College Asked to Advise HHS Task Force on Oversight of Genetic and Genomic Tests
Gail Vance, MD, FCAP, and member of the CAP’s Board of Governors was asked to serve as an ad hoc member of the U.S. Health and Human Services Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) Oversight Task Force. The Task Force will be responsible for guiding SACGHS’ continuing exploration of oversight of genetic and genomic tests and to address specific questions posed by the Secretary.
Dr. Vance’s appointment followed a presentation she gave to SACGHS (PDF, 181 K) on Monday regarding the CAP Laboratory Accreditation Program and its influence on the quality of laboratory–developed genetic and genomic tests. She explained how the CAP’s current laboratory accreditation standards can serve as a model to ensure the quality of laboratory–developed tests and genetic tests in particular.
The CAP’s Laboratory Accreditation Program requires laboratories to demonstrate the analytic and clinical validity of genetic laboratory tests with standards that go well beyond the existing regulatory requirements of genetic testing laboratories. CAP–accredited laboratories are therefore already held accountable to these higher standards, which advances patient care, protects public health and improves genetic testing.
The CAP recommended to SACGHS that oversight of laboratory–developed tests include the demonstration of analytical and clinical validity of tests through the laboratory inspection process.
Two bills recently introduced in the U.S. Senate could impact the future of laboratory oversight. The Genomics and Personalized Medicine Act introduced by Senator Barack Obama (D-IL) calls for an Institute of Medicine study on oversight of genetic tests as well as the addition of a genetic specialty to the Clinical Laboratory Improvement Amendments of 1988. The Laboratory Test Improvement Act, introduced by Senator Edward Kennedy (D-MA), would require Food and Drug Administration review of all laboratory–developed tests.
We will continue to report any new developments regarding genetic laboratory tests in Statline.
Direct Billing Legislation Passed in Kansas
Both chambers of the Kansas legislature in March unanimously passed legislation requiring direct billing of anatomic pathology services (PDF, 33K). The Kansas Society of Pathologists and the College worked collaboratively with the Kansas Medical Association (KMA) for this success that will prevent treating physicians from making a profit by charging a patient a mark up on the price of the pathology service performed by an outside laboratory.
In a supplemental note on the Senate bill (PDF, 25 K), the KMA’s support of the legislation was documented, stating that “the issue is being addressed because in some other states a few physician groups have billed the patient substantially more than the amount billed to the practice by the pathologist or clinical laboratory that actually performed the tests.” It went on to explain that the KMA “concluded that being proactive through statutory action is desirable to make it clear that such practices are not appropriate.” The KMA’s conclusion is consistent with ethics guidelines of the American Medical Association.
Kansas Governor Kathleen Sebelius is expected to sign the legislation.
Twelve states have direct billing laws for certain pathology services and six have anti–markup laws.
The College is actively supporting several state pathology organizations in efforts to pass various related legislation; all news will be reported in Statline.
College Opposes United Healthcare Policy
The College sent a letter to a senior vice president at United HealthGroup March 21 stating its concerns about UnitedHealthcare’s policy that requires all participating physicians and health care professionals to refer laboratory services only to an in-network laboratory provider. The letter, signed by national medical specialty societies representing more than 220,000 physicians and providers, stated strong opposition to the policy and “any health plan policy that penalizes practicing physicians for making clinical decisions that are in the best interest of their patients.”
Under the policy, providers will be penalized if they make referrals to non–participating laboratories by imposing a financial penalty, decreasing payments to the provider, changing reward eligibility and premium designation or terminating the provider’s contract.
The College cited long–standing policy of the American Medical Association and the American Osteopathic Association that physicians are the primary advocates for their patients and should make clinical decisions based on the best interest of the individual patient. Physicians should therefore have the freedom to choose the laboratory provider that will be involved in the diagnostic and therapeutic decisions for their patients. The College concluded that physicians are legally and ethically accountable to their patients and therefore should be free of attempts by a health plan to intimidate providers to adhere to a cost–reduction measure that has not been proven and fails to take quality into account.
The College also has learned that many contracted regional and local pathology service providers are not identified as participating providers in the UnitedHealthcare network. UnitedHealthcare allows other providers and patients to search for in-network laboratories through an online tool called the Lab Locator.
The College is interested in knowing if other pathologists and laboratories that have signed contracts with UnitedHealthcare are not included in this database and ask you to report the discrepancy to dmeyer@cap.org. Please include the full name of your group and/or laboratory and the zip codes of the service areas covered by your contract with UnitedHealthcare.
