Overview

The following legislative is an update and summary of federal legislative and regulatory actions of interest to the pediatric academic community. We hope that this information will assist you in your advocacy as the 110^th Congress begins in earnest. There are several critical and high priority pediatric and child health issues that will need the collective wisdom and support of the entire pediatric community. This includes: the reauthorization of the State Child Health Insurance Program (SCHIP), the reauthorization of the Best Pharmaceuticals for Children Act (BPCA), the Pediatric Rule (PREA), the Prescription Drug User Fee Act (PDUFA) and the reintroduction of the pediatric medical device legislation. The Public Policy Council member organizations played a pivotal role in all of these initiatives when first authorized and your advocacy will again be needed. We encourage you to share this legislative report with your colleagues.  Members of the American Pediatric Society, Society for Pediatric Research and the Association of Medical School Pediatric Department Chairs are urged to reach out to their Members of Congress to advocate for key health and pediatric-specific issues. 

 

This report includes information on the following issues:

 

• Pediatric Research

• Pediatric Drugs

• Pediatric Medical Devices

• Pediatric Workforce

• FY 2007 Budget/Appropriations

• FY 2008 Budget

• Pandemic Influenza

• Access to Health Care

• 2007 PAS Annual Meeting – PPC/APA sponsored sessions

• Congressional Calendar

• How to Contact Congress and the President

• Join the AAP Federal Advocacy Action Network

 

 

FY PEDIATRIC RESEARCH 

National Institutes of Heath (NIH) Reauthorization: In the final hours of the 109^th Congress, the NIH reauthorization bill appeared dead, as the Senate refused to take up the measure for a variety of reasons both substantive and political.  However, in the final moments of the second session of the 109^th Congress, an amended bill did pass in both chambers following significant negotiations with Senators Arlen Specter (R-PA.) and Tom Harkin (D-IA), the chair and ranking member of the Senate Labor-HHS-Education Appropriations Subcommittee, and Senators Mike Enzi (R-WY) and Edward Kennedy (D-MA), the chair and ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee and Representative Barton.  The amended version of the bill increases the authorization levels for NIH to $30.3 billion in FY 2007 and $32.8 billion in FY 2008, which represent increases of 7 percent and 8.2 percent respectively. The bill also authorizes "such sums as may be necessary" for FY 2009. The final bill eliminated the 50% funding formula for the common fund, replacing it with a provision leaving common fund funding to the discretion of the NIH Director. 

 

The final version of the bill also included a Clinical and Translational Science Award (CSTA) provision added by the Senate and supported by the National Association of Children’s Hospitals. The provision requires the NIH Director to establish a mechanism within CTSA program "to preserve independent funding and infrastructure for pediatric clinical research by allowing the appointment of a secondary principal investigator under a single CTSA with direct authority over a separate budget and infrastructure for pediatric research, or otherwise securing institutional independence of pediatric clinical research centers with respect to finances, infrastructure, resources, and research agenda." The Director is to provide an evaluation and comparison of outcomes and effectiveness in these programs as part of a biennial report to Congress.

 

President Bush signed the reauthorization legislation into law on January 15 as P.L. 109-687.

 

National Children’s Study:  The Joint Resolution signed into law by President Bush on February 15, 2007, included $69 million for the National Children’s Study for FY 2007.  This represented a major victory for children and came largely as a result of the long and hard-fought advocacy efforts of many organizations including many in the pediatric community on behalf of the NCS on Capitol Hill.

 

Funding issues were of prime concern to the December 5, NCS Advisory Committee that includes several pediatricians on it including the chair of the Public Policy Council Dr. Myron Genel. In addition, the Committee discussed the following:

·         Within the next 18 months, the writing of the study protocol and the peer review of the protocol should be completed.

·         A special notice for additional study centers was published in the Federal Register in October 2006.  The notice stated that there was an intent to post a request for proposals (RFP) for awards in 2007, but that doing so was conditional on FY 2007 funding.  In the case of a CR funding the NCS at FY 2006 levels for FY 2007, it is likely that, although the study will continue, no new centers will be opened.

·         As funding for the NCS is a continued concern, the Committee might need to consider ways to cut costs without damaging the credibility of the study.  While the sample size and the longitudinal-nature of the study should not be changed, cost-savings could be achieved by opening new centers incrementally.

