BILL ANALYSIS                                                                                                                                                                                                    Ó



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          Date of Hearing:  March 15, 2016


                            ASSEMBLY COMMITTEE ON HEALTH


                                   Jim Wood, Chair


          AB 1696  
          (Holden) - As Amended March 7, 2016


          SUBJECT:  Medi-Cal:  tobacco cessation services


          SUMMARY:  Requires Medi-Cal to cover tobacco cessation services.  
           Specifically, this bill:  



          1)Requires that the tobacco cessation services covered under  
            Medi-Cal be subject to utilization controls.

          2)Requires tobacco cessation services to include all  
            intervention recommendations assigned a grade A or B by the  
            United States Preventive Services Task Force (USPSTF).



          3)Requires tobacco cessation services to include the following:



             a)   A minimum of four quit attempts per year, with no  
               required break between attempts, for all beneficiaries 18  
               years of age or older who use tobacco;

             b)   For beneficiaries under 18 years of age, be provided  








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               services in accordance with the American Academy of  
               Pediatrics guidelines and intervention recommendations,  
               assigned a grade A or B by the USPSTF;



             c)   At least four tobacco cessation counseling sessions per  
               quit attempt, as specified, at the option of the  
               beneficiary; and,



             d)   A 12-week treatment regimen of any medication approved  
               by the federal Food and Drug Administration (FDA) for  
               tobacco cessation, including prescription and  
               over-the-counter (OTC) medications, with at least one  
               prescription and all OTC medications made available without  
               prior authorization, as specified.



          4)Requires the Department of Health Care Services (DHCS) to seek  
            any federal approvals necessary to implement the provisions of  
            this bill.  Provides that this bill is only to be implemented  
            to the extent that federal financial participation is  
            available and not otherwise jeopardized and that the state has  
            obtained all necessary federal approvals.

          5)Requires DHCS, by December 31, 2017, to issue guidelines and  
            enter into an agreement that authorizes the California  
            Smokers' Helpline or its successor, as administered by the  
            Department of Public Health (DPH), to directly furnish OTC  
            nicotine replacement therapy to Medi-Cal beneficiaries  
            enrolled in smoking cessation services provided by the state  
            tobacco use cessation quit line.



          6)Requires DHCS, by July 1, 2018, to issue guidelines and to  








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            provide incentives to adult Medi-Cal beneficiaries who use  
            tobacco products to motivate them to enroll and participate in  
            evidence-based tobacco use cessation services.



          7)Requires DHCS, by December 31, 2017, to issue guidelines to  
            Medi-Cal managed care plans (MCPs) that provide instructions  
            on requirements to annually report tobacco use rates among  
            adults enrolled in the MCP, as follows:



             a)   Allows MCPs to collect tobacco use status from enrollees  
               at the time of enrollment, and allows primary enrollees to  
               report the tobacco use status of other adult family members  
               via proxy;

             b)   Requires DHCS to publish and post on its Internet  
               Website annual adult tobacco use rates for each MCP; and,



             c)   Prohibits the tobacco status to be used by DHCS or MCPs  
               to deny coverage or treatment of tobacco-related illnesses.



          EXISTING LAW:  



          1)Establishes the Medi-Cal Program under the direction of DHCS,  
            as California's Medicaid program, to provide qualifying aged,  
            blind, disabled, and low-income individuals health care and a  
            uniform schedule of benefits.

          2)Requires prior authorization for coverage of specified  
            Medi-Cal services.








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          3)Requires all preventive services that are assigned a grade of  
            A or B by the USPSTF to be provided without any cost sharing  
            by Medi-Cal beneficiaries, so the state can receive an  
            increased federal medical assistance percentage for these  
            services.



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



          COMMENTS:  


          
          1)PURPOSE OF THIS BILL.  According to the author, quitting  
            tobacco products is a difficult feat that many individuals  
            attempt every year with little success on their own.  The  
            author states tobacco products can cause cancer, respiratory  
            and heart diseases, and birth defects, and their use is still  
            the leading preventable cause of death in the United States.   
            The author contends that though the dangers of smoking are  
            better understood now than 50 years ago, cigarettes are  
            addictive and smoking rates in the Medi-Cal population are  
            still too high.  The author asserts this bill provides smokers  
            with the tools necessary to fight their addiction to tobacco  
            products by mandating Medi-Cal coverage to clinically proven  
            treatments.  The author maintains that studies have shown that  
            the comprehensive coverage of these treatments has led to  
            decreases in the population of smokers.  The author concludes  
            that the state must remove all barriers to treatments that  
            make quitting the use of tobacco products possible.
          