College Supports House Passed Legislation to Help Reduce Breast and Cervical Cancer Rates
Earlier this week, the U.S. House of Representatives passed The National Breast and Cervical Cancer Early Detection Program Reauthorization Act of 2007, H.R. 1132. The bill has been reported out of the Senate Committee on Health, Education, Labor, and Pensions and is awaiting Senate action.
The legislation reauthorizes and improves the National Breast and Cervical Cancer Early Detection Program (NBCCEDP). The program provides breast and cervical cancer screening and diagnostic services to low–income, uninsured and underserved women in all fifty states, the District of Columbia, United States territories and 13 American Indian/Alaskan Indian tribes.
The College sent letters of support to bill sponsors Tammy Baldwin (D-WI), Marsha Blackburn (R-TN), Lois Capps (D-CA), Sue Myrick (R-NC) and Henry Waxman (D-CA).
Since its inception in 1991, the NBCCEDP has provided more than 2.9 million women with mammograms, Pap tests and other services for the early detection of breast and cervical cancer. The program has helped diagnose more than 29,000 cases of breast cancer, 94,000 precursor cervical lesions, and 1,800 cervical cancers. While these numbers are impressive, only about 15% of eligible women receive breast cancer screenings and only 7% are screened for cervical cancer.
Many deaths from breast and cervical cancers could be avoided if more underserved women can be reached. Nationally, breast cancer deaths have declined due, in part, to mammograms that catch the disease at its earliest stages. The same can be said for cervical cancer. The American Cancer Society estimates that 11,150 women will be diagnosed with cervical cancer this year. However, the incidence of cervical cancer has declined by 50% over the last 30 years due to the Pap test. Sadly, many women are still not being screened. This is especially true for low–income and minority women.
The College supports the funding increase provided in the bill, but believes that funding at even higher levels is necessary to significantly increase the number of women brought into the program and save lives.
Senate Passes War Spending Bill, AFIP Language Included
Language that would preclude the use of federal funds to reorganize or disestablish the Armed Forces Institute of Pathology (AFIP) through the remainder of 2007 was included in the U.S. Troop Readiness, Veterans’ Care, Katrina Recovery, and Iraq Accountability Appropriations Act, 2007, which passed the U.S. Senate today. The language to S.965 was offered by Senator Edward Kennedy (D-MA).
The Department of Defense recommended that the AFIP be dismantled as part of the Base Realignment and Closure Commission recommendations. The Kennedy language removes any doubt about its future through 2007 and allows for further consideration by Congress of the AFIP’s fate. The College coordinated a coalition effort of approximately 25 medical, research and patient advocacy organizations to send letters of support (PDF, 16 K) for the Kennedy amendment.
Since its inception over a century ago, the AFIP has built its reputation through excellence in pathology diagnosis and consultation, education and research.
The $123.2 billion war-spending bill must be reconciled with the U.S. House of Representatives before it is signed or vetoed by President Bush.
Don’t Delay, Apply for you NPI Today
The College would like to remind its members that they should have already applied for their National Provider Identifier (NPI), which will replace the existing Medicare legacy identifiers in use today for standard transactions.
The compliance date is May 23 and the Centers for Medicare and Medicaid Services estimates that it may take up to 120 days to implement the NPI into business practices.
The move to using NPIs is part of CMS&38217;s initiative to improve electronic transactions for healthcare and complies with a requirement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The NPI must be used by most HIPAA–covered entities.
You can apply for your NPI free–of–charge by visiting the CMS Web site.
If you already have your NPI, CMS requires that you also list your existing legacy identifier on the claim. The CMS claims–processing systems will reject claims if they do not include the legacy identifier.
Members Encouraged to Attend Advocacy School
The College is encouraging members to attend its Advocacy School April 30 through May 2 in Washington, DC. Advocacy School provides members an outstanding opportunity to receive in-depth political advocacy training, learn about the College’s key issues and the legislative process, hear from Congressional guest speakers and meet with lawmakers and their staff.
With several issues affecting the future of our practice in the balance, such as suspending the federal cytology proficiency testing program and stopping proposed cuts to Medicare physician payments, now is the time to get more involved.
Last year, the Advocacy School’s participants met with more than 70 House and Senate offices to continue the College's extensive campaigns on various legislative issues. This year will be equally as active for pathology issues in Congress and we need to make our voices heard.
If you would like to attend the CAP Advocacy School this spring, or have any further questions, please contact Susan Askew by e-mail or at 202-354-7105. The CAP covers all expenses for those who choose to attend Advocacy School.
(For Statline reprint permission, please contact Gretchen Schaefer.)
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