College of American Pathologists
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  STATLINE — CAP’s Bi–Weekly Federal and
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May 9, 2013  •  Volume 29, Number 10
Next Issue: May 23, 2013
© 2013 College of American Pathologists

In This Issue:

CAP ’13 Policy Meeting Emphasizes Reform Challenges, Opportunities

Pathologists’ commitment to precision and quality medicine—the health care reform law’s tenets—is becoming ever more central to system reform, emphasized CAP leaders, lawmakers and health care policy experts at the CAP 2013 Policy Meeting, held May 6-8 in Washington, DC.

Specifically, the law is now driving value over volume while constraining costs and producing savings, said former Obama Administration Policy Chief Nancy-Ann DeParle (pictured), in her opening keynote to the over 150 meeting attendees. An architect of the health care law, DeParle explained that pathologists need to seize opportunities to drive down costs, while helping other providers determine how to deliver efficient and quality patient care.

More Policy Meeting Coverage on CAPConnect

The College’s new online members-only community features daily recap blogs from this year’s Policy Meeting. In addition, Michael Brown, MD, FCAP blogs on why visiting the Hill to meet with lawmakers is an important first step in forming impactful relationships.

Sean Cavanaugh (pictured), Director of the CMS Innovation Center (CMMI) had a similar message during his luncheon keynote. “The role of the Innovation Center is to test programs and ideas, and determine how and if they should be applied nationally. We look to groups like yours to come to us with ideas for improving care and lowering health care costs.”

Of course, the challenge is delivering this care at a lower cost, said CAP leader Richard Friedberg, MD, PhD, FCAP. “Last year’s pay cuts and the shift from volume to value put the pressure on us to demonstrate our value,” he explained in his presentation on CAP’s advocacy priorities.

Dr. Friedberg outlined the three priorities members took to the Hill on Wednesday, May 8: electronic health record Meaningful Use penalty relief; closing the Stark law loophole that allows physicians to self-refer AP services, and funding for graduate medical education (GME).

These and other issues impacting pathology were the subject of a dynamic exchange of ideas by a panel of pathology leaders (pictured) from across the specialty including, Jennifer L. Hunt, MD, MEd, FCAP, President, Association for Molecular Pathology; Ritu Nayar, MD, FCAP, President-elect, American Society of Cytopathology; Gregory A. Schmunk, MD, FCAP, President, National Association of Medical Examiners; Ann Thor, MD, FCAP, President, Association of Pathology Chairs; Lee H. Hillborne, MD, MPh, FASCP DLM(ASCP), FCAP, Past President, American Society of Clinical Pathology; and CAP President Stanley R. Robboy, MD, FCAP. All agreed that speaking with a single voice on key issues impacting pathologists is critical to moving our policy agenda forward in this time of change.

“Right now, the College is focused on mitigating cuts in pathology payment as well as influencing new payment models, particularly in the genomic medicine realm, where we are working to ensure that pathologists have a leadership role,” he explained. “But we’re also focused on securing preferential funding for GME, including preserving existing pathology slots and securing relief from Meaningful Use penalties.”

HIT Infrastructure

In addition to Meaningful Use, pathologists must contribute to HIT policies as a national framework continues to evolve. Indeed, speaker Sen. Richard Burr (R-NC) (pictured with CAP Past President Jared Schwartz and current CAP President Stanley Robboy), called on pathologists to provide their perspectives on bolstering the nation’s HIT infrastructure.

Sen. Burr, joined Sens. John Thune (R-SD), Lamar Alexander (R-TN), Pat Roberts (R-KS), Tom Coburn (R-OK), and Mike Enzi (R-WY), in releasing a white paper in April, REBOOT: Re-examining the Strategies Needed to Successfully Adopt Health IT. The paper outlines concerns with current federal HIT policy, including increased health care costs, lack of momentum toward interoperability, potential waste and abuse, patient privacy, and long-term sustainability.

“Provide us your best ideas, tell us how to do this right,” he closed. “We need to create the architecture, establish system certainty, and then invest in making this a robust HIT system.”

