Thursday, September 29, 2016

It looks like paying donors of bone marrow/ blood stem cells will remain illegal...

The long story of whether some forms of blood stem cell (marrow) donation may be compensated seems to be coming to an end, back where it began.  Here's the new HHS/HRSA regulation, saying that whether as marrow or in the blood stream, these are considered organs under the National Organ Transplant Act, so no valuable consideration can be given...

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HHS/HRSARIN: 0906-AB02Publication ID: Spring 2016 
Title: Definition of Human Organ Under Section 301 of the National Organ Transplant Act of 1984 
Abstract:This final rule clarifies that peripheral blood stem cells are included in the definition of bone marrow under section 301 of the National Organ Transplantation Act of 1984, as amended and codified in 42 U.S.C. 274e.
Agency: Department of Health and Human Services(HHS) Priority: Info./Admin./Other 
RIN Status: Previously published in the Unified AgendaAgenda Stage of Rulemaking: Final Rule Stage 
Major: No Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Pub. L. 109-129    Stem Cell Therapeutic and Research Act of 2005, as amended in 2010 by Pub. L. 111-264   
Legal Deadline:  None
ActionDateFR Cite
NPRM 10/02/2013 78 FR 60810   
NPRM Comment Period End 12/02/2013 
Final Rule 11/00/2016 
Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined 
Small Entities Affected: No Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Dr. James Bowman
Medical Director, Division of Transplantation
Department of Health and Human Services
Health Resources and Services Administration
5600 Fishers Lane, Room 12C-06,
Rockville, MD 20857
Phone:301 443-4861 

HT: Kim Krawiec


ariel karlinsky said...

The court decision from 2011 doesn't matter at all? This "final rule" simply overrides it?

Al Roth said...

I'm no lawyer...but I think the 1984 National Organ Transplant Act, which forbids paying for transplant organs, states that an "organ" will be defined by being on a list that the Secretary of Health and Human Services will supply, and so this is an amended list, to get around the court decision...

ariel karlinsky said...

This is very sad.
So now the only way to overturn this is by legislation at the federal level?

ariel karlinsky said...

Jeff Rowes, the principal lawyer from the IJ case back in 2011 sent me this email in regards to "what happens next?":

Hi Ariel,

The rule isn’t actually final yet, but that’s a technical point. The rule will become final in a couple of months. The path forward isn’t just legislative. The proposed rule conflicts squarely with the decision the federal court of appeals (9th circuit on the west coast) reached in the case that we won. So we will immediately sue to have the new rule set aside. We will sue in DC, meaning that it will proceed to the federal court of appeals here in DC. If the DC circuit upholds the rule, then there will be a fundamental conflict between two federal courts, so that means that it could go up to the Supreme Court.

Once we succeed in getting the rule invalidated, then the other side can try to get the statute amended in Congress. They tried once after we won the first time and they didn’t have any traction. But I suspect this case won’t go the legislative route for a couple of years.