College of American Pathologists
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September 2, 2010  •  Volume 26, Number 18
Next Issue: September 16, 2010
© 2010 College of American Pathologists

In This Issue:

CAP’s PFS Comments Center on Payment, Self-Referral Issues
Meaningful Use Update: HHS Names Initial EHR Certification Bodies
FDA Extends LDT Comment Period, Comes to an “Understanding” with CMS
CMS Recommends Withdrawing Proposed Cytology PT Rule
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CAP’s PFS Comments Center on Payment, Self-Referral Issues

As Washington sharpens its focus on health care payment reforms, the CAP is urging the Centers for Medicare & Medicaid Services (CMS) to expand disclosure requirements about physician ownership interests while ensuring adequate reimbursement for pathologists, according to comments to the agency on proposed payment revisions under the 2011 Physician Fee Schedule (PFS).

Regarding specific payment issues, the College supports CMS’s proposal to make adjustments—or rebase—the Medicare Economic Index (MEI). To maintain stability, the agency is considering making the MEI physician work adjustment to the conversion factor rather than directly to the physician work relative value units (RVUs). In addition to reconfiguring the MEI, the College also urged CMS to make permanent the technical component (TC) grandfather provision for certain physician pathology services.

The College also submitted comments on CMS’s proposal to require a physician’s or non-physician practitioner’s (NPP) signature on all laboratory requisitions as a way to eliminate any uncertainty as to whether the document is a requisition or an order. The CAP—and the AMA—disagreed with this initiative, adding that this will only lead to further confusion, increased administrative burden, and potential harm to patients forced to wait for laboratory tests delayed by this requirement.

Payment Remarks

In addition to payment issues, the College in its comments on the proposed PFS remarked on the disclosure requirements addressed in the rule that are now required under the in-office ancillary services (IOAS) exception. It also took the opportunity to encourage CMS to tighten the IOAS exception and correct the anti-markup rule.

The CAP has long been concerned about the impact on quality and costs when ordering physicians have an economic self-interest in laboratory testing. In a self-referral environment, or when physicians order based on financial interest, there is an enormous potential for tests to be over-utilized, lower quality of results, and reduce efficiencies in laboratory medicine.

While the recent health care reform law included new disclosure requirements for magnetic resonance imaging (MRI), computed tomography (CT), and positron emission tomography (PET), the CAP urged CMS to extend the requirement for anatomic pathology (AP) services. Furthermore, the College advocated that AP services no longer be included in the IOAS exception.

“Although disclosure of financial interest in anatomic pathology services is an important regulatory step to enhance transparency, control of self-referral arrangements can only be accomplished by removing the economic self-interest of ordering physicians,” stated the comments. “In this regard, the CAP urges CMS to exclude anatomic pathology from the in-office ancillary services (IOAS) exception to the physician self-referral regulations.”

The push for both expanding the disclosure requirement as well as removing from the IOAS exception AP and other services, such as physical therapy, radiology, and radiation oncology, was also outlined in a separate comment letter submitted to CMS Administrator Donald Berwick, MD, by a coalition of laboratory and certain other providers of designated health services. Members of this coalition include the CAP, the American Clinical Laboratory Association, the American Society for Clinical Pathology, and the American College of Radiology.

The IOAS exception was not the only self-referral issue that the CAP commented on; the letter also remarked on the anti-markup rule. The CAP urged CMS to reinstate the statutory requirements and accompanying rules restricting the ability of physicians to mark up “purchased” diagnostic tests, regardless of who is performing or supervising the service.

Quality Comments

With quality-based payment models becoming a focus of health care reform, the CAP also commented on the agency’s Physician Quality Reporting Initiative (PQRI).

For claims-based reporting, the College commended CMS for adjusting the percentage of relevant claims for success to 50% instead of the previous requirement of 80%. This is currently the only mechanism through which pathologists can participate and claims-based reporting is fraught with difficulties. However, for individual physician specialties that do not have at least three PQRI measures available to them, the College wants providers to be able to report via a registry.

The College also applauded the agency for developing the Group Practice Reporting Option (GPRO) II, as this will likely allow greater pathologist participation in the program. However, the CAP is concerned that the reported performance will be attributed inappropriately to individual physicians. Therefore, CMS should clearly indicate on the Physician Compare website how it derived the performance rating for each physician.

Meaningful Use Update: HHS Names Initial EHR Certification Bodies

HHS has announced the initial slate of certified electronic health record (EHR) vendors to support the agency’s final meaningful use rule. Registration for the first phase of this rule will begin January 2011.

While this progress signifies HHS’s commitment to making EHR technology a reality, nationwide compliance is far from certain. In fact, a mere 2% of U.S. hospitals have indicated having EHRs that would meet federal meaningful use criteria, according to a recent survey conducted by the journal Health Affairs.

The U.S. will need more than 50,000 qualified and trained health IT professionals to implement the Health Information Technology for Economic and Clinical Health (HITECH) Act, estimates the Office of the National Coordinator for Health Information Technology.

For pathologists, eligibility concerns continue to be paramount, as detailed in recent issues in Statline. But moving beyond eligibility, pathology informatics leaders are focusing on what demands the current and future stages of the meaningful use rule are going to present for laboratory information management.

