BILL ANALYSIS Ó
AB 2253
Page 1
Date of Hearing: May 8, 2012
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 2253 (Pan) - As Introduced: February 24, 2012
SUBJECT : Clinical laboratory test results: electronic
conveyance.
SUMMARY : Authorizes the conveyance of clinical laboratory test
results (lab test results) relating to human immunodeficiency
virus (HIV) antibody test, presence of antigens indicating a
hepatitis infection, abusing the use of drugs, or test results
related to routinely processed tissues that reveal malignancy,
as specified, by Internet posting or other electronic means to a
patient where the patient requests a conveyance, the health care
professional deems the conveyance as the most appropriate means,
and a health care professional has first discussed the results
with the patient.
EXISTING LAW :
1)Provides that a patient authorized by law to consent to
medical treatment, and any patient representative, shall be
entitled to inspect patient records upon presenting to the
health care provider a written request for the records, and
upon payment of reasonable costs, as specified. Provides that
a health care provider must permit the inspection during
business hours within five working days after receipt of the
written request. States that the costs of copying shall not
exceed $0.25 per page or $0.50 per page for records that are
copied from microfilm and any additional reasonable clerical
costs, as specified.
2)Requires a health care professional at whose request a test is
performed to provide or arrange for the provisions of the
results of a clinical laboratory test to the patient who is
the subject of the test if requested by the patient, in plain
language in oral or written form. Authorizes the results to
be conveyed in electronic form if requested by the patient and
if deemed most appropriate by the health care professional who
requested the test.
3)Requires that the consent of the patient to receive his or her
laboratory results by Internet posting or other electronic
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means to be obtained in a manner consistent with specified
requirements.
4)Provides that if a health care professional arranges for the
provision of test results by Internet posting or other
electronic manner, the results shall be delivered to a patient
in a reasonable time period, but only after the results have
been reviewed by the health care professional. States that
access to clinical laboratory test results shall be restricted
by the use of a secure personal identification number when the
results are delivered to a patient by Internet posting or
other electronic manner.
5)Indicates that the test results to be reported to the patient
must be recorded in the patient's medical record, and must be
reported to the patient within a reasonable time period after
the test results are received at the offices of the health
care professional who requested the test.
6)Prohibits the conveyance to a patient by Internet posting or
other electronic means for the following clinical laboratory
test results: HIV antibody test, presence of antigens
indicating hepatitis infection, abusing the use of drugs, or
test results related to routinely processed tissues, including
skin biopsies, Pap smear tests, products of conception, and
bone marrow aspirations for morphological evaluation, if they
reveal a malignancy.
7)States that patient identifiable test results and health
information shall not be used for any commercial purpose
without the consent of the patient, as specified.
8)Defines health care provider to include a licensed health
facility, clinic, home health agency, physician and surgeon,
podiatrist, dentist, and optometrist.
9)Specifies that an electronic health record (EHR) system or
electronic medical record (EMR) system shall: a) protect and
preserve the integrity of medical information; b)
automatically record and preserve any change or deletion of
any electronically stored medical information, as specified;
and, c) a patient's right to access or receive a copy of his
or her EMR upon request shall be consistent with applicable
state and federal laws governing patient access to, and the
use and disclosure of, medical information.
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FISCAL EFFECT : None
COMMENTS :
1)PURPOSE OF THIS BILL . The author is the sponsor of this
measure. According to the author, this bill is necessary to
remove barriers for patients in accessing lab test results
relating to HIV, hepatitis, abuse of drugs, and certain
processed tissues, through an Internet posting or other
electronic format. Federal regulators are easing the
requirements for patients to directly access their clinical
lab results, and California's prohibition on access to these
specific lab results is hindering the widespread use of EHR.
Additionally, the federal stimulus program, the American
Recovery and Reinvestment Act of 2009 (ARRA), signed by
President Obama in 2009 is offering incentive payments to
eligible professionals and hospitals that implement meaningful
use of EHRs. This bill would assist eligible professionals
and hospitals to qualify for these incentive payments while
allowing patients to take an active role in their health care.
2)BACKGROUND .
a) Patient Access to Clinical Laboratory Test Results .
State and federal laws govern the release of patient
medical information, including those of lab test results.
California entitles patients to the right to inspect and
copy their patient records upon written request and payment
of reasonable costs incurred in locating and making the
records available. Patients are also authorized to obtain
the results of lab test results performed at the request of
a health care professional. These lab test results may
also be conveyed in electronic form if requested by the
patient and deemed appropriate by the health care
professional who requested the test. However, lab test
results relating to HIV antibody tests, presence of
antigens indicating a hepatitis infection, abusing the use
of drugs, or test results related to routinely processed
tissues that reveal malignancy cannot be conveyed to a
patient by Internet posting or other electronic means.
