College of American Pathologists
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November 24, 2010  •  Volume 26, Number 24
Next Issue: December 9, 2010
© 2010 College of American Pathologists

In This Issue:

Breaking News: House Approves 31-Day SGR Freeze to Delay 23% Cut
CMS Focuses on Coordinating Care with Launch of Innovation Center
AMA Meeting Highlights Pathologists’ Role in Team Approach to Personalized Medicine
Pa. Governor Rendell (D) Signs AP Disclosure Bill into Law
CAP Outlines Pathologists’ Central Role in NCQA ACO Criteria
CAP Submits Genetic Testing Registry Concerns to NIH
Red Flags Rule Enforcement Set to Begin on Jan. 1
OIG Looking at Lab Utilization, Payment in 2011
AMA Offering Dec. 7 Webinars on Preparing for Payer Audits
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Breaking News: House Approves 31-Day SGR Freeze to Delay 23% Cut

November 29—This afternoon the House of Representatives approved a bill delaying the 23% cut to Medicare physician payments until Dec. 31. The Senate approved this legislation—H.R. 5712, the Physician Payment and Therapy Relief Act of 2010—on Nov. 19 and the legislation now awaits President Obama’s anticipated signature into law.

With this temporary “patch” in place, Congress can now focus on the longer-term Sustainable Growth Rate formula (SGR) “fix” recently introduced in the House by Representatives John Dingell (D-MI), Henry Waxman (D-CA), Pete Stark (D-CA), and Frank Pallone (D-NJ). This bill, H.R. 6427, the Medicare Physician Payment Update Extension Act, replaces the impending cuts with a 1 percent positive update for 2011.

However, a yearlong fix is estimated to cost $16 billion, according to the American Medical Association. Therefore, Congress will need to identify funding sources to cover this large price tag in order for it to generate enough support to pass both the House and Senate. CAP continues to monitor this legislation and urges all pathologists to log onto to contact their Members of Congress in support of H.R. 6427.

CMS Focuses on Coordinating Care with Launch of Innovation Center

Earlier this month, CMS officially launched the Center for Medicare and Medicaid Innovation Center (CMMIC), an initiative created under the health care reform law.

The focus of the CMMIC will be to identify and test coordinated care models designed to improve health care delivery and payment systems, according to Acting Director Richard Gilfillan, MD. “By working together with innovative and committed providers we can create a system that works better for everyone,” he said in a statement. “We want to identify, validate, and scale models that have been effective in achieving better outcomes and improving the quality of care, but may be relatively unknown.”

AMA Meeting Highlights Pathologists’ Role in Team Approach to Personalized Medicine

2010 AMA Meeting Pathologists are driving the expansion of personalized medicine among specialty physicians and their role will only become more central as health care shifts to a coordinated-care delivery model, noted CAP member Samuel K. Caughron, MD, FCAP, at the 2010 American Medical Association Interim Meeting of the House of Delegates (HOD), held earlier this month in San Diego.

Because pathologists are experts in complex diagnostics and interpretation, they are the medical experts that can bridge basic science to clinical information by translating biologic data, he explained during a presentation before members of the Specialty and Service Society Caucus (SSS), the largest caucus in the AMA’s House of Delegates (HOD). The SSS is made up of over 130 national medical societies, military service groups and professional interest medical associations, including the College.

“Pathologists are already working with systems conducive to sequential test algorithms, and they have been grappling with health IT systems for years,” Caughron added.

Joining Dr. Caughron was Lori J. Heim, MD, FAAFP, board chair of the American Academy of Family Physicians. She discussed personalized medicine’s implications for primary care and described how physicians are overcoming barriers in integrating personalized medicine into everyday practice. She also noted the numerous ways that pathologists and primary care providers can collaborate to advance personalized medicine. The session was moderated by James L. Caruso, MD, FCAP who was recently elected to serve on the governing council of the SSS. The eight-person Governing Council oversees the caucus and is elected by the SSS membership.

