College of American Pathologists
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September 30, 2010  •  Volume 26, Number 20
Next Issue: October 14, 2010
© 2010 College of American Pathologists

In This Issue:

Register Now for CAP’s Oct. 6 Webinar on Meaningful Use
CAP Leaders Detail Strategies to Transform Future of Pathology
Frist Predicts Better Health Care Dialogue Post-November Elections
Uncertainty Surrounds Next SGR Fix with Nov. 30 Deadline Looming
IOAS Coalition Urges MedPAC to Halt Abusive Self-Referral Arrangements
Digital Pathology Focuses on Forward Push Amid Regulatory Uncertainty
SACGHS To Disband, Last Meeting Will Be Oct. 5-6
CAP Comments on Proposed Cytotech Scope Restrictions in CA
Follow CAP Advocacy on Twitter

Register Now for CAP’s Oct. 6 Webinar on Meaningful Use

CAP Webinar
HIT Policy & Perspective: What does “Meaningful Use” Mean for Pathology?

- Moderator: David L. Booker, MD, FCAP, Chairman of Pathology at Trinity Hospital, Augusta, GA
- Robert Anthony, CMS’s Office of E-Health Standards and Services
- Philip Chen, MD, PhD, Director of Informatics, Dept of Pathology, University of Miami Miller School of Medicine
- Walter H. Henricks, MD, Director of the Center for Pathology Informatics at the Cleveland Clinic
To register for this meeting:
  1. Go online.
  2. Register for the meeting.
For assistance:
  1. Go to
  2. On the left navigation bar, click “Support”.
Any questions, please contact Julie McDowell, CAP’s Manager of Advocacy Communications.

Now that HHS’s final rule on the “Meaningful Use” of electronic health record systems is in its initial phase, pathologists are confronting numerous challenges, including eligibility issues and addressing the needs of customers, clients, and other health care providers who are striving to comply with the current and future stages of the rule.

To tackle these issues, the College is sponsoring a Webinar, “HIT Policy & Perspective: What does ‘Meaningful Use’ Mean for Pathology?” on Oct. 6, from 4 PM-5:30 PM Eastern Time. Exclusively for CAP members and practice forum participants, this Webinar will address key challenges, including:

  • How should pathologists prepare to comply with Meaningful Use requirements?
  • If unable to qualify, can a pathologist still receive an incentive payment? If so, how?
  • What will health system stakeholders, including specialty physicians, expect from laboratory information systems?

Attendees will learn about approaches to these challenges from a CMS representative and pathology informatics leaders (see box for speaker listing and a link to register).

Sponsored by the CAP’s Advocacy Division, Practice Management Committee, and the Diagnostic Intelligence and Health Information Technology (DIHIT) Committee.

CAP Leaders Detail Strategies to Transform Future of Pathology

The seminal event of this week’s CAP ’10 annual meeting was the detailing of the College’s plans for a Transformation initiative, focused on fostering new and enhanced roles for pathologists in the rapidly evolving health care landscape.

While CAP leaders have been calling for a Transformation push for some time, speakers at this multi-media plenary laid out why these initiatives are so important—i.e, the “Case for Change”—and what exactly these efforts will entail. Held Tuesday, Sept. 28, Chicago television journalist Phil Ponce moderated the event featuring panel discussions interspersed with video presentations from over 35 leading pathologists and other health care experts across the country who provided evidence supporting the Case for Change.

Nearly 70% of pathologists recently surveyed by CAP believe that transforming the specialty needs to occur in order to remain relevant and competitive.

The College’s CEO Charles Roussel then outlined initiatives that the CAP is undertaking through the Transformation Program Office (TPO). The Transformation Steering Committee—comprised of both members and staff—oversees the programs of the TPO.

Roussel explained that the Transformation initiative will define, model, and demonstrate a new set of value-added services that no other physician specialty can perform as well as pathologists and that creates new economic opportunities for pathologists and improves patient outcomes. Many of these efforts focus on education and training resources for members in support of molecular pathology, genomic interpretation, and informatics. The College is also ensuring that pathologists are in lead positions in developing evidence-based guidelines and tools for clinical application of advancing technologies, such as genomic analysis and digital pathology.

