BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 2418
AUTHOR: Bonilla
AMENDED: May 27, 2014
HEARING DATE: June 25, 2014
CONSULTANT: Boughton
SUBJECT : Health care coverage: prescription drugs: refills.
SUMMARY : Requires a health plan contract or health insurance
policy issued, amended, or renewed on or after January 1, 2016,
that provides coverage for prescription drug benefits and that
imposes a mandatory mail-order restriction for some or all
covered prescription drugs to establish a process for enrollees
to opt out of that restriction. Permits and applies a pro-rated
daily cost-sharing rate to the refills of prescriptions that are
dispensed by a participating pharmacy for less than the standard
refill amount if the prescriber or pharmacist indicates that the
refill for less than the standard amount is in the best interest
of the enrollee or insured and is for the purpose of
synchronizing the refill dates of the enrollee's or insured's
medications. Allows
for early refills of covered topical ophthalmic products at 70
percent of the predicted days of use.
Existing law:
1.Requires health care service plans to be regulated by the
Department of Managed Health Care (DMHC) and health insurers
to be regulated by the California Department of Insurance
(CDI).
2.Requires health care 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.Limits, for an individual or group health care service plan
contract or health insurance policy issued, amended, or
renewed on or after January 1, 2015, that provides coverage
for prescribed, orally administered anticancer medications
used to kill or slow the growth of cancerous cells, the total
amount of copayments and coinsurance an enrollee or insured is
required to pay for orally administered anticancer medications
Continued---
AB 2418 | Page 2
to $200 for an individual prescription of up to a 30-day
supply.
4.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.
5.Requires, under regulations, a plan that provides coverage for
prescription drugs through a mail order pharmacy to have
written policies and procedures documenting that the plan's
mail order arrangements are in compliance with applicable
California and federal laws regarding pharmacists and pharmacy
services.
6.Requires, under regulations, the mail order pharmacy process
to conform effectively and efficiently to a plan's processes
for prior authorization for coverage of medically necessary
drugs as required, and to include standards for timely
delivery and a contingency mechanism for providing the drug if
a mail order provider fails to meet the delivery standards.
This bill:
1.Requires a health plan contract or health insurance policy
issued, amended, or renewed on or after January 1, 2016, that
provides coverage for prescription drug benefits and that
imposes a mandatory mail-order restriction for some or all
covered prescription drugs to establish a process for
enrollees to opt out of that restriction.
2.Authorizes the opt out process to require the use of a plan's
participating pharmacy that is not a mail-order-only pharmacy,
at the discretion of the plan and requires 30 days' written
notice before the election to opt out is effective. Requires
the opt-out process to comply with all of the following
requirements:
a. Prohibit the imposition of conditions or
restrictions on an enrollee or insured opting out of
the mandatory mail-order restriction. "Conditions or
restrictions" include, but are not limited to,
requiring prescriber approval or submission of
documentation by the enrollee, insured or prescriber;
b. Allow an enrollee or insured to opt out of the
mandatory mail-order restriction, and revoke his or
AB 2418 | Page
3
her prior opt out of the restriction, at any time;
c. Require the choice by an enrollee or insured
to opt out to be valid for the duration of the plan
year or until the enrollee or insured elects to revoke
the opt out, whichever occurs first, provided that the
enrollee or insured remains enrolled in the same
product with either the same subscriber or
policyholder, with respect to individual plan
contracts or policies, or the same plan sponsor, with
respect to group plan contracts or policies; and,
d. Requires a health plan or insurer to provide
an enrollee or insured who obtains a covered
prescription drug that is subject to the mandatory
mail-order restriction with a separate written notice
of the restriction and any exceptions upon dispensing
of the first fill of the drug or no less than 30 days
prior to the restriction taking effect for the first
refill of the drug. Requires this written notice to be
in addition to any information contained in the plan's
or insurer's evidence of coverage or evidence of
benefits. Requires the notice to inform the enrollee
or insured of the right to opt out of the mandatory
mail-order restriction and instructions on how to do
so.
