BILL ANALYSIS Ó
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 415
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AUTHOR: Logue
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AMENDED: May 27, 2011
HEARING DATE: June 29, 2011
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REFERRAL: Business, Professions and Economic
Development 1
CONSULTANT:
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Chan-Sawin
SUBJECT
Healing arts: telehealth
SUMMARY
Revises the Telemedicine Development Act of 1996 (TDA) to
update and define terminology related to telehealth and
current practice. Amends the verbal and written informed
consent requirements prior to the delivery of health care
via telemedicine. Removes various requirements imposed by
health care service plans (health plans), health insurers,
and Medi-Cal for patients to receive health care services
through telehealth. Removes the sunset date authorizing
teleopthalmology and teledermatology by store and forward
in the Medi-Cal program.
CHANGES TO EXISTING LAW
Medical practices & medical privacy
Existing federal law:
Prohibits, under federal regulations implementing the
federal Health Insurance Portability and Accountability
Act, a health plan, health care clearinghouse or a health
care provider, who transmits health information in
electronic form, from using or disclosing protected health
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information, for purposes other than medical treatment,
payment, or health care operations, as defined, without
written authorization of the patient, with exceptions.
Requires covered entities, and their business associates,
to provide notice of medical privacy breaches involving the
unauthorized acquisition, access, use, or disclosure of
protected health information to each individual whose
information has been subject to a breach within 60 days of
the discovery of the breach.
Provides that if a law enforcement official determines that
notice of a medical privacy breach would impede a criminal
investigation or cause damage to national security, the
notice shall be delayed, in a specified manner.
Existing state law:
Prohibits, under the Confidentiality of Medical Information
Act, licensed or certified health care professionals,
clinics and health facilities, health plans and insurers,
and contracting entities, as defined, from disclosing or
using a patient's medical information for any purpose not
necessary to provide health care services to the patient
and related administrative functions, without first
obtaining authorization from the patient or the patient's
representative, as specified, with exceptions.
Establishes the Medical Board of California (MBC) to
exercise licensing, regulation and disciplinary functions
in accordance with the Medical Practice Act (MPA).
Establishes procedures for physicians to obtain verbal
and/or written informed consent for specified treatments
and procedures, such as hysterectomies, psychosurgery,
electroconvulsive therapy, and assisted oocyte production.
Establishes the TDA, which defines telemedicine as the use
of information technology to deliver medical services and
information from one location to another, and imposes
several requirements governing the delivery of health care
services through telemedicine.
Defines, in the MPA, telemedicine as the practice of health
care delivery, diagnosis, consultation, treatment, transfer
of medical data, and education using interactive audio,
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video, or data communications.
Defines interactive to mean an audio, video, or data
communication involving a real-time (synchronous) or near
real-time (asynchronous) two-way transfer of medical data
and information.
Specifies that neither a telephone conversation nor an
electronic mail message between a health care practitioner
and patient constitutes telemedicine.
Requires the health care practitioner, who has ultimate
authority over the care or primary diagnosis of the
patient, to obtain verbal and written informed consent from
the patient or the patient's legal representative prior to
the delivery of health care via telemedicine, except when
the patient is not directly involved in the telemedicine
interaction (e.g., health care practitioners consulting
with one another), in an emergency situation when a patient
is unable to give informed consent, and the patient is
under the jurisdiction of the California Department of
Corrections and Rehabilitation (CDCR) or any other
correctional facility.
Establishes a separate informed consent procedure
specifically for telemedicine that requires at least all of
the following information be given to the patient or the
patient's legal representative verbally and in writing:
The patient or the patient's legal representative
retains the option to withhold or withdraw consent at
any time without affecting the right to future care or
treatment or program benefits;
A description of the potential risks, consequences,
and benefits of telemedicine;
All existing confidentiality protections apply;
All existing laws regarding patient access to
medical information and copies of medical information
and copies of medical records apply; and,
Prohibits dissemination of any patient identifiable
images or information from the telemedicine
interactions to researchers or other entities from
occurring without consent.
