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ePolicy News December, 2011

Wednesday, November 30, 2011



ASCP Joins CGI to Tackle Workforce Shortage

ASCP has made a Commitment to Action at the 2011 Clinton Global Initiative (CGI) America Meeting in Chicago to alleviate the shortage of laboratory professionals. Expanding the Laboratory Workforce for the 21st Century is a five-year ASCP commitment to expand the capacity of the clinical laboratory workforce in the state of New York, with implications for future similar initiatives across the nation. ASCP’s commitment activities include the expansion of current educational programs, curriculum development for both classroom and distance learning, the establishment of a coordinated network of clinical rotation sites, the creation of an accelerated technician to technologist career pathway, and the development of an electronic instrumentation simulation laboratory. As a result of these activities, ASCP and its CGI partners seek to increase the number of graduating laboratory professionals in New York from approximately 10 percent each year over a five-year period.

The mission of CGI is to inspire, connect, and empower a community of global leaders to forge solutions to the world's most pressing challenges. By fostering partnerships, providing strategic advice, and driving resources toward effective ideas, CGI helps its members—organizations from the private sector, public sector, and civil society—maximize their efforts to alleviate poverty, create a cleaner environment, and increase access to health care and education. Established in 2005 by President Bill Clinton, CGI convenes global leaders to create and implement innovative solutions to the world's most pressing challenges. CGI Annual Meetings have brought together more than 150 heads of state, 20 Nobel Prize laureates, and hundreds of leading CEOs, heads of foundations and NGOs, major philanthropists, and members of the media. ASCP Immediate Past President and Professor and Chair of the Department of Pathology and Anatomical Science at the State University of New York at the University of Buffalo, Buffalo, N.Y., John E. Tomaszewski, MD, FASCP, attended this year’s CGI’s Annual Meeting, Sept. 20–22, New York City.

CGI members have made more than 2,100 commitments, which are already improving the lives of nearly 400 million people in more than 180 countries. When fully funded and implemented, these commitments will be valued at $69.2 billion.



Supercommittee Fails to Ink Deficit Reduction Deal

The Congressional Supercommittee, tasked with the responsibility of identifying at least $1.2 trillion in deficit savings, has failed in its task, announcing that the committee was unable to agree on a package of spending cuts as a result of an inability to reach consensus on the issue of tax increases on wealthy Americans.

As a result, the “trigger cuts,” $1.2 trillion in previously agreed to across-the-board spending cuts on defense and nondefense spending are scheduled to go into effect in 2013. Most of the $1.2 trillion in saving will occur in defense spending.

The trigger cuts will also affect Medicare-reimbursed physicians and other providers with a 2-percent cut in reimbursement rates, scheduled to go into effect in 2013. A more pressing issue is the looming 30-percent cut in the physician fee schedule that is attributable to the flawed sustainable growth rate (SGR). With the collapse of the Supercommittee, physician and other provider groups have turned their attention to the issue of overriding the SGR-related cuts, which is scheduled to go into effect on Jan. 1, 2012.

Though many provider groups, including ASCP, had urged the Supercommittee to find a permanent fix to the SGR’s flaws, at this point it does not appear that the future of such a reform is promising. Thus, Medicare-reimbursed providers may be stuck with the reality of annual (or other) legislative overrides of SGR-related cuts.

New Legislation Challenges FDA Jurisdiction Over LDTs

Representative Michael Burgess (R-Texas) introduced legislation that would essentially strip the Food and Drug Administration (FDA) of its authority to regulate laboratory developed tests (LDTs), and place it with the Centers for Medicare & Medicaid Services (CMS). The proposed legislation, “Modernizing Laboratory Test Standards for Patients Act” (H.R. 3207) seeks to amend the Public Health Service Act, establishing a notification and review process for those laboratory tests that are developed and used solely in-house. The FDA has long maintained that the Public Health Service Act granted the agency authority over LDTs as medical devices subject to premarket review even though it has exercised this authority only with regard to analyte-specific reagents and certain types of assays, specifically in vitro diagnostic multivariate index assays (IVDMIAs).

The bill calls for the establishment of a test registry to which laboratories will be required to submit data regarding analytical and clinical validity when introducing new LDTs. Laboratories would be granted additional time to provide comparable data for LDTs already in use. In addition to granting CMS regulatory authority over LDTs, the bill also calls for agency to oversee direct-to-consumer testing with the stipulation that laboratories must demonstrate that patients will have access to pre- and post-test counseling services from a health care provider or a genetic counselor.

The legislation is clearly an attempt to head off efforts by the FDA to step up its regulation of LDTs out of concern over long approval delays that might hinder innovation and U.S. competitiveness.

While the Burgess bill makes its way through the legislative process, the FDA continues to move forward with its plans to release a draft guidance in the near future outlining how the agency intends to regulate LDTs. At a recent FDA roundtable meeting of laboratory organizations attended by ASCP, Alberto Gutierrez, Ph.D., Director of the Office of In Vitro Diagnostics Device Evaluation and Safety, reiterated what he and other FDA representatives have been stating for the past year — that the agency fully intends to implement LDT regulation using a risk-based approach and a third-party review process. Read more here.

