SGO Issues Dec. 3, 2015
UHC to require genetic counseling prior to BRCA testing approval
Ovarian tests included in FDA report on lab-developed tests
Nine quality indicators accepted for consideration by CMS
Professionalism Challenge grant applications due Jan. 19
Effective Jan. 1, 2016, UnitedHealthcare will require patients to receive genetic counseling from an independent genetics care provider (who is not employed by a genetic testing lab) prior to approval of authorization for BRCA testing. This requirement will only apply to UnitedHealthcare commercial members with medical necessity benefit plans.
According to UnitedHealthcare’s Frequently Asked Questions document regarding the New BRCA Genetic Counseling Requirement, “Genetic care providers employed or contracted with a laboratory who are part of an integrated health system that routinely delivers health care services beyond the laboratory testing itself are considered independent.”
The UHC document also states that genetic testing for BRCA mutations requires documentation of medical necessity by one of the following health care professionals who has evaluated the patient and intends to engage in post-test follow-up counseling:
- Board-eligible or board-certified genetics counselor
- Advanced genetics nurse
- Genetics clinical nurse
- Advanced practice nurse in genetics
- Board-eligible or board-certified clinical geneticist
- A board-certified care provider with experience in cancer genetics who has provided cancer risk assessment on a regular basis and received specialized, ongoing training in cancer genetics.
Lee-may Chen, MD, from the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center and Chair of the SGO Clinical Practice Committee, noted that the policy changes, which include documented training in genetics and taking a three-generation family history of the patient, should not significantly affect access to genetic counseling and testing for gynecologic cancer and other at-risk patients.
“Those who provide cancer risk assessment on a regular basis already have experience, assuming they also receive specialized ongoing training in cancer genetics,” she said.
“A practicing oncologist who is up to date in their knowledge and skills in medical genetics should be able to easily elicit a three-generation pedigree and document their counseling,” said Dr. Chen. “By assuring expertise, patients will be afforded better care by a more thorough understanding of the risks, benefits, implications, and unknowns in germline genetic testing.”
Dr. Chen added that SGO has a goal to provide specialized ongoing training required in the maintenance of credentials.
“Through sessions at the Annual Meeting, webinars and other modules in SGO Connect Ed, as well as presentations at the Allied Health and Early Faculty Workshops sponsored each year, the SGO has multiple formats to promote this knowledge,” she said. “As a product of the SGO Genetics Summit this past summer, SGO and additional stakeholder organizations are collaborating to develop a toolkit for providers on genetics and testing ovarian cancer patients, high risk individuals, and their family members.”
On Nov. 16, the Food and Drug Administration (FDA) released a report arguing in favor of additional government oversight of laboratory-developed tests (LDTs), based on 20 case studies—including three ovarian cancer tests—where “in the absence of compliance with FDA requirements…these products may have caused or have caused actual harm to patients.”
Of particular interest to gynecologic oncologists are the following ovarian cancer LDT tests, where the FDA believes that government oversight could potentially provide “assurance the test meets minimum performance standards” and “evaluation of manufacturer claims,” among other benefits.
For the PreOvar KRAS-Variant Ovarian Cancer Screening Test, the FDA cited a “Clinical Consequence” that “women with false-positive tests may undergo unnecessary surgery to remove healthy ovaries; women with ovarian cancer may receive other inappropriate treatments.”
The FDA noted that in September 2010 SGO “released a statement that the test was developed and marketed to the public with insufficient clinical validation. Concerned that the initial study was too small to generate a definitive assessment of ovarian cancer risk, researchers from the Ovarian Cancer Association Consortium performed an independent evaluation of over 21,000 subjects, finding no evidence of an association between the KRAS-variant and ovarian cancer.”
Additionally, the FDA warned of a Clinical Consequence that “women with false-positive tests may undergo unnecessary surgery to remove healthy ovaries” for both the OvaCheck Ovarian Cancer Screening and Detection Test and OvaSure™ Ovarian Cancer Screening Test.
In July 2008, SGO issued a formal statement that additional clinical validation of the OvaSure’s effectiveness was needed before it should be offered outside a research study. FDA notified the manufacturer in August 2008 that it considered OvaSure to be a “high-risk test that has not received adequate clinical validation, and may harm the public health.” By October 2008, OvaSure was pulled from the market.
William M. Burke, MD, gynecologic oncologist from Columbia University Medical Center and Vice Chair SGO Clinical Practice Committee, noted that FDA report, “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies,” indicates that the agency is “stepping up to the plate” by enforcing existing regulations and reflecting concerns that SGO raised several years ago.
“The FDA’s renewed interest in greater regulation of laboratory-developed tests were set forth in 1976 as part of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, which seeks to improve the safety, efficacy, and clinical validity of LDTs and thereby limiting potential patient harm,” said Dr. Burke. “This endeavor by the FDA is in alignment with SGO’s mission to serve our patients’ best interest.”
Dr. Burke added that such oversight has become increasingly important with the rise of direct-to-consumer marketing by health care companies, especially if those products lack clinical validation.
“The FDA’s focus on stricter regulation of LDTs should help limit the number of tests that may cause unnecessary harm to women with gynecologic cancers,” he said. “In the future, collaboration between the FDA, medical societies, and private companies will be paramount in order to provide patients with potentially lifesaving technology while reducing the risks that come with any medical intervention.”
The Centers for Medicare and Medicare Services Program (CMS) has selected for consideration nine of the 15 quality measures for ovarian, endometrial and cervical cancers submitted by SGO’s Policy, Quality and Outcomes Taskforce on June 1. These quality measures were submitted for possible inclusion in the Physician Quality Reporting System (PQRS) for 2017, which will be the first reporting year for the Merit Incentive Payment System (MIPS).
The Measure Applications Partnership (MAP), which is convened by the National Quality Forum, will review SGO’s nine measures in addition to more than 100 measures under consideration by convening stakeholders in an intensive annual review. Should SGO’s measures be accepted, they will be published in the CY 2017 Proposed Medicare Physician Fee Schedule Rule and will again be open for comment. The acceptance and implementation of quality measures for use by SGO members will drive improvement in patient outcomes, inform patients and influence payment.
Physicians working to advance medical professionalism in their practice may apply for a $25,000 grant from the ABIM Foundation and Council of Medical Specialty Societies (CMSS).The Professionalism Challenge grant program will fund up to four projects over a two-year period. Projects will be led by practicing physicians who propose a solution to an obstacle that is keeping them from fulfilling the principles and professional commitments defined in Medical Professionalism in the New Millennium: A Physician Charter. Application deadline is Jan. 19, 2016. Recipients will be announced in March 2016.