BILL ANALYSIS                                                                                                                                                                                                    �






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

          BILL NO:       SB 1052
          AUTHOR:        Torres
          AMENDED:       March 28, 2014
          HEARING DATE:  April 23, 2014
          CONSULTANT:    Boughton

           SUBJECT  :  California Health Benefit Exchange: annual report.
           
          SUMMARY  :  Prohibits a plan from being selected as a Qualified  
          Health Plan (QHP) participating on California's Health Benefit  
          Exchange (Covered California) if it does not post searchable  
          formularies on its Internet websites that are standardized and  
          meet certain specifications.  Requires Covered California to  
          link to QHP formularies and create a search function for  
          potential enrollees to search by drug and therapeutic category.   
          Requires Covered California to evaluate and report on the  
          effectiveness of the activities undertaken to market and  
          publicize the availability of health care coverage and federal  
          subsidies, as well as outreach and enrollment activities,  
          including populations that may experience barriers to  
          enrollment, such as the disabled and those with limited English  
          language proficiency.

          Existing federal law:
          1.Requires under the federal Affordable Care Act (ACA)  
            non-grandfathered individual and small group health insurance  
            plans and policies to cover ten essential health benefits  
            (EHBs), including prescription drugs and under regulatory  
            guidance, authorizes states to establish a benchmark plan.

          2.Establishes under the federal ACA, market places for  
            individuals and small groups to purchase QHPs, which must  
            cover EHBs, and meet other federal requirements.  Authorizes  
            states to establish state level health benefit exchanges.

          3.Requires under federal regulations regarding prescription drug  
            benefits, that a health plan, with regard to EHB, cover at  
            least the greater of one drug in every United States  
            Pharmacopeia (USP) category and class; or the same number of  
            prescription drugs in each category and class as the EHB  
            benchmark plan; and, submit its drug list to the federal  
            Exchange, the State, or U.S. Office of Personnel Management.   
            Requires a health plan providing EHBs to have procedures in  
                                                         Continued---



          SB 1052 | Page 2




            place that allow an enrollee to request and gain access to  
            clinically appropriate drugs not covered by the health plan.

          4.Requires under federal regulations under the Summary of  
            Benefits and Coverage (SBC) specified content including among  
            other items:  a description of the coverage, including cost  
            sharing, for each category of benefits identified by the  
            Secretary of the Department of Health and Human Services (HHS)  
            in guidance; the cost-sharing provisions of the coverage,  
            including deductible, coinsurance, and copayment obligations;  
            and for plans and issuers that use a formulary in providing  
            prescription drug coverage, an Internet address (or similar  
            contact information) for obtaining information on prescription  
            drug coverage.


          Existing state law:
          5.Establishes Covered California as an independent government  
            entity governed by a five member board of directors to  
            selectively contract with QHPs and administer premium  
            assistance and cost sharing subsidies.

          6.Authorizes Covered California to adopt standardized QHP  
            benefit designs.

          7.Requires Covered California to maintain an Internet Web site  
            through which enrollees and prospective enrollees of QHPs may  
            obtain standardized comparative information on QHPs.

          8.Establishes Kaiser Small Group Health Plan as California's EHB  
            benchmark plan.

          9.Establishes the California Department of Insurance (CDI) to  
            regulate health insurance pursuant to the Insurance Code and  
            the Department of Managed Health Care (DMHC) to regulate  
            health plans under the Knox-Keene Act.

          10.Prohibits a disability policy (another name for health  
            insurance policy) from being issued or delivered until  
            specified information is filed with the Commissioner and  
            either 30 days expires without notice from the Commissioner,  
            or, the Commissioner gives his written approval prior to that  
            time.

          11.Requires according to CDI regulations on EHBs, an individual  
            or small group health insurance policy to provide coverage for  




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            prescription drugs that complies with specified state law and  
            federal regulations.  Requires a health insurer to submit all  
            of the following to the Commissioner together with a health  
            insurance policy form, as specified, and annually on July 1  
            thereafter:

                  a.        A list reporting the number of chemically  
                    distinct prescription drugs covered in each USP  
                    category and class and an attestation to the truth and  
                    accuracy of the list;
                  b.        Any prescription drug list and/or formulary  
                    associated with the policy form;
                  c.        Consumer documents describing prescription  
                    drug benefits and limitations on coverage, including  
                    any prescription drug list and/or formulary associated  
                    with policy form that is provided to consumers; and,
                  d.        An attestation of compliance with DMHC  
                    regulations, as specified.