The College’s President-Elect Stanley J. Robboy, MD, FCAP, attended the session, noting that pathologists have an unprecedented opportunity to transform the health care delivery system. “Delivering personalized medicine will rely heavily on clinical collaboration with our colleagues,” he explained. “Pathologists need to be ready to meet this demand by being able to speak directly with patients about what the genetic information means to help our clinical colleagues use the genetic information to guide treatment.”

Pa. Governor Rendell (D) Signs AP Disclosure Bill into Law

Pennsylvania law will soon require a referring physician—who orders but does not perform or supervise anatomic pathology services—to provide written disclosure to the patient or payer regarding the actual cost of these services, as well as the name and location of the laboratory providing the service. Recently passed by state legislators, the Governor signed this disclosure bill on Nov. 23, which will become effective 60 days from the signing date.

Partnering with the Pennsylvania Association of Pathologists, the CAP supported HB 2521, which passed the state House on Nov. 15 following unanimous concurrence to state Senate technical amendments. The College has a long history of working with state pathology societies; including those in North Carolina, Nebraska, and Texas, to pass disclosure laws similar to Pennsylvania. Since 2003, these partnerships have helped to enact billing laws of anatomic pathology services for over 110 million patients.

CAP Outlines Pathologists’ Central Role in NCQA ACO Criteria

Diagnostic services and providers—pathologists—must be at the core of any accountable care organization (ACO) structure, noted the CAP in its recent comments to the National Committee for Quality Assurance (NCQA) regarding its draft ACO accreditation criteria. The NCQA sought public comment on this evaluation criteria developed by the group’s multi-stakeholder ACO Task Force.

As a leading accrediting and certification organization focused on improving health care quality, any criteria established by the NCQA is likely to influence policymakers. CMS policymakers in particular are likely keeping a close eye on how private entities like NCQA might assess ACOs, as agency officials develop final regulations scheduled to be released by the end of this year.

In terms of the NCQA draft criteria, the organization was particularly interested in hearing which physician specialties should be included in the ACO, and whether they should have a governing role in the structure. The College believes that having pathologists in the ACOs not only as participants, but in leadership roles such as representatives on a board or committee, “will further achievement of effective population health management, efficient delivery of care, reduction in duplicate and unnecessary services and avoidance of downstream costs,” stated the Vice President of Advocacy, John H. Scott, in written comments to the NCQA.

Concerns about Measures, EHRs

In addition to governance, the CAP also commented on two other areas of ACO structure: measures and data used to evaluate performance and integrated electronic health record (EHR) systems.

While recognizing the need to apply nationally accepted, validated measures to assess ACO performance, the College indicated its continued concern over the “one-size fits all approach” used to develop measures under the current Medicare physician quality reporting system. “The process has over the years impeded timely review and adoption of submitted performance measures,” said Scott. CMS has approved two CAP measures on breast and colon cancer. However, the College has submitted five other measures, but these are still working their way through the process.

Another concern is EHR access. NCQA’s draft criteria require that EHR and integrated electronic systems be accessible to all ACO participating providers. The College commends this requirement, as laboratory information systems and anatomic pathology systems do not generally have access to EHRs, thus hampering the pathologist’s ability to get all the clinical information necessary to determine appropriate testing, test interpretation, and follow up from which a more integrated ACO environment could benefit.

“Pathologists are in a key role to assure the quality of laboratory tests by collecting, surveying, analyzing, and using patient population clinical results to guide therapy, best practices, and safety for patients and patient populations,” explained Scott in his comments. “Pathologists’ professional judgment supported by full access to the EHR further this goal.”

CAP Submits Genetic Testing Registry Concerns to NIH

Genetic test definition and clinical utility evidence were the focus of some of the comments submitted to the National Institutes of Health (NIH) in response to the agency’s “request for information” (RIF) questions issued by the agency to stakeholders regarding the forthcoming genetic testing registry (GTR).

Conceived as a centralized online resource for information about the availability and scientific basis of genetic tests, the NIH is planning to make the GTR publicly available next year. In these most recent comments, the College noted that the registry’s definition of this type of testing is broader than the standard definition. The comment letter to NIH Director Francis Collins, MD, PhD suggested that there will be unintended consequences from the current broad definition. “We believe a very structured and deliberate approach should be pursued to make this registry truly useful.”

