Don't ban compensation for bone-marrow donors- Sally Satel, Alan D. Viard | regu

[sherri]

http://www.aei.org/article/health/comment-on-rin-0906-ab02/



Comment Re: Health Resources and Services Administration, HHS RIN 0906-AB02
December 2, 2013
 
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.1
 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recommend that the proposal be withdrawn.
Background
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 Circuit2
 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
                                                             1
 Health Resources and Services Administration, Department of Health and Human Services, “Change to the
Definition of ‘Human Organ’ under Section 301 of the National Organ Transplant Act of 1984,” 78 Federal
Register 60810 (October 2, 2013). 2
 Flynn v. Holder, 684 F.3d 852 (9th Cir. 2012). This decision, issued on March 27, 2012, denied the government’s
petition for rehearing of the panel’s original December 1, 2011 decision and amended that decision to correct
typographical errors and to address an argument made in the government’s petition. The time period for the
government to petition the U.S. Supreme Court for certiorari elapsed on June 25, 2012, with no petition having been
filed. 2 
 
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.3
 
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.4
 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.
 
 
 
                                                             3
 Under NOTA section 301(b), 42 U.S.C. §274e(b), a violation of section 301(a) is a felony carryi