3.Prohibits this bill from being construed to limit or prohibit
differential copayments in the form of financial incentives
whereby an enrollee's or insured's cost sharing is reduced
when he or she uses mail order rather than a community
pharmacy.
4.Requires a health plan contract or insurance policy issued,
amended, or renewed on or after January 1, 2016, that provides
coverage for prescription drug benefits to permit and apply a
prorated daily cost-sharing rate to the refills of
prescriptions that are dispensed by a participating pharmacy
for less than the standard refill amount if the prescriber or
pharmacist indicates that the refill for less than the
standard amount is in the best interest of the enrollee or
insured and is for the purpose of synchronizing the refill
dates of the enrollee's or insured's medications and all of
the following apply:
a. The prescription drugs being synchronized are
covered and authorized by the health plan contract or
AB 2418 | Page 4
health insurance policy;
b. The prescription drugs being refilled for less
than the standard amount are not subject to quantity
limits or other utilization management controls that
are inconsistent with the synchronization plan,
including, but not limited to, controlled substance
prescribing and dispensing guidelines intended to
prevent misuse or abuse;
c. The prescription drugs being synchronized are
dispensed by a single participating pharmacy;
d. The patient has completed at least 90
consecutive days on the prescription drugs being
synchronized;
e. The prescription drugs being refilled for less
than the standard amount are of a formulation that can
be effectively split over the required short fill
period to achieve synchronization; and,
f. The prescriber has not done either of the
following with respect to the prescription drugs being
refilled for less than the standard amount:
i. Indicated, either orally or in his
or her own handwriting, "No change to quantity,"
or words of similar meaning; or,
ii. Checked a box on the prescription
marked "No change to quantity," and personally
initialed the box or checkmark.
5.Exempts, from 1) through 4) above, a drug that is not
available at a participating community pharmacy due to any of
the following:
a. An industry shortage listed on the Current
Drug Shortages Index maintained by the federal Food
and Drug Administration (FDA);
b. A manufacturer's instructions or restrictions;
c. Any risk evaluation and management strategy
approved by the FDA; or,
d. A special shortage affecting the plan's
network of participating pharmacies.
6.Requires a health plan contract or health insurance policy
issued, amended, or renewed on or after January 1, 2016, that
provides coverage for prescription drug benefits to allow for
early refills of covered topical ophthalmic products at 70
percent of the predicted days of use.
AB 2418 | Page
5
7.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, this bill has been amended and implications of the
mandatory mail order provisions have been clarified since the
California Health Benefits Review Program (CHBRP) analyzed it.
Cost estimates from CHBRP have been modified, and costs are
estimated as follows:
1.Potential one-time costs to DMHC of $200,000 for plan
licensing, regulatory, and enforcement costs (Managed Care
Fund). Ongoing costs are likely to be minor.
2.Minor one-time costs to CDI, in the range of $30,000
(Insurance Fund) for oversight and enforcement.
3.Negligible costs for provision of services through the
California Public Employees' Retirement System (CalPERS)
benefit plans (General Fund/federal/special/local funds).
4.State expenditures for Medi-Cal Managed Care Plans are
estimated to increase by at least $154,000 annually.
5.Increased employer-funded premium costs in the private
insurance market of at least $845,000 annually.
6.Increased premium expenditures by employees and individuals
purchasing insurance of at least $500,000 annually, as well as
increased out-of-pocket expenditures of at least $1.8 million.
7.To the extent this bill precludes the ability of plans and
insurers to direct enrollees, for certain drugs, to mandatory
mail order pharmacies with which plans have pricing agreements
for certain drugs, there could be significant cost pressures
to the market beyond that estimated by CHBRP. This cost
pressure is likely to grow over time, as this bill will limit
the ability of pharmaceutical benefits managers to use
mandatory mail order pharmacies for certain high-cost drugs.
PRIOR VOTES :
Assembly Health: 19- 0
Assembly Appropriations:17- 0
AB 2418 | Page 6
Assembly Floor: 75- 1
COMMENTS :
1.Author's statement. According to the author, poor medication
adherence is a major barrier to achieving better patient
outcomes. This bill provides patients with a choice between
either picking up their medication at a local pharmacy or
having their medication delivered through mail order programs.
