College of American Pathologists
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June 9, 2011  •  Volume 27, Number 12
Next Issue: June 23, 2011
© 2011 College of American Pathologists

In This Issue:

CAP Highlights to CMS Pathologists’ Potential Roles in ACOs
Noted Pathologist James Madara, MD, Named AMA CEO
Members Urged to Complete 2011 Practice Characteristics Survey
FDA Releases Draft Guidance on RUO/IUO Reagents
Coalition Forms to Oppose Efforts to Ease NY Self-Referral Laws
Medicare Local Coverage Determination Webinar Now Online
Keep Up with the Latest CAP Advocacy News on Twitter

CAP Highlights to CMS Pathologists’ Potential Roles in ACOs

While Medicare’s proposed accountable care organization (ACO) rule doesn’t impede pathologists from actively contributing to the model’s success, one concern is that it may not enable pathologists to maximize their value within the health care system. The College outlined these and other observations in official comments to CMS on the proposed rule, submitted earlier this week.

AMA, Other Provider Groups Sound Off on Proposed Rule

To the extent pathologists participate in an ACO, they should also have leadership roles within the ACO’s governance structure, the comments noted. Specifically, many of the quality measures that will be used to evaluate an ACO’s performance derive partially or entirely from laboratory data. This should not be surprising, as the laboratory is the first to obtain this information and can serve as the integrative coordinator of this health data.

These leadership roles are built on a solid foundation of providing core diagnostic services, explained James Crawford, MD, PhD, FCAP, a member of the CAP ACO Network Steering Group and one of the contributors to the CMS comments. “One of the most important value propositions that pathologists bring to ACOs is in selecting tests, advising on proper utilization, and interpreting results,” he explained. “In my experience, this is a contribution welcomed by other providers.” Dr. Crawford is Senior Vice President for Laboratory Services at New York’s North Shore-Long Island Jewish (LIJ) Health System and Chairman of Pathology/Laboratory Medicine, North Shore University Hospital and LIJ Medical Center. He will be speaking on the College’s behalf about the role that ancillary providers such as pathologists have in coordinated care models at the Second National ACO Summit on June 27-28 in Washington, D.C. The Summit is sponsored by the Brookings’ Engelberg Center for Health Care Reform and The Dartmouth Institute for Health Policy and Clinical Practice. The College is a member of the Brookings-Dartmouth ACO Learning Network.

Managing Population Health

Pathologists can also help ACOs achieve the broader goal of population management, according to Dr. Crawford. This was also noted in the comments, as CAP members currently in leadership positions in their ACO or coordinated care structure have been able to optimize their impact improving medical care and coordination while reducing costs. “They have done this in part, by using published evidence and local data to galvanize the action of care teams in support of quality outcomes,” stated the comments.

Dr. Crawford also believes that pathologists can be leaders in population management. “Pathologists in leadership roles further ACO achievement of effective population health management; efficient delivery of care; and reduction in downstream costs, through contributions to coordinated care management across the spectrum of health care sites,” he explained.

The comments also indicated that pathologists could participate in ACOs in numerous different environments. For example, pathologists and their clinical laboratories could serve multiple ACOs, as well as be charter ACO members of integrated delivery systems, although this would be determined depending on the market and type of ACO model, explained Dr. Crawford. “ACOs will be built locally, and each will pursue its own solution,” he explained. “Whether the clinical laboratory is a charter member or participating in numerous ACOs will be determined at the local level. Either situation works towards improving patient care, which is the bottom line.”

Difficulty Meeting Measures

One of the key components of ACOs is meeting the 65 proposed quality measures. All of these measures must be met in order to share in the ACO’s savings and avoid penalties like performance monitoring and even possible termination.

That all of these 65 measurements must be met could prove onerous for many providers, and could deter some organizations from forming or participating in an ACO. Specific to the CAP, while many of the measures involve laboratory data, none take into account how pathologists directly contribute to the health care system and patient care.

This has also been true regarding stage one measures in the HHS’s Meaningful Use of electronic health records (EHRs) program. The proposed ACO rule indicates that measures associated with electronic exchange of patient information must be consistent with the Meaningful Use requirements under this federal EHR Incentive program.

Unfortunately, pathologists cannot meet the majority of current objectives in the federal Meaningful Use program to qualify for an incentive, as they are outside the scope of the specialty’s practice. This positions pathologists to be at risk for penalties under Medicare, starting in 2015, under the Meaningful Use program. In addition, many pathologists are even further hampered by their lack of access to patients’ EHR. A member of the CAP Board of Governors, David L. Booker, MD, FCAP, recently outlined these challenges during his testimony at a federal HIT hearing (Statline, May 26, 2011). This May 13 hearing focused on specialty providers and Meaningful Use.

Self-Referral Issues

The College also took the opportunity to comment on any impact that the ACO proposed rule could have on self-referral of anatomic pathology services.

