Sunday, November 3, 2013

The law and politics of bone marrow and compensation for donors

The Department of Health and Human Services is proposing new regulations that would put bone marrow more clearly into the class of organs for which payment is forbidden by the National Organ Transplant Act of 1984. This is in response to the decision by the Ninth Circuit to make compensation legal for bone marrow donations made through the harvesting of blood stem cells directly from the blood.

Here's the relevant page from the Federal Register: Federal Register/ Vol. 78, No. 191 / Wednesday, October 2, 2013 / Proposed Rules

Here are my earlier posts on the courts and compensation for bone marrow donation.

Since I'm not licensed to practice law in North Carolina or anywhere else, I wrote to Kim Krawiec to ask whether HHS could simply overrule the Ninth Circuit with a regulation, or whether Congress would have to get involved.

Here is Kim's reply:
"... new legislation is probably not needed to overturn the 9th circuit ruling -- that is certainly the position of HHS.  Here is the relevant language from NOTA (with emphasis mine): (1) The term “human organ” means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and 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.  

The only question would be whether HHS exceeded its authority in some way through this change. I'm sorry to say that such a claim would be an uphill battle.  One might imagine, for example, a claim that the statute only permits the addition of "organs" and HSCs drawn from peripheral blood are not an organ (as the 9th Circuit concluded).  But courts are extremely deferential to agencies on these questions of interpretation (the term is "Chevron deference", named after a Supreme Court case establishing the standard). Courts are very reluctant to overturn agency interpretations of this sort and defer to the agency interpretation unless it is unreasonable.  Hopefully the interpretation (assuming the proposed reg is enacted) will be challenged, but I think this one will be a tougher fight than the first case."

HT: Bob Slonim

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