BILL ANALYSIS                                                                                                                                                                                                    



                                                                  SB 1096
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          Date of Hearing:   June 17, 2008

                            ASSEMBLY COMMITTEE ON HEALTH
                              Mervyn M. Dymally, Chair
                    SB 1096 (Calderon) - As Amended:  May 23, 2008

           SENATE VOTE  :   21-16
           
          SUBJECT  :   Medical information.

          SUMMARY  :   Amends the Confidentiality of Medical Information Act  
          (CMIA) to authorize a pharmacy to mail written communications to  
          a patient without the patient's authorization, if specified  
          conditions are met.  Specifically,  this bill  :   

          1)Creates an exception to the prohibition in the CMIA that  
            prohibits the sharing, selling, or use of a person's medical  
            information for marketing without the express authorization of  
            the person by defining a written communication mailed to a  
            patient by a pharmacy as necessary to provide health care  
            services to the patient, if all of the following conditions  
            are met:

             a)   The communication is written in the same language as the  
               prescription label produced by the pharmacy when the  
               medication is prescribed;

             b)   The written communications instructs the patient to  
               contact the prescribing or dispensing health care  
               professional if:

               i)     The patient has questions about the medication;
               ii)    The patient is having difficulty adhering to the  
                 medication due to adverse effects, dosing requirements or  
                 other causes.

             c)   The written communication pertains only to the  
               prescribed course of medical treatment, and does not  
               describe or mention any other pharmaceutical products.   
               Limits the written communication to the following diseases:

               i)     Diabetes;
               ii)       Osteoporosis;
               iii)      Asthma;
               iv)       Chronic Obstructive Pulmonary Disease;








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               v)     Cancer;
               vi)       Gastric Disorder;
               vii)      Hypertension;
               viii)  Cardiovascular Disease;
               ix)       Thyroid Disorder;
               x)     Organ Transplantation;
               xi)       Chronic Eye Disorder;
               xii)      Rheumatoid Arthritis and Osteoarthritis;
               xiii)  Renal Disorders;
               xiv)      Parkinson's Disease
               xv)       Seizures;
               xvi)      Multiple Sclerosis;
               xvii)      Depression;
               xviii) Schizophrenia;
               xix)       Bipolar Disorder;
               xx)        Anxiety Disorders; and,
               xxi)       Attention Deficit Disorder.

             d)   Prohibits further written communication if there are no  
               refills remaining on the 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;

             e)   Requires all product information in the written  
               communication to be consistent with current federal Food  
               and Drug Administration (FDA) approved product package  
               insert, and provide fair and balanced information regarding  
               the product's benefits and risks in accordance with the FDA  
               requirements and policies;

             f)   Requires a copy of each communication to be submitted to  
               the FDA Center for Drug Evaluation and Research, Division  
               of Drug Marketing, Advertising and Communications, prior to  
               program implementation;

             g)   Requires evidence-based or consensus-based practice  
               guidelines to be the basis of any information provided to  
               patients in order to improve overall patient health,  
               prevent clinical exacerbations or complications, or promote  
               patient self-management strategies;

             h)   Requires all personally identifiable medical information  
               collected, used or disclosed to be kept confidential and  








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               used solely to deliver the written communication to the  
               patient.  Access to such information is limited to  
               unspecified authorized persons and any entity that receives  
               the information must comply with existing requirements  
               related to confidentiality and security, as specified;

             i)   Requires, if the communication is paid for by a  
               manufacturer, distributor, or provider of a health care  
               product or service, the communication to disclose whether  
               the pharmacy received direct or indirect remuneration from  
               a third party for making the communication and the  
               disclosure is in a clear and conspicuous location, in a  
               typeface no smaller than 14-point type; and,

             j)   Requires a pharmacy to offer the patient, at the time  
               the patient picks up his or her initial prescription an  
               opportunity to opt out, as specified, including at the time  
               a patient picks up the prescription and that the written  
               communication contains instructions for how the patient may  
               opt out of future communications.

           EXISTING LAW  :

          1)Prohibits, under CMIA, 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, except as specified.  Specifically  
            prohibits the sharing, selling, or use of a person's medical  
            information for marketing without express authorization of the  
            person.

