Change to the Definition of ‘‘Human Organ’’ Under Section 301 of the NOTA?

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http://www.gpo.gov/fdsys/pkg/FR-2013-10-02/pdf/2013-24094.pdf

DEPARTMENT OF HEALTH AND  HUMAN SERVICES

42 CFR Part 121

RIN 0906–AB02

Change to the Definition of ‘‘Human Organ’’ Under Section 301 of the National Organ Transplant Act of 1984

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: This notice seeks public
comment on the proposed change in the
definition of ‘‘human organ’’ in section
301 of the National Organ and
Transplant Act of 1984, as amended,
(NOTA) to explicitly incorporate
hematopoietic stem cells (HSCs) within
peripheral blood in the definition of
‘‘bone marrow.’’ This would clarify that
the prohibition on transfers of human
organs for valuable consideration
applies to HSCs regardless of whether
they were recovered directly from bone
marrow (by aspiration) or from
peripheral blood (by apheresis). This
amendment will also conform section
301 to the provisions of the Stem Cell
Research and Therapeutic Act of 2005,
as amended.

DATES: To be considered, comments
should be submitted by December 2,
2013. Subject to consideration of the
comments submitted, the Department
intends to publish final regulations.

ADDRESSES: You may submit comments,
identified by Regulatory Information
Number RIN 0906–AB02, by any of the
following methods, but the first option
is preferred:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: http://
www.hrsa.gov/. Follow the instructions
for submitting comments on the Agency
Web site.
• Email: SGrant@hrsa.gov. Include
RIN 0906–AB02 in the subject line of
the message.
• Fax: (301) 594–6095.
• Mail: Shelley Grant, MHSA, Branch
Chief, Blood Stem Cell Transplantation
Program, Division of Transplantation,
Healthcare Systems Bureau, Health
Resources and Services Administration,
5600 Fishers Lane, Room 12C–06,
Rockville, Maryland 20857.
Instructions: All submissions must
include the agency name and RIN for
this rulemaking. All comments received
will be posted without change to
http://www.hrsa.gov/, including any
personal information provided.
Additional information concerning the
submission of comments and/or the
rulemaking process can be obtained
from the Regulations Officer, Division of
Policy Information and Coordination,
Health Resources and Services
Administration, 5600 Fishers Lane,
Room 14–101, Rockville, Maryland
20857.

Docket: For access to the docket to
read background documents or
comments received, go to the Division
of Transplantation, Healthcare Systems
Bureau, Health Resources and Services
Administration, 5600 Fishers Lane,
Room 12C–06, Rockville, Maryland
20857, weekdays (Federal holidays
excepted) between the hours of 8:30
a.m. and 5 p.m. To schedule an
appointment to view public comments,
phone (301) 443–7757.
FOR FURTHER INFORMATION CONTACT:
Shelley Grant, MHSA, at the above
address; telephone number (301) 443–
8036.

SUPPLEMENTARY INFORMATION:
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http://ij.org/bone-marrow-release-11-13-2013?utm_content=buffer3a469&utm_source=buffer&utm_medium=twitter&utm_campaign=Buffer

Federal Officials Move to Block Life-Saving Research
HHS’ Proposed Rules Would Undo Court Ruling Legalizing Bone Marrow Compensation
 
“The Constitution does not allow government agencies to simply redefine words in order to grant themselves more power.”
 
