College of American Pathologists
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October 14, 2010  •  Volume 26, Number 21
Next Issue: October 28, 2010
© 2010 College of American Pathologists

In This Issue:

Congressional Lab Tours: Rep. Roskam (R-Ill.) Visits Alexian Brothers Medical Center
CAP, Medical Specialties Call for SGR Update Through 2011
Experts Detail Meaningful Use Challenges, Opportunities for Pathologists
Flexibility Needed in ACO Fraud-and-Abuse Rules
CAP to HHS: Patient-Centered Care Must be Based on Personalized Medicine
CMS Announces New Self-Referral Disclosure Protocol
PA Senate Passes AP Disclosure Bill
Texas Expands Malpractice Coverage to Include Autopsies
NIH to Hold Nov. Public Meeting on Developing Genetic Test Registry
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Congressional Lab Tours:
Rep. Roskam (R-Ill.) Visits Alexian Brothers Medical Center

Roskam Lab Tour Illinois Congressman Peter J. Roskam recently toured the Alexian Brothers Medical Center’s pathology laboratory in Elk Grove. The tour was led by CAP member Peter F. Bernhardt, MD. Located northwest of Chicago, this facility has a staff of more than 900 physicians, representing more than 80 medical and surgical specialties. This facility has an estimated annual patient volume of 18,000 inpatients.

Rep. Arcuri (D-NY) Visits Cortland Path Lab

In related news, Congressman Michael A. Arcuri recently toured the Courtland Regional Medical Center’s pathology laboratory, located in New York’s Finger Lakes region. CAP member William Shang, MD, led the tour.

CAP, Medical Specialties Call for SGR Update Through 2011

The College, the American Medical Association (AMA), and other physician groups are pushing for a longer term “fix” of the sustainable growth rate (SGR) to avert the 23% cut set to take effect on Dec. 1. The current 2.2% update expires on Nov. 30. The cut then increases to 30% on Jan. 1, 2011, based on the current SGR formula.

This diverse group of medical specialties are backing an increase to Medicare reimbursement rates that lasts until the end of 2011, arguing that an extension through the end of next year will provide physicians with some much-needed budget stability. This past year featured multiple short-term SGR patches and, subsequently, physicians found it difficult to cope financially. “[In 2010], many practices were forced to seek loans to meet payroll expenses, lay off staff, or cancel capital improvements and investments in electronic health records and other technology,” stated a letter from the CAP, the AMA, and other medical specialty organizations sent in September to House Speaker Nancy Pelosi (D-CA) and Republican Leader John Boehner (R-OH), asking Congress to to take action during the first week of its lame-duck session in November.

Planning for the Future

There appears to be confidence in Washington that Congress will address the SGR issue during the lame duck session. However, it is unclear when this fix will be enacted, prompting concerns as the expiration date is the end of that month.

One rumored—and familiar—scenario is that the SGR will expire, and CMS will once again advise physicians to hold claims for two weeks. During this time, Congress will pass a longer-term fix. In addition to temporarily halting cuts to the SGR, this legislative package is also expected to authorize the continuation of other tax extenders that expire at the end of the year, including rural provisions such as the TC “grandfather”.

In the meantime, the AMA is offering a Medicare Participation Kit to help “physicians evaluate their options and choose the direction that is right for their practice” in preparation for the 30% cut at the beginning of 2011 that will occur without Congress’ intervention. Physicians have until Dec. 31, 2010, to modify their status with the Medicare program, according to the AMA.

Experts Detail Meaningful Use Challenges, Opportunities for Pathologists

With Jan. 1 registration soon getting underway for the initial phase of HHS’s final meaningful use rule, many pathologists remain confounded by not only the eligibility requirements, but also whether they will qualify for incentive payments over the next ten years of the program. However, while the rule does present significant challenges, therein lies opportunities for pathologists, explained the speakers at CAP’s Oct. 6 Webinar, “Health Information Technology Policy & Perspective: What Does ‘Meaningful Use’ Mean for Pathology?”

“Over the next ten years, under this program, non-hospital based doctors and hospitals could receive as much as $27 billion in incentive payments towards equipment to digitize patients’ medical records,” said moderator David L. Booker, MD, FCAP, Chairman of Pathology, Trinity Hospital, Augusta, GA, and on the CAP Board of Governors. “To qualify for the incentives, physicians must report quality measures that are largely outside of the scope of pathologists’ practice, and hospital-based physicians were excluded from the incentives because hospitals were expected to take care of their health IT needs. However, as many of you know, this rule is already impacting pathologists.”

CMS officials recognize that some of the meaningful use objectives are not applicable to every provider’s clinical practice, explained speaker Robert Anthony, a Health Insurance Specialist from the agency’s Office of E-Health Standards and Services. “There are exclusions for objectives that are outside of the provider’s scope of practice,” he noted. “For example, [one exclusion would be] for pathologists who do not e-prescribe.”