          2)Defines "marketing," under the CMIA as a communication about a  
            product or service that encourages the recipient to purchase  
            or use the product or service.  States 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)   Certain specified communications to health plan  
               enrollees; or,
             c)   Remunerated communications that are tailored to the  
               individual circumstances of a person, as part of a disease  
               management program for chronic and seriously debilitating  
               or life-threatening conditions, to educate that person  








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               about both treatment options and adherence to a prescribed  
               course of medical treatment, if the person communicated to  
               is notified that the communicator has been remunerated and  
               by whom, and the person is given the opportunity to opt out  
               of future communications. 

          3)Prohibits, under the federal Health Insurance Portability and  
            Accountability Act (HIPAA), in general, covered entities from  
            using or disclosing personal health information (PHI) except  
            pursuant to a written authorization signed by the patient or  
            for treatment, payment or health care operations. 

          4)Prohibits, under HIPAA, health care entities from disclosing  
            PHI for "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.  Exempts from this prohibition,  
            marketing in the form of a "face-to-face communication" from  
            the entity to the individual. 

          5)Defines "marketing" under HIPPA to include communications  
            about a product or service that encourages the recipient to  
            purchase or use the product or service, except where the  
            communications:  describe a health-related product or service  
            that is provided by, or included in a plan of benefits of, the  
            provider; are made for the treatment of the individual; or,  
            are made for case management or care coordination, or to  
            recommend alternative treatments to the individual. 

          6)Under federal law, if a HIPAA privacy provision conflicts with  
            a provision of state law, the provision that is most  
            protective of patient privacy prevails.

          7)Under federal Public Law 104-180, enacted in 1995, establishes  
            a national goal of providing useful written prescription drug  
            information to consumers with the specific goal of providing  
            that information to 75% of individuals receiving new  
            prescriptions by the year 2000 and to 95% by the year 2006.

           FISCAL EFFECT  :   None

           COMMENTS  :

           1)PURPOSE OF THIS BILL  .  According to the author, this bill is  
            intended to clarify that written communication about the  








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            specific prescription drug a patient is receiving, as compared  
            to information on other potential prescription drugs, products  
            or information is not marketing for purposes of the patient  
            privacy protections under the CMIA.  The author contends that  
            it is well documented that adherence to chronic therapies is  
            very poor and offers extensive evidence related to the levels  
            of non-adherence to treatment regimens for chronic conditions.  
             According to the author, non-adherence to prescription drug  
            therapy costs the United States (U.S.) health care system over  
            $177 billion each year.  The author points out that many  
            pharmacies currently run programs to provide patients  
            information about their prescriptions, including information  
            on how to take the medication, the potential side effects, the  
            importance of staying on therapy, as well as refill reminders  
            by mail.  The author contends that these types of programs are  
            considered "treatment" under federal HIPAA but some pharmacies  
            and pharmaceutical companies are reluctant to support these  
            programs because California's medical privacy law does not  
            define these programs as treatment.

           2)BACKGROUND  .   The appropriate use of personal health  
            information is an increasingly important issue as medical  
            records evolve into electronic files, and large, sophisticated  
            insurance, billing and care management databases are developed  
            by health plans and providers with multiple purposes.   
            Organizations that provide or pay for health care now  
            routinely collect information on patient diagnoses,  
            prescriptions, and health services utilization.  Patient  
            databases can be the foundation of important care management  
            and case management programs, can allow health plans and  
            providers to effectively communicate with patients on their  
            care choices and options, and can facilitate improved quality  
            of care, through tracking, reporting and transparency of  
            health care services and outcomes.   At the same time,  
            according to a February 2000 article in the  Journal of the  
            American Medical Association  (  JAMA  ), "Uses and Abuses of  
            Prescription Drug Information in Pharmacy Benefits Management  
            Programs," breaches of confidentiality in electronic files may  
            be more serious than with paper records because databases  
            allow access to large amounts of information on many  
            individuals.  Though recent changes to U.S. Department of  
            Health and Human Services HIPAA regulations may allow  
            pharmaceutical companies to access patients' personal medical  
            records, California law is far stricter in preserving the  
            confidentiality of patient medical information.  Federal  








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            regulations establish only minimum standards that are exceeded  
            by laws in many states, including California.

