[Congressional Record Volume 156, Number 132 (Tuesday, September 28, 2010)]
[Senate]
[Pages S7620-S7621]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BROWN of Massachusetts (for himself, Ms. Snowe, Mr. 
        Bennett, Mr. Corker, Ms. Collins, Mr. Voinovich, Mr. Alexander, 
        and Mr. Chambliss):
   S. 11. A bill to restore the application of the 340B drug discount 
program to orphan drugs with respect to children's hospitals; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. BROWN of Massachusetts. Mr. President, I come to the floor today 
to speak about a bill that I am introducing today along with several of 
my Senate colleagues. My bill protects the lives of the most vulnerable 
among us our Nation's children by ensuring children's hospitals across 
the country are able to purchase orphan drugs at a discount.
  I am pleased to be joined by my colleagues: Senators Snow, Bennett, 
Corker, Collins, Voinovich, Alexander, and Chambliss today, to stand 
together to provide for and protect the ability of children's hospitals 
to access medicines for their patients at a reduced price.
  As my colleagues are aware, access to orphan drugs are critically 
important to children, many of whom, if they are ill, suffer from rare 
disease or conditions. Orphan drugs, by definition, are designed and 
developed to help and treat diseases or conditions that affect fewer 
than 200,000 people, many of whom are children. On a daily basis, the 
Children's Hospital of Boston uses most of the 347 medicines that are 
designated orphan drugs.
  The bill my colleagues and I are introducing today restores and 
protects the ability for children's hospitals to access those 
outpatient medicines through the 340B drug discount program authorized 
in the Public Health Services Act. Access to this program and the 
corresponding discount saves the Children's Hospital of Boston nearly 
$3 million annually, but more importantly, Children's Hospital of 
Boston is able to save lives as a result. Hospitals and doctors at 
children's hospitals are able to access life-saving medicines, children 
live better lives, and families are given a piece of mind.
  Passing this bill quickly is the right thing to do and I encourage 
the Senate to act swiftly to enact my legislation to ensure that 
children's hospitals can once again receive discounted pricing on these 
life-saving medicines.

[[Page S7621]]

  There is no cause for delay. The House has passed this restorative 
language twice already. The Senate needs to do the same.
  I believe quick passage is possible quick passage should be possible 
because of the support and efforts that I have seen demonstrated by my 
fellow Senators.
  Senator Sherrod Brown has been a thoughtful leader on this issue and 
I respect and admire him for his work. Because of his leadership and 
perseverance, he was able to secure the support of sixteen Democratic 
Senators in favor of this legislation, all of whom signed a letter to 
the Majority Leader, expressing their support to restore access to this 
very important program.
  I am hopeful that Senator Sherrod Brown and I can continue to work 
across party lines and with all of our colleagues to reach agreement 
and find resolution on this.
  My door is always open to my colleagues who are willing to work 
together to solve common problems. In this instance, our Nation's 
children deserve that we come together and protect their access to 
medicines that will save their lives.
  Mr. President, I ask unanimous consent that the text of the bill and 
letters of support be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                 S. 11

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. CONTINUED INCLUSION OF ORPHAN DRUGS IN DEFINITION 
                   OF COVERED OUTPATIENT DRUGS WITH RESPECT TO 
                   CHILDREN'S HOSPITALS UNDER THE 340B DRUG 
                   DISCOUNT PROGRAM.

       (a) Amendment.--Subsection (e) of section 340B of the 
     Public Health Service Act (42 U.S.C. 256b) is amended by 
     striking ``covered entities described in subparagraph (M)'' 
     and inserting ``covered entities described in subparagraph 
     (M) (other than a children's hospital described in 
     subparagraph (M))''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall take effect as if included in the enactment of section 
     2302 of the Health Care and Education Reconciliation Act of 
     2010 (Public Law 111-152).
                                  ____



                                                  U.S. Senate,

                                   Washington, DC, August 5, 2010.
     Hon. Harry Reid,
     Majority Leader, U.S. Senate, Hart Senate Office Building, 
         Washington, DC.
       Dear Majority Leader Reid: We are writing to ask that a 
     technical correction to Section 2302 of the Health Care and 
     Education Reconciliation Act (HCERA) be provided at the 
     earliest opportunity. The Section exempted orphan drugs from 
     required discounts for newly eligible entities added to the 
     340B statute under the Act. PPS-exempt children's hospitals 
     were included among these entities, when in fact they were 
     already eligible for and participating in the 340B program.
       Since the HCERA provision was effective upon enactment, it 
     is imperative that a retroactive correction be made as soon 
     as possible. Both the House and Senate have included this 
     correction in various pieces of legislation, but none of 
     these bills have been signed into law. We thank you for your 
     efforts to date to fix this problem and respectfully ask for 
     your continued help in ensuring another legislative vehicle 
     for the prompt passage of a technical correction restoring 
     the children's hospitals' ability to fully participate in the 
     340B drug discount program.
       Children's hospitals use on a daily basis most of the 347 
     drugs that have received orphan drug status. The hospitals 
     participating in the 340B drug discount program have achieved 
     significant savings. They estimate that those savings would 
     be reduced dramatically with the orphan drug exemption. If 
     the exemption is not corrected, the children's hospitals will 
     have to pay wholesale prices for these drugs or leave the 
     340B program.
       We would appreciate your continued support to ensure that 
     children's hospitals do not lose the critical benefit 
     provided by the 340B program.
           Sincerely,
         Sherrod Brown; John F. Kerry; Joseph I. Lieberman; ------
           ; Al Franken; Amy Klobuchar; Mary L. Landrieu; Debbie 
           Stabenow; Maria Cantwell; Kirsten E. Gillibrand; 
           Christopher J. Dodd; Robert P. Casey, Jr.; Carl Levin; 
           Dianne Feinstein; Herb Kohl; Arlen Specter; Barbara 
           Boxer.
                                  ____