Quality Assessment Challenges

Pathologists are not only struggling to comply with the federal Meaningful Use program. Participating in CMS value-based purchasing (VBP) programs, including the Physician Quality Reporting System (PQRS) program, is also proving difficult. Pathologists are limited in claims-based reporting because of the few codes that they report, such as 88305, explained CAP member Emily Volk, MD, FCAP, in a panel discussion on opportunities and challenges for pathologists in VBP.

“The College is taking the lead on developing appropriate metrics for pathologists,” she explained, adding that the CAP has developed 15 measures over the past six years, five of which are included in the 2013 PQRS.

The CAP also believes that physicians without metrics in VBP programs through no fault of their own should not be penalized for non-participation, and that flexibility is needed in VBP programs to address specialty specific variation in medical practice, explained Dr. Volk (pictured), who is Medical Director of Pathology and Laboratory Medicine at Baptist Health System in Houston, Texas.

In response, panelist and CMS Deputy Chief Medical Officer Shari M. Ling, MD (pictured), advised CAP members to continue the conversation about these challenges with the agency, which is tasked with implementing aspects of the reform law, including the VBP initiatives. “Despite these challenges and the operational mandate, there’s an opportunity to achieve the true north, which is better outcomes for patients,” said Dr. Ling. However, Dr. Ling also cited restrictions in CMS’ legal authority and limitations of its claims data. Both could present potential barriers to pathologists’ benefitting from new incentive programs.

Genomic, Coordinated Care Roles

Ensuring pathologists’ roles in both new technologies and delivery models was also central to the meeting’s theme. Genomic medicine offers numerous roles for pathologists, explained CAP leader Debra G.B. Leonard, MD, PhD, FCAP (pictured), during a panel on the public policy agenda for advancing genomics and personalized medicine. The primary opportunities include integrating genomic results with clinical data, and collaborating on patient management decisions based on genomic test results as part of the clinical care team.

“We specialize in understanding disease processes and applying this knowledge to new clinical tests that direct patient care,” said Dr. Leonard, who is Chair of Pathology at the University of Vermont College of Medicine. “Therefore, we have a key role in conveying the significance of genomic and molecular test results to physicians and patients.”

However, there are challenges, particularly related to regulatory oversight and reimbursement. “Genomic medicine is happening,” she stated. “But the integration of genomic testing into pathology practice continues to require advocacy efforts.”

Discussions at the meeting related to the pathologist’s role in coordinated care models, such as accountable care organizations (ACOs), emphasized the dependence on laboratory measures to achieve the goals of quality and cost savings.

In a panel on pathology’s experience with care coordination and new payment models, David O. Scamurra, MD, FCAP, explained how his team from Eastern Great Lakes Pathology participates in Buffalo, New York-based Catholic Health’s ACO. Their participation includes quality assessment through proficiency testing, turn-around-time measures, and utilization. Dr. Scamurra and his team developed test guidelines to decrease utilization of expensive tests. They have also introduced new tests, including tests for C. difficile, which improve patient outcomes and quality.

“In my experience, pathology provides the means to achieve the ACO goals through quality testing and data management,” said Dr. Scamurra. “If the ACO is a city, then pathologists are the water; the ACO can’t get to where it wants to go in patient care improvement without us.”

Visit the CAP 2013 Policy Meeting set on Flickr to see a selection of photos from the meeting.

CAP Pushes CMS for Meaningful Use Answers

Citing a continuing lack of clear information from CMS and ONC on rules guiding the Medicare meaningful use program, CAP elevated its efforts to help pathologists avoid possible Meaningful-Use penalties starting in 2016 by bringing the issue to the attention of CMS Acting Administrator and Chief Operating Officer, Marilyn Tavenner this week.

