Cord Blood Legislation

In the final days of 2005, the US Congress unanimously passed legislation to create a National Cord Blood Program to fund public banks accepting donations for transplants.  President George W. Bush signed it into law on 20 Dec 2005.  The official title of the program is the "C.W. Bill Young Cell Transplantation Program."

This web page explains:

• History of the Legislation
  
• Recommendations from Institute of Medicine (IoM) Report
• Structure of the Program described in 2005 H.R. 2520
• Senate Amendments to the program
  
• Appropriations to fund the program
  

Thanks to lobbying by a small group of doctors including Dr. Pablo Rubinstein of the NY Blood Center and Dr. Joanne Kurtzberg of Duke University, on 12 June 2003 legislation was first proposed to establish a national program of public cord blood banks.  Dr. Rubinstein claimed that an inventory of 150,000 cord blood donations would be enough to supply the transplant needs of 90% of the American public.

On 24 July 2003, the House of Representatives introduced 2003 H.R. 2852, called the Cord Blood Stem Cell Act of 2003.  On 3 Oct 2003, the Senate introduced a companion bill 2003 S.1717.

Subsequently, this legislation became incredibly bogged down in rivalry between the NY Blood Center (NYBC) and the National Marrow Donor Program (NMDP), both of whom wished to control the national cord blood program.  The NY Blood Center even renamed their website "www.NationalCordBloodProgram.org".

To clarify these issues, on 23 Jan 2004 Congress commissioned an Institute of Medicine (IoM) study to make recommendations on the ideal structure of a national cord blood program.   The National Academy of Sciences proceded to assemble an IoM Committee and held a series of meetings on 2 June,  18-19 August,  29 Sept 2004, and 15 Dec 2004.

Meanwhile, between Jan 2003 and June 2004, the NY Blood Center and their ally Thermogenesis (Nasdaq: KOOL) spent $330,000 on lobbying, according to the US Senate Office of Public Records   (reported on this website Nov 2004).   Opponents of the NMDP managed to block the bill, H.R. 3034, which would re-authorize their budget.   During the same time period, the NMDP spent $860,000 on lobbying, according to the same data base.  In February and March of 2005, the NYBC lobbied Congress to introduce yet another set of Cord Blood Stem Cell Acts, H.R. 596 and S.681, which are replays of the 2003 legislation that triggered the IoM study.


In March 2004, reauthorization of the budget for the National Marrow Donor Program (NMDP), an event that happens once every five years, was stalled for the first time. The Bill H.R. 3034 passed the House but not the Senate. Cancer patients and medical societies launched campaigns urging reauthorization.  One sentence in the bill broadens "bone marrow" to include "any other source of hematopoietic progenitor cells." Sen. Sam Brownback (R-KS) has issued a "Values Action Report" alleging that the NMDP intends to take over all sources of stem cells, including embryonic stem cells. As a result, the NMDP reauthorization is now being opposed by groups who oppose the use of embryonic stem cells.  By an odd coincidence, Brownback is the same Senator who sponsored the Cord Blood Stem Cell Act of 2003 in collaboration with the NY Blood Center.  The NMDP and NYBC are rivals for control of a National Cord Blood Program.


At the Institute of Medicine  second meeting three original committee members have been removed and replaced with three new members. Here is the revised committee roster;

Position papers on the Cord Blood Stem Cell Act of 2003:
NY Blood Center (released May 2004) and
National Marrow Donor Program (released late summer 2004)



Finally, the Institue of Medicine released their report, "Establishing a National Hematopoietic Stem Cell Bank Program", on 14 April 2005.  The IoM did not side with either the NYBC or the NMDP, but set a course down the middle.  The chapters of the IoM report are available on this website.

Consequently, on 24 May 2005, the NYBC and NMDP reached a compromise and the House of Representatives passed H.R. 2520, "The Stem Cell Therapeutic and Research Act of 2005".  The provisions of H.R. 2520 are itemized in section below on the structure of the national cord blood program.  It reauthorizes the bone marrow budget of NMDP and establishes a cord blood program in parallel to the NMDP.  A companion bill, S.1317 was introduced to the Senate.

Finally, on 15 Dec 2005, the House Majority Leader submitted a "unanimous consent request" for the Stem Cell Therapeutic and Research Act of 2005.  This precipitated some last-minute frantic lobbying to convince Congressmen that the cord blood bill should be decoupled from another bill on research with embryonic stem cells.  At last, both H.R.2520 and S.1317 were passed on 16 Dec 2005 by voice vote.

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On 14 April 2005, at 4PM EST, the Institute of Medicine released the report from the Committee on Establishing a National Cord Blood Stem Cell Bank Program.  Extremely abbreviated summary:

• The primary goal of the national program is to maximize patient access in the most efficient, cost-effective, and ethical manner possible.
• The U.S. Department of Health and Human Services (DHHS) should establish a new National Cord Blood Policy Board to set rules for the donation, collection, and use of this resource.
• The new National Cord Blood Policy Board should be established at the level of the DHHS Secretary to ensure that it is distanced from other HHS programs (such as NMDP).
• The HHS dept HRSA should solicit proposals for a new Cord Blood Coordinating Center to manage daily operations of cord blood banking and allocation nationwide.
• No current organization has all the necessary capabilities to serve as the Cord Blood Coordinating Center (this implicitly means neither NMDP nor NYBC).
• In particular, techniques of HLA typing and measures of quality control both need to be standardized.
• Cord blood donors must give fully informed consent prior to delivery.
• The FDA should move "promptly" to license cord blood.
• The majority of funding available for the national cord blood bank program should be targeted to expanding the inventories of participating banks.
• According to an economic analysis conducted for the study, the point at which the costs of banking exceed the benefits for the patient population is 200,000 units.