In addition, this bill streamlines the prescription refill
process by ensuring that all of the patient's chronic
medications can be refilled on the same schedule and allows
patients who run out of eye drops to obtain early refill.
Patients that do not take their medications regularly are at
greater risk of developing poor health outcomes and
hospitalization. By creating processes that support and
improve patient access to medications, patients experience
better health outcomes and improved quality of life and
patients who pick up their medications at their local pharmacy
have the opportunity to talk with their pharmacist about how
to properly take their medications and to understand the
positive benefits of taking their medication.
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 major findings of
CHBRP's analysis.
a. Enrollees. CHBRP estimates that in 2015, 23.1
million enrollees will have coverage for outpatient
prescription drugs that could be affected by this bill,
including some Medi-Cal beneficiaries and CalPERS
enrollees. CHBRP estimates that 1.1 million enrollees
have mandatory mail-order without an AB 2418 compliant
process. Around 10.28 million do not have coverage for
synchronized refills, and 10.43 million do not refill
coverage for topical ophthalmic products at or after 70
percent. Among CalPERS enrollees, all members have an AB
2418 compliant opt out process for mandatory mail order,
only 50 percent have compliance for synchronizing drug
refills and topical ophthalmic at 70 percent.
b. Impact on expenditures. Total expenditures are
AB 2418 | Page
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estimated to increase by $3.3 million (.003 percent).
Increases in per member per month premiums for the newly
mandated terms of benefit coverage in all markets would
be less than $.10 in DMHC-regulated plans and CDI
policies. CHBRP estimates out-of-pocket expenses would
increase by $61.87 per enrollee among approximately
29,821 enrollees switching from mandatory mail-in-order
refills to retail pharmacy refills. In response to
concerns raised by Blue Shield of California regarding
CalPERS, CHBRP re-queried requesting information on
enrollees with coverage for specialty drugs that might be
subject to mandatory mail requirement. The revised
responses indicate that a minority of CalPERS enrollees
and a minority of enrollees in the broader market do
indeed have coverage for specialty drugs subject to
mandatory mail requirements. Furthermore, the revised
responses listed mandatory mail requirements for which
mail (or shipping from a specialty pharmacy network) is
not required by the manufacturer or the FDA. CHBRP
initiated a new analysis to see how expenditures might be
altered by switching some specialty drug refills from
mail (or shipping) to retail pharmacies, and determined
that such a switch could increase expenditure impact
beyond CHBRP's estimated impacts, but MarketScan data on
these refill costs is inconclusive, probably due to an
industry-wide confusion as to whether "mail" and
"shipping" are synonymous.
c. EHBs. AB 2418 would not exceed California's
definition of EHBs.
d. Medical effectiveness. CHBRP found insufficient
evidence to determine the effect of the three provisions
(mandatory mail opt-out requirements, synchronization
denial prohibition, and early topical ophthalmic product
refill denial prohibition) may have on adherence. The
absence of evidence is not evidence of no effect.
Specifically:
For the mail order opt-out provision , CHBRP did not
identify any studies comparing mandatory mail order
with opt-out to mandatory mail order without opt-out.
