BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 1739|
|Office of Senate Floor Analyses | |
|(916) 651-1520 Fax: (916) | |
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THIRD READING
Bill No: AB 1739
Author: Waldron (R)
Amended: 8/2/16 in Senate
Vote: 21
SENATE HEALTH COMMITTEE: 8-0, 6/29/16
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,
Pan, Roth
NO VOTE RECORDED: Wolk
SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/11/16
AYES: Lara, Bates, Beall, Hill, McGuire, Mendoza, Nielsen
ASSEMBLY FLOOR: 79-0, 5/5/16 (Consent) - See last page for
vote
SUBJECT: Medi-Cal: allergy testing
SOURCE: Thermo-Fisher Scientifics
DIGEST: This bill requires the Medi-Cal 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 (a type of blood test).
ANALYSIS:
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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 the Medi-Cal 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.
2)Requires DHCS to update its provider bulletins, as necessary,
to reference the most current professional literature and
guidance related to allergy testing.
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
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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
and treatment of allergies. This bill corrects 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 also requires 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
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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.
3)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."
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: No
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 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
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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.
SUPPORT: (Verified 8/9/16)
Thermo-Fisher Scientific (source)
American Federation of State, County and Municipal Employees,
AFL-CIO
California Health+ Advocates
California Life Sciences Association
One individual
OPPOSITION: (Verified 8/9/16)
Department of Finance
Department of Health Care Services
ARGUMENTS IN 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 National Institute of Allergy and
Infectious Diseases 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
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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.
ARGUMENTS IN OPPOSITION: The Department of Finance (DOF) writes
in opposition that this bill could potentially result in
increased costs in the low millions of dollars, and General Fund
resources to implement these provisions are not included in the
2016 Budget Act. DOF argues this bill limits DHCS' flexibility
to form its Medi-Cal allergy testing policy according to the
most appropriate clinical guidelines and consensus standards,
and that DHCS already takes into account information available
from the National Institutes of Health as required by this bill,
but also relies on research from the American Academy of
Allergy, Asthma & Immunology, and has the discretion to also
consider research from other entities. DOF states DHCS already
has the authority to update its provider bulletins and updates
them as appropriate, so this bill is unnecessary, and DOF states
it is arguable whether access problems to blood tests exist due
to current policy, as nearly six times as many Medi-Cal
beneficiaries received blood tests versus skin prick tests in
2015. It is unclear if conforming with the specific entities'
standards for allergy testing will have any impact on access.
ASSEMBLY FLOOR: 79-0, 5/5/16
AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker,
Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke,
Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley,
Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier,
Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson,
Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger
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Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey,
Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes,
McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte,
O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez,
Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting,
Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon
NO VOTE RECORDED: Beth Gaines
Prepared by:Scott Bain / HEALTH / (916) 651-4111
8/15/16 20:17:19
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