·         An informed consent video/interactive tool is being developed for the study.  The prototype video describes the study itself and the study’s goals, outlines the benefits (no direct benefit to participants), and the risks (i.e. duty to report suspected child abuse) involved in participation. The prototype version is directed to already pregnant women, but there will eventually be two additional tools—one directed at women who are not yet pregnant and one at fathers. 

 

Further information and updates are available at http://www.nationalchildrensstudy.gov.

 

Animal Enterprise Terrorism Act: On Monday, November 27, President Bush signed the Animal Enterprise Terrorism Act (AETA) into law.  This legislation, which received tremendous bi-partisan support in both the House and Senate, amends the Animal Enterprise Protection Act (Title 18, Sec. 43 of the US Criminal Code) and expands criminal prohibitions against the use of force, violence, and threats involving animal enterprises and increased penalties for violations of these prohibitions. The AETA will provide greater protections against intimidation and harassment of researchers and will for the first time address campaigns of secondary and tertiary targeting that cause economic damage to research enterprises. The PPC supported this legislation.

 

Genetic Information Nondiscrimination Act (GINA): H.R. 493, The Genetic Information Nondiscrimination Act (GINA), was reintroduced in the House of Representatives on January 16, 2007.  A bipartisan group of 143 original cosponsors—90 Republicans and 53 Democrats—joined the bill’s sponsors—Representatives Slaughter (D-NY), Biggert (R-IL), Eshoo (D-CA), and Walden (R-OR)—in its introduction.  The bill currently has 205 cosponsors. It’s companion bill in the Senate, S. 358, was introduced shortly thereafter on January 22 by Senator Olympia Snowe (R-ME). It now has 25 bipartisan cosponsors. The Senate Health, Education, Labor and Pensions (HELP) Committee passed the legislation out of committee on January 31.  The bill was approved 19-2 with no amendments in a brief committee meeting off the Senate floor.  The two “no” votes came from Senators Coburn (R-OK) and Burr (R-NC).  The House Education and Labor Committee voted on February 14 to move the bill out of their committee, but they made slight changes to the version approved by the Senate HELP Committee.  The House Energy and Commerce and Ways and Means Committees because of overlapping jurisdiction must also consider the bill, at least in pro forma fashion.

 

GINA prohibits discrimination on the basis of genetic information with respect to health insurance and employment. Its purpose is to establish basic legal protections that will enable and encourage individuals to take advantage of genetic screening, counseling, testing, and new therapies that will result from the scientific advances in the field of genetics. The legislation also prevents health insurers from denying coverage or adjusting premiums based on an individual's predisposition to a genetic condition, and prohibits employers from discriminating on the basis of predictive genetic information. Additionally, GINA would stop both employers and insurers from requiring applicants to submit to genetic tests, maintain strict use and disclosure requirements of genetic test information, and impose penalties against employers and insurers who violate these provisions.  In prior congresses, similar legislation has been passed in the Senate, but has never passed in the House.  In his remarks at a NIH Roundtable on Advances in Cancer Prevention on January 17, President Bush urged Congress to pass legislation that makes genetic discrimination illegal.

 

Members of APS, SPR and AMSPDC are encouraged to contact your Senators and urge them to bring GINA to the Senate floor as soon as possible with no weakening amendments and then to vote “yes” when S. 358 reaches the Senate floor and to contact your Representatives and urge them to “cosponsor” H.R. 493.

 

 

PEDIATRIC DRUGS 

BPCA/PREA: The Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) have been important policy innovations that have expanded the information about drugs available to pediatricians, families, and other health professional that prescribe drugs for children and adolescents.  These laws have resulted in 117 new drug labels with dosing changes, updated safety information, new formulations, etc. 

 

BPCA and PREA will both sunset on October 1, 2007, and will be due for reauthorization in the same year as the Prescription Drug User Fee Act (PDUFA).  PDUFA allows FDA to collect “user fees” from pharmaceutical companies to offset the costs of drug approval. 

As in past reauthorizations of PDUFA, Members of Congress will likely attempt to add a number of riders to the bill. 

