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ePolicy News March, 2012

Thursday, March 1, 2012



Fix to SGR Harms Laboratory Medicine, Patients
ASCP Generates 3,600 Letters to Hill in 36 Hours

On Feb. 22, President Obama signed legislation extending the payroll tax cut, continuing unemployment benefits, and delaying a scheduled cut in Medicare physician reimbursement rates. The measure, which overall costs about $143 billion, blocks a sustainable growth rate (SGR)-imposed cut of 27 percent until the end of 2012. Congress will need to pass additional legislation later this year to prevent what is currently estimated as a 32-percent cuts from occurring in 2013.

The cost of the physician pay fix cost roughly $18 billion for the remaining 10 months of 2012. To pay for the fix, Congress made several partially offsetting cuts intended to save about $21.2 billion over 10 years. Of these cuts, about $2.7 billion would come from the Medicare Clinical Laboratory Fee Schedule. This cut will go into effect in 2013. In addition, Congress is phasing out the technical component grandfathering provision that covers the technical component of surgical pathology services for certain hospital’s patients.

The cuts to the clinical laboratory fee schedule were included in drafts of a congressional compromise at the eleventh hour, leaving the clinical laboratory industry little time to raise concern about the proposed cuts, which disproportionally affect clinical laboratories. That said, ASCP launched a grassroots advocacy campaign that received outstanding support from its members: more than 3,600 letters in 36 hours flooded Congressional offices raising concern about the impact on laboratories.

Though, we were ultimately unable to reverse the proposed cuts, ASCP applauds the quick work of those took action to protect the nation’s clinical laboratories from further cuts in Medicare reimbursement.

ASCP Endorses Price-Kind Bill to Fix Meaningful Use Pathologist Penalty

ASCP has formally endorsed a bipartisan legislative proposal, HR 4066, sponsored by U.S. Representatives Tom Price (R-GA) and Ron Kind (D-WI) to reform the way the Medicare Meaningful Use standards treat pathologists. Under the Medicare Meaningful Use requirements, which outline the government’s requirements for satisfaction of the Electronic Health Records (EHR) Incentive Program, physicians who fail to satisfy the reporting requirements will have their Medicare reimbursement rate cut beginning in 2015.

Unfortunately for the vast majority of pathologists, it may be impossible to satisfy the reporting requirements necessary to meet the Meaningful Use requirements. (For more information, click here and here.) For example, pathologists would have to satisfy a host of patient reporting requirements, such as reporting smoking status, changes in the patient’s vital signs, and sending reminders to patients for preventive/follow-up care. Failure to satisfy these mandates not only denies pathologists the ability to receive some of the incentive money Medicare has been providing for adoption of EHR technologies but would also result in payment reductions for failure to participate.

ASCP alerted the Centers for Medicare & Medicaid Services (CMS) to the flaws in the Meaningful Use program as part of its comments on the Stage 1 meaningful use proposed requirements. CMS, however, indicates that it was unable to address ASCP’s concerns about the reporting requirement’s impact on pathologists due to the way Congress structured the statute governing the program. As a result, a legislative change, such as that proposed by U.S. Representatives Price and Kind, is needed to prevent cuts in pathologist reimbursement. ASCP will be actively supporting the legislation, which Representatives Price and Kind introduced after working with the College of American Pathologists (CAP), in its advocacy efforts and will feature it as one of the core issues that will be addressed at the upcoming ASCP Capitol Hill Day.

In a related development, the Department of Health and Human Services has released new proposed rules to implement the Stage 2 Meaningful Use requirements. Under the proposed Stage 2 standards, eligible physicians (those not employed by hospitals) and hospitals would have to use computerized physician order entry (CPOE) for more than 60 percent of medication, laboratory and radiology orders, double the share required under the Stage 1 standards. This requirement is one of more than a dozen core objectives that eligible physicians and hospitals would have to meet to satisfy the Meaningful Use equirements. Other core objectives include the use of electronic prescribing for more than 50 percent of prescriptions issued, the recording of demographic data for more than 50 percent of patients, recording of vital signs in more than 80 percent of patient encounters, and recording smoking status for more than 80 percent of patients. The proposed percentages represent a significant increase in the use requirements outlined in the Stage 1 requirements.



ASCP Urges CMS to Change Physician Sunshine Act

ASCP recently submitted comments on the Center for Medicare & Medicaid Services’ (CMS) proposed transparency reporting requirements. Its comments addressed its concern about how the proposal could affect continuing medical education. In its comments, ASCP raised objections that the proposed rule exceeded its statutory authority when it included third parties, such as continuing medical education (CME) providers. In commenting on the proposed rule, ASCP worked with both the Council of Medical Specialty Societies (CMSS) and the American Medical Association (AMA) in urging CMS to exclude accredited CME from the rule’s reporting requirements.

The proposed rules implement the Physician Payment Sunshine Act, which requires that beginning in 2012, manufacturers of specified drugs, medical devices, and biologics, and medical devices participating in U.S. federal healthcare programs must begin tracking any transfers of value or payments of $10 or more directly to physicians and teaching hospitals. That said, CMS proposed that the rule apply to faculty at accredited CME events or even, more broadly, to all attendees of an accredited CME event provided the CME provider accepts funding from covered manufacturers. Such a result could trigger huge reporting obligations for accredited CME providers and could adversely affect the ability of CME providers to supply educational products. For a copy of the ASCP Comments, click here (PPSA). ASCP also cosigned letters submitted by CMSS and AMA.

