BILL ANALYSIS Ó AB 1696 Page 1 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 AB 1696 Page 2 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 AB 1696 Page 3 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. AB 1696 Page 4 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. AB 1696 Page 5 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. AB 1696 Page 6 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 AB 1696 Page 7 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 AB 1696 Page 8 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, AB 1696 Page 9 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, AB 1696 Page 10 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. AB 1696 Page 11 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 AB 1696 Page 12 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. AB 1696 Page 13 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. AB 1696 Page 14 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 AB 1696 Page 15 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 AB 1696 Page 16 Opposition California Association of Health Plans Analysis Prepared by:An-Chi Tsou / HEALTH / (916) 319-2097