 

Senators Kennedy (D-MA) and Enzi (R-WY) have proposed a large “drug safety” bill that gives FDA broad new authorities to require post-market studies and other types of surveillance, including the ability to impose civil monetary penalties for noncompliance.  The Kennedy/Enzi bill would also establish a federal clinical trials database. 

 

Other Members of Congress have introduced bills that would address disputes between branded drugs and generics such as the use of citizen petitions and “30 month stays.”  A bill introduced by Senators Deborah Stabenow (D-MI) and Trent Lott (R-MS) and its companion in the House, introduced by Rep. Henry Waxman (D-CA), would, among several other items, also limit or tier the patent extension provided by BPCA. Representatives of the generics industry have said that the BPCA exclusivity extension is being abused and that Congress should reexamine it as it comes due for reauthorization.

 

Staff for the Senate Heath, Education, Labor and Pensions (HELP) Committee has announced the committee’s intention to move all FDA-related bills in March as a large package, including BPCA and PREA. The Public Policy Council, as it did in the past, will join the efforts of the Academy to work with Senate co-sponsors to be ready for the HELP Committee timeline.

  

 

PEDIATRIC MEDICAL DEVICES 

On December 6 Senators Chris Dodd (D-CT) and Mike DeWine (R-OH) introduced the Pediatric Medical Device Safety and Improvement Act of 2006.  This legislation is supported by the National Organization for Rare Disorders, the Elizabeth Glaser Pediatric AIDS Foundation, the American Thoracic Society, the American Pediatric Society, the Association of Medical School Pediatric Department Chairs, and the Society for Pediatric Research, all of whom are committed to moving it through Congress upon its anticipated reintroduction in the 110^th Congress. PPC and AMSPDC member Jon Abramson, MD was very involved in the development of this bill and lead a task force in its development.

 

 

PEDIATRIC WORKFORCE/GRADUATE MEDICAL EDUCATION 

GME Financing for Children’s Hospitals (CHGME) –Reauthorization: On September 28, the House passed legislation reauthorizing the CHGME program for five years (through FY 2011) with a spending ceiling of $330 million per year.  The Senate passed the same bill two days earlier on September 26.  The bill makes improvements to the CHGME program by strongly encouraging participating hospitals to report important new data measures to the Department of Health and Human Services, including:

 

·         Types of resident training programs;

·         Numbers of full-time equivalent resident training slots in each training program and the number of slots filled each training year from July 1 through June 20 of the following year;

·         Types of resident training related to the health care needs of different populations, such as children who are “underserved” for reasons of family income or geographic location;

·         Changes in residency training since the first year in which the hospital received CHGME support; Numbers of FTE residents who, upon completion of training, care for children within the hospital’s service area or within the borders of the state in which the hospital is located.

 

The PPC worked very closely with the National Association of Children’s Hospitals (N.A.C.H.) to seek passage of this important legislation. President Bush signed the CHGME bill into law (P.L. 109-307) on October 6.

 

CHGME Funding: Efforts are underway with NACH to insure that adequate and equitable funding is provided for CHGME in FY 2008 - $330 million. Current funding is $297 million the same amount as FY 2006. Senators Bond (R-MO), Kennedy (D-MA), Coleman (R-MN), and Murray (D-WA and Representatives Eschoo (D-CA), Waxman (D-CA), and Pryce (R-OH) are circulating “dear colleague” letters requesting $330 million for CHGME in the FY 2008 Labor-HHS Appropriations bill.

 

Title VII Health Professions Program- Appropriations:  In FY 2006, Title VII funding was slashed by more than 50%, with funding dropping from $300 million to a mere $145 million in although the FY 2007 JR boosted Title VII funding to $185 million, this victory was short-lived as President Bush’s FY 2008 Budget proposal slashed Title VII funding to just $10 million. According to the specific language in the joint resolution most of the new funding in FY 2007 is related to funding geriatric programs - $31.5 million – that returns funding to the FY 2005 level; “not less than $5 million shall be used for pediatric dentistry programs; not less than $5 million will be used general dentistry and not less than $24.614 million for family medicine programs” – the remainder is for medicine and pediatrics. HPNEC’s FY 2008 funding request is $550 million, based on a calculation of FY 2005 levels plus inflation.