          The  JAMA  article also states that professional ethics require  
            physicians to maintain patient confidentiality, which enables  
            people to seek medical care and to disclose information to  
            their providers.  Confidentiality also prevents stigma and  
            discrimination in health insurance or employment.   
            Furthermore, confidentiality ensures respect for patients as  
            persons because patients are offended by breaches of  
            confidentiality, even breaches that health care professionals  
            may consider commonplace (e.g., using patients' names in  
            discussion).  For these reasons, state and federal laws place  
            role-specific obligations on health care providers to protect  
            confidentiality.  Although confidentiality is important, there  
            are exceptions, including patients authorizing disclosure of  
            information.  Even without patient permission, health care  
            providers may be required by law to report certain infectious  
            diseases to public health officials, gunshot wounds to police,  
            and serious threats of violence by psychiatric patients to  
            intended victims.  These exceptions to confidentiality are  
            ethically justified because they prevent physical harm to  
            third parties or protect the public health.  Other exceptions  
            to confidentiality may be ethically justified because patients  
            benefit from the efficient flow of personal health  
            information.  The  JAMA  article points out, however, that it  
            may be difficult to determine and demonstrate patient benefit  
            for individual programs and purposes.  

           3)CMIA  .  CMIA is the principle California statute governing the  
            confidentiality of medical information, and generally  
            speaking, prohibits a health care provider, health plan,  
            health insurer or pharmaceutical manufacturer from disclosing  
            patient medical information absent an authorization signed by  
            the patient or the patient's legal representative in  
            compliance with strict statutory standards.  The CMIA defines  
            a pharmaceutical company as any company that manufactures,  
            sells, or distributes pharmaceuticals, medications, or  
            prescription drugs, or its agents or representatives, but does  
            not include provider or pharmacy benefit programs.  Under  
            CMIA, pharmaceutical companies are prohibited from requiring  
            patient to authorize disclosure of medical information as a  
            condition of receiving medications, except as follows:  a) as  
            a condition to enrollment in a patient assistance program or  
            prescription drug discount program; b) as a condition to  








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            enrollment in clinical trial; c) as a condition of prior  
            access to medications in limited supply; or, d) as a condition  
            to responding to patient communication.

           4)PATIENT ADHERENCE  .  Adherence (compliance) is the degree to  
            which a patient follows a treatment regimen.  For drugs,  
            adherence requires that the prescription be obtained promptly  
            and the drug be taken as prescribed in terms of dose, dosing  
            interval, and duration of treatment.  The problem of poor  
            patient adherence has been extensively researched, but the  
            rates of nonadherence have not changed much in the past three  
            decades.  Adherence is worst with chronic disorders requiring  
            complex, long-term treatment (e.g., juvenile diabetes,  
            asthma).  Children are less likely than adults to follow a  
            treatment regimen.  Parents may not clearly understand  
            prescription instructions and, studies show, within 15  
            minutes, forget about half of the information given by their  
            physician.  Elderly persons follow treatment regimens as well  
            as other adults, but factors that decrease adherence (e.g.,  
            inadequate finances, use of multiple drugs or drugs that must  
            be taken several times a day) are more common among the  
            elderly. 

            An April 2008 research brief by the  AARP Public Policy  
            Institute  entitled, "How Prescription Drug Use Affects Health  
            Care Utilization and Spending by Older Americans: A Review of  
            the Literature," found that research does show that  
            appropriate prescription drug use can lead to improved health  
            outcomes for many chronic conditions and should be encouraged,  
            particularly among older adults with chronic conditions.   
            However, the AARP report also found that patient adherence to  
            prescription drug regimens can best be improved by reducing  
            prescription drug prices, adding coverage for the uninsured,  
            and reducing cost sharing for those with prescription drug  
            coverage.  The research brief suggested that in order to  
            increase adherence to drug regimens it may be necessary to  
            target cost sharing for prescription drugs by type of  
            medication and patient condition to minimize unintended  
            consequences in other areas, such as non-drug spending and  
            health outcomes.  

