BILL ANALYSIS Ó SENATE COMMITTEE ON HEALTH Senator Ed Hernandez, O.D., Chair BILL NO: AB 1696 --------------------------------------------------------------- |AUTHOR: |Holden | |---------------+-----------------------------------------------| |VERSION: |May 31, 2016 | --------------------------------------------------------------- --------------------------------------------------------------- |HEARING DATE: |June 22, 2016 | | | --------------------------------------------------------------- --------------------------------------------------------------- |CONSULTANT: |Scott Bain | --------------------------------------------------------------- SUBJECT : Medi-Cal: tobacco cessation services SUMMARY : Requires tobacco cessation services to be a covered benefit under the Medi-Cal program, subject to utilization controls. Requires tobacco cessation services to include all intervention recommendations assigned a grade A or B by the United States Preventive Services Task Force (USPSTF). Requires the Department of Health Care Services (DHCS) to issue guidelines and enter into an agreement that authorizes the California Smokers' Helpline to directly furnish at least one form of over-the-counter nicotine replacement therapy, as described by the USPSTF, to Medi-Cal beneficiaries enrolled in smoking cessation services provided by the helpline. Requires DHCS to include medical assistance with smoking and tobacco use cessation rates among adults enrolled in Medi-Cal managed care plans in its Healthcare Effectiveness Data and Information Set quality measures. Existing law: 1)Establishes the Medi-Cal program, administered by the DHCS under which basic health care services are provided to qualified low-income persons. 2)Establishes a schedule of benefits under the Medi-Cal program, which includes the purchase of prescribed drugs, subject to the Medi-Cal List of Contract Drugs and utilization controls. 3)Requires that preventive services assigned a grade of A or B by the U.S. Preventive Services Task Force be provided to Medi-Cal beneficiaries without any cost sharing by the beneficiary in order for the state to receive increased federal contributions for those services, as specified. AB 1696 (Holden) Page 2 of ? 4)Authorizes a pharmacist to furnish nicotine replacement products approved by the federal Food and Drug Administration (FDA) for use by prescription only, in accordance with standardized procedures and protocols developed and approved by both the California Board of Pharmacy and the Medical Board of California in consultation with other appropriate entities, if specified conditions are met. This bill: 1)Requires that tobacco cessation services are covered benefits under the Medi-Cal program, subject to utilization controls. Requires tobacco cessation services to include all intervention recommendations assigned a grade A or B by the USPSTF, as periodically updated. 2)Requires tobacco cessation services to include a minimum of four quit attempts per year, with no required break between attempts, for all beneficiaries 18 years of age and older who use tobacco. 3)Requires tobacco cessation services to be provided in accordance with the American Academy of Pediatrics guidelines and the intervention recommendations, as periodically updated, assigned a grade A or B by the USPSTF for Medi-Cal beneficiaries under 18 years of age. 4)Requires, in addition to the services described above, and only to the extent consistent with the intervention recommendations assigned a grade A or B by the USPSTF, tobacco cessation services to include: a) At least four tobacco cessation counseling sessions per quit attempt that may be conducted in person or by telephone and individually or as part of a group, at the beneficiary's option; b) A 12-week treatment regimen of any medication approved by the federal Food and Drug Administration for tobacco cessation, including prescription and over-the-counter (OTC) medications. c) At least one prescription medication and all OTC medications to be available without prior authorization. Requires a prescription from a provider with authority to prescribe and proof of Medi-Cal coverage to be sufficient documentation to fill a prescription for OTC tobacco cessation medications. AB 1696 (Holden) Page 3 of ? 1)Prohibits Medi-Cal beneficiaries from being required to receive a particular form of tobacco cessation service as a condition of receiving any other form of tobacco cessation service. 2)Requires DHCS, effective January 1, 2017, to seek any federal approvals necessary to implement this bill that DHCS determines are necessary. 