Requires a patient or the patient's legal representative to
sign a written statement prior to the delivery of health
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care via telemedicine, indicating that the patient or the
patient's legal representative understands the written
information provided and that this information has been
discussed with the health care practitioner, or his or her
designee.
Makes the patient's written consent statement part of the
patient's medical record.
Specifies that a practitioner's failure to comply with the
requirements related to the additional informed consent to
be unprofessional conduct, but not a misdemeanor.
Makes various legislative findings and declarations related
to telehealth.
This bill:
Deletes the term "telemedicine" and replaces it with
"telehealth." Defines telehealth as the mode of delivering
health care services and public health via information and
communication technologies to facilitate the diagnosis,
consultation, treatment, education, care management, and
self-management of a patient's health care while the
patient is at the originating site and the health care
provider is at a distant site.
States that telehealth facilitates patient self-management
and caregiver support for patients and includes synchronous
interactions and asynchronous store and forward transfers.
Defines asynchronous store and forward to mean the
transmission of a patient's medical information from an
originating site to the health care provider at a distant
site without the presence of the patient.
Defines distant site to mean a site where a health care
provider who provides health care services is located while
providing these services via a telecommunications system.
Defines originating site to mean a site where a patient is
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located at the time health care services are provided via a
telecommunications system or where the asynchronous store
and forward transfer occurs.
Replaces provisions in the MPA relating to written and
informed patient consent prior to the delivery of health
care via telemedicine with the requirement for providers,
prior to the delivery of health care via telehealth, to
verbally inform the patient that telehealth may be used,
obtain verbal consent from the patient for this use, and
document the verbal consent in the patient's medical
record.
Requires all laws regarding the confidentiality of health
care information and a patient's rights to his/her medical
information to apply to all telehealth interactions.
Telehealth provisions relating to health plans and insurers
Existing state law:
Prohibits health plans and insurers from requiring
face-to-face contact between a health care provider and a
patient for services appropriately provided through
telemedicine, subject to all terms and conditions of the
contract agreed upon between the enrollee or subscriber and
the plan or insurer. Applies this prohibition to Medi-Cal
managed care contracts only to the extent telemedicine
services are covered by and reimbursed under the Medi-Cal
fee-for-service program, and Medi-Cal managed care
contracts are amended to add coverage of telemedicine
services and make any appropriate capitation rate
adjustments.
Prohibits health plans and insurers from being required to
pay for consultation provided by the health care provider
by telephone or facsimile machines.
Requires that a patient receiving such services to be
notified of the right to receive interactive communication
with the distant provider upon request.
This bill:
Repeals a prohibition on health plans and insurers that
prevents them from requiring face-to-face contact between a
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health care provider and a patient for services
appropriately provided through telemedicine, and replaces
it with a prohibition on health plans and insurers from
requiring in-person contact between a health care provider
and a patient before payment is made for the covered
services appropriately provided through telehealth.
Specifies that this requirement shall not be interpreted to
authorize a health plan or insurer to require the use of
telehealth when the provider has determined that such use
is inappropriate.
Requires every health plan, including those contracting
with the Medi-Cal managed care Program, and every health
insurer to adopt payment policies, as specified, to
compensate providers who provide covered health care
services through telehealth, subject to the terms and
conditions of the contract between the enrollee or
subscriber and the health plan or insurer.
Prohibits a health plan, a health insurer, and Department
of Health Care Services (DHCS) from limiting the type of
setting where services are provided for the patient or by
the health care provider.
Telehealth provisions relating to Medi-Cal
Existing state law:
Establishes the Medi-Cal program, administered by DHCS,
under which health care services are provided to qualified
low-income persons.
Specifies that face-to-face contact between a health care
provider and a patient shall not be required under the
Medi-Cal program for services appropriately provided
through telemedicine, subject to reimbursement policies
developed by the Medi-Cal program to compensate licensed
health care providers who provide health care services,
which are otherwise covered by the Medi-Cal program,
through telemedicine, as specified.
Defines, for the purposes of Medi-Cal, "teleophthalmology
and teledermatology by store and forward" as an
asynchronous transmission of medical information to be
reviewed at a later time and at a distant site by a
physician who is trained in ophthalmology or dermatology,
where the physician at the distant site reviews the medical
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information without the patient being present in real-time.