          2)BACKGROUND.








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             a)   Tobacco use in California and the United States.   
               According to a 2015 study done by DPH, California has one  
               of the lowest smoking rates in the nation, second only to  
               Utah.  A survey done by the Behavioral Risk Factor  
               Surveillance System shows that California's overall adult  
               smoking rate was 11.7% in 2013.  However, California is the  
               state with the highest number of smokers because it is by  
               far the most populous state in the nation.  The DPH report  
               also highlights that although adult smoking rates have  
               declined significantly - between 1998 and 2013, rates have  
               dropped by 51% - it also notes that the decline in  
               California's tobacco use rates has slowed in recent  
               history.  The report warned that a loss in momentum could  
               lead to an increase in tobacco use rate in the near future,  
               which could have serious implications for reversing the  
               substantial progress made in California to reduce  
               tobacco-related diseases and the associated health care  
               cost savings that accrued as a result of the decline in  
               smoking.  Nonetheless, rates within California remain  
               consistently lower than rates in the rest of the United  
               States.
             
             b)   USPSTF Recommendations.  Created in 1984, the USPSTF is  
               an independent, volunteer panel of national experts in  
               prevention and evidence-based medicine.  The USPSTF states  
               it works to improve the health of all Americans by making  
               evidence-based recommendations about clinical preventive  
               services such as screenings, counseling services, and  
               preventive medications.  The USPSTF assigns each  
               recommendation a letter grade (an A, B, C, or D grade or an  
               I statement) based on the strength of the evidence and the  
               balance of benefits and harms of a preventive service.  The  
               recommendations apply only to people who have no signs or  
               symptoms of the specific disease or condition under  
               evaluation, and the recommendations address only services  
               offered in the primary care setting or services referred by  
               a primary care clinician.








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               The current USPSTF A and B recommendations on tobacco use  
               are as follows:



               i)     Clinicians ask all adults about tobacco use, advise  
                 them to stop using tobacco, and provide behavioral  
                 interventions and FDA-approved pharmacotherapy for  
                 cessation to adults who use tobacco (Grade A);

               ii)    Clinicians ask all pregnant women about tobacco use,  
                 advise them to stop using tobacco, and provide behavioral  
                 interventions for cessation to pregnant women who use  
                 tobacco (Grade A); and,



               iii)   Clinicians provide interventions, including  
                 education or brief counseling, to prevent initiation of  
                 tobacco use in school-aged children and adolescents  
                 (Grade B).



             c)   Tobacco Use Cessation Quit Line.  In 1992, the  
               California Smokers' Helpline became the first quit line in  
               the nation to offer free, statewide services for tobacco  
               users wanting to quit.  According to DPH, the California  
               Smokers' Helpline is a proven service that doubles a  
               person's chance of successfully quitting, and served as the  
               model for the rest of the country.  Quit line services are  
               now available in all 50 states.
             
               California's quit line provides telephone counseling, text  
               messaging support services, self-help materials, and online  
               help to callers, free of charge, in six different  








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               languages.  The quit line Website states Asian-language  
               speakers and Helpline callers who live with children five  
               years of age and younger, may be eligible for free nicotine  
               patches delivered directly to their homes.


               
             d)   Drugs Approved by the FDA.  There are currently a  
               variety of FDA-approved OTC nicotine replacement products,  
               including skin patches, lozenges, and chewing gum; these  
               products are available under brand or generic names to  
               individuals over the age of 18.  The only prescription  
               nicotine replacement product approved by the FDA is  
               Nicotrol.  The FDA has also approved two products for  
               tobacco cessation that do not contain nicotine:  Chantix, a  
               drug aimed at reducing cravings, and Zyban, an  
               anti-depressant focused on maintaining chemical balance as  
               a patient receives treatment.
             
             e)   Tobacco cessation treatments and coverage in the ACA.   
               Section 2502 of the Patient Protection and Affordable Care  
               Act (ACA) requires that smoking cessation drugs be removed  
               from the list of drugs that states may exclude from  
               coverage in their Medicaid program, effective January 1,  
               2014.  This section also explicitly prohibited state  
               Medicaid programs from excluding FDA-approved cessation  
               medications from coverage.  The Centers for Medicare and  
               Medicaid Services issued guidance to states, specifying  
               that OTC smoking cessation drugs are also no longer  
               excluded from coverage or otherwise restricted under the  
               Medicaid program.