          12.Requires, under state regulations, a health plan to file an  
            EHB worksheet to demonstrate compliance with EHB requirements,  
            including prescription drug benefits, as required by state law  
            and federal regulations, including the plan's prescription  
            drug list and/or formulary. Requires the EHB Filing Worksheet  
            to include a certification that the plan's drug list meets or  
            exceeds the prescription drug formulary requirements specified  
            in federal regulations. 

          13.Requires, under state regulations, every health plan that  
            provides coverage for outpatient prescription drug benefits to  
            provide coverage for all medically necessary outpatient  
            prescription drugs except as specified.

          14.Establishes, under state regulations, standards for  
            outpatient prescription drug benefit plans.


          This bill:
          1.Includes along with the information required in the annual  
            report of Covered California the total number of uninsured  
            Californians as a percentage of the state population and an  
            evaluation of the effectiveness of the activities undertaken  
            to market and publicize the availability of health care  
            coverage and federal subsidies, as well as outreach and  
            enrollment activities, including populations that may  




          SB 1052 | Page 4




            experience barriers to enrollment, such as the disabled and  
            those with limited English language proficiency. Requires the  
            evaluation to be conducted by an independent entity selected  
            by Covered California.

          2.Prohibits a QHP from being offered through Covered California  
            unless the carrier offering the plan does all of the  
            following:

                  a.        Posts the formulary for the QHP on the  
                    Internet Web site of the carrier in a manner that is  
                    accessible and searchable by potential enrollees,  
                    enrollees, and providers. Updates the formulary posted  
                    within 24 hours of any changes;

                  b.        Uses a standard template to display the  
                    formulary for all QHPs offered by the carrier.   
                    Requires the template to use the USP classification  
                    system, and organize drugs by therapeutic class,  
                    listing drugs alphabetically; and,

                  c.        Includes both of the following on any  
                    published formulary for the QHP, including, but not  
                    limited to, the formulary posted in 2a):
                        i.             Any prior authorization or step  
                         edit requirements for each specific drug included  
                         on the formulary; and,

                        ii.            The range of coinsurance cost to a  
                         potential enrollee of each specific drug included  
                         on the formulary, as follows:

                            1.                  Under $100 - $
                            2.                  $100-$250 -$$
                            3.                  $251-$500 - $$$
                            4.                  Over $500 - $$$$

          3.Requires Covered California to ensure that its Internet Web  
            site provides a direct link to the formulary posted before the  
            plan is offered through Covered California.

          4.Requires Covered California to create a search tool on its  
            Internet Website that allows potential enrollees to search for  
            QHPs by a particular drug and by a particular therapeutic  
            condition.





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          5.Defines "formulary for the QHP" as the complete list of drugs  
            preferred for use and eligible for coverage under the QHP and  
            includes the drugs covered under the pharmacy benefit of the  
            plan and the medical benefit of the plan.

           FISCAL EFFECT  :  This bill has not been analyzed by a fiscal  
          committee.
           
           COMMENTS  :  
            1. Author's statement.  According to the author, the ACA, in  
            addition to increasing insurance market competition, sought to  
            improve transparency in health benefits through  
            consumer-friendly tools such as the standardized summary of  
            benefits and coverage. However, the lack of access to clear  
            and comparable information on prescription drug coverage and  
            cost-sharing significantly undermines these goals.  The  
            absence of a window-shopping feature for health plan  
            formularies on Covered California's website remains a  
            significant problem for patients. We should make it easy for  
            consumers, especially patients with chronic conditions, to  
            make an apples-to-apples comparison of prescription drug  
            coverage.

               Currently, eight states offer the ability to view plan  
            formularies.  Nevada has gone so far as to allow consumers to  
            search for any drug on any of the plan formularies offered  
            through their state marketplace simply by entering the drug  
            name.  In February the Centers for Medicare and Medicaid  
            Services (CMS) published the "Draft 2015 Letter to Issuers in  
            the Federally-facilitated Marketplace" which proposes to  
            collect direct formulary links from all issuers in the  
            Federally-facilitated Marketplace for the 2015 plan year. With  
            almost 10,000 Federal Drug Administration-approved  
            prescription drug products, consumers may have difficulty  
            identifying a plan that includes the prescription drugs they  
            need and out-of-pocket costs they can afford.
               
