By Jean Amos Wilson, PhD Chair, Professional Relations Committee e-mail: jamoswilson@bhlinc.com

“The Hill” visits have begun!

The first AMP contingent - Andrea Ferreira-Gonzalez, Jennifer Lieb, Mark Sobel and Mary Williams - met on March 11 with five Senate offices – Enzi (R WY), Kennedy (D MA), Harkin (D IA), Burr (R NC), and Mikulski (D MD)- that are actively engaged in policy that directly impacts molecular pathology.  The goal of the day was to develop relationships to position AMP as a credible resource.  The Congressional staff was eager for input from AMP on health reform, oversight and reimbursement of genetic tests, and direct-to-consumer (DTC) genetic testing. The staff seemed particularly interested in DNA patents, as they were not aware that the human genome was being patented.  Last, AMP learned that Senator Kennedy plans to reintroduce his Laboratory Tests Improvement Act and Senator Burr is searching for a co-sponsor to also reintroduce the Genomics & Personalized Medicine Act (GPMA).  In the meeting with Senator Mikulski’s office, AMP raised the issue of co-sponsoring the GPMA with Senator Burr, and the staff seemed interested in this possibility.  The day could not have gone any better and was a very successful launch of AMP’s presence in the Halls of Congress. 

The visits proved to be even more valuable and timely than we could have possibly anticipated, since Senator Enzi’s staff had immediate needs for guidance from AMP on comparative effectiveness research.  Specifically, Senator Enzi’s office requested information on policies that will drive personalized medicine for inclusion in their comparative effectiveness research legislation.  With the help of HEALTHfutures, our government relations consultants, AMP provided an initial response within 48 hours and will provide additional information to respond to this request within the month.  In our initial response, we stated that AMP believes that existing infrastructure and agencies, such as the Agency for Heathcare Research and Quality, should be responsible for comparative effectiveness research (CER) and that we are concerned that the creation of a new institute would tax funds that could be spent directly on the CER itself.  Instead, we believe that agencies and offices already in existence can facilitate CER.  We also stated our hope that any CER proposal will include research to explore the value, beyond mere cost, of diagnostic tests to a patient, provider, payer and the larger health care system. 

CER is gathering more attention in Congress and among other policy makers who see it as a method to examine the comparative effectiveness of treatments, including how they relate to coverage and reimbursement decisions.  We responded to a request from the Institute of Medicine for recommendations regarding priorities for spending on CER and identified the following areas:  Clinical outcomes research, proficiency testing, test interpretation and reporting, valuation and reimbursement, and comparative methodology research.  We invite you to read this correspondence as well as all AMP letters and position statements on our website at http://www.amp.org/Gov/Positions.htm.

In the coming weeks, the Professional Relations Committee (PRC) will comment to the SACGHS on their draft report  “Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests” (available at http://oba.od.nih.gov/SACGHS/sacghs_public_comments.html).  We will also draft a statement that summarizes our position on the role of laboratory and personalized medicine in Healthcare Reform.  Following this, we will follow new legislation and provide AMP perspective in helping to guide these bills in a practical world that considers the paradoxical goals of cost containment and increased coverage.  We will continue to work with other societies and professional groups to find areas of common ground, so as to increase the volume of our combined voices.

In the meanwhile, the PRC has been incredibly busy, making plans to develop position statements on oversight, establishment and propagation of local coverage determinations, evidence standards, genetic intellectual property and personalized medicine.  We thank Jan Nowak and Roger Klein for authoring comment to MEDCAC on genetic testing (February meeting) and genetic screening (May meeting).  Roger is also leading an ad hoc group consisting of members of Professional Relations Committee, Clinical Practice Committee and Economic Affairs Committee that will provide a response to the Genentech Citizen Petition on laboratory developed tests.