College of American Pathologists
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May 11, 2012  •  Volume 28, Number 10
Next Issue: May 24, 2012
© 2012 College of American Pathologists

In This Issue:

CAP 2012 Policy Meeting Outlines Reform Challenges, Opportunities

Expert Speakers: Payment, Delivery Reforms Not Waiting for Supreme Court Decision

While the Supreme Court weighs the constitutionality of the reform law, the health care system is already changing from a fragmented, fee-for-service model to one that rewards measuring effectiveness, improving quality, and containing delivery costs. These systemic changes—spurred by clinical and technological innovations—are presenting pathologists with striking opportunities and challenges that were discussed by CAP leaders, lawmakers and health care policy experts at the CAP 2012 Policy Meeting, held May 7-9 in Washington, DC.

Leaders at the CAP 2012 Policy Meeting Amidst this climate of disruptive change, CAP leaders explained to the over 100 meeting attendees the importance of identifying threats and challenges and aligning behind an agenda that supports the specialty now, and helps make the College’s vision of the future a reality. The meeting’s sessions reflected CAP’s “Now” and “Future” policy agenda, with sessions focused on ensuring the pathologist’s role in coordinated care, genomic medicine and molecular diagnostics, Meaningful Use, and payment.

“Issues of the day are important—they allow us to deal with what’s at hand,” explained Paul N. Valenstein, MD, FCAP, Secretary-Treasurer on the College’s Board of Governors, during a presentation on how pathologists need to adapt in order to thrive (PowerPoint, 4.9 MB). “But we need to prepare for tomorrow’s agenda, as it’s quite clear that we will need to find ways to get compensated for providing value beyond typical reimbursement models.”

Valenstein encouraged attendees to begin considering how they will adapt to change, suggesting it might require changes to their practices, as well as their roles as pathologists.

“Assess the services you offer and the settings in which you practice. Develop a near-term plan focused on efficiency and a long-term plan to extract value in a coordinated care setting,” Valenstein said. He encouraged pathologists to expand their scope of practice to provide new value in an evolving ecosystem, and delegate services for which technology or other extenders can meet standards of care. He spoke of the need to fundamentally change pathology graduate medical education to keep up with the changes in the environment, and urged all pathologists to engage at the local, state, and national levels to increase the visibility and credibility of the specialty.

“Pathologists have an important role in choosing the right test, which is often less expensive, Valenstein said. “We are poised to play a role in lowering downstream expenses. That is really where the honey is—and it doesn’t always mean the newest or most expensive technology. All we really need to be do to be successful is put the patient first, which is what we always do. The benefit pathologists provide to patients is the measure of our success.”

This includes providing value to coordinated care models, such as accountable care organizations (ACOs). At this year’s meeting, the CAP Policy Roundtable announced the release of a white paper, Contributions of Pathologists in Accountable Care Organizations: A Case Study. The paper recounts the contributions pathologists are making at three leading health systems, including Geisinger Health Systems in Danville, Pa.; the Accountable Care Alliance in Omaha, Nb.; and Catholic Medical Partners in Buffalo, N.Y. (See related story below).

As outlined in this paper and reiterated throughout the meeting, payment and delivery reforms through coordinated care are well underway. The initial ACOs launched under the Medicare Shared Savings Program in April, with more sites set for a July launch. And private payers are aggressively pursuing ACO opportunities, explained speaker Kavita Patel (PowerPoint, 1.7 MB), MD, the Managing Director for Clinical Transformation and Delivery at the Brookings Engelberg Center for Health Care Reform.

“It’s clear that payment is swiftly moving away from fee-for-service, which is why we are encouraging pathologists to get involved as soon as they hear that an ACO is forming, even if you are not invited to these initial discussions,” she said. “Use this CAP White Paper as a foundation to collaborate with your clinical colleagues to determine how pathology fits into your community’s coordinated care model.”

