Read the Latest Issue of STATLINE

January 13, 2015

In This Issue:

Significant changes are needed to the Food and Drug Administration (FDA) draft guidance on oversight of laboratory-developed tests (LDTs), the CAP said during testimony at an FDA public workshop January 8 and 9.

The CAP has not endorsed the FDA proposed LDT oversight guidance published in October 2014. The CAP will seek significant changes to the FDA draft guidance and the College will detail its proposed changes in its formal comments to the FDA due in February.

Consistent with the CAP's longstanding LDT policy, the College seeks a regulatory framework that:

  • assures quality laboratory testing for patients
  • allows for continued innovation in diagnostic medicine
  • establishes the least burdensome regulatory requirements for laboratories

During the FDA public workshop at the National Institutes of Health Campus in Bethesda, MD, CAP experts provided testimony on the CAP’s position on LDT oversight. Speaking on behalf of the CAP were Council on Government and Professional Affairs (CGPA) Chair George F. Kwass, MD, FCAP; CGPA Vice Chair Emily Volk, MD, FCAP; and Gail Vance, MD, FCAP, member of the CAP Personalized Healthcare Committee. The CAP testified during five of the six workshop sessions.

The CAP discussed the FDA proposal and advocated for changes. For instance, the definition of an LDT should include tests developed by a CLIA certified laboratory and performed by a clinical laboratory in the healthcare system in which the test was developed. The CAP does not support a narrow definition of an LDT by the FDA that places established LDTs into a medical device category.

"The FDA's definition of LDTs would exclude many innovative LDTs developed and used within healthcare systems," Dr. Kwass said in his testimony. "We have heard concerns from our members that as written the guidance would impact their ability to provide appropriate and critical testing for their patients."

In the draft guidance, the FDA proposes that when a clinical laboratory modifies an FDA cleared or approved device in a way that affects device performance or its intended use it is considered to be a device manufacturer. The CAP recognizes that laboratories may modify an existing LDT to improve performance. For example, some laboratories have modified a test to automate a manual method. The clinical claim and performance characteristics for the test do not change.

"In this case, the CAP believes the change should not constitute the creation of a new LDT," Dr. Volk said. "However, we acknowledge that a major analytic change or new clinical claim to an existing LDT creates the need for a new LDT designation."

Also during the workshop, Dr. Vance addressed the role of pathologists and developing an optimal risk classification scheme in the oversight guidance. The CAP believes that the process for classification and prioritization should be based on risk and the novelty of the LDTs. The CAP had proposed an approach that views high-risk LDTs as proprietary algorithm tests that should require FDA review. But based on the draft guidance, the CAP estimates 1,000 LDTs considered to be companion diagnostics would be classified as high-risk LDTs. They would require premarket approval applications even though these tests were well-established in medical practice and the standard of care.

"We believe that pathologists' participation is critical throughout the LDT process, because we already work in concert with other clinicians to improve the development application, interpretation, and dissemination of laboratory tests," Dr. Vance said. "Further, we believe that the pathologists should be involved in the prioritization process because we have expertise in the clinical and anatomic pathology laboratory specialties such as microbiology, immunology, chemistry, hematology, immunohematology, cytopathology, histopathology, genetic testing and informatics. In addition, pathologists have a long history of being responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures; record and report test results promptly, accurately and proficiently; and assure compliance with the applicable regulations."

Back to the top

Former Centers for Medicare & Medicaid Services (CMS) Administrator Don Berwick, MD, will give the CAP 2015 Policy Meeting keynote address in May.

Prior to serving as Administrator of the CMS, Dr. Berwick was the founding CEO of the Institute for Healthcare Improvement, a nonprofit dedicated to improving healthcare around the world. A pediatrician by background, he has also served on the faculties of the Harvard Medical School and the Harvard School of Public Health.

In his keynote address, Dr. Berwick will present a vision of how, through continual improvement, innovations in healthcare delivery, stronger leadership, and smarter policy, America can forge a system that satisfies our patients, achieves better outcomes, respects our limited resources, and honors our moral imperative to care for the disadvantaged. His focus on improving quality has gained him a reputation as a powerful motivator who can encourage institutions and individuals to do their work better.

Learn, Network and Impact the Profession. Join your colleagues at the 2015 CAP Policy Meeting May 4-6, 2015 in Washington, DC. Focus on the issues most important to pathologists now and in the future.

Back to the top

More Medicare patients will be served by accountable care organizations (ACOs) in 2015 following the addition of 89 new ACOs joining the Medicare Shared Savings Program (MSSP).

The program continues to grow with more than 7.8 million Medicare patients being served by 424 ACOs. Many of the new 89 ACOs include groups and hospitals where CAP members practice. The CMS posted a full list of new ACOs on its website.

The overwhelming majority of ACOs in the MSSP are in track one and can earn financial incentives for meeting quality measures and lowering cost. ACOs willing to take on greater financial risk under the MSSP’s track two can be eligible for higher incentives, but are also responsible for financial losses. In December 2014, the CMS also proposed its MSSP rule that would update a 2011 regulation that launched the MSSP. Notable changes in the CMS proposal include:

  • Extending the one-sided ACO track otherwise set to expire where groups are eligible for incentives, but not responsible for financial losses
  • Adding a track three for ACOs seeking to share increased levels of financial risk for the possibility of greater reward
  • Refining beneficiary assignment methodology as it relates to assignment to non-physicians (e.g. nurse practitioners, physician assistants) and other specialists that could provide primary care services excluding pathologists, emergency medicine, diagnostic radiology and about 31 other specialties
  • Making additional data available to ACOs for population-based activities and easing the administrative burden associated with beneficiaries opting out of claims data sharing

The CAP expects to provide additional information on the proposed rule and will be monitoring the final rule. Following a comment period, a number of additional changes are expected.

Back to the top