In the midst of its takeover of the nation’s health care system, the Department of Health and Human Services is now looking to implement a rule to undo a lifesaving court ruling from this past year which allowed compensation for bone marrow donors.  The Institute for Justice, which won the victory in court on behalf of cancer patients from across the nation, today announced a plan to oppose proposed new regulations.  IJ’s victory in Flynn v. Holder made clear that it is legal to offer compensation to most bone marrow donors.  HHS’s effort, however, would reverse the ruling and re-instate a decades-long ban on donor compensation.
“Every day, people die while waiting to find a compatible bone marrow donor,” explained IJ Senior Attorney Jeff Rowes, lead counsel for the plaintiffs in Flynn v. Holder.  “The goal of our lawsuit was to enable researchers to find out if donor compensation would lead to more donors.  Our victory made that possible, but now HHS once again wants to make it a felony punishable by up to five years in prison just to do basic research on a promising, lifesaving initiative.”
The original landmark case began in October 2009 when the Institute for Justice filed suit against the U.S. Attorney General on behalf of cancer patients, the parents of children with deadly diseases, a renowned bone marrow doctor, and a nonprofit group to challenge the prohibition on compensating bone marrow donors set forth in the National Organ Transplant Act (NOTA) of 1984.  NOTA made it a serious crime to compensate someone for a human organ for transplantation.  The Act defined bone marrow as an organ.
In a ruling that became final in the summer of 2012, however, the 9th U.S. Circuit Court of Appeals ruled that the ban on donor compensation could not be applied to the most common method of marrow donation.  Most modern bone marrow transplants now occur using a technique that extracts marrow cells from the bloodstream rather than from the hip bone, which was the traditional method of donation.  Because this technique is almost identical to the technique used by donors of other blood parts like plasma, the court held that Congress could not have meant to include it when it banned compensation for “organs.”
Under the new regulations, though, this ruling would be reversed.  The Department of Health and Human Services has proposed a rule that would define “organ” to include marrow cells donated through the bloodstream, effectively re-imposing the ban on compensation.
“The federal government’s proposed rule is illegal and unconstitutional because it is based on a falsehood,” said Rowes.  “Cells taken from your bloodstream aren’t ‘organs,’ which is why no one has ever thought NOTA prohibits paying people for platelets.  The Constitution does not allow government agencies to simply redefine words in order to grant themselves more power.”
The proposed regulation would ban marrow compensation just when empirical research has begun into the effects of compensating donors.  A team of economists—Nicola Lacetera of the University of Toronto, Mario Macis of Johns Hopkins University, and Robert Slonim of the University of Sydney—were in the process of finalizing a research proposal that would have investigated the effects of donor compensation when they learned of the new rule.
“These new regulations make it impossible for researchers to obtain the necessary evidence to inform policy.  Our proposed studies would be made illegal by these new provisions,” explained Macis, who, along with Lacetera and Slonim, has published some of the leading work showing that economic incentives can be effectively used to increase blood donations without affecting blood supply safety.  “Properly designed compensation for bone marrow donors could similarly lead to significant increases in donations, thus giving potentially hundreds or thousands of people in need of a transplant every year a greater chance of survival.  At a minimum, the federal government should not make it illegal for researchers to find out whether incentives can help address the shortage of bone marrow donors.”
“I don’t think that anybody should go to jail just for trying to save somebody’s life,” added Doreen Flynn, who has three children with Fanconi anemia, a blood disease that frequently requires a bone marrow transplant and who was the lead plaintiff in the original lawsuit.  “If paying donors results in more marrow donations, we should pay them.  And it shouldn’t be a crime to investigate it.”
“We know what doesn’t work,” said Robert McNamara, also a senior attorney with the Institute and co-lead counsel in the case.  “We have 30 years of experience with an altruism-only marrow-donor program, and we know that has not succeeded in recruiting enough donors.  The only question is whether offering compensation can achieve better results.  We will not allow the federal government to make it a felony to find out the answer.  Hopefully, we will do that by persuading the government not to adopt this rule, but if we have to, we will sue them again.  And we will win—again.”
The proposed regulation is currently open for a period of public comment through December 2, 2013.  Individuals who have been impacted by blood-borne cancer or bone marrow donations are encouraged to leave comments on the Department of Health and Human Services’ website:  http://www.regulations.gov/#!submitComment;D=HRSA_FRDOC_0001-0115.
Individuals who support the efforts of Doreen Flynn and the researchers looking to improve the number and quality of bone marrow donors are encouraged to leave their comments on the HHS comment site.