The Case for Change

In building a Case for Change and determining a Transformation strategy, the College sought—and continues to seek—data on the challenges facing pathologists.

Many of these challenges center on new payment trends and a shift towards pay-for-performance, coordinated care models of health care delivery, such as Accountable Care Organizations (ACOs). In these models, payment is hard-wired to data proving improved patient outcomes and optimum utilization that result in profit sharing.

Amidst all of these challenges, there are significant opportunities opening up for pathologists as health care undergoes seismic shifts. These opportunities are largely rooted in emerging technology, such as digital pathology and genomic analysis. The plenary speakers emphasized that these advances are shifting the fundamental nature of health care and the practice of medicine, and pathologists have a singular opportunity to take a leadership role in the development and practice of areas like personalized medicine.

But pathologists need to seize ownership of these evolving areas—and fast, according to speaker Mark S. Boguski, MD, PhD, Associate Professor at Harvard Medical School’s Center for Biomedical Informatics. “I predict that within three years whole genome analysis will be the standard of care for certain cancers,” he explained. “The genome is the specimen of the future and pathologists, with their core competencies, have a singular opportunity to claim ownership of its clinical interpretation for medical application.”

Transformation Strategies

To confront these challenges and take advantage of the opportunities presented by all of these changes in health care, CAP CEO Roussel described key efforts launched through the TPO, which was established last year.

Currently, the TPO is conducting in-depth analysis to develop detailed scenarios outlining the future of pathology. Over the next two years, research will focus on four key areas, under the direction of certain CAP leaders:

  • Supply & Demand, led by Stanley J. Robboy, MD, FCAP, CAP President-Elect
  • Future Services and Roles, led by Barbarajean Magnani, PhD, MD, FCAP
  • Practice and Service Models, led by Ed Catalano, MD, FCAP
  • Emerging Technologies, led by Debra Leonard, MD, PhD, FCAP

Some of the issues analyzed will be determining the skills and services most likely to be in demand, how pathologists can receive fair reimbursement, and what the future needs will be. “We then intend to fund pilot projects at the local level—to show that we can do the things we say we can do,” said Roussel.

The TPO is also working with the Advocacy office in Washington, DC, on defining new roles for pathologists in different care settings, such as ACOs. In addition, the CAP is slated to launch the Policy Roundtable in coming months. Roussel explained that this Roundtable is expanding current advocacy efforts through developing policy recommendations.

Roussel also described two important components of the TPO that got underway last year: the CAP Center for Pathology and Laboratory Quality and the CAP Institute. The Center is developing evidence- and consensus-based practice guidelines and whitepapers focused on patient care outcomes. The Institute is responsible for producing education programs specific to new skills and knowledge related to transforming the scope of pathology. In the future, the Institute will be an incubator for pilot projects designed to stimulate transformation, as well as demonstrate and enhance the value of pathologists.

Following Roussel’s framework on what the College doing to drive transformation, Gene N Herbek MD, FCAP, emphasized the leadership role that members need to play to tackle these challenges. “Rethinking how we shape our practice around all the opportunities we have to help optimize patient outcomes is probably the most important step we can take towards truly transforming pathology, and this is going to take leadership,” said Dr. Herbeck, who is Secretary-Treasurer on the CAP Board of Governors. “No one is just going to appoint us to be in charge of what we know we’re best suited to do.”

For developing news and additional information on these initiatives, visit CAP’s Transformation Website.

Frist Predicts Better Health Care Dialogue Post-November Elections

Frist Predicts Better Health Care Dialogue Post-November Elections With the mid-term elections little over a month away, former Senator William H. Frist, MD (R-TN) is speculating that Republicans will take back the House and pick up seven seats in the Senate, he explained following his speech at this year’s Residents Forum/House of Delegates Luncheon on Sept. 25 at CAP ’10. This will result in a more balanced government and better dialogue when it comes to the health care reform law, but greater flexibility and responsiveness from all lawmakers is important to ensure successful implementation.

Because implementation will take at least 10 years, the former Senate Majority Leader said at least four more election cycles will shape the law’s final outcome. “I predict we will not see repeal, although there might be some limited defunding of some of the more egregious provisions of the law,” he told Statline. “The state governors, of which there will be at least 24, will have to slow down implementation in their states for budgetary reasons, as well as lack of IT and infrastructure reasons. The big thing is for all of us to help shape this together.”

