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February 17, 2015

Citing concerns that purported evidence lacks credibility and is unsubstantiated, the CAP continues to vigorously oppose a Medicare local coverage determination (LCD) on special histochemical and immunohistochemical (IHC) stains which the Medicare Administrative Contractor Noridian now proposes to adopt in both of its jurisdictions.

Noridian proposes adopting the LCD on special stains for providers in 13 Western states represented by Medicare jurisdictions E and F. The same coverage policy was first drafted by the contractor Palmetto GBA for jurisdiction 11, which includes North Carolina, South Carolina, Virginia, and West Virginia.

Despite concerns from the CAP and pathologists, Palmetto finalized the special stains LCD for jurisdiction 11 on January 29 with few changes to the original draft policy. The policy becomes effective March 16. The CAP continues to urge the policy's withdrawal.

At a February 5 open Contractor Advisory Committee meeting in San Diego, CA the CAP and the California Society of Pathologists (CSP) called on Noridian to withdraw the proposed policy. The College will continue its opposition by working with state pathology societies and local pathologists who would be affected by the LCD.

Members of the CAP with questions about the LCDs or how to get involved during the LCD public comment period should contact Nonda Wilson, Manager, CAP Economic & Regulatory Affairs. The public comment period for the Noridian LCD for jurisdiction E ends March 30. The LCD comment period for jurisdiction F ends April 10.

Amongst the CAP's concerns, the purported evidence used to support the LCD lacks scientific credibility, is inconsistent, and is frequently contradictory. Furthermore, the coverage policy interferes with pathologists’ professional judgment and will have an adverse impact on patient access to pathology services.

The CAP will continue to keep members informed on the latest news on this issue through STATLINE.

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The molecular diagnostics company Myriad Genetics, Inc. has ended its BRCA patent litigation against seven laboratories by agreeing to settle pending patent infringement cases. The settlements effectively end an effort to restrict access to genetic testing for patients.

Under settlement agreements made in the wake of recent adverse appeals court rulings, Myriad Genetics dropped lawsuits and other disputes related to patent claims on BRCA1 and BRCA2. According to recently published news reports and press releases, Myriad Genetics has stated it would no longer sue the companies on any of the patents it asserted.

The latest actions ultimately stem from the 2013 landmark Supreme Court decision Association of Molecular Pathology et al. vs. Myriad Genetics. The CAP was a plaintiff in the case in which Myriad's claims to isolated BRCA1 and BRCA2 genes were invalidated.

In the adverse ruling on December 17, 2014, the US Federal Circuit affirmed a US District Court's ruling that had denied Myriad Genetics a preliminary injunction motion against two laboratories testing for breast cancer genes BRCA1 and BRCA2. The Federal Circuit ruled that patent claims at issue during the preliminary injunction proceedings were not eligible.

The Federal Circuit indicated that other claims in the litigation may also be patent ineligible, though it did not rule on those claims, because they were not at issue in the preliminary injunction proceedings. The CAP had provided a declaration in support of the two laboratories, Ambry Genetics Corp. and Gene by Gene, in the case at the District Court.

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Sign up today to register for the CAP's February 26 webinar, Results from CAP's 2014 Practice Characteristics Survey.

The Practice Characteristics Survey is a primary source of basic data on the socioeconomic aspects of CAP member practices, and tracks and reports changes that are occurring in the practice of pathology among College members. In December, the 2014 Practice Characteristics Survey Report was published by the CAP Policy Roundtable, a subcommittee of the Council on Government and Professional Affairs.

This 60-minute presentation will review the survey findings and provide a forum for CAP members to ask questions about the report. The webinar is February 26 at 2 PM ET and will feature Policy Roundtable Subcommittee Chair Michael B. Cohen, MD, FCAP; Policy Roundtable Survey Project Team Chair Thomas M. Wheeler, MD, FCAP; and Policy Roundtable Director David J. Gross, PhD.

Register today!

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The American Medical Association House of Delegates (AMA HOD) is the policymaking arm of the AMA and additional delegates from the CAP produces a stronger voice for all pathologists.

The size of the CAP's delegation is determined by the number of CAP members who are also AMA members. In his August 2014 CAP TODAY column, CAP President Gene N. Herbek, MD, FCAP, emphasized the value of AMA membership to the pathology specialty.

"I think everyone understands it is the quality of AMA advocacy around the concerns of all physicians that allows us to devote CAP advocacy resources to pathology-specific issues," Dr. Herbek stated. "Yet I have come to realize that some of our members have the mistaken idea that CAP membership defines the number of CAP delegate slots in the AMA House of Delegates. Allow me to clarify: The size of our delegation is determined by the number of CAP members who are also AMA members. The House of Delegates is medicine's policymaking body, and your AMA membership is a vote for pathology."

AMA members vote for the national medical specialty society that best represents them at the HOD. Every physician member is allowed one vote, and for every 1,000 votes received, national medical specialties receive one additional delegate in the AMA HOD. For more information, visit the AMA membership website.

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