           2. Cancer Drug Coverage In Health Insurance Marketplace Plans,  
            March 2014. A study published by the sponsors of this bill,  
            entitled Cancer Drug Coverage in Health Insurance Marketplace  
            Plans, studied QHPs of 62 health insurance issuers across five  
            states and the District of Columbia.  The study indicates that  
            California and New York do not have a window-shopping  
            function, and the District of Columbia's window-shopping  
            function does not include web links to formularies, so data  




          SB 1052 | Page 6




            for the study had to be gathered directly from issuer  
            websites.  Issuers do not use a common organizational  
            structure for formularies, making comparisons difficult.  The  
            lack of information on medical benefit drugs may make it  
            impossible for cancer patients to find out if their  
            intravenous chemotherapy is covered, as cancer drugs typically  
            administered by a physician, such as intravenous chemotherapy,  
            are often not listed on formularies.  The report indicates  
            that in California the study authors were unable to find  
            sufficient formulary information to complete the analysis for  
            one issuer.  Additionally, in every state at least one plan  
            appears to cover fewer drugs than the benchmark in at least  
            one class.  With regard to cost-sharing, in California,  
            individual silver plans are required to have a $250 drug  
            deductible, a $2,000 medical deductible, and standard 20  
            percent coinsurance on specialty drugs.   Most cancer drugs  
            are covered on the highest cost-sharing tiers.  Cost sharing  
            reduction plans are available to enrollees with income between  
            100 and 250 percent of the federal poverty level.
           
           3. Study on compliance with EHB Requirements.  In February  
            2014, the American Journal of Managed Care released a study,  
            entitled Complying with State and Federal Regulations on  
            Essential Drug Benefits:  Implementing the Affordable Care  
            Act, which indicated that all plans consistently covered at  
            least one drug per pharmacologic class, with the exception of  
            nonsedating antihistamines, which are mostly over the counter.  
             In California, all oral contraceptives, with the exception of  
            emergency contraceptives, all smoking cessation products, and  
            all osteoporosis products are covered by all three QHPs.  In  
            California, three percent of antidepressents were not covered  
            and three percent of antipsychotics were not covered.  Across  
            California, six percent of antidiabetic medications were not  
            covered.  The study concludes among other things that health  
            plans are not fully compliant with state and federal  
            regulations.  Additionally, there are significant differences  
            among plans related more to cost sharing and conditions of  
            reimbursement, such as prior authorization, step edits, and  
            quantity limits than to drug coverage, and that plans will  
            have to adjust their formularies to meet minimum requirements.
           
           4.  Federal EHB Requirements.  According to the federal EHB  
            review guide, in conjunction with the policy that plans must  
            offer the one drug in every USP category and class or the  
            number of drugs in each USP category and class offered by the  
            EHB-benchmark, whichever is greater, HHS is considering  




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            developing a drug counting service to assist states and  
            issuers with implementation of the proposed prescription drug  
            policy.  The federal government clarified in the Standards  
            Related to Essential Health Benefits, Actuarial Value, and  
            Accreditation Final Rule ("EHB Rule") that drugs must be  
            chemically distinct to be counted as more than one drug.  
            Issuers will need to know the extent of drug coverage in the  
            state's EHB-benchmark plan in order to comply. The following  
            summarizes the process CMS uses and will continue to use to  
            classify and categorize drug products covered by state  
            EHB-benchmark plans. The process produces a count of distinct  
            drug entities by state. CMS collected a list of trade-standard  
            11-digit National Drug Codes (NDCs) to identify the individual  
            drug products covered by the EHB-benchmark plan's drug list.  
            The NDCs identify the drug product, its package size and type,  
            and its manufacturer, distributor, reseller, or labeler. While  
            NDCs are an industry-standard identification code, they do not  
            provide the information needed to count, group and classify  
            chemically distinct drugs for the purposes of EHB.
               
          5.  DMHC EHB Worksheet.  To demonstrate compliance with the  
            prescription drug EHBs required under the ACA,  DMHC requires  
            health plans to complete a form indicating the number of  
            prescription drugs offered by the health plan in each class  
            and category of prescription drugs, as specified. Health plans  
            must make whatever modifications are necessary to their  
            current formularies so that the number of prescription drugs  
            they cover equal or exceed the number listed in the "EHB  
            Submission Count" column. They are also required to attach the  
            health plan's prescription drug list and/or formulary to the  
            worksheet. 

          6.  QHP Requirements.  QHP standard benefit designs, as it  
            relates to prescription drugs, has more to do with cost  
            sharing requirements than formulary requirements.  For 2014,  
            for a silver plan the standard prescription drug benefit is as  
            follows:


           ---------------------------------------------------------------- 
          |Annual      |$15,856-$17,|$17,235-$22,|$22,980-$28,|$28,725-$45,|
          |Income      |235         |980         |725         |960         |
          |------------+------------+------------+------------+------------|
          |Monthly     |$19-$57     |$57-$121    |$121-$193   |$193-$364   |
          |Premium     |            |            |            |            |




