College of American Pathologists
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February 3, 2011  •  Volume 27, Number 3
Next Issue: February 17, 2011
© 2011 College of American Pathologists

In This Issue:

Senate Fails to Pass Repeal Amendment, but Legal Challenges Loom
AMA’s PCPI Approves Five New Pathology Measures
Brookings’ Personalized Medicine-HIT Event Underscores Challenges
CAP Launches Member ACO Network
Rep. Roe Introduces Bill to Repeal IPAB
Sen. Leahy Proposes Forensic Reform Legislation
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Senate Fails to Pass Repeal Amendment, but Legal Challenges Loom

The Senate, by a vote of 47 to 51, failed to pass an amendment introduced by Sen. Mitch McConnell (R-KY) to repeal the entire Affordable Care Act (ACA) on Feb. 2. However, opponents of the ACA from both the Senate and House of Representatives appear intent on pursing repeal efforts, and the law continues to face legal challenges.

Outside of Congress and in the federal courts, U.S. District Judge Roger Vinson from Florida ruled in late January that the law was unconstitutional. In response to the district court decisions, Department of Justice (DOJ) attorneys are likely to ask for a stay while they appeal this decision to the 11th Circuit Court in Atlanta, one legal analyst, Peter Urbanowicz, a former HHS attorney and a managing partner with Alvarez & Marsal in Washington, D.C., told Statline. A stay would allow implementation, both on the federal and state level, to move forward.

“HHS and the federal agencies will likely move ahead with issuing regulations,” he explained. Regarding the most recent decision, attorney generals from the 26 states who were plaintiffs may advise state regulators to halt implementing various provisions of the reform law. However, they are likely to be challenged by federal HHS regulators. “Many states will probably move ahead and see what the 11th Circuit Court, and ultimately the Supreme Court decide,” he explained.

With this latest decision, there are now four federal rulings on the constitutionality of the health care reform law. Two decisions support the law while this decision and another in Virginia rule against the law. However, Urbanowicz views this most recent case as the likely candidate to go on to the Supreme Court because it was the “best briefed, best argued, and best reasoned decision.”

Like the ruling in Virginia, this decision in Florida invalidated the individual mandate. But it went further by invalidating the entire law because it did not include a severability clause. “Without this clause, Judge Vinson determined that other provisions could not be carved out because the individual mandate is central to the rest of the law,” said Urbanowicz. “Congress could try to repass the entire law without the mandate and with a severability clause in there, but that is obviously not going to happen for political reasons.”

AMA’s PCPI Approves Five New Pathology Measures

Five pathology measures developed by the College have been approved by the AMA’s Physician Consortium for Performance Improvement (PCPI). This approval is an important milestone in expanding the number of nationally recognized pathology quality measures. The CAP has long been concerned that measures used in Medicare’s current quality incentive program—the Physician Quality Report System (PQRS)—do not apply to pathologists.

PCPI-Approved Pathology Measures

Barrett’s Esophagus
Esophageal biopsies with a diagnosis of Barrett’s esophagus that also include a statement on dysplasia.

Radical Prostatectomy Pathology Reporting
Reports include the pT category, the pN category, the Gleason score and a statement about margin status.

Turn around time (TAT) for routine non-gynecologic cytopathology specimens.

Immunohistochemical (IHC) Evaluation of HER2 for Breast Cancer Patients
Quantitative HER2 evaluation by IHC uses the system recommended by the ASCO/CAP guidelines.

Bone Marrow and FNA/Direct Specimen Acquisition
Bone Marrow and Fine Needle Aspiration (FNA)/Direct Specimen Acquisition timeout procedure.

The five PCPI-approved measures cover cytopathology, Barrett’s esophagus, radical prostatectomy pathology reporting, immunohistochemical evaluation of HER2 for breast cancer patients, as well as bone marrow and fine needle/direct specimen acquisition (see box). CMS is currently reviewing these measures for inclusion in the 2012 PQRS. In addition, the National Quality Foundation (NQF) has been notified that the measures are ready for its endorsement process.