             Federal guidance in the ACA recommends the following coverage  
               for each cessation attempt:  i) four tobacco cessation  
               counseling sessions of at least 10 minutes each (including  
               telephone counseling, group counseling, and individual  
               counseling) without prior authorization; and, ii) all  








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               FDA-approved tobacco cessation medications (including both  
               prescription and over-the-counter medications) for a 90-day  
               treatment regimen when prescribed by a health care provider  
               without prior authorization.
             
             f)   DHCS Policy on Tobacco Cessation.  On September 3, 2014,  
               DHCS released policy letter 14-006 to provide MCPs with  
               minimum requirements for comprehensive tobacco cessation  
               services.  The requirements, similar to federal guidance on  
               the issue, are for the following:


             
               i)     Coverage of all seven FDA-approved tobacco cessation  
                 medications, at least one of which must be available  
                 without prior authorization - a cost-containment  
                 procedure that requires a prescriber to obtain permission  
                 to prescribe a medication prior to prescribing it - and  
                 any additional tobacco cessation medications once  
                 approved by the FDA; 
               
               ii)    Coverage of a 90-day treatment regimen of  
                 medications with other requirements, restrictions, or  
                 barriers; and a minimum of two separate quit attempts per  
                 year, with no mandatory break required between quit  
                 attempts;


               
               iii)   MCPs may not require members to attend counseling  
                 sessions or classes prior to receiving a prescription for  
                 an FDA-approved tobacco cessation medication;


               
               iv)    MCPs must ensure that individual, group, and  
                 telephone counseling is offered to members who wish to  
                 quit smoking, whether or not those members opt to use  
                 tobacco cessation medications; and,








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               v)     Four counseling sessions of at least 10 minutes each  
                 in length for at least two separate quit attempts a year  
                 without prior authorization.


               
               The DHCS policy letter also specified requirements for  
               annual assessments, services for pregnant tobacco users,  
               provider training, and referral to the California Smokers'  
               Helpline.


               Notable differences between the requirements of this bill  
               and the requirements under DHCS' policy on coverage of  
               tobacco cessation products include a minimum requirement  
               under the DHCS policy and federal guidance for the length  
               of counseling sessions, and a modestly increased treatment  
               regimen (90 days under federal guidance and DHCS policy vs.  
               84 days under this bill).  This bill also requires coverage  
               for a minimum of four quit attempts per year, with no  
               required break between attempts, for all Medi-Cal  
               beneficiaries 18 years of age and older who use tobacco,  
               whereas federal guidance and DHCS policy states coverage  
               should be for at least two quit attempts.  Finally, this  
               bill requires all OTC medications and at least one  
               prescription medication be available without prior  
               authorization, whereas the DHCS policy is to cover all  
               seven FDA-approved tobacco cessation products, at least one  
               of which must be available without prior authorization.

             g)   Second Extraordinary Legislative Session.  On June 16,  
               2015, Governor Jerry Brown issued a proclamation calling  
               for an Extraordinary Session devoted to matters pertaining  
               to Medi-Cal and services for people with developmental  
               disabilities.  One of the charges of which is to improve  
               the efficiency and efficacy of the health care system,  








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               reduce the cost of providing health care services, and  
               improve the health of Californians.  To meet the Governor's  
               request, the Legislature recently passed a package of  
               tobacco control bills that, if signed by the Governor, will  
               raise the smoking age to 21, regulate e-cigarettes in the  
               same manner as traditional tobacco products, allow counties  
               to tax tobacco products, increase tobacco licensing fees,  
               close loopholes that allow smoking in the workplace, and  
               ensure all of Californians schools are smoke-free.  Further  
               details on these bills are noted below.
             
          3)SUPPORT.  The American Cancer Society Cancer Action Network  
            (ACS), a cosponsor of this bill, states the ACA has made  
            tobacco cessation treatments more accessible by including them  
            in the Essential Health Benefits that must be covered by all  
            health plans; however the guidelines as to how to implement  
            cessation treatments are unclear and results in varying  
            degrees of coverage between health plans.  The American Heart  
            Association/American Stroke Association, also a cosponsor of  
            this bill, states that federal funding for tobacco cessation  
            services has been made available as a result of Medi-Cal  
            expansion; ensuring Medi-Cal recipients in both  
            fee-for-service and managed care models have access to  
            comprehensive cessation coverage will help decrease tobacco  
            use rates and its associated costs.  The American Lung  
            Association in California, also a cosponsor of this bill,  
            states this bill will bring California into compliance with  
            federal guidance.
          