Sunsets the provision authorizing the provision of
teleophthalmology and teledermatology services for the
purposes of Medi-Cal, in January 1, 2013.
This bill:
Prohibits in-person contact between a health care provider
and a patient before payment is made in the Medi-Cal
program subject to reimbursement policies adopted by DHCS
to compensate a licensed health care provider who provides
health care services through telehealth that are otherwise
reimbursed pursuant to Medi-Cal.
Prohibits DHCS from requiring a provider to document a
barrier to an in-person visit for Medi-Cal coverage of
services provided via telehealth.
Prohibits DHCS from limiting the type of settings where
services are provided for the patient or by the health care
provider for the purposes of payment for covered services
or treatment provided via telehealth.
Clarifies that this bill may not be interpreted to
authorize DHCS to require the use of telehealth when the
provider has determined that it is not appropriate.
Deletes the January 1, 2013 sunset date in existing law
that authorizes teleophthalmology and teledermatology
services by store and forward in the Medi-Cal program.
FISCAL IMPACT
According to the Assembly Appropriations Committee
analysis:
Unknown one-time workload costs to DHCS, unlikely
to exceed $100,000, to modify regulations, develop
specific payment policies, and communicate the new
policies via provider bulletins.
Potential unknown additional costs, or savings, for
telehealth services in the Medi-Cal program. The cost
impacts would depend on changes in payment policies
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developed by DHCS and any resulting changes in
provider billing behavior. A significant increase in
the use of telehealth could have indirect fiscal
impacts on Medi-Cal and health plans and insurers.
However, these potential impacts are speculative and
would be effects of the broader adoption of
telehealth, not specific impacts of this bill.
BACKGROUND AND DISCUSSION
According to the author, California was the first state to
pass telehealth legislation in 1996. The Telemedicine
Development Act (TDA) of 1996, among other things,
established telemedicine as a legitimate means of receiving
health care services, and provided parameters for
reimbursement in both private and public health coverage
plans. When first passed in 1996, telemedicine was still
an unknown entity to many. According to the author, there
have been significant technological advances and changes in
the health and policy landscape, and the author believes
that the provisions of the original TDA and its subsequent
amendments are outdated and may inhibit the full adoption
of telehealth in this state and its potential benefits,
such as reducing costs, increasing access and improving the
quality of care. For example, the author states that
restrictions on providing health care services and
consultations through email and phone services in state law
do not reflect current practices by private payers who have
utilized these options in order to deliver care in a more
efficient and effective manner.
The author states that AB 415 cleans up provisions in
current law that have provided barriers in adopting the
advances and changes made in the last 15 years, in addition
to reducing the duplicative administrative work and
barriers regarding telehealth. The author believes AB 415
will also improve access for residents of medically
underserved areas of the state, especially children, older
adults, and those who cannot afford to travel to receive
specialty care. By providing a mode for the timely
delivery of care, the author asserts that this will prevent
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avoidable hospitalizations and, in turn, decrease morbidity
and mortality rates from unmanaged or inadequately managed
chronic diseases.
Telehealth
Telehealth is a mode of delivering health care services and
public health using information and communication
technologies that enable the diagnosis, consultation,
treatment, education, care management, and self-management
of patients. It includes telemedicine, which is the
diagnosis and treatment of illness or injury, and
telehealth services can range from diagnosis, treatment,
assessment, monitoring, communications, and education.
Currently, telehealth services are primarily delivered in
three ways:
Video conferencing, which is used for real-time
patient-provider consultations, provider-to-provider
discussions, and language translation services;
Patient monitoring, in which electronic devices
transmit patient health information to health care
providers; and
Store and forward technologies, which
electronically transmit pre-recorded videos and
digital images, such as X-rays, video clips, and
photos, between primary care providers and medical
specialists.
Telehealth is commonly used to address the problems of
inadequate provider distribution and is used in the
development of health systems in rural and medically
underserved areas. It has the potential to reduce costs,
improve quality, change the conditions of practice and
improve access to health care services.