 

Reauthorization: Although Title VII reauthorization was discussed at various times throughout the 109^th Congress, no legislative action was taken.  It remains to be seen what action, if any, will take place in the 110^th Congress. It is not anticipated that the Title VII bill will be reauthorized in its entirety but perhaps specific provisions may be reauthorized.

 

Physicians for Underserved Areas Act: The Physicians for Underserved Areas Act extends the J1 visa program for an additional two years.  The waiver program allows foreign physicians, including pediatricians, trained in the U.S. to remain in the nation for three years, provided that they treat patients in medically underserved areas.

 

 

 2007 BUDGET AND APPROPRIATIONS 

FY 2007 Joint Resolution (P.L.110-5): Almost 4 ½ months behind schedule, the FY 2007 funding process finally reached closure on February 15, 2007, with President Bush signing the FY 2007 joint resolution, HJR 20.  Due in large part to the advocacy efforts of the pediatric community and its many public health partners, the joint resolution (JR) included a $2.3 billion funding increase for health and education programs over FY 2006 levels.  NIH was one of the JR’s biggest winners, receiving a funding increase of $620 million over FY 2006.  Community Health Centers also received a funding boost, gaining a $207 million increase. The immunization program, section 317, received an additional $32 million.  The Title VII health professions program received a slight funding increase of $40 million over last year.  Programs that were proposed for elimination such as EMSC and universal newborn hearing screening were funded. However, the vast majority of other programs, including the Maternal and Child Health Block Grant and AHRQ, received flat funding at 2006 levels.

 

FY 2008 BUDGET 

The President’s 2008 budget proposal was released on February 5, 2007.  This year’s budget and appropriations process is anticipated to be even more complicated than in prior years, as “pay-as-you-go” legislation was instituted at the outset of the 110^th Congress and President Bush will likely force the Democrats’ hand to make difficult political choices regarding which discretionary programs should receive funds in this tight fiscal climate.  While the FY 2008 budget proposal in many places looked remarkably like the past two years there were a few notable exceptions – AHRQ received a modest increase of $11 million, the FDA an increase of $95 million, and an additional increase in funding for the Ryan White program. Stay tuned, as your advocacy will be essential as the funding process moves forward in the months ahead.

 

 

 

 

 

ACCESS TO HEALTH CARE 

Deficit Reduction Act (DRA) Technical Corrections: On December 9, 2006, Congress passed technical corrections to last year’s Deficit Reduction Act (DRA) as part of the “tax extenders” bill (H.R. 6111, the “Tax Relief and Health Care Act of 2006”).  The language appears to solve some of the problems caused by the DRA for foster children, as they are now exempt from any requirement to document their citizenship and identification to qualify for Medicaid.  Additionally, some of the cost-sharing provisions for the poorest Medicaid recipients appear to have been rescinded.  However, technical corrections do not appear to have adequately addressed the changes the DRA made to the Early and Periodic Screening Diagnostic and Treatment (EPSDT) Program, nor do they appear to have rescinded the policy change for newborns that had formerly been deemed eligible for Medicaid coverage.  As such, Congress will likely consider further technical amendments to the DRA during the 110^th Congress.

 

State Child Health Insurance Program (SCHIP) Shortfall: Also in its final days of legislative activity, the 109^th Congress agreed to act on the SCHIP funding shortfall expected in 14 states and threatening up to 500,000 children by attaching a “temporary fix” provision on to the National Institutes of Health reauthorization bill.  The temporary fix reallocates money from states that did not use all of their SCHIP funding allotments in 2004 ($125 million total) and 2005 ($136 million total) to shortfall states.  Unfortunately, as of May 4, 2007, some states may begin to run out of funds and be forced to reduce enrollment, curtail benefits, increase patient fees or reduce provider payments. 

 

SCHIP Reauthorization: The 110th Congress is slated to reauthorize the SCHIP law, which is scheduled to expire Sept. 30, 2007. Some of the key issues that must be addressed in reauthorizing SCHIP that SCHIP has funding needed to cover more children, eliminate red-tape barriers to enrollment, and address quality and accountability of child health coverage. 

