BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: SB 1418 Hearing Date: April 18,
2016
-----------------------------------------------------------------
|Author: |Lara |
|----------+------------------------------------------------------|
|Version: |April 13, 2016 |
-----------------------------------------------------------------
----------------------------------------------------------------
|Urgency: |No |Fiscal: |Yes |
----------------------------------------------------------------
-----------------------------------------------------------------
|Consultant|Sarah Huchel |
|: | |
-----------------------------------------------------------------
Subject: Clinical laboratory testing
SUMMARY: Allows direct access laboratory (lab) testing and does not
require a healing arts licensee to review the results of a lab
test he or she did not order.
Existing state law:
1)Provides for the licensure, registration, and regulation of
clinical laboratories and various clinical lab personnel,
including cytotechnologists, by the California Department of
Public Health. (Business and Professions Code (BPC) §§
1200-1327)
2) States that the chapter regulating clinical labs does not
authorize any person to practice medicine and surgery or to
furnish the services of physicians for the practice of
medicine and surgery. Current law further emphasizes that the
chapter does not repeal or in any manner affect any provision
of this code relating to the practice of medicine. (BPC §
1240)
3) Defines "diagnose" or "diagnosis" for the purposes of
regulating the practice of medicine to include any
undertaking by any method, device, or procedure whatsoever,
and whether gratuitous or not, to ascertain or establish
whether a person is suffering from any physical or mental
SB 1418 (Lara) Page 2
of ?
disorder. Such terms shall also include the taking of a
person's blood pressure and the use of mechanical devices or
machines for the purpose of making a diagnosis and
representing to such person any conclusion regarding his or
her physical or mental condition. (BPC § 2038)
4) States that any person may request, and any registered lab
may perform, the following waived lab tests: pregnancy,
glucose level, cholesterol, occult blood, and any other test
for which there is a test approved by the federal Food and
Drug Administration (FDA) for sale to the public without a
prescription in the form of an over-the-counter test kit. The
results from any test may be provided directly to the person
requesting the test if the test is on or for his or her own
body. These test results shall be provided in a manner that
presents clear information and that identifies results
indicating the need for referral to a physician and surgeon.
(BPC § 1246.5)
5) Requires a person conducting or operating a clinical lab to
accept assignments for tests only from and make reports only
to persons licensed under the provisions of law relating to
the healing arts or their representatives. A report of
results issuing from a clinical lab shall show clearly the
name and address of the lab and the name of the director.
(BPC § 1288)
Existing federal law:
1)Establishes conditions that laboratories must meet for
certification to perform testing on human specimens under
Clinical Laboratory Improvement Amendments (CLIA). (Title 42,
Code of Federal Regulations (CFR) § 493.1)
2)Establishes standard requirements for information presented on
clinical lab test reports. (42 CFR § 493.1291)
This bill:
1) Authorizes a person to request, and a licensed clinical lab
or public health lab to perform, any lab test that the
laboratory offers to the public without an order from a
healing arts licensee or their representative.
2) States that if a lab test of a person is conducted without an
SB 1418 (Lara) Page 3
of ?
order from a healing arts licensee or their representative,
the test results shall be provided to the person who was the
subject of the test.
3) Requires the test results report to state in bold type that
it is the responsibility of the person who was tested to
arrange with his or her health care provider for consultation
and interpretation of the test results.
4) States that a healing arts licensee is not required to review
or act on a lab test result if the healing arts licensee or
their representative did not order the lab test. States that
a healing arts licensee shall not be subject to liability or
disciplinary actions for failure to review or act on the
results of a lab test of any person if the healing arts
licensee or their representative did not order the lab test.
5) States that it does not require that any lab test be covered
by a health care service plan contract or health insurance
policy.
6) Deletes provisions of law requiring assignments for tests
only from and to make reports only to persons licensed under
the provisions of law relating to the healing arts or their
representatives.
FISCAL
EFFECT: This bill is keyed "fiscal" by the Legislative Counsel.
