BILL ANALYSIS Ó AB 1162 Page 1 Date of Hearing: May 13, 2015 ASSEMBLY COMMITTEE ON APPROPRIATIONS Jimmy Gomez, Chair AB 1162 (Holden) - As Amended April 23, 2015 ----------------------------------------------------------------- |Policy |Health |Vote:|18 - 0 | |Committee: | | | | | | | | | | | | | | |-------------+-------------------------------+-----+-------------| | | | | | | | | | | | | | | | |-------------+-------------------------------+-----+-------------| | | | | | | | | | | | | | | | ----------------------------------------------------------------- Urgency: No State Mandated Local Program: NoReimbursable: No SUMMARY: This bill requires tobacco cessation services to be a covered Medi-Cal benefit, and specifies terms of coverage, including coverage of unlimited quit attempts, no age limits, and no required breaks between attempts. AB 1162 Page 2 This bill defines "quit attempt" as a 90-day treatment regimen of any FDA-approved tobacco cessation medication with no barriers or restrictions, as well as specified counseling sessions. FISCAL EFFECT: 1)Costs in the range of $650,000 (GF/federal) to Medi-Cal annually, based on an approximate 10% increase in utilization of tobacco cessation services. A California Health Benefits Review Program (CHBRP) analysis is not available, but certain assumptions from prior analysis were used to construct this estimate. The utilization estimate is subject to significant uncertainty. We estimate 2,500 individuals will attempt to quit and 100 will successfully quit based on the increased utilization of services. 2)Potential additional increased costs in the same $650,000 range, or greater, due to increased drug prices. This bill would reduce the ability of the Department of Health Care Services (DHCS) to negotiate supplemental rebates with manufacturers of tobacco cessation products since all tobacco cessation products would automatically be included in the Fee-for-Service formulary, and a similar dynamic would exist for Medi-Cal managed care. In addition, new drugs would automatically be covered without restriction, leading to unknown future increased costs. 3)Potential short-term (1-3 year) reductions in health care costs associated with Medi-Cal enrollees who successfully quit. A 2012 study of the Massachusetts Medicaid program found each $1 spent on medications, counseling, and promotion and outreach for Medicaid smokers was associated with a reduction AB 1162 Page 3 of $3.12 (range $3.00 to $3.25) in Medicaid expenditures for cardiovascular hospital admissions, resulting in net savings between $2.00 and $2.25. Long-term cost savings are also possible, but are subject to significant uncertainty. Potential long-term savings are also offset by increased longevity. COMMENTS: 1)Purpose. The author asserts that FDA-approved tobacco cessation medications and counseling are very effective methods of having smokers quit, yet maintains that access to these services is sometimes difficult for Medi-Cal recipients due to the many barriers to access, including requiring prior-authorization and step therapy. The purpose of this bill is to remove all restrictions on tobacco cessation services, increasing their availability. 2)Background. According to CDC estimated that approximately 45% of California's Medi-Cal population smoke. Section 2502 of the Patient Protection and Affordable Care Act (ACA) requires Medicaid programs to cover FDA-approved cessation medications, and further guidance specifies over-the-counter smoking cessation drugs must also be covered. DHCS Policy on Tobacco Cessation. On September 3, 2014, DHCS released policy letter 14-006 to provide Medi-Cal managed care health plans (MCPs) with minimum requirements for comprehensive tobacco cessation services. The requirements, similar to federal guidance on the issue, include: a) Coverage of all seven FDA-approved tobacco cessation medications, at least one of which must be available without prior authorization, and any additional tobacco AB 1162 Page 4 cessation medications once approved by the FDA. b) Coverage of a 90-day treatment regimen of medications without other requirements, restrictions, or barriers; and a minimum of two separate quit attempts per year, with no mandatory break required between quit attempts. c) MCPs may not require members to attend counseling sessions or classes prior to receiving a prescription for an FDA-approved tobacco cessation medication. d) Cessation counseling must be offered; four counseling sessions of at least ten minutes each in length for at least two separate quit attempts a year without prior authorization. Prior CHBRP Analysis. A CHBRP analysis of a related bill, AB 1738 (Huffman) in 2012, indicated the following: a) The average cost per quit attempt, including counseling and drug treatment, was around $440. b) CHBRP estimated a 27.4% increase in utilization of tobacco cessation services as a result of gaining coverage for such services. c) CHBRP attributed between 7 and 12.4 years of life gained for each quitter to the smoking cessation coverage mandate. d) CHBRP found clear and convincing evidence that smoking cessation is a cost-effective preventive treatment that AB 1162 Page 5 results in improvements in multiple long-term health outcomes and reduces both direct medical costs and indirect costs associated with smoking. 1)Staff Comments. a) Cost-effectiveness. In their 2012 analysis of AB 1758, CHBRP notes: "It is generally accepted that interventions that cost less than $50,000 per Quality Adjusted Life Year, such as mammography, are viewed by society as cost effective. According to these standards, smoking cessation programs are highly cost effective in the long term, producing significant reductions in mortality and morbidity at a net cost that is well below the $50,000/QALY threshold. In addition, [..] a meta-analysis of the economic literature found that in nearly every case, smoking cessation programs are either cost saving or highly cost effective. This is borne out in the fiscal analysis above, which estimates costs in the range of low thousands of dollars per unadjusted life year gained (assuming 7 and 12.4 years of life gained for each quitter). Although not quality adjusted, this is well below the $50,000/QALY standard and indicates increased expenditures on tobacco cessation are highly cost-effective even in spite of marginally higher drug costs. However, prices of future drugs are unknown. b) Potential unintended consequences. Under current law, health plans and pharmaceutical benefit managers attempt to meet patient needs for medication in a way that minimizes costs and meets clinical standards of appropriate care. Prior authorization, for example, is not only employed to contain costs, but to allow a clinical review to ensure medication is prescribed appropriately and to allow consideration of safer alternatives. Staff notes that AB 1162 Page 6 despite cost-effectiveness of tobacco cessation spending, a complete prohibition on prior authorization may have unintended consequences that could increase costs without providing a benefit to patients. In addition, future FDA-approved medications may have unknown costs and risks to patient safety. The author may wish to closely examine the bill's total prohibition on prior authorization to ensure the design of this tobacco cessation benefit mandate does not have unintended consequences, either from a cost or patient safety perspective. If there are drugs that are significantly more expensive without commensurate clinical benefit or patient safety concerns for which prior authorization would be protective of patient safety, staff suggests allowing prior authorization or other utilization review in those cases. Staff suggests the author consider adding a sunset in order to assess, and address, any unintended consequences. c) Evaluation. Furthermore, the author may wish to consider an evaluation of the impact of this bill on cessation outcomes, as well as patient safety. Such an evaluation could provide valuable data as to whether the improved outcomes the bill seeks actually occur, and could provide evidence-based best practices for the design of tobacco cessation benefits. d) Does this bill accomplish the author's stated intent to allow coverage without restriction? Finally, the bill is drafted in a confusing way, specifying coverage of "quit attempts" and defining quit attempts as including medication and counseling. However, it appears the bill is intended to offer broad coverage of tobacco cessation medication and services in a "whatever it takes" manner, without conditioning the provision of one service on acceptance of another. Staff suggests the bill be re-drafted such that the products and services required to be covered are clearly listed, and parameters related to the products or services are listed separately-for example, AB 1162 Page 7 as prohibitions on requiring prior authorization or other restrictions. Analysis Prepared by:Lisa Murawski / APPR. / (916) 319-2081