 

 

PANDEMIC INFLUENZA 

National Strategy for Pandemic Influenza Implementation Plan: On December18, 2006, the White House released a report providing a six-month update on the National Strategy for Pandemic Influenza Implementation Plan (Implementation Plan).  The Implementation Plan itself was released in May 2006.  In conjunction with the report’s release, Rajeev Venkayya, M.D., Special Assistant to the President for Homeland Security, hosted an interactive teleconference call with stakeholders to address their concerns regarding the status of the implementation plan.  Staff participated in this call. The report finds that 92 percent of action items due within six months have been completed, with 8 percent "in progress." The due dates for twelve items related to community containment are postponed until February 1, 2007, pending additional analysis, and were not included in the report.  The six-month progress report is available at http://www.pandemicflu.gov/plan/federal/stratergyimplementationplan.html

 

Pandemic and All-Hazards Preparedness Act: The Pandemic and All-Hazards Preparedness Act passed in final hours of the 109^th Congress.  The legislation reauthorizes (through 2011) a law related to bio-terrorism and disease outbreak preparedness and would establish the Biomedical Advanced Research and Development Authority (BARDA) to coordinate federal efforts to produce countermeasures against biological weapons and diseases. The legislation includes a provision allowing the Secretary to track the initial distribution of federally purchased influenza vaccine in an influenza pandemic.

 

 

2007 PEDIATRIC ACADEMIC SOCIETIES ANNUAL MEETING

 

PLENARY SESSION: The PPC and APA state of the art plenary session, entitled "Healthcare for Immigrant Children," will explore the numerous issues entailed in addressing the health needs of immigrant children and youth in the US and Canada.  A panel of speakers will review what we know about the health of immigrant children, the barriers to care experienced by these children (including issues of language, culture, and race) and strategies to address these barriers and improve health for these children and their families.  Panelists include Marie DesMeules, Public Health Agency of Canada, Centre for Chronic Disease Prevention and Control; Glenn Flores, MD, FAAP, Medical College of Wisconsin, Center for the Advancement of Underserved Children; and Mara Youdelman, J.D., LL.M., of the National Health Law Program.   Lisa Simpson, MB, BCh, MPH, FAAP, Chair, APA Public Policy and Advocacy Committee will moderate this session. This two- hour session begins at 4:15 on Sunday, May 6.

 

LEGISLATIVE BREAKFAST: The 21st annual legislative breakfast sponsored by the Public Policy Council scheduled is scheduled for 7:00 a.m. on Monday, May 7. The speaker will be Dr. James James, of the American Medical Association who will explore "Pediatricians, Pediatric Populations and Public Health Preparedness."  Dr. James will discuss the ethical basis of the physician’s responsibility to respond to public health emergencies and, consequently, the profession’s responsibility to ensure the adequate education and training to enable effective response.  The roles of individual physicians will be expanded upon and the importance of an “all hazards,” “all specialty” approach that integrates medicine and public health will be defined.   The necessary and special contribution of pediatricians will be highlighted, as will the special considerations for dealing with pediatric populations under catastrophic conditions. 

 

SPECIAL PLENARY SESSION: “The National Children’s Study: Update and Future Plans” begins at 12:15 p.m. on Monday, May 7.  This special symposium will present an update on the National Children’s Study, which is prepared to begin recruitment of subjects for an ambitious, longitudinal study.  However, in 2006, budget problems surfaced that threatened the implementation of the study.  The panel presenters will discuss the current status of the project, the anticipated budgetary outlook, options to implement the study and respond to questions from the audience.  Panelists include Duane Alexander, Director, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD; Peter C. Scheidt, Director, National Children's Study, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD; and Alan R. Fleischman, Chair, National Children’s Study Federal Advisory Committee, New York Academy of Medicine, New York and National Institutes of Health, Bethesda, MD.

 

 

 

2007 Congressional Calendar (110^th Congress – First Session)
April 2 – 9:                   Easter Recess  (Senate)

April 2 – 13:                 Easter Recess (House)
May 28 - June 1:          Memorial Day Recess
July 2 - 6:                     July 4th Recess
August 6 - Sept. 3:       August Recess
October 26:                  Target Adjournment (House)

 

 

HOW TO CONTACT YOUR MEMBER OF CONGRESS: 

Write: The letter remains the most popular choice of communication with a congressional office.  If you decide to write a letter, remember to be courteous, to the point, and include key information and personal examples to support your position.  Address only one issue in each letter and, if possible, keep the length to one page.

