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March 19, 2019

In This Issue:

The CAP urged the Centers for Medicare & Medicaid Services (CMS) to include a flexible process that allows for evolving cancer therapy technologies and to ensure recognition of the lifesaving role that pathologists play in the chimeric antigen receptor T-cell (CAR T-cell) treatment process. In a proposal by the CMS for Coverage with Evidence Development (CED), which would cover FDA-approved CAR T-cell therapies, the CAP said the CMS should ensure that the final coverage policy is flexible for new technologies and that the agency create clear guidance for reimbursements for all CAR T-cell therapy care-team physicians, including pathologists.

In a March 15 letter to the CMS, the CAP asked the agency to ensure that its final coverage policy for CAR T-cell therapy be flexible so that the cutting-edge therapies are accessible to patients as soon as they are available. CAR T-cell therapy is a type of cancer therapy that uses a patient’s own immune system to fight the disease. Therefore, pathologists need the CMS to establish a routine protocol that would extend “coverage for newer therapies as new technologies advance with the accumulation of scientific evidence through ongoing clinical trials,” as stated in the letter.

As essential members of the cancer patient management team, pathologists play a critical role during the development of CAR T therapies by harvesting the blood-derived T lymphocytes for the development of genetically modified autologous CAR T cells. To correctly represent pathologists in this process, the CAP requested the CMS recognize the critical patient-centered care services provided by pathologists and other health care professionals during both the pre- and post-manufacturing phases of CAR T therapy. Moreover, the CAP would like the CMS to ensure fair payment for their services with established guidance.

The proposed coverage policy would require Medicare to cover the CAR T-cell therapy nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment.
This proposal was issued by the CMS on February 15.

The CMS is expected to issue its final decision on the proposal no later than May 17, 2019.

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Using data from the 2018 Practice Leader Survey, the CAP published an issue brief focused on which pathologists are most likely to have been denied access to provider networks. When pathologists are not allowed to join provider networks, their services are more likely to result in “surprise billing” for patients because pathology services are subject to out-of-network charges.

The CAP published the latest issue brief on current practice trends for pathologists, providing a snapshot of current pathology business environments exclusively for members. The latest issue brief Lock reviewed denial rates for pathology practices seeking to join a provider network, a significant issue that interferes with pathologists trying to provide quality patient care.

All of the CAP issue briefs are developed by the Policy Roundtable and help pathology practice leaders deal with the changing business landscape. The data from the practice leaders survey informs the advocacy priorities set by the CAP.

Check out the latest pathology practice data reports and issue briefs.

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The CMS is providing a preview score for eligible pathologists who are classified as facility-based clinicians for the 2019 Merit-based Incentive Payment System (MIPS) performance period. By providing this preview, the Medicare agency said it hoped to offer facility-based physicians, like pathologists, a possible view of their potential Quality and Cost performance scores. This preview is based on earlier data from the Hospital Value-Based Purchasing and will help pathologists decide which way to participate in MIPS in the 2019 performance period, either through facility-based scoring, or through the submission of quality measures, to provide them with the highest payout.

Beginning in 2019, MIPS eligible clinicians and groups who are eligible for facility-based measurement scoring will automatically have their MIPS quality and cost category scores assigned based on their attributed facility’s Hospital Value-Based Purchasing program. Facility-based pathologists and groups can also report MIPS data separately, and the CMS will use the highest score towards their MIPS final score.

While there are no submission requirements for individual clinicians in facility-based measurement, a pathology group must submit data in the Improvement Activities category to be measured as a group under facility-based measurement. Individual clinicians who are facility-based should also attest to Improvement Activities separately to maximize their MIPS score. 

Pathologists can check if they are eligible as a facility-based physician on the CMS Quality Payment Program participation look-up tool. The look-up tool will also indicate which facility you are attributed to if you are classified as a facility-based clinician.

A pathologist is considered facility-based if you are a MIPS eligible clinician type and you:

  1. Billed at least 75% of your covered professional services in a hospital setting (ie, inpatient hospital (POS 21), on-campus outpatient hospital (POS 22), or emergency room (POS 23) between October 1, 2017 and September 30, 2018;
  2. Billed at least one service in an inpatient hospital (POS 21) or emergency room (POS 23) between October 1, 2017 and September 30, 2018; and
  3. Can be attributed to a facility with a Hospital Value-based Purchasing score.

How to Access the Facility-Based Preview 

To access the facility-based preview, sign into the QPP website. From the Home page, click Preview Facility Score, or click the Facility-Based Preview link in the left-hand navigation.

To learn more about facility-based measurement for MIPS in 2019, view the 2019 Facility-based Measurement Fact Sheet and the Facility-based Preview FAQs or email CAP MIPS experts at

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Secretary of Health and Human Services (HHS) Alex Azar appointed Norman Sharpless, MD to be the acting Commissioner of the US Food and Drug Administration (FDA). 

Dr. Sharpless is the director of the National Cancer Institute, which is a division of the National Institutes of Health. He previously served as director of the University of North Carolina Lineberger Comprehensive Cancer Center and was a practicing oncologist specializing in leukemia.

Although Dr. Sharpless had been mentioned as a possible successor as the FDA Commissioner, the HHS stated that the appointment is temporary and the search for a permanent commissioner is underway.

FDA Commissioner Scott Gottlieb, MD, announced his resignation in March and is set to leave the agency in April.

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