CHOP Government Affairs, Community Relations and Advocacy staff advocates on the federal governmental level on behalf of our patients, clinicians, the Hospital and our network of specialty and primary care locations. Important federal issues and programs we lobby for include, but are not limited to:
We also actively participate in the legislative and regulatory process on specific issues that are very important for our patients including drug shortages, traumatic brain injury research and funding and regulations around the National Institutes of Health and electronic health records.
Our team assists CHOP clinicians and Hospital staff with preparing written testimony for presentation before United State Senate and House Committees on issues relevant to our patients, and with providing comments on federal regulations. This involvement helps CHOP influence government on behalf of children's health at both the legislative and regulatory levels.
Please visit Medicaid 101 for more inforamtion.
In December 2011, Dr. John M. Maris, Chief of the Division of Oncology, Director of the CHOP Research Institute’s Center for Childhood Cancer Research, testified before the United States Senate Committee on Health, Education, Labor and Pensions in a full committee hearing entitled “Prescription Drug Shortages: Examining a Public Health Concern and Potential Solutions.” Dr. Maris provided insight on CHOP’s experience with drug shortages as well as the impact of shortages and drug substitutions on patient care. The government affairs team assisted Dr. Maris with preparing his written and oral testimony.
As a follow-up to Dr. Maris’ testimony in December 2011 on the prescription drug shortage crisis; on April 6, 2012, Dr. Maris submitted comments to the United States Senate Committee on Health, Education, Labor and Pensions on their draft bipartisan legislation. Among other requirements, the legislation would require manufacturers to provide more notice to providers of an impending shortage, it would allow the FDA to expedite the review process for a drug on shortage, and would require an FDA review of regulations, guidance and policies and an annual report to Congress on drug shortages. Despite the national focus on the drug shortage crisis in the last year, CHOP has unfortunately not seen a decrease in the number of drugs on short supply. The government affairs team assisted Dr. Maris with preparing his comments.
On Monday, July 9, 2012, President Obama signed into law S. 3187, The Food and Drug Administration Safety and Innovation Act (FDA-SIA), legislation to reauthorize industry user fees that fund FDA drug and device reviews. The legislation was approved by the House and Senate with overwhelming bipartisan majorities. The FDA-SIA takes significant steps toward alleviating the record-number of drug shortages threatening patient care and skyrocketing drug costs in recent years. In addition to instituting an early-warning notice system to give providers six months of advance notice ahead of shortages, the law creates an FDA Task Force charged with creating a strategic plan to enhance FDA’s ability to prevent and mitigate shortages, allows expedited review of applications and expedited plant inspections that may mitigate a shortage. It also requires the FDA to maintain a publicly available, up-to-date list of drugs in shortage, including the cause and estimated duration of the shortage.
In March 2012, Dr. Flaura Koplin Winston, Founder and Scientific Director of CHOP’s Center for Injury Research and Prevention, testified before the United States House Energy and Commerce Subcommittee on Health in a hearing entitled “A Review of Efforts to Prevent and Treat Traumatic Brain Injury.” Dr. Winston emphasized prevention, the need for timely and proficient acute care within the hours or days post-injury and the importance of recovery and reintegration into society. She also emphasized the need for more funding for injury prevention research as well as for the education of future scientists and investigators. The government affairs team assisted with the preparation of Dr. Winston’s testimony.
May 7, 2012: CHOP submitted comments to CMS on EHR incentive program: Stage 2
On May 7, 2012, CHOP’s Dr. Michael Apkon (Senior Vice President, Medical Affairs and Chief Medical Officer) submitted comments to the Centers for Medicare and Medicaid Services (CMS) on Stage 2 regulations for the Electronic Health Record (EHR) Incentive Program or “meaningful use.” This program will “provide incentive payments to eligible professionals, eligible hospitals and critical access hospitals (CAHs) as they adopt, implement, upgrade or demonstrate meaningful use of certified EHR technology.” The program has the potential to increase the quality of patient care, gain better efficiency and collect better data; however, thus far it has shown a strong adult focus, lacking an adequate amount of pediatric measures.
Under the proposed rule, children’s hospitals will struggle to meet the number of required measures because there are still not enough that apply to our pediatric patient population. Many of the objectives will require our Hospital, pediatricians and specialists to collect and analyze data for our small number of patients over the age of 18, requiring much time and work without an increase in quality. Working closely with Dr. Apkon, CHOP IT staff, and many of our clinicians, the Government Affairs staff helped submit comments to CMS.
Please refer to the Children's Hospital Association (CHA) and the American Association of Medical Colleges (AAMC) websites for more information on issues facing children's hospitals.