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...
HT: Kim Krawiec
| View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
| HHS/HRSA | RIN: 0906-AB02 | Publication 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 Agenda | Agenda 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 | ||||||||||||
Timetable:
|
| 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
The court decision from 2011 doesn't matter at all? This "final rule" simply overrides it?
ReplyDeleteI'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...
ReplyDeleteThis is very sad.
ReplyDeleteSo now the only way to overturn this is by legislation at the federal level?
Jeff Rowes, the principal lawyer from the IJ case back in 2011 sent me this email in regards to "what happens next?":
ReplyDeleteHi 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.
-Jeff