The Medicare Meaningful Use program was created to help all physicians adopt interoperable electronic health record systems. However the program’s primary care and office-based physician focus has frustrated a number of medical specialties, including pathologists, whose scope of practice and the information systems they use prevent them from qualifying for the program’s incentives but provide no protection from penalties which would come in the form of pay cuts—up to 2% per year, starting in 2015 based on 2013 reporting.

To date, CAP argued for and secured an automatic hardship exception for pathologists when penalties begin in 2015. However, with Meaningful Use Stage 2 starting in 2014 and no solution in sight, the College took its concerns last week to CMS’s highest-ranking official.

The letter from CAP Governor Richard Friedberg, MD, PhD, FCAP, advocates for removing the threat of penalties and urged CMS to grant pathologists a full five-year exception from meeting the requirements. It also sought the Agency’s support for legislation providing permanent relief for the vast majority of pathologists who cannot meet the requirements.

CAP Challenges AHRQ on Genetic Test Definitions

CAP went on record again challenging the Agency for Healthcare Research and Quality’s (AHRQ’s) definition of genetic tests and expressing concern that AHRQ’s test classifications are scientifically inaccurate.

Specifically, CAP recommended clearly distinguishing genetic and somatic mutations, and diagnostic tests from tests for predisposition to cancer or screening in its comments on the AHRQ Update on Genetic Tests Currently Available for Clinical Use in Common Cancers. The College commented on the report, which was done at the request the Coverage and Analysis Group of the Technology Assessment Program (TAP) at CMS.

The CAP believes that the report’s inclusion of acquired mutations in the definition of genetic testing is scientifically inaccurate. “A genetic test is the analysis of human DNA, RNA, chromosomes, proteins, or metabolites to detect inheritable genotypes, mutations, or chromosomal changes. All genetic tests are fundamentally the same in that they all detect an inherited genotype, mutations, or chromosomal changes,” CAP stated.

CAP went on to state “molecular tests for acquired mutations are not genetic tests. These tests evaluate acquired, rather than inherited, mutations. While these tests will typically target nucleic acid substrates (eg, DNA, RNA, chromosomes) and employ the basic terminology of genetic testing (eg, genotype, mutation, karyotype), these tests and analytes have absolutely no heritable consequences. Unlike a true genetic abnormality, they may not be constant through an individual’s lifetime nor be evident in every cell of in an individual.”

The College expressed similar criticism on earlier editions of the same report.

Medicare Cost Growth Slows, Raises Doubts for IPAB Role

Two recent government reports projecting a sustained drop in Medicare cost growth are raising questions about the need for the Independent Payment Advisory Board (IPAB), the body mandated in the Affordable Care Act to ensure Medicare cost growth remains within targeted rates set by CMS. By both accounts, current growth projections are well below the targets.

Just last week the CMS acting Chief Actuary’s report, stated “the projected 5-year average growth in Medicare per capita spending is 1.15 percent, and the 5-year average growth target is 3.03 percent. Because the projected 5-year Medicare per capita growth rate does not exceed the Medicare per capita target growth rate, there is no applicable savings target for implementation year 2015 (determination year 2013).”

In February, the Congressional Budget Office released its 2013 budget baseline lowering Medicare growth projections by 15% from its 2010 estimate. If this calculation holds true, the IPAB would not need to make recommendations before 2022.

The IPAB is still not operational. It has no budget, and no one has been appointed to serve on it, despite continued support from President Obama. If and when it is appointed, it will have unprecedented authority to make spending recommendations for Medicare which Congress would be bound to enact.

Correction: Provider Edits Planned for May 1 Are Delayed

CMS has confirmed that it will not implement denial of claims that fail to meet edits requiring referring and ordering physicians to be enrolled in Medicare until further notice.

Once implemented, the edits will require referring and ordering physicians listed on claims for laboratory services to be enrolled in Medicare or have valid opt-out status or the claims will be denied. According to a new announcement issued by CMS two weeks ago, the edits remain in place but denial of claims has been delayed.

(Editor’s note: We regret erroneously reporting in the last issue of Statline that the edits would go into effect on May 1. CMS reversed that directive just after Statline was sent out.)


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