One study that examined the effects of mandatory mail
order, in comparison to optional mail order, found
that mandatory mail order was associated with lower
medication adherence. Because of the limited number of
studies on this topic, CHBRP assessed the quality of
the evidence as insufficient to make a determination
AB 2418 | Page 8
on effectiveness. There is a substantial body of
research on the effects of mail order compared to
retail pharmacies. However, these studies are of
limited relevance to AB 2418 because they all involved
either optional mail order participants or an
undifferentiated combination of optional and mandatory
participants. There are known differences in the
characteristics of individuals who choose mail order
over retail pharmacies, with the former group more
likely to be white/non-Hispanic, aged 65 or over, and
have private insurance (Stagnitti, 2008). In addition,
several researchers have found that optional mail
order users have different behaviors related to
medication use, such as higher adherence even before
beginning to use mail order (Devine et al., 2010;
Iyengar et al., 2013). Therefore, studies that do not
specifically focus on enrollees with a
mandatory-mail-order provision do not provide evidence
for or against the medical effectiveness of either a
mandatory-mail-order provision or an opt-out from
mandatory mail. Several of the studies that CHBRP
examined were conducted by organizations with an
interest in the outcomes of the study, such as retail
pharmacy chains (Khandelwal et al., 2011) or mail
order pharmacy companies (Devine et al., 2010; Iyengar
et al., 2013). A systematic review of studies of the
impact of industry sponsorship on research findings
concluded that sponsorship of studies of drugs or
medical devices by manufacturers is associated with
results and conclusions that are more favorable to
their products (Lundh et al., 2012). It is worth
noting that each type of organization found that its
own medication delivery method resulted in higher
adherence rates.
For the refill synchronization provision , CHBRP
identified two relevant studies, but only one provided
evidence for or against refill synchronization
specifically. That study found that medication
adherence was improved for patients with all drug
refills synchronized in comparison to patients with no
refill synchronization. Again, because of the limited
literature on this topic, CHBRP found the quality of
the evidence to be insufficient to make a
determination on effectiveness.
For the topical ophthalmic products refill provision,
CHBRP did not identify any studies or practice
AB 2418 | Page
9
guidelines that examined either refill or brief lapses
in treatment of these drugs. The lack of studies in
this area again led to a determination of insufficient
evidence.
e. Benefit coverage. CHBRP estimates the following:
1.07 million enrollees would gain an AB 2418 compliant
opt-out process for mandatory mail order; 10.28 million
would gain coverage for synchronization refills, and
10.43 enrollees would have coverage for topical
ophthalmic product refills at 70 percent of expected days
of use.
f. Utilization. Retail pharmacy refills would increase
by .26 percent with a commensurate decrease in mandatory
mail refills due to switching from mail to retail
refills. The switch rates are estimated to be at 23.3
percent. CHBRP cannot estimate the impact associated
with synchronizing refills. Topical ophthalmic product
refills would increase by .12 percent. In one year, .1
more prescriptions per 1,000 covered enrollees would be
refilled for topical ophthalmic products.
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, postmandate, is unknown. Please note that the
absence of evidence is not evidence of no effect. It is
possible that an impact, positive or negative, could
result, but current evidence is insufficient to inform an
estimate.
h. Other states and Medicare. According to CHBRP, 18
states prohibit mandatory mail order, six states restrict
mandatory mail order and 13 states have incentives for
mail order restricted. One state (Oregon) requires
synchronization refills, and four states require early
refills for topical ophthalmic products. In addition,
CHBRP indicates that the Centers for Medicare and
Medicaid Services (CMS) has provisions to the three
required in this bill.
3.Specialty drugs. According to a February 2014 issue brief
published by America's Health Insurance Plans (AHIP), 25
percent of U.S. spending on prescription drugs in 2012 was on
specialty drugs. Specialty drugs are structurally complex and
often require special handling or delivery mechanisms and are
AB 2418 | Page 10
priced much higher than traditional drugs. The treatment
regimen for some of the most expensive specialty drugs can
cost $750,000 per year. Because of the comparatively high
cost of these drugs, the commercial trend for pharmaceutical
spending in 2012 was driven almost entirely by increases in
the unit cost of specialty drugs. Spending on specialty drugs
has shown no signs of abating; similar double digit increases
are forecast for 2013-2015. In 2013, 60 percent of the drugs
approved by the federal FDA are expected to be specialty
drugs. While these drugs offer tremendous promise when
medically necessary, their high costs and extended use has put
a strain on the health system and health plans, employers and
other stakeholders are searching for ways to restrain cost
growth while maintaining access to safe and effective drugs
for patients. According to the brief, based on 2010 data the
following conditions had the following average cost per
treatment member per year: Inflammation Conditions - $14,455,
Multiple Sclerosis - $24,118, Cancer - $11,089, Pulmonary
Hypertension - $32,570, and Respiratory Conditions - $18,550.