Center for Connected Health Policy report on telehealth
In February 2011, the Center for Connected Health Policy
(CCHP) issued a report with 13 recommendations to update
California's TDA. The revisions to existing law that this
bill contemplates are based on the following
recommendations from the CCHP report:
Update the term "telemedicine" used in current law
to "telehealth," to reflect changes in technologies,
settings, and applications for medical and other
purposes;
Include the asynchronous application of
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technologies in the definition of telehealth and
remove the 2013 sunset date for Medi-Cal reimbursement
of teledermatology, teleophthalmology, and
teleoptometry services;
Remove restrictions in the current telemedicine
definition that prohibit telehealth-delivered services
provided via email and telephone;
Eliminate the current Medi-Cal requirement to
document a barrier to an in-person visit for coverage
of services provided using telehealth;
Require private health care payers and Medi-Cal to
cover encounters between licensed health practitioners
and enrollees irrespective of the setting of the
enrollee and providers; and
Remove the requirement necessitating an additional
informed consent waiver be obtained prior to any
telehealth services being rendered.
The CCHP indicates that telehealth is a mode of providing
services, not a treatment or procedure, but is treated in
California law in the same manner as highly invasive
procedures. The report states that by eliminating the
duplicative required written informed consent, more
patients can make more expedient choices regarding their
care.
Related bills
AB 386 (Galgiani) would require CDCR to have an operational
telemedicine services program in all state prisons, as
specified, by January 1, 2016. Held on the Suspense File
in Assembly Appropriations Committee.
SB 946 (Committee on Health) would incorporate some of the
same terminology changes proposed in this bill. Set for
hearing in Assembly Health Committee for July 5, 2011.
Prior legislation
AB 175 (Galgiani), Chapter 419, Statutes of 2010, for the
purposes of Medi-Cal reimbursement, expands, until January
1, 2013, the definition of "teleophthalmology and
teledermatology by store and forward" to include services
of an optometrist who is trained to diagnose and treat eye
diseases.
AB 2120 (Galgiani), Chapter 260, Statutes of 2008, extends
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the Medi-Cal telemedicine reimbursement authorization until
January 1, 2013.
AB 329 (Nakanishi), Chapter 386, Statutes of 2007,
authorizes the MBC to establish a pilot program to expand
the practice of telemedicine, and to convene a working
group. Specifies that the purpose of the pilot program is
to develop methods, using a telemedicine model, of
delivering health care to those with chronic diseases and
delivering other health information, and requires MBC to
make recommendations regarding its findings to the
Legislature within one calendar year of the commencement
date of the pilot program. MBC reports that this pilot
program is currently commencing.
AB 1224 (Hernandez), Chapter 507, Statutes of 2007, adds
optometrists to the list of health care providers covered
under laws governing telemedicine services.
AB 2661 (Dymally) of 2007 would have added telephone
communication to the definition of telemedicine, would have
require the practitioner practicing telemedicine by
telephone to use an electronic medical record, and would
have provided that a practitioner may be designated by the
patient. Failed passage out of Assembly Health Committee.
AB 354 (Cogdill), Chapter 449, Statutes of 2005, expands
telemedicine provisions by providing that, from July 1,
2006 through December 31, 2008, face-to-face contact
between a health care provider and a patient shall not be
required for the Medi-Cal program for store and forward
teleophthalmology and teledermatology services.
SB 1341 (Kuehl) of 2004 would have expanded the definition
of telemedicine to include the use of store-and-forward
technology for teledermatology and teleophthalmology
services, and to allow Medi-Cal reimbursement for these two
types of services provided by health care practitioners via
telemedicine. Vetoed by the Governor.
AB 116 (Nakano), Chapter 20, Statutes of 2003, clarifies
that the TDA applies to marriage and family therapists
(MFTs) so that MFTs may deliver services using interactive
audio, video, or data communications without direct contact
with the patient.
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SB 1665 (Thompson), Chapter 864, Statutes of 1996,
establishes the TDA, to set standards for the use of
telemedicine by health care practitioners and insurers.
