BILL ANALYSIS
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THIRD READING
Bill No: SB 1096
Author: Calderon (D)
Amended: 5/8/08
Vote: 21
SENATE HEALTH COMMITTEE : 6-4, 4/9/08
AYES: Cedillo, Maldonado, Negrete McLeod, Steinberg,
Wyland, Yee
NOES: Kuehl, Aanestad, Alquist, Cox
NO VOTE RECORDED: Ridley-Thomas
SENATE JUDICIARY COMMITTEE : 3-2, 4/29/08
AYES: Harman, Ackerman, Steinberg
NOES: Corbett, Kuehl
SENATE FLOOR : 17-17 (FAIL), 5/22/08
AYES: Ackerman, Calderon, Cedillo, Correa, Florez, Harman,
Maldonado, Margett, Negrete McLeod, Oropeza, Perata,
Scott, Steinberg, Torlakson, Vincent, Wyland, Yee
NOES: Aanestad, Alquist, Ashburn, Battin, Corbett, Cox,
Ducheny, Hollingsworth, Kehoe, Kuehl, Lowenthal, Machado,
McClintock, Migden, Romero, Simitian, Wiggins
NO VOTE RECORDED: Cogdill, Denham, Dutton, Padilla,
Ridley-Thomas, Runner
SUBJECT : Medical information
SOURCE : Adheris
DIGEST : This bill allows a pharmacy or an entity
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authorized by the pharmacy, to mail written communications
to a patient pertaining to a prescribed course of
treatment, without the patient's authorization, under
specified conditions.
Senate Floor Amendments of 5/8/08 provide that the written
communications which is allowed for in this bill and will
not require prior patient authorization will be limited to
the following diseases: diabetes, osteoporosis, asthma,
chronic obstructive pulmonary disease, cancer, gastric
disorder, hypertension, cardiovascular disease, thyroid
disorder, organ transplantation, chronic eye disorder,
rheumatoid arthritis and osteoarthritis, renal disorders,
Parkinson's disease, seizures, multiple sclerosis,
depression, schizophrenia, bipolar disorder, anxiety
disorders, and attention deficit disorder.
ANALYSIS :
Existing Federal Law and Regulations
1.Prohibits entities that use electronic means to transmit
or receive medical information (referred to as "covered
entities") from using or disclosing personal health
information for purposes other than medical treatment or
payment, or health care operations, as defined, except
pursuant to a written authorization signed by the
patient.
2.Prohibits, with limited exceptions, health care entities
from disclosing personal health information for the
purposes of marketing without prior authorization from
the patient, and further requires that the authorization
specify when the marketing involves direct or indirect
remuneration to the entity from a third party. Under the
regulations, "marketing" is defined to include
communication about a product or service that encourages
the recipient to purchase or use the product or service.
3.Exempts from the definition of "marketing" communications
that describe a health-related product or service that is
provided by, or included in, a plan of benefits of the
covered entity; communications made for the treatment of
the individual, and communications made to facilitate
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case management or care coordination, or to recommend
alternative treatments, providers, or care settings, to
the individual.
4.Provides that a face-to-face marketing communication from
the entity to the individual does not require
authorization from the patient.
5.States that, if a HIPPA privacy provision conflicts with
a provision of state law, the provision that is most
protective of patient privacy prevails.
6.Establishes a national goal of providing useful written
prescription drug information to consumers, with the
specific goal of providing written information to 75
percent of individuals receiving new prescriptions by the
year 2000 and to 95 percent by the year 2006.
7.Provides that prescription drug advertising sponsored by
a product's manufacturer cannot be false or misleading,
must present a fair balance between the risks and
benefits of the product, must reveal material facts
relevant to the product or its use, and must disclose, or
provide for the disclosure of, all risks contained in the
product's labeling.
Existing State Law
1.Prohibits a provider of health care, health care service
plan, or health care contractor from disclosing a
person's medical information without first obtaining that
person's authorization, with exceptions, as specified.
2.Prohibits a provider of health care, a health care
service plan, contractor, or corporation, and its
subsidiaries and affiliates from intentionally s haring,
selling, using for marketing, or otherwise using any
medical information, as defined, for any purpose not
necessary to provide health care services to a patient,
except as expressly authorized by the patient, enrollee,
or subscriber, or as otherwise required or authorized by
law.