                                   Children's Hospital Boston,

                                      Boston, MA, August 24, 2010.
     Senator Scott Brown,
     Russell Senate Office Building,
     Washington, DC.
       Dear Senator Brown: We write with urgency to request your 
     leadership on a pressing issue facing Children's Hospital 
     Boston. An unintentional error in the Health Care Education 
     and Reconciliation Act (HCERA) is threatening children's 
     hospitals access to discounts on orphan drugs through the 
     drug discount program authorized under section 340B of the 
     Public Health Service Act.
       The 340B program allows a number of safety net providers to 
     purchase outpatient pharmaceuticals at discounted rates, 
     thereby expanding access to care to low income and vulnerable 
     populations. The program saves Children's Hospital Boston 
     between $1.5 and $3 million annually and is of no cost to the 
     government. Participation in this program has made it 
     possible for the hospital to control costs in a challenging 
     environment and ensure patient access to outpatient drugs, 
     such as Botox (used to reduce spasticity in patients with 
     cerebral palsy and other neurological disorders) and 
     Rituximab (used to treat non-Hodgkins lymphoma and to 
     alleviate the effects of severe juvenile arthritis).
       Children's hospitals were included in the 340B program 
     through an amendment to Medicaid in the Deficit Reduction Act 
     of 2005. Federal guidance enabling them to enroll in the 
     program was finally published in September 2009, and 25 
     children hospitals, including Children's Hospital Boston, are 
     now participating. The Patient Protection & Affordable Care 
     Act (PPACA) added some new types of hospitals as eligible 
     entities to the 340B statute and also included the children's 
     hospitals so that they would be subject to same regulatory 
     requirements as other eligible providers. When HCERA amended 
     the PPACA with a last minute provision exempting orphan drugs 
     from discounts received by all of the newly eligible 
     providers, children's hospitals were unfortunately included, 
     even though they were already eligible for and participating 
     in the 34013 program.
       Without a technical correction restoring 340B discounts for 
     orphan drugs, Children's Hospital Boston is facing the loss 
     of most of its savings from the 340B program and the choice 
     of either leaving the program or paying wholesale prices for 
     orphan drugs. Orphan drugs, i.e. drugs developed to treat a 
     disease that afflicts relatively few, are widely used in 
     children's hospitals, given their role in caring for the 
     sickest children with the most complex health care needs. In 
     addition, orphan drugs may also be used more widely in 
     treating other diseases or conditions. Indeed, Children's 
     Hospital Boston currently uses most of the 347 drugs with 
     orphan drug status on a daily basis.
       The Massachusetts Biotechnology Council (MassBio), which 
     represents more than 600 biotechnology companies, 
     universities and academic institutions dedicated to advancing 
     cutting edge research, urges a correction to this problem. As 
     you likely know, the focus of MassBio is to foster an 
     environment in the state where biotechnology companies can 
     succeed. For MassBio, as well as the member companies, true 
     success means that research and development leads to 
     treatments that reach the most vulnerable patients in our 
     state. As such, it is critical that institutions like 
     Children's Hospital Boston have ready access to the 
     pharmaceuticals they need to treat seriously ill children.
       As the months pass and denials of discounts for orphan 
     drugs begin, we are gravely concerned about the cost impact 
     of this mistake on Children's Hospital Boston. The hospital 
     employs more than 8,000 people, treats thousands of very sick 
     children annually and is the safety-net provider for 
     Massachusetts children. Children's has worked diligently in 
     coordination with insurers and others in the industry to 
     reduce health care costs and improve efficiency.
       Without immediate legislative action, Children's Hospital 
     Boston will be forced to withdraw from this cost saving, 
     health care enhancing program. As leaders in the 
     Massachusetts health care industry and partners in improving 
     community health, we ask you to take a leadership role in the 
     correction of the issue. Corrective language was included in 
     the two tax extenders bills that passed in the House. 
     However, the language, while uncontroversial, has not been 
     included in any legislation that has passed the Senate.
       We hope that you will agree to serve as an original 
     cosponsor of the legislation drafted by Senator Sherrod Brown 
     (attached) and contact the Majority and Minority leadership 
     in the Senate to insist that this issue not be tied up in 
     politics.
           Sincerely,
     James Mandell, MD,
       CEO, Children's Hospital Boston.
     Robert K. Coughlin,
       President & CEO, MassBio.
                                 ______