Legislative and Regulatory Updates
Take Action – Pediatric Subspecialty Loan Repayment Funding
In February, NASPGHAN joined the pediatric community in sending a letter [link to OMB letter] to the Office of Management in Budget asking that President Obama include funding for the Pediatric Subspecialty Loan Repayment Program in his fiscal year 2014 budget. The program was established under the Affordable Care Act, but, to date, the program has not received funding from Congress. The President is expected to release his budget in April. House and Senate lawmakers are currently in the process of making their funding requests to appropriators for the next fiscal year. Please take a moment to email your members of Congress before April 12 and ask them to request funding for the Pediatric Subspecialty Loan Repayment Program.
NASPGHAN President Speaks at Global Product Safety Summit
On February 27, NASPGHAN President Athos Bousvaros, MD, presented on pediatric ingestion hazards, with a focus on high-powered magnet ingestions, during a session at the International Consumer Product Health and Safety Organization annual meeting in Washington, DC. He was joined on a panel by Jonathan Midgett, Coordinator of the Children's Hazards Team at the U.S. Consumer Product Safety Commission, as well as by two panelists who focused their remarks on the hazards of button cell batteries. The session, which provided good visibility for NASPGHAN, was attended by approximately 200 individuals representing manufacturers, retailers, attorneys and advocacy groups.
NASPGHAN Comments on Nutrition Product Shortages
As mandated by a 2012 law, the Food and Drug Administration (FDA) must develop and implement a strategic plan for enhancing the Agency’s response to preventing and mitigating drug shortages. In March, NASPGHAN responded to a request for comment from the newly formed FDA Drug Shortages Task Force on issues related to the development of the strategic plan. Specifically, NASPGHAN used the request for comment as an opportunity to highlight its concerns with the ongoing national shortage of parental nutrition products and certain trace minerals and vitamins. The letter [link to ltr] suggested that the FDA partner with professional societies, like NASPGHAN, by providing them early information regarding impending or actual shortages and by facilitating changes to treatment paradigms to help manage scarce resources.
Health Community Asks for More Funding
NASPGHAN joined hundreds of public health groups in March with a request [link to letter] to House and Senate Budget leaders for a strong funding allocation for health agencies and programs in the fiscal year 2014 budget resolution. Both the House and Senate have passed their respective budget resolutions, which do not carry the force of law but will serve as a blueprint for fiscal policy decision making. The House and Senate budget resolutions differ significantly and foreshadow the legislative battles that lie ahead this year. In particular, the House resolution lowers the funding cap in fiscal year 2014 for domestic discretionary spending beyond what is required by the Budget Control Act, which is likely to have a negative impact on funding for public health programs administered through the Department of Health and Human Services.
House Passes CHGME Legislation
On Feb. 4, 2013, the U.S. House of Representatives passed by a vote of 352-50 legislation (H.R. 297) that would reauthorize the Children’s Hospital Graduate Medical Education (CHGME) program at its current annual funding level of $330 million through 2017. First authorized in 1999, the program supports 56 U.S. hospitals and trains more than 5,000 medical students each year. The bill has been sent to the Senate for consideration.
Congress Completes Work on FY2013 Spending
Nearly six months into the fiscal year, Congress passed and the President signed into law a bill (H.R. 933) that provides funding for the federal government for the remainder of the 2013 fiscal year, which ends September 30. The bill includes a continuing resolution for the Department of Labor, Health and Human Services and Education, which essentially funds those departments and their programs at fiscal year 2012 levels and to which the across-the-board sequestration, or cuts, will occur. The bill provides a $71 million increase to the National Institutes of Health (NIH), which falls far from filling the $1.5 billion hole created in the NIH’s fiscal year 2013 budget due to sequestration.
H.R. 933 also provides funding for the Department of Defense (DoD), including $50 million for the Peer-Reviewed Medical Research Program (PRMRP). The PRMRP funds research with direct relevance to military health and is limited to medical areas specified by Congress, which includes inflammatory bowel disease. It is unclear at this time to what extent the DoD medical research programs will be impacted by sequestration.