COMMENTS:
1. Purpose. This bill is Author sponsored. According to the
Author's office, "this bill would remove barriers in existing
law regarding individuals ordering their own laboratory
tests. It would open the market for Californians to all
laboratory tests, with [sic] having to be symptomatic in
order to get a doctor to order the test and insurance to pay
for it.
"The current restrictions ultimately result in costly
outcomes for patients and the health system itself, and
inhibit[s] individuals from accessing tests that will help
them prevent disease and illness, leading the State to be at
the forefront of a nationwide movement towards increased
SB 1418 (Lara) Page 4
of ?
patient engagement, autonomy, and personal ownership of
health outcomes."
2. Background. The traditional gatekeeper model of healthcare
requires a licensed healthcare provider to order lab testing
for his or her patient. The patient is tested by a lab,
which then provides the results to the provider who
interprets the results and consults with the patient.
However, deviations in this model began to appear in the
1950s, according to a 2012 policy paper by the American
Society for Clinical Laboratory Science, when certain
over-the-counter (OTC) urine tests became available. This
progression accelerated with home diabetes testing,
increasing availability of other OTC tests, and now the
marketplace is opening further to accommodate direct access
testing for those tests a lab makes available to the public.
3. State access laws. California currently allows individuals
to obtain pregnancy, glucose, cholesterol, occult blood, and
any other OTC tests approved by the FDA without an order from
a healthcare licensee.
According to information provided by Theranos, a company that
provides direct access testing, nine states allow consumers
to order some tests directly from a lab. Last year, Arizona
passed HB 2645, which made it the first state to explicitly
allow consumers to order any publicly available test
directly.
4. Regulation of laboratory developed tests (LDTs). As direct
access testing gathers momentum and companies develop new
technologies and business strategies to adapt, concerns have
been raised about the regulation of laboratory developed
tests (LDT).
FDA defines a LDT as an in vitro diagnostic test that is
intended for clinical use and designed, manufactured, and
used within a single lab. LDTs are a significant part of the
direct access test market. While LDTs were explicitly
included in the 1976 Medical Device Amendments to the Food,
Drug and Cosmetic (FD&C) Act, by its own admission, FDA has
generally not enforced those provisions.
The Centers for Medicare & Medicaid Services (CMS) regulates
SB 1418 (Lara) Page 5
of ?
laboratories, including those that develop LDTs, under CLIA.
CLIA governs the accreditation, inspection and certification
process for laboratories, but they do not assess the clinical
validity of a LDT (i.e., the accuracy with which the test
identifies, measures, or predicts the presence or absence of
a clinical condition or predisposition in a patient).
The Office of Public Health Strategy and Analysis Office
within the FDA issued a report on November 16, 2015 that
argued for increased FDA oversight of LDTs titled "The Public
Health Evidence for FDA Oversight of Laboratory Developed
Tests: 20 Case Studies of the Commissioner Food and Drug
Administration."
The report states, "As technology and science have advanced,
LDTs have increased in complexity and availability and are
now used to diagnose common, serious medical conditions,
including cancer and heart disease. Others guide therapy for
these and other conditions, while still others predict one's
personal risk of developing a particular disease. Some
individual laboratories that initially developed LDTs have
now morphed into separate businesses that market complex
tests nationwide. These activities take place in much larger
populations than the local or limited patient populations who
may have used these products four decades ago. As the field
of medicine evolves, the need for accurate, reliable, and
clinically meaningful tests is essential. ?But inaccurate or
unreliable LDTs and unsupported or disproven claims can
undermine progress in Precision Medicine and other fields."
In addition to the lack of clinical validation, the report
notes the following concerns about LDTs:
Deficient adverse event reporting.
No premarket review of performance data.
Unsupported manufacturer claims.
Inadequate product labeling.
Lack of transparency.
Threats to the scientific integrity of clinical
SB 1418 (Lara) Page 6
of ?
trials.
