agency's request for information on implementing the Merit-based Incentive Payment System (MIPS) and alternative payment models (APMs) sections of federal law that repealed the Medicare sustainable growth rate (SGR) formula in April.

In a November 17 letter to the CMS, the CAP states it would work with the agency as it designs the MIPS and APM details to measure appropriately physicians who typically do not furnish services that involve face-to-face interaction with patients.

"The CAP believes considerable accommodations or alternate measures will be necessary to meet this clause in the Medicare Access and CHIP Reauthorization Act (MACRA)," the CAP said. "Currently, pathologists are not accounted for in two of the four MIPS categories (pathologists are currently exempt from Meaningful Use, and not accounted for under Resource Use because they do not provide primary care services.)"

Read the CAP's full comment letter.

The CMS announced its request for information on September 28. The agency sought public comment on certain aspects of the law that repeals the SGR methodology and establishes a system for future reimbursement updates over several years. The MIPS, a key provision of the law, will sunset payment adjustments under the current Physician Quality Reporting System (PQRS), the Value-Based Payment Modifier (VBM), and Electronic Health Records (EHR) Incentive Program known as meaningful use. These programs will be consolidated to create the new MIPS beginning in 2017 and affecting physician payments in 2019.

In the letter, the CAP responded to several questions posed by the CMS. For example, the CMS asked if it should maintain the same or similar reporting criteria under MIPS as under the PQRS? The CAP states the CMS should maintain the current mechanisms available and make improvements to the reporting program. "The reporting criteria should be as simple as possible," the CAP said. "CMS should eliminate many of the existing criteria, including reporting on cross-cutting measures, reporting on three National Quality Domains. These and other criteria unnecessarily complicate the program and do not provide any additional assurance of quality."

The law includes a CAP provision that gives flexibility to the Health and Human Services Secretary to develop measures and activities for physicians, including pathologists, who do not have face-to-face interaction with patients. In addition, the law promotes the development of APMs by providing incentive payments for eligible professionals participating in certain APMs beginning in 2019 and exempting them from MIPS. The law encourages the creation of additional physician-focused payment models, which would include models designed for specialist physicians.

As to criteria to be considered for quality measures required by a non-Medicare payer to qualify for a combination all-payer and combination Medicare alternative payment threshold, the CAP pointed out that pathologists’ activities provide the infrastructure and foundation for effective and appropriate care. "Pathologists, by virtue of their capabilities and roles already coordinate care and execute many of the objectives under MACRA and other efforts targeted at increasing integration to improve patient care and the patient experience overall," the CAP said. As the CAP stated at the beginning of the letter, the CAP will work with the CMS as the agency develops the MIPS and APM programs. The CAP will report more news on the Medicare MIPS and APM in future editions of STATLINE.

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The CAP is inviting stakeholders to provide comments on draft quality measures for pathologists through a short survey. Your comments are important as CAP leaders work to ensure pathologists can participate in Medicare value-based initiatives.

The CAP convened its Measures & Performance Assessment (M&PA) Subcommittee to assess opportunities for the development of evidence-based performance measures for pathologists. The CAP M&PA Subcommittee, which is part of the CAP Economic Affairs Committee, proposes these measures to promote the highest quality of care.

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