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Medicaid Contract Purchasing Specifications

Sample Purchasing Specifications Related to Tobacco-Use Prevention and Cessation Services

A Technical Assistance Document

(October 2002)

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This document sets forth illustrative language for the purchase of tobacco-use prevention and cessation services from managed care organizations (MCOs) by state agencies administering Medicaid, other state agencies and other managed care purchasers. It has been prepared by the George Washington University Center for Health Services Research and Policy (CHRSP or the Center) in conjunction with officials from the Centers for Disease Control and Prevention (CDC), who provided expertise, direction, and financial support for its development.

These sample purchasing specifications were drafted with guidance from experts in the identification and treatment of tobacco-use prevention and cessation, with medical specialties in epidemiology and primary care, health care services/delivery specialists. Policymakers, managed care officials, and state Medicaid agency representatives reviewed them. They are recommended to purchasers for consideration because, in the opinion of experts, they reflect best practices. These specifications do not reflect a formal legal policy, nor are they part of a formal practice guideline.

The contents of this document are optional for state policymakers. However, these sample purchasing specifications provide purchasers with a broad menu of draft provisions relating to the types of tobacco-use prevention and cessation services that have previously been identified in the Consensus Public Health Service Guideline 1 as clinically effective in identifying and treating individuals who use tobacco. Experts estimate that for every dollar spent on smoking cessation activities for pregnant women, Medicaid saves three dollars.2

This document should be viewed as a tool to assist managed care purchasers to identify key tobacco-related issues as they negotiate and draft their purchasing agreements with MCOs.

This document is not designed to stand alone. Instead, its provisions are intended to be incorporated, in whole or in part, into more comprehensive purchasing agreements. Thus the document only contains illustrative language relating to the definition and delivery of tobacco-use prevention and cession-related services. It does not contain language relating to issues such as payment, resolution of disputes between the state or other purchasers and the MCO, remedies, termination, and other elements that would be essential to any purchasing agreement. This language may be incorporated into purchasing agreements in any of several types of formats, including contracts, requests for proposals (RFPs), requests for information (RFIs), and general service agreements.

This document is organized into two Parts. The first Part contains illustrative language defining tobacco-use prevention and cessation benefits. The second Part contains illustrative language articulating general MCO duties relating to the delivery of the tobacco-use prevention and cessation benefits described in the first Part. Taken together, these two Parts reflect a consistent set of policies that are organized to facilitate negotiation and drafting of purchasing agreements. However, the individual elements are designed to be portable so that they can be used independently of the rest of the language. Italic insertions in certain provisions identify places in the illustrative language where a drafter may wish to insert references to relevant state laws or regulations or adapt the provisions to the particular needs or judgments of the purchaser. Explanatory commentary or references are provided as footnotes.

Unless otherwise noted, all specifications in this document related to the medical management of tobacco-use prevention and cessation services and treatments and their delivery are based in whole or in part on the best judgment and opinions of persons knowledgeable in tobacco-use prevention and cessation, general health care practice, health care delivery and health services organization and management.

These specifications, which are part of a Purchasing Specification Series, may be downloaded from http://www.gwhealthpolicy.org/managedcare_purchasingspecs.htm or may be obtained in diskette form from:

Center for Health Services Research and Policy
Department of Health Policy
School of Public Health and Health Services
The George Washington University Medical Center
2021 K Street, NW Suite 800
Washington, DC 20006

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SAMPLE PURCHASING SPECIFICATIONS

RELATED TO TOBACCO-USE PREVENTION AND CESSATION

Part 1. Services Related to Tobacco-use Prevention and Cessation

§101. In General

§102. Scope of Benefit

§103. Diagnostic and Treatment Services for Enrollees Who Use Tobacco

§104. Diagnostic and Treatment Services for Enrollees Who Are Recent Quitters

§105. Services for Pregnant Enrollees Who Use Tobacco

§106. Services for Adolescent and Pre-Teen Enrollees Who Use Tobacco

§107. Preventive Services to Reduce Tobacco-Use Initiation

§108. Pharmacotherapy Services for Enrollees Who Use Tobacco

§109. Tobacco-Use Counseling Programs

§110. Tobacco-Related Disease Management Services

§111. Guideline

§112. Coverage Determination Standards and Procedures

§113. Tobacco-Use Related Definitions

§101. In General

(a) Duty to Identify Enrollees Who Use Tobacco or Who Are Recent Quitters — Contractor, and each provider participating in Contractor's provider network, shall:

(1) comply with the requirements of §103(a) to identify newly enrolled individuals who use tobacco or who are recent quitters (as defined in §113(g));

(2) implement a provider reminder or prompt system 3 (as defined in §113(e)) for providers and health care institutions in every clinical setting in which an enrollee may receive care, so that providers and health care institutions will be aware of the tobacco-use status of the enrollee at every encounter or visit; and

(3) ensure that current tobacco usage is documented on the encounter or claims form by providers using an ICD-9-CM Diagnostic Code of 305.1.4