Genomic Opportunities

Also on CAP’s Now and Future Agenda is maximizing the pathologist’s role in genomic medicine. Pathologists have an opportunity to lead the medical community in genomic medicine, particularly in pre-analytical and clinical consultation with other physicians and potentially patients, noted speaker Debra G.B. Leonard, MD, PhD, FCAP. Dr. Leonard noted (PowerPoint, 3.6 MB) that the decreasing cost of genome sequencing—now less than $3,000—is driving adoption of genomic analysis. However, several factors are hindering the speed of this adoption, including regulatory and payment uncertainty, as well as the need for more evidence of clinical utility.

This call for more genomic clinical utility data was echoed by speaker Patricia Deverka, MD, from the Center for Medical Technology Policy, who also spoke about the role of pathologists in genomic medicine (PowerPoint, 1.1 MB). The lack of evidence on how genetic tests improve health outcomes is a “major stumbling block” for reimbursement and clinical adoption, she explained. “The CAP is key to developing evidence of clinical utility,” said Dr. Deverka. “We need to document evidence of actual clinical practice—only then will we have the greatest impact.”

Payment Threats

AMA Immediate Past President Cecil B. Wilson On the Now agenda, two of CAP’s most immediate advocacy priorities are replacing the SGR (with the current patch set to expire in 2013) and closing the loophole on self-referral of AP services.

SGR repeal should be the concern of every physician, and is the chief advocacy goal of the American Medical Association (AMA), according to AMA Immediate Past President Cecil B. Wilson (PowerPoint, 2.4 MB), who spoke to a full meeting room. Although Congress is not expected to pass any major legislation before the November election, Dr. Wilson urged pathologists to stay active in the struggle to repeal and replace the SGR.

”Don’t succumb to issue fatigue, he warned. “It’s critically important that physicians continue to be engaged in the SGR issue,” he added.

The other issue on everyone’s mind was self-referral. Publication of CAP-sponsored research by prominent health care economist Jean M. Mitchell, PhD, on the billing practices of self-referring urologists was met with renewed fervor from attendees who welcomed the report’s clear evidence that physicians who self refer bill Medicare for more services. This report, appearing in a recent issue of Health Affairs, also showed that of the cases studied, the self-referring physicians detected a lower rate of cancer than non-self referring physicians, and it documented a dramatic increase in utilization by one practice after it made the switch from non-self-referring to become a self-referring practice.

HIT Issues

Rep. Tom Price, MD (R-GA) In addition to current payment threats, CAP is also focused on health information technology (HIT) issues. The College is currently building support for legislation (H.R. 4066) sponsored by Rep. Tom Price, MD (R-GA) that would exclude pathologists from penalties under the current the federal electronic health record incentive (EHR) program.

Rep. Price, a meeting keynote speaker, told attendees that this element of the regulation is the “poster child” for the disconnect between medicine and lawmakers. “Pathologists work with patients differently, and should be penalized for not checking a box as outlined in the Meaningful Use program,” he said.

The College is supporting this bill, as they are unable to comply with the federal EHR “Meaningful Use” requirements, explained speaker Walter H. Henricks (PowerPoint, 2.4 MB), MD, FCAP, Director of Cleveland Clinic’s Center for Pathology Informatics, during an HIT session. Another challenge of pathology’s participation in this federal program is the quality of laboratory data in an EHR. Many pathology departments are facing issues with the integrity of laboratory data, even after implementing certified EHRs, explained Dr. Henricks.

The College reiterated these concerns to the ONC in comments on its Stage 2 Meaningful Use objectives, set to be implemented in 2013. ONC official Jodi G. Daniel also spoke at the Policy Meeting (PowerPoint, 2.5 MB) and reassured attendees that the College’s concerns are under consideration. She also emphasized that the agency believes that the appropriate use of laboratory data in a federal EHR system is a key aspect to this program’s success.

Educating Lawmakers

The meeting concluded with a “Hill Day” on May 9. During visits with 180 members of Congress and their staffs, CAP members discussed repealing the SGR; closing the in-office ancillary services (IOAS) exception loophole for pathology services; and supporting H.R. 4066 to exclude pathologists from Meaningful Use penalties.