Residents Team Up to Address Threat to GME Funding

ASCP’s Resident Council along with the Resident Forum Executive Committee of the College of American Pathologists (CAP) recently joined forces to oppose proposed cuts to Graduate Medicate Education. In a letter addressed to members of the Congressional Supercommittee, that has been charged with coming up with the needed cuts to slash the nation’s deficit, both groups maintained that the proposed 60-percent cut, approximately $60 billion to Graduate Medical Education, would have detrimental affects on both the profession of medicine and ultimately patient care and access. The Supercommitee failed in reaching its goal and deadline. (See related story above.) ASCP had recently collaborated with the American Association of Medical Colleges (AAMC) to urge people to weigh in with letters to their members of Congress and Senators to reconsider these cuts. The Society’s efforts were led by Chris Cogbill, MD, Chair of ASCP’s Resident Council. Read the joint letter here.

Policy Briefing Focuses on Future Role of Genetic Testing in Cancer Care

The American Clinical Laboratory Association (ACLA), in partnership with Results for Life, held a policy briefing recently entitled The Innovation Revolution: Genetic Testing in Today’s Cancer Care. The discussion included congressional perspectives, as well as cancer care expert perspectives on how genetic testing is redefining the treatment of cancer. Speakers include Rep. Michael Burgess, MD, (R-TX), Vice Chair of the House of Energy and Commerce Health Subcommittee, and Rep. Charles Gonzalez (D-TX), Member of the House Energy and Commerce Health Subcommittee. Both members of Congress weighed in on the value of genetic testing in the formation of health policies that strive to improve the health and economic well-being of the nation.

While molecular genotyping and targeted therapies to transform diagnostics and treatment of a wide range of cancers promise better health outcomes, challenges are ahead. Mara Bloom, Executive Director of Massachusetts General Hospital Cancer Center, stated that some of the challenges include, “access to genotyping, clinical relevance, physician education, patient education and payer coverage.” In addition, a report from the Results for Life, “Genetic Tests Help Physicians Target Medication and Dosage for Cancer Patients” indicate that many genetic tests are now available or in development for treatment of lung, ovarian, prostate, and other cancers. A partnership between the healthcare and policy sectors is needed, so that genetic and genomic testing can be accessible to those who need it. The field of laboratory medicine will play a large role in the area of genomics now and in the future. ASCP continues to monitor government policies that are being developed as a response to the issues related to genetic testing.

For information on the effects of genetic testing in the economy, the Battelle Technology Partnership is currently developing a report on “The Economic and Functional Impacts of Genetic and Genomic Clinical Laboratory Testing.” Its anticipated completion will be in early December 2011.



Marilyn Tavenner Named New CMS Administrator

President Barack Obama has named Marilyn Tavenner as administrator of Centers for Medicare & Medicaid Services (CMS). Ms. Tavenner is currently serving as CMS deputy administrator and has played a key role in overseeing key activities at the agency including Medicare, Medicaid, and the implementation of various aspects of the Affordable Care Act. Her career has ranged from service as a staff nurse to Secretary of Virginia's Health and Human Services and 25 years of service in the leadership of the Hospital Corporation of America. Ms. Tavenner succeeds Donald Berwick who was a controversial CMS nominee who was never able to win confirmation in the U.S. Senate. She will serve as acting administrator while her nomination to become CMS administrator is considered by the U.S. Senate.

ASCP Supports CLIA Patient Access Rule, Urges Fix of Anti-Markup Rule

On Nov. 14, ASCP submitted comments on a proposed regulation that would allow patients to receive a copy of their laboratory test results directly from the clinical laboratory. The rule allows a patient to receive “completed test reports,” upon request, directly from the clinical laboratory. ASCP supported the rule lauding CMS’s “efforts to empower patients by encouraging them to obtain and understand their personal health data.” That said, ASCP advised the agency that “quality care is best preserved when patients seek out their physician’s interpretation of this information, so that their test results are interpreted in the context of that patient’s unique medical history.” The proposed rule would amend the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and Health Insurance Portability and Accountability Act.

In addition to commenting on the proposal to allow patients to receive a copy of their test results from the laboratory, ASCP raised an issue that relates to the agency’s flawed anti-markup rule on diagnostic services. The anti-markup rule requires that the technical component of a pathology service be supervised by a physician, but it does not require that the physician be a pathologist.

This loophole occurs because the TC of 88305 is not subject to CLIA. ASCP urged the agency to amend the CLIA requirements to cover the TC of 88305, which should have the effect of bolstering the anti-markup rule as a tool to prevent clinicians from marking up pathology services and engaging in self-referral. 



Public Comment Period Open for CAP/IASLC/AMP Lung Cancer Biomarkers Guideline

The CAP Pathology and Laboratory Quality Center has partnered with the International Association for the Study of Lung Cancer (IASLC) and the Association for Molecular Pathology (AMP) to determine proper test selection and techniques for non-small cell lung cancer biomarker tests, better ensuring appropriate therapies for lung cancer patients.

The CAP/IASLC/AMP Lung Cancer Biomarkers guideline provides evidence-based recommendations for the molecular testing of lung cancer. Lung cancer is the leading cause of cancer-related mortality, accounting for 1.4 million deaths each year worldwide. About 160,000 deaths of those 1.4 million occur each year in the United States. Fortunately, the past decade brought major advances in our understanding of the pathogenesis and management of lung adenocarcinoma. Specifically, the discovery of the biologic and therapeutic importance of acquired genetic alterations in two genes that encode pharmacologically targetable tyrosine kinases involved in growth factor receptor signaling, EGFR and ALK, has changed the way these cancers are diagnosed and treated.

The CAP, IASLC and AMP welcome comments to the draft recommendations. ASCP is pleased to provide information about this important opportunity. Please visit by Monday, Dec. 19 to review the draft recommendations and post your comments.




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