BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 1177
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|AUTHOR: |Gomez |
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|VERSION: |July 8, 2015 |
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|HEARING DATE: |July 15, 2015 | | |
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|CONSULTANT: |Vince Marchand |
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SUBJECT : Primary care clinics: written transfer agreements.
SUMMARY : Prohibits a primary care clinic, notwithstanding current
regulations or any other law, from being required to enter into
a written transfer agreement with a nearby hospital as a
condition of licensure.
Existing law:
1)Licenses and regulates primary care clinics and specialty
clinics by the Department of Public Health (DPH). Primary care
clinics are either "community clinics" or "free clinics,"
while specialty clinics include surgical clinics, chronic
dialysis clinics, rehabilitation clinics, and alternative
birth centers.
2)Defines "alternative birth center" as a clinic that is not
part of a hospital and that provides comprehensive perinatal
services and delivery care to pregnant women who remain less
than 24 hours at the facility. Alternative birth centers can
be specifically licensed as a specialty clinic, or can be
provided as a permitted service by a licensed primary care
clinic.
3)Prohibits physicians from performing procedures in an
outpatient setting using anesthesia, except local anesthesia
or peripheral nerve blocks, or both, complying with the
community standard of practice, in doses that, when
administered, have the probability of placing a patient at
risk for loss of the patient's life-preserving protective
reflexes, unless in one of the following outpatient settings:
a) An ambulatory surgical center that is
CMS-certified;
AB 1177 (Gomez) Page 2 of ?
b) A tribal clinic, as specified;
c) A clinic operated directly by the United
States or any of its departments;
d) A clinic licensed by DPH;
e) A health facility licensed as a general acute
care hospital;
f) A dental office using anesthesia pursuant to
specified provisions of law; or,
g) An outpatient setting that has been accredited
by an accreditation agency that is approved to issue
certificates of accreditation to outpatient settings
by the Medical Board of California (MBC).
4)Requires MBC to adopt standards for accreditation and, in
approving accrediting agencies to perform accreditation of
outpatient settings, to ensure that the certification program,
at a minimum, includes specified standards, including
requiring the accredited outpatient setting to do one of the
following:
a) Have a written transfer agreement with a local
hospital;
b) Permit surgery only by a licensee who has
admitting privileges at a local hospital, with the
exception that licensees who may be precluded from
having admitting privileges by their professional
classification are required to have a written transfer
agreement with licensees who have admitting privileges
at a local hospital; or
c) Submit for approval by an accrediting agency a
detailed procedural plan for handling medical
emergencies that is required to be reviewed at the
time of accreditation, and prohibits any reasonable
plan from being disapproved by the accrediting agency.
5)Defines "conscious sedation," in the Dental Practice Act, as a
minimally depressed level of consciousness produced by a
pharmacologic or nonpharmacologic method, or a combination
thereof, that retains the patient's ability to maintain
independently and continuously an airway, and respond
appropriately to physical stimulation or verbal command.
Existing Title 22 regulations:
1)Requires primary care clinics to maintain written transfer
agreements, which include provisions for communication and
AB 1177 (Gomez) Page 3 of ?
transportation, with one or more nearby hospitals and other
inpatient health facilities as appropriate to meet medical
emergencies. Requires essential personal, health and medical
information to either accompany the patient upon transfer or
be transmitted immediately by telephone to the receiving
facility.
2)Permits primary care clinics, except for those providing
abortion or birthing services, to request that DPH waive the
written transfer agreement requirement above. Requires the
clinic to demonstrate to DPH that all nearby hospitals and
other inpatient health facilities, as appropriate to meet
medical emergencies have refused to enter into transfer
agreements.
This bill:
1)Prohibits primary care clinics, notwithstanding a current
regulation or any other law, from being required to enter into
a written transfer agreement with a nearby hospital as a
condition of licensure, except as provided in 2) below.
