BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  AB 299
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          Date of Hearing:   April 23, 2013

              ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER  
                                     PROTECTION
                              Richard S. Gordon, Chair
               AB 299 (Holden and Bloom) - As Amended:  April 16, 2013
           
          SUBJECT  :   Pharmacy

           SUMMARY  :   Prohibits pharmacies from contracting with a health  
          care service plan or disability insurer that requires mail-order  
          only service, or imposes an opt-out process for mail-order  
          service.  Specifically,  this bill  :  

          1)Prohibits a nonresident pharmacy or a pharmacy located in this  
            state 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.

          2)Makes other technical and clarifying changes.

          3)States that no reimbursement is required by this act pursuant  
            to Section 6 of Article XIIIB of the California Constitution  
            because the only costs that may be incurred by a local agency  
            or school district will be incurred because this act creates a  
            new crime or infraction, eliminates a crime or infraction, or  
            changes the penalty for a crime or infraction, within the  
            meaning of Section 17556 of the Government Code, or changes  
            the definition of a crime within the meaning of Section 6 of  
            Article XIIIB of the California Constitution.

           EXISTING FEDERAL LAW  requires Medicare Part D sponsors to  
          include retail pharmacies in their contract pharmacy network.  
          (Title 42, Chapter IV, Subchapter B, Part 423, Subpart C,  
          Section 423.120)  

           EXISTING STATE LAW  :

          1)Establishes the California Board of Pharmacy to regulate the  
            Pharmacy Law. (Business and Professions Code (BPC) Section  
            4000 et seq.)

          2)Defines a "nonresident pharmacy" as one that is located  








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            outside California and ships, mails, or delivers, in any  
            manner, controlled substances, dangerous drugs, or dangerous  
            devices into California. (BPC 4112 (a))
                                  
          3)Establishes the parameters for health care service plans under  
            the Knox-Keene Health Care Service Plan Act of 1975. (Health  
            and Safety Code 1340 et seq.)

           FISCAL EFFECT  :   Unknown

           COMMENTS  :   

           1)Purpose of this bill  .  This bill would prohibit health plans  
            serving Californians from requiring their enrollees or  
            insureds to receive drugs exclusively through a mail-order  
            service, or imposing an opt-out provision for mail-order  
            service rather than an opt-in approach.   Supporters contend  
            that mandatory mail-order prescription fulfillment disrupts  
            the relationship between the patient and the pharmacist and  
            does not necessarily result in cost savings, while opponents  
            argue that it is a necessary tool for cost reduction.  This  
            bill sponsored by the California Pharmacists Association.    

           2)Author's statement  .  According to the author, "AB 299 protects  
            patient choice by putting an end to mandatory mail order  
            policies and practices that require patients to succumb to  
            complex and burdensome 'opt out' procedures.

            "This bill does not interfere with the mail order process in  
            any way for patients who want to receive their drugs through  
            the mail.  Furthermore, it also does not interfere with health  
            plans and insurers' ability to establish pharmacy networks or  
            cost sharing arrangements.

            "This bill will restrict mail-order pharmacies from making [a]  
            profit from this policy that discriminates against HIV/AIDS  
            patients, elderly enrollees, women, cancer patients and the  
            seriously ill by prohibiting mandatory mail order policies."

           3)Litigation over new mail-order only policies  .  Current state  
            law places no restrictions on whether an insurer can require  
            mail-order for its beneficiaries.  In late 2012, Anthem Blue  
            Cross (ABC) sent notice to some enrollees that certain drugs  
            would only be available through a mail-order pharmacy.  If the  
            enrollees wanted to stay with their retail pharmacy, the  








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            medicine would no longer be covered and the enrollee would  
            have to pay the full cost.  ABC offered an exemption to this  
            new policy that required the endorsement of a treating  
            physician, but the exemption was only good for a limited  
            period of time, and ABC would base that period of time on the  
            reason for the exemption.

            ABC was subsequently sued by Consumer Watchdog on behalf of  
            HIV/AIDS patients whose drugs came under ABC's mandatory  
            mail-order program. The lawsuit was premised on the concern  
            that HIV/AIDS patients were being discriminated against due to  
            their medical condition, a violation of the Unruh Civil Rights  
            Act.  ABC is in settlement discussions with Consumer Watchdog  
            and has since suspended its mail-order pharmacy requirement.

           4)Role of the pharmacist  .  Pharmacists are a vital part of a  
            patient's clinical care team, a fact recognized by both  
            proponents and opponents of this bill.  Mail-order programs  
            tout 24/7 access to a registered nurse or a pharmacist via  
            phone, but proponents of this bill emphasize that the  
            relationship between patients and local retail pharmacists  
            versus pharmacists available by phone are not the same.   
            Supporters argue that a patient is likely to visit his or her  
            local pharmacy more frequently than his or her physician, and  
            so when issues of adherence, side effects, dosing  
            complications and other barriers arise, it is often the  
            pharmacist that first learns of the problem because he or she  
            is able to have a personal face-to-face intervention with the  
            patient.  Working with the prescriber, as necessary, the  
            pharmacist can intervene before the problem complicates the  
            health of the patient.  While a pharmacist or nurse on a  
            telephone may have the capacity to handle these issues, the  
            barriers presented by technology and anonymity may make the  
            relationship more tenuous.  