 

To a Senator:                             To a Representative:

The Honorable (name)  The Honorable (name)

United States Senate                 United States House of Representatives

Washington, DC 20510            Washington, DC 20515

 

Dear Senator ________:          Dear Representative ____:

 

Fax:  Currently it is best to fax and not mail your letter to Congress.  Fax numbers are available through the Capitol Hill Switchboard (202) 224-3121, or you can look up your members of Congress on “Thomas” the official website for Congress, available at http://thomas.loc.gov/, by going to “House Directory” or “Senate Directory” from the front page. 

 

Call: You can contact your Senators and Representative's offices by calling the U.S. Capitol Hill Switchboard at (202) 224-3121.  If you do not know who your Representative is, the switchboard operator will be able to direct you to the proper office. Ask to speak to the staff member who works on health care issues. Be prepared to leave a very short message as well as your name and address.  You can also call your legislators in their home districts; if you are a member of the American Academy of Pediatrics, information about local offices is available on the AAP Member Center website, www.aap.org/moc.

 

E-mail: All of members of Congress now have e-mail addresses, but there is no set format for them. On some members web sites there is a mechanism to directly email most notably if you are a constituent.  We suggest calling the congressional office to get an accurate e-mail address or visit www.aap.org/moc the Member Center website of the AAP. Be sure to identify, in the subject line, that you are a constituent along with the legislative topic of the email correspondence.

 

  

 

HOW TO CONTACT THE PRESIDENT 

Write: The Honorable George W. Bush

The White House

1600 Pennsylvania Avenue

Washington, DC  20500

 

Call: 202-456-1414

Fax:  202-456-2461

E-mail: president@whitehouse.gov

 

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CONSIDER JOINING THE AAP FEDERAL ADVOCACY ACTION NETWORK (FAAN) 

The American Academy of Pediatrics invites you to become a member of the Federal Advocacy Action Network (FAAN).  Coordinated by the AAP Department of Federal Affairs, FAAN is a network of AAP members who help support federal legislative and regulatory activities from their position as constituents.  FAAN members play an important role in passing federal legislation that benefits children and pediatricians.

 

The AAP Department of Federal Affairs gives FAAN members the information and tools you need to persuade your legislators.  For example, each month via e-mail you will receive FAAN MAIL with updates on AAP legislative priorities in Washington, D.C.  We will keep you up to date with timely information with “THIS JUST IN.”  You will also receive “SPECIAL ALERTS” when immediate action is needed by you on a key issue. 

 

To join FAAN go to the Member Center of the AAP web site, www.aap.org/moc, and click on Federal Affairs, then click on Join FAAN and follow the easy directions.  The Members Only Channel has some great tools to make your advocacy work easy.  Find the names of Congressional representatives, contact legislators via e-mail, read about daily congressional activity, view actual bills and use the media contact list.

 

If you are already a member of FAAN, thank you!  If you are interested in joining FAAN and have questions, please contact Priscilla Ring (pring@aap.org) in the AAP Department of Federal Affairs at 800/336-5475.  Together we can make a real difference for children and pediatricians!

 

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Public Policy Council Members: 

APS                 Myron Genel, MD; Jimmy Simon, MD

SPR                 Christine Gleason, MD; Elena Fuentes-Afflick, MD, MPH

AMSPDC       Russell Chesney, MD; Jon Abramson, MD

 

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Report Submitted By:

Myron Genel, MD, Chairman

Karen M. Hendricks, JD, Washington Coordinator

Stephanie Russell, JD, Legislative Assistant

 

Additional information and resource material on these and other pediatric and child health issues are available from: Washington Coordinator, Karen M. Hendricks, JD (KHendricks@aap.org) or Stephanie A. Russell, JD, (SRussell@aap.org).

 

Public Policy Council

c/o American Academy of Pediatrics

601 13^th Street, NW

Suite 400 North

Washington, D.C. 20005

Phone: 800/336-5475 or 202/347-8600; Fax: 202/393-6137

 

           

Please visit the Public Policy Council on the web at -- www.aps-spr.org

 

 

February 26, 2007