“This rule has potentially profound implications for the laboratory,” said Walter H. Henricks, MD, medical director of pathology informatics at Cleveland Clinic. “Once a physician office implements an EHR, it will want laboratory results to be transmitted electronically into the practice’s EHR. Sending laboratory results only via fax or even separate Web portals will no longer be sufficient in these situations.” Henricks is a member of CAP’s Diagnostic Intelligence and Healthcare Information Technology (DIHIT) Committee. He is also speaking at the Pathology Informatics 2010 conference, held later this month in Boston, MA.

Opportunities and Challenges

The final rule dictates that 40% of a patient’s laboratory test results whose results are in a positive/negative or numerical format must be stored as “structured” data in a certified EHR. Henricks said it is unclear what the definition of structured will be but it will likely be mandated by the certification process for EHR technology. It is important to note that this requirement is not applicable to anatomic pathology reports.

More importantly, as this is a requirement for “meaningful use” of EHR technology, it underscores expectations that physicians/providers will have for receiving their laboratory data—most often through interfaces with their own EHR technology—so that they can meet the requirement. Interfaces, however, are typically a challenge to launch and maintain. “Implementing interfaces takes people, money, and patience, not only to get up and running, but also to maintain,” he added.

One of the limitations with current interface and EHR systems, however, is that they are designed to move data in only one direction—from the lab to the patient’s record. The goal of the meaningful use rule is for providers to build a fully-developed EHR system. But for this to be realized, pathology and laboratory information system communications with the doctor’s office needs to be bi-directional, explained Stephen Black-Schaffer, MD, FCAP, of Massachusetts General Hospital (MGH) and an Associate Professor of Pathology at Harvard Medical School.

“If a full-scale, bi-directional operation is not implemented, then we are really not getting all of the benefits of the EHR system,” said Dr. Black-Schaffer, who is also vice-chair of CAP’s Economic Affairs Committee.

While the current meaningful use criteria may not be interpreted as requiring bi-directional capability, Dr. Black-Schaffer recommends that laboratories begin planning on how to include these capabilities in their systems, and advocating for the benefits of such a system in their medical communities. “It’s important for laboratories to include this now, before the systems are in place,” he added. “However hard, it’s easier to include capabilities from the beginning, than it is to make the case for change of a system that’s already installed.”

Also looking ahead to the future, Cleveland Clinic’s Henricks suspects that interoperability standards related to data will likely also be required in subsequent phases of the meaningful use rule. Compliance with standards such as HL7 and LOINC may no longer be optional. “Making these standards mandatory might bubble up more in future stages or could eventually become part of the certification process,” he explained. He added that requirements related to computerized physician order entry (CPOE) for laboratory test orders will likely be included in future rule phases.

Dr. Henricks is the co-author (with Yale University Pathology Informatics Director John Sinard, MD, PhD) of a CAP Virtual Informatics College course on LIS, as well as the author of a course on meaningful use of EHRs.

FDA Extends LDT Comment Period, Comes to an “Understanding” with CMS

In response to a request, the FDA is extending the comment period to Sept. 15 to solicit stakeholder feedback on its oversight of laboratory-developed tests (LDTs). In a notice on the Federal Register, the agency didn’t identify who requested the extension, but said that requester asserted that the “initial time period was insufficient to respond fully to FDA’s specific requests for comments and to allow potential respondents to thoroughly evaluate and address pertinent issues.”

In its comments on LDT oversight to the agency, the CAP urged the FDA and CMS to coordinate oversight efforts to avoid duplicative regulatory burdens on laboratories. Other stakeholders have pushed for the same synchronization, and it appears the agency officials got the message. In June, CMS and FDA signed a “memorandum of understanding” to work together to enhance information sharing, promote efficient use of expertise and tools for analysis and validation, and build infrastructure and processes to meet the “common needs for evaluating the safety, efficacy, utilization, coverage, payment, and clinical benefit of drugs, biologics and medical devices.”

CMS Recommends Withdrawing Proposed Cytology PT Rule

CMS is proposing withdrawing the proposed rule for cytology proficiency testing (PT), and maintaining the current standard, agency officials announced earlier this week at the Clinical Laboratory Improvement Advisory Committee (CLIAC), held Sept. 1-2 in Atlanta, GA. The agency is recommending an update to the interpretive guidelines with some technical changes, as well as monitoring ongoing performance.

While CLIAC appears to want more analysis on the existing cytology PT requirements, the CAP opposes proficiency testing of pathologists and has been critical of the existing program and this proposed rule published in January 2009. According to the CAP, the Cytology PT program fails to measure competency, is not supported by science, and does not improve health outcomes. In a March 2009 letter to CMS, the CAP urged CMS to withdraw the proposal in favor of considering meaningful alternatives, such as a mandatory education approach with a testing component.

In the meantime, while CMS might now seek to abandon this proposal, CLIAC is more cautious. The committee recommended additional performing or performance analysis and evaluation before taking action.

A lack of clear consensus on the proposed rule is driving the withdrawal recommendation, explained officials. In fact, 77% of stakeholders disagreed with the proposed rule during the comment period. Many sought a continuing education requirement. CMS said this would be impossible, as the requirement was not in the notice of proposed rulemaking (NPRM), nor do they have jurisdiction over education programs. Agency officials also explained that they were not provided any direction on frequency or other technical components related to testing.

In related news, CMS officials announced that in 2009, cytotechs and pathologists/cytotechs had a 97% passing rate for the national cytology PT program.

CAP’s March 2009 comments to CMS on the cytology PT NPRM can be found online; the College’s letters to policymakers on this issue can also be found online.

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