            Healthcare trends are also moving towards fuller use of a  
            pharmacists' training, which includes more extensive  
            interactions with patients, including vaccinations and  
            wellness counseling.   

           5)Cost savings .  Opponents of the bill argue that prohibiting a  
            mail-order option restricts the freedom of health plans to  
            determine the most effective way of controlling rising  
            prescription drug costs.  However, a 2011 article published in  
            the American Journal of Managed Care suggests that while  








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            requiring mail-order can result in lower costs, it also  
            results in higher patient dissatisfaction.  Although many  
            patients voluntarily choose mail-order, those who were  
            required to receive their drugs by mail tended to discontinue  
            therapy prematurely.  

            A more recent study for the National Community Pharmacists  
            Association Foundation found that cost savings may be less  
            substantial than anticipated.  The study reported that "while  
            mail order pharmacies may be able to offer lower costs as a  
            result of efficiencies in dispensing and purchasing, the use  
            of different ingredient cost schedules for mail and retail  
            pharmacies, differences in utilization and wastage rates, and  
            differences in rates of generic substitution could lower the  
            savings that plans actually realize."

           6)Medicare  .  Medicare currently requires Medicare Part D  
            sponsors to have a network of retail pharmacies sufficient to  
            ensure that the majority of beneficiaries are within 2 - 15  
            miles of a retail pharmacy.        

           7)Arguments in support  .  The California Pharmacists Association  
            writes, "Mandatory mail order policies unfairly restrict  
            patient choice.  They are included in nearly 20% of health  
            policies, such as the recent Anthem Blue Cross plan that  
            denied cancer, HIV/AIDS, and other sensitive populations  
            access to community pharmacies.  In mandatory mail programs,  
            patients are automatically enrolled without their consent.   
            Patients in these programs no longer have the option to obtain  
            their prescription medications from in-network community  
            pharmacies where they have a relationship with a pharmacist  
            whom they know and trust.  This disrupts the patient-provider  
            relationship that is so important for patients with chronic  
            and complex medical medications.

            "Allowing patients to select the method of receiving their  
            prescription medications that best suits their needs improves  
            adherence to prescribed therapies.  Research has shown  
            comparable levels of medication adherence among patients who  
            receive their prescription drugs in-person and patients who  
            receive them via mail order when patients have the choice of  
            selecting what is best for them.  However, when patients do  
            not have a choice, outcomes suffer.  A 2011 study found  
            medication adherence to be higher when mail order is voluntary  
            than when mail order is mandatory." 








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           8)Arguments in opposition  .  Anthem Blue Cross writes, "There are  
            many advantages when using mail order:

             a)   Free shipping and choice of delivery site (an enrollee  
               could elect to have drugs sent to work or home or even  
               their doctor's office);

             b)   Medications are shipped directly to the enrollee's house  
               or location of choice, saving time and gas money;

             c)   Mail order pharmacy may be particularly beneficial for  
               elderly or homebound patients, patients with disabilities,  
               and those with inadequate access to transportation;

             d)   Longer supply - most mail order benefits allow for a 90  
               day supply of maintenance drugs as opposed to a 30 day  
               supply;

             e)   The longer days' supply usually allows for lower member  
               out-of-pocket costs; and,

             f)   Customer service representatives and pharmacists are  
               available 24 hours a day, seven days a week to enrollees  
               utilizing mail order services.

            "Mail order pharmacies are licensed and utilized for the  
            delivery of maintenance medications for conditions such as  
            high cholesterol, high blood pressure and diabetes.  They are  
            not used or required for emergency medications, or episodic  
            needs such as antibiotics for infections like strep throat. 

            "AB 299 essentially precludes health plans from requiring  
            enrollees to use mail order services for certain prescriptions  
            by prohibiting mail order pharmacies from contracting with  
            health plans that have such a requirement, even when health  
            plans offer a straightforward exception (opt-out) process to  
            enrollees.  AB 299 unnecessarily restricts the freedom of  
            health plans to determine the most effective way of  
            controlling rising prescription drug costs.  Imposing such a  
            restriction is unnecessary, unwarranted and inflates health  
            care costs for Californians.  AB 299 will increase  
            prescription drug costs and result in higher co-pays for  
            enrollees." 









                                                                  AB 299
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           9)Double-referral  .  This bill is double-referred, and if passed  
            by this Committee, it will be referred to the Assembly Health  
            Committee.

           REGISTERED SUPPORT / OPPOSITION  :   

           Support 
           
          California Pharmacists Association (sponsor)
          AARP
          AIDS Healthcare Foundation
          Black Women for Wellness
          California Commission on Aging
          California Healthcare Institute
          California National Organization for Women
          California Senior Legislature
          Center for Latino Community Health, Evaluation, and Leadership  
          Training
          Common Ground
          Disability Rights California
          L.A. Gay and Lesbian Center
          National Association of Chain Drug Stores
          National Community Pharmacists Association
          National Multiple Sclerosis Society
          Project Inform
          Rite Aid

           Opposition 
           
          Aetna
          Anthem Blue Cross
          America's Health Insurance Plans
          Blue Shield of California
          Express Scripts
          California Association of Health Plans
          Association of California Life and Health Insurance Companies
           
          Analysis Prepared by  :    Sarah Huchel / B.,P. & C.P. / (916)  
          319-3301