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Citing the potential severe negative consequences to Medicare patients, the CAP opposed a draft national coverage determination (NCD) policy for next-generation sequencing (NGS) and urged the Centers for Medicare & Medicaid Services (CMS) to make substantial changes.

On November 30, 2017, the CMS proposed a wide-ranging NCD that would set limits on all current and future uses of NGS technologies in all Medicare patients with advanced cancer. The CAP responded to the proposed NCD with a January 17, 2018, letterdetailing its concerns for potential impacts on Medicare patients.

"The implementation of the proposed NCD criteria would have profound adverse and immediate consequences for access to therapies by Medicare beneficiaries, and treating physician's ability to order medically necessary tests," the CAP stated. "Future development of test-based cancer therapies would also be impacted."

In this proposed coverage, the CMS would cover NGS testing for patients with advanced cancer as long as the NGS test is run by a laboratory/platform that has been US Food and Drug Administration (FDA) approved or cleared and in a disease state where there is an FDA approved companion diagnostic and drug.

If a test is run by a laboratory that has been cleared or as an FDA approved in vitro diagnostic (not a “companion in vitro diagnostic”) in a patient with a disease where there is FDA-approved companion diagnostic and drugs, then the CMS will pay for the test if data is collected as part of a prospective registry under Coverage with Evidence Development (CED). The CMS will pay for NGS testing for patients within a NIH-NCI National Clinical Trial Network clinical trial, as part of coverage with evidence development.

The CAP is concerned that the proposed NCD constitutes an anomalous attempt to specify the medically reasonable and necessary clinical utilization of an entire family of methodologies, rather than more appropriately addressing the detection of specific genetic mutations that are clinically relevant. The implementation of the proposed NCD criteria would have profound adverse and immediate consequences for access to therapies by Medicare beneficiaries and treating physician’s ability to order medically necessary tests.

The CAP wants to ensure that patients will have minimal impact from the scope and framework of the NCD as it will restrict and deny patients and Medicare beneficiaries’ access to care.

Stay tuned for more updates in STATLINE.

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The FDA formally announced that whole slide imaging systems as Class II, on January 9, 2018. The CAP continues to advocate for digital pathology on behalf of its members on this issue, while ensuring the digital tool is being used properly for its intended clinical use.

With this approval, manufacturers will have an easier time in getting final FDA clearance for whole slide imaging (WSI) devices. In April 2017, the FDA cleared the de novo process as the first WSI system to allow pathologists to use digital pathology technology for review and interpretation of slides prepared from biopsied tissue.

The CAP has actively engaged with the FDA on its guidance for how the agency assesses digital pathology whole slide imaging devices. The CAP agreed with the FDA's approach to focus on such parameters as registration of focus errors, stitching errors and completeness of the WSI.

The CAP will continue to engage with the FDA to advocate on digital pathology issues.

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Does your practice still need to report 2017 Merit-based Incentive Payment System (MIPS) data? Under MIPS, quality only represents 85% of your score for pathologists. The other 15% is based on affirming that you do certain quality improvement activities in your practice.

To help all eligible clinicians report MIPS for 2017, the Centers for Medicare & Medicaid Services (CMS) recently launched a portal to help with the Quality Payment Program 2017 MIPS reporting. As a service to CAP members, the CAP identified the 13 Improvement Activities that are most pertinent to pathologists. This will help you save time, so you don't need to review the full list of 92 activities published by the CMS.

The new CMS module is available on the Quality Payment Program website. Eligible clinicians can submit their 2017 performance data for the Quality Payment Program until March 31, 2018. However, if you have already submitted your 2017 MIPS data via the CAP 2017 MIPS Reporting Tool, then you are covered.

Eligible clinicians are encouraged to log in early and often to familiarize themselves with the system. Data can be updated at any time during the submission period. Once the submission period closes on March 31, 2018, the CMS will calculate your payment adjustment based on your last submission or submission update.

Eligible clinicians who need assistance with the data submission system may contact the Quality Payment Program by email at or toll free at 1-866-288-8292.

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Registration is open for the 2018 CAP Policy Meeting.

The CAP's annual Policy Meeting, which is scheduled April 30–May 2, at the Washington Marriott in Washington, DC, will connect CAP members with government leaders and policy experts to discuss the impact of federal regulation on their pathology practices.

New regulations are taking shape that will impact pathology reimbursements for years to come. Attendees at the CAP’s Policy Meeting will receive the latest information and analysis on the implementation of new Medicare and laboratory regulations. The CAP is actively engaged in the legislative and regulatory arenas on the critical issues facing pathology and laboratory medicine, including physician payment reform, reducing regulatory burdens, and improving health care quality.

The Policy Meeting will also include discussions with congressional offices during the CAP's Annual Hill Day on May 2, which is the specialty's opportunity to focus on the federal issues most important to pathologists now and in the future.

The Policy Meeting is a benefit of CAP membership. There is no fee to register.

Register for the 2018 Policy Meeting.

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