The College also noted its concerns about gathering clinical utility evidence. Some RIF responders recommended that clinicians and genetics professionals (including laboratories) provide clinical utility evidence rather than test developers and/or test providers. The vetting of clinical utility evidence is a multidisciplinary process involving laboratory professionals, researchers, and the clinicians who order these tests for their patients, noted the College. “Clinical validity and clinical utility are linked to the various clinical contexts in which a test may have relevance,” explained the comments. “Any model whereby each individual lab is required to submit ‘clinical utility’ evidence would be absolutely unworkable.”

Red Flags Rule Enforcement Set to Begin on Jan. 1

Enforcement of the Federal Trade Commission’s (FTC) “red flags rule” is set to begin on Jan. 1, 2011, unless the agency opts to further extend the current enforcement delay. The rule, which aims to mitigate identity theft, requires businesses deemed as creditors to implement an identity-theft prevention and detection plan by the enforcement date. The agency defines “creditors” as banks, credit card companies, mortgage lenders, and physicians who do not receive full payment at the time of service.

Even though there are Congressional efforts and a lawsuit pending to try to stop the application of this rule to physician groups, any delay will have to come from the FTC. Earlier this year, the American Medical Association (AMA), the American Osteopathic Association, and the Medical Society of the District of Columbia sued to prevent the FTC from applying the red flags rule to all physicians. In August, the Council of Medical specialty Societies joined the suit. This move expanded the scope of the lawsuit to include those physician specialists who are not members of the three organizations that filed the original suit.

However, the AMA suit is currently on hold while a similar suit brought by the American Bar Association (ABA) is under appeal. The ABA initially sued the FTC to exempt lawyers from the rule. While the suit was initially decided in favor of the ABA, the FTC is appealing the decision.

In Congress, lawmakers have introduced two bills that exclude health care practices—among other businesses—with 20 or fewer employees from the red flags rule. The Senate introduced a bill (S. 3416) earlier this year; the House introduced a similar bill (H.R. 3763) in October 2009 that passed by an overwhelming majority (400-0). However, passing the Senate version in a lame duck Congress could prove challenging. Divisive issues, including expiring tax cuts, passing a budget continuing resolution, and extending unemployment benefits, are expected to preoccupy both chambers therefore leaving little time for other issues.

For more information on setting up a prevention program, visit the FTC’s website, which features guidelines and templates.

OIG Looking at Lab Utilization, Payment in 2011

The HHS Office of Inspector General (OIG) will review a number of laboratory and diagnostic testing-related issues next year, including utilization rates and a comparison of Medicare and public payer payment rates, according to the agency’s recently released 2011 Work Plan.

The OIG noted in 2008, Medicare paid approximately $7 billion for clinical laboratory testing services—a 92% increase compared to annual spending in 1998. OIG attributes most of this growth to increased volume. The agency will analyze the types of tests ordered, as well as the volume. The report will also examine how physician specialty, diagnosis, and geographic difference affect ordering of tests.

In addition to utilization, the OIG will also review payment rate variances next year. The Office will compare Medicare laboratory payment rates for the 10 most utilized lab tests with those of other public payers, including the Department of Veterans Affairs (VA) and State Medicaid programs.

AMA Offering Dec. 7 Webinars on Preparing for Payer Audits

The AMA is offering three free webinars on Dec. 7 to discuss ways that physician practices can prepare for governmental and private payer audits. The event, entitled “Could Your Practice Be at Risk for a Payer Audit?” will be hosted by industry expert Frank Cohen.

The webinars will be held at noon, 1:30 p.m., and 3:00 p.m. Eastern Time on Dec. 7 (click on links to register). In addition to discussing audits and how physicians can prepare their practices, Mr. Cohen will briefly demonstrate how small physician practices can access their audit risk through the AMA’s new Practice Analysis Tools for Healthcare (AMA PATH). A question-and-answer session will follow the presentation.

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