One of the proposals reviewed this year is the CDC draft for the National Public Action Plan for the Detection, Prevention and Management of Infertility which was open to public comment through June 2012. The goal of the draft was to develop an action plan for infertility treatment within the United States. After review, the LegCom expressed the general opinion that the document lacked the requisite specificity to determine the merits or drawbacks of such a plan. Numerous questions regarding the implementation, data gathering and funding lacked enough detail to render support at this time. The LegCom opinion was forwarded to the CRB President for consideration.
As part of the Patient Protection and Affordable Care Act (ACA), we realized the passage of an excise tax on medical devices that would affect the costs associated with a multitude of devices used within an ART Program. This cost would surely be passed on to the end users and ultimately the patient. Fortunately and hopefully, attempts are being made to rescind this 2.3% tax.
Naturally, several Personhood initiatives and legislative bills were introduced in 2012, including one perennial bill at the Federal level. The LegCom continues to track these efforts and make ourselves available as a resource when necessary. For the 2012 Personhood campaign, the LegCom worked to inform through the CRB newsletter. We conducted an informational campaign by drafting and submitting an e-mail blast containing a form letter to congressional members expressing our opposition to Personhood legislation. More recent has been the drafting of a position statement on Personhood that is currently under review.
The news so far this past year hasn’t been all doom and gloom, though. There has been pro-fertility care legislation making its way through Congress that would provide help with the ever increasing costs associated with infertility treatment. The Family Act provides tax incentives specifically directed towards infertility costs, while The Women Veterans and Other Healthcare Improvements Act would provide additional help from the Department of Veterans Affairs for fertility treatment of severely wounded veterans and their spouses.
Our agenda this year also includes several projects, including a review of existing laws prohibiting or restricting the use of semen and sperm between serodiscordant couples who are otherwise sexually intimate partners.
As some of you may have noticed, the LegCom has acquired the oversight of regulatory issues previously performed by the Regulatory Task Force (RTF). Thus, we continue to monitor the progress of FDA oversight on Laboratory Developed Testing, and of course are keeping an eye on the ever-changing landscape of State and Federal CLIA requirements as they pertain to certification and laboratory management.
The LegCom continues to grow, not only in scope, but in personnel as well. The members of the LegCom would like to welcome its newest member, Dr. Marlane Angle. Dr. Angle will be a valuable resource to the committee considering her expertise in the field and familiarity with industry. We look forward to utilizing all her talents.
We continue to develop open lines of communication with other organizations such as RESOLVE and ASRM in order to bolster the efficient exchange of information. We want to foster the same with you. Please feel free to contact the LegCom through the CRB at CRB-AAB@AAB.org and to the attention of the LegCom, or feel free to contact the Chair directly at Stanley.Harris@nmhs.org. On behalf of David Battaglia, Marlane Angle, Dara Berger, and Barbara Timm, I would like to thank the CRB, and the Executive Board, for guidance and support.Stanley Harris, ELD/TS(ABB)
Chair, CRB LegCom