STATLINE

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In This Issue:

• CAP Nominees Appointed to Medicare Clinical Laboratory Reimbursement Board
• Pathologists, Hospitals Urge NY to Remove Ban on Consults With Patients
• CAP '15 Session Will Highlight IOM Study on Diagnostic Error
• STATLINE Readership Survey Now Open

Two pathologists nominated by the CAP will serve on a panel charged with setting Medicare reimbursement rates for clinical laboratory services.

CAP nominees Stephen N. Bauer, MD, FCAP, and Stanley R. Hamilton, MD, FCAP, were both chosen for the panel, the Centers for Medicare & Medicaid Services (CMS) announced on August 7. Dr. Bauer is a former CAP President and has expertise in clinical laboratory science, economics and the development of validation, safety, and application of laboratory tests. Dr. Hamilton is a molecular pathologist with expertise in molecular diagnostics and molecular laboratory administration. Both pathologists are members of the CAP Economic Affairs Committee.

The Protecting Access to Medicare Act of 2014 directs the Health and Human Services (HHS) Secretary to consult with an expert outside advisory panel composed of 15 individuals and a chairperson with expertise in issues related to clinical diagnostic laboratory tests. Panelists must include representatives of clinical laboratories, molecular pathologists, clinical laboratory researchers, and individuals with expertise in laboratory science or health economics.

According to the 2014 federal law, the panel will provide input and recommendations to the HHS Secretary and the CMS on:

• The establishment of payment rates for new clinical diagnostic laboratory tests, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test;
• The factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests; and
• Other aspects of the new payment system.

In addition to Dr. Bauer and Dr. Hamilton, the CMS appointed Geoffrey Baird, MD, PhD; Vickie Baselski, PhD; William Clarke, PhD, MBA, DABCC, FACB; Judith Davis, MS; Curtis A. Hanson, MD, FCAP; Kandice Kottke-Marchant, MD, PhD, FCAP; Raju Kucherlapati, PhD; Bryan A. Loy, MD, FCAP, MBA; Gail Marcus, MS.E, MBA.; Carl Morrison, MD, DVM, FCAP; Victoria M. Pratt, PhD, FACMG; Michele M. Schoonmaker, PhD; and Rebecca Sutphen, MD. CMS Medical Officer Steve Phurrough, MD, will be the panel's chair.

The panel's first meeting will take place on August 26.

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New York City hospitals have joined the CAP and New York pathologists to call for the repeal of a regulation prohibiting pathologists from conferring with patients on their laboratory test results.

The New York City Health and Hospitals Corporation—an integrated healthcare system of hospitals, health centers, long-term care, nursing homes, and home care—sent a July 29 letter in support of the CAP and New York State Society of Pathologists' (NYSSPATH's) request to rescind a state Department of Health regulation that prohibits patient contact with the pathologist medical director of the laboratory providing their diagnosis.

"As previous communications submitted by the pathology organizations affirm that pathologists have a medical obligation and a legal duty of care to their patients, this regulation constitutes a legal impediment to the appropriate discharge of that obligation and legal duty," the letter stated. "Furthermore, of commensurate concern, the faithful discharge of that duty and obligation under this regulation could be construed to jeopardize the legal compliance of laboratories in hospitals that we represent."

Previously, the CAP and NYSSPATH called on the state to repeal the regulation. In February 2014, the federal Department of Health and Human Services (HHS) finalized a rule allowing patients to request and receive test results from the laboratory. The HHS also preempted state laws that impede patients directly receiving test results from the laboratory.

The state Department of Health initially declined and requested clinical justification for rescinding the regulation. The CAP provided that justification in a letter on October 21, 2014. In addition, more than 100 New York physicians and 40 hospitals signed a document to strongly supporting the clinical evidence for rescinding the state rule.

The CAP and NYSSPATH have continued to urge the state to remove prohibitions on pathologists from having discussions with patients about their laboratory test results. On July 13, 2015, the CAP and NYSSPATH stated proposed regulation to address patient access still contained restrictions on pathologist-patient conversations.

"This language should be deleted as it directly conflicts with the purpose of the rule change, for conformance with federal law authorizing the communication of test results to the patient directly from the clinical laboratory," CAP President Gene N. Herbek, MD, FCAP, wrote in a letter on behalf of the CAP and NYSSPATH. "Of further concern, the proposal rule maintains a prohibition on the clinical laboratory and pathologist, as the director of the clinical laboratory, responding to patient inquiries on test results that the patient may now directly access from the laboratory."

The CAP and NYSSPATH strongly stated that pathologists are morally obligated to communicate with their patients and regulatory impediments to patient discussions with pathologists should be removed.

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At CAP '15 in Nashville on October 4-7, the CAP will host a session on understanding the Institute of Medicine (IOM) study on diagnostic error.

The CAP expects the IOM will publish the study on diagnostic error in health care in September. The CAP supports efforts to prevent errors in all stages of the testing process and supports studying the issue of diagnostic errors and working to ensure quality tests for patients. An IOM committee has been studying the issue for nearly two years.

The CAP is a sponsor of the IOM report, along with the American College of Radiology, American Society for Clinical Pathology, and several other physician and patient organizations and foundations. Two CAP members, Michael B. Cohen, MD, FCAP, and Michael Laposata, MD, PhD, FCAP, are on the 21-member IOM study committee.

Dr. Cohen and Emily E. Volk, MD, FCAP, will lead the presentation on the IOM report at CAP ’15 annual meeting. The session is scheduled to begin at 5:30 PM ET on Monday, October 5.

The IOM states that the study committee was tasked with examining the current definitions of diagnostic error and illustrative examples; the epidemiology, burden of harm, and costs associated with diagnostic error; and current efforts to improve diagnosis. The IOM report will also study diagnostic errors by clinicians, in addition to radiology and pathology. The committee also is developing recommendations to reduce diagnostic error in health care and action items for stakeholders.

In April 2014, the CAP submitted comments to the IOM. While errors can occur during every step of the testing process, the frequency of errors is low in the pre-analytic, analytic, and post-analytic phases, the CAP stated.

The CAP will continue to keep members informed about the IOM study in future editions of STATLINE.

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The CAP invites CAP members to participate in a quick survey regarding our STATLINE newsletter. Your valuable feedback will allow us to evaluate and improve the e-newsletter to best meet your needs. Please take a moment to participate in our STATLINE readership survey.

The survey should take approximately 5-10 minutes to complete. As a thank you for your time and feedback, we also invite you to enter into a drawing to win one of three $100 Amazon.com gift cards. If you would like to enter, please submit your name and information at the end of the study.

The CAP recognizes the value of your time and privacy. Please be assured that your individual information will be kept strictly confidential and your email address will not be distributed to anyone. All results are reported in aggregate format.

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