These measures were developed under the auspices of the Public Health Policy Committee by the CAP Measures Development Workgroup, the Cytopathology Committee, and the Molecular Oncology Committee, with input from the American Urological Association.

Qualifying for MOCP Incentives

This year’s PQRS features an additional incentive for some eligible providers—although not pathologists. As required by the Accountable Care Act, CMS is introducing a new Maintenance of Certification Program (MOCP) Incentive this year, allowing some PQRS–eligible physicians to receive an additional 0.5% incentive payment. To obtain the incentive, qualified providers must meet certain requirements in conjunction with participation in a qualified MOCP. However, the current pathology MOCP requirements do not meet the criteria for a qualifying MOCP. Therefore, pathologists will not be eligible for this incentive in 2011.

Brookings’ Personalized Medicine-HIT Event Underscores Challenges

Addressing reimbursement and policy barriers are two significant challenges for furthering personalized medicine through health information technology (HIT), industry and academia experts noted at a recent panel discussion sponsored by The Brookings Institution on Jan. 28.

CAP member Mark Boguski, MD, PhD, FCAP (far left), speaks about the opportunity for pathologists in personalized medicine at The Brookings Institution. “It’s vital to connect genomics and personalized medicine through electronic medical records,” said Darrell M. West, PhD, Director of Brookings’ Center for Technology Innovation. “The current administration is missing the opportunity to move personalized medicine forward by not removing policy barriers, such as certain privacy rules.”

The event also featured the release of the Brookings’ white paper, Enabling Personalized Medicine Through Health Information Technology, authored by Dr. West. This publication makes a case for revamping current HIT policy so that pharmacogenomic data can be incorporated into electronic medical records (EMRs) and patients can reap the benefits of advances in personalized medicine.

The College assisted Brookings and Dr. West by highlighting some of pathologists’ top HIT concerns. At this event, one of the panelists, CAP member Mark Boguski, MD, PhD, FCAP, noted one of the challenges for pathologists in this area is the inability to access patient data through HIT systems. “To the extent that most pathologists don’t have access to EMRs, it is a detriment to the entire health care system,” he explained.

Another challenge for all providers—including pathologists—is being reimbursed for services related to personalized medicine. But reimbursement has to start with coding, noted keynote speaker David J. Brailer, MD, PhD, the former National Coordinator for Health Information under President George W. Bush.

“Reimbursement for personalized medicine will be hard right now with health care reform, but we have to begin working to develop a reimbursement scheme,” explained Dr. Brailer, adding that this will be a challenge, as the House of Medicine has been slow to embrace new diagnosis codes. “We need to have a ‘killer app’ that really plows through these reimbursement barriers,” he said, hinting that this could possibly be in the form of a new diagnostic test.

While there are significant barriers for pathologists, there are also opportunities, added Dr. Boguski, who is an Associate Professor, Center for Biomedical Informatics at Harvard Medical School. “Given that 75% of an EMR is composed of laboratory and pathology data, there is a tremendous role for pathologists in quality assurance, quality control, and predictive modeling that we are just beginning to become involved with,” he said.

CAP Launches Member ACO Network

The College recently convened its first meeting of the CAP Accountable Care Organization (ACO) Network, comprised of members who are participating at some level in this coordinated care model of delivering health care services.

With CMS set to release final regulations this month, the College is launching this member Network to gather and share information regarding the role that pathologists will play in ACOs. The CAP is tracking the evolution of key early-adopter ACOs currently underway or in development. The shared intelligence it provides will be instrumental in guiding the CAP’s policies regarding ACOs and in the development of relevant member resources.

Joining the CAP ACO Network

CAP members who work in a facility that is currently—or will be—part of an ACO are encouraged to join the Network.

For more information, please e-mail us. Please be sure to include your name, facility, contact information, and current status in forming an ACO.

