As I have written many times in this blog, expanding access to genetic counselors is a top initiative of the NSGC. Many of you realize that there are multiple potential barriers to patients who may benefit from talking with a genetic counselor. We have several initiatives pending to improve coverage of genetic counselors’ services (including the initiative I wrote about July 23, 2010), but we also have a task force dedicated to identifying different ways patients can access genetic counselors. The NSGC “Service Delivery Model Task Force”, led by NSGC member Stephanie Cohen, is attempting to identify existing methods genetic counselors use to communicate with patients, such as face-to-face or telephone counseling.
Although the most common models counselors use to communicate with patients are probably face-to-face and telephone-based genetic counseling, there are other models that exist including videoconferencing, internet-based, and face-to-face group counseling. There may even be some novel methods that most genetic counselors don’t realize are available or effective.
Many genetic counselors prefer to provide face-to-face genetic counseling for a variety of reasons including better communication of complex concepts and ease of psychosocial assessment. However, any genetic counselor who has practiced for a significant amount of time knows that there are always some patients who can’t take advantage of face-to-face genetic counseling. Sometimes patients live in a rural area without a genetics service within reasonable driving distance. Other times, a patient’s work schedule does not allow him or her enough time for an in-person appointment during work hours. Some patients may just simply not understand how a session with a genetic counselor will help them but would be open to an exchange over the phone or email to learn about how they might benefit. All of these are reasons why genetic counselors should consider other methods for delivering their services.
We also need to evaluate delivery models from different points of view. It is obviously important that patients be able to reach genetic counselors through a proposed delivery model, but we also have to think about efficiency. How long do patients have to wait for a particular method of delivery? What factors contribute to that wait time? How are different delivery models reimbursed? These are all critical questions to determine whether a delivery model will truly increase access.
In addition to how genetic counselors communicate to patients, there are also different modes through which patients are referred. Most of us think of the individual physician referring the patient to a local genetic counselor, but some physicians work with genetic counselors in laboratories or at a genetics center to help them triage patients to determine which patients need to meet personally with a genetic counselor. Both referral models and counseling delivery models are important to understand if we want to find efficiently collaborate with other health care providers.
The Service Delivery Model Task Force needs your help! Please take 10 minutes to complete a survey: http://www.zoomerang.com/Survey/WEB22AYQ94SBFE. The survey includes questions that address all of the points above, and the Task Force can’t start its work without input from NSGC members in the trenches. Please help us move forward on this important initiative.
Tuesday, August 24, 2010
Tuesday, August 3, 2010
FDA Oversight of Genetic Testing
Many NSGC members are aware of the public meeting the FDA held on July 19-20 to gain input from stakeholders about oversight of laboratory-developed tests (LDTs). I was proud to represent the NSGC and excited to hear the many positive references made to the role of genetic counselors. I want to share some highlights from the meeting.
The meeting opened with an overview by FDA officials of the history of oversight of LDTs, which they defined as tests designed, manufactured, and utilized by a single lab. (Some of you may recognize the term “home brew”, which has clearly fallen out of favor!) Obviously, there are many types of tests in the LDT category, but genetic tests are one type. The FDA has practiced “enforcement discretion” over LDTs historically because most LDTs were performed by hospital-based labs with small test volumes and close communication between the lab pathologist, clinician, and patients. Over the last two decades, the environment has changed. The volume of LDTs has increased dramatically, and LDTs are offered and marketed by large-scale commercial labs with less communication with the ordering clinician and the patient. There is also an increase in use of accompanying complex software and multiplex testing and more emphasis on predicting disease rather than diagnosing disease based on symptoms. Therefore, the FDA representatives stated that CLIA oversight of laboratories is no longer sufficient to protect the public, and the FDA has decided to invoke its oversight authority over LDTs.
However, the FDA speakers were careful to state that they have made no final decision in regards to how LDTs will be regulated, and they held the public meeting to seek input from a broad range of stakeholders.
