BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 1739
---------------------------------------------------------------
|AUTHOR: |Waldron |
|---------------+-----------------------------------------------|
|VERSION: |June 2, 2016 |
---------------------------------------------------------------
---------------------------------------------------------------
|HEARING DATE: |June 29, 2016 | | |
---------------------------------------------------------------
---------------------------------------------------------------
|CONSULTANT: |Scott Bain |
---------------------------------------------------------------
SUBJECT : Medi-Cal: allergy testing
SUMMARY : Requires the Department of Health Care Services, for
individuals with a medical history of specified allergies, to
treat serologic-specific IgE tests (a type of blood test) and
skin tests as equivalent confirmatory tests in their clinical
efficacy, and to provide the same standard of coverage for
either test.
Existing law:
1)Establishes the Medi-Cal program, which is administered by the
Department of Health Care Services (DHCS), under which
qualified low-income individuals receive health care services.
2)Establishes a schedule of benefits under the Medi-Cal program,
and authorizes the use of utilization controls, including
prior authorization, that may be applied to those covered
benefits and that are reviewed for, among other things,
medical necessity. Physician services are a covered benefit,
subject to utilization controls.
3)Requires, pursuant to Medi-Cal regulation, outpatient
physician services to be covered if they are medically
necessary to protect life, to prevent significant illness or
significant disability, or to alleviate severe pain, subject
to limitations.
This bill:
1)Requires DHCS to treat serologic-specific IgE tests and
percutaneous skin tests as equivalent confirmatory tests in
their clinical efficacy, and to provide the same standard of
coverage for either test for those individuals with a medical
history consistent with any of the following:
AB 1739 (Waldron) Page 2 of ?
a) An inhalant allergy;
b) A food allergy;
c) Hymenoptera venom allergy or an allergy to
stinging insects;
d) Allergic bronchopulmonary aspergillosis (ABPA);
e) Certain parasitic diseases; or,
f) Allergies to specific drugs.
1)Requires DHCS to update its provider bulletins, as necessary,
to reference the most current professional literature and
guidance related to allergy testing.
FISCAL
EFFECT : According to the Assembly Appropriations Committee,
uncertain, likely minor overall fiscal effect in the FFS
Medi-Cal program (GF/federal). Blood testing utilization could
go up, while utilization of skin tests could go down. The net
effect is unknown.
PRIOR
VOTES :
-----------------------------------------------------------------
|Assembly Floor: |79 - 0 |
|------------------------------------+----------------------------|
|Assembly Appropriations Committee: |19 - 0 |
|------------------------------------+----------------------------|
|Assembly Health Committee: |18 - 0 |
| | |
-----------------------------------------------------------------
COMMENTS :
1)Author's statement. According to the author, historically,
allergies were diagnosed by an allergy specialist who used a
"skin-prick" test to infect the skin of a patient and waited
to see what the patient reacted to. This requires a patient to
be referred to an allergist by their primary care doctor and
requires the patient to undergo a series of pricks to their
skin. But now blood tests are equally effective in diagnosing
allergies and can be ordered directly by a primary care
physician without referring the patient to a specialist.
Medi-Cal's provider manual explicitly favors skin testing over
blood testing by requiring a primary doctor to identify a
"Contraindication" to skin testing before ordering a blood
test. This is contrary to National Guidelines. Combined with
too few allergy specialists, this creates an access to care
problem for Medical patients who need an efficient diagnosis
AB 1739 (Waldron) Page 3 of ?
and treatment of allergies. This bill would correct this
inequity by requiring DHCS to treat blood allergy tests and
skin allergy tests as equivalent in their sensitivity and
accuracy for confirming allergies. This bill would also
require DHCS to update its provider bulletins to reference the
most current professional literature and guidance related to
allergy testing.
