College of American Pathologists
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September 16, 2010  •  Volume 26, Number 19
Next Issue: September 30, 2010
© 2010 College of American Pathologists

In This Issue:

CAP Moves Digital Interoperability Forward by Contributing to DICOM Standard
Lab, Pathology Groups Press FDA for Continued Engagement on LDT Oversight
CAP Joins Medical Groups in Requesting Practical, Affordable HIPAA Changes
MedPAC Considering Self-Referral Issue—With Caution
Joint Commission Seeks Input on New Lab, Pathology Standards
PMC Launches CAP-Funded HIT Task Force
PathPAC Pursues $1 Million Fundraising Goal
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CAP Moves Digital Interoperability Forward by Contributing to DICOM Standard

The Digital Imaging and Communications in Medicine (DICOM) Standards Committee, of which the CAP is a member, today announced the release of medical image exchange standard Supplement 145, representing a major step forward in integrating pathology whole slide digital images into daily laboratory operations.

Currently, most hospitals use a picture archiving and communication system (PACS) to manage and store radiology images. However, to advance pathology in the digital arena, hospitals and laboratories must adopt whole slide digital imaging. Until now, PACS software and the DICOM core standard did not accommodate pathology whole slide images. Now, this new standard supplement, “Whole Slide Microscopic Images,” will facilitate health information interoperability of pathology medical images, various whole slide imaging equipment manufacturers, PACS, and EHRs. It will also allow health care professionals flexibility, such as panning and zooming, when interacting with the image.

“This is a significant leap for pathology,” said Louis D. Wright, Jr., MD, FCAP, CAP governor and co-chair of CAP’s Diagnostic Intelligence and Health Information Technology (DIHIT) Committee. “Pathology will now have a universal language for digitizing microscope slides. This, in turn, will help pathologists assure the quality of these digital slides.”

For more information, visit

Lab, Pathology Groups Press FDA for Continued Engagement on LDT Oversight

The College is joining with other laboratory medicine groups in encouraging the FDA to continue engaging with stakeholders before moving ahead with any laboratory developed test (LDT) oversight framework.

In a letter sent to FDA’s Director of the Center for Devices and Radiological Health, Jeffery E. Shuren, MD, in mid-September, the CAP and other groups asked the agency to host “interactive meetings” with laboratory medicine groups to discuss specific issues related to the framework of this regulation. Other groups signing on to the letter include the American Association for Clinical Chemistry, the American Clinical Laboratory Association, and the American Society for Clinical Pathology.

One of the issues cited in the letter is concern about FDA resources, particularly in consideration of current oversight provided by national and state authorities, as well as accreditation entities like the College. “The potential additional resources necessary to assume this regulatory function cannot be underestimated,” state the letter. “In question is how FDA will approach the regulation of multiple similar, if not the same, laboratory developed tests submitted by clinical laboratories.”

Also at issue is how the agency will enact this new oversight regulation. At a July public hearing, Dr. Shuren emphasized that rulemaking is not required because the agency is just discontinuing its enforcement discretion policy over these types of tests. However, given the significant shift in policy, it is the CAP’s position that rulemaking is appropriate, as outlined in the letter.

“When the FDA eventually does move ahead with a proposal, it should be done through an interactive, transparent, and accountable process such as is the case with formal rulemaking,” said the letter.

The CAP’s risk-based proposal to regulate LDTs can be found online.

CAP Joins Medical Groups in Requesting Practical, Affordable HIPAA Changes

In its comments to HHS Secretary Sebelius on proposed HIPAA modifications, the College united with other physician and medical group leaders in ensuring that any changes related to privacy and security safeguards are “practical, flexible, and affordable.” Furthermore, any revisions should not hinder the flow of health information data for treatment, payment, and related operations.

Specifically, these comments addressed HHS’s proposal to expand the current definition of “business associates” (BAs), who are required to comply with HIPAA. The expanded definition would include patient safety organizations, health information organizations, vendors of personal health records (PHRs), or anyone who transmits health data and routinely accesses protected health information (PHI). Subcontractors of BAs would also need to comply with the HIPAA requirements. The College supports these proposals, and the letter emphasizes that BAs, as well as subcontractors, should be held directly accountable for breaches.