            Other studies have noted that a multi-disciplinary approach,  
            involving health care practitioners at all levels may have the  
            greatest chance of improving patient adherence and could  
            include the following:  a) simplifying the drug regimen  








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            characteristics, including providing patients with a variety  
            of adherence aids to help organize their medications (e.g.,  
            medication boxes) and remember dose times (alarms); b)  
            imparting knowledge through health care practitioners  
            communicating clearly the purpose for the drug, the dosage and  
            regimen; c) clinicians uncovering and addressing the belief  
            systems of patients which may serve as barriers to their  
            compliance; d) patient communication ranging from  
            physician-patient communication, sending mail or telephonic  
            reminders, to involving patients' families in the dialogue; e)  
            clinicians overcoming stereotypes and biases around which  
            patients may be most likely to fail in adhering to treatment  
            regimens; and, f) regular evaluation of patient adherence by  
            clinicians which can be done by self-reports, pill counting,  
            and in some cases measuring serum or urine drug levels.

           5)NATIONAL COUNCIL ON PATIENT INFORMATION AND EDUCATION (NCPIE)  .  
             The author provided a 2007 report by the National Council on  
            Patient Information and Education (NCPIE), "Enhancing  
            Prescription Medicine Adherence: A National Action Plan" which  
            sets forth ten national priorities for improving patient  
            adherence to drug regimens.  The author points out that one of  
            the ten NCPIE recommendations is to seek regulatory changes  
            and remove state or federal road-blocks for adherence  
            assistance, including ensuring that state and federal laws  
            related to patient privacy and the use of prescription data do  
            not unduly limit the ability of pharmacies to communicate with  
            patients about the importance of adhering to their prescribed  
            course of therapy.  According to the NCPIE Internet web site,  
            NCPIE is a coalition of over 125 diverse organizations whose  
            mission is to stimulate and improve communication of  
            information on appropriate medicine use to consumers and  
            health care professionals.  NCPIE members include consumer,  
            business, and health care professional organizations,  
            government agencies and non-government standard setting  
            organizations.  NCPIE's average annual revenues of  
            $350,000-$400,000 per year come primarily from member dues,  
            with business organizations paying the highest dues level of  
            $7,500 per year, and consumer organizations paying annual dues  
            of $150.

           6)PENDING LAWSUIT .  There is a class action lawsuit pending in  
            San Diego Superior Court,  Weisz v. Albertsons, Inc;  
            Sav-On-Drug Stores, Inc.; Osco Drug, Inc., Jewel Osco, Inc.;  
            Elensys, Inc.; Adheris, Inc  ., Case No. GIC830069, San Diego  








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            County Superior Court.  The complaint alleges that Albertsons'  
            pharmacy customers received direct mail and phone  
            solicitations derived from confidential customer medical  
            information provided to the pharmacy solely to fill  
            prescriptions.  A plaintiff, Privacy Rights Clearinghouse  
            (Clearinghouse), alleges that Albertsons receives between  
            $3.00 and $4.50 from pharmaceutical companies per inquiry  
            letter and $12 to $15 per phone inquiry.  Plaintiffs further  
            allege that Albertsons' pharmacies extracted customer  
            confidential medical information from prescriptions and then  
            placed it in a database that can be retrieved by specific  
            medical characteristics. According to the complaint,  
            Albertsons sold this information to pharmaceutical companies  
            in order to pursue carefully crafted marketing campaigns  
            without pharmacy customers' written authorization.  The  
            lawsuit contends that pharmaceutical companies wrote or  
            approved the content of the solicitations to the pharmacies'  
            customers, which were processed and mailed by Albertsons  
            marketing personnel on its letterhead.

           7)POTENTIAL FOR ABUSE  .  According to the 2000  JAMA  article, a  
            pharmacy program that made headlines in 1998 dramatized how  
            personal health information can be both used and abused in the  
            era of managed care and computers.  Two Washington, D.C.,  
            pharmacy chains, CVS and Giant Foods, sent patient  
            prescription records to a database marketing firm, Elensys  
            (former corporate name of Adheris, Inc. (Adheris) the sponsor  
            of this bill).  Elensys mailed patients reminders to refill  
            prescriptions or information about new drugs as proposed to be  
            authorized in this bill.  One mailing informed patients who  
            had purchased products for nicotine replacement therapy about  
            bupropion, a new pill for smoking cessation.  Drug  
            manufacturers paid the pharmacy chains and Elensys for these  
            mailings.  Until they received the letters, patients did not  
            know that their medical information was being used in this  
            way.  Elensys said that drug companies had no direct access to  
            pharmacy records and that patients could opt out of the  
            program by returning a form.  Critics objected that the  
            program crossed the line between medicine and marketing.   
            According to the  JAMA  article, critics of the Elensys project  
            objected that its goal was self-interest rather than patient  
            benefit, that patients did not authorize it, that third  
            parties had access to confidential health information, and  
            that safeguards for confidentiality were lacking.  In  
            addition,  JAMA  reported that many patients in the Elensys  








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            program felt wronged because they had not authorized the sale  
            of their personal health information.  The pharmacy chains  
                                   canceled the program after news stories elicited public  
            outrage.  

