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April 2, 2019

In This Issue:

The CMS announced it would reopen its national coverage determination (NCD) on next-generation sequencing (NGS) panels. The action followed stakeholder concerns regarding Medicare’s implementation of the NCD. The CAP had urged the CMS to change its NCD policy implementation on NGS for patients with advanced cancer and continues to engage with the CMS on this issue.

In March 2018, the CMS released the final version of its NCD for NGS which provided Medicare coverage to an NGS test cleared by the FDA as a companion diagnostic for patients that met specific criteria. The NCD issued in March 2018 also indicated that Medicare Administrative Contractors (MACs) may determine coverage of other NGS test for patients that also meet the specific criteria.

However, during the implementation of the new policy, the CMS issued instructions to apply the terms of the NCD to both somatic and germline NGS-based testing for patients with cancer. This revised interpretation of the NCD acts to block NGS testing coverage for early-stage cancer patients who may have a genetic predisposition based on family history.

In a January 28 letter to the CMS, the CAP, and other concerned stakeholders asked the CMS to revise its current interpretation of the NCD by limiting it to somatic tumor testing and to communicate this change to the MACs. The letter was in response to the CMS’ interpretation that the NCD will apply to both somatic and germline NGS-based testing for late-stage cancers. The final NCD was widely interpreted by industry to apply only to somatic tumor testing.

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The CAP urged federal lawmakers to support the Resident Physician Shortage Reduction Act of 2019, which is designed to alleviate national physician workforce and shortage issues by lifting the graduate medical education (GME) funding cap and expanding the number of residency slots.

The legislation, sponsored by Sens. Robert Menendez (D-NJ), John Boozman (R-AR), and Charles Schumer (D-NY), in the Senate and Reps. Terri Sewell (D-AL) and John Katko (R-NY) in the House, would phase in 15,000 additional Medicare-supported residency slots over five years and would set aside a percentage of the slots for specialties designated as shortage areas.

According to the most recent projections, the United States will face a physician shortage of between 42,600 and 121,300 physicians by 2030. For pathology, studies show a projected shortage of trained pathologists in both the short- and long-term. For forensic pathology, a current shortage exists that has been exacerbated by the role forensic pathologists play in investigating drug overdose deaths and certifying the cause of death, the CAP noted in a March 25 letter sent to the bill’s sponsors.

“While these slots won’t be apportioned to forensic pathology, these slots will increase the number of graduate medical students, thereby increasing the pool from which to draw the next generation of pathologists, including forensic pathologists,” wrote Donald Karcher, MD, FCAP, chair of the CAP Council on Government and Professional Affairs. “As such, the CAP strongly supports this bill.”

The Senate bill, S. 348, has been referred to the Senate Committee on Finance. The House bill, H.R. 1763, has been referred to the House Ways and Means Committee and the House Energy and Commerce Committee. The CAP will provide updates as the legislation progresses.

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Experts from the American Medical Association (AMA) and Brookings Institute will join CAP leaders for a discussion on national health care policy and politics during the 2019 Policy Meeting April 29-May 1.

With health care being the number one campaign issue in the November elections, debate on proposals to how to best protect patients and cut costs has continued in 2019. While some politicians still call for repeal of the Affordable Care Act, other lawmakers have advocated to enact “Medicare for All” legislation to provide national health insurance for all Americans. During this session attendees will gain a deeper understanding of the politics and health care debate in Washington and how it affects the practice of pathology. The panel will feature Emily E. Volk, MD, MBA, FCAP, who is vice chair of the CAP Council on Government and Professional Affairs (CGPA). Joining Dr. Volk will be William E. Kobler, MD, a family physician who serves on the AMA Board of Trustees, and Matthew Fiedler, PhD, who is a fellow with the Center for Health Policy in the Brookings Institute’s Economic Studies Program. The panel discussion will be moderated by CGPA Chair Donald S. Karcher, MD, FCAP.

Register and join your colleagues at the 2019 Policy Meeting April 29-May 1 in Washington, DC. In addition to unique opportunities to hear from leaders and newsmakers in US politics, the 2019 Policy Meeting is your chance to speak directly to members of Congress and their staff during the CAP’s annual Hill Day on May 1. The Policy Meeting is the pathologist’s opportunity to educate legislators and policy experts on the value that pathology brings to the health care continuum.

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The CMS launched a new competition to accelerate innovative solutions to predict health outcomes and improve the quality of care for patients. The CAP will closely watch any innovations that affect the practice of pathology.

“The Artificial Intelligence Health Outcomes Challenge is an opportunity for innovators to demonstrate how artificial intelligence tools – such as deep learning and neural networks – can be used to predict unplanned hospital and skilled nursing facility admissions and adverse events,” said CMS Administrator Seema Verma.

In partnership with the American Academy of Family Physicians and the Laura and John Arnold Foundation, the challenge will engage innovators from all sectors, not just from health care, to harness artificial intelligence solutions to predict health outcomes. The CMS and partnering organizations will award up to $1.65 million in total to selected participants.

Interested innovators may apply at Up to 20 participants will be selected to participate in stage 1 and stage 2. During stage 1, participants will develop algorithms that predict health outcomes from Medicare fee-for-service data and strategies and methodologies to explain the artificial intelligence-driven predictions to frontline clinicians and physicians while building trust in the data. Participants in stages 1 and 2 of the competition will use Medicare claims data sets provided by the CMS to develop their algorithms and solutions.

The deadline for submitting applications is June 18. More information is available at and

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