The federal Clinical Laboratory Improvement Amendments of
1988 (CLIA), administered by the Centers for Medicare and
Medicaid Services (CMS), established standards for all
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clinical laboratory testing, and included provisions
relating to the reporting out of lab test results. Current
CLIA regulations limit a laboratory's disclosure of lab
test results to three categories of individuals: i) the
"authorized person;" ii) the person responsible for using
the test results for treatment; and, iii) the referring
lab. An "authorized person" is defined as the individual
under state law who is authorized to order or receive test
results, or both. Under this definition, CLIA defers to
state law on the release of these results.
The federal Health Insurance Portability and Accountability
Act of 1996 (HIPAA), established national standards to
protect the privacy and security of personal health
information. Among other provisions, HIPAA's Standards for
Privacy of Individually Identifiable Health Information
(Privacy Rule) provides individuals with a general right of
access to inspect and obtain a copy of his/her protected
health information, including laboratory test reports,
which are part of an individual's medical records.
However, HIPAA's Privacy Rule does not apply to protected
health information maintained by a CLIA covered entity
where state law prohibits access.
b) ARRA and Patient Access to Lab Test Results . On
February 2009, President Obama signed ARRA aimed at
stimulating the economy, and included various provisions
including the establishment of the Office of the National
Coordinator for Health Information Technology (ONC) to
facilitate and expand the use of health information
technology (HIT) according to nationally established
standards. ARRA also incorporated the Health Information
Technology for Economic and Clinical Health Act (HITECH)
which included a number of funding opportunities to advance
HIT, and support the adoption of EHR. To improve and
increase the use of EHRs, HITECH created a federal
incentive payments program for eligible professionals
(generally doctors), and hospitals when they adopt EHRs and
demonstrate use in ways that can improve quality, safety,
and effectiveness of care. Eligible professionals can
receive as much as $44,000 over a five-year period through
Medicare. For Medicaid, eligible professionals can receive
as much as $63,750 over six years for adopting,
implementing, and upgrading certified EHR technology but
must demonstrate meaningful use in subsequent years in
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order to qualify for additional payments. To satisfy the
meaningful use requirement and qualify for payments, an
eligible professional must demonstrate the use of certified
EHR technology in a meaningful manner, including the use of
electronic prescribing, provide for the electronic exchange
of health information to improve the quality of health
care, such as promoting care coordination, and submission
of quality measures, as specified. To qualify for the
incentive payments, the certified technology must include
patient demographic and clinical health information, such
as medical history and problem lists, and have the capacity
to provide clinical decision support to assist physician
order entry, capture and query information relevant to
healthcare quality, and exchange electronic health
information with, and integrate such information from other
sources. ARRA also includes provisions relating to privacy
and security of EHR, and provides that an individual has a
right to access certain information about him/her in
electronic format.
HITECH also created a Federal Advisory Committee known as the
Health Information Technology Policy Committee (Committee)
to identify barriers to the adoption and use of HIT. Among
other efforts, Committee members and stakeholders perceived
CLIA regulations as imposing barriers to the exchange of
HIT, specifically certain limitations on an individual's
access to his or her own records, preventing patients from
taking a more active role in their personal health care
decisions. As a result, CLIA staff worked with the ONC and
CMS and concluded that provision of direct patient access
to lab test results would support the commitments and goals
of the U.S. Department of Health and Human Services (HHS)
and CMS on the widespread adoption of EHRs. On July 14,
2010, HHS issued a proposed rule to implement most of the
privacy and security provisions of HITECH, including those
provisions strengthening an individual's right to receive
an electronic copy of his or her protected health
information, where such information is maintained
electronically in one or more designated record sets. On
September 14, 2011, proposed rules were enacted to amend
CLIA to specify that, upon a patient's request, a
laboratory may provide access to completed test reports
that, using the laboratory's authentication process, can be
identified as belonging to a particular patient. The
proposed rules would also amend HIPAA's Privacy Rule to
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provide individuals the right to receive their test reports
directly from laboratories by removing the exceptions for
CLIA laboratories. These proposed rules are currently
pending.
Recognizing the disparity among states in allowing patient
access to lab test results, the proposed rules also
contained a specific preemption language. The proposed
rules indicate that "a number of states have laws that
prohibit a laboratory from releasing a test report directly
to the patient or that prohibit the release without the
ordering provider's consent. If adopted, the proposed
changes to HIPAA's Privacy Rule would preempt any contrary
State laws that prohibit the HIPAA-covered laboratory from
directly providing access to the individual."
c) Paper on Electronic Release of Clinical Lab Results . In
January 2010, the California HealthCare Foundation released
a study entitled "Electronic Release of Clinical Laboratory
Results: A Review of State and Federal Policy" (CHCF
paper). The CHCF paper conducted a review of state laws
and interviews with key stakeholders to determine policy
issues and challenges related to electronically sharing of
lab test results. The research suggests that about 70% to
80% of data contained in a medical record consists of lab
records and results, and that 70% of clinical decision
making is based on or assisted by lab test results. The
CHCF paper stated that although many electronic health
information exchanges currently identify the sharing of lab
test results as a priority, the legal and policy framework
that permits these exchanges is not clear. The release of
lab results are governed by CLIA, HIPAA, and numerous
state-specific medical release and lab licensing laws which
are subject to disparate interpretation by various
stakeholders.
