- Proposed bone-marrow rule would likely reduce the availability of life-saving bone-marrow transplants
We write to comment on the October 2, 2013 proposal to amend 42 C.F.R. §121.13 with respect to compensation for donors of peripheral bone marrow stem cells. Because the notice of proposed rulemaking fails to offer an adequate justification for the proposed regulation, which would likely reduce the availability of life-saving bone marrow transplants, we respectfully recommend that the proposal be withdrawn.
Section 301(a) of the National Organ Transplant Act (NOTA), 42 U.S.C. §274e(a), enacted in 1984, prohibits the knowing acquisition, receipt, or other transfer of any “human organ” for valuable consideration for use in human transplantation if the transfer affects interstate or foreign commerce.
NOTA section 301(c)(1), 42 U.S.C. §274e(c)(1), as amended in 1988, defines “human organ” to mean “the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof.” The provision further states that the term also encompasses “any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation.”
On March 9, 2007, HHS invoked that grant of regulatory authority to adopt 42 C.F.R. §121.13. The regulation added “intestine, including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract” to the statutory definition of human organ. On July 3, 2013, HHS amended the regulation, effective July 3, 2014, to add “any vascularized composite allograft defined in §121.2” to the definition.
A unanimous three-judge panel of the U.S. Court of Appeals for the Ninth Circuit recently ruled that the term “bone marrow,” as used in NOTA section 301(c)(1), includes cells extracted from the bone marrow through aspiration (a technique that requires hospitalization and anesthesia and involves inserting large hollow needles into the cavities of the donor's hip bone), but does not include peripheral bone marrow stem cells extracted from the bloodstream through apheresis.
Under the latter technique, blood is taken from a donor's vein, filtered by an apheresis machine to collect the peripheral bone marrow stem cells, and then returned to the donor through a needle in the other arm. The donation of peripheral bone marrow stem cells through apheresis is similar to an ordinary blood donation, except that the process takes several hours and requires that medication be taken during the five days before the donation. The Ninth Circuit panel held that the peripheral bone marrow stem cells extracted from the bloodstream through apheresis are part of the blood, not part of the “bone marrow” referred to in NOTA section 301(c)(1).
The October 2, 2013 proposed regulation would amend 42 C.F.R. §121.13 by adding “other hematopoietic stem/progenitor cells without regard to the method of their collection” to the definition. In effect, the proposed regulation would overturn the Flynn decision by including peripheral bone marrow stem cells in the definition of organs for which compensation cannot be paid. In doing so, the proposed regulation would extend the scope of the prohibition on donor compensation beyond what NOTA, as authoritatively construed by the Ninth Circuit, does on its own. Because a violation of the prohibition is a criminal offense, the proposed regulation would transform conduct that is currently legal into a felony that potentially carries severe criminal penalties.
Moreover, the proposed regulation would place new obstacles in the path of the 12,000 people with cancer and blood diseases who need bone marrow transplants. Locating a marrow donor is often a needle-in-a-haystack affair. The odds that two random individuals will match are less than one in 10,000 for whites and non-blacks and much lower for blacks. Among the few who are matched after being tissue-typed via cheek swab, nearly half refuse to follow through with the actual donation. Then the hunt for another donor begins, an added delay that some patients – a number that is difficult to pin down, but which is estimated to be between 1,000 and 3,000 per year – don’t survive.
To be sure, NOTA section 301(c)(1) expressly grants HHS authority to expand the definition of human organ. But, it does not authorize HHS to do so without adequate justification. Unfortunately, the notice of proposed rulemaking (NPRM) scarcely pretends to offer a reasoned justification for the regulatory change. The lack of reasoned justification is particularly disturbing, in view of the proposed regulation’s potential life-and-death consequences.