Demanding Interfaces

One primary way that meaningful use already is affecting many labs is the increasing demand for interfaces between laboratory information systems (LIS) and physician practices, explained speaker Walter H. Henricks, MD, medical director of pathology informatics at Cleveland Clinic. Dr. Henricks is a member of CAP’s Diagnostic Intelligence and Healthcare Information Technology (DIHIT) Committee, co-author (with Yale University Pathology Informatics Director John Sinard, MD, PhD) of a CAP Virtual Informatics College course on LIS, and the author of a CAP course on meaningful use of EHRs.

One key question, however, is the format of the data. At least 40% of clinical laboratory tests—where the results are in a positive/negative numerical format—need to be incorporated into the electronic health record (EHR) as “structured” data. “This is only realistically possible with an interface from the laboratory,” said Dr. Henricks. “‘Structured’ has yet to be defined, but it will likely depend on the final certification requirements.” HHS’s Office of the National Coordinator for Health Information Technology recently posted a Certified HIT Product List (CHPL) that provides a comprehensive listing of products certified under the agency’s Temporary Certification Program.

Pathology-Related Objectives

While data transmission and eligibility remain looming questions, it’s important for pathologists to realize that they do have an important role, as there are meaningful use requirements related to pathology, explained the last Webinar speaker, Philip Chen, MD, PhD, Director of Informatics, Dept of Pathology, University of Miami Miller School of Medicine. These include eight of the 15 core objectives (eligible physicians must choose three required core measures and substitute alternate core measures where necessary):

  • Computerized physician order entry (CPOE)
  • Report ambulatory clinical quality measures to CMS/states
  • Implement one clinical decision support rule
  • Provide Patients with an electronic copy of their health information, upon request
  • Record demographics
  • Maintain an up-to-date problem list of current and active diagnoses
  • Capability to exchange key clinical information among providers of care and patient-authorized entities electronically
  • Protect electronic health information

He added that other physicians will also be relying on the lab to supply data to help them meet the meaningful use requirements.

While there are many questions surrounding the pathologists’ role in meaningful use, Dr. Chen advised Webinar attendees to explore where to implement the goals of the meaningful use final rule in their own workflow and their clients’ workflow. “It’s possible that in our environment, we need to expand our practice to the other side of the interface—meaning the EHR,” he explained. “If we have the methodologies ready, we’ll be better prepared when the meaningful use requirements become more specific for our profession.”

A recording and handouts from his Webinar, “Health Information Technology Policy & Perspective: What Does ‘Meaningful Use’ Mean for Pathology?” is now available online. This event was sponsored by the CAP‘s Advocacy Division, Practice Management Committee, and the Diagnostic Intelligence and Health Information Technology (DIHIT) Committee.

Flexibility Needed in ACO Fraud-and-Abuse Rules

Physician and provider groups emphasized that fraud-and-abuse regulations must be flexible if accountable care organizations (ACOs) are to realize their potential of reforming health care through greater collaboration, stakeholders told CMS, the HHS Office of Inspector General (OIG), and Federal Trade Commission (FTC) officials at a public workshop on Oct. 5.

CMS is expected to launch an ACO program by early 2012, as dictated by the health care reform law. The agency expects to issue a proposed rule sometime this fall.

This reform law—the Patient Protection and Affordable Care Act (PPACA) of 2010—provides the HHS Secretary authority to waive certain aspects of current fraud-and-abuse and antitrust requirements, as well as develop safe harbors so that physicians know when and how they can collaborate, and when they cannot, said FTC Chairman Jon Leibowitz. These requirements involve antitrust, Stark (including self-referral), anti-kickback, and civil monetary penalty laws.

Will Massachusetts Lead the Way?

Massachusetts’ Secretary of Health and Human Services is slated to submit a proposal outlining a new payment system as part of an ACO model by early next year. Called a “global payment” system, the state would pay providers a flat, per-patient fee. They would also qualify for incentives based on quality and cost savings.

The challenge before the policymakers, therefore, is exactly how to retool these rules for ACOs to ensure that they are not unduly burdensome, noted HHS Inspector General Daniel R. Levinson at the workshop, which had an estimated 300 attendees. “The fraud–and-abuse laws enforced by our office should not stand in the way of improving quality and reducing costs,” he added. “As the Medicare and Medicaid programs incorporate and test new payment and delivery models, there is need for fresh thinking about program integrity and the type of risks faced by our programs and beneficiaries.”

Model Diversity

One of the challenges is establishing legal rules that apply to the diversity of ACOs. This is especially important as the number of ACOs expand and continue to diversify. “Forcing people to follow a limited set of models will be problematic,” said Harold D. Miller, Executive Director of the Center for Healthcare Quality & Payment Reform (Pittsburgh). “I think we want to distinguish between having requirements related to structure—which should be avoided at all costs—and outcomes, which is preferable.”

