BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 1831
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|AUTHOR: |Low |
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|VERSION: |June 9, 2016 |
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|HEARING DATE: |June 22, 2016 | | |
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|CONSULTANT: |Teri Boughton |
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SUBJECT : Health care coverage: prescription drugs: refills
SUMMARY :1) Requires a health plan contract or health insurance policy
issued, amended, or renewed on or after July 1, 2017 that
provides coverage for prescription drug benefits to allow for
early refills of covered topical ophthalmic products, as
specified.
Existing law:
1)Regulates health plans by the Department of Managed Health
Care (DMHC) and health insurers by the California Department
of Insurance (CDI). Establishes the Department of Health Care
Services to administer the Medi-Cal program.
2)Requires health plans and health insurers that cover
prescription drug benefits to provide notice in the evidence
of coverage and disclosure form to enrollees/insureds
regarding whether the plan uses a formulary.
3)Mandates the ten federally required Essential Health Benefits
(EHBs) including prescription drug coverage and establishes
Kaiser Small Group health plan as California's EHB benchmark
plan for non-grandfathered individual and small group health
plan contracts and insurance policies.
This bill:
1)Requires a health plan contract or health insurance policy
issued, amended, or renewed on or after July 1, 2017 that
provides coverage for prescription drug benefits to allow for
early refills of covered topical ophthalmic products (TOPs)
according to the following standards:
a) For a 30-day supply, at least 23 days and less
AB 1831 (Low) Page 2 of ?
than 30 days from the later of either the original
date that the prescription was distributed to the
enrollee, or the date of the most recent refill that
was distributed to the enrollee;
b) For a 90-day supply, at least 68 days and less
than 90 days from the later of either the original
date that the prescription was distributed to the
enrollee or the date of the most recent refill that
was disturbed to the enrollee; and,
c) The refills requested by the enrollee not
exceed the number of additional quantities prescribed
by the enrollee's participating health plan provider.
2)Prohibits anything in this bill from being construed to
establish a new mandated benefit or to prevent the application
of deductible or copayment provisions in a plan contract.
FISCAL
EFFECT : According to the Assembly Appropriations Committee:
1)According to the California Health Benefits Review Program
(CHBRP):
a) Costs of $360,000 to Medi-Cal (General Fund/federal) and
$4,000 to the California Public Employees' Retirement
System for increased premiums.
b) Increased employer-funded premium costs in the private
insurance market of approximately $260,000.
c) Increased premium expenditures by employees and
individuals purchasing insurance of $200,000, and increased
out-of-pocket expenses of $110,000.
2)Minor costs to CDI (Insurance Fund) and DMHC (Managed Care
Fund) to verify plans and insurers comply with this
requirement.
PRIOR
VOTES :
AB 1831 (Low) Page 3 of ?
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|Assembly Floor: |71 - 8 |
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|Assembly Appropriations Committee: |14 - 4 |
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|Assembly Health Committee: |17 - 0 |
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COMMENTS :
1)Author's statement. According to the author, TOPs are used to
treat a wide array of acute and chronic conditions, such as
glaucoma and conjunctivitis. Patients often have difficulty
self-administering the appropriate amount of eye drops,
thereby requiring early refills of their medication.
Interruptions in drug therapy for eye-related conditions
potentially have serious consequences, like irreversible
vision loss. Thus, AB 1831 seeks to provide better patient
outcomes by improving a patient's ability to adhere to
medication dispensing requirements. Moreover, this bill aligns
state law with federal Medicare guidelines as it relates to
refill standards for topical ophthalmic products.
2)CHBRP analysis. AB 1996 (Thomson, Chapter 795, Statutes of
2002), requests the University of California to assess
legislation proposing a mandated benefit or service and
prepare a written analysis with relevant data on the medical,
economic, and public health impacts of proposed health plan
and health insurance benefit mandate legislation. CHBRP was
created in response to AB 1996. Below are key findings of
CHBRP's analysis.
TOPs are a class of drugs that include eye drops and ointments
that are used to treat multiple eye diseases and conditions.
TOPs can be prescribed for both acute and chronic conditions.
Chronic eye conditions would include diseases with long-term
treatments, lasting months, years, or the rest of patients'
lives. AB 1831 would most likely affect a subset of patients
who require multiple refills of TOPs to treat chronic
diseases.
Studies using pharmacy claims data have shown that up to 90%
of glaucoma patients do not refill their TOP medication
consistently (i.e., in a way that would permit continuous
availability of TOPs) and that approximately 25% of patients
AB 1831 (Low) Page 4 of ?
may be without eye drops an average of 109 days per year
(Gurwitz et al., 1998; Nordstrom et al., 2005; Quigley and
Broman, 2006). However, these studies could not clarify the
reasons or consequences of refill inconsistency, such as if
this is due to behavioral factors or issues with obtaining a
refill, or if patients' vision was deteriorating as a result.