According to the April 24, 2014 CHBRP analysis of AB 1917
(Gordon), there is no standard industry definition of
specialty prescription drugs, but it is generally recognized
by many payers as prescription drugs with an average minimum
monthly cost of $1,150. Other criteria may include
prescription drugs that treat a rare disease, require special
handling, or have a limited distribution network.
Medicare Part D establishes requirements for its specialty
tier. Drugs with sponsored negotiated prices that exceed the
dollar-per-month amount established by CMS may be placed on
the specialty tier. These are a limited number of drugs that
are used by a small proportion of beneficiaries. The current
specialty tier threshold is $600 per 30 days. Based on trends
over the last three years that met the threshold, Part D
utilization, and the costs associated with these drugs, CMS
concluded that this value continues to identify outlier
claims- 99 percent of 30 day equivalent prescription drug
events are below this value.
4.Medication adherence. According to CHBRP, medication
adherence can be defined as "...the extent to which patients
take medications as prescribed by their health care providers"
(p. 487) (Osterberg and Blaschke, 2005). Direct measurement of
adherence is very difficult as it requires either observation
AB 2418 | Page
11
of the patients actually taking their medication or
measurement of a metabolite of the medication through
laboratory testing (Osterberg and Blaschke, 2005). CHBRP finds
insufficient evidence to suggest that any of the provisions in
AB 2418, (opt-outs from mandatory mail order, refill
synchronization, or early refills for topical ophthalmic
products) would improve medication adherence. Although CHBRP
estimates a very limited increase in filled prescriptions for
topical ophthalmic medications due to the 70 percent refill
provision, CHBRP estimates that these enrollees (on average)
could have filled their prescriptions at 75 percent to 80
percent; the extra time (generally a single day) of use is
unlikely to have a measurable impact on adherence.
5.Pharmacy Benefit Managers (PBMs). According to the Federal
Trade Commission, many health plan sponsors offer their
members prescription drug insurance and hire PBMs to manage
these pharmacy benefits on their behalf. As part of the
management of these benefits, PBMs assemble networks of retail
and mail-order pharmacies so that the plan sponsors' members
can fill prescriptions easily and in multiple locations. PBMs
contract with employers, labor unions, insurance companies,
the state, Medicaid (Medi-Cal in California) and Medicare
managed care plans, and managed care companies (collectively,
"plan sponsors") to manage pharmacy benefits. There are large
PBMs (Express Scripts/Medco, and Caremark), small and
insurer-owned PBMs (Aetna, Cigna Corporation, Wellpoint Health
Networks), retailer-owned (Eckerd Health Systems, PharmaCare
Management Services [a subsidiary of CVS Corp]), Walgreens
Health Initiative or stand-alone retail pharmacies (CVS Corp,
Rite Aid Corporation, Walgreen and Wal-Mart Stores, Inc).
6.Related legislation. AB 1917 (Gordon) establishes limits on
the copayment, coinsurance, or any other form of cost sharing
for a covered outpatient prescription drug for an individual
prescription of 1/12 (equivalent to $529 for 2014) or
($3,175 for 2014) of the annual out-of-pocket limit (which is
$6,350 for 2014), as specified under the federal Patient
Protection and Affordable Care Act with respect to a
non-grandfathered individual or group health plan contract or
insurance policy.
SB 1176 (Steinberg), requires a health plan or health insurer
to track the accumulation of cost sharing for covered EHBs and
makes a health plan or insurer responsible for notifying the
AB 2418 | Page 12
enrollee or insured when the maximum accrual limit has been
reached and requires the plan or insurer to reimburse the
enrollee or insured if cost sharing exceeds annual limits. SB
1176 was heard in Assembly Health Committee on June 17, 2014
and passed with a 14-5 vote.
7.Prior legislation. AB 299 (Holden) would have prohibited a
pharmacy that delivers prescriptions via mail, from entering
into, or being a party to, an agreement with a health care
service plan or disability insurer that requires a plan
enrollee or insured to utilize mail order services or that
requires a plan enrollee or insured to opt out of a mail order
process. AB 299 was held in the Assembly Appropriations
Committee.