2)Medi-Cal Manual of Criteria. Under existing law, DHCS is
authorized to use utilization controls for covered Medi-Cal
benefits. The DHCS Manual of Criteria sets for the procedures
and codes for providers to use to bill allergy testing and
desensitization. It contains the procedure codes and
instructions for billing, and the medical reference for the
coverage criteria. The Manual of Criteria for allergy testing
and desensitization was changed by DHCS in March 2009, June
2012, April 2013, December 2014, and June 2015.
Medi-Cal coverage policy of allergy testing was the subject of
an August 12, 2014 Assembly Health Committee informational
hearing entitled "Medi-Cal: When Reimbursement Policies
Interfere with the Standard of Care." Subsequent to the
hearing, on May 15, 2015, Medi-Cal removed the requirement
that laboratories submit documentation of medical necessity
with claims for IgE testing reimbursement. However,
limitations on Medi-Cal coverage for IgE did not apply to skin
testing remain. For example, current coverage for the allergen
specific IgE test must include documentation in the patient's
medical record, with one of the following numbered criteria:
a) The patient has persistent asthma and the test
is needed to determine the potential sensitivity to
perennial indoor allergens to which the patient is
exposed;
b) At least one of the following conditions is
documented in the patient's medical record:
i. Widespread skin disease
ii. Patients receiving medications
that may confound the results of skin
testing or interfere with the detection or
management of anaphylaxis;
iii. Uncooperative patients;
iv. When the history suggests
significant risk of anaphylaxis from skin
testing; or,
v. Patients undergoing work-up for
major allergic reaction, including possible
anaphylaxis or severe urticarial.
AB 1739 (Waldron) Page 4 of ?
1)Medical literature on blood and skin tests for allergies. In a
February 2010 article in the Journal of Allergy and Clinical
Immunology from Johns Hopkins School of Medicine entitled
Clinical Laboratory Assessment of Immediate-type
Hypersensitivity it is stated that: "For food and respiratory
allergy, IgE antibody as detected in the serum by using
current autoanalyzer technology and in the skin by using the
epicutaneous test are considered equivalent as confirmatory
tests in terms of their sensitivity and accuracy
2)Support. Thermo Fisher Scientific, the sponsor of this bill,
argues that Medi-Cal's coverage policy for allergy testing is
inconsistent with national guidelines, best practices, and the
most recent scientific literature. Food allergy guidelines of
the NIAID and the asthma guidelines of the National Heart,
Lung, and Blood Institute's recognize that blood tests and
skin tests are equivalent in their efficacy for diagnosing
allergic sensitizations.
A physician from Miller Children's Hospital in Long Beach
states that updating testing guidelines will have a major
positive impact on Medi-Cal patients suffering from allergies.
The physician writes that, in a perfect world, every patient
suffering from an allergic disease would receive their care
from a specialist. Unfortunately, allergy specialists are a
very scarce resource, especially for the Medi-Cal population,
with unacceptably long wait times. It is not realistic for
DHCS, or any payer, to rely solely on the efforts of
specialists to be able to skin test every Medi-Cal patient
that requires an allergy test.
The CaliforniaHealth+ Advocates (CH+A) writes in support that
this bill will improve patient care, eliminate unnecessary
restrictions on primary care physicians' ability to utilize
blood tests as a diagnostic tool for determining sensitivity
to allergens in Medi-Cal patients, save money by ensuring
timely diagnosis of allergies in Medi-Cal patients, and
eliminate unnecessary referrals to an allergist for skin
testing. In doing so, CH+A writes this bill eliminate
unnecessary barriers to care and create greater equity across
our health system.
