BILL ANALYSIS
SB 221
Page 1
Date of Hearing: June 9, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
SB 221 (Walters) - As Amended: April 21, 2009
SENATE VOTE : 37-0
SUBJECT : Home dialysis agencies.
SUMMARY : Repeals existing law authorizing the licensure and
regulation of home dialysis agencies (HDAs).
EXISTING LAW :
1)Establishes HDAs, defined as specified entities engaged in
providing dialysis treatments and other therapeutic assistance
to patients in their homes.
2)Defines "home dialysis treatment" as the treatment and care
given to patients of HDAs and administered by a physician and
surgeon, a qualified registered nurse, a qualified licensed
nurse, or a qualified hemodialysis technician, according to a
patient care plan.
3)Prohibits specified entities from operating HDAs unless a
license has been issued by the Department of Health Services
(DHS) (now the Department of Public Health (DPH)).
4)Requires applicants for a HDA license to meet specified
requirements, including that they prescribe written policies
relating to patient care, staffing requirements, personnel
training and supervision, and evaluation of the services
provided by the HDA; maintain clinical records on each
patient, as specified; and, establish procedures for
transferring patients in need of emergency medical care to a
hospital.
5)Requires HDAs to provide a minimum level of services including
nursing services, nutritional counseling, and medical social
services; perform assessments of a patient's home to ensure a
safe physical environment for the performance of dialysis; and
meet specified requirements governing dialysis equipment,
supplies, and waste disposal.
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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 sponsor of this bill,
the California Dialysis Council, at the time that the HDA
licensing law was enacted in 1990, there was a company known
as Home Intensive Care (HIC) that provided products and
supplies to home dialysis patients and billed Medicare for
those services under a billing option known as "Method 2
billing." The sponsor asserts that the statutes governing the
licensure of HDAs were enacted to provide an avenue for HIC in
particular to be licensed as such an agency, in order to
quality for this billing method. However, the sponsor notes
that, before HIC could obtain a HDA license, the Method 2
billing approach was eliminated by Medicare, and subsequently,
HIC went out of business. The sponsor argues that current law
regarding HDAs needs to be repealed because the only company
that supported home dialysis went out of business before the
law could be implemented. Furthermore, the sponsor adds that
repealing current statute will remove confusion that has since
arisen with respect to dialysis services provided in skilled
nursing facilities (SNFs), as these laws were only intended to
apply to home dialysis in which a patient has his or her own
dialysis machine and performs dialysis at home.
2)BACKGROUND . The National Institute of Diabetes, Digestive and
Kidney Diseases (NIDDK) reports that 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 (PD), and
hemodialysis (HD). PD uses a catheter placed near a patient's
abdomen to act as a filter that allows toxins and fluid to be
removed from the blood. HD 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 (ESRD), otherwise known as kidney failure. Standard
(HD) treatment is delivered in a clinic three to four times a
week with each treatment taking three to four hours to
complete. However, NIDDK indicates that a small but growing
number of clinics also offer home HD in addition to standard
treatment. Initially, patients receive training to learn how
to do HD treatments at the clinic, with assistance from a
dialysis nurse. The clinic then provides a machine for use in
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the home or helps the patient obtain a machine from a
supplier. During the initial training period, which lasts
from three to eight weeks, the patient learns to prepare
equipment and supplies; perform proper needle placement; check
his or her blood pressure and pulse; maintain records of the
treatments; clean the equipment and the dialysis area; and,
order supplies. Clinical staff is required to ensure that the
patient is confident about performing each of these tasks
before allowing the patient to administer HD at home.
Patients return to the clinic once a month to see the kidney
specialist, dialysis nurse, and dietitian. A blood sample is
tested to ensure the HD treatments are working and to detect
any problems that need to be treated, such as anemia or high
potassium levels.
3)HDAs . The HDA model described in existing law enables a
patient to receive staff-assisted dialysis treatment in his or
her own home. Existing statute regulating these agencies
defines a "home" as a house, apartment, SNF, intermediate care
facility, congregate living facility, or other setting where
dialysis is provided by at least one staff person per patient.
