College of American Pathologists
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April 28, 2011  •  Volume 27, Number 9
Next Issue: May 12, 2011
© 2011 College of American Pathologists

In This Issue:

Rep. Jordan (R-OH) Tours St. Rita’s New Vision Medical Laboratory
House Majority Leader Cantor to Address 2011 Policy Meeting
Futurescape Report: CAP Leaders Say Embrace Innovation’s Challenges, Opportunities
Prometheus Case Update: CAP Petitions SCOTUS in Support of Mayo
CAP Outlines Access, Interface Concerns in ONC’s Strategic Plan
CAP, Specialty Groups Speak Out Against Proposed RUC Changes
Watch for the Practice Characteristics Survey—Coming Soon
Washington State Governor Enacts Direct Billing Legislation
Keep Up with the Latest CAP Advocacy News on Twitter

Rep. Jordan (R-OH) Tours St. Rita’s New Vision Medical Laboratory

CAP member Joseph Sreenan, MD, FCAP, leads Ohio Rep. Jim Jordan  (R) on a lab tour.Ohio Republican Congressman Jim Jordan recently toured the St. Rita’s New Vision Medical Laboratory in Lima.

CAP member Joseph Sreenan, MD, FCAP, led the Congressman’s tour. Dr. Sreenan is currently serving as a Governor of the Ohio Society of Pathologists.

House Majority Leader Cantor to Address 2011 Policy Meeting

House Majority Leader Eric Cantor (R-VA) will join Sen. John Barrasso, MD (WY), Vice Chair of the Republican Senate Caucus, and Rep. Jim Matheson (D-UT) in addressing attendees to this year’s CAP Policy Meeting, which will be held next week at Four Points by Sheraton in Washington, D.C. Pollster William D. McInturff, co-founder of Public Opinion Strategies, will also deliver a lunch keynote forecasting the upcoming 2012 elections.

In addition to these political speakers, PBS NewsHour’s health care policy correspondent Susan Dentzer and Roll Call Editor Morton Kondracke will headline this year’s agenda. Leaders from federal regulatory agencies, including CMS Deputy Administrator Jonathan Blum, will also speak on pressing issues facing CAP members, including pathology’s role in ACOs and other proposed health care delivery models, pay-for-performance, and the pathology’s challenges regarding HIT.

Online registration remains open for this May 2-4 event. Please note that the event is limited to only 100 attendees. Registration is $350 and includes all meeting materials, breakfasts, lunches, breaks and cocktail receptions. For more information on the 2011 Policy Event, please contact or Melissa Stegun at 800-323-4040, x7110.

Futurescape Report: CAP Leaders Say Embrace Innovation’s Challenges, Opportunities

The breakneck emergence of innovative technologies and the shift away from traditional reimbursement models is creating new challenges—and opportunities—for pathologists, said CAP leaders at the recent Futurescape Conference, sponsored by the CAP Foundation and held Apr. 15-17 in Rosemont, Ill. The event focused on harnessing the potential of new technologies in the area of genomic medicine and digital pathology while integrating them into current practice.

With Medicare costs doubling for some pathology services over the last 10 years, the specialty—like other provider specialties—is on the radar of lawmakers looking to cut spending, said keynote speaker Jeffrey L. Myers, MD, FCAP, Director of the University of Michigan Medical Center’s Division of Anatomic Pathology. “With fee-for-service increasingly looking like a relic, the argument that more money means better care is being scrutinized as never before,” he explained.

This pressure makes the case for embracing innovation, through emerging technologies in the areas of molecular testing and digital pathology, noted Myers. “The answers to our challenges live among us as pathologists, we just haven’t tapped into them yet,“ he said, adding that innovation also means taking risks and not being afraid to fail. “We must embrace the certainty of failure.”

In fact, pathologists are particularly suited to confront the challenges borne out of genomic medicine and current market forces, pointed out CAP President Stephen N. Bauer, MD, FCAP. “Pathologists have always been among those at the forefront of developing technologies, helping to shape their most effective practical applications,” he said. “The time has never been more critical for all of us to get involved...we need to advocate, plan, and define new and enhanced roles for pathologists and foster greater recognition of the pathologist as a physician and a critical member of the patient care team.”

Prometheus Case Update: CAP Petitions SCOTUS in Support of Mayo

The College is supporting Mayo Collaborative Services’ and Mayo Clinic Rochester’s (known collectively as Mayo) request seeking judicial review from the U.S. Supreme Court regarding its appeal against Prometheus Labs. In challenging Prometheus’s patent claims on a method of monitoring therapeutic efficacy by measuring a patient’s metabolite blood-levels, Mayo asserts that because these methods simply involve evaluating the body’s natural responses to illness and medical treatment, they do not meet the patentable subject matter standard of section 101 of the Patent Act.