While elections continue to shape the health care reform law, the move to a more team-based approach, such as in coordinated care models, is reshaping the delivery environment. Given this backdrop, Frist said that pathologists must aggressively assert their value. This value is significant in a world of rapidly advancing genomics and proteomics, as well as increasing consumer engagement in medicine. “It’s not much fun having to justify your specialty to a group of other health professionals, but that is what will be absolutely necessary,” he added.

Uncertainty Surrounds Next SGR Fix with Nov. 30 Deadline Looming

The current physician fee “patch” is set to expire in two months, and given the tumultuous political climate surrounding the mid-term elections, policymakers are not left with many options in crafting the next short-term fix to the sustainable growth formula (SGR).

On Nov. 30, the current 2.2% pay hike that physicians received under the most recent patch will expire, and Medicare reimbursement rates will be cut by 23%. Beginning in January 2011, this cut will climb to nearly 30 percent.

The CAP, along with the American Medical Association (AMA) and other medical societies, continues to urge Congress to pass a permanent fix Earlier this week, the College, along with the AMA, wrote to House Speaker Nancy Pelosi (D-CA) and Republican Leader John Boehner (R-OH), asking Congress to to take action during the first week of its lame-duck session in November to once again avert a Medicare physician fee cut.

The lame duck session will convene sometime after the Nov. 2 elections take place. However, insiders tell Statline that the $330 billion it would cost to fix the SGR makes any meaningful legislation unlikely during a lame duck Congressional session.

Proposing the Next Patch

As for another short-term patch, one proposal being mentioned is a 13-month freeze on the 23% cut, which would cost an estimated $120 billion. But as the proposal has no “pay-for” offers, this measure would perpetuate “cliff financing.”

A few other options are circulating on Capitol Hill. One is a tax extender bill that could be introduced during the lame duck session. Not only would this bill stop the cut, but it would also extend the technical component (TC) grandfather provision, which is scheduled to expire on December 31, 2010.

In the Senate, Democrats and Republicans are rumored to be working on separate proposals for an 18-month SGR extension. It’s unclear how the Democrats’ proposal plans to pay for the extension, while the Republic bill proposes paying for a fix using medical malpractice reform and other health care spending reductions.

What is clear is that details remain vague on these and other proposals under discussion by lawmakers and stakeholders. Statline will continue to closely follow this issue.

IOAS Coalition Urges MedPAC to Halt Abusive Self-Referral Arrangements

Citing concerns about abusive self-referral business arrangements, CAP and other members of the In-Office Ancillary Services (IOAS) Coalition continue to implore MedPAC to exclude certain diagnostic tests—specifically AP tests—from the IOAS exception to the Stark law. Members of the IOAS Coaltion also include the American Clinical Laboratory Association (ACLA) and the Association for Clinical Pathology (ASCP).

The Coalition expressed concern that at the most recent MedPAC meeting on Sept. 14, the commission did not extensively discuss AP services in relation to the IOAS exception. In a letter to MedPAC Chairman Glenn M. Hackbarth, the Coalition noted that because of the nature of AP testing, these procedures almost invariably cannot be performed at the time of an office visit. Therefore, the Coalition supports removing AP services from the IOAS exception. Another solution is applying a time-based approach, and removing those services that cannot be done at the time of the office visit, which includes AP services.

The Coalition also mentioned in its letter that to address concerns about over-utilization, the Coalition is funding Georgetown University research demonstrating the impact of self-referral arrangements on AP volumes. The Coalition is expected to release initial findings of this study in the coming months.

Concerns about Proposed Approaches

While thanking MedPAC for their attention to these arrangements, the Coalition also expressed concerns about some of their proposals for curtailing the increased utilization of AP services, such as applying “same day” criteria to the exception, rather than the same office visit criteria. The proposed options are inconsistent with the original intent of the Stark law, which was focused on permitting services performed under these arrangements during an office visit for patient convenience.