Given these proposed changes, BAs will likely need to implement amendments to current agreements to reflect these modifications. To this end, the letter urged HHS to provide sample amendments/addendums to BA agreements that would exemplify how existing contracts can comply with the new HIPAA requirements. “In addition, we urge HHS to produce a sample BA agreement template that covers all of the HIPAA requirements, including the final HIPAA modifications,” stated the letter.

Disclosure Comments

In contrast, the CAP and signing organizations did take issue with the proposed changes to the “right to request restriction of use and disclosure of PHI” requirement in the American Recovery and Reinvestment Act of 2009 (ARRA).

Under this law, providers must honor an individual’s request to not disclose PHI to health plans, unless otherwise required by law. In these proposed HIPAA modifications, physicians would be responsible for informing other health care providers who subsequently render services related to the individual—including pharmacists or specialists like pathologists—of the patient’s request.

The letter strongly objected to this provision, adding that the patient needs to make the restriction request directly to subsequent providers. This is especially challenging for specialists like pathologists who do not frequently see the patient, and would not likely receive such a request directly from the patient.

In terms of a timeline, the comments requested that HHS extend the compliance date for implementation of any new standards to a year—rather than 180 days—beyond the effective date of the final rule. This extension will help allow additional time for compliance with modifications to HIPAA standards and implementation specifications. In regards to the proposed changes to the BA agreements, the letter supported HHS’s current proposal of allowing current entity/BA/subcontractor agreements to continue to operate for up to one year beyond the final rule’s compliance date.

MedPAC Considering Self-Referral Issue—With Caution

The Medicare Payment Advisory Commission (MedPAC) continues to be concerned about the growth of ancillary services in physician offices, although members stopped short of making any recommendations that would be presented to Congress in their next report, at the most recent meeting in Washington, DC, on Sept. 13-14. Instead, the commission appears to be taking a measured approach in making recommendations for short-term methods to ensure that services—such as imaging and pathology testing—are not over-utilized in a self-referral environment. This approach appears to reflect the commission members’ intent that any proposed near-term changes not adversely affect long-term reforms to health care delivery systems, such as through coordinated care models like accountable care organizations (ACOs).

FTC, CMS, HHS to Hold ACO Workshop on Oct. 5 in Baltimore

A workshop on issues related to ACOs will be held at CMS headquarters in Baltimore, MD, on Oct. 5. Free and open to the public, the workshop is sponsored by the Federal Trade Commission, CMS, and the HHS Office of Inspector General. Workshop topics will include anti-trust, physician self-referral, and anti-kickback laws. More details can be found online.

In its June report, MedPAC staff acknowledged the role of the in-office ancillary services (IOAS) exception under the Stark law in the rapid volume growth of services—including laboratory services—permitted under the IOAS exception. The impact on quality and costs when ordering physicians have an economic self-interest in laboratory testing has been a priority advocacy issue for the CAP. Earlier this year, the College and other members of the IOAS Coalition met with MedPAC Deputy Director Jim Matthews and Senior Analyst Ariel Winter to discuss the impact that improper anatomic pathology (AP) arrangements can have on overutilization of testing services.

Payment Reform Options

Throughout this most recent meeting, discussion centered on policy options that MedPAC is considering in formulating recommendations to Congress. For diagnostic imaging and lab tests, policy options include excluding services from the in-office exception unless provided on the same day as the visit, excluding from the exception unless the practice is clinically integrated, reducing payments for tests performed by self-referring physicians, prior authorization for advanced imaging services, and packaging or bundling payment for testing services. While bundling typically refers to one payment for multiple, major procedures performed by several providers across an episode of care, packaging refers to a single payment for multiple services rendered by a single provider.

The consensus among the MedPAC members appears to favor reducing payments to self-referring physicians (particularly if there is a way to identify abusive self-referral patterns), packaging, as well requiring prior authorization and/or notification from Medicare.

However, one of the MedPAC Commissioner Nancy Kane, DBA, from the Harvard School of Public Health, noted that prior authorization would likely be an administrative burden on CMS, as well as a source of conflict with patients. “I see the potential for some nasty interactions with beneficiaries,” she said.