Members of the Network are in varying degrees of engagement in ACOs—some have just been notified that their facility will become part of an ACO, while others are actively involved in the planning process. Of the 21 members of the CAP ACO Network, over half are participating in some way in an ACO, according to a brief survey conducted in January. Institutions represented by members include Geisinger Health System in Danville, Pa.; Massachusetts General Hospital, part of Partners HealthCare in Boston; Aria Health System in Philadelphia; Bon Secours St. Mary’s Hospital in Richmond, Virginia; TriState Health Partners in Hagerstown, Maryland; and Oschner Clinic in New Orleans.

One member, William G. Price, MD, Medical Director, Carilion Clinic’s Solstas Lab Partners in Roanoke, Va., told Statline that he is looking for resources to help his facility determine how anatomic pathology services fit into an ACO. “One thing I hope to get out of the CAP Advocacy Network are some ‘tools’ to work with, so pathologists will know what they can bring to the process to help it and to make sure that we are considered necessary to get it to work,” he explained.

In addition to this member group, the CAP also recently joined the 2010-2011 Brookings-Dartmouth ACO Learning Network, headed up by Dartmouth Institute for Health Policy and Clinical Practice’s Elliott Fisher, MD, and former CMS Administrator Mark McClellan, MD, PhD, who is now with the Brookings Institution’s Engelberg Center for Health Care Reform.

Rep. Roe Introduces Bill to Repeal IPAB

Tennessee Congressman Phil Roe, MD (R) is seeking to eliminate the Independent Payment Advisory Board (IPAB) created under the Affordable Care Act. He recently introduced The Medicare Decisions Accountability Act (HR 452), which currently has at least 23 cosponsors. In addition to Rep. Roe’s proposal, there are rumors that Sen. John Cornyn (R-TX) is currently creating legislation to introduce in that chamber. During the last Congress, Sen. Cornyn introduced legislation to repeal IPAB.

This bill does not currently have any Democrat sponsors. However, Republicans are hopeful that the legislation will garner bipartisan support due to the fact that last Congress more than 40 Democratic Representatives signed onto a “Dear Colleague” letter supporting IPAB’s removal from the Patient Protection and Affordable Care Act.

“The creation of the IPAB is a flawed mandate in Obamacare that must be repealed,” commented Rep. Roe when he announced the bill. “This board’s sole purpose is to control Medicare costs—giving this board the authority to approve and deny funding for care. The IPAB does not have a mandate to improve patient care, but simply to meet a budget.“

The AMA, as well as the College, has been critical of this provision of the health care reform law. The CAP wrote to Congress in 2009—prior to passage of this law—expressing concern about how the existence of IPAB transfers responsibility for Medicare coverage and payment decisions to an unelected body in the Executive Branch. Furthermore, the fast track legislative approval process for consideration of the board’s recommendations limits the ability of Congress to revise or reverse IPAB’s policy decisions.

Sen. Leahy Proposes Forensic Reform Legislation

Senate Judiciary Committee Chairman Patrick Leahy (D-VT) introduced S. 132, the Criminal Justice and Forensic Science Reform Act of 2011, a bill that would strengthen the criminal justice system by reforming forensic laboratories across the country. The bill also encourages federal, state, and local governments to implement systems to ensure qualified individuals perform medical-legal death examinations, which may impact the practice of forensic pathology.

The CAP has long been concerned that many states rely on coroners instead of forensic pathologist (FP) medical examiners to conduct autopsies. As his staff developed the bill, Advocacy staff met with Sen. Leahy’s office to communicate the College’s position on these issues. In addition, the CAP has partnered with the National Association of Medical Examiners (NAME) and a broader coalition, the Consortium of Forensic Science Organizations (CFSO) to coordinate and advance reforming the national forensic pathology agenda.

One of the primary provisions of the bill is establishing an Office of Forensic Science within the Justice Department. In addition, it provides a pathway to develop standards for accreditation of forensic laboratories, certification of forensic practitioners, and educational programs.

The legislation relies on findings from the National Academy of Science report in February of 2009 asserting significant problems in the field of forensic science needing immediate attention.

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