MedPAC is also considering bundling or packaging payments for certain designated health services—including imaging and pathology services—to clamp down on over-utilization. But the Coalition is concerned this move could have negative results. “Anatomic pathology services are unique, separately identifiable and independent physician services,” stated the letter. “We believe that a bundling or packaging approach could have a negative effect on the provision of quality services and would provide an incentive to render less than medically necessary care to beneficiaries.”

Requiring prior authorization for advanced imaging services was also discussed at the September meeting. The Coalition’s letter expressed concern about Medicare prior authorization requirements for all testing services. “We are also concerned about the prior authorization option given not only the administrative burden and cost associated with such programs, but also the potential for disruption in patient care,” stated the letter.

Digital Pathology Focuses on Forward Push Amid Regulatory Uncertainty

Digital pathology continues to generate industry buzz, especially with numerous heavy hitters like Aperio, Olympus, and Bioimagene displaying a significant presence at this week’s CAP ’10 meeting. Standardization is also moving forward with the recent release of the medical image exchange standard Supplement 145 from The Digital Imaging and Communications in Medicine (DICOM) Standards Committee, of which the CAP is a member.

However, while there are over a dozen FDA 510(k) clearances for digital analysis of immunohistochemistry procedures, the waiting game continues for how the agency wants to regulate digitalization of hematoxylin and eosin (H&E) slides using whole slide imagng (WSI) systems, according to Steve Potts, PhD, CEO of digital pathology service provider Flagship Biosciences (Flagstaff, AZ). Potts recently spoke at a histology image analysis webinar on regulation and digital pathology hosted by Denver-based Digital Pathology Consultants.

There has been no word from the FDA since October 2009, when stakeholders—including the CAP and digital pathology companies—testified before the agency’s Hematology and Pathology Devices Advisory Committee during a public comment period to address oversight of whole slide imagining (WSI) systems.

One key issue is whether these systems should be subjected to the agency’s Class II or Class III requirements. While Class II products are frequently “cleared” by the 510(k) process, Class III devices must go through the PMA process. This process requires more investment—both in money and time—as the device has to be “approved” as safe and effective after undergoing clinical trials. The CAP testified at the hearing, primarily on recommendations for validating WSI systems.

Dr. Potts speculates that WSI will likely be considered Class II devices and will need to be cleared by the FDA. He added that subsequent pathology procedures using this device will then be considered laboratory developed tests (LDTs), as the regulatory filings will likely be for specific applications. However, this could further delay momentum, as the FDA is currently crafting LDT oversight framework.

Nevertheless, Dr. Potts believes that once these regulatory barriers are negotiated, digital pathology will move ahead at breakneck speed. “When this technology starts to move into labs and pathology practices, it will come fast,” he predicted.

SACGHS To Disband, Last Meeting Will Be Oct. 5-6

Officials are indicating that the federal charter authorizing the Secretary’s Advisory Committee on Genetics and Genetics, Health, and Society (SACGHS) would not be renewed because the group had fulfilled its mandate. The final meeting would be held Oct. 5-6.

Created almost a decade ago, SACGHS wrote reports and policy recommendations to the HHS Secretary. The Committee’s Website stated that it had addressed the major topics in its charter, including integrating genetic and genomic technologies into health care and public health; and the clinical, public health, ethical, economic, legal, and societal implications of these genetic technologies.

CAP Comments on Proposed Cytotech Scope Restrictions in CA

Proposed regulations in California would unduly restrict the scope of work for qualified cytotechnologists, the College’s President Stephen N. Bauer, MD, FCAP, wrote in a letter to the state’s Department of Public Health.

The CAP is supporting concerns raised by the American Society of Cytopathology (ASC) and California Society of Pathologists (CSP) on these new restrictions. Of particular concern is that the proposed regulation restricts the scope of molecular work permitted under CLIA for qualified cytotechnologists. The College is therefore urging the department to amend the regulations to ensure that qualified cytotechnologists can perform functions in California that are consistent with their scope of work performed in other states.

“Cytotechnologists have a unique and valued role in the clinical laboratory,” wrote Dr. Bauer in the letter. “We believe that such changes to the proposed regulation are consistent with quality laboratory services and will be of benefit to patients.”

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Follow CAP Advocacy on Twitter 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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