Waivers should also be extended to cover capital expenditures related to upfront costs that will fall on many providers who want to participate in an ACO, explained a number of stakeholders. One example is investing in an ACO’s electronic health record (EHR) system. Depending on the size of the practice, these costs could total $1 million for some physician groups, said Robert Saner, an attorney representing the Medical Group Management Association. In addition, Saner explained that HHS should waive certain legal restrictions that impact IT-related costs.

CAP to HHS: Patient-Centered Care Must be Based on Personalized Medicine

A nationwide health care quality strategy should include personalized medicine in order to be truly patient-centered, the College has indicated to the HHS. The agency requested feedback on developing a National Health Care Quality Strategy and Plan.

The health care reform law requires HHS to submit an initial National Quality Strategy to Congress by Jan. 1, 2011. However, the document is expected to evolve over time, eventually including goals, as well as priorities and measures associated with each goal.

In its comments, the CAP noted that advances in molecular and genetic medicine are driving greater individualization of health care, which is influencing both preventative and treatment options. This underscores the primary role that pathologists play in health care delivery. “It is critical that this element of health care delivery, i.e. the role of laboratories and pathologists, be recognized in developing and implementing this National Quality Strategy,” said the CAP’s comments.

The national strategy also needs to recognize the value of local, patient-centered providers and avoid centralizing essential elements of health care delivery such as diagnosis into national centers.

“The importance of the clinical laboratory and the professionals who deliver quality laboratory data and diagnoses, and are available for consultation cannot be overstated in the success of any National Health Care Quality Strategy and Plan, particularly as we enter the era of molecular medicine,” stated the College in its comments.

CMS Announces New Self-Referral Disclosure Protocol

In accordance with the health care reform law, CMS released the Medicare self-referral disclosure protocol (SRDP) in late September. This protocol allows health care providers to disclose any real or potential violations of the Stark law’s self-referral requirements.

The new law called on the HHS Secretary, with the cooperation of the agency’s Office of the Inspector General (OIG), to establish a Medicare SRDP to facilitate these disclosures. In addition, the law allows the Secretary to reduce any financial penalties associated with violations. The Secretary bases this decision on a number of factors, including timeliness of self-disclosure, financial position of the disclosing party, as well as the nature and extent of the improper or illegal practice. The law also indicates that providers are required to report within 60 days of indentifying any instances of Stark Act violation overpayments.

It is important to note that this protocol is unrelated to any violation from CMS via the agency’s physician self-referral advisory opinion process. After reviewing a disclosure submission, CMS will coordinate with the OIG and Department of Justice, and may conclude that the disclosure warrants law enforcement investigation.

PA Senate Passes AP Disclosure Bill

The Pennsylvania Senate unanimously (49-0) voted on Oct. 12 to pass disclosure legislation related to anatomic pathology services. The proposed legislation requires 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.

The College has been working with the Pennsylvania Association of Pathologists (PAP) on this legislation. The bill—HB 2521—passed the House in July, and then passed the Senate Banking and Insurance Committee in September with a technical amendment. Because the bill was amended in the Senate, it must now go back to the House for concurrence.

The CAP and PAP are hoping to have a House vote on the bill when it returns in a lame duck session following the November elections. Both the Pennsylvania Medical Society and the Hospital Association of Pennsylvania are supporting the legislation.

Texas Expands Malpractice Coverage to Include Autopsies

The Texas Medical Liability Trust (TMLT) is broadening autopsy malpractice coverage for all physician policyholders. TMLT’s original opposition to the coverage was rooted in previous case law, which held that an autopsy was not a “health care liability claim” and a corpse was not a patient. Texas law defines a “patient” as “a person who is admitted to a hospital or residing in a nursing home”. The Texas Society of Pathologists (TSP), with CAP assistance, sent a letter urging this expanded coverage, arguing that the Texas Medical Board ruled in 2001 that it considers an autopsy part of the practice of medicine. Following the letter and further negotiations with TSP, the TMLT ultimately decided to amend all its physician policies to cover autopsies.

NIH to Hold Nov. Public Meeting on Developing Genetic Test Registry

The National Institutes of Health (NIH) will hold a Nov. 2 public meeting to gather stakeholder input on developing the agency’s proposed Genetic Test Registry (GTR). Registration is free, but space is limited. Pre-registration is available online.

The NIH announced plans to develop a registry in March 2010. Expected to be publicly available in 2011, the agency is designing the GTR as a centralized online resource for information about the availability and scientific basis of genetic tests. While the College is not opposed to a voluntary initiative, it has expressed concerns about legislative efforts that proposed a mandatory registry of genetic tests, specifically related to the cost and effectiveness of such an initiative.

Throughout June and July 2010, the NIH gathered feedback on the proposed GTR. As a follow-up, the November meeting will focus on areas lacking consensus among the comments received last summer. The meeting will begin with an overview of the public comments, as well as a presentation of prototype data elements for the registry. The remainder of the meeting will be dedicated to a moderated discussion of responses to specific questions about the GTR. The meeting agenda will be available on the Internet.

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