The College joined other physician groups in filing an amicus brief in late April with the Supreme Court in support of Mayo’s request for the Court to review the most recent U.S. Court of Appeals for the Federal Circuit decision’s unfavorable finding.

This recent Federal Court decision was handed down last December. That court heard the case upon remand from the Supreme Court, on the same day as its June 2010 decision in Bilski v. Kappos decision, for determination consistent with Bilski. This Supreme Court decision found that the Patent Act’s machine-or-transformation test is not the sole determinant of patentability.

Requesting High Court Review

In their Apr. 20 brief to the Supreme Court, the CAP and other “amici” (meaning “friends of the court” or supporters) asserted that this case warrants review because the rulings run counter to the Court’s longstanding position prohibiting the patenting of laws of nature, physician phenomena, and abstract ideas. In addition, the brief noted that Prometheus’ patents are rooted in an observation of naturally occurring phenomena, and therefore are not patentable. “The patents at issue here give Prometheus exclusive private ownership not of a new drug, a new diagnostic test, or even a new method of diagnosing a particular disease,” stated the brief. “Rather, the patents at issue effectively award Prometheus exclusive ownership of a pre-existing diagnostic test based on the mere observation of a naturally-occurring phenomenon: the correlation between the levels of certain metabolites produced naturally in the human body in response to administration of certain doses of thiopurine drugs, and the efficacy and toxicity of those drugs.”

This marks the second time that the CAP has supported Mayo through an amicus brief, and is in line with the College’s long-standing position against the issuing of gene patents. The College believes that issuance of human health-related gene patents limits access to medical care, jeopardizes the ability to practice medicine in the best interest of patients, and raises the cost of care. This stance is evident in the College’s participation as a co-plaintiff, represented by the American Civil Liberties Union (ACLU), in the case challenging Myriad Genetics’ patents on human DNA. While a federal court issued a ruling invalidating Myriad’s patent claims on BRCA1 and BRCA2 genes, the decision is currently under review by the U.S. Court of Appeals for the Federal Circuit. Ultimately, this case is expected to decided by the Supreme Court.

CAP Outlines Access, Interface Concerns in ONC’s Strategic Plan

Although embracing the government’s vision to establish an IT system that empowers individuals and improves population health, the College remains concerned about pathologists’ ability to comply with certain aspects of the federal five-year national IT strategy because of challenges related to access, interface obstacles, and related interoperability issues.

The College’s comments were in response to a request for comments on the specific goals of the Office of the National Coordinator (ONC) for Health Information Technology’s (HIT) Federal Health Information Strategic Plan 2011-2015 (see box for information on the specific goals).

Five Goals of the ONC’s 2011-2015 Strategic Plan

  1. Achieve Adoption and Information Exchange Through Meaningful Use of Health IT
  2. Improve Care, Population Health, and Reduce Health Care Costs through the Use of Health IT
  3. Inspire Confidence and Trust in Health IT
  4. Empower Individuals with Health IT to Improve their Health and the Health Care System
  5. Achieve Rapid Learning and Technological Advancement

In terms of the federal Meaningful Use of Health IT program, the CAP’s primary concern continues to be that the objectives and measures are unworkable for pathologists, even though they meet the definition of eligible providers (EPs). For example, one of the Meaningful Use Stage 1 requirements is to maintain 80% of patient records in certified EHRs. But because pathologists are often blocked from accessing EHRs and typically don’t input data directly into this technology, they will be prevented from qualifying under the Meaningful Use criteria. The same also holds true for many draft objectives in Stages 2 and 3 of the program—they are outside the scope of pathology practice and usual interactions with patients.

Also, current practice standards need to be further defined, noted the CAP. These standards need to recognize that pathologist access to the EHR is essential to improve patient care through laboratory testing, reporting, and clinical action. In addition, standards related to laboratory data exchange and interfaces need to be established, including who is responsible for ensuring the laboratory data is properly managed in an information exchange.

The CAP’s comments also noted the significant investment that laboratories must make in establishing multiple interfaces, compounded by many EHR and LIS vendors’ vested financial interest in maintaining proprietary, costly interfaces. “This is a significant obstacle to interoperability,” said the CAP in its comments. “Incentives need to change that favor standardization of data exchanges for these systems, lowering the cost of interfaces.”

A full copy of these comments is available online.

CAP, Specialty Groups Speak Out Against Proposed RUC Changes

The College is joining other specialty physician groups—as well as the AMA—in raising concerns about proposed legislation that would significantly alter the role of the Relative Value Update Committee (RUC). A multispecialty physician expert panel convened by the AMA, the RUC makes recommendations to the government on reimbursement for physician services.