CMS Extends Pioneer Application Deadlines

CMS is pushing back some deadlines for its Pioneer ACO Model:

  • Letters of intent will be due June 30, rather than June 10.
  • Applications must be postmarked on or before August 19, about a month later than the previous deadline of July 18.
Announced last month, agency officials are targeting this program for organizations and providers who have already begun coordinating care for patients, and is designed to work in coordination with private payers to achieve cost savings and improve quality across the ACO.

In comments on the proposed rule, the CAP was pleased with CMS’s rigor on self-referral, anti-kickback and antitrust violations leading to termination of ACO agreements. Theoretically, the move from a straight fee-for-service model to one that strives to align provider incentives should reduce the motivation to excessively self-refer “motivated by profit and generation of additional costs and services,” according to the comments. Nevertheless, the CAP is encouraging CMS to monitor self-referral issues in ACO models.

The CAP also commented on self-referral and related issues in the ACO waiver designs proposal from CMS and the Office of the Inspector General (OIG). The HHS Secretary has the authority under the health care reform law to waive certain fraud and abuse laws. In its comments, the CAP reiterated its longstanding concern about the impact on utilization and costs when ordering physicians have an economic self-interest in laboratory testing.

In addition to seeking feedback on overall self-referral concerns, the OIG specifically asked for comments on whether the anti-kickback statute should be waived for ACO arrangements that satisfy existing safe harbor for EHR donations, but are expected to occur after the scheduled 2013 sunset date. This would necessitate an extension of that sunset date.

The CAP recognizes that achieving the goals of the ACO program demands electronic flow of information. However, as it relates to maintaining laboratories as protected donors, the CAP objects to extending the EHR donation safe harbor beyond 2013. “The divergence between current laboratory EHR donation practices and those originally contemplated and intended under the safe harbor when established in 2006 is significant,” concluded the CAP in its comment letter. “It results in negative effects on access to health care services, quality, competition, cost to the federal health care programs and overutilization.”

Noted Pathologist James Madara, MD, Named AMA CEO

The AMA has announced that distinguished academic pathologist, James L. Madara, MD, will take over as Executive Vice President and CEO as of July 1. The current EVP and CEO, Michael Maves, MD, will end his tenure on June 30.

Dr. Madara comes to the AMA from Leavitt Partners, where he was senior advisor at the health care consulting firm started by former Secretary of Health and Human Services Mike Leavitt. Before joining Leavitt Partners, Dr. Madara was at the University of Chicago from 2002-2009, where he served as the Thompson Distinguished Service Professor and Dean at the University of Chicago Pritzker School of Medicine, as well as the CEO of the University of Chicago Medical Center. Prior to this post, he was the Timmie Professor and Chair of Pathology and Laboratory Medicine at the Emory University School of Medicine in Atlanta.

In addition, Dr. Madara has served as President of the American Board of Pathology and as Editor-in-Chief of the American Journal of Pathology. He recently received the Davenport Award for lifetime achievement in gastrointestinal disease from the American Physiological Society.

Shortly after the appointment announcement, CAP President Stephen N. Bauer, MD, FCAP, took the opportunity to welcome Dr. Madara to the AMA. “Your leadership through this critical moment in time will help determine the delivery of healthcare for at least a generation,” wrote Dr. Bauer in a letter to Dr. Madara. “Like you, the CAP believes physicians must take an active role in directing how American health care changes, and we have already begun to prepare our members for the changes ahead. We would welcome the opportunity to meet with you to discuss the ways that we can work together to improve care on behalf of our patients.”

Members Urged to Complete 2011 Practice Characteristics Survey

All practicing CAP fellows are encouraged to complete the 2011 Practice Characteristics Survey, which is now live.

This survey is a key component of informing College’s advocacy efforts of the regional market pressures and environmental changes impacting pathologists. By completing the survey, respondents are helping the College collect vital practice characteristic data and information on challenges facing pathology practices. In addition, the survey provides useful compensation and practice-related data to all CAP members.

Survey answers are kept strictly confidential and the results will only be reported in aggregate form or in a manner that does not identify information about an individual. Any questions about the survey can be addressed by Nonda Wilson, Advocacy Division, by email or by phone at 202-354-7116.

FDA Releases Draft Guidance on RUO/IUO Reagents

As the FDA continues to pursue a risk-based approach to regulating laboratory developed tests (LDTs), agency officials are also clarifying that reagents intended for clinical use should not be labeled as for research use only (RUO) or for investigational use only (IUO), according to a recently released draft guidance.

The FDA is directing this guidance to manufacturers of RUO and IUO reagents, which are often key components of LDTs. This draft guidance emphasizes that reagents intended for use in clinical diagnosis are not considered RUO or IUO. “The marketing of unapproved and uncleared IVD [in vitro diagnostic] products for purposes other than research or investigation (for example, for clinical diagnostic use) has led in some cases to diagnostic use of laboratory tests with unproven performance characteristics and manufacturing controls that are inadequate to ensure consistent manufacturing of the finished product,” states the guidance. Comments on the guidance are due Aug. 29, 2011.