More than 3,000 Groups Ask Congress to Stop Sequestration
NASPGHAN was one of more than 3,000 organizations that sent a letter to Congress in February asking that non-defense discretionary programs be protected from harmful cuts for deficit reduction. The organizations instead called on Congress to pursue a balanced approach to deficit reduction. Because Congress could not reach a deal earlier this year on avoiding across-the-board cuts, or sequestration, as called for under a 2011 law, President Obama was forced to issue on March 1 an executive order putting sequestration into effect. Sequestration will trim $85 billion from fiscal year 2013 spending. While sequestration will harm many public health programs, it does not impact Medicaid.
Final Sunshine Regulations Published
On February 1, the Centers for Medicare and Medicaid Services (CMS) released final regulations implementing the Physician Payments Sunshine Act (Sunshine Act). The new “National Physician Payment Transparency Program: Open Payments” is aimed at increasing public awareness of financial relationships between drug and device manufacturers and certain health care providers. Beginning Aug. 1, 2013, manufacturers of drugs, medical devices and biologicals, for which payment is available under Medicare, Medicaid and SCHIP, must begin tracking and then report to CMS certain payments and items of value paid or given to physicians and teaching hospitals. The first reporting period is Aug. 1 - Dec. 31, 2013. CMS will release reported information to the public through a searchable website in September 2014. Beginning January 2014, physicians can register with CMS, which will allow them to review their reported information for any inaccuracies before it becomes public. It is expected that the 45-day review period for 2013 reported information will begin in mid-April 2014. A summary of the final rule is available.
NASPGHAN Comments on Proposed Magnet Safety Standards
On November 18, NASPGHAN submitted comments to the Consumer Product Safety Commission (CPSC) in support of its proposed safety standards for high-powered magnet sets. The letter detailed the results of the NASPGHAN magnet survey led by NASPGHAN member R. Adam Noel, M.D., as well as the results of study, conducted by Mazen Abbas, D.O., M.P.H., and Cade Nylund, M.D., which analyzed the National Electronic Surveillance System database and found a rise in magnet ingestions from 2009-2011.
In the proposed rule, the CPSC defines magnet sets as any aggregation of separable, permanent magnetic objects that are marketed primarily as a manipulative or construction desk toy for general entertainment, such as sculpture or stress relief. If a magnet set contains a magnet that fits within the small parts cylinder that CPSC uses for testing toys, magnets from that set would be required to have a flux index of 50 or less or would otherwise be banned. NASPGHAN issued its support for CPCS’s proposed definition of a magnet set, but also recommended, at a minimum, that individual magnets that are sold to be used in conjunction with a magnet set should be required to meet the proposed safety standard. NASPGHAN also suggested that CPSC explore the feasibility of applying the proposed safety standard to all individual magnets or to consider other restrictions on the sale of individual magnets.
CPSC must now consider the public comments it received on its proposed safety standard before issuing a final regulation. When those regulations will be issued is unknown. In its letter, NASPGHAN encouraged the CPSC to act swiftly to finalize its proposed safety standard. NASPGHAN thanks those pediatric gastroenterologists who submitted comments to the CPSC in support of the proposed rule.
In related news, on December 19, the CPSC filed a lawsuit against another high-powered magnet manufacturer, Star Networks, USA. The company originally agreed to cease sales of its high-powered magnet sets, but resumed sales in November. The CPSC has similar lawsuits pending against Maxfield & Oberton, the importer of Buckyballs, and Zen Magnets.
Press Events on Magnet Ingestions Put NASPGHAN in the Spotlight
NASPGHAN gained national media attention this fall when it released the results of its member survey on magnet ingestions at a press conference held on October 23 in conjunction with the American Academy of Pediatric’s National Conference & Exhibition in New Orleans. NASPGHAN members, R. Adam Noel, M.D., Associate Professor of Pediatrics at Louisiana State University School of Medicine, and Mark Gilger, M.D., Professor of Pediatrics; Baylor College of Medicine & Texas Children’s Hospital, briefed reporters on the survey results and why high-power magnets pose significant danger to children. Dr. Noel and Dr. Gilger were accompanied at the press conference by Braylon Jordon and his parents. Braylon Jordon suffered severe intestinal injury as a result of a high-powered magnet ingestion earlier this year and may require a bowel transplant. The press conference and survey results were covered by major media outlets, including CNN and Consumer Reports.
