BILL ANALYSIS �
SB 534
Page 1
Date of Hearing: July 2, 2013
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
SB 534 (Ed Hernandez) - As Amended: April 9, 2013
SENATE VOTE : 34-0
SUBJECT : Health and care facilities.
SUMMARY : Requires, until the California Departments of Public
Health (DPH) and Developmental Services (DDS) adopt regulations
for licensure for Intermediate Care Facilities for the
Developmentally Disabled - Nursing (ICF/DD-N), these facilities
comply with applicable federal certification standards.
Requires chronic dialysis clinics, surgical clinics, and
rehabilitation clinics to comply with federal certification
standards until DPH has adopted regulations for those
facilities. Specifically, this bill :
1)Requires, until DPH adopts regulations relating to the
provision of services by a chronic dialysis clinic, a surgical
clinic, or rehabilitation clinic, the following facilities
licensed or seeking licensure to comply with the following
federal certification standards in effect immediately
preceding January 1, 2013:
a) Requires a chronic dialysis clinic to comply with
applicable federal certification standards for an end stage
renal disease clinic;
b) Requires a surgical clinic to comply with applicable
federal certification standards for an ambulatory surgical
clinic (ASC); and,
c) Requires a rehabilitation clinic to comply with
applicable federal certification standards for a
comprehensive outpatient rehabilitation facility.
2)Requires until the DPH and DDS adopt regulations pursuant to
existing law, relating to services by ICF/DD-N, licensed
facilities to comply with applicable federal certification
standards in effect immediately preceding January 1, 2013.
3)Deletes a requirement that regulations developed by DPH and
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DDS pertaining to ICF/DD-N and ICF/DD-continuous nursing (CN)
include licensing fee schedules appropriate to facilities
which will encourage their development.
EXISTING LAW :
1)Establishes licensure for specified clinics by DPH, including
primary care clinics as well as specialty clinics which
include: surgical clinics, chronic dialysis clinics, and
rehabilitation clinics.
2)Requires DPH to adopt reasonable rules and regulations as may
be necessary to enable DPH to carry out the purposes of
provisions of law governing the various types of clinics
licensed by DPH.
3)Requires those regulations to prescribe the kinds of services
which may be provided by clinics in each category of licensure
and the minimum standards of adequacy, safety, and sanitation
of the physical plant and equipment, minimum standards for
staffing with duly qualified personnel, and minimum standards
for providing the services offered. Requires these minimum
standards to be based on the type of facility, the needs of
the patients served, and the types and levels of services
provided.
4)Licenses and regulates various types of facilities by DPH,
including ICF/DD-N, which is defined as a facility with a
capacity of four to 15 beds that provides 24-hour personal
care, developmental services, and nursing supervision for
persons with developmental disabilities who have intermittent
recurring needs for skilled nursing care but have been
certified by a physician as not requiring continuous skilled
nursing care.
5)Requires DPH and DDS to jointly develop and implement
licensing regulations appropriate for ICF/DD-N and ICF/DD-CN
facilities. Requires, among other things, that the
regulations ensure that residents of an ICF/DD-N and ICF/DD-CN
receive appropriate medical and nursing services and
developmental program services in a normalized, least
restrictive physical and programmatic environment appropriate
to individual resident need.
6)Requires DPH to propose licensing fees for all of its clinics
and facilities at a level that will not require the licensing
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and certification program to seek General Funds to support its
activities unless otherwise specified in statute.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill
would require four health facility categories currently
regulated by DPH to comply with facility-specific federal
certification requirements to meet state licensing
requirements until DPH adopts state regulations. These
facilities are already required to meet federal requirements
in order to receive Medicare and Medicaid funding; this bill
simply gives authority to state regulators to enforce these
standards until such time that DPH adopts regulations specific
to these facilities.
2)BACKGROUND . According to DPH, as of April 2, 2013, there are
173 designated health care facilities that have been issued a
state license. This includes 98 chronic dialysis clinics, 57
ICF/DD-N's, 16 surgical clinics, and two rehabilitation
clinics. Among these four facility types, 166 facilities
(96%) had an active license while the rest, seven (4%) did
not. To date, DPH has not adopted state regulations for these
facilities, but relies on the federal certification standards
to determine licensure.
DPH is currently in the process of drafting regulations for the
ICF/DD facilities, however, committee staff is not aware of
any regulations in process for the surgical clinics, chronic
dialysis clinics, and rehabilitation clinics.
