SGO Issues July 30, 2015
SGO comments on genetic testing coverage
FDA hosting Ovarian Cancer Endpoints Workshop
August is National Immunization Awareness Month
CMS counts down 10 facts about the ICD-10 transition
Allied Workshop registration and housing open
Reminder: Membership status update due July 31
SGO on July 24 commented on a draft Medicare Local Coverage Determination (LCD) Policy regarding BRCA1 and BRCA2 Genetic Testing and recommended that coverage for those at high risk for breast or ovarian cancer with a first-degree relative with a known mutation be included in the proposed LCD’s indications for Medicare coverage.
Regarding referral to various experts, SGO requested that the policy reflect the NCCN guidelines, which state that “oncologists, surgeons, oncology nurses and other healthcare professionals with expertise and experience in cancer genetics could also be providers of cancer risk assessment and genetic counseling, to ensure consistency with NCCN guidelines.”
SGO submitted its comments to Palmetto GBA, a Medicare Administrative Contractor (MAC) for the Centers for Medicare and Medicaid Services (CMS). This draft policy specified nationally covered indications for Medicare coverage of genetic testing. The Chair and Vice Chair of SGO’s Coding and Reimbursement Taskforce, Barbara A. Goff, MD, and Mark Shahin, MD, and taskforce member Mary Cunningham, MD, were instrumental in reviewing the indications and providing their expertise.
The Food and Drug Administration (FDA) is hosting the Ovarian Cancer Endpoints Workshop in cooperation with SGO, the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO), on Thursday Sept. 3, 2015, in Silver Spring, MD. This workshop will provide a forum for discussion of ovarian cancer, from the current state of science to novel clinical trial designs, biomarkers, statistical issues in clinical trials and how to evaluate new classes of agents such as immunotherapies.
This conference is an outgrowth of SGO’s in-depth exploration of this topic since 2013, when SGO published a white paper on ovarian cancer clinical trial endpoints, authored by Thomas J. Herzog, MD; Deborah K. Armstrong, MD; Mark F. Brady, MD; Robert L. Coleman, MD; Mark H. Einstein, MD; Bradley J. Monk, MD; Robert S. Mannel, MD; J. Tate Thigpen, MD; Sharee A. Umpierre, MD; Jeannine A. Villella, MD and Ronald D. Alvarez, MD.
That paper led to the development of a guidance document on clinical trial designs in 2014 and subsequent discussions with the FDA requesting a reassessment of endpoints. The “SGO guidance document for clinical trial designs in ovarian cancer: A changing paradigm” was written by Dr. Herzog, Dr. Alvarez, Dr. Secord, Dr. Mannel, Dr. Monk, Dr. Coleman and Barbara A. Goff, MD.
The objective of the public workshop on ovarian cancer is to provide a venue for an in-depth discussion of the current science in ovarian cancer and potential new development pathways for ovarian cancer agents. The goals are:
- To review the current state of science of ovarian cancer biology and implications for clinical trial design;
- To discuss and explore emerging measures of treatment effect, including circulating factors and both tissue and imaging biomarkers;
- To discuss endpoints reflective of the diversity of disease and patient populations and how this impacts available trial designs and context for these endpoints; and
- To explore novel treatment designs relative to discovery and regulatory approval.
“The unprecedented pace of discovery has far exceeded our capacity to evaluate potentially beneficial interventions using traditional models of trial design. This has placed a premium on patient selection, novel trial designs guided and informed by biomarkers, and the precision of outcomes assessment,” said SGO President Robert L. Coleman, MD. “This workshop brings together experts in each of these domains along with vital insight and perspective from our regulatory partners. We are so pleased to have this opportunity for open discussion and strategic planning as we continue our quest to improve the care of our patients.”
The free public workshop will be from 8 a.m. to 5 p.m. at the FDA’s White Oak Campus Great Room. Seating is limited. The workshop may also be viewed by webcast. Click here to register.
The National Public Health Information Coalition (NPHIC) has declared August to be National Immunization Awareness Month (NIAM). This annual observance highlights the value of immunization across the lifespan, and NPHIC, in collaboration with the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), has developed communication toolkits to help promote vaccinations, including those for human papillomavirus (HPV).
The toolkits include ready-to-publish articles, sample key messages, news releases, social media messages, FAQs, NIAM logos and banners and web links. Of particular interest to physicians who are promoting the HPV vaccine, the NIAM campaign will focus on immunizations for preteens and teens during the week of Aug. 2-8. An abbreviated “Ready for school” toolkit is available to help health care providers convey the importance of vaccines for children of all ages.
Health care providers are encouraged to reach out to NPHIC and CDC with questions and to share their plans and activities for NIAM. Email Brad Christensen at email@example.com or Ian Branam at firstname.lastname@example.org or visit NPHIC’s NIAM Website for more information.
On July 17, the Centers for Medicare & Medicaid Services (CMS) released a video that counts down 10 facts about the ICD-10 transition. SGO is also presenting two webinars, hosted by coding expert Brad Hart, to help members and their practices to effectively manage this change. For additional information about ICD-10, visit the CMS website.
Registration and housing is now open for the Allied Health Professionals Workshop, which will be held Dec. 5-6, 2015, at the Robert H Lurie Medical Research Center of Northwestern University in Chicago. The deadline for early bird registration is Monday, Oct. 12.
Tomorrow, July 31, is the deadline for SGO members to update their member status. Please visit the SGO website’s Membership Categories page to access the appropriate form. Dues received from July 1 to Dec. 31 are applied to the following year, although membership becomes active upon approval.