          SB 1052 | Page 8




          |consumer    |            |            |            |            |
          |Portion(Bala|            |            |            |            |
          |nce paid by |            |            |            |            |
          |federal     |            |            |            |            |
          |subsidy)    |            |            |            |            |
          |------------+------------+------------+------------+------------|
          |Generic     |$3          |$5          |$20         |$25         |
          |------------+------------+------------+------------+------------|
          |Brand       |No          |$50 plus    |$250 plus   |$250 plus   |
          |medications |Deductible  |copay       |copay       |copay       |
          |may be      |            |            |            |            |
          |subject to  |            |            |            |            |
          |Annual Drug |            |            |            |            |
          |Deductible  |            |            |            |            |
          |before you  |            |            |            |            |
          |pay the     |            |            |            |            |
          |Copay       |            |            |            |            |
          |------------+------------+------------+------------+------------|
          |Preferred   |$5          |$15         |$30         |$50         |
          |Brand copay |            |            |            |            |
          |after Drug  |            |            |            |            |
          |Deductible  |            |            |            |            |
           ---------------------------------------------------------------- 

           7. Draft 2015 Letter to Issuers in the Federally-facilitated  
            Marketplace In 2015, CMS is proposing for the federal Exchange  
            the ability for issuers to indicate whether a drug (identified  
            through its RxNorm Concept Unique Identifier or RxCUI12) is  
            considered a "medical drug" covered under a plan's medical  
            benefit. CMS believes that this revision will provide greater  
            clarity with respect to how drugs are covered and paid for  
            while ensuring that medical benefit drugs are taken into  
            account when evaluating potential QHPs for compliance with  
            federal regulations. Issuers will continue to be required to  
            submit their entire drug lists, including drugs covered either  
            under the prescription drug or the medical benefit, to the  
            count service in order to test for compliance with the  
            benchmark drug counts. Under a similar proposal, issuers will  
            have the option of identifying a drug as a "preventive drug"  
            covered at zero cost. As part of the QHP Application, issuers  
            must provide a URL to their formularies and must also provide  
            information regarding formularies to consumers, pursuant to  
            federal Summary of Benefits and Coverage regulations. CMS  
            expects the URL link to direct consumers to an up-to-date  
            formulary where they can view the covered drugs, including  
            tiering and cost sharing, that are specific to a given QHP.  




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            The URL provided to the federal Exchange as part of the QHP  
            Application should link directly to the formulary, such that  
            consumers do not have to log on, enter a policy number or  
            otherwise navigate the issuer's website before locating it. If  
            an issuer has multiple formularies, it should be clear to  
            consumers which directory applies to which QHP(s). 

               CMS also intends to propose through rulemaking that state  
            Exchanges may require issuers to temporarily cover  
            non-formulary drugs, including drugs that are on the issuer's  
            formulary but require prior authorization or step therapy, as  
            if they were on the issuer's formulary during the first 30  
            days of coverage, for coverage beginning on January 1 of each  
            year, starting with the 2015 plan year. This proposed policy  
            would also allow those newly enrolled in a QHP to receive  
            coverage for a non-formulary drug during this time period  
            without using the exceptions process. This would prevent  
            disruptions in treatment for new enrollees while the issuer  
            and/or the enrollee pursues prior authorization, step therapy,  
            and/or drug exception processes and would only apply to  
            enrollees who change QHPs or who become newly enrolled in a  
            QHP after having other non-QHP coverage. As stated in the  
            interim final rule published on December 17, 2013, issuers are  
            encouraged to accommodate the needs of new enrollees by  
            covering a transitional fill of non-formulary drugs to new  
            enrollees. Also being contemplated are policies to help with  
            transitions for other types of care (e.g., continuity of  
            access to specialists for individuals in the midst of a course  
            of cancer treatment). 
          
          8.  Related legislation. AB 1917 (Gordon) limits, for a health  
            care service plan contract or health insurance policy that is  
            subject to specified annual out-of-pocket limits,   the  
            copayment, coinsurance, or any other form of cost sharing for  
            a covered outpatient prescription drug for an individual  
            prescription for a supply of up to 30 days to 1/24 of the  
            annual out-of-pocket limit. Requires an enrollee who is  
            eligible for a reduction in cost sharing through a QHP offered  
            through the Exchange not be required to pay in any single  
            month more than 1/24 of the annual limit on out-of-pocket  
            expenses for that product. AB 1917 is currently pending in the  
            Assembly Committee on Health.
          