3)FEDERAL REGULATORY STANDARDS . The federal regulatory
standards for chronic dialysis clinics (referred to as End
Stage Renal Centers in federal regulations), surgical clinics
(referred to as ASC in federal regulations), and
rehabilitation clinics, among other things, set forth the
various standards required at each facility in order to
qualify for Medicare and Medicaid participation by the Centers
for Medicare and Medicaid Services (CMS). Depending on the
facility in question, the regulations set requirements for the
facilities management and governing body, what services may be
offered and safety and cleanliness standards. Standards also
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include, but are not limited to, requirements covering patient
rights, the administration of anesthesia, if applicable,
medical records, privacy, and infection control. The federal
regulatory standards for ASCs also include as part of their
requirements for coverage with CMS that the ASC must comply
with state licensure requirements.
4)SUPPORT . This bill is sponsored by DPH. DPH states that
this bill would enable it to adopt existing federal regulatory
standards as the state licensing standards for chronic
dialysis clinics, rehabilitation clinics, surgical clinics,
and ICF/DD-Ns. DPH states that it functions as the regulatory
agency for approximately 30 different types of health care
facilities and clinics. DPH states that it does not have
state licensing standards in place for chronic dialysis
clinics, rehabilitation clinics, surgical clinics, and
ICF/DD-Ns. Federal standards for these facilities exist, but
DPH lacks the statutory authority to enforce the standards.
In the absence of such authority, DPH states that it may only
recommend action by CMS to stop Medicare and Medicaid program
funding if the health care facility is out of compliance.
5)POLICY QUESTION . What assurances does the Legislature have
that the federal certification standards are sufficient to
serve as state licensing standards? The Committee may wish to
ask the sponsor to describe those requirements.
6)SUGGESTED AMENDMENT . In light of the question raised in 5)
above, the Committee may wish to consider amending the bill to
do the following:
a) Sunset the provisions of this bill on January 1, 2018.
b) Require DPH, by July 1, 2017, to conduct at least one
public hearing and submit a report to the relevant
Legislative Committees, describing the extent to which the
federal certification standards are sufficient, or not, as
a basis for state licensing standards, and make
recommendations for any California specific standards which
may be necessary.
7)POLICY CONCERN/PROPOSED AMENDMENTS . This bill does not
specifically reference the "applicable federal certification
standards" that chronic dialysis clinics, surgical clinics,
rehabilitation clinics, and ICF-DD facilities should comply
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with. In response to that concern, the sponsor has offered
the following amendments:
a) On page 3, line 3, delete the word "applicable" and on
line 4, after "clinic" insert: , Title 42 Code of Federal
Regulations, sections 494.1 through 494.180
b) On page 3, line 6, delete the word "applicable" and on
line 7 after "clinic" insert: , Title 42 Code of Federal
Regulations, sections 416.1 through 416.52
c) On page 3, line 8 delete the word "applicable" and on
line 10, after "facility" insert: , Title 42 Code of
Federal Regulations, sections 485.50 through 485.74
d) On page 4, line 34, delete the word "applicable" and on
line 35, after "disabilities" insert: , Title 42 Code of
Federal Regulations Sections 483.400 through 483.480
8)DOUBLE REFERRAL . This bill is double referred. Should it
pass out of this Committee it will be heard by the Assembly
Committee on Aging and Long-Term Care.
9)RELATED LEGISLATION . AB 1312 (Brown) of 2013 authorizes DPH
to, without taking regulatory action, update references in
regulations to health care standards of practice adopted by a
recognized state or national association. AB 1312 was held in
Assembly Health Committee.
10)PREVIOUS LEGISLATION .
a) The California Ambulatory Surgery Association (CASA) has
sponsored several bills intended to establish
state-specific licensure criteria for ASCs:
i) AB 2308 (Plescia) of 2006, would have required the
Department of Health Services (now DPH) to convene a
workgroup to develop licensure criteria to protect
patients receiving care in ASCs and to submit workgroup
conclusions and recommendations to the appropriate policy
committees of the Legislature no later than March 1,
2007. AB 2308 was vetoed by the Governor.
ii) AB 543 (Plescia) of 2007 would have established
licensing requirements for surgical clinics and would
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have required, effective January 1, 2008, that all
surgical clinics meet specified operating and staffing
standards. AB 543 was vetoed by the Governor.
iii) AB 2122 (Plescia) of 2008 would have established the
California Outpatient Surgery Patient Safety and
Improvement Act which would have required surgical
clinics to meet prescribed licensing requirements and
standards, including compliance with Medicare Conditions
of Participation. AB 2122 was held in the Assembly
Appropriations Committee.
b) AB 832 (Jones) of 2009, was also sponsored by DPH and
would have required DPH to convene a workgroup, no later
than February 1, 2010, to consider and develop
recommendations for state oversight and monitoring of ASCs,
to ensure public health and safety. AB 832 was held in the
Assembly Appropriations Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
California Department of Public Health (sponsor)
Opposition
None on file.
Analysis Prepared by : Lara Flynn / HEALTH / (916) 319-2097