3)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 at least one form of over-the-counter nicotine replacement therapy, as described by the USPSTF, to Medi-Cal beneficiaries enrolled in smoking cessation services provided by the helpline. Requires the guidelines, at a minimum, to address requirements for pharmacists and physicians in furnishing nicotine replacement products under this bill consistent with existing law authorizing pharmacist to furnish prescription nicotine products. Defines "directly furnish" as providing directly to the beneficiary by mail with no further action required on the part of the beneficiary. 4)Requires DHCS, by December 31, 2017, to include medical assistance with smoking and tobacco use cessation rates among adults enrolled in Medi-Cal managed care plans in its Healthcare Effectiveness Data and Information Set (HEDIS). Permits DHCS to use data collected under this bill for quality improvement projects to increase cessation by Medi-Cal enrollees who use tobacco products. Prohibits tobacco use status from being used by DHCS or a Medi-Cal managed care plan to deny coverage or treatment of tobacco-related illnesses. 5)Requires this bill to be implemented only to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained. FISCAL EFFECT : According to the Assembly Appropriations Committee: 1) Increased costs due to increased utilization of smoking cessation services. Under current practice, about 30,000 AB 1696 (Holden) Page 4 of ? Medi-Cal beneficiaries access smoking cessation services at a total annual cost of about $4 million per year. Assuming that the expanded benefits required in the bill result in increased demand for smoking cessation services of 10% to 20%, the bill would result in increased costs of $400,000 to $800,000 per year (General Fund [GF]/federal). 2) Short-term cost savings due to reduced smoking-related health care costs for Medi-Cal beneficiaries. A review of a smoking cessation benefit in the Massachusetts Medicaid program indicates that reducing smoking by beneficiaries led to a net reduction in health care costs of about $2 for each $1 spent on the program. Using the assumptions for utilization increase above, potential cost savings of $800,000 to $1.6 million per year. The long-term health care spending impacts of reduced tobacco use are less clear, because reduced health care spending on smoking-related conditions will be offset by people living longer, though such "costs" are generally considered societally beneficial. 3) Minor administrative costs to update existing Medi-Cal policies for the provision of smoking cessation services (GF/ federal). PRIOR VOTES : ----------------------------------------------------------------- |Assembly Floor: |63 - 14 | |------------------------------------+----------------------------| |Assembly Appropriations Committee: |14 - 6 | |------------------------------------+----------------------------| |Assembly Health Committee: |17 - 1 | | | | ----------------------------------------------------------------- COMMENTS : 1)Author's statement. According to the author, quitting tobacco products is a difficult feat that many attempt every year. Tobacco products are still the leading preventable cause of death in the United States. Though the dangers of smoking are better understood now than 50 years ago, cigarettes are more addictive and smoking rates in the Medi-Cal population are AB 1696 (Holden) Page 5 of ? still too high. In addition to efforts to discourage people from smoking, This bill gives smokers the tools to fight the addiction. The coverage ensured by this bill would guarantee Medi-Cal patients have access to clinically proven treatments. Studies have shown that the comprehensive coverage of these treatments has led to decreases in the smoking population. As a state, we must remove barriers to treatments that make quitting possible. 2)Background. According to the Centers for Disease Control and Prevention, tobacco use is the leading preventable cause of death in the United States. Every year, smoking kills 480,000 Americans and costs the nation at least $130 billion in medical care costs for adults and more than $150 billion in lost productivity, imposing a heavy economic burden on private employers, private health plans, and federal, state, and local governments. The cost of tobacco use to California is estimated to be $18.1 billion annually. According to data from 2001 to 2010 published by the Centers for Disease Control and Prevention in 2011, most smokers want to quit smoking (69%), and over half (52%) tried to quit in the previous year, but only 6% were successful. The USPSFT reviewed new evidence in the U.S. Public Health Service's 2008 clinical practice guideline and determined that the net benefits of tobacco cessation interventions in adults and pregnant remain well established. The USPSTF found convincing evidence that smoking cessation interventions, including brief behavioral counseling sessions and pharmacotherapy delivered in primary care settings are effective in increasing the proportion of smokers who successfully quit and remain abstinent for one year. The USPSTF concluded that there is high certainty that the net benefit of tobacco cessation interventions in adults is substantial, and there is high certainty that the net benefit of augmented, pregnancy-tailored counseling in pregnant women is substantial. 