          9.   Prior legislation. SB 639 (Hernandez), Chapter 316,  
            Statutes of 2013, codifies provisions of the ACA relating to  




          SB 1052 | Page 10




            out-of-pocket maximums on cost-sharing, health plan and  
            insurer actuarial value coverage levels and catastrophic  
            coverage requirements, and requirements on health insurers for  
            coverage of out-of-network emergency services. Applies  
            out-of-pocket limits to specialized products that offer EHBs  
            and permits carriers in the small group market to establish an  
            index rate no more frequently than each calendar quarter.
          
               AB 1453 (Monning), Chapter 854, Statutes of 2012, and SB  
                                             951 (Hernandez), Chapter 866, Statutes of 2012, establish  
            California's EHBs.

               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.  
           
         10.  Support.  According to the National Multiple Sclerosis  
            Society - CA Action Network, people living with MS have very  
            high medical expenses.  They make frequent health care visits  
            and rely on expensive prescription medications to help manage  
            their disease.  There are ten injectibles and three oral  
            medications used to help manage MS.  These medications have no  
            generic equivalents and are typically placed on specialty drug  
            tiers, which make them subject to more costly co-insurance,  
            rather than a standard co-payment.  Therefore, when selecting  
            a health insurance plan, many patients living with MS find  
            that their top priority is determining whether their drugs are  
            contained on a plan drug formulary, as well as comparing the  
            cost sharing requirements for these medications across plans.   
            Currently, there is no easy way to find and navigate this  
            information.   This bill will provide a simple way for an  
            individual to determine which of their drugs are covered by an  
            Exchange plan, as well as compare plans based on coverage of  
            their particular prescription drugs.  The California  
            Healthcare Institute strongly supports legislation that  
            provides patients and their families with access to treatments  
            and a higher quality of life.
         
          11.  Opposition.  According to the California Association of  
            Health Plans, this bill inappropriately micromanages Covered  
            California's contracting process by prohibiting plan  
            participation in the Exchange if the plan does not meet the  
            bureaucratic specifications of this bill.  Under this bill not  
            only would a plan have to post its drug formulary on its  




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            website (something many plans already do) but the plan would  
            also be required to update the formulary under unrealistic  
            time frames and to post drug management and share-of-cost  
            related information. Nothing in the bill helps control the  
            underlying cost pressures of prescription drugs. This is  
            unfortunate considering the alarmingly high price-tag of many  
            new specialty drugs. Policymakers and consumers could benefit  
            from knowing how the underlying cost of new drugs is driving  
            share of-cost.  The Association of California Life and Health  
            Insurance Companies (ACLHIC) believe this measure is not  
            necessary and thinks the 24-hour adherence requirement is not  
            administratively feasible.  

         12.  Applicability Across the Market.  California took early  
            steps to establish Covered California, pass rate review  
            requirements, establish EHB, expand Medi-Cal and adopt  
            insurance market reforms to implement aspects of the ACA.  An  
            overarching objective in the development of the California  
            implementing legislation has been to ensure, to the extent  
            possible, that laws applicable to plans and insurers  
            participating in Covered California are also applied to plans  
            and insurers not participating in Covered California to keep a  
            level regulatory playing field and to minimize  
            disproportionate health risk (which impacts premium rates) in  
            Covered California.  Consistent with this effort this bill  
            should be amended to apply formulary disclosure and search  
            functionality to all health plans and insurance policies.
         
         13.  Time Frame and Stakeholder Process.  This bill does not  
            establish a time frame for implementation of the technology  
            requirements related to formulary disclosure and  
            standardization.  Covered California is still a new start up  
            organization.  Health plans and insurers are undergoing major  
            regulatory and market transition along with an influx of new  
            enrollments because of the ACA.  In addition, federal  
            requirements, which are contemplating some similar  
            requirements, are not completely final.  At the same time,  
            consumers have been prompted by virtue of federal tax penalty  
            to shop for and enroll in health insurance.  This bill should  
            be amended to stage implementation so that requirements, which  
            may be more difficult to implement can be done so in a  
            reasonable time frame.  Furthermore, this bill should be  
            amended to establish a stakeholder process and an independent  
            study to inform the development of formulary format  
            standardization.




          SB 1052 | Page 12




         
          
           SUPPORT AND OPPOSITION  :
          Support:  American Cancer Society Cancer Action Network  
                    (sponsor)
                    Association of Northern California Oncologists
                    California Arthritis Foundation Council
                    California Healthcare Institute
                    California Primary Care Association
                    Huntington's Disease Society of America
                    Lupus Foundation of Southern California
                    Medical Oncology Association of Southern California
                    National Multiple Sclerosis Society - CA Action  
                    Network
                    Pharmaceutical Research and Manufacturers of America
                    Project Inform

          Oppose:   Association of California Life and Health Insurance  
                    Companies 
                    Anthem Blue Cross
                    California Association of Health Plans





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