NIH Releases Genetic Test Registry

The National Institutes of Health (NIH) Director, Francis S. Collins, MD, PhD, unveiled the Genetic Testing Registry (GTR) this week at NIH’s observance of international Rare Disease Day. The GTR, available at, features a versatile search interface that allows users to search by test, condition, gene, genetic mutation, and laboratory. It also serves as a portal to other medical genetics information, with context-specific links to practice guidelines and a variety of genetic, scientific, and literature resources available through the National Library of Medicine at NIH. To view video tutorials on how to use the GTR, go to

The GTR staff appreciates the comments it received from interested stakeholders during GTR’s development and welcomes additional feedback as you become familiar with the Registry. To submit comments and questions, please use


ASCP Reiterates Opposition to Gene Patents,
Patient Safety Paramount

In keeping with ASCP’s goal to promote and protect patient safety, the Society submitted public comments at a public hearing regarding genetic testing. As a patient-centric organization, the Society’s mission is to protect patient safety while promoting advances in medicine. To that end, ASCP maintains that the impact of gene patenting on research and innovation has been and will continue to be the subject of intense debate. However, in the final analysis, ASCP believes that the policy in the best interest of patients is the one which should prevail. ASCP has joined with many other pathology and clinical organizations to support the elimination of gene patents. That support is driven by the over-riding principle of patient-centered advocacy—acting first and always in the best interests of our patients.

The issues of gene patents and genetic testing were discussed at a meeting Feb. 16 at the United States Patent and Trademark Office (USPTO). The purpose of the meeting was to gather information on the genetic diagnostic testing for a report required by the America Invents Act (AIA). Among the speakers were Teresa Stanek Rea, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office. Ms. Rea stated that the goal of the public hearing was for patients to be able to receive second opinions about genetic tests. She also encouraged stakeholders to take the following into consideration the 1) consequences of patents in healthcare, 2) the institutions that should play an active role, and 3) the public policies to explore for the tests to be more widely available.

The public comment period ends March 26, 2012. The final report will be due to Congress June 16. Transcripts of the hearings will be available on the USPTO website, To view ASCP’s comments: See related story below.


ACLU Launches Public Education Campaign on Impact of Gene Patenting

Last month, the American Civil Liberties Union (ACLU) launched a public education campaign to illustrate the harms of gene patenting. The campaign, “Taking Back Our Genes,” uses photographs and stories to reveal the true impact of gene patenting on people’s lives.

In 2009, ASCP and several other medical associations, geneticists, genetic counselors, patient advocates, and patients, represented by the ACLU and the Public Patent Foundation (PUBPAT), filed a lawsuit challenging the legality of patents on two human genes, BRCA 1 and BRCA 2, associated with hereditary breast and ovarian cancer. Last year, a divided three-judge panel reversed a lower court ruling upholding the right of Myriad Genetics, to patent the two “isolated” human genes, thus granting the company the exclusive right to perform diagnostic tests on the genes, while preventing other researchers from even looking at the genes without first obtaining permission from Myriad. The decision permits the continuation of Myriad's monopoly on the BRCA genes, making it impossible for women to access alternate tests or get a comprehensive second opinion about their results. It also allows Myriad to continue charging a high price for its tests.

Currently, the Supreme Court has been petitioned to hear an appeal of the case. You can visit Taking Back Our Genes to learn more about the lawsuit and the personal toll that gene patenting has had on patient care.

ASCP Supports Workload Recommendations for Pap Screening

ASCP provided a public statement before the Clinical Laboratory Improvement Advisory Committee (CLIAC) supporting the American Society of Cytopathology’s (ASC) workload recommendations for automated Pap test screening. George Birdsong, MD, FASCP, offered ASCP’s comments before CLIAC. The meeting, held in Atlanta, Feb. 14–15, also provided updates from the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Board of Scientific Counselors (BSC), the Coordinating Council on the Clinical Laboratory Workforce (CCCLW), and Centers for Medicare & Medicaid Services (CMS).

The purpose of the Automated Cytology Workload discussion was to inform CLIAC of the FDA revised method for counting workload for cytology semi-automated screening devices, ask CLIAC members to provide input on the best approach to keep laboratories informed of product labeling changes, and to consider ASC Taskforce Recommendations to lower the workload maximum when using cytology semi-automated screening devices. The Cleveland Clinic’s Tarik Elsheikh, MD, outlined ASC’s recommendations and stated that minimization of the number of false negative cases coupled with high specificity are keys to a successful screening program. In addition, the current maximum workload limits for image guided screening are certainly too high for most cytotechnologists to achieve.

As a patient-centric organization, ASCP strongly supports the ASC’s efforts to promote the safety of women by adopting evidence-based workload limits for the screening of image-guided Pap tests by cytotechnologists. ASCP noted in its statement that the evidence pertaining to current workload limits indicates that they are extremely high and “may be associated with significant reduction in sensitivity.” CLIAC supported the data presented by the speakers and recommended standardized criteria be developed, so that the Department of Health and Human Services (HHS) can appropriately determine the maximum workload limit using semi-automated screening instruments. For more information, go to



Pathology’s Collective Effort to Amend Washington State Autopsy Legislation

ASCP along with the College of American Pathologists (CAP), the Washington State Society of Pathologists (WSP), and the National Association of Medical Examiners (NAME) joined to urge amendments to State Senate Bill 6037 dealing with autopsy imaging. The groups were concerned that the legislation placed unnecessary limits on the access and use of photos and other images conducted during an autopsy. ASCP requested an amendment to the legislation to provide for the use of autopsy images for teaching and training purposes. The legislation has been tabled; reconsideration of the bill is slated for 2013. To view ASCP’s letter to Washington State Senator Jerome Delvin, click here or to view SB 6037, click here


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