BILL ANALYSIS Ó
AB 2750
Page 1
Date of Hearing: May 4, 2016
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez, Chair
AB
2750 (Gomez) - As Amended April 7, 2016
-----------------------------------------------------------------
|Policy |Rules |Vote:|11 - 0 |
|Committee: | | | |
| | | | |
| | | | |
|-------------+-------------------------------+-----+-------------|
| |Health | |16 - 0 |
| | | | |
| | | | |
|-------------+-------------------------------+-----+-------------|
| | | | |
| | | | |
| | | | |
-----------------------------------------------------------------
Urgency: No State Mandated Local Program: NoReimbursable: No
SUMMARY:
This bill exempts specified health care providers storing human
cell, tissue, or cellular- or tissue-based product (tissue) that
is regulated by the federal Food and Drug Administration (FDA)
AB 2750
Page 2
from state licensure as a tissue bank if all of the following
apply:
a)The tissue has been obtained from a licensed tissue bank.
b)The tissue is stored in accordance with specified guidelines.
c)The tissue is used for the express purpose of implantation
into or application on a patient, and is not intended for
further distribution.
FISCAL EFFECT:
A potential decrease of about 40% in workload, and a
commensurate $260,000 reduction in annual fee revenue to the
California Department of Public Health (CDPH) Tissue Bank
licensing program. Remaining fee revenues and the fund balance
in the Tissue Bank Licensing Fund appear to be adequate to
support remaining workload. A tissue bank license fee costs
$975 annually.
COMMENTS:
1)Purpose. According to the author, due to the burdens of
licensure, many hospitals and ambulatory surgical centers
located in California opt not to obtain a tissue bank license
from the state, and instead make daily deliveries of the
specified tissue grafts at the beginning of the calendar day,
using couriers to return any unused tissue grafts at the end
of the day. The author states this is inefficient and costly.
This bill is sponsored by the MiMedx, a private company that
AB 2750
Page 3
processes, markets, and distributes human amniotic tissue. The
sponsor believes it is unnecessary for providers to be
licensed as tissue banks with the state when they are only
storing tissue for use in their own patients in accordance
with FDA regulations and oversight.
2)Background. A tissue bank is defined as an establishment that
collects, processes, stores, or distributes tissue (cells,
groups of cells, segments of eyes and other body parts, sperm,
blood, and other fluids) for transplantation into humans.
Current law requires CDPH to adopt regulations on or before
January 1, 2004, governing tissue banks, and requires the
regulations to be based on criteria used by tissue bank trade
associations in their accreditation processes. Finally, it
requires every tissue bank to have a valid license. CDPH has
not issued regulations as required by existing law. CDPH
maintains that any facility collecting, processing, storing,
or distributing human tissue for purposes of transplantation
needs to be licensed as a tissue bank, as specified in the
law. Eight exemptions have been added over the years; this
bill would add a ninth exemption.
3)Related Legislation. AB 1822 (Bonta) of 2014 was substantially
similar to this bill. AB 1822 was vetoed by the Governor who
stated, in part, "While I support eliminating overly
burdensome regulation, I'm not convinced that the bill strikes
the right balance between safety and economy. I will direct
the Department of Public Health to continue working with
interested parties to develop an approach that balances
appropriate oversight with cost savings for suppliers." CDPH
has developed an Frequently Asked Questions document to
clarify the application of current law, but it has not
addressed the problem that this bill seeks to address.
This bill does not address the veto message, as it is
substantially similar to AB 1822, but neither has CDPH
developed a different approach that balances oversight and
cost savings, as indicated in the veto message.
AB 2750
Page 4
Analysis Prepared by:Lisa Murawski / APPR. / (916)
319-2081