3)Affordable Care Act Changes to Tobacco Cessation Coverage. Section 2502 of the Patient Protection and Affordable Care Act (ACA) prohibited drugs used to promote smoking cessation, including agents approved by the FDA for over-the-counter for purposes of promoting tobacco cessation, from being excluded from Medicaid coverage. In addition, Section 4107 of the ACA required Medicaid coverage of tobacco cessation counseling and AB 1696 (Holden) Page 6 of ? pharmacotherapy (FDA-approved OTC and prescription drugs) for pregnant women, and prohibited cost-sharing for these services. The seven FDA-approved medications include five forms of nicotine replacement therapy (NRT): the patch, gum, inhaler, nasal spray, and lozenge, as well as two non-NRT medications, bupropion SR (brand name Zyban if used for tobacco cessation and Wellbutrin if used as an antidepressant), and varenicline (brand name Chantix). Three forms of NRT (the patch, gum, and the lozenge) are available OTC. The other two forms of NRT (the inhaler and the nasal spray), as well as the two non-NRT medications, are available by prescription. The patch is available by prescription as well as OTC. 4)Current Medi-Cal coverage of tobacco cessation. Medi-Cal beneficiaries have a higher prevalence of tobacco use than the general California population. In the 2011-12 California Health Interview Survey, 16.1% of adult and teen Medi-Cal beneficiaries were current smokers, as compared to 12.1% of adults and teens not covered by Medi-Cal. In the 2013 Medi-Cal Managed Care Consumer Assessment of Healthcare Providers and Systems survey, a median of 18.2% of respondents reported current smoking (with a range of 10% to 27% among Medi-Cal plans). DHCS indicates expenditures on smoking deterrents in 2014 was $1 million in FFS and $3.1 million in managed care. Coverage of tobacco cessation medication varies, depending upon whether the beneficiary is in FFS Medi-Cal or Medi-Cal managed care plan, and the particular Medi-Cal managed care plan the beneficiary is enrolled in. In 2016-17, Medi-Cal is projected to enroll 14.1 million individuals, of whom 75.89% (10.7 million people) are projected to be in managed care plans. For FFS Medi-Cal, DHCS is required to use the following criteria when adding a drug to the Medi-Cal contract drug list: (a) the safety of the drug; (b) the effectiveness of the drug; (c) the essential need for the drug; (d) the potential for misuse of the drug; and, (e) the cost of the drug. In September 2014, DHCS released Policy Letter 14-006 to provide Medi-Cal managed care health plans with minimum requirements for comprehensive tobacco cessation services. The chart below shows the differences between this bill and AB 1696 (Holden) Page 7 of ? current DHCS policy set forth in the Policy Letter: ------------------------------------------------------- |Tobacco | AB 1696 | DHCS Policy for | |Cessation | | Medi-Cal Managed Care | |Requirements | | Plans | |-------------+-----------------+-----------------------| |Number of | At least 4 per | At least 2 separate | |quit | year |quit attempts per year | |attempts | | | |-------------+-----------------+-----------------------| |Prohibition | Yes | Yes | |on requiring | | | |a break | | | |between quit | | | | attempts | | | |-------------+-----------------+-----------------------| |Number of | At least 4 per |At least 4 of at least | |tobacco | quit attempt. | 10 minutes duration | |cessation | | | |counseling | | | |services | | | |-------------+-----------------+-----------------------| |Counseling | In person, |Plans must ensure that | |Session | telephone, | individual, group and | | | individual or | telephone counseling | | | group, at | is offered. Does not | | | beneficiary |specify at beneficiary | | | option | option | |-------------+-----------------+-----------------------| |Tobacco | 84 days (12 |90 | |cessation | weeks) |days | |drug | | | |treatment | | | |regimen | | | |duration | | | |-------------+-----------------+-----------------------| |Coverage of |Any FDA-approved | Must cover 7 | |tobacco | medication for | FDA-approved tobacco | |cessation | tobacco |cessation medications, | AB 1696 (Holden) Page 8 of ? |approved by | cessation, | at least one without | |the federal | including | prior authorization. | |FDA for |prescription