3.Defines "marketing" as a communication about a product or
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service that encourages the recipient to purchase or use
the produce ore service, and provides that marketing does
not include any of the following:
A. Oral or written communications for which the
communicator does not receive direct or indirect
remuneration.
B. Communications by a health plan to its enrollees
concerning plan providers and the services they
provide and the availability of more cost-effective
pharmaceuticals.
C. Remunerated communications that are tailored to
the individual circumstances of a person made in
order to educate or advise the person about treatment
options and to maintain a person's adherence to a
prescribed course of medical treatment for a chronic
condition, as defined, if the person is notified that
the provider or health plan that is making the
communication ahs been remunerated and by whom, and
the person is given the opportunity to opt out of
future communications.
This bill deems a written communication mailed to a patient
by a pharmacy to be necessary to provide health care
services to the patient and provides that prior
authorization will not be required, if all of the following
apply:
1.The written communication is in the same language as the
prescription label and instructs the patient when to
contact a health care professional.
2.The written communication encourages the patient to
adhere to a prescribed course of medical treatment as
prescribed by a licensed health care professional and
may include information about the particular prescribed
pharmaceutical drug as authorized in this section.
3.The written communication pertains only to the
prescribed course of medical treatment and does not
describe or mention any other pharmaceutical products.
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4.The written communication contains only product-related
information that is consistent with the current federal
Food and Drug Administration (FDA) approved product
package insert and provides fair and balanced
information regarding the products benefits and risks in
accordance with FDA requirements and policies.
5.Provides that the written communications will be limited
to the following diseases:
A. Diabetes.
B. Osteoporosis.
C. Asthma.
D. Chronic Obstructive Pulmonary Disease.
E. Cancer.
F. Gastric Disorder.
G. Hypertension.
H. Cardiovascular Disease.
I. Thyroid Disorder.
J. Organ Transplantation.
K. Chronic Eye Disorder.
L. Rheumatoid Arthritis and Osteoarthritis.
M. Renal Disorders.
N. Parkinson's Disease.
O. Seizures.
P. Multiple Sclerosis.
Q. Depression.
R. Schizophrenia.
S. Bipolar Disorder.
T. Anxiety Disorders.
U. Attention Deficit Disorder.
6.Provides that further written communication shall not be
provided if there are no refills remaining on a
prescribed course of therapy and there are no doses
remaining on the final prescribed refill, or the
pharmacy has been notified by a health care provider
that a prescribed course of therapy has been
discontinued or substituted with a different drug.
7.A copy of each written communication version is
submitted to the FDA Center for Drug Evaluation and
Research, Division of Drug Marketing, Advertising and
Communications, prior to program implementation.
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8.The written communication uses evidence-based or
consensus-based practice guidelines as the basis of any
information that is provided to patients in order to
improve their overall health, prevent clinical
exacerbations or complications, or promote
self-management strategies.
9.All personally identifiable medical information
collected, used, and disclosed is used solely to deliver
the written communication to the patient.
10.The entity that receives the information complies with
existing requirements concerning confidentiality and
security of information.
11.The pharmacy has a written agreement with the entity
that receives the information that requires the entity
to maintain the confidentiality of the information is
receives from the pharmacy and prohibits the entity from
disclosing or using the information for any purpose
other than to deliver to the patient the written
communication that is the subject of the written
agreement.
12.If the written communication is paid for, in whole or in
part, by a manufacturer, distributor, or provider of a
health care product or service, the written
communication discloses whether the pharmacy receives
direct or indirect remuneration from a third party for
making the written communication and discloses, in a
clear and conspicuous location, the source of the
sponsorship.
13.The communication contains instructions describing how
the patient may opt out of future communications and no
further sponsored message is made to the individual
after 30 calendar days from the date the individual
makes the opt out request.
Background
FDA Requirements Pertaining to Accuracy of Advertising .
Current FDA regulations provide that prescription drug
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advertisements sponsored by a product's manufacturer cannot
be false or misleading, must present a fair balance between
the risks and benefits of the product, and must, depending
on the medium in which the advertisement appears, either
disclose all the risks contained in the product's approved
labeling, or make adequate provision for disseminating the
product's labeling to the audience. In addition,
representations in advertising that refer to a drug as the
"drug of choice," or make a claim that the drug is superior
to other drugs must be supported by "substantial evidence."
Advertisements designed to inform or alert consumers to
health conditions are not subject to these requirements.
