BILL ANALYSIS
SJR 13
Page 1
Date of Hearing: June 15, 2010
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SJR 13 (Oropeza) - As Introduced: June 2, 2009
SENATE VOTE : 36-0
SUBJECT : New dialysis clinic licensure and certification.
SUMMARY : Urges the President and the federal Centers for
Medicare and Medicaid Services (CMS) to enact legislation to
expedite the process for dialysis clinic licensure.
Specifically, this resolution :
1)Makes various findings and declarations relating to the
critical need for more end stage renal disease dialysis
clinics in California and the lengthy federal requirements
dialysis clinics must meet to obtain licensure.
2)Memorializes CMS to adopt regulations and the President and
Congress to enact legislation to improve the process for
timely licensure and certification surveys of new dialysis
clinics to provide patients with access to these services as
soon as possible and to eliminate the chilling impact on new
clinic construction in California.
EXISTING FEDERAL LAW establishes various requirements that
health care providers, including specialty clinics, must meet to
participate in the Medicare and Medicaid programs.
EXISTING STATE LAW :
1)Charges the Department of Public Health (DPH) with the
regulation and oversight of primary care clinics and specialty
clinics.
2)Defines a chronic dialysis clinic as a type of specialty
clinic that provides less than 24-hour care for the treatment
of patients with end-stage renal disease, including renal
dialysis services.
FISCAL EFFECT : None
COMMENTS :
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1)PURPOSE OF THIS RESOLUTION . According to the author, the
current process for licensing a dialysis clinic in order to
receive Medicare certification, and thus Medicare funding, is
onerous, cumbersome, and unnecessarily slow, resulting in
delays that impact patient care. The author notes that
current federal requirements for a new clinic to undergo both
a state licensure survey and a separate federal survey, which
do not occur at the same time, mean that patients may wait up
to a year for a new facility to open. The author points out
that this delay has the dual effect of reducing the incentive
for a dialysis provider to open new facilities while causing
patients to often travel much farther than necessary to access
dialysis services. The author states that this resolution is
intended to urge CMS to simply allow state and federal
licensure surveys to occur simultaneously in order to speed up
the licensing process and allow more clinics to open in the
state.
2)DIALYSIS . According to the National Institute of Diabetes,
Digestive and Kidney Disease, dialysis is a treatment for
patients with kidney disease to remove wastes, toxins, and
fluids from the blood when the kidneys have failed. There are
two types of dialysis, peritoneal dialysis, and hemodialysis.
Hemodialysis uses a catheter that is placed in a patient's arm
to remove, clean, and return blood to the body, and it is the
most common treatment for end-stage renal disease, otherwise
known as kidney failure. Standard dialysis treatment is
delivered in a clinic three to four times a week with each
treatment taking three to four hours to complete.
3)LICENSING & CERTIFICATION . Health care facilities in
California are licensed, regulated, inspected, and/or
certified by several public and private agencies at the state
and federal levels, including the Licensing and Certification
Program (L&C) of DPH and the federal CMS. These agencies
have separate, and sometimes overlapping, jurisdictions. L&C
is responsible for ensuring health care facilities comply with
state laws and regulations. Additionally, L&C cooperates with
CMS to ensure that facilities that accept Medicare and
Medicaid (Medi-Cal in California) payments meet federal
requirements.
L&C indicates that a facility that has submitted a licensing
application is initially subject to a licensing survey, which
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focuses on building standards, policies and procedures, the
credentialing of staff, and equipment and supplies. A
facility seeking to receive Medicare and Medicaid payments
must submit a separate application to CMS. Once that
application is approved, L&C conducts a federal certification
survey, which is designed to ensure that the facility can
provide services in compliance with federal regulations.
DPH reports that while it is unable to estimate the length of
time it takes to conduct the initial licensing and
certification surveys, it believes it has improved the
timeliness of the surveys. The timelines for the surveys also
differ among its field offices, depending on their workload.
L&C's licensing survey work is funded through license facility
fees and it receives federal funding for the certification
surveys. DPH notes that since a facility cannot operate
without first having a license, and the federal certification
survey assesses how a facility is actually delivering care to
patients in accordance with federal regulations, it is
impossible for L&C surveys to be conducted concurrently under
existing law.
4)CMS CONDITIONS OF PARTICIPATION . CMS develops minimum health
and safety standards that health care providers must meet in
order to participate in the Medicare and Medicaid programs.
States conduct initial and periodic surveys, or inspections,
to determine whether the provider complies with these
conditions of participation on behalf of CMS. CMS establishes
conditions of participation for such health care providers as
ambulatory surgical centers, dialysis facilities, federally
qualified health centers, home health agencies, hospitals, and
nursing facilities.
5)FEDERAL SURVEY CATEGORIES . Currently, CMS establishes
priorities for initial certification surveys. Tier 1 consists
of statutorily mandated surveys for hospitals, acute care
facilities, skilled nursing facilities, and home health
agencies, as well as surveys conducted in response to
immediate jeopardy complaints. Tier 2 consists of surveys in
response to other complaints. Tier 3 consists of end-stage
renal disease facilities and transplant centers. CMS
designates a higher priority for certification surveys to
these facilities than to other types of providers, due to the
heavy reliance of patients who need these services on
Medicare, and the lack of accreditation options for these
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facilities. Tier 4 consists of initial certifications of all
other provider types that have the option to achieve Medicare
status by demonstrating compliance through an approved
accrediting organization, as well as any other types of
providers not otherwise included in Tier 3. While CMS
maintains that California is receiving sufficient funding to
conduct Tier 1 through 3 survey work, funding for Tier 4
facilities, including for initial certification surveys, is
generally acknowledged to be insufficient.
6)PRIOR LEGISLATION .
a) SB 112 (Oropeza), Chapter 559, Statutes of 2009, revises
the training requirements for certified hemodialysis
technicians.
b) SB 1474 (Alquist) of 2008 would have required DPH to
promulgate regulations for implementing procedures
governing the surveillance, and reporting of, violations of
patient rights and sanitary standards at chronic dialysis
clinics, as specified. SB 1474 was set for a hearing in
the Senate Health Committee but the hearing was cancelled
at the request of the author.
7)SUPPORT . The sponsor of this resolution, the California
Dialysis Council, notes that there is currently a delay in the
licensure and certification surveys done by DPH of more than
12 months in some cases. The sponsor asserts that, given the
delays in opening new facilities due to the separate licensing
and certification surveys that must be conducted, this
resolution will help to address the dearth of dialysis clinics
in the state by making the process more timely. Fresenius
Medical Care North America and DaVita, providers of dialysis
services, write that it is crucial that the federal government
enact legislation to streamline the current process as the
number of dialysis patients in California in dire need of
licensed and certified clinics is growing daily.
REGISTERED SUPPORT / OPPOSITION :
Support
California Dialysis Council (sponsor)
DaVita
Fresenius Medical Care North America
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Opposition
None on file.
Analysis Prepared by : Cassie Rafanan / HEALTH / (916)
319-2097