            The Health Officers Association of California supports this  
            bill, stating that despite its diminishing prevalence over the  
            last decade, the use of tobacco continues to threaten public  
            health and drain the state's health care resources, with an  
            annual cost of $18 billion for California taxpayers.  To  
            reduce the impact of tobacco use, the Health Officers  
            Association of California states it is important for our state  
            to invest in making tobacco cessation services more accessible  
            to tobacco users who are willing to quit.









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          4)OPPOSITION.  The California Association of Health Plans (CAHP)  
            states this bill will increase costs to the state by requiring  
            Medi-Cal MCPs to pay for tobacco cessation drugs in a manner  
            that is inconsistent with policies of both DHCS and sound  
            medical management.  CAHP also states MCPs already comply with  
            the requirements of the DHCS Policy letter.  Opposition also  
            asserts that removing all prior authorization protocols and  
            requiring plans to cover all specific medications would create  
            a new benefit mandate, which would result in higher state  
            costs in Medi-Cal reimbursement rates to plans in order to  
            reflect the benefit expansion.
          
          5)RELATED LEGISLATION.



             a)   AB 1594 (McCarty) prohibits the smoking of a tobacco  
               product or the use of an electronic cigarette on a campus  
               of the California State University or the California  
               Community Colleges; authorizes the enforcement by a fine;  
               and, requires the funds to be used to support educational  
               programs and tobacco use cessation treatment options for  
               students.  AB 1594 is currently pending in the Assembly  
               Higher Education Committee. 
             
             b)   SBX2 5 (Leno) and ABX2 6 (Cooper) define the term  
               smoking for purposes of the Stop Tobacco Access to Kids  
               Enforcement Act; expand the definition of a tobacco product  
               to include e-cigarettes and extend current restrictions and  
               prohibitions against the use of tobacco products to  
               electronic cigarettes.  SBX2 5 is pending on the Governor's  
               desk.  ABX2 6 is pending on the Assembly Floor.


             
             c)   SBX2 6 (Monning) and ABX2 7 (Stone) prohibit smoking in  
               owner-operated businesses and remove specified exemptions  








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               in existing law that allow tobacco smoking in certain  
               workplaces.  SBX2 6 was heard on August 19, 2015 in the  
               Senate Committee on Public Health and Developmental  
               Disabilities and passed on a 9 to 2 vote.  SBX2 6 passed  
               out of the Senate on August 27, 2015 and is pending in the  
               Assembly.  SBX2 6 is pending on the Assembly Floor.  ABX2 7  
               is pending on the Governor's desk.



             d)   SBX2 7 (Ed Hernandez) and ABX2 8 (Wood) increases the  
               minimum legal age to purchase or consume tobacco from 18 to  
               21.  SBX2 7 is pending on the Governor's desk.  ABX2 8 is  
               pending on the Assembly Floor.


             
             e)   SBX2 8 (Liu) and ABX2 9 (Thurmond and Nazarian) clarify  
               charter school eligibility for tobacco use prevention  
               program (TUPE) funds; require the California State  
               Department of Education to require all school districts,  
               charter schools, and county offices of education receiving  
               TUPE funds to adopt and enforce a tobacco-free campus  
               policy; prohibit the use of tobacco and nicotine products  
               in any county office of education, charter school, or  
               school district-owned or leased building, on school or  
               district property, and in school or district vehicles; and,  
               require all schools, districts, and offices of education to  
               post a sign reading "Tobacco use is prohibited" at all  
               entrances.  SBX2 8 is pending a vote on the Assembly Floor.  
                ABX2 9 is pending on the Governor's desk.


             
             f)   SBX2 9 (McGuire) and ABX2 10 (Bloom) allow counties to  
               impose a tax on the privilege of distributing cigarettes  
               and tobacco products.  SBX2 9 is pending on the Assembly  
               Floor.  ABX2 10 is pending on the Governor's desk.









