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Citing issues associated with the inclusion of biospecimens as human research subjects, the CAP detailed in a formal comment letter several concerns with draft "Common Rule" changes under the Federal Policy for the Protection of Human Subjects. The CAP urged the Department of Health and Human Services (HHS) to revise and reissue its proposed regulation.

"It is imperative to have regulations governing human research that balance human protection enhancements and impose minimal burden on researchers," the CAP stated in its comments.

Read the CAP's comments on the Common Rule.

The proposal includes in the definition of human subjects as individuals about whom an investigator conducting research obtains, uses, or analyzes biospecimens regardless of whether the biospecimen contained identifiable information. While the CAP strongly believes informed consent should be obtained as part of the general surgical process, the CAP is concerned about the broad inclusion of biospecimens in the definition of human subjects.

Pathologists interact with specimens in many ways, but are primarily involved—in the laboratory setting—with the evaluation and diagnosis of blood, body fluids or tissue specimens. These evaluations usually have prognostic implications. Once these evaluations are completed, there are, in many instances, residual specimens remaining.

The expansion of the proposed human research requirements potentially will diminish the effectiveness of researchers by requiring overlapping and incongruent administrative activities that are counter to research activities conducted within academic institutions today. If the HHS Office of Human Research Protections moves forward with biospecimens in the definition for human subjects, the CAP recommended several changes:

  • Allow for informed consent to be obtained as part of the general surgical process,
  • Waive or exempt non-identified specimens from the proposed rule; and,
  • Agree research with non-identifiable biospecimens collected prior to the compliance date of that provision will continue to be outside the scope of the Common Rule.

The CAP strongly supports the proposal including certain quality assurance or improvement activities involving implementation of an already accepted practice to improve the quality or delivery of health care. And, the CAP supports the proposal including secondary research use of non-identifiable biospecimens where no new information about an individual is generated.

Pathologists are the laboratory custodians of these residual specimens and some portions must be retained. Residual specimens are needed by clinical laboratories to conduct quality assurance and quality control activities mandated by CLIA. Because the pathologist using a residual sample does not interact with the patient for whom the tissue sample was derived, he or she does not have the ability to ensure that consent for future research was properly obtained at the time of collection. The CAP believes greater clarity is needed on who should be obligated to ensure that appropriate consent was obtained.

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Senate Finance Committee Chair Orrin Hatch (R-UT) and Ranking Member Ron Wyden (D-OR) proposed a delay and other changes to the Centers for Medicare & Medicaid Services' (CMS') draft rule creating a new Medicare payment system for clinical laboratory services as mandated by the 2014 Protecting Access to Medicare Act (PAMA).

The CMS issued its proposed PAMA regulation in September 2015. Once final, the regulation would establish a new clinical laboratory reimbursement system that replaces fees under the Medicare clinical laboratory fee schedule (CLFS). The CAP submitted comments to the CMS calling for significant changes to the proposed rule on November 23. The CAP advocates that the new payment system should reflect the full range of laboratories providing clinical laboratory services and the implementation timeline for new requirements be delayed.

In December, a grassroots effort by the CAP and other associations representing the laboratory medicine community urged lawmakers to sign on to letters to the CMS that also urged changes and delays to the PAMA regulation. A total of 19 senators and 44 representatives signed the letters.

To calculate payments under the new system, PAMA requires certain laboratories to submit to Medicare their reimbursements paid by private payers. Under the CMS' proposed rule, organizations that receive more than 50% of their Medicare revenues from the clinical laboratory and physician fee schedules in a data collection period are subject to reporting and data submission requirements. In addition, the agency proposed a low expenditure threshold so that laboratories that are paid less than $50,000 per year on the CLFS are excluded from reporting. Laboratories would be paid under the new system starting January 1, 2017.

The CAP called for an extension of both the data submission and collection deadlines in the proposed rule, which would require laboratories to submit reimbursement data from July 1-December 31, 2015 no later than March 31, 2016. In a January 6 letter, Sens. Hatch and Wyden also called for a delay.

"The March 31 deadline is particularly unrealistic given that a final rule containing the information that laboratories will need to report has yet to be published," the senators said.

The senators also urged the CMS to develop a new methodology for identifying laboratories that must report private payment rates. "We believe that CMS should use a methodology for identifying laboratories that balances fairness and burden," they wrote.

In its comments to the CMS on the proposed rule, the CAP objected to the limited scope of entities required to submit data indicating it must be broadened to improve the accuracy of private payer and market rates. Based on the proposed definition of applicable laboratories, hospitals and virtually all physician office laboratories will be excluded. The CAP stated that with these key categories of laboratories not included the result will be an inaccurate and understated weighted median upon which CLFS rates will be based beginning in 2016.

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Registration is now open for you to join your colleagues at the 2016 CAP Policy Meeting May 2-4 in Washington, DC. The annual event is the pathology specialty's opportunity to focus on the federal issues most important to pathologists now and in the future.

The 2016 Policy Meeting will feature guest speakers from Washington and pathology leaders from across the country. On May 4, pathologists will visit with their elected officials during the CAP's annual Hill Day. Meeting with your representative or senator is your chance to discuss the issues affecting pathology and the patients you care for every day.

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