College of American Pathologists
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September 15, 2011  •  Volume 27, Number 19
Next Issue: September 29, 2011
© 2011 College of American Pathologists

In This Issue:

CMS Proposes Direct-to-Patient Lab Test Reporting Rule
Rep. Pete Sessions (R-TX) Tours Methodist Pathology Laboratory
CAP Continues to Support Mayo as Prometheus Case Moves Closer to Supreme Court
CLIAC Focuses on Pathologists’ Role in Developing EHR Systems
House Subcommittee to Hold Medicare Provider Extenders Hearing
Senate Approves Bill Calling for Gene Patent Study
Keep Up with the Latest CAP Advocacy News on Twitter

CMS Proposes Direct-to-Patient Lab Test Reporting Rule

Citing the need to empower patients and advance patient-centered care enabled by health information technology (IT), CMS launched National Health IT Week by proposing a new rule giving patients and their authorized representatives direct electronic access to their own laboratory test result reports. The College is currently analyzing potential implications of the proposed rule and is planning to submit comments to the agency.

The Sept. 14 notice of proposed rulemaking (NPRM) was issued by CMS’s CLIA office, the CDC, and the HHS Office of Civil Rights, which oversees the HIPAA privacy rule. The NPRM indicates the rule will require modifications to CLIA. Under the current regulation, CLIA limits disclosing test results to authorized persons, which includes the individual ordering and/or receiving the test results, the person responsible for using the test results for treatment, and the referring lab. Currently, CLIA defers to state law governing whether patients can access their laboratory test results directly from the laboratory.

Proposed Laboratory Requirements

Under the proposed rule, state law regulating the release of laboratory test results would be preempted, if the law is contrary to the contemplated rule. In addition, this proposed rule will change the way HIPAA is interpreted, as the current rule provides an exception to patients’ rights to access their information where a state law bars disclosure. According to CMS, 39 states and territories prohibit the laboratory from providing direct reports to patients.

The proposed rule requires laboratories to provide the individual with access to the information in the electronic form and format requested by the individual. Laboratories would be allowed to charge reasonable cost-based fees reflecting the labor costs for creating an electronic copy of the information and supplies. Prior to providing access, laboratories would be responsible for verifying the identity of the requesting individual. If the test order is accompanied only by anonymous identifiers, the laboratory would not be required to provide access.

Rep. Pete Sessions (R-TX) Tours Methodist Pathology Laboratory

CAP member Dr. Saad (left) led Rep. Pete Sessions (R-TX) on a recent tour of the pathology laboratory at Methodist Dallas Medical Center. Surgeon Martin L. Koonsman, MD, FASC (center) was also on the tour, highlighting Methodist’s physician-team approach to patient care.National Republican Congressional Committee Chairman Rep. Pete Sessions (TX) recently toured the pathology laboratory at Methodist Dallas Medical Center. The tour was led by CAP member A. Joe Saad, MD, FCAP, a member of the CAP’s Federal and State Affairs Committee.

The tour highlighted Methodist’s multidisciplinary approach to cancer care, explained Dr. Saad. Indeed, Martin L. Koonsman, MD, FASC, breast surgeon and President of the Medical Staff, was also on the tour.

“In breast cancer cases, we are prospectively reviewing and constantly monitoring a patient’s care with surgeons, oncologists, and other physicians, as we pointed out to Rep. Sessions,” Dr. Saad explained, adding that the importance of laboratory testing—such as HER2, ER, and PR testing—in treatment and prognosis was also emphasized to the congressman.

In addition to the pathologists’ role in cancer care, Dr. Saad also explained to Rep. Sessions the role of the clinical laboratory in the hospital’s quality improvement efforts. “We discussed how health information technology tools, including critical values and delta flag alerts, ensure that our patients are receiving top quality care,” he told Statline.

This recent tour of the Methodist Dallas lab was not the first time Dr. Saad had met Rep. Sessions. The two had previously toured a Dallas-area independent lab, and Dr. Saad has visited Rep. Sessions’ Capitol Hill office. Lab tours and Hill visits are key ways that relationships develop between CAP members and members of Congress. Check out the recently posted PathNET video on CAP’s Advocacy site for more information on lab tours.

CAP Continues to Support Mayo as Prometheus Case Moves Closer to Supreme Court

The College is continuing to support Mayo Collaborative Services’ and Mayo Clinic Rochester’s (known collectively as Mayo) case against Prometheus Labs. By recently signing on to an amicus brief backing Mayo, the CAP is supporting the merits of Mayo’s appeal to the U.S. Supreme Court, stating that because Prometheus’ methods evaluate the body’s natural responses to illness and medical treatment, they do not meet the patentable subject matter standard of section 101 of the Patent Act.

This recent brief focuses on the merits of Mayo’s case against Prometheus’ patent claims on a method of monitoring therapeutic efficacy by measuring a patient’s metabolite blood levels. The College also joined other physician groups in signing onto an amicus brief in April supporting Mayo’s petition to the Supreme Court seeking judicial review of the case, also known as “cert”. The Supreme Court granted cert in late June, and will now likely hear the case before the end of the year. A ruling from the Court is expected mid-2012.

CLIAC Focuses on Pathologists’ Role in Developing EHR Systems

Robust electronic health record systems (EHRs) must be developed in concert with pathologists given the complexity of laboratory data, David Booker, MD, FCAP told the Clinical Laboratory Improvement Advisory Committee (CLIAC) at an Aug. 31 meeting.