Draft Guidance Concerns

At last month’s CAP 2011 Policy Meeting, speaker Alberto Gutierrez, PhD, Director of FDA’s Office of IVD Device Evaluation and Safety, emphasized that his office is continuing to develop a risk-based framework to close regulatory gaps and address high-risk LDTs (Statline, May 12, 2011). The College is helping to inform the FDA in their development of this risk-based model, as the College has already developed a proposed model that classifies LDTs based on risk as well as requiring analytic and clinical validation of these tests.

The CAP appreciates that the FDA is taking a broad view of LDTs, including all aspects of this complicated issue as it develops a regulatory oversight approach. However, one concern about this most recent guidance from the FDA is that it targets manufacturers of reagents, rather than test manufacturers, noted CAP Board Member Paul Valenstein, MD, who is also President of Joint Venture Hospital Laboratories in Michigan. “The focus of regulatory efforts should be on ensuring the integrity of LDT performance, not on the provenance or lineage of reagents that go into LDTs,” he told Statline.

Furthermore, the draft guidance makes reagent manufacturers responsible for evaluating the activities of their customers. Dr. Valenstein believes this is ill-advised, adding that in the pharmaceutical world, drug companies are not held accountable for off-label use of medications by physicians, provided that the companies do not promote off-label use. “Similarly, ASR manufacturers should not be held accountable for off-label use of RUO/IUO reagents by laboratories, so long as the ASR manufacturer does not promote off-label use,” he explained.

Finally, Dr. Valenstein believes that removing IUO and RUO reagents from LDTs may have a negative impact on patient care. “There are IUO and RUO reagents that are essential components of generally accepted LDTs and for which no reasonable FDA-cleared substitute is available,” he said. “Medical care will be disrupted if IUOs and RUOs cannot be used in properly-validated LDTs.”

Coalition Forms to Oppose Efforts to Ease NY Self-Referral Laws

Legislation that would significantly curb anti-self-referral provisions in New York is moving through the state’s chambers, prompting the CAP and other stakeholders to speak out about the potential negative impact on providers and patients if these proposals become law.

Most recently, SB 4660 was introduced on April 14 and referred to the state Senate Committee on Health. This is a companion bill to AB 3551, which passed the state assembly in February. Both bills would weaken New York State’s restrictions on physician self-referral. If passed, this new law would void certain protections against financial abuse and inducement for improper test ordering and referrals, explained the New York State Clinical Laboratory Association, the New York State Society of Pathologists, the CAP, the American Society for Clinical Pathology, and the American Clinical Laboratory Association in a June 3 Coalition Statement.

A potential change to current regulations pertaining to electronic health record donation was one particular concern noted by the provider groups in the statement. If passed, these bills would allow for abusive business practices—as defined by the state’s Department of Health (DOH)—whereby clinical laboratories could be impelled to offer or donate EHR systems to ordering physicians. In fact, the New York DOH has previously stated that “these arrangements have the potential to adversely impact competition, reduce quality of services, and risk potential overutilization of healthcare services, resulting in unnecessary increased overall healthcare costs.”

Stark Law Exceptions Could Take Effect

The Coalition also addresses how changes to anti-self referral provisions would spur other abusive business practices. For example, this legislation could supersede current statutes necessary to protect against referring physician markups on laboratory services that they do not perform or supervise, fee-splitting, kick-back incentives, and unnecessary over-utilization of laboratory services.

Finally, the legislation could mean that the federal Stark law exceptions would take effect. This could potentially be construed to create exceptions to current New York state direct billing requirements for pathology and laboratory services. “Adoption of these federal exceptions will conflict with the State’s current comprehensive requirement for direct billing of pathology/laboratory services (Public Health Law§ 586.),” said the statement. “The direct billing requirement in New York State law, and in other states, helps to control healthcare costs by denying improper financial incentives for ordering physicians to over-utilize pathology services for profit.”

The CAP Advocacy’s State Affairs staff is actively engaged on this issue; Statline will continue to report developing news.

Medicare Local Coverage Determination Webinar Now Online

A replay of the recent CAP Advocacy webinar, “Understanding Medicare’s Local Coverage Determinations: A Primer for CAP Members,” and companion presentation materials are now available online.

This hour-long webinar highlights Medicare’s Local Coverage Determination (LCD) process, the role of Contractor Advisory Committee (CAC) representatives in influencing local payment policies, and available CAP resources to assist pathology CAC representatives.

The webinar speakers include members affiliated with CAP’s Council of Government and Professional Affairs’ Economic Affairs Committee (EAC): moderator, George F. Kwass, MD, FCAP, Chair, Department of Pathology, Merrimack Valley Hospital, Haverhill, Mass., Member, CAP Board of Governors; Mark S. Synovec, MD, FCAP, President, Topeka Pathology Group, Topeka, Kansas, former Chair, EAC; W. Stephen Black-Schaffer, MD, FCAP, Associate Chief & Training Program Director, Massachusetts General Hospital Pathology Service, Associate Professor of Pathology at Harvard Medical School, Vice-Chair, CAP EAC./p>

Keep Up with the Latest CAP Advocacy News on Twitter

CAP Advocacy is now on on Twitter. Follow CAP Advocacy’s daily “tweets” 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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