3)Opposition. DHCS writes in opposition that this bill will
change current Medi-Cal policy and contradicts the
recommendation of the American Academy of Allergy, Asthma, and
Immunology (AAAAI) and the American College of Allergy, Asthma
and Immunology (ACAAI). DHCS states Medi-Cal's allergy testing
AB 1739 (Waldron) Page 5 of ?
policy is based upon the AAAAI and ACAAI clinical practice
guidelines that recommend the skin prick test as the preferred
procedure to test for allergies, and Medi-Cal allows for IgE
test when the patient's medical condition requires another
mode of testing other than skin prick. DHCS writes this bill
do not reflect current practice guidelines from the leading
medical associations for allergy testing, and DHCS writes that
AAAAI is working on a new primer/guideline for allergy testing
that it expects to publish later this year. DHCS concludes by
noting that current Medi-Cal policy for ordering IgE tests
does not pose a barrier to access for fee-for-service
beneficiaries as DHCS data shows that more beneficiaries are
receiving IgE tests than skin prick tests, and when DHCS
removed manual review for IgE tests as skin prick tests,
nearly six times as many beneficiaries received the IgE test
as skin prick tests.
4)Policy issues.
a) Statutory declaration of equivalent confirmatory
tests. This bill, as written, would statutorily require
DHCS to declare serologic-specific IgE tests and
percutaneous skin tests as equivalent confirmatory tests
in their clinical efficacy, and would require DHCS to
provide the same standard of coverage. The impetus for
this bill is current Medi-Cal coverage for the
serologic-specific IgE tests is subject to additional
criteria that existing skin allergy tests are not.
Proponents cite medical literature as to why current
Medi-Cal coverage is out-of-date and not consistent with
other payors and current medical literature.
However, statutorily declaring two types tests as
equivalent in clinical efficacy has the disadvantage of
codifying a coverage standard that, even if accurate now,
may not be accurate in the future if allergy testing
improves. Codifying such a standard in existing law would
require subsequent statutory changes if medical evidence
and practice guidelines change. In addition, statutorily
requiring the same standard of coverage may limit DHCS
and Medi-Cal managed care plans' ability to negotiate
lower prices if the tests are of equal efficacy but the
cost of a particular test is significantly higher than
the other. Finally, the Legislature is generally not well
equipped to evaluate the clinical efficacy of competing
medical tests and procedures, as compared to
peer-reviewed literature published in scientific or
medical journals, national expert panels, or consensus
AB 1739 (Waldron) Page 6 of ?
practice guidelines.
b) Coverage based on medical history. The coverage in
this bill is for individuals with a medical history
consistent with various allergies, including a food
allergy, an allergy to venom or stinging insects, drug
allergies or an inhalant allergy. However, allergy
testing is typically used to strengthen a diagnosis of
patients who present with allergy symptoms following a
clinical history and physical examination. These
individuals may or may not have a medical history
consistent with allergies. In lieu of coverage based on
medical history, the coverage in this bill could be based
on "symptoms compatible with an allergic disorder" or
words to that effect.
To address the issues in a) and b), alternative language
to the language in this bill is as follows:
14133.75(a) The department shall treat serologic-specific
IgE tests and percutaneous skin tests as equivalent
confirmatory tests in their clinical efficacy, and shall
provide the same standard of coverage for either test for
those individuals with a medical history consistent with
any of the following: The department shall provide the
same standard of coverage for serologic-specific IgE
tests and percutaneous skin tests if peer-reviewed
medical literature supports a determination that those
tests are equivalent confirmatory tests in terms of their
clinical efficacy. If that determination is made the
department shall provide coverage for either test for a
beneficiary who has symptoms consistent with any of the
following:
(1) An inhalant allergy.
(2) A food allergy.
(3) Hymenoptera venom allergy or an allergy to stinging
insects.
(4) Allergic bronchopulmonary aspergillosis (ABPA).
(5) Certain parasitic diseases.
(6) Allergies to specific drugs.
(7) The department shall update its provider bulletins,
as necessary, to reference the most current professional
literature and guidance related to allergy testing
SUPPORT AND OPPOSITION :
Support: Thermo-Fisher Scientific (sponsor)
American Federation of State, County and Municipal
Employees, AFL-CIO
AB 1739 (Waldron) Page 7 of ?
California Life Sciences Association
One individual
Oppose: Department of Health Care Services
-- END --