The CHCF paper analyzed the licensing statutes and
regulations of various states, including California. The
CHCF paper indicated that the licensing statutes and
regulations of 26 states and territories are silent with
respect to who is authorized to receive lab test results.
Licensing laws in the remaining 29 states and territories
expressly address who is authorized to receive these lab
results. Among these 29 states and territories, the CHCF
paper identified six general categories of entities to
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which clinical laboratories may release lab test results:
i) the authorized person who requested the test; ii)
persons authorized to use, receive, or responsible for
using or receiving test results; iii) the agent or designee
of the person who requested the test or who is authorized
to receive the test; iv) those directed by the person who
requested the test; v) the patient (with no other
permission required); and, vi) the patient only with the
permission of the person who ordered the test.
The CHCF paper identified several policy considerations,
including the need for appropriate mechanisms and
timeframes to allow patients to access their health care
information, including lab results since patients are
increasingly involved in and responsible for managing their
own care. Additionally, it states that as the federal
government invests in EHRs through the ARRA initiatives,
the meaningful use requirements for providers eligible to
receive incentives have many EHR vendors rapidly adapting
their systems to comply.
d) Justification for the Release of Lab Test Results . An
article published by Kaiser Health News (KHN) entitled
"Both Patients and Physicians Can Suffer When Test Results
Aren't Reported" tells the story of a patient who had a
year-long delay in her breast cancer diagnosis when her
test results were mistakenly sent to another provider and
she did not have access to the results. The KHN article
points out that aside from the medical consequences that
are sometimes life altering, there are financial
consequences for providers when tests are not promptly
reported. KHN points to a recent study in the Journal of
American College of Radiology (JACR study) which found that
annual medical malpractice payouts for communication
breakdowns, including failing to share test results, more
than quadrupled nationally between 1991 and 2010, from $22
million to $91 million. The JACR study examined medical
malpractice claims from 425 hospitals and 52,000 providers.
Of the 306 cases in which test results were specifically
cited as a factor in a malpractice case, the most common
problem was that the patient did not receive the test
results (143 cases); and the second most common problem was
that the clinician did not receive the results, (110
cases). Other problems included delays and slow turnaround
in reporting findings and test results that were filed
before the clinician reviewed them. The article also
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pointed out that since physicians, specifically primary
care doctors are often reviewing hundreds of test results
in a given week, patient follow-up and access becomes
significant.
3)SUPPORT . The California Society of Pathologists states that
this measure is a step towards greater patient involvement in
their healthcare and the use of electronic medical records.
4)OPPOSE UNLESS AMENDED . The American Civil Liberties Union of
California has an oppose unless amended position and
recommends that the authorization for the release in
electronic conveyance be made in writing to ensure that the
patient understands and agrees to receive the results
electronically.
5)AMENDMENTS REQUESTED . The Clinical Laboratory Association
requests an amendment to delete the current prohibition in law
relating to the release of lab test results relating to HIV,
hepatitis, abuse of drugs, and certain processed tissues
because federal regulation will already require that all lab
results be made available directly to patients and is expected
to be enacted this year and would preempt all state laws.
6)POLICY CONSIDERATIONS . Should California law authorize
patient access to lab test results in electronic form without
conditions? As indicated above, lab test results performed at
the request of a health care professional may be conveyed to
the patient in electronic form if requested by the patient and
if deemed most appropriate by the health care professional.
Additionally, test results can be delivered to the patient
only after the results have been reviewed by the health care
professional. Since federal laws (CLIA and HIPAA) are
proposed to be amended to allow patient access to lab test
results, and the federal government continues to invest in
EHRs, consideration should be given as to whether existing
limitations making patient access to lab test results
dependent on the approval of a health care professional is
still a sound policy. If the federal rules become final as
they are proposed, it appears these rules should preempt
California law.
Moreover, the amendments proposed by this bill would allow test
results relating to HIV, hepatitis, abuse of drugs and
malignant tissue to be conveyed to patients in the same way as
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any other lab test result; this raises the question as to why
existing law's carve-out for these results is even necessary.
REGISTERED SUPPORT / OPPOSITION :
Support
California Society of Pathologists
Opposition
None of file.
Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916)
319-2097