and | Must cover additional | |tobacco |OTC medications. | medications once | |cessation, | | FDA-approved. | |including | | | |prescription | | | |and OTC | | | |-------------+-----------------+-----------------------| |Prior | At least one | Must cover 7 | |authorization| prescription | FDA-approved tobacco | |/ | medication and |cessation medications, | |utilization | all OTC | at least one without | |review |medications must | prior authorization. | |limitations | be available | Does not otherwise | | | without prior | prohibit utilization | | | authorization. | review. | |-------------+-----------------+-----------------------| |Prohibition | Yes | Prohibits plans from | |on receiving | | requiring | |one form of | | beneficiaries to | |tobacco | | attend classes or | |cessation as | | counseling sessions | |a condition | | prior to receiving a | |of receiving | | prescription for an | |any form of | | FDA-approved tobacco | |tobacco | |cessation medication. | |cessation | | | ------------------------------------------------------- 5)Tobacco Helpline. The state Tobacco Helpline (1-800-NO-BUTTS) has been in existence since 1992. It provides free telephone counseling, self-help materials, and online help in multiple languages to help Californians quit smoking. It is administered by the University of California San Diego via an interagency agreements with CDPH using state special funds (from the Health Education Account of Proposition 99, the Tobacco Protection and Health Initiative from 1988) and federal grant funds. The Helpline has also received funding from other sources including various grants from First 5, and Los Angeles County. The hotline serves approximately 40,000 individuals a year, more than half of whom are enrolled in Medi-Cal. AB 1696 (Holden) Page 9 of ? DHCS received a five-year grant from the Centers for Medicare and Medicaid Services (CMS) as part of the Medicaid Incentives for the Prevention of Chronic Disease (MIPCD) Program. The California project was called the Medi-Cal Incentives to Quit Smoking (MIQS) Project. The MIQS project incentivized Medi-Cal members who smoke to engage in counseling with the California Smokers' helpline. Under the project (which has ended), Medi-Cal members could receive a free, four -week supply of nicotine patches mailed directly to their home. Helpline counselors told Medi-Cal members if they qualified based on how much they smoke (at least six cigarettes daily) and determined the dosing. Refills of the nicotine patches were provided as needed. Medi-Cal members could receive a $20 gift card bonus, which was mailed after completion of the first 30-40 minute Helpline counseling session. 6)Health plan performance measures. The federal Centers for Medicaid and Medicaid Services (CMS) requires states, through their contracts with Medicaid managed care plans, to measure and report on performance to assess the quality and appropriateness of care and services provided to members. DHCS implemented a monitoring system to provide an objective, comparative review of Medi-Cal managed care plans quality-of-care outcomes and performance measures called the External Accountability Set (EAS). DHCS designates performance measures every two years, and requires Medi-Cal managed care plans to report on the measures annually. DHCS is not mandated by statute to collect particular HEDIS measures in Medi-Cal managed care, and DHCS does not currently require reporting on HEDIS measures related to tobacco use. However, DHCS requires participation of Meid-Cal managed care plans in the Consumer Assessment of Healthcare Providers and Systems survey every three years, which does assess tobacco use and cessation efforts. During the 2014 calendar year, DHCS held contracts with 23 full-scope Medi-Cal managed care plans and three specialty managed care plans. For 2015, DHCS required reporting on 14 HEDIS measures for full-scope Medi-Cal managed care plans and one measure developed by DHCS and the managed care plans, with guidance from the external quality review organization. Several of the HEDIS measures include more than one indicator, bringing the total measure rates required for Medi-Cal managed care plans reporting to 30. The required measures provide information on access to AB 1696 (Holden) Page 10 of ? care for women, adolescents, and children; use of imaging studies for low back pain; screening for diseases such as cervical cancer; weight assessment and counseling for nutrition and physical activity for children and adolescents; care provided to beneficiaries with chronic diseases such as diabetes; hospital readmissions rates; and utilization of outpatient and emergency department care. In addition to reporting HEDIS measures, Medi-Cal managed care plans were required to report separate rates for their Seniors and Persons with Disabilities (SPD) and non-SPD populations for a selected group of measures. 