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The CAP strongly urged the Centers for Medicare and Medicaid Services (CMS) to change its implementation of a national coverage determination (NCD) on next-generation sequencing for patients with advanced cancer.

The NCD, finalized March 16, 2018, included substantial changes called for by the CAP and other stakeholders. However, recent instructions from the CMS to its contractors has raised concern with the implementation of the final NCD. Under the NCD, any diagnostic laboratory test using NGS that is approved or cleared by the Food and Drug Administration (FDA) as a companion diagnostic for any patient that meets the patient criteria for recurrent, relapsed, refractory, metastatic and advanced stages III or IV cancer would be covered nationally.

In the January 28 letter to the CMS, the CAP and other concerned stakeholders emphasized that while they understand that the NCD was requested for a somatic-based test, the CMS’ instructions to its Medicare Administrative Contractors (MACs) to apply the terms of the NCD to both somatic and germline NGS-based testing for patients with cancer is problematic.

The letter is in response to the CMS’ recent interpretation that the NCD will apply to both somatic and germline NGS-based testing for late-stage cancers. The final NCD had been widely interpreted by industry to apply only to somatic tumor testing. Stakeholder groups like the CAP think that the CMS’ interpretation is erroneous.

“The implication of this interpretation is both germline and somatic tumor NGS-based testing will become non-covered for Medicare beneficiaries with early-stage cancer,” the groups write. “Our organizations believe that the inclusion of NGS-based testing for germline mutations represents significant policy overreach by CMS that will have unintended consequences on the care delivered to Medicare beneficiaries, particularly those who may have a genetic predisposition to cancer-based on a family history or other relevant criteria.”

The CMS has elected to move forward with an overly broad interpretation of the NCD that contradicts and reverses previously established policies, the groups add. As a result, the NCD will supersede existing LCDs that provide coverage for NGS-based testing for hereditary breast and ovarian cancer syndromes and Lynch syndrome in patients who do not have advanced cancer.

“Consequently, only tests utilizing older, less-advanced and more expensive non-NGS methods will be available for Medicare coverage,” the letter states. “If the agency continues to proceed with this problematic interpretation that expands the NCD to germline testing for patients with cancer, patients with early-stage cancer will receive suboptimum care.”

While the CAP and the other groups initially were pleased that the CMS finalized the NCD to allow MACs to retain the ability to develop LCDs for certain NGS-based tests, they, “are now very alarmed that the CMS is communicating instructions that do not align with what is outlined in the finalized NCD.” As such, they are calling on 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.

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Time is running out for pathologists who need to submit data for the 2018 Merit-Based Incentive Payment System (MIPS) to avoid a payment penalty in 2020. The submission deadline for attesting to Improvement Activities in order to avoid a penalty is April 2.

MIPS eligible pathologists who have not reported through the CAP’s Pathologists Quality Registry or another reporting mechanism will need to manually attest to Improvement Activities.

The CAP developed a resource to help pathologists participating in MIPS determine which Improvement Activities are most applicable to them. Non-patient facing pathologists need to attest to one high-weighted or two medium-weighted Improvement Activities, which represent 15% of a pathologist’s MIPS score, in order to receive credit in this category.

The CMS has resources, including a video to help you if you are manually attesting to Improvement Activities. Keep in mind that some of this may be aimed at patient-facing clinicians. Pathologists as non-patient facing clinicians only need to attest to one high-weighted or two medium-weighted Improvement Activities.

Even though the 2018 MIPS reporting for the Pathologists Quality Registry is closed, staff can still answer questions for 2018 MIPS reporting at

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Beginning of 2019, Medicare replaced its Quality Payment Program (QPP) login system with the HCQIS Access Roles and Profile (HARP) system. If you are a pathologist, you need HARP credentials to log in to check your QPP reporting status and possible changes to that status, and review QPP performance feedback reports. These instructional videos can help navigate the QPP login system:

  1. Create a QPP Account – reviews how to create a new HARP account.
  2. Connect to an Organization: Practice – reviews how to request access for a practice so you can view, submit, and manage data on behalf of the practice.

If you have further questions, please contact or check out the CMS user guide.

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With health care continuing to be a top domestic policy concern in Congress, PathPAC will continue to be a critical political engagement tool for pathologists. The health care public policy process is controlled by legislators who are elected to office. Pathology will be facing a slew of issues in this 116th Congress, such as 

  • Surprise billing
  • Protecting Access to Medicare Act (PAMA)
  • Laboratory-developed tests (LDTs)

The good news is that pathologists do have a voice and lawmakers want to hear from health care experts. An important tool that CAP members have to ensure that candidates running for office are educated about pathology is the CAP’s political action committee, PathPAC. PathPAC is the only political action committee that represents pathologists at the federal level.

Moreover, the PathPAC is viewed by candidates as good stewards in the campaign finance world. Since PathPAC can only be funded by individual members of the CAP, candidates know that PathPAC represents actual providers delivering quality health care to patients around the country.

The PathPAC is looking to grow its previous success in 2019. For the 2018 cycle, this includes years 2017 and 2018, the PathPAC donated to over a hundred members of Congress/candidates for office. More than 85% of those pro-pathology candidates won on election night, making the PathPAC one of the top 25 medical PACs for the 2018 election cycle. PathPAC helps to position pathologists as the experts to inform decisions about health care policy in Congress.

If every CAP member, roughly 12,000 pathologists, used our monthly contribution form and gave $10 a month for 10 months, or $100 a year, PathPAC would have the largest medical profession PAC in the country. That donation level is about the same as a Netflix Account or that Spotify premium subscription.

Learn more about the PathPAC.

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Date. February 26, 2019
Time: 1 PM ET- 2 PM ET

With the 2018 mid-term election, almost 100 new members of Congress have started and need your help to learn more about the importance and impact that Pathology has in health care. Join Donald Karcher, MD, FCAP, chair of the CAP Council on Government and Professional Affairs, David Gang, MD, FCAP, chair of the Federal and State Affairs Committee, and Jennifer Forsyth, MD, FCAP, a member of the Federal and State Affairs Committee, to learn about how your voice matters to help educate the new Congress on health care issues important to pathologists. Register today for this complimentary webinar hosted by the CAP.

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