           8)LEGISLATIVE HISTORY  .  In 2003, the Legislature enacted AB 715  
            (Chan), Chapter 562, Statutes of 2003, to help ensure that  
            California law protects patients against the unauthorized use  
            of their medical information for marketing purposes.  AB 715  
            requires health care providers to obtain authorization from a  
            patient before using the patient's medical information for  
            "marketing," and specifically prohibited health care providers  
            from accepting direct or indirect remuneration to communicate  
            with a patient regarding a product or service if the  
            communication encouraged the patient to purchase or use that  
            product or service, except in specified circumstances.

          The next year, Catalina Health Resource, a company that partners  
            with pharmacies to produce communications that are the subject  
            of this bill, joined pharmacists and retailer groups in  
            sponsoring AB 746 (Matthews) of 2004.  AB 746 would have  
            exempted from the AB 715 marketing prohibitions any written  
            communication from a pharmacist to a patient during the  
            "face-to-face" dispensing of a prescription drug, regardless  
            of marketing content, if the pharmacist is available to answer  
            questions about the communication, the communication assists  
            the pharmacy in meeting the goals of federal requirements to  
            distribute useful information regarding a dispensed  
            prescription drug, and the communication is, in its  
            "majority," made up of health information relating to the  
            disease or health condition for which the dispensed drug was  
            prescribed.  AB 746 faced opposition from consumer groups  
            including Consumers Union and the California Public Interest  
            Research Group (CALPIRG), and died in the Senate.

          Consumers Union, CALPIRG, and other consumer groups then  
            sponsored SB 401 (Ortiz) in 2005, attempting to explicitly  
            designate written communications given by a pharmacist to a  
            patient as "marketing" when they are sponsored by a third  
            party and include the trade name or commercial slogan for a  
            drug or therapy other than the drug or therapy being  
            dispensed.  SB 401 made exceptions for names or slogans  
            provided for specified medical purposes.  SB 401 passed the  
            Senate, but died in the Assembly.  









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          Late in the 2006 session, Catalina sponsored AB 2364 (De La  
            Torre), which would have amended the CMIA to allow "marketing"  
            of "sponsored" or "paid advertisements" by third parties to  
            pharmacy patients when they pick up their prescriptions.  AB  
            2364 died in the Senate.  In 2007, AB 1587 (DeLaTorre), also  
            sponsored by Catalina, and virtually identical to AB 2364,  
            failed passage in the Senate Judiciary Committee.  Also in  
            2007, Adheris, sponsor of this bill, sponsored SB 843  
            (Calderon), virtually identical to this bill, but SB 843 was  
            never heard in committee.  

           9)RELATED LEGISLATION  .  

             a)   SB 843 (Calderon), pending in the Senate, would allow a  
               pharmacy to make specified communications to a patient,  
               without the patient's authorization, so long as the patient  
               may opt out of receiving those communications, as  
               specified.  SB 843 would also require disclosure if the  
               communications are paid for by a manufacturer, distributor,  
               or provider of a health care product or service.  

             b)   AB 1587 (De La Torre) exempts from the definition of  
               marketing, for purposes of CMIA, certain written  
               communications given by a pharmacist to a patient when a  
               prescription is dispensed.  AB 1587 is set for hearing on  
               June 24, 2008 in the Senate Committee on Judiciary.