A month later on November 20, NASPGHAN participated in a press conference hosted by U.S. PIRG (Public Interest Research Group) to release its 2012 Trouble in Toyland report, which identified high-powered magnets among the most dangerous toys available for sale. NASPGHAN was represented at the Washington, D.C. press conference by Bryan Rudolph, M.D., a pediatric gastroenterology fellow at Children's Hospital at Montefiore, Albert Einstein College of Medicine. Dr. Rudolph was joined at the press conference by U.S. Consumer Product Safety Commission Commissioner Robert Adler. The event received widespread media coverage, including coverage by major television networks and the Associated Press.
NASPGHAN Nominates Pediatric GI to Serve on Federal Dietary Committee
NASPGHAN has nominated Praveen S. Goday, M.B.B.S., to serve on the 2015 Dietary Guidelines Advisory Committee (DGAC). The U.S. Department of Health and Human Services and Department of Agriculture are required to publish the Dietary Guidelines for Americans at least every five years. The last time the Guidelines were published was 2010. The Guidelines form the basis for federal food and nutrition policy and education activities. Dr. Goday, associate professor of the Pediatrics Division of Pediatric Gastroenterology and Nutrition at the Medical College of Wisconsin, is vice chair of NASPGHAN’s Nutrition Committee. Good luck to Dr. Goday!
Federal Medicaid Parity Regulations Finalized but Implementation at Risk
On November 6, the Centers for Medicare and Medicaid Services (CMS) issued a final rule implementing a section in the Affordable Care Act that requires Medicaid rates in 2013 and 2014 must not be less than the Medicare rates for those years, or, if greater, the Medicare rates that would be applicable in those years using the 2009 conversion factor. Effective Jan. 1, 2013, the higher rates will be applied to primary care services furnished by a physician with a specialty designation of family medicine, general internal medicine, or pediatric medicine. The final rule also provides for higher payment for subspecialists related to those specialty categories as recognized by the American Board of Medical Specialties, American Osteopathic Association, and the American Board of Physician Specialties. For example, a pediatric gastroenterologist would qualify for the higher payment if he/she rendered one of the specified primary care services by virtue of that physician’s subspecialty within the qualifying specialty of pediatric medicine. Additionally, physicians who are in those designated specialties but not Board certified (are Board eligible) can also qualify if at least 60 percent of the codes billed by the physician for all of calendar year 2012 were for the evaluation and management (E&M) codes and vaccine administration codes specified in the final rule. Codes eligible for the higher payment are E&M codes 99201 through 99499 and vaccine administration codes. This includes codes within the specified range that are not currently covered by Medicare. In June, NASPGHAN sent a letter to CMS supporting the inclusion of primary care services provided by pediatric subspecialists among those eligible for higher Medicaid payments.
In December, NASPGHAN learned that Congress is targeting the enhanced payments for elimination in order to offset other spending needs as part of the broad fiscal cliff and budget negotiations. NASPGHAN joined other organizations throughout the medical community and sent a letter to Congress asking lawmakers to protect the Medicaid parity law.
Letter to Nickelodeon: Stop Advertising Junk Food to Kids
In a letter to the executives of Nickelodeon, NASPGHAN, as a member of the Food Marketing Workgroup convened by the Center for Science in the Public Interest (CSPI), asked the company to implement strong nutrition standards for all of the company’s food marketing to children. NASPGHAN members can send their own message through the CSPI’s action center to Nickelodeon asking that it stop advertising junk food to kids.
National Pediatric Research Network Act Passes House
On September 19, the U.S. House of Representatives passed legislation that would authorize the NIH to establish up to 20 pediatric research consortia across the United States. The bill requires that a subset of the consortia would be required to focus primarily on pediatric rare diseases and conditions. The bill also establishes a data coordination center to facilitate the sharing of research findings in a timely manner and to provide the CDC assistance with the establishment of patient data registries. The bill is awaiting consideration in the Senate.
Washington Report - September 2012
Washington Report - July 2012
Washington Report - March 2012
Washington Report - January 2012
Washington Report - December 2011