Links to the full report (open PDF-file in a new window):

Title Page
Cast and Contents
Executive Summary
Chapter 1. Introduction
Chapter 2. HPC Transplantation
Chapter 3. Research on HPC Uses
Chapter 4. Banks and Banking 
Chapter 5. Ethical and Legal Issues
Chapter 6. National Inventory
Chapter 7. Proposed National Structure


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The NY Blood Center (NYBC) and the National Marrow Donor Program (NMDP) reached a compromise in the quest for a national cord blood registry: On 24 May 2005, the House of Representatives passed, by a vote of 430 to 1, the bill H.R. 2520 "Stem Cell Therapeutic and Research Act of 2005". This bill is a marriage between the stalled NMDP re-authorization (HR 3034) and the NYBC proposal for a national cord blood program (HR 596). HR 2520 was passed under a suspension of rules which only occurs if there is prior agreement by interested parties. The full text of HR 2520 can be read in the Congressional Record at thomas.loc.gov:

• HR 2520 allocates $79 million to compile a national inventory of 150,000 high-quality cord blood units for transplantation.
• Collected cord blood which is not suitable for transplantation will go to peer-reviewed research.
• The National Cord Blood Program is now renamed the C.W. Bill Young Cell Transplantation Program. This name is associated with the DoD branch of the NMDP.
• The Dept of Health and Human Services (HHS) will contract directly with banks for bone marrow and/or cord blood services.
• The bone marrow and cord blood programs will be at the same administrative level, and may be under one contract or two.
• This effectively means that patients will have one-stop shopping for stem cell transplants.
• The cord blood contract must be competed during the first year and qualifying banks must be willing to enlist for 10 years.
• Qualifying cord blood banks must comply with section 379 of the Public Health Service Act. This was the 1998 legislation authorizing the NMDP registry. It remains to be seen if cord blood banks in the national registry will have to comply with current NMDP protocols for "participating" cord blood banks.
• There will also be a contract for collection of transplant outcomes data, like the work performed by CIBMTR.
• An advisory committee will oversee all forms of hematopoietic stem cell transplants.
• Within 6 months of the enactment of this program, the committee must define what is a "high-quality" cord blood unit.
• These compromises partly follow the recommendations of the Institute of Medicine report, but push the cord blood program into parallel with the current bone marrow program.
• At present, HHS has $19 million to start spending on cord blood collection, even though this legislation is still pending in the Senate.

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Senate amendments to the original House bill:

Cord blood transplants are still not "licensed" by the FDA, but are given under an "investigational new drug" (IND) status.  In some cases, patients' insurance companies use this loophole to deny coverage for a CB transplant.  An amendment to H.R. 2520 requires the FDA to report on requirements for licensing cord blood units, within 90 days of the passage of the bill.

The Senate amendments also revise the existing Section 379 of the Public Health Services Act (42 U.S.C. 274k) to be consistent with the new requirements of H.R. 2520.   The bone marrow and cord blood programs will have parallel status and the umbrella organization above them will be called the C. W. BILL YOUNG CELL TRANSPLANTATION PROGRAM.

The Health Resources and Services Administration (HRSA) must release a Request for Proposal (RFP) for the initial establishment of the cord blood program.  In principle, all of the following may be competed:

1. Participating Cord Blood Banks
2. Bone Marrow Coordinating Center (this contract is currently held by the National Marrow Donor Program, or NMDP)
3. Cord Blood Coordinating Center
4. Single-Point of Patient Access (in case 2. and 3. are won by different organizations)
5. Outcomes DataBase
6. Office of Patient Advocacy

Starting in 2007, up to 5% of annual funds may be given to the Sibling Donor Cord Blood Program  at CHORI, as a demonstration program.

For the purposes of the program, a Qualified Cord Blood Bank is one that has the "requisite accreditations", has established a "confidential system" of tracking donor ID and linkage to the mother, and "encourages donation".

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The actual funding of the program is dependent on the 2006 appropriations for the US Dept's of Labor, Health and Human Services, and Education.  This has not yet been approved.

On 16 Dec 2005, Senator Harkin testified that his subcommittee had appropriated $19.8 million over the past two years for the National Cord Blood Stem Cell Banking Program.  For fiscal year 2006, he and Senator Specter have requested $9.9 million.  However,  the conference committee has cut that down to $4 million, "meaning 3,900 fewer units of cord blood will be collected"  (at a cost of $1025 each).  Moreover, when Dept of Defense appropriations are made, there may be an additional 1% cut for all other federal programs.

To be continued....


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