2)Requires a primary care clinic where anesthesia is used in
compliance with the community standard of practice, in doses
that when administered have the probability of placing a
patient at risk for loss of the patient's life-preserving
protective reflexes, to do one of the following:
a) Have a written transfer agreement with a local
accredited or licensed acute general care hospital;
b) Permit procedures requiring this level of
anesthesia to be performed only by a licensee who has
admitting privileges at a local accredited or licensed
general acute care hospital, except that a licensee
who may be excluded from having admitting privileges
due to his or her professional classification or other
administrative limitations is required to have a
written transfer agreement with a licensee who has
admitting privileges at a local accredited or licensed
acute care hospital; or,
c) Submit for approval from an accrediting agency
a detailed procedural plan for handling medical
emergencies that is required to be reviewed at the
time of accreditation. Prohibits a reasonable plan
from being disapproved by the accrediting agency.
AB 1177 (Gomez) Page 4 of ?
3)Exempts a primary care clinic from the requirement in 2) above
if it submits to DPH any competent evidence that demonstrates
to DPH that at least one nearby hospital, as defined, or other
inpatient health facility has elected to not enter into a
transfer agreement with that primary care clinic. Defines
"competent evidence" as evidence that is relevant and of such
a nature that it can be received by a court of law, and
includes an affidavit of someone with the legal authority to
bind the clinic operation.
4)Specifies that primary care clinics are not required to have a
hospital transfer agreement with a nearby hospital, if that
clinic provides only the following types of analgesia and
sedation services:
a) Local anesthesia;
b) Peripheral nerve blocks;
c) A combination of both local anesthesia and
peripheral nerve blocks; or,
d) Conscious sedation, as defined in existing
law.
5)Requires DPH to repeal, no later than July 1, 2016, specified
Title 22 regulations that require primary care clinics to have
a written transfer agreement with a hospital.
FISCAL
EFFECT : According to the Assembly Appropriations Committee
analysis of the introduced version of this bill, it would have
negligible state fiscal effect.
PRIOR
VOTES :
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|Assembly Floor: |51 - 28 |
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|Assembly Appropriations Committee: |12 - 5 |
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|Assembly Health Committee: |14 - 5 |
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COMMENTS :
1)Author's statement. According to the author, under current
AB 1177 (Gomez) Page 5 of ?
California law, clinics are obliged to obtain a hospital
transfer agreement (HTA) from a nearby hospital as a condition
of licensure in order to begin performing services. DPH
regulations allow clinics who cannot get an HTA from a nearby
hospital to apply for a waiver to this requirement. However,
clinics that provide abortions or birthing services are not
allowed to apply for a waiver, even if a local hospital won't
agree to enter into an HTA. The author states that this
effectively allows a hospital that does not want to enter into
an HTA to prevent an abortion clinic from opening. The author
notes that if this bill is enacted, this regulation will be
repealed and unenforceable, and will give Californians equal
access to reproductive services and the ability to choose.
2)Hospital transfer agreements. The requirement for a written
transfer agreement between primary care clinics and a local
hospital, which is the subject of this bill, is contained in
the Title 22 regulations governing primary care clinics. There
are also a handful of places where written transfer agreements
are statutorily required, and would not be affected by this
bill. For example, a rural general acute care hospital that
does not provide surgical and anesthesia services is required
to maintain a written transfer agreement with one or more
general acute care hospitals that provide surgical and
anesthesia services. A mobile health care services unit
(generally speaking, a bus outfitted as a mobile clinic that
is operated by a licensed clinic or hospital) is required to
maintain written transfer agreements that include provisions
for communication with, and transportation to, one or more
nearby hospitals as needed to meet medical emergencies.
Finally, as discussed in existing law above, an accredited
outpatient surgical setting, which uses general anesthesia, is
required to either have a written transfer agreement with a
hospital, only permit surgery by physicians who have admitting
privileges at a hospital, or have a "detailed procedural plan
for handling medical emergencies" that is approved by the
accrediting agency.