AB 219 (Perea), Chapter 661, Statutes of 2013, limits the total
amount of copayments and coinsurance an enrollee or insured is
required to pay for orally administered anticancer medications
to $200 for an individual prescription of up to a 30-day
supply. Governor Brown wrote in a message approving AB 219
that this policy is not without the potential for unintended
consequences and that placing a price cap on a specific class
of drugs for a specific class of diseases might not be a
policy for the ages. A sunset on the bill allows for
examination of intended and unintended consequences before
embracing the policy long term.
SB 1301 (Ed Hernandez), Chapter 455, Statutes of 2012,
authorizes a pharmacist to dispense not more than a 90-day
supply of a dangerous drug other than a controlled substance
pursuant to a valid prescription, except for psychotropic
medication or drugs or controlled substances, as specified.
SB 1195 (Price), Chapter 706, Statutes of 2012, requires a
contract that is issued, amended, or renewed on or after
January 1, 2013, between a pharmacy and a carrier or a PBM to
provide pharmacy services to beneficiaries of a health benefit
plan to comply with standards and audit requirements.
8.Support. Proponents, such as the ALS Association of Greater
Sacramento, write that approximately 50 percent of patients
with chronic health conditions do not take their medications
as directed by their doctor. Patients who do not take
medications as prescribed do not benefit from that treatment
and are more likely to experience deteriorating health and
complications that require hospitalization, which leads to
AB 2418 | Page
13
increased healthcare spending. This bill promotes strategies
that have been recommended by leading health organizations to
increase medication adherence. Providing patients with an
early refill of eye drops prevents patients from skipping
doses simply because they accidentally spilled drops when
applied. The American Cancer Society Cancer Action Network
indicates that one of the largest risk factors for a cancer
diagnosis is age, and it is especially important that aging
individuals have the opportunity to consult with both
physicians and pharmacists about their prescription
medications. BayBIO, BIOCOM and the Biotechnology Industry
Organization writes that poor medication adherence accounts
for as much as $290 billion per year in avoidable medical
costs usually from hospitalizations and outpatient visits.
The California Pharmacists Association and the California
Healthcare Institute co-sponsor this bill and indicate that as
medication experts, pharmacists can play a key role in helping
improve medication adherence. Between 50 and 75 percent of
patients do not follow prescriber instructions or do not take
their prescribed medications at all. Overall poor medication
adherence accounts for as much as $290 billion per year in
avoidable medical spending. According to the sponsors, most
large health plans and insurers offer Medicare Part D
products, and because of that already comply with these same
requirements today.
9.Opposition. AHIP writes that mail order pharmacy services are
not a restriction on benefits, but rather an important part of
prescription drug care management practices, and consumer
service that should not be prohibited. Broad opportunities
for opting out of mail order will raise the cost of providing
pharmacy benefits and will have important implications for the
delivery of prescriptions in the future. Health plans must be
able to maintain discretion to implement care management
techniques. As there are more block buster or specialized
drugs entering the market with extremely high pricing, health
plans need the tools to manage such costs to keep drugs
affordable for patients and reduce their impact on premiums
and cost sharing. This is imperative as the drug manufacturer
often has sole control over the price of the drug and patent
protections prevent market competition that would
traditionally combat unreasonable pricing. Specialty
medications can average $29,000 per year with some drugs
costing as much as $750,000. Health plans need flexibility to
exclude certain drugs including specialty pharmacy drugs,
AB 2418 | Page 14
compounded drugs, and risk-evaluation medications from the
opt-out process established in this bill. With regard to
synchronization of prescription drugs, it can create
challenges for medical management if not properly applied, and
in some respects is not administratively feasible.