The advertisements may discuss, among other things, the
symptoms of a given medical condition, the availability of
treatment, and the benefits of treatment, and may encourage
consumers to seek information from their health care
provider.
Prescription Drug and Use Compliance . The National Council
of Patient Information and Education (NCPIE) study released
in August 2007cites research suggesting that non-adherence
costs Americans about $100 billion annually, including
roughly $47 billion for drug-related hospitalizations, and
is associated with roughly 40 percent of nursing home
admissions. Including indirect costs, the estimate rises
to $177 billion annually.
In a 2007 Journal of American Pharmacy Association article,
a study showed that interventions do positively impact
medication adherence. The study showed that groups that
received intervention (phone calls, letters, or both) on
average obtained more units of medication; the impact of
the interventions was greater among the group who received
both letters and phone calls; and only the group that
received both letters and phone calls showed a significant
treatment effect.
A recent telephone survey, conducted jointly by USA Today ,
Kaiser Family Foundation and the Harvard School of Public
Health, finds that four in 10 Americans (and half of those
regularly taking at least one medication) report
experiencing at least one of three cost-related concerns in
their family: 16 percent say it is a "serious" problem to
pay for prescription drugs; 29 percent say they have not
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filled a prescription in the past two years because of the
cost,; and 23 percent say they have cut pills in half or
skipped does in order to make a medication last longer.
People are most likely to report one of these three issues
if they lack drug coverage (52 percent), if they have low
incomes (54 percent) or if they take four or more drugs
regularly (59 percent).
FISCAL EFFECT : Appropriation: No Fiscal Com.: No
Local: No
SUPPORT : (Verified 5/12/08)
Adheris (source)
Alliance for Better Medicine
American Russian Medical Association
California Council of Community Mental Health Agencies
California Retailers Association
Community Life Improvement Program
Charles R. Drew University of Medicine & Science
Los Angeles Society of Allergy, Asthma & Clinical
Immunology
Mental Health Association in California
National Association of Cancer Patients
National Consumers League
National Association of Chain Drug Stores
Rite Aid
OPPOSITION : (Verified 5/12/08)
American Civil Liberties Union
California Alliance for Retired Americans
California Medical Association
Consumer Federation of California
Consumer Watchdog
Consumers Union
Privacy Rights Clearinghouse
ARGUMENTS IN SUPPORT : The sponsor, Adheris, a medical
information company that provides the written
communications referenced in this bill under contract with
pharmacies and pharmaceutical companies, believes that the
bill will provide California residents a clear health care
benefit by providing valuable information. The company
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notes that adherence to chronic therapies is poor and that
lack of adherence to therapies for hypertension, stroke
prevention, diabetes, and asthma not only results in poor
patient outcomes, but also costs Medicaid millions of
dollars in unnecessary hospitalizations and other medical
procedures. The company asserts that programs run by
retail pharmacies, which may include information on how to
take the medication, potential side effects, as well a
refill reminders, are considered "treatment" under HIPAA
regulations, but that California law does not clearly
define such programs as part of "treatment" and are, thus,
denied this benefit. Other supports, such as Community
Life Improvement Program, believe that healthcare
information designed to encourage proper use of prescribed
medicines is vital to an effective treatment regimen. The
Mental health Association in California writes that once
the doctor and patient have found the right medication, it
is important to keep patients compliant.
ARGUMENTS IN OPPOSITION : The California Medical
Association (CMA) writes that this bill allows unfettered
direct marketing to consumers of pharmaceutical and health
information using patients' confidential medical
information. CMA believes this concept will interfere with
the physician-patient relationship and could lead to
misinformation and confusion for patients, as well as
increased health costs through the direct-mail promotion of
drugs. CMA also states that this bill places the burden on
the patient to opt-out of this communication after the fact
and believes patients should be in charge of who uses their
medical information and why, so they can make informed
decisions in consultation with the doctor.
Additionally, the Consumer Federation of California (CFC)
and the Privacy Rights Clearinghouse (PRC) state that this
bill raises significant privacy concerns for patients. PRC
believes that it is a critical principle of privacy
protection that if a person's private information is to be
used or transferred, that they be asked first, and that any
program must contain an agreement by the patient that their
information will be used as part of a mailing program. CFC
emphasizes that the will allows a third party to send
reminder mailings that may be in direct contradiction to a
physician's recommended course of treatment. CFC believes
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that the measure intrudes on patient privacy and interferes
with the doctor-patient relationship.
CTW:cm 5/23/08 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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