Ezekiel J. Emanuel, MD, PhD The sponsor of H.R. 4066, Rep. Price, told attendees during a keynote address that even though Congress is waiting for a Supreme Court decision before moving forward with any health care-related legislation, lawmakers are really looking for guidance from physicians right now in thinking about future legislation. “Many lawmakers just don’t understand what you do,” Price added. “Educate them on your issues, because to influence is to educate.”

When asked about the future of health care reform, Rep. Price predicted that the Supreme Court would rule against the law by a vote of 7-2. Another keynote speaker, former White House health care policy advisor Ezekiel J. Emanuel, MD, PhD, predicted the law would be affirmed by a vote of 6-3.

“In my opinion, it’s an open-and-shut case, the health care reform act is constitutional,” said Dr. Emanuel during a luncheon keynote address on May 7, adding that Congress has the authority to require the individual mandate under the Constitution’s commerce clause.

Regardless of the decision, both Drs. Price and Emanuel, along with many CAP leaders, believe that certain elements of the reform law are sure to move forward, particularly the move to establish coordinated care systems like ACOs.

Indeed, Dr. Emanuel believes that it will be reforms like ACOs—particularly when it comes to bundling payment—that will ultimately increase efficiency, reduce costs and drive innovation. “Through ACOs, bundled payments, penalties for infections, errors and readmissions, health reform will spur innovations that will lower costs, increase quality,” he said. “Payment reform is absolutely essential…bundling payment is a key paradigm in driving the shift away from fee-for-service and from volume toward improved quality.”

CAP ACO White Paper Analyzes Pathologist’s Role in Improving Quality, Reducing Costs

Pathologists are demonstrating leadership in helping ACOs improve patient care and reduce costs, despite payment and health information technology (HIT)—challenges, outlined a white paper released at this week’s 2012 College of American Pathologists’ Policy Meeting in Washington, D.C.

The paper, Contributions of Pathologists in Accountable Care Organizations: A Case Study, analyzed how pathologists are leading three established ACOs—Geisinger Health Systems in Danville, Pa.; the Accountable Care Alliance in Omaha, Nb.; and Catholic Medical Partners in Buffalo, N.Y. At these institutions, pathologists have added value by developing laboratory ordering protocols, identifying and managing chronic illness among beneficiaries, improving physician access to actionable data from the laboratory, and fostering greater collaboration with other clinicians.

But challenges remain, most notably how to pay for pathology contributions, indicates the report. It will also take a shift in HIT systems, making them bi-directional, thus allowing pathologists to access patient data across the EHR and other clinicians to access to laboratory data. However, it’s imperative that pathologists define their role in coordinated care, explained Donald Karcher, MD, FCAP, Chair, CAP ACO Network Steering Group.

“All physicians are confronting a fee-for-service environment defined by falling reimbursement rates,” he explained. “However, coordinated care models present a growth opportunity for pathologists, even though there are some challenges to address and policy changes that must occur for pathologists to realize their potential contribution to ACOs.”

CAP Outlines Stage 2 Meaningful Use Concerns to ONC, CMS

Pathologists continue to grapple with the applicability of Meaningful Use requirements to pathology practices while pushing for a more interoperable HIT system that embraces laboratory data, the College stated in May 7 comments regarding the federal electronic health record incentive (EHR) program.

The CAP submitted comments to two agencies: the Office of the National Coordinator for Health Information Technology (ONC), which puts forth the rules for certifying technology; and CMS, which sets the program’s incentives and penalties, as well as the requirements for being a meaningful user.

Meaningful Use Timeline
  • Stage 2 is set to begin in 2014
  • Stage 3 is scheduled for 2016

In its comments to CMS (PDF, 372 K), the College reiterated the difficulties that pathologists have in meeting Meaningful Use requirements designed for office-based physicians, while appreciating the agency’s consideration of relieving pathologists from being penalized under the program. The agency is considering providing relief to providers who lack face-to-face interaction with patients; lack follow-up with patients; and lack control over the availability of certified EHRs. While CMS said all these elements would have to be present for relief, CAP believes that any one of these criterion should be sufficient.

