BILL ANALYSIS Ó
AB 1739
Page 1
CONCURRENCE IN SENATE AMENDMENTS
AB
1739 (Waldron)
As Amended August 2, 2016
Majority vote
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|ASSEMBLY: |79-0 |(May 5, 2016) |SENATE: |36-0 |(August 18, |
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Original Committee Reference: HEALTH
SUMMARY: Requires the Department of Health Care Services
(DHCS), in the evaluation of patients for allergy under
fee-for-service Medi-Cal, to treat serologic-specific IgE tests
and skin tests as equivalent confirmatory tests.
The Senate amendments require the standard of coverage and
medical necessity for allergy tests to be consistent with
consensus standards and recommendations in clinical guidelines
from the National Institutes of Health, Clinical and Laboratory
Standards Institute, and the most current peer-reviewed medical
literature pertaining to the utilization of modern
serologic-specific IgE tests.
FISCAL EFFECT: According to the Senate Appropriations
Committee, likely increased Medi-Cal costs in the hundreds of
thousands per year (General Fund and federal funds). The fiscal
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impact of the bill is subject to some uncertainty. DHCS
indicates that under the bill it would likely change its current
policy that limits the number of allergen units in a blood test
from the current limit of 24 to the current limit for skin tests
of 65. It is not clear to what extent physicians ordering blood
tests would actually increase the number of units per test.
However, because the per unit cost of blood tests is
considerably higher than the per unit costs for skin tests, any
increase in the number of units per test would increase state
costs. For comparison, the cost difference between the current
maximum number of units for blood tests and the maximum number
of units allowed for skin tests (at current utilization rates)
would be about $1 million per year.
COMMENTS: According to the author, this bill ensures that
Medi-Cal patients with allergies receive the same level of care
as private health insurance patients based on nationally
recognized professional guidelines. Under existing coverage and
payment policies for fee-for-service Med- Cal patients, allergy
testing using an IgE blood test is not treated equally with
percutaneous skin testing for allergies. If a primary care
physician wishes to diagnose allergies, a referral to a
specialist for skin testing is allowed. However, if the primary
care physician wishes to order a blood test to diagnose
allergies without a referral, the physician must document a
contraindication to skin testing for the blood test to be
ordered. This bill will ensure that primary care doctors are
able to diagnose allergies without referral to a specialist and
will therefore save Medi-Cal patients the time and effort it
takes to find, make an appointment and see one of the limited
number of specialists who accept Medi-Cal patients. The author
believes this will further save the Medi-Cal system money by
reducing the costs associated with referrals to specialists.
Asthma is a chronic inflammatory disease of the airways. Asthma
is widespread; in California an estimated 2.5 million adults
have asthma along with about 700,000 children. It is one of the
most common chronic diseases of childhood. The exact cause of
asthma is unknown and it cannot be cured. Asthma can be
controlled with self-management education, appropriate medical
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care, and avoiding exposure to environmental triggers. Allergen
exposure is a significant trigger that can worsen symptoms for
many patients with asthma.
Food allergies are an immune-based disease that has become a
serious health concern in the United States. A recent study
estimates that food allergy affects 5% of children under the age
of five years and 4% of teens and adults, and its prevalence
appears to be on the increase. The symptoms of this disease can
range from mild to severe and, in rare cases, can lead to
anaphylaxis, a severe and potentially life-threatening allergic
reaction. There are no therapies available to prevent or cure
food allergies. The only prevention option for the patient is
to avoid the food allergen.
How best to determine what those allergens are, and how Medi-Cal
coverage policy should approach this issue, was the subject of
an August 12, 2014, Assembly Health Committee informational
hearing, 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 which did not apply to skin testing remain.
The current Medi-Cal Provider Manual states that coverage for
allergen specific IgE must include documentation in the
patient's medical record with one of the following numbered
criteria:
1)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, or
2)At least one of the following conditions is documented in
the patient's medical record:
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a) Widespread skin disease
b) Patients receiving medications that may confound
the results of skin testing or interfere with the
detection or management of anaphylaxis
c) Uncooperative patients
d) When the history suggests significant risk of
anaphylaxis from skin testing;
e) Patients undergoing work-up for major allergic
reaction, including possible anaphylaxis or severe
urticarial.
The provider manual also states that manual review of the
claims is no longer required. Without evidence of medical
necessity documented in the patient's medical record, claims
billed may be denied.
In correspondence between the former Chair of the Assembly
Health Committee and the Director of DHCS the former Chair
expressed his concern that Medi-Cal policy, even with the
changes of May 15, 2016, unnecessarily inhibits access and
timely care for many Medi-Cal patients and is inconsistent
with the latest science or with many policies in the
commercial markets and other state Medicaid programs.
Anthem Health Insurance and Kaiser Permanente both cover allergy
blood tests and skin tests equivalently. According to
information requested by the Committee and provided by the
sponsor, two of six Medicare claims processing contractors
(representing 20 states) treat blood tests and skin test
equivalently, the others currently do not. The sponsor states
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that it has embarked on an educational campaign with the other 4
contractors.
In a December 2010 report of the National Institute of Allergy
and Infectious Diseases (NIAID) sponsored expert panel entitled
Guidelines for the Diagnosis and Management of Food Allergy in
the U.S., published in the Journal of Allergy and Clinical
Immunology, it is stated that both IgE blood tests and skin
tests are safe and useful for identifying food 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." In a
supplement to the March 2008 issue of the Annals of Allergy,
Asthma, & Immunology entitled Allergy Diagnostic Testing: An
Updated Practice Parameter, it is stated that: "There are no
clinical scenarios in which immunoassays for allergen specific
IgE can be considered either absolutely indicated or
contraindicated. There are some situations in which
immunoassays may be preferable to skin testing for the
diagnostic evaluation of patients."
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. 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. 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
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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.
Analysis Prepared by:
Paula Villescaz / HEALTH / (916) 319-2097 FN:
0004158