College of American Pathologists
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August 5, 2010  •  Volume 26, Number 16
Next Issue: August 19, 2010
© 2010 College of American Pathologists

In This Issue:

House Republicans Vent HITECH Eligibility, Penalty Concerns
Senate Republicans Push to Repeal Payment Advisory Board
Joint Pathology Center Set to Open April 2011
CDC on Personal Genetic Testing: “Not Ready for Prime Time”
CAP Highlights Pathology Agenda at National Conference of State Legislatures
Mass. Lawmakers Revising Health Care Payment System
CAP Urges Consistency in Federal Oversight of Array-Based Cytogenetic Testing
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House Republicans Vent HITECH Eligibility, Penalty Concerns

The initial phase of HHS’s final meaningful use electronic health record (EHR) rule is now underway, but some House Republicans are expressing concerns that many medical specialties, including pathology, will not be able to meet HHS’s meaningful use criteria anytime soon, causing specialty physicians to miss out on incentive payments that could total $44,000 over the next five years. CAP has long been concerned that most pathologists would not qualify for incentive payments under the existing criteria.

The current regulatory approach, as outlined in 2009’s Health Information Technology for Economic and Clinical Health (HITECH) Act, is too “one-size-fits-all,” meaning that some physician groups will be shut out, according to comments made by Reps. Michael C. Burgess, MD (R-TX) and Phil Gingrey, MD (R-GA) at a hearing on the implementation of the legislation, held by the House Energy and Commerce Health Subcommittee on July 28.

In addition to eligibility questions, both Congressmen were critical about the short lead-time to comply with incentive requirements before facing financial penalties in five years. Rep. Burgess, who spent nearly 30 years practicing as a ob/gyn in northern Texas, told HHS’s National HIT Coordinator, David Blumenthal, MD, that he was critical of these penalties, noting that EHR vendors face no similar fines for failing to create a software program deemed certifiable by the federal government.

Additional information on the hearing, including testimony PDFs, is available on the subcommittee’s website. CMS is hosting an EHR Incentive Program conference call for hospitals on Aug. 11. The agency said details would be forthcoming and would be posted on the program’s website.

Senate Republicans Push to Repeal Payment Advisory Board

Five Republican Senators are seeking to repeal a controversial feature of the new health care reform law, the Independent Payment Advisory Board (IPAB), arguing that the new government entity will give the HHS Secretary the authority to circumvent Congress in making Medicare payment decisions. In late July, Sen. John Cornyn (R-TX) introduced The Health Care Bureaucrats Elimination Act (S.3653), backed up by co-sponsors Senators Orrin Hatch (R-UT), Jon Kyl (R-AZ), Pat Roberts (R-KS), and Tom Coburn (R-OK).

The new reform law fails to address escalating health care costs, noted Sen. Hatch in a statement. “The White House chose to punt tough decisions to a bunch of bureaucrats with no accountability to the American people,” he said. “In response, we’ve come together with this common-sense legislation to put a stop to an unelected board with unprecedented power over the health decisions of every American senior.”

The advisory board would be staffed by 15 representatives from various areas of health care. Many stakeholders have raised concerns about the potential lack of transparency associated with shifting responsibility for Medicare coverage payment decisions to an unelected body under the jurisdiction of the President of the United States. CAP spoke out in opposition to this provision during the debate leading up to the health care reform law. The College now fears that any fast-track legislative approval process related to consideration of IPAB’s recommendations can limit Congress’ ability to revise or reverse these decisions. In addition, it is unclear whether all relevant specialty physician groups, like pathology, will have representation on the IPAB.

Joint Pathology Center Set to Open April 2011

The Joint Pathology Center (JPC) will begin its mission of providing secondary consultation for the federal government, education, research, and operation of the National Pathology Tissue Repository in Forest Glenn, Maryland, by next April, the center’s interim director and CAP member, Colonel Thomas Baker, MD, told Statline. The JPC will be fully operational and staffed by 29 full-time pathologists by September 2011.

“Our mission is to serve as the premier pathology reference center for the federal government,” said Dr. Baker. “We’ll be establishing our mission in April 2011, but that will just be the starting point.” He hopes to partner and collaborate with other federal agencies on secondary consultations, research, and education.

CAP advocated for the establishment of the JPC, which preserves the key functions of the Department of Defense’s (DoD) Armed Forces Institute of Pathology (AFIP), including the National Pathology Tissue Repository and secondary consultation services. The AFIP is slated to close permanently by Sept. 15, 2011, as a result of the 2005 Defense Base Realignment and Closure Law (BRAC). Earlier this year, AFIP officials announced that after Sept. 30, 2010, it would no longer accept non-federal civilian consultation cases.

Once it begins operations, the JPC pathologists will perform secondary and telepathology consultations at the Forest Glen facility, where the National Pathology Tissue Repository will be located. A 6,000-square-foot histology laboratory will be located at the new Walter Reed Medical Center on the campus of the National Naval Medical Center in Bethesda, Maryland. There will also be a 3,600 square-foot state-of-the-art molecular laboratory in Bethesda to support consultation. Baker noted that all subspecialities will be represented at these facilities, and services offered to the Department of Defense and Veterans Administration, as well as other federal agencies.