Comments to the ONC (PDF, 402 K) echoed these concerns while focusing on the need for a robust, reliable, and interoperable EHR that accurately structure, capture and describe the patient’s clinical information. Such an EHR architecture will enable reliable laboratory flow across the continuum, transitions, and history of patient care. CAP further stated that any laboratory standard needed to be fully pilot-tested and validated before implementation is mandated through the certification rules.

Mass. Lawmakers Propose Landmark Reforms in New Bills

Massachusetts lawmakers are poised to overhaul the state’s health care system as outlined in bills introduced this week in both the Senate and the House. Senate debate is scheduled to begin next week.

In addition to EHR, wellness, prevention and chronic care management initiatives, both bills promote the establishment of ACOs, an important element of the federal health care reform law. The Senate bill establishes certification for “Beacon ACOs” focused on reducing costs, improving quality, and protecting patients. These ACOs would receive contracting preference for state-funded programs. The House bill also proposes a formal structure for ACOs, as well as medical homes.

Both bills call for the implementation of “Alternative Payment Methodologies”, which could include bundled payments, shared savings, episodic payments or global budgets.

The Senate bill requires all state-funded programs to move to such a model by July 1, 2014, but excludes private health plans from the requirement. The House bill requires all payers, public and private) to implement alternative payment methodologies by January 1, 2015.

The House bill creates a quasi-public “Authority”, governed by an 11-person board appointed to establish the health care cost growth benchmark, and assist in the development of best practices for care delivery and payment reform models.

CAP and the Massachusetts Society of Pathologists are analyzing the two bills, and will recommended changes in comments to Massachusetts lawmakers later this week. Watch for more details in issues of Statline.

Palmetto Delays MolDx Requirement till June 1, 2012

The start date for the Palmetto Molecular Diagnostic (MolDx) reporting program is delayed until June 1, 2012, Palmetto GBA announced this week. This means that codes not appropriately identified or coded will be rejected beginning on this date. Palmetto did not provide a reason for this latest delay, only that it would continue to encourage providers to register their tests and attain the Z-code/PTI identifiers, and will send notices to providers who file molecular test claims without the new codes.

Although Palmetto has already revised the MolDx program with CAP input, the College has persistently called on CMS to suspend the program outright, citing concerns that Palmetto’s coding requirements violate the Health Insurance Portability and Accountability Act (HIPAA), including misapplication of the local coverage determination (LCD) process.

“The fact that the MolDx Program and the Revised MolDx Program violate HIPAA remains the CAP’s key area of concern,” wrote Jonathan L. Myles, MD, FCAP, in a March 27 letter to CMS Acting Administrator Marilyn B. Tavenner. “If a provider desires to file an electronic health care claim, a health plan must accept such a transaction that is filed in HIPAA standard format. Furthermore, only HIPAA-approved code sets may be required by a plan in connection with electronic health care claims.” Dr. Myles, who is Chair of the CAP Economic Affairs Committee, joined other College members in a March 28 conference call with Deputy Administrator and Director for the Center for Medicare Jonathan Blum.

CMS officials have said they will respond to CAP’s concerns. This latest delay is not considered to be the last word on the issue. Watch for updates in future issues of Statline.

Federal Appeals Court Sets July Date to Hear Myriad Case

Oral arguments on the Myriad gene patent case will begin July 20 at the Court of Appeals for the Federal Circuit in Washington, D.C.

After ruling unanimously in favor of Mayo Collaborative Services in its case against Prometheus Laboratories’ medical patents on March 26, the Supreme Court vacated a July 2011 decision of the Court of Appeals for the Federal Circuit in the Myriad gene patent case. In addition, the Supreme Court remanded the Myriad case to the Federal Circuit Court of Appeals for further consideration in light of Mayo v. Prometheus.

Statline will continue to follow developing news.

Keep Up with the Latest CAP Advocacy News on Twitter

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


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