Outside of clinical laboratory professional organizations, the NSGC was one of only two professional associations to present. I presented the NSGC perspective based on the discussions that the Public Policy Committee has had on regulation of genetic testing. While some increased regulation is likely needed to address the expansion of genetic testing into tests for common disease and pharmacogenetics, it will be important for the regulations to maintain access to genetic testing for rare disease or genetic variants affecting small populations. In addition, regulating testing alone will not address the risk of misapplication or misinterpretation of genetic testing results by individuals without specialized training in genetics and counseling.
Many of the stakeholders referenced the value genetic counselors bring to patients and doctors. Two consumer advocacy groups mentioned the value of genetic counselors, and an expert panel on the topic of “Patient and Clinical Implications” discussed that many healthcare providers don’t have sufficient training to interpret many of the new LDTs. The spokesperson for the Ovarian Cancer National Alliance served on the panel and specifically stated that her organization tells patients that they should talk with a genetic counselor prior to genetic testing.
Overall, the meeting was an important one for genetic counselors. The outcome of the FDA’s actions will have significant impact on the practice of genetic counseling. In addition, the NSGC’s presence at the meeting as one of the only professional associations in attendance demonstrated genetic counselors’ commitment to protecting patients and the high standards of the profession.
For more feedback on the meeting, you can review NSGC tweets on Twitter by following NSGC_org. Also, the Public Policy Committee has posted a blog on the House of Representative’s Energy and Commerce Committee hearing on DTC genetic testing and can be found at http://nsgcpublicpolicy.blogspot.com/.
The meeting opened with an overview by FDA officials of the history of oversight of LDTs, which they defined as tests designed, manufactured, and utilized by a single lab. (Some of you may recognize the term “home brew”, which has clearly fallen out of favor!) Obviously, there are many types of tests in the LDT category, but genetic tests are one type. The FDA has practiced “enforcement discretion” over LDTs historically because most LDTs were performed by hospital-based labs with small test volumes and close communication between the lab pathologist, clinician, and patients. Over the last two decades, the environment has changed. The volume of LDTs has increased dramatically, and LDTs are offered and marketed by large-scale commercial labs with less communication with the ordering clinician and the patient. There is also an increase in use of accompanying complex software and multiplex testing and more emphasis on predicting disease rather than diagnosing disease based on symptoms. Therefore, the FDA representatives stated that CLIA oversight of laboratories is no longer sufficient to protect the public, and the FDA has decided to invoke its oversight authority over LDTs.
However, the FDA speakers were careful to state that they have made no final decision in regards to how LDTs will be regulated, and they held the public meeting to seek input from a broad range of stakeholders.
Outside of clinical laboratory professional organizations, the NSGC was one of only two professional associations to present. I presented the NSGC perspective based on the discussions that the Public Policy Committee has had on regulation of genetic testing. While some increased regulation is likely needed to address the expansion of genetic testing into tests for common disease and pharmacogenetics, it will be important for the regulations to maintain access to genetic testing for rare disease or genetic variants affecting small populations. In addition, regulating testing alone will not address the risk of misapplication or misinterpretation of genetic testing results by individuals without specialized training in genetics and counseling.
Many of the stakeholders referenced the value genetic counselors bring to patients and doctors. Two consumer advocacy groups mentioned the value of genetic counselors, and an expert panel on the topic of “Patient and Clinical Implications” discussed that many healthcare providers don’t have sufficient training to interpret many of the new LDTs. The spokesperson for the Ovarian Cancer National Alliance served on the panel and specifically stated that her organization tells patients that they should talk with a genetic counselor prior to genetic testing.
Overall, the meeting was an important one for genetic counselors. The outcome of the FDA’s actions will have significant impact on the practice of genetic counseling. In addition, the NSGC’s presence at the meeting as one of the only professional associations in attendance demonstrated genetic counselors’ commitment to protecting patients and the high standards of the profession.
For more feedback on the meeting, you can review NSGC tweets on Twitter by following NSGC_org. Also, the Public Policy Committee has posted a blog on the House of Representative’s Energy and Commerce Committee hearing on DTC genetic testing and can be found at http://nsgcpublicpolicy.blogspot.com/.
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