AMERICAN LEGISLATORS SLOWLY JOINING THE IMMUNOSUPPRESSIVE DRUG COVERAGE EFFORT

U.S. congressional efforts are slowly in process, seeking to close the ridiculous catch-22 that ensnares kidney transplant recipients 36 months after transplantation. This bureaucratic trap halts Medicare coverage of their expensive immunosuppressive medications but resumes payment for dialysis when the resulting rejection causes the kidney to fail. In two prior postings on this blog; March 7, 2013 and  May 27, 2013 status reports on the Senate and House versions of the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2013 were provided.

Today's report is that additional co-sponsors have "signed on" to each bill. The Senate bill, initially introduced by Senator Durbin from Illinois, now has 11 co-sponsors. This means that 12/100 Senators, or 12% have committed to supporting the bill. Another 88 to go! Are your Senators on board? Use this Senate link to check whether both of your Senators have "signed on". If they have not, please give them a phone call......or send them an e-mail. Ask them to sign on to S.323 (the formal # for this bill in the Senate).

The current status in the House of Representatives is that 67 members have "signed on" to co-sponsor Representative Michael Burgess' original bill. This makes a total of 68/435, or 16% who have committed to supporting the bill.   Use this House link to determine whether your Representative is on the list and, if not, contact him/her. Ask for support of H.R. 1428.

Together we can make a difference. Legislators DO respond to their constituents. If we make it very clear that this Catch-22 is unacceptable, that we insist on change, and that we hold our own politicians accountable, we can be the agents of change. Take a few moments to take the simple steps outlined above. And, pass the link for this blog to someone else who will help make the change. We do have this power. You have this power. Please use it.

FACE + HAND TRANSPLANTS : NEW NAME, NEW REGULATORY NICHE

Clinical transplantation has moved forward in leaps and bounds, surpassing the speed of the U.S.  government in addressing regulatory standards for new transplant types. This is neither an irrelevant nor a minor issue and has just been definitively addressed by the Final Rule published in the July 3, 2013 Federal Register. The National Organ Transplant Act (NOTA) originally enacted in 1984 had defined a specific list of transplant organs based on all of the transplant types that were performed in that era. The Organ Procurement and Transplantation Network (OPTN) and United Network for Organ Sharing (UNOS) oversee and regulate those types of organ transplantation with a fully developed set of bylaws for member institutions and policies that determine how transplants are undertaken. These transplants currently include:

ORGAN TRANSPLANTS

Kidney
Liver
Heart
Lung
Pancreas
Intestine (any part of the intestinal tract)

In contrast, human cells or tissue for transplantation are under the regulatory jurisdiction of the Food and Drug Administration (FDA) under Section 361 of the Public Health Service Act and 21 CFR parts 1270 and 1271.  Examples (not inclusive) of Cell and Tissue "Implants/Transplants" include:

CELL + TISSUE "IMPLANTS/TRANSPLANTS" 

Bone

Skin

Cornea

Ligaments

Stem cells

Peripheral blood

Cord blood

Oocytes

Semen

Face, hand, larynx, and abdominal wall transplants are all examples of transplants that did not clearly fit into either of the two pre-existing categories. Agreeing with advocates within the transplant community, the Secretary of Health and Human Services issued this Final Rule that has formally created a new category of Vascularized Composite Allografts (VCA), (allograft = transplant between non-identical members of the same species) that is defined based on functions below (ischemia is a period of interrupted blood, see below):

VASCULARIZED COMPOSITE ALLOGRAFTS 

1. Vascularized - requires blood flow by surgical connection
2. Contains multiple tissue types
3. Recovered from a human donor as an anatomical/structural unit
4. Transplanted into a human recipient as an anatomical/structural unit
5. Minimally manipulated or processed (but may be cut or shaped)
6. For homologous use (i.e., to be used for the same purpose in the recipient as it was in the donor)
7. Subject to ischemia and therefore stored only temporarily
8. Subject to allograft rejection and generally requiring immunosuppression

The Final Rule also clearly stipulates that VCA transplants fall under the jurisdiction of the OPTN/UNOS, not the FDA. Major implications of this definition are that VCA transplants may only be performed at OPTN member institutions in good standing. New policies specifically applicable to VCA transplants clearly need to be developed by the OPTN/UNOS.

Because of the unique issues pertaining to donor consent for these specific transplant types, wherein donor identification may be retained (e.g., fingerprints and facial identifiers), the Final Rule implies that donor specific consent should be undertaken on a case-by-case basis. This is the current ad hoc practice. But new issues of allocation will arise if the number of transplants begins to grow substantially. For example, there is no other transplant type in which skin color may be relevant!

Overall, a new field of medicine is currently developing at a very rapid pace. This one step is an important one. It will be challenging and exciting as others are made. Stay tuned.