Specific to the issue of running out of TOP medication, 25% of
a sample of glaucoma patients reported experiencing any early
exhaustion of eye drop bottles (i.e., running out of eye drops
before they were due to be refilled), with 5% reporting early
bottle exhaustion five or more times a year (Moore et al.,
2014). Poor vision was a risk factor for early exhaustion
among those who run out at least five times per year. The top
reasons patients cited for early TOP exhaustion were that more
than one drop came out (31%), there was an insufficient amount
in the bottle (18%), or the drop size was too large or
inconsistent (18%) (Moore et al., 2014).
a) Enrollees. CHBRP estimates that in 2017, 25.2
million Californians will have health insurance that
would be subject to AB 1831.
b) Impact on expenditures. An increase of 0.0007% or
$955,000 (premiums and cost sharing) would occur.
c) EHBs. The mandate would alter the terms but not
require new benefit coverage and so would not exceed
EHBs.
d) Medical effectiveness. There is insufficient
evidence to suggest that the limited number of additional
days of adherence made possible by AB 1831 would
measurably impact the effectiveness of treatment or
related health outcomes.
e) Benefit coverage. The terms of coverage for 85% of
enrollees would change, where coverage had been available
for TOPs refills at and after 75% to 85% of projected
use, refills would be covered at 70% of projected use.
f) Utilization. Due to earlier refills, annual
utilization of TOPs would increase by 0.5%.
g) Public health. Due to insufficient medical
effectiveness evidence and unlikely impact on adherence
despite very limited increases in filled prescriptions,
the public health impact on health outcomes, gender or
racial/ethnic disparities, and premature death in the
first year, post-mandate, is unknown. CHBRP notes that
the absence of evidence is not evidence of no effect. It
is possible that an impact, positive or negative, could
AB 1831 (Low) Page 5 of ?
result, but current evidence is insufficient to inform an
estimate.
3)Other states and Medicare. According to CHBRP, there are laws
relevant to coverage for early refills for TOPs in a number of
other states, including AK, CT, KY, MO, NJ, NY, OR, RI, and
WY.
4)Medicare Part D. On June 2, 2010 the Centers for Medicare &
Medicaid Services (CMS) released the following guidance to
Medicare Part D sponsors related to TOPs. "CMS is re-issuing
this guidance based on complaints we have received regarding
the application of early refill edits (i.e. refill-too-soon
edits) to TOPs. CMS recognizes that early refill edits are an
important utilization management tool used to promote
compliance and prevent waste. However, it is equally important
that Part D sponsors implement such edits in a manner that
does not unreasonably put beneficiaries at risk of
interruptions in drug therapy that potentially have serious
consequences. Part D sponsors need to take into consideration
differences that some dosage forms, such as topical
ophthalmics, present when establishing early refill edits.
Edits based on an algorithm that is appropriate for tablets
and capsules are not necessarily appropriate for other dosage
forms for which administration is not as easily measured and
controlled. This is not to say that Part D sponsors should not
implement early refill edits for such medications, especially
given that these edits can identify inappropriate use, but it
does mean that such edits need to reasonably accommodate waste
that can be anticipated given the nature of these products and
their self-administration among the Medicare patient
population. Part D sponsors also should be prepared to allow
overrides of these edits on a case-by-case basis when
appropriate and necessary to prevent unintended interruptions
in drug therapy."
5)Related legislation. AB 2050 (Steinorth) would require health
plans and health insurers to cover the synchronization of
prescription drugs under specified circumstances. AB 2050 is
pending in the Senate Health Committee.
6)Prior legislation. AB 2418 (Bonilla of 2014), would have
required health plan contracts and health insurance policies
to allow for the synchronization of prescription refills, and
permit refill of topical ophthalmic medications at 70% of the
AB 1831 (Low) Page 6 of ?
predicted days of use, effective January 1, 2016. AB 2418 was
vetoed by the Governor. The Governor's veto message included
the following: "The bill would require health plans and
insurers to apply a prorated daily cost-sharing rate to the
refills of certain medications if the prescriber or pharmacist
indicates it is in the best interest of the patient and it is
for the purpose of synchronizing refill dates for the
patient's medications. The bill also allows for early refills
of covered eye products. While I understand the importance of
encouraging people to take their prescribed medications, the
bill lacks explicit patient consent before changes are made to
refills; nor does the bill speak to the supportive elements
that have made synchronization programs anecdotally
successful. Medication adherence is complicated. Solutions to
this problem will likely require a more holistic approach and
collaboration between doctors, patients, pharmacists and
health plans."
7)Support. The California Academy of Eye Physicians writes this
legislation is in patient's best interests, particularly for
anti-glaucoma and antibiotic agents that can be viewed as site
saving. The California Optometric Association writes that CMS
stressed the necessity for early refills to prevent
interruptions in drug therapy that potentially have serious
consequences. According to the California Life Sciences
Association TOPs, such as eye drops, can be difficult to apply
and it is often common for patients to waste or use more eye
drops than necessary when drops hit their cheeks or two eye
drops come out at once. They are used to treat a variety of
conditions including glaucoma, conjunctivitis, among others.
Diseases like glaucoma, when inadequately treated or
untreated, can result in irreversible vision impairment and
blindness. The Community Health Partnership writes that when
a patient runs out of eye drops, a patient may have to pay the
full cost of the prescription if he or she runs out of eye
drops before the scheduled refill. When faced with the option
of paying full price for the prescription or waiting until the
scheduled refill date, many low-income patients may choose to
go without the medication for weeks instead of paying out of
pocket. Interruptions in drug therapy for eye-related
conditions potentially have serious consequences, including
irreversible vision loss.
SUPPORT AND OPPOSITION :
Support: California Academy of Eye Physicians and Surgeons
AB 1831 (Low) Page 7 of ?
(cosponsor)
California Optometric Association (cosponsor)
American Federation of State, county and Municipal
Employees
California Life Sciences Association
California Pharmacists Association
Community Health Partnership
Congress of California Seniors
Health Access California
Roots Community Health Center
Several Individuals
Oppose: None received
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