           10)SUPPORT  .  Adheris supports this bill arguing that it would  
            provide California residents with a clear health care benefit  
            through the provision of valuable information to prescription  
            drug consumers.  Adheris offers data showing that adherence to  
            chronic therapies is estimated to be at 50% and that  
            non-adherence can result in suboptimal clinical outcomes for  
            patients.  Adheris contends that an important approach to  
            addressing the problem of non-adherence is the provision of  
            information to patients about the prescriptions doctors have  
            written for them.  Adheris describes itself as a provider of  
            adherence programs and, under federal HIPAA, for purposes of  
            sharing patient medical information, a business associate of  
            its retail pharmacy clients.  Adheris claims that  
            communications mailed as part of these programs are unbiased  
            and always consistent with current FDA-approved product  
            package insert, and provide fair and balanced information on  
            the product risk and benefits.  Adheris maintains that this  
            bill is necessary because California law does not clearly  








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            define these types of programs as treatments, making  
            California pharmacies and pharmaceutical companies reluctant  
            to participate.  The National Association of Chain Drug Stores  
            states that this bill will ensure that patients receive  
            written information that helps them better understand their  
            health conditions and preventive care and obtain optimal  
            results from their treatments.  The American Russian Medical  
            Association supports this bill, stating it would like to see  
            patients continually informed with communications that  
            increase adherence and compliance with their prescribed  
            treatments.  The National Association of Cancer Patients  
            believes this bill would improve the treatment of cancer  
            patients and others with chronic diseases by providing them  
            with additional information about the medicines they take to  
            treat the disease.


           11)OPPOSITION  .   Consumer advocacy and provider organizations  
            oppose this bill stating that this bill raises significant  
            patient privacy concerns.  The California Medical Association  
            (CMA) is concerned that this bill would interfere with the  
            doctor-patient relationship.  CMA contends that the  
            communications authorized in this bill, presumably using  
            third-party materials from drug makers, would neither require  
            the patient's authorization nor a physician's recommendation  
            for the information to arrive in the mailbox.  CMA argues that  
            this bill allows pharmaceutical marketing entities to practice  
            medicine through the mail, outside of any physician/patient  
            interaction.  CMA further argues that pharmacies do not have  
            information on diagnoses so the language in this bill  
            permitting the mailings based on diagnoses is unworkable and  
            troubling.  


          The Clearinghouse states that pharmacies providing information  
            to patients is allowable under the CMIA but this bill is only  
            needed because of third party involvement in and payment for  
            the mailings authorized.   The Clearinghouse states that this  
            bill would allow a third party, drug manufacturers and drug  
            marketing entities, to send reminder mailings that may be in  
            direct contradiction of the physician's recommended course of  
            treatment.  The Clearinghouse maintains that it is a simple  
            but critical principle of privacy protection that if a  
            person's private information is to be used, transferred or  
            disclosed, they should be asked about it first and must agree  








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            to the disclosure, otherwise known as "opting in."  

          Health Access opposes this bill because it increases direct to  
            consumer drug advertising; allows pharmacists to violate  
            patient privacy by selling patient information; allows drug  
            companies to decide what types of drug effectiveness  
            information is provided to consumers, where they might  
            overstate benefits and understate negative effects; and,  
            interferes with the doctor-patient relationship.  

          The American Civil Liberties Union (ACLU) references the right  
            of privacy in the California Constitution and quotes from the  
            initiative which added that provision that it was intended to  
            "prevent government and business interests from stockpiling  
            unnecessary information about us and from misusing information  
            gathered for one purpose in order to serve another purpose or  
            to embarrass us."  ACLU writes in opposition that most people  
            consider their medical and financial information among the  
            most private information about them.  ACLU concludes that  
            disclosure of medical information generally should only take  
            place with the individual's affirmative consent, unless there  
            is some compelling state interest and the disclosure is  
            narrowly tailored to meet that interest.  

          The State Board of Pharmacy opposes this bill expressing serious  
            concerns that if enacted, this bill would provide consumers  
            with potentially unnecessary marketing information, disguised  
            as medical information, but which is sponsored by drug  
            manufacturers.  The Department of Health Care Services (DHCS)  
            opposes this bill because there is no enforcement mechanism at  
            FDA to review and approve the materials that will be submitted  
            to FDA as required by this bill.  Finally, DHCS is concerned  
            that this bill could increase costs to the Medi-Cal program by  
            encouraging inappropriate use of more expensive drugs marketed  
            via the mailings.

