BILL ANALYSIS                                                                                                                                                                                                    Ó






                             SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:       SB 1301
          AUTHOR:        Hernandez
          AMENDED:       March 29, 2012
          HEARING DATE:  April 11, 2012
          CONSULTANT:    Moreno

          SUBJECT  :  Prescription drugs: 90-day supply.
           
          SUMMARY  :  Permits a pharmacist to dispense up to a 90-day supply 
          of a drug, other than a controlled substance, pursuant to a 
          prescription that specifies the initial dispensing of a lesser 
          amount followed by periodic refills of that amount if certain 
          requirements are met.

          Existing law:
          1.Provides for the practice of pharmacy and the licensing and 
            regulation of pharmacies and pharmacists by the Board of 
            Pharmacy within the Department of Consumer Affairs.

          2.Specifies certain requirements regarding the dispensing and 
            furnishing of dangerous drugs and devices, and prohibits a 
            person from furnishing any dangerous drug or device except 
            upon the prescription of a physician, dentist, podiatrist, 
            optometrist, or veterinarian.

          3.Prohibits a prescription for any dangerous drug or dangerous 
            device from being refilled except upon authorization of the 
            prescriber, as specified.

          4.Permits a prescription for a dangerous drug or dangerous 
            device to be refilled without the prescriber's authorization 
            if the prescriber is unavailable to authorize the refill and 
            if, in the pharmacist's professional judgment, failure to 
            refill the prescription might interrupt the patient's ongoing 
            care and have a significant adverse effect on the patient's 
            well-being.  Permits the prescription to be filled only after 
            making every reasonable effort to contact the prescriber. 
            Requires the pharmacist to inform the patient and the provider 
            that the prescription was refilled under this circumstance.
          
          This bill:
          1.Permits a pharmacist to dispense up to a 90-day supply of a 
            dangerous drug other than a controlled substance pursuant to a 
                                                         Continued---



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            valid prescription that specifies the initial dispensing of a 
            lesser amount followed by periodic refills of that amount if :
               a.     The total quantity of dosage units dispensed does 
                 not exceed the total quantity of dosage units authorized 
                 by the prescriber on the prescription, including refills;
               b.     The prescriber has not specified on the prescription 
                 that dispensing the prescription in an initial amount 
                 followed by periodic refills is medically necessary; and
               c.     The pharmacist is exercising his or her professional 
                 judgment.

          2.Prohibits anything in this bill from being construed to 
            require a health care service plan, health insurer, workers' 
            compensation insurance plan, pharmacy benefits manager (PBM), 
            or any other person or entity, including, but not limited to, 
            a state program or state employer, to provide coverage for a 
            dangerous drug in a manner inconsistent with a beneficiary's 
            plan benefit.

           FISCAL EFFECT  :  This bill has not been analyzed by a fiscal 
          committee.

           COMMENTS  :
          1.Author's statement.  According to the author, the cost of a 
            filled prescription is based on the "Product Cost + Dispensing 
            Cost." For each trip to the pharmacy, the patient must not 
            only pay for the additional product but also the other costs 
            that are associated with dispensing that drug.  The author 
            states that paying for the professional services of a 
            pharmacist and pharmacy technicians only once, rather than 
            three times, allows the payer and patient to accrue 
            significant savings. A patient that visits the pharmacy every 
            month to refill a maintenance prescription creates higher 
            health care costs because repeat visits cost more than a 
            single visit. Additionally, patient non-compliance with their 
            prescription drugs drives up health care costs. Failure to 
            take prescribed medications can lead to deterioration of the 
            patient's health, which, in turn, leads to higher-cost 
            medications or medical interventions. By 2014, there will be 6 
            million more Californians insured.  As more Californians 
            become insured, we must ensure patients have access to care 
            and reduce overall health care costs for chronic conditions.  
            SB 1301 is a simple effort toward increasing consumer access 
            to health care and local pharmacists.

          2.PBMs and mail-order pharmacies. Increasing numbers of 




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            employers, labor unions, and managed care companies 
            (collectively, "plan sponsors") that offer prescription drug 
            insurance coverage often hire PBMs to manage these benefits.  
            According to a 2005 Federal Trade Commission study of PBMs, 
            they use mail-order pharmacies to manage prescription drug 
            costs. Many PBMs also own their own mail-order pharmacies. 
            Plan sponsors often encourage patients with chronic conditions 
            who require repeated refills to seek the discounts that 90-day 
            prescriptions and high-volume mail-order pharmacies can offer. 
            As medication prices continue to rise faster than inflation, 
            one method to control pharmacy benefit costs is for health 
            plans and PBMs to offer 90-day supply coverage which reduces 
            costs via a decrease in dispensing fees and potentially 
            increases adherence, according to an article in the American 
            Journal of Health-System Pharmacy titled "Ninety-day versus 
            thirty-day drug dispensing systems." The authors concluded 
            that dispensing less expensive drugs for 90 days rather than 
            30 days to patients with chronic diseases would result in 
            significant cost savings without compromising safety, despite 
            the possibility of increased waste when drugs are 
            discontinued. 