Generally, a HDA provides the medications, needles, tubing,
artificial dialyzers, dialysis fluids, dialysis machines,
water treatment equipment, and other products used in home
dialysis. DPH reports that, while existing law allows for the
licensure of HDAs, it has never actually been implemented in
California and, to date, there have not been any providers
licensed in the state to operate as an HDA.
4)DIALYSIS SERVICES IN SKILLED NURSING HOMES . In June 2007,
DHS, now DPH, stated in an All Facilities Letter (AFL) that
long-term care providers, including SNFs, were not authorized
under current statute to provide dialysis services to
residents and prohibited these services from being provided by
facility staff, hospital-based staff, or by staff under
contract with a licensed dialysis clinic. Although DPH
indicated in the letter that current law allowing HDAs to be a
licensed category was out of date since no license had been
issued under this authority, it also specified that unless the
law was modified to allow for the safe delivery of dialysis
services in a home setting, which could include a SNF,
dialysis services were prohibited from being provided by a
long-term care facility.
Subsequently, in August 2007, DPH issued a revised AFL to
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clarify the letter issued two months earlier. In the revised
letter, DPH stated that, upon further review, it determined
that dialysis services were permitted to be provided in SNFs
pursuant to current regulations, which allow for dialysis to
be provided as an optional service. The letter further
clarified that a SNF must meet specified federal certification
standards, be approved by DPH to provide the dialysis
services, and the services must be added to the facility's
license. The letter stated that these dialysis services may
only be provided to residents of the facility, and not to the
general public, and permitted a SNF that does not employ
qualified persons to provide dialysis services to contract
with an outside provider that meets all applicable standards.
Lastly, the letter indicated that SNFs must have written
policies and procedures in place for the management of
dialysis services.
5)OTHER TYPES OF DIALYSIS PROVIDERS . DPH indicates that
currently, patients receiving dialysis can receive these
services in an acute hospital, outpatient ESRD clinic, chronic
dialysis clinic, or as a patient in a SNF. There are
approximately 400 licensed and certified chronic dialysis
clinics in California which serve over 50,000 dialysis
patients. Generally, these clinics are licensed as standalone
facilities. According to DPH, ESRD clinics and chronic
disease clinics cannot provide home HD to patients at this
time. DPH reports that there is a certification program for
these providers to do a home dialysis training program to
provide products, supplies, training, and support to patients
who wish to do home dialysis treatments on their own. The
services provided to patients who wish to perform home
dialysis are required to at least be equivalent to those
provided in the clinics, and to meet most of the same
standards governing quality and safety, home patient training,
monitoring, and support services.
6)PRIOR LEGISLATION . SB 749 (Royce), Chapter 586, Statutes of
1989, provides the authority for DPH to license HDAs, subject
to specified requirements and conditions, including payment of
a biennial licensing fee.
7)SUPPORT . The California Association of Health Facilities
(CAHF) writes in support that this bill will provide more
stable guidance from the state to facilities with regard to
the authority to perform dialysis services. CAHF notes that
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clear authority to allow these services to be provided in
facilities will benefit patients who are too ill to be safely
transported between a dialysis clinic and their facility of
residence. CAHF states that this bill will resolve issues
about where to transfer patients currently residing in SNFs
who are in need of dialysis while addressing the backlog of
patients at acute care hospitals who require a lower level of
care but are also in need of these services. The National
Kidney Foundation adds that this bill is needed to repeal
statutes that were established for a company that no longer
exists and that were originally intended to allow this company
to use a billing method that Medicare no longer uses.
REGISTERED SUPPORT / OPPOSITION :
Support
California Dialysis Council (sponsor)
California Association of Health Facilities
National Kidney Foundation
Opposition
None on file.
Analysis Prepared by : Cassie Rafanan / HEALTH / (916)
319-2097