           12)POLICY QUESTIONS  .  

              a)   Approach  .  In order to fall within the limits of the  
               CMIA, this bill would define pharmacy mailings as treatment  
               "necessary to provide health care services."   In general,  
               a patient's health care provider is the one who determines  
               a patient's course of treatment, including any medications  
               needed.  Should information provided by pharmacists and  
               potentially developed and paid for by drug manufacturers,  








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               however informative or useful, be considered "treatment"  
               under the law?  
              
              b)   Privacy concerns  .  This bill would authorize disclosure  
               of communications from pharmacies, without the patient's  
               consent, if, among other things, the communication  
               encourages the patient to adhere to a prescribed course of  
               treatment.  Presumably the mailings will be targeted and  
               rely on specific patient information about current and past  
               medications, gender, age, etc., and given the specified  
               conditions in this bill, assumptions about the underlying  
               health conditions for which the medications were  
               prescribed, in order to provide relevant information.   
               Access to the patient's information would be limited to  
               "authorized persons" but exactly who would be authorized is  
               not defined.   Given that a patient's medical information  
               is one of the most private and sensitive areas of  
               information about a person, should this bill require  
               affirmative patient authorization, an opt-in instead of  
               only an opt-out, before any such materials can be sent to  
               the patient?
































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              c)   Nature of the information  .   

               i)     This bill requires the written communications that  
                 will be sent to patients to be consistent with  
                 FDA-approved product package inserts.  DHCS indicates  
                 that there is no mechanism at FDA for review and approval  
                 of the types of informational materials as are  
                 contemplated in this bill.  In addition, pharmacies are  
                 not subject to FDA regulation and would be the entities  
                 sending the materials.  How would enforcement of these  
                 provisions be ensured and who would be responsible for  
                 enforcement?  
               ii)    This bill requires that communications which will be  
                 sent to patients be based on evidence or consensus but  
                 provides no further definition.  What standards would  
                 apply to the requirement for evidence-based or  
                 consensus-based information to be used in the materials?   

               iii)   This bill limits communications to those encouraging  
                 the patient to adhere to the "prescribed course of  
                 treatment."  However, the pharmacy will have the  
                 information about prescriptions filled, but may not know  
                 the health care provider's recommended duration or full  
                 treatment regimen.  A particular pharmacy may not have  
                 information about all of the patient's prescriptions and  
                 information could be provided for drugs that might  
                 interact with other medicines the patient is taking.   
                 What assurances are there that the material and  
                 information provided to patients will be consistent with  
                 the directions and recommendations of their personal  
                 health care provider?  How will the information be  
                 developed in a way to avoid encouraging patients to seek  
                 medications that might conflicts with prescriptions not  
                 filled at the pharmacy sending the materials?

              d)   Costs  .  To the extent that these programs encourage  
               adherence to a brand name instead of a generic, costs could  
               increase for both patients and any third party payers.   
               Might the provisions of this bill result in increased  
               overall health care costs for state programs, such as  
               Medi-Cal, and for private insurance?

           13)DOUBLE REFERRAL  .  This bill has been double referred.  Should  
            this bill pass out of this committee, it will be referred to  
            the Assembly Committee on Judiciary.








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           REGISTERED SUPPORT / OPPOSITION  :

           Support 
           
          Adheris, Inc. (sponsor)
          American Russian Medical Association
          Asthma & Allergy Foundation of America - California Chapter
          California Council of Community Mental Health Agencies
          California Retailers Association
          California Seniors Advocate League
          Community Life Improvement Program
          Global Russian American Health Alliance
          Los Angeles Society of Allergy, Asthma & Clinical Immunology,  
          Inc.
          Mental Health Association in California
          National Association of Cancer Patients
          National Association of Chain Drug Stores
          National Consumers League
          Rite Aid

           Opposition 
           
          AARP
          American Civil Liberties Union
          California Academy of Family Physicians
          California Alliance for Retired Americans
          California Department of Health Care Services
          California Medical Association
          California Nurses Association
          California Pharmacists Association
          California State Board of Pharmacy
          Consumer Federation of California
          Consumer Watchdog
          Consumers Union
          Department of Health Care Services
          Health Access
          Planned Parenthood Affiliates of California
          Planned Parenthood Golden Gate
          Planned Parenthood Mar Monte
          Privacy Rights Clearinghouse

           Analysis Prepared by  :    Deborah Kelch  / HEALTH / (916)  
          319-2097