Another Commissioner, former CMS Deputy Administrator Herb Kuhn, also expressed concerned about prior authorization. Now with the Missouri Hospital Association, Kuhn said requiring prior authorization or notification could present for a very uncomfortable situation for both the ordering physician and Medicare beneficiary if patients are denied services like timely MRI testing without Medicare authorization.

Kane added that reducing payment rates for services performed by self-referring physicians would likely help control unnecessary testing volumes. But she cautioned against making drastic payment overhauls, as she believes that many of these issues will be eventually resolved with the advent of ACOs and similar models. “I’m in favor of doing less now in the short term and more in the long-term,” she added.

Joint Commission Seeks Input on New Lab, Pathology Standards

New and revised standards for laboratory specialty areas from The Joint Commission are now open for comment until Oct. 20. Specialty areas relevant to pathology include cytogenetics, cytology, histopathology, and molecular testing.

The Joint Commission created these updates in response to customer surveys conducted during the fall of 2009, The Joint Commission’’s Executive Director of Laboratory Accreditation, Jennifer Rhamy, told Statline. “What we wanted to do is to improve transparency, as well as ensure consistency of the accreditation process,” she added.

Rhamy also emphasized that the goal of these new and revised standards is not to increase the administrative burden on accredited labs. Rather, many customers asked for additional details and specificity on standards, particularly in areas that involve emerging and increasingly complex technologies, such as cytogenetics and molecular testing.

“We are absolutely not trying to make these standards more burdensome,” she explained. “We don’t want to be prescriptive and inhibit the practice of pathology.”

New Primary Care Home Option

In related news, The Joint Commission is expanding its ambulatory health care organization accreditation to include a “primary care home option”. Standards for the Primary Care Home Initiative are expected to be posted for a field review in late 2010, and pilot testing is expected to begin in early 2011. The final standards are expected to be available in spring 2011, and on-site surveys are expected to begin in July 2011.

This preliminary launch announcement included few details, and it is unclear how laboratory and pathology operations will be involved in the pilot program. However, this primary care home model is similar to other coordinated care models—like accountable care organizations—that deliver patient care through a provider-team approach.

PMC Launches CAP-Funded HIT Task Force

The Personalized Medicine Coalition (PMC) has formed a task force focused on advising and educating the coalition and policymakers on how health information technology (HIT) can best facilitate future breakthroughs in personalized medicine.

With financial support from the College and McKesson Corporation, one of the task force’s goals is to develop specific and actionable recommendations on better aligning HIT with personalized medicine. This includes recommending how to integrate scientific and clinical capabilities into the HIT infrastructure, improve financial incentives to support HIT and personalized medicine innovation, and what future legislative and executive actions are needed to maximize the benefits of the government’s $40 billion investment in HIT adoption.

PathPAC Pursues $1 Million Fundraising Goal

The College’s political action committee—PathPAC—recently set a goal to raise $1 million to bolster its political muscle by raising and distributing funds supporting legislative and political success on Capitol Hill. The official launch of the campaign will occur at the CAP Annual Meeting, held Sept. 26-29 in Chicago.

“The CAP has an ambitious legislative agenda due to the many issues that affect pathology and laboratory medicine,” CAP President Stephen N. Bauer, MD, FCAP, told Statline. “Based on our legislative agenda and the growth and advancement of the specialty of pathology, we have set the goal of $1 million per year for PathPAC fundraising.”

With the implementation of the health care reform law, health care delivery is changing at an unprecedented pace. Given this upheaval, pathologists need to stand together to emphasize that they are critical members of a patient’s health team, according to Richard A. Bernert, MD, FCAP, and chairman of the PathPAC Board of Directors.

“The transformation of our specialty cannot mature fully without an effective and unified voice at the federal level,” Dr. Bernert told Statline. “As health care reform continues to evolve, pathologists must be sure that our profession has a clear, unified, and loud voice on our legislative issues. A strong PAC can make that happen.”

To make a contribution, please contact Susan Askew, CAP’s Manager of Political Programs. Also, be sure to stop by the Advocacy booth at CAP ’10 to read about the College’s federal and legislative priorities.

Follow CAP Advocacy on Twitter

Follow CAP Advocacy on Twitter 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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