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             g)   SBX2 10 (Beall) and ABX2 11 (Nazarian) revise the  
               Cigarette and Tobacco Products Licensing Act of 2003 to  
               change the retailer license fee from a $100 one-time fee to  
               a $265 annual fee, and increase the distributor and  
               wholesaler license fee from $1,000 to $1,200.  SBX2 10 is  
               pending on the Assembly Floor.  ABX2 11 is pending on the  
               Governor's desk.



             h)   SBX2 14 (Ed Hernandez) imposes an additional excise tax  
               of $2 per package of 20 cigarettes, and imposes an  
               equivalent one-time "floor stock tax" on the cigarettes  
               held or stored by dealers and wholesalers.  Imposes a tax  
               on e-cigarettes equivalent to the $2 per package tax  
               imposed on cigarettes by this bill.  Requires revenue from  
               tobacco and e-cigarette taxes to be used for various  
               tobacco use prevention and research, law enforcement,  
                                                                  medical school education, for improved payments for  
               Medi-Cal funded services, and to backfill existing  
               tobacco-tax funded services for any revenue decline  
               resulting from the additional tax.  Imposes a managed care  
               organization provider tax (MCO tax) on health plans and  
               continuously appropriates funds from the MCO tax for  
               purposes of funding the nonfederal share of Medi-Cal  
               managed care rates, and transfers $230 million, to be used  
               upon appropriation by the Legislature, to increase the  
               funding provided to regional centers and to increase rates  
               paid to providers of service to the developmentally  
               disabled.  Repeals the 7% reduction in hours of service to  
               each In-Home Supportive Services recipient of services.   
               SBX2 14 died on Senate Third Reading.


             
          6)PREVIOUS LEGISLATION.









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             a)   AB 1162 (Holden) of 2015 was nearly identical to this  
               bill.  AB 1162 would have required tobacco cessation  
               services to be a covered benefit under the Medi-Cal  
               program, as specified.  AB 1162 was vetoed along with five  
               other bills.  The veto message stated that:

                 "These bills unnecessarily codify certain existing health  
                 care benefits or require the expansion or development of  
                 new benefits and procedures in the Medi-Cal program.


                 Taken together, these bills would require new spending at  
                 a time when there is considerable uncertainty in the  
                 funding of this program. Until the fiscal outlook for  
                 Medi-Cal is stabilized, I cannot support any of these  
                 measures."



             b)   SB 220 (Yee) of 2010 would have required a health plans  
               and insurers to cover over a minimum of two courses of  
               treatment in a 12-month period for all smoking cessation  
               treatments rated "A" or "B" by the USPSTF, which shall  
               include counseling and over-the-counter medication and  
               prescription pharmacotherapy approved by the FDA.  SB 220  
               also requested the California Health Benefits Review  
               Program to prepare an analysis of the state cost savings as  
               a result of the bill provisions.  SB 220 was vetoed by the  
               Governor.

             c)   AB 2662 (Dymally) of 2007 would have required that one  
               provision of one form of Medi-Cal covered tobacco cessation  
               services benefits, either pharmacotherapy or counseling, to  
               not be a precondition to receive the other.  AB 2662 was  
               held in the Senate Appropriations Committee.

             d)   SB 576 (Ortiz) of 2005 would have required health plans  
               and health insurers to provide specified tobacco cessation  
               coverage and would have prohibited plans and insurers from  








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               applying deductibles or co-payments to those benefits.  SB  
               576 was vetoed by the Governor.

          7)POLICY COMMENT.   This bill is similar to AB 1162 (Holden) of  
            2015, which the Governor vetoed last year due to costs  
            pressures on the Medi-Cal program.  The Committee may wish to  
            ask the author how he will address the Governor's veto.
            
          8)TECHNICAL AMENDMENT.  This bill requires DHCS to provide  
            instructions on requirements to annually report tobacco use  
            rates among adults enrolled in the MCP.  This bill also  
            requires DHCS to publish and post on its Internet Website  
            annual adult tobacco use rates for each MCP.  It is unclear if  
            the intent of the latter requirement is to have DHCS publish  
            the rates of annual use of tobacco products for adults, or to  
            publish various rates of adult tobacco use (e.g. demographics,  
            types of tobacco product used, etc.) annually.  The Committee  
            may wish to clarify what data DHCS should publish.
          
          REGISTERED SUPPORT / OPPOSITION:




          Support




          American Cancer Society Cancer Action Network (cosponsor)
          American Heart Association/American Stroke Association  
          (cosponsor)
          American Lung Association in California (cosponsor)
          Association of California Healthcare Districts
          California Optometric Association
          California Pan-Ethnic Health Network
          County Health Executives Association of California
          Health Officers Association of California
          








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          Opposition


          California Association of Health Plans





          Analysis Prepared by:An-Chi Tsou / HEALTH / (916) 319-2097