The JPC will also offer pathology consultative services in specialty areas like nerve biopsy, depleted uranium, and testing on imbedded fragments from wounded soldiers. Depleted uranium analysis is performed for many Gulf War veterans, while imbedded fragment testing is currently performed for soldiers who are victims of improvised explosive devices (IEDs) in Iraq and Afghanistan.

CDC on Personal Genetic Testing: “Not Ready for Prime Time”

The Centers for Disease Control and Prevention (CDC) are concerned about recent data indicating that direct-to-consumer or personal genetic tests are changing the way some health care providers care for their patients, said Muin Khoury, MD, PhD, director of the agency’s Office of Public Health Genomics.

In a video commentary on, Dr. Khoury cites a 2008 CDC survey of 1,880 health care providers that found 42% of providers were aware of personal genomic tests, and over 40% of these aware providers had one or more patients in the past year ask him or her about having this type of test. In fact, 15% of the respondents reported that patients brought their test results to the physician for discussion.

“Most of these health care providers said the test results changed some aspect of the patient’s care, such as screening tests offered and medications or dosages prescribed,” said Dr. Khoury. “CDC is concerned about such premature use of personal genomic tests by consumers because these tests are not ‘ready for primetime’.”

There are three key factors currently holding this area of testing back: analytical validity (many now do not meet quality standards of the laboratories), clinical validity (data too much in flux now), and clinical utility (lack of evidence on the potential harm and benefits of these tests).

Nevertheless, since patients continue to request these tests, Khoury recommends discussing these limitations with patients, as well as using the discussion as an opportunity to encourage patients to record and update family health history. “Family health history can help health care providers assess the presence of many genetic conditions and whether patients and their relatives may have an increased risk for specific diseases,” he added.

Dr. Khoury’s commentary is available on; free registration is required for access.

CAP Highlights Pathology Agenda at National Conference of State Legislatures

CAP member Rawhi Omar, MD, PhD, (l) and the College’s State Affairs Manager Mikael Troubh (r) at National Conference of State Legislatures in late July. CAP members recently interacted with state legislators from across the country at the National Conference of State Legislatures, held July 26-28 at Kentucky International Convention Center in Louisville, KY. Approximately 5,000 legislators and staff attended this annual event, making it an effective venue for communicating and educating state lawmakers on the important public policy issues affecting pathologists.

The CAP delegation was represented by local members Rawhi Omar, MD, PhD, and Shengli Lu, MD, both of the Robley Rex Veterans Affairs Medical Center in Louisville, as well as Mikael Troubh, Manager, CAP State Affairs. They introduced legislators to the College’s mission and advocacy agenda, along with programs that support patient care including CAP’s My Health Test Reminder and The College representatives also presented attendees a visual analysis of tissue specimens from a microscope and screen provided by Olympus Inc.

Mass. Lawmakers Revising Health Care Payment System

Massachusetts legislators have passed Senate Bill 2585, which will revise certain aspects of the state’s health care payment system, such as small business insurance premiums. The bill fell short of a major overhaul of the payment system, which was the original intent of many state policymakers focused on controlling costs and reforming the fee for service payment model. Massachusetts’s Governor Deval Patrick is expected to sign the legislation.

The bill also includes a pilot program for bundled payments and the reporting of quality measures. The state’s division of health care finance and policy will launch the pilot program in 2011 promoting provider and payers to enter into contracts that include bundled payments for certain services.

In terms of the quality measures provision, the new law requires Massachusetts Department of Public Health to implement regulations “requiring the uniform reporting of a standard set of health care quality measures for each health care provider facility, medical group, or provider group” known as the “Standard Quality Measure Set.”

CAP Urges Consistency in Federal Oversight of Array-Based Cytogenetic Testing

The College recently submitted comments to the FDA on regulating array-based cytogenetic tests noting that this emerging technology should be no different from other laboratory tests introduced into medical practice. The College emphasized that pathologists and other laboratory professionals use their professional expertise and knowledge of the literature and available resources to interpret the results of array-based cytogenetics. In addition, CAP urged the agency to avoid burdensome regulations that might restrict access to these tests.

“Array-based cytogenetics constitutes an important and expanding aspect of the medical practice of laboratory professionals for decades to come,” stated the College. “The College therefore has a keen interest in ensuring that our ability to interpret tests based on professional expertise in order to provide high quality diagnostic services to patients and other physicians we serve is not unduly restricted. Patient care is compromised when diagnostic testing services are less readily and affordably available because of burdensome regulation.”

The FDA convened a June 30 meeting to gather stakeholder input on challenges related to evaluating performance, determining clinical significance, reporting results, and interpreting these tests. Some examples of this type of testing include microarray-based comparative genomic hybridization (aCGH) arrays and single-nucleotide polymorphism (SNP) arrays.

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