While written transfer agreements can vary by hospital, DPH
provides on its website an example of a transfer agreement
that meets its requirements. This form is two pages long, with
11 itemized requirements, such as a requirement that
transferring institutions send with the patient forms that
include information on the medical course of treatment
followed by the transferring institution and other pertinent
medical, administrative, and social information. Other
AB 1177 (Gomez) Page 6 of ?
requirements include ensuring that the hospital make available
its diagnostic and therapeutic services, and to be accountable
for the recognition of need for social services. The form also
specifies that charges for services performed are to be
collected by the institution rendering services, and that
neither facilities has any liability to the other for such
charges.
3)Related legislation. SB 396 (Hill), would require a surgical
clinic to be eligible for licensure by DPH regardless of
physician ownership, deems a surgical clinic to have met
licensure requirements if they are federally certified,
requires inspections of accredited outpatient surgical
settings to be unannounced, and requires both accredited and
federally certified surgical settings to be subject to the
same reporting requirements to the Office of Statewide Health
Planning and Development as licensed surgical clinics. SB 396
passed the Senate Health Committee by a vote of 9-0 on April
29, 2015, and is pending in the Assembly Appropriations
Committee.
AB 941 (Wood), would exempt, from licensure and regulation, by
DPH any clinic operated by a federally recognized Indian tribe
under a contract with the United States pursuant to the Indian
Self-Determination and Education Assistance Act, regardless of
the location of the clinic. AB 941 passed the Senate Health
Committee by a vote of 8-0 on June 24, 2015, and is pending in
the Senate Appropriations Committee.
AB 1130 (Gray), would expand the licensure exemption for
intermittent clinics that are operated by licensed clinics on
separate premises by permitting these intermittent clinics to
be open for up to 30 hours per week, instead of only 20 hours
per week. AB 1130 passed the Senate Health Committee by a vote
of 8-0 on June 24, 2015, and is pending in the Senate
Appropriations Committee.
4)Prior legislation. AB 980 (Pan, Chapter 663, Statutes of
2013), required the California Building Standards Commission
(CBSC) to adopt emergency regulations to delete a provision of
the 2013 California Building Standards Code that established
building standards for primary care clinics that provide
abortion services, and prohibited the CBSC from adopting any
building code standards for clinics providing medication or
aspiration abortion services that differ from construction
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standards applicable to other primary care clinics. Required
DPH, no later than July 1, 2014, to repeal or revise
regulations relating to abortion services in primary care
clinics to ensure that any requirements specific to abortion
services are consistent with applicable law and medical
standards of care.
5)Support. This bill is sponsored by Planned Parenthood
Affiliates of California (PPAC), which states that this bill
would delete an obsolete regulation that restricts abortion
clinics from obtaining an exemption if they cannot enter into
a transfer agreement with a local hospital. PPAC states that
the Legislature vested DPH with the authority to regulate and
license clinics, but by requiring hospital transfer agreements
as a condition of licensure, DPH has essentially delegated
some of its licensure authority to the hospitals. PPAC states
that any hospital corporation with either a moral objection or
a desire to secure a competitive edge can refuse to sign a
transfer agreement and bring a clinic's license application to
a halt. PPAC states that the existing regulations around the
hospital transfer agreement acts like a targeted restriction
on abortion providers, or a TRAP law. Community clinics that
provide abortion services, like Planned Parenthood, are
singled-out and in this case are unable to file for an
exemption from the hospital transfer agreement requirement.
According to PPAC, although California's laws and regulations
tend to be progressive around abortion and comprehensive
reproductive health care, this bill will address some of the
last remaining policies that single out abortion providers.
The California Family Health Council also supports this bill,
stating that this bill would expand access to essential sexual
and reproductive health care by removing barriers to primary
clinics from getting licenses to operate. The Community Clinic
Association of Los Angeles County states in support that the
decision of whether to grant a license to a clinic should rest
exclusively with the state and should not hinge upon securing
an agreement with an independent entity that, for a variety of
reasons, may or may not be cooperative.