TDA specifies, in part, that face-to-face contact between a
health care provider and a patient shall not be required
under the Medi-Cal program for services appropriately
provided through telemedicine, when those services are
otherwise covered by the Medi-Cal program, and requires a
health care practitioner to obtain verbal and written
consent prior to providing services through telemedicine.
Arguments in support
The California State Rural Health Association (CSRHA), the
sponsor of the bill, states that telehealth and other
health information technologies (HIT) are critical tools
for California's rural health care safety net, and have the
potential to increase health care access, quality, and the
cost-effectiveness of care in rural communities, especially
for specialty care. Telehealth and other HIT can ensure
that rural patients receive timely care that otherwise
would be unavailable to them. CSRHA believes that the lack
of adequate care increases the costs of health care in
rural communities. Further, telehealth allows rural
communities to care for patients in their home community
rather than requiring them to travel to distant cities, and
allows more health care dollars to be spent in the rural
community where the patient's home is located. CSRHA also
asserts that telehealth and other advanced HIT applications
can alleviate chronic shortages of specialty care providers
and increase the ability of rural communities to attract
and retain health care providers.
The Children's Partnership (TCP) supports this bill because
low-income children living in medically underserved areas -
both rural and parts of urban areas - face geographic and
economic barriers to accessing health care. TCP states
that telehealth helps to overcome these barriers - such as
provider shortages, transportation costs, and lost time
from work and school - by using technology to bring the
care to where the children are located.
According to the University of California (UC), which
supports this bill, there are three major initiatives
underway to expand the use of telehealth technologies and
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expertise throughout the state. The first is the
California Telehealth Network (CTN), a recent statewide
broadband initiative to provide managed broadband access to
hundreds of primarily rural health care facilities
throughout California. The CTN expects to link more than
800 qualified sites, including the five UC academic health
systems, Stanford University, University of Southern
California, and Loma Linda University in a peer-to-peer
network which will be one of the largest in the nation. A
second initiative nables the expansion of existing
telemedicine programs at UC medical school campuses to
provide facilities and state-of-the-art equipment to expand
use of telemedicine across the state. Lastly, the
Specialty Care Safety Net Initiative is a collaborative
effort between UC medical school specialty departments and
safety net clinics in California. The initiative seeks to
identify barriers to adoption and sustainability of
telehealth programs in high-need specialties such as
dermatology, endocrinology, hepatology, neurology,
orthopedics and psychiatry.
PRIOR ACTIONS
Assembly Health: 16- 0
Assembly Appropriations:17- 0
Assembly Floor: 76- 0
COMMENTS
1. Reporting of telehealth services under the Medi-Cal
program. Current law contains a provision requiring DHCS
to report to the Legislature, on or before January 1, 2008,
the number and type of services provided, and payments
made, related to the application of store and forward
telemedicine for teleophthamology and teledermatology.
Given that AB 415 would remove existing barriers to
telehealth services and have the likely result of
increasing the use of telehealth beyond teleopthamology and
teledermatology, the author may wish to include a reporting
requirement to track telehealth usage and best practices.
2. Suggested technical amendments:
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(a) On page 5, strike out lines 1-2 inclusive and
insert:
system or where the asynchronous store and forward
service originates.
(b) On page 6, strike out lines 15-16 inclusive
and insert:
with Section 14087.96), Article 2.91 (commencing
with Section14089), or Chapter 8 (commencing with
Section 14200) of the Welfare and Institutions
Code.
POSITIONS
Support: AgeTech California
Association of California Healthcare Districts
BayBio
California Association of Physician Groups
California Center for Rural Policy at Humboldt
State University
California Healthcare Institute
California Hospital Association
California Medical Association
California State Rural Health Association
Continua Health Alliance
Del Norte Clinics, Inc.
Kaiser Permanente
Kings View Corporation
Latino Coalition for a Healthy California
Medical Board of California
National Multiple Sclerosis Society - California
Action Network
Occupational Therapy Association of California
Peach Tree Healthcare
Regional Council of Rural Counties
Rural Health Sciences Institute
The Children's Partnership
University of California
Oppose: None received.
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