7)Prior legislation. AB 1162 (Holden of 2015), was very similar 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 by the Governor 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. 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 includes counseling and OTC 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. AB 2662 (Dymally of 2007), would have prohibited the provision of one form of Medi-Cal covered tobacco cessation service (either pharmacotherapy or counseling) as a condition of receiving the other service. AB 2662 was held on the Senate Appropriations Committee suspense file. AB 1696 (Holden) Page 11 of ? SB 576 (Ortiz of 2005), would have required health plans and insurers to provide coverage for two courses of tobacco cessation treatments per year, including counseling and prescription and over-the-counter medications, and prohibited plans and insurers from applying deductibles but allowed specific co-payments for those benefits. SB 576 was vetoed by the Governor. 8)Support. This bill is jointly sponsored by the American Heart Association/American Stroke Association, the American Lung Association, and the American Cancer Society Cancer Action Network to ensure all Medi-Cal patients are able to access tobacco cessation treatments. The sponsors argue that the success rate of smokers quitting their addiction to tobacco is still very low, due in part because many smokers try to quit without the assistance of tobacco cessation services. The sponsors noted that although the ACA has made tobacco cessation treatments more accessible, current guidelines as to how to implement these treatments are unclear, thereby resulting in differences in coverage between health plans. In addition, the sponsors state that Medi-Cal patients face barriers to treatment services due to prior authorization and step therapy treatment requirements. Supporters argue this bill provides needed clarity for Medi-Cal participants on tobacco cessation services and ensures access to comprehensive insurance coverage for these services. Supporters conclude that increased access to smoking cessation treatments and eliminating barriers will reduce the incidence of tobacco-related diseases and will lower health care costs. 9)Opposition. The California Association of Health Plans (CAHP) writes in opposition that this bill will increase costs to the state by requiring Medi-Cal managed care plans to pay for tobacco cessation drugs in a manner that is inconsistent with policies of DHCS. CAHP argues Medi-Cal managed care plans already comply with the requirements of the DHCS policy letter, and that weakening prior authorization requirements designated to ensure the right care is delivered under appropriate circumstances will drive up costs. CAHP also argues tracking tobacco rates of enrollees would be difficult and an unnecessary administrative burden. Finally, CAHP objects to the provision in this bill making counseling AB 1696 (Holden) Page 12 of ? sessions at patient option may leave out some beneficiaries who need the help most, including patients who have tried and failed therapies several times. 10)Amendments. This bill authorizes the California Smokers' Helpline to furnish OTC and prescription nicotine replacement therapy. Amendments to this provision are needed to distinguish between the authority to furnish OTC products and the authority of physicians and pharmacists to furnish prescription nicotine replacement therapy medication. 11) Policy issues. Recent DHCS policy. DHCS policy for Medi-Cal managed care plans was released in September 2014 and has been in effect for less than a year. This bill expands the scope of that coverage in several ways. Has sufficient time elapsed to know whether the provisions of that policy are adversely affecting tobacco cessation services and should be expanded? SUPPORT AND OPPOSITION : Support: American Heart Association (co-sponsor) American Cancer Society (co-sponsor) American Lung Association (co-sponsor) Association of California Healthcare Districts California Academy of Physician Assistants California Black Health Network California Chapter of the American College of Emergency Physicians California Dental Association California Life Sciences Association California Optometric Association California Pharmacists Association County Health Executives Association First 5 Association of California Health Access California Health Officers Association of California March of Dimes Mental Health America of California Two individual physicians Oppose: California Association of Health Plans Local Health Plans of California -- END -- AB 1696 (Holden) Page 13 of ?