6)Oppose unless amended. The California Chapter of the American
College of Emergency Physicians (California ACEP) states that
they are opposed unless amended to make all clinics equal by
allowing community clinics providing birthing or abortion
services to apply for an exemption from the written transfer
agreement requirement. According to California ACEP, while it
AB 1177 (Gomez) Page 8 of ?
supports the goal of removing barriers to licensing for
clinics offering reproductive services, it is opposed to the
solution offered in this bill of eliminating transfer
agreements with a local hospital for all community clinics as
a condition of licensure. California ACEP states that transfer
agreements between community clinics and one or more nearby
hospitals are important to ensuring that clinics can
adequately coordinate care for patients facing medical
emergencies. California ACEP states that while it is of course
true that a patient can always be transported to an emergency
department by ambulance without accompanying medical
information, it is always better for the patient if the
treating emergency physician has access to personal, health,
and medical information. California ACEP notes that under
current law, clinics may ask DPH to waive the transfer
agreement requirement, as long as those clinics do not provide
birthing or abortion services. Rather than eliminate transfer
agreements for all community clinics, California ACEP states
that this bill should be amended to make all clinics equal by
allowing community clinics providing birthing or abortion
services to apply for an exemption. The California Medical
Association also opposes this bill unless amended with the
same amendment requested by California ACEP.
7)Oppose. This bill is opposed by Concerned Women for America
(CWA), which states that operators of abortion clinics would
benefit from the passage of this bill since abortion
facilities would be able to open without the requirement of
having to get a transfer agreement with a local hospital. CWA
states that in El Centro, a Planned Parenthood recently
opened, and that after months of public outcry by thousands of
Imperial County residents to dissolve a transfer agreement
between El Centro Regional Medical Center, suddenly this bill
makes its way through the California Legislature. CWA states
that women will be endangered further if abortion facilities
are not required to have a transfer agreement with a local
hospital, and that loosening the reins on abortion clinics
will lead to serious injury and death for women. The
California Right to Life Committee (CRLC) also opposes this
bill, stating that primary care clinics are a benefit to their
communities, so one would assume that the medical personnel
would want to include transfer agreements as an important and
valid component of licensure. CRLC states that it has read
about serious situations developing when such facilities have
not had such transfer agreements.
AB 1177 (Gomez) Page 9 of ?
8)Proposed amendments.
a) Recent amendments to this bill generally incorporate
the same transfer requirements that apply to accredited
outpatient surgical settings where general anesthesia is
used to those primary care clinics that use the same
level of general anesthesia. These amendments were in
response to a suggestion from committee staff that while
most primary care clinics do not perform procedures
utilizing general anesthesia, to the extent that they do,
they should meet the same requirements the law imposes on
accredited outpatient surgical settings. Following
further discussions between committee staff, author and
sponsor, the author will propose amendments that further
refine these provisions by, among other things,
simplifying the language, and by requiring these clinics
to attempt to obtain a transfer agreement from two
hospitals, instead of just one, before being exempted
from the transfer requirement.
b) The American Congress of Obstetricians and
Gynecologists, District IX (ACOG, expressed concern to
the author and committee staff that in deleting the
transfer agreement requirement, this bill would also
apply to primary care clinics that are approved by DPH to
be an alternative birth center as a special service.
According to ACOG, written transfer agreements are part
of the standard of care for birthing centers, and while
standards of care do not always have to be written into
the law, it is different when it has been the law and is
being expressly deleted. To address this concern, the
author has proposed amendments to specifically require
alternative birth centers that are licensed as primary
care clinics to maintain a written transfer agreement
with a hospital.
SUPPORT AND OPPOSITION :
Support:
Planned Parenthood Affiliates of California (sponsor)
California Family Health Council
Community Action Fund of Planned Parenthood Orange and San
Bernardino Counties
Community Clinic Association of Los Angeles County
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Planned Parenthood Action Fund of Santa Barbara, Ventura, and
San Luis Obispo Counties
Planned Parenthood Action Fund of the Pacific Southwest
Planned Parenthood Advocacy Project Los Angeles County
Planned Parenthood Mar Monte
Planned Parenthood Northern California Action Fund
Planned Parenthood Pasadena and San Gabriel Valley
Oppose:
California Chapter of the American College of Emergency
Physicians (unless amended)
California Medical Association (unless amended)
California Right to Life Committee
Concerned Women for America of California
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