          3.Other states.  According to the sponsor of this bill, the 
            California Retailers Association (CRA), 20 states have varying 
            statutes that in some way permit 90-day dispensing (Alaska, 
            Arizona, Colorado, Florida, Hawaii, Idaho, Illinois, Kentucky, 
            Main, Michigan, Montana, Nebraska, New York, North Carolina, 
            Rhode Island, South Carolina, South Dakota, Texas, Vermont, 
            and Wyoming). For example, New York mandates that if a health 
            plan or insurer offers a 90-day supply through a mail-order 
            pharmacy, the enrollee can obtain the same supply at a retail 
            pharmacy, provided the pharmacy accepts the same contractual 
            terms and conditions as the mail-order pharmacy. Indiana has 
            legislation pending on the Governor's desk that permits 90 
            days' worth of medication upon the request of the patient if 
            the patient has completed an initial 30-day supply of the 
            drug. However, a pharmacist is required to notify the 
            prescriber of the change in the quantity filled and comply 
            with state and federal laws and regulations concerning the 
            dispensing limitations concerning a prescription drug. 
          4.Double referral.  This bill is double referred.  Should it 
            pass out of this committee, it will be referred to the Senate 
            Committee on Business, Professions and Economic Development.

          5.Support.  According to CRA and the National Association of 
            Chain Drug Stores (NACDS), a single chain drug store makes 




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            approximately 4.5 million calls a month to get authorization 
            to dispense a prescription refill in excess of a 30-day 
            supply.  CRA and NACDS state that because physicians are 
            typically busy and unable to take these calls, consumers end 
            up either having to wait for authorization or they end up 
            settling for the 30-day supply, leaving before the physician 
            calls back.  CRA, NACDS, and Aging Services of California 
            (ASC) write that not only are these calls burdensome to the 
            physicians and pharmacists, the patient is ultimately 
            inconvenienced and will need to return to the pharmacy two 
            additional times and pay two additional co-payments that he or 
            she would have saved under this proposal.  ASC further states 
            that by allowing a 90-day supply, this bill will make it 
            easier for patients to adhere to their treatment, live 
            healthier lives and lower costs throughout the health care 
            system.  The County of Los Angeles contends that this bill 
            will increase access to needed medications and improve the 
            health of many County residents with chronic health conditions 
            that are easily controlled with prescribed medications. BIOCOM 
            writes that this bill will likely reduce missed dosages and 
            increase dosage compliance by patients by allowing them to 
            have to refill prescriptions less often, and could reduce 
            total prescription costs by reducing the number of pharmacy 
            visits.
          
          6.Support if amended.  The California Medical Association (CMA) 
            is concerned that this bill could weaken the physician's 
            ability to monitor a patient's progress and, if necessary, 
            modify the patient's drug regimen. By eliminating refills, 
            physicians would lose a valuable tool often used to monitor 
            the progress of their patient's treatment. CMA additionally 
            states that, while this bill does not apply to controlled 
            substances, there are still other dangerous drugs that aren't 
            on the controlled substance list that can still be very 
            hazardous to the patient if dispensed improperly and misused. 
            CMA is asking for amendments to ensure physician autonomy over 
            the amount of drugs prescribed. 

          7.Oppose unless amended.  The California Psychiatric Association 
            (CPA) writes that from a psychiatric physician standpoint, 
            many psychiatric medications are toxic or lethal, and that 
            potential is increased significantly when a patient presents 
            with suicidal ideation.  The CPA would prefer that the primary 
            thrust of this bill provide that physicians have the ability 
            to "opt in" to this measure, and failing that, exempting 
            psychotropic medications, prescribed by any physician of any 




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            specialty or subspecialty, from the provisions of this bill.

          8.Amendments. The author intends to amend the bill as follows:
            On page 2, delete lines 3 through 18 and insert:
               4064.5 (a) A pharmacist may dispense not more than a ninety 
               (90) day supply of  medication pursuant to a valid 
               prescription that specifies the initial dispensing of a 
               lesser amount followed by periodic refills of that amount 
               if the patient has completed an initial thirty (30) day 
               supply of the drug therapy and all of the following 
               requirements are satisfied:
                  (1)       The total quantity of dosage units dispensed 
                    does not exceed the total quantity of dosage units 
                    authorized by the prescriber on the prescription, 
                    including refills.
                  (2)       The prescriber has not specified on the 
                    prescription that dispensing the prescription in an 
                    initial amount followed by periodic refills is 
                    medically necessary. 
                  (3)       The pharmacist is exercising his or her 
                    professional judgment. 
               (b) A pharmacist dispensing pursuant to this section shall 
               notify the prescriber of the change in the quantity filled.
               (c) This section does not apply to psychotropic medication, 
               as defined in Welfare and Institutions Code Section 369.5 
               (d).

           SUPPORT AND OPPOSITION  :
          Support:  California Retailers Association (sponsor)
                    Aging Services of California
                    BIOCOM
                    California Healthcare Institute
                    Los Angeles County Board of Supervisors
                    National Association of Chain Drug Stores
                    Three individuals
                    
          Oppose:   California Psychiatric Association (unless amended)
          
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