Introduced by Congressman Jim McDermott, MD (D-WA) on March 30, the “Medicare Physician Payment Transparency and Assessment Act of 2011” would use independent analytic contractors to conduct surveys and collect data for physician services paid under Medicare. In addition, the legislation (H.R. 1256) would compare recommendations from the RUC with public data collected by independent analysts.

However, CMS has attempted to use contractors to gather such information in the past, both in the 1990s and in 2007, and it proved unsuccessful, noted the College and 46 other physician specialty groups in an Apr. 6 letter to House Speaker John Boehner (R-OH). Ultimately, the letter noted, the RUC provides CMS with recommendations, but final reimbursement decisions are up to federal officials. “CMS participates in every RUC meeting,” stated the letter. “After each review is completed, the Secretary of Health and Human Services and CMS review the RUC’s recommendations and will then accept, modify, or reject any of the recommendations.”

Confronting Bias Charges

The letter also addressed Rep. McDermott’s criticism that the RUC is biased to medical specialty services while undervaluing primary care provider services. “It is important to note that the RUC does not review ‘primary care’ or any specific specialty in terms of relative value,” said the letter. “Rather, it reviews the relative value of individual services that physicians perform–regardless of specialty.” In fact, according to the most recent report from the Medicare Payment Advisory Commission (MedPAC), between 2006 and 2011, Medicare payments for many physician services were reduced from 2006 levels for non-primary care physicians. However, Medicare payments to primary care have increased by 22.5 percent according to MedPAC.

The AMA also responded to these and related RUC criticisms in an Apr. 5 letter to Rep. McDermott. In fact, the letter noted that the RUC has recommended values for other services that are frequently performed by primary care physicians, such as telephone calls and team conferences, that CMS has declined to cover. “All of these gains for primary care have come at the expense of the physicians in other specialties who voted in support of these payment increases, due to budget neutrality requirements,” wrote AMA’s CEO Michael D. Maves, MD. “This hardly supports an assertion that primary care is disadvantaged in the RUC process.”

Watch for the Practice Characteristics Survey—Coming Soon

In the coming weeks, practicing members of the College will receive an invitation to participate in the Practice Characteristics Survey. Participants can access the survey online after its official launch.

The survey is a key component of informing CAP’s advocacy efforts, said President Stephen N. Bauer in the April issue of CAP Today. “A firm grasp of regional market pressures and environmental changes will help align our advocacy with practice needs,” he wrote. By completing the survey, participants will help the College capture vital practice characteristic data and information on challenges facing pathology practices, in addition to providing members with useful practice and compensation related data.

This year’s survey—the ninth since 1994—has been revised to more accurately reflect the current market and environmental issues impacting pathology practices today. Revisions were a collaborative effort of experts from across the College. This included a survey work group of select member pathologists, members of the Diagnostic Intelligence and Health Information Technology Committee (DIHIT), and advocacy and practice management staff.

Washington State Governor Enacts Direct Billing Legislation

Legislation requiring direct billing of anatomic pathology services passed the Washington State legislature on April 8, and was subsequently signed into law on April 20, 2011, by Gov. Chris Gregoire (D).

The Washington State Society of Pathologists (WSSP), in collaboration with the College, worked to pass HB 1190, which will ensure that patients are billed for anatomic pathology (AP) services only by the physician that performs or supervises the service, in order to protect the patient from having a “mark-up charge” added by an ordering physician.

The AMA considers the markup of laboratory services to be an unethical practice. At present, more than 75% of the U.S. population is billed for certain pathology services under a direct billing, anti-markup or disclosure law at either the federal or state level.

In 2005, the Washington State Attorney General (AG), in response to a request for an opinion prepared by WSSP and CAP, determined that mark-ups of AP services are unlawful under state law. The College, along with the WSSP, is pleased that enactment of this new law will effectively protect patients against unlawful mark-up charges and promote compliance with the AG opinion. The legislation is expected to become effective on July 1, 2011.

Direct Bill Leg Pending in Indiana

In related news, direct billing legislation is also pending in Indiana. If this bill passes, Indiana will be the 18th state with a direct billing law.

The bill—H.B. 1017—unanimously passed both of the state’s legislative chambers; passing the House on March 30 by a vote of 96 to 0 and the Senate on April 19 by a vote of 48 to 0. However, as different versions were passed in each chamber, the bill is currently in conference committee. Once the conference committee agrees on language, the bill will then need to be approved again by both chambers.

Keep Up with the Latest CAP Advocacy News on Twitter

CAP Advocacy is now on on Twitter. Follow CAP Advocacy’s daily “tweets” to keep pace with regulatory and legislative news affecting the pathology industry. For the latest health care news, be sure to check out the what we are following on Twitter.


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