Synchronization could threaten patient safety by increasing
the risk for confusion as pharmacies, providers, patients and
health plans attempt to work through the administrative
complications of synchronization of multiple medications. On
ophthalmic prescription, AHIP supports uniformity with
national guidelines as it relates to refill standards for
topical ophthalmic products. Under the Medicare program, CMS
recommends that carriers permit refills at 70 percent of the
predicted days of use for topical ophthalmic products. AHIP
encourages early refill standards that ensure quality care for
enrollees and proposes language that permits a refill of
topical ophthalmic drugs at 70 percent of the predicted days
of use or between one to five days prior to the refill date as
long as the provider authorizes the early refill. Blue Shield
of California believes this bill would eviscerate the benefits
their members realize from specialty mail order programs,
which help Blue Shield to leverage discounts on prescription
drug benefit. Blue Shield believes as drafted, this bill
would require that the vast majority of specialty drugs be
made available at every in-network retail pharmacy - not just
through contracted specialty pharmacies.
10.Oppose unless amended. Molina Healthcare indicates that some
brick and mortar pharmacies can order and dispense specialty
drugs, using specialty pharmacies can save up to 30 percent on
the price of these very expensive drugs. Molina suggests
section 2 be amended to add a provision stating that
subdivision (a) does not apply to drugs that meet the
following criteria, even if those drugs are provided chiefly
by mail order:
a. Biological in nature, such as developed from living
organism or its products, such as antibodies,
interleukins, blood products, and vaccines;
b. FDA-indicated for treating rare or orphan diseases;
c. Require special handling and storage;
d. Require patient education and monitoring to ensure
effectiveness and/or safety; and,
e. Have significant monthly ingredient costs.
Express Scripts Holding Company requests the opt-out exclude
AB 2418 | Page
15
specialty medications and apply only to maintenance
medications, and the bill establish an alternative to mail
service under specified circumstances. Amendments are needed
to specify those drugs eligible for synchronization including
limiting the bill to chronic medications that the patient has
been titrated on a minimum of three months, and exceptions for
opioids, stimulants and other highly addictive drugs.
Additionally, Express Scripts request an amendment to include
language to allow refills up to five days prior to the next
scheduled refill instead of 70 percent Medicare standard.
SUPPORT AND OPPOSITION :
Support: California Healthcare Institute (Co-Sponsor)
California Pharmacists Association (Co-Sponsor)
American Academy of Physical Medicine and
Rehabilitation
American Federation of State, County and Municipal
Employees, AFL-CIO
ALS Association
American Cancer Society
American Nurses Association\California
Association of Northern California Oncologists
BayBio
BIOCOM
Biotechnology Industry Organization
California Association of Area Agencies on Aging
California Association of Physician Group
California Chronic Care Coalition
California Council for the Advancement of Pharmacy
California Grocers Association
California Health Collaborative
California Hepatitis C Task Force
California Optometric Association
California Pan-Ethnic Health Network
California Senior Advocates League
California Senior Legislature
California Urological Association
Central Drug Store
Contra Costa County Public Guardian/Conservators
Department
Congress of California Seniors
Hemophilia Council of California
Herndon Pharmacy
Huntington's Disease Society of America
International Foundation for Autoimmune Arthritis
AB 2418 | Page 16
Latina Breast Cancer Agency
La Clinica de La Raza, Inc.
Latinas Contra Cancer
Mental Health America of California
Mental Health Systems
National Association for the Advancement of Colored
People
National Association of Chain Drug Stores
National Multiple Sclerosis Society
Patterson Family Pharmacy
Pharmaceutical Research and Manufacturers of American
Rehabilitation Services of Northern California
Rite Aid
Sacramento Latino Medical Association
Safeway
SEIU - UHW (United Healthcare Workers West)
Spondylitis Association of America
The Wall Las Memorias
United Food and Commercial Workers Union
United Nurses Associations of California/Union of
Health Care Professionals
Walgreens
Oppose:Aetna
American's Health Insurance Plans
Anthem Blue Cross
Association of California Life and Health Insurance
Companies
Blue Shield of California
California Association of Health Plans
CSAC Excess Insurance Authority
CVS Caremark
Express Scripts
CMP Employees Retiree Trust
Molina Healthcare of California (unless amended)
Pharmaceutical Care Management Association
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