Read the Latest Issue of STATLINE
January 19, 2016
CAP-Model ACO Advisory Board Bill in New Jersey Vetoed by Governor
New Jersey Governor Chris Christie on January 19 vetoed legislation that would have required accountable care organizations (ACOs) in the state to establish Clinical Laboratory Advisory Boards.
With the support of patient and physician advocacy groups, the legislation supported by the CAP and New Jersey Society of Pathologists (NJSP) had passed the NJ Senate by a unanimous vote of 38-0 on January 11. Last year, the bill passed the state Assembly by a 72-0 vote on May 14.
The bill would have required ACOs to establish clinical laboratory testing advisory boards with the participation of a pathologist medical director. The boards are designed to help the ACO identify and eliminate unnecessary testing while making sure that patients enrolled in the ACO receive all medically necessary pathology and laboratory tests. Similar laws requiring advisory boards have been adopted in Massachusetts and Illinois.
The CAP and NJSP had urged Governor Christie to sign the bill.
"The very purpose of ACOs is coordination of patient care across a spectrum of medical specialties, thus a state mandated physician advisory process to develop any guidelines or protocols for clinical laboratory/pathology services promotes the ACOs' objectives," CAP President Richard C. Friedberg, MD, PhD, FCAP, wrote in a January 13 letter to Governor Christie. "Patients benefit because the mandated advisory board will help to ensure ACOs do not improperly reduce or limit pathology services, including complex genomic testing, when medically necessary for optimal patient care."
"The NJSP believes that every ACO will need to utilize clinical laboratory tests to achieve their goal of controlling health care costs and improving patient outcomes," Brian Erler, MD, PhD, FCAP stated in a January 13 letterto Gov. Christie. "It is estimated that 70% of all health care decision making stems from laboratory tests. Laboratory tests are critical to the diagnosis, treatment and prevention of diseases, and are needed to monitor and measure diagnostic expediency, treatment efficacy and patient population health status within an ACO."
The Medical Society of New Jersey, the Association of Pathology Chairs, and the Association for Molecular Pathology have endorsed the legislation. National patient advocacy groups endorsing the CAP-model legislation include The Leukemia and Lymphoma Society, The National Brain Tumor Society, The Lung Cancer Alliance, and The American Society of Breast Disease.
Cast Your AMA Medical Specialty Society Vote for the CAP
As an American Medical Association (AMA) member, you can strengthen the voice of pathology in the AMA by voting for the College of American Pathologists (Specialty society code number 828) as your specialty representative on policy issues in the AMA House of Delegates.
Why is this critical? Pathology is a small specialty, but we have many issues. The AMA has a great deal of influence with government, regulators, and with public and private payers. We need help on coverage issues, fraud and abuse, graduate medical education, medical liability, and anti-trust issues.
In 1996, the AMA established proportional representation for specialty societies in its policy making body, the House of Delegates. To determine this proportional representation, the AMA and the Pathology Section Council are asking you to tell the AMA which specialty society best represents your interests in the AMA House of Delegates.
Your vote is vitally important. AMA policy is debated and set at the House of Delegates. Pathology needs to be well represented. Designating your specialty society representative in no way effects your state’s representation in the AMA’that continues to be based on your state's total number of AMA members.
Please take a moment to vote. The easiest way to vote is visiting ama-assn.org/go/ballot. To make pathology's voice even stronger, please vote today. Make your AMA membership count.
Register Today for the 2016 CAP Policy Meeting
Registration is now open for you to join your colleagues at the 2016 CAP Policy Meeting May 2-4 in Washington, DC. The annual event is the pathology specialty's opportunity to focus on the federal issues most important to pathologists now and in the future.
The 2016 Policy Meeting will feature guest speakers from Washington and pathology leaders from across the country. On May 4, pathologists will visit with their elected officials during the CAP's annual Hill Day. Meeting with your representative or senator is your chance to discuss the issues affecting pathology and the patients you care for every day.
CAP Engages with FDA on Standards for NGS
The CAP remains engaged with the Food and Drug Administration (FDA) as the agency develops standards for evaluating the performance of next-generation sequencing (NGS) and the use of databases for establishing clinical relevance of human genetic variants.
On December 24, 2015, the CAP responded to specific questions posed by FDA in two discussion papers. Previously, in November 2015, the CAP testified at two public workshops discussing the papers. The CAP offered comments on the FDA's development of performance standards for evaluating NGS tests and use of curated databases containing information about human genetic variation as part of the agency's oversight of NGS-based in vitro diagnostic tests.
In the CAP letter regarding standards for NGS tests, the CAP provided detail of its accreditation and proficiency testing (PT) programs. The PT program allows laboratories to evaluate their performance regularly and improve the accuracy of the patient results they provide. In 2015, the CAP offered PT for NGS where laboratories have the ability to test up to 200 variants in a method-based challenge using gene panels, exome, and/or genome sequencing. The CAP plans to follow the initial NGS PT program for germline variants with NGS PT for the detection of somatic variants and other NGS clinical testing applications.
"The CAP's accreditation and proficiency testing programs address assessment of analytical performance, and the CAP has developed a specific checklist to address Next Generation Sequencing technologies," the CAP said. "The FDA should not require a parallel approval process, and we encourage the FDA to consider the existing quality control mechanisms in place."
In the CAP letter regarding use of databases for establishing the clinical relevance of human genetic variants, the CAP stated its Personalized Healthcare Committee recently published organizing principles for the databases in the article Standards for Clinical Grade Genomic Databases. The article, published in the November 2015 edition of Archives of Pathology & Laboratory Medicine, states the principles should serve as a foundation for future development of specific standards that support use of such databases for patient care.