“I emphasized that pathologists need to be involved in the early phase, including development of EHR functionality—as well as implementation—and must participate in ongoing maintenance,” Dr. Booker, who is on the CAP Board of Governors, explained to Statline following the Committee meeting. “They must have complete access to the EHR, as pathologists are the only physicians with a legitimate claim to access all patient records, given they are responsible for all patient testing.”

Oversight of the federal health IT program involves a number of different agencies. While the HHS Office of the National Coordinator (ONC) sets the technical and certification standards for the national EHR Incentive Program, CMS sets the program objectives, as well as any rules involving payment. CMS has a non-voting representative on CLIAC, which is supported by the Centers for Disease Control and Prevention (CDC).

Dr. Booker noted the vast amount of laboratory data that goes into any EHR, and the complexity of this data. Most importantly, he pointed out the problems that can result when this data is not properly integrated into the EHR. “In institutions where the pathologists lack EHR access, lab data errors may occur without the knowledge of the pathologist, who may be unable to even troubleshoot the problem,” he said. “For example, IT personnel in hospitals have built formulas in their EHRs that create errors in lab reporting—without the lab’s knowledge or input. The only solution is to involve pathologists in the development and implementation process—right from the beginning, and to maintain involvement in any changes to the EHR related to laboratory testing.”

Best Practices in Reporting Gynecologic Cytopathology Test Results/PT

  • Monitoring interpretive rates for cytotechnologists individually and in comparison to the entire laboratory. Individual interpretive statistics should be provided to cytotechnologists and pathologists as feedback.
  • Monitoring pathologist upgrade rates of cytotechnologist interpretations, especially changes from NILM to SIL+ and ASC-US to HSIL.
  • Maximizing the number of high risk cases in prospective rescreens including positive high-risk HPV cases with normal Pap test.
  • Review cytologic-histologic correlation either contemporaneously with biopsy in discrepant cases or retrospectively within a three-to-four month period after issuance of both reports.
  • Positive Predictive Value of a positive Pap test is helpful to standardize benchmarking and should be calculated annually.

Best Practices in Gynec. Cytopathology

In addition to EHRs, CLIAC’s August meeting also discussed best quality practices associated with gynecologic cytopathology. CAP member Joseph Tworek, MD, FCAP, presented findings from a CDC collaborative project that was awarded to the College. Beginning in September 2009, the project focused on evaluating current practices in reporting gynecologic cytopathology test results, as well as cytopathology proficiency testing (PT).

To review quality assurance related to the analytic portion of the Pap test, senior project author Dr. Tworek and his collaborators reviewed questionnaire responses from 541 laboratories, as well as input from 100 individuals who attended a conference to discuss Pap test quality practices.

At the CLIAC meeting, Dr. Tworek highlighted key best practices identified by the collaborative group (see box for details on a number of key best practices). Presentation materials on quality measures identified in the study, as well as complete audio from the Gynecologic Quality Practices Consensus Meeting, can be found online on the Cytopathology Topic Center page. Recommended practices will appear in the Archives of Laboratory Medicine and Pathology in early 2012.

House Subcommittee to Hold Medicare Provider Extenders Hearing

The House Ways and Means Subcommittee on Health will hold a hearing next week on Sept. 21 regarding certain Medicare provider payment provisions set to expire at the end of this year. This includes the provision allowing independent laboratories to bill Medicare for the technical component (TC) of surgical pathology services for hospital patients, also known as the TC “grandfather” clause.

While CMS included terminating this provision in its 2012 proposed physician fee schedule (PFS)—as it has in previous years—Congress is again being called upon to authorize an extension. Congress has been extending this provision since CMS began including the termination in its proposed PFS. As it did in its recent comments to CMS on the 2012 proposed PFS, the College continues to oppose the agency’s proposal to end the policy. The CAP has long advocated making this grandfather policy permanent, and will submit testimony in support of an extension for this hearing. To this end, the College is supporting legislation (H.R. 2461) introduced by Rep. Geoff Davis (R-KY) in early July that would make permanent the TC grandfather policy.

Senate Approves Bill Calling for Gene Patent Study

By the end of this week, President Obama is expected to sign the patent reform bill (H.R. 1249) passed by Congress requesting the U.S. Patent and Trademark Office (USPTO) to study and provide recommendations on the best ways to provide independent second opinions within the current environment of exclusive gene patents. The Senate approved the America Invents Act on Sept. 8; the House approved the bill in late June.

Prior to the Senate vote, the bill’s author Sen. Patrick Leahy (D-VT) submitted a statement clarifying that nothing in the legislative language implies the validity of gene patents, nor has any bearing on the ongoing litigation related to the Myriad Genetics gene patent case. The College is a co-plaintiff represented by the American Civil Liberties Union (ACLU) in the case contesting Myriad Genetics’ patent claims on BRCA 1 and BRCA 2 genes (see related story).

“A gene patent may or may not be valid, and that has no impact on the USPTO study, which mentions the existence of gene patents issued by the USPTO (but still subject to a validity challenge), but focuses on the effect of patents and exclusive licensing of genetic diagnostic tests, regardless of whether there are relevant patents,” read Sen. Leahy’s statement.

Keep Up with the Latest CAP Advocacy News on Twitter

CAP Advocacy is now 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 what we are following on Twitter.


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