No comprehensive listing of all LDTs currently
being used.
Thus, while CLIA oversight is important, it alone does not
ensure that LDTs are properly designed, consistently
manufactured, and are safe and effective for patients.
FDA released a Draft Guidance for Regulatory Oversight of
LDTs (Guidance) on July 31, 2014 and intends to finalize it
this year. The Guidance describes a risk-based framework for
regulating LDTs based on the existing medical device
classification system. According to the Guidance, "In
determining the risk an LDT poses to the patient and/or the
user, FDA will consider several factors including whether the
device is intended for use in high risk disease/conditions or
patient populations, whether the device is used for screening
or diagnosis, the nature of the clinical decision that will
be made based on the test result, whether a
physician/pathologist would have other information about the
patient to assist in making a clinical decision (in addition
to the LDT result), alternative diagnostic and treatment
options available to the patient, the potential
consequences/impact of erroneous results, [and] number and
type of adverse events associated with the device, etc."
Tests will be divided into three classes, on which FDA
intends to issue specific information within 18 months of the
Guidance's finalization.
This Guidance is timely because Theranos, an innovator in the
direct access space, has been recently highlighted in the
media about concerns with its LDT testing and clinical
practices. CMS issued a letter in January 2016 indicating
Theranos' facility was not in compliance with certification
standards for CLIA and that their "deficient practices" pose
"immediate jeopardy to patient health and safety." The
following month, The Journal of Clinical Investigation
published a report questioning Theranos' lab results. The
Journal published a study that tested 60 healthy adults using
Theranos' proprietary finger prick method (in which a smaller
volume of blood is drawn from a patient's finger) and a
traditional blood draw from two other major clinical testing
SB 1418 (Lara) Page 7
of ?
services, Quest and LabCorp, to compare the respective
accuracy in 22 common clinical lab tests. The analysis
indicated concerns with Theranos' testing system because the
samples were rejected at a higher rate than the other
companies,' and there were significant variations in results
between the testing services.
The report concluded that, "While laboratory practice
standards exist to control this variability [in testing
services, sample collection times, and subjects that
influenced the lab results], the disparities between the
testing services we observed could potentially alter clinical
interpretation and health care utilization. Greater
transparency and evaluation of testing technologies would
increase their utility in personalized health management."
Essentially, broad use of LDT may not be in the best
interests of consumers until better regulation of the quality
of the testing and results are available.
1. Test results interpretation California law restricts the
ability to diagnose to certain licensed healthcare providers.
"Diagnose," as defined in law, includes the use of
mechanical devices for the purpose of representing any
conclusion regarding a person's medical condition. Giving
consumers direct access to lab results places labs in a
delicate position of informing results without implying
disease.
This bill will require test results reports to state in bold
type that it is the responsibility of the person who was
tested to arrange with his or her health care provider for
consultation and interpretation of the test results.
Healthcare providers are also exempt from liability for
failing to review or act on a lab report that he or she did
not order.
2. Policy considerations. Current law restricts the authority
for broad lab testing to licensed healthcare providers who
are in a better position than most consumers to understand
the possibilities and limitations of various lab tests.
Acknowledging the market deficiencies raised by the FDA and
its planned regulatory intervention, policymakers should
consider whether California should allow consumers direct
access to lab tests in advance of federal regulation, given
SB 1418 (Lara) Page 8
of ?
the potential significant health impacts of false positives
and negatives.
3. Author's amendments. The Author is accepting the following
amendments to ensure greater quality for laboratory processes
and testing:
On page 2, line 6, after "a," insert "laboratory certified by
CLIA or a CLIA authorized accreditor to perform high
complexity tests"
On page 2, line 6, delete "licensed clinical laboratory or
public health"
On page 2, line 7 delete the first "laboratory" and after
"any," insert "FDA-approved"
On page 2, line 8, after "public," insert "on a direct access
basis"
SUPPORT AND OPPOSITION:
Support: None on file.
Opposition: None on file.
-- END --