BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: SB 221
S
AUTHOR: Walters
B
AMENDED: As Introduced
HEARING DATE: April 1, 2009
2
CONSULTANT:
2
Green/
1
SUBJECT
Home dialysis agencies
SUMMARY
Repeals existing law which provides for the licensure and
regulation of home dialysis agencies.
CHANGES TO EXISTING LAW
Existing law:
Existing law establishes "home dialysis agencies," which
are defined as specified entities that engage in providing
home dialysis services and other therapeutic services to
patients in their homes. Existing law defines "home
dialysis services" as the treatment and care given to
patients of a home dialysis agency which are administered
by a physician, qualified registered or licensed nurse, or
qualified hemodialysis technician pursuant to a patient's
care plan.
Existing law requires home dialysis agencies to be licensed
by the Department of Public Health (DPH), and sets forth
various requirements a home dialysis agency must meet in
order to qualify for licensure, having specified policies
relating to patient care, personnel training and
qualifications, and recordkeeping. Home dialysis agencies
Continued---
STAFF ANALYSIS OF SENATE BILL SB 221 (Walters)Page 2
are required to provide specified services, including
nursing, nutritional counseling, medical, and social
services, perform assessments of a patient's home to ensure
a safe physical environment for the performance of
dialysis, and meet specified requirements relating to
dialysis equipment, supplies, and waste disposal.
This bill:
This bill would repeal existing statute which provides for
the licensing and regulation of home dialysis agencies, and
make findings and declarations that the statute has created
confusion and misunderstandings with respect to dialysis
services provided in skilled nursing facilities (SNFs).
FISCAL IMPACT
Unknown.
BACKGROUND AND DISCUSSION
According to the author, when the home dialysis services
statutes were enacted in 1990, there was a company known as
Home Intensive Care which was providing products and
supplies to home dialysis patients and billing Medicare for
their services under a billing approach known as "Method 2
billing." The author states that the statutes establishing
home dialysis agencies was enacted so that Home Intensive
Care could obtain a license as such an agency, in order to
quality for this billing method. However, the author
states that prior to Home Intensive Care's licensure as a
home dialysis agency, the billing method was eliminated by
Medicare, and subsequently, Home Intensive Care went out of
business. Since the change by Medicare, the author states
that no other business has sought licensure as a home
dialysis agency.
The author asserts that the existence of home dialysis
agency laws has created confusion and misunderstandings
with respect to dialysis services provided in skilled
nursing facilities, as these laws were intended to apply to
home dialysis, where a patient has his or her own dialysis
machine and dialyzes at home. The author states that the
only company that supported this type of treatment went out
of business before this law could be implemented, and thus,
STAFF ANALYSIS OF SENATE BILL SB 221 (Walters)Page 3
the law should be repealed.
Home dialysis agencies
The home dialysis agency model set forth by existing law is
one where a patient would receive staff-assisted dialysis
treatment in his or her own home. The home dialysis agency
law defines a "home" as a house, apartment, skilled nursing
facility (SNF), intermediate care facility, congregate
living facility, or other setting where dialysis is
provided by at least one staff person per patient.
According to DPH, although existing statute allows for
licensure of home dialysis agencies, it has never been
implemented, and no provider has been licensed as a home
dialysis agency.
Dialysis services in SNFs
In June 2007, the then Department of Health Services, now
referred to as DPH, issued an All Facilities Letter (AFL)
stating that the provision of dialysis services in a
long-term care setting, including SNFs, was not authorized.
The department interpreted the home dialysis agency
statutes as applicable to SNF dialysis providers; since no
provider was licensed as a home dialysis agency, the
department ordered the delivery of dialysis services in
SNFs to cease.
In August 2007, DPH issued a subsequent All Facilities
Letter which superseded and clarified the letter issued two
months prior. In this letter, DPH stated that, upon
further review, it had determined that dialysis services
may be provided in SNFs under existing regulations, which
allow for the provision of dialysis as an optional service.
DPH clarified that SNFs must meet specified federal
certification standards, and be authorized by DPH to
provide the dialysis services, and that the services must
be added to the facility's license. The letter provided
that these dialysis services may only be provided to
residents of the facility, and not to the general public,
and further provided that if the SNF does not employ
qualified persons to provide dialysis services, it may
contract with an outside service that meets all applicable
standards for providing dialysis services. SNFs are
required to have written policies and procedures for the
management of dialysis services.
STAFF ANALYSIS OF SENATE BILL SB 221 (Walters)Page 4
Other dialysis provider types
Patients may also receive dialysis services in an acute
care hospital, end-stage renal disease (ESRD) clinic, or
chronic dialysis clinic. There are approximately 400
licensed and certified chronic dialysis clinics in
California which serve over 50,000 dialysis patients.
These clinics are generally licensed as freestanding
clinics.
Additionally, ESRD and chronic dialysis clinics, with
certification from DPH, may provide products, supplies,
training, and support to patients who wish to perform
dialysis treatments on their own at home. These services
provided to patients who wish to dialyze at home must be at
least equivalent to those provided in the clinics, meet
most of the same quality and safety standards, as well as
standards for home patient training, monitoring, and
support services.
Arguments in support
The California Dialysis Council (CDC) states that no entity
has ever requested licensure under the home dialysis agency
law, and that the existing of the law has created confusion
among certain dialysis providers. The CDC states that this
bill will help avoid such confusion by repealing the home
dialysis agency law.
The California Association of Health Facilities states that
the home dialysis statute has caused confusion among health
care providers as to whether or not the provision of
dialysis services in SNFs is permitted. CAHF explains that
in 2007, this confusion resulted in a small group of
providers meeting with DPH to ask for clarification on the
law. CAHF states that the meeting prompted DPH's June 2007
AFL disallowing dialysis services in SNFs, which as later
retracted and replaced by the August 2007 AFL clarifying
that dialysis services may be provided in SNFs as an
optional service. CAHF states that this statute is
out-dated, and has never been applied, and that by
repealing the statute, facilities will have clear authority
to provide dialysis services to patients who are often so
ill, that they cannot be safely transported between a
dialysis clinic and their facility of residence.
POSITIONS
STAFF ANALYSIS OF SENATE BILL SB 221 (Walters)Page 5
Support: California Dialysis Council (sponsor)
California Association of Health Facilities
Oppose: None received
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