(b) Basic Service Duty — Contractor shall:

(1) cover and furnish, or arrange for the furnishing of, appropriate treatment for each enrollee who uses tobacco or who is a recent quitter (as defined in §113(g)), including the items and services enumerated in §102, in accordance with:

(A) the Guideline described in §111; and

(B) the coverage determination standards and procedures under §112;

(2) ensure sufficient education, resources and evaluation/feedback to promote provider interventions (as described in §§103, 105, and 106) for enrollees who use tobacco;

(3) ensure sufficient education, resources and evaluation/feedback to promote relapse prevention interventions (as described in §§104, 105, and 106) for enrollees who are recent quitters (as defined in §113(g));

(4) assess the delivery and follow-up of such interventions in staff performance evaluations and through periodic chart audits [Drafter: insert specified time frame if desired]; and

(5) provide for appropriate levels of provider reimbursement for providers who deliver effective tobacco-use counseling treatments, including designating tobacco-use counseling treatment as a reimbursable activity for fee-for-service providers and including these duties in the defined duties of those providers working under capitated systems.

(c) Delivery of Services — Contractor shall furnish, or arrange for the furnishing of, items and services covered under §102 for each enrollee who uses tobacco or who is a recent quitter (as defined in §113(g)) in accordance with the requirements for delivery of services enumerated in Part 2.

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§102. Scope of Benefit

(a) For Enrollees Who Use Tobacco

(1) Covered Items and Services — Contractor shall furnish, or arrange for the furnishing of, to each enrollee who uses tobacco:

(A) items and services enumerated in paragraph (2) that are not excluded from coverage under paragraph (3); and

(B) tobacco-related disease management services described in §110.

(2) Items and Services — The items and services covered under this purchasing agreement are:

(A) Diagnostic and Treatment Services described in §§103-104;

(B) If applicable, Services for Pregnant Enrollees described in §105;

(C) If applicable, Services for Adolescent and Pre-Teen Enrollees described in §106;

(D) Pharmacotherapy Services described in §108;

(E) Tobacco-Use Counseling Services described in §109; and

(F) Other services determined to be medically necessary under §112.

(3) Items and Services Not Covered

(A) Complementary alternative medicine, including acupuncture, homeopathy, herbal medicine, and hypnosis; and

(B) Any services not recommended in the Guideline described in §111. [Drafter: Enumerate any other services that will not be covered]

(b) For Enrollees Who Are Recent Quitters

(1) Covered Items and Services — Contractor shall furnish, or arrange for the furnishing of, to each enrollee who is a recent quitter (as defined in §113(g)):

(A) items and services enumerated in paragraph (2) that are not excluded from coverage under paragraph (3); and

(B) tobacco-related disease management services described in §110.

(2) Items and Services — The items and services covered under this purchasing agreement are:

(A) Diagnostic and Treatment Services described in §§103-104;

(B) If applicable, Services for Pregnant Women described in §105;

(C) If applicable, Services for Adolescents and Pre-Teens described in §106;

(D) Tobacco-Use Counseling Services described in §109; and

(E) Other services determined to be medically necessary under §111.

(3) Items and Services Not Covered

(A) Complementary alternative medicine, including acupuncture, homeopathy, herbal medicine and hypnosis; and

(B) Any services not recommended in the Guideline described in §111.

(c) Preventive Services to Reduce Tobacco-Use Initiation. Contractor shall furnish or arrange to have furnished to all enrollees under age 25 who are not current tobacco users or recent quitters the preventive services described in §107.

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§103. Diagnostic and Treatment Services for Enrollees Who Use Tobacco

(a) Identification of Newly Enrolled Individuals Who Use Tobacco — Contractor shall:

(1) determine whether an enrollee presents with an history of tobacco use at the first encounter between a newly enrolled individual and a provider participating in Contractor's provider network;

(2) ensure that each provider, hospital or other clinical site at which the enrollee may receive medical care 5 establishes a provider reminder or prompt system for enrollees who use tobacco (as defined in §113(e)), determines the extent of current and/or past tobacco use and indicates such information in the following categories:

(A) current tobacco user;

(B) recent quitter (ceased using tobacco within the past year) (as defined in §113(g));

(C) former tobacco user (ceased using tobacco more than a year ago) (as defined in §113(c)); or

(D) non-user (never used tobacco);

(3) ensure that each provider:

(A) asks:

(i) each enrollee who is not a pregnant woman during each encounter between the provider and enrollee:

(I) if the enrollee uses tobacco products;

(II) if a current tobacco user, whether the enrollee wants to quit tobacco use;

(III) if a current tobacco user, whether the enrollee had previously attempted to quit and the results of those attempts;

(IV) if a current tobacco user, whether the enrollee had previously used pharmacotherapy or counseling interventions in previous attempts to quit;

(ii) each enrollee who is a pregnant woman during each encounter between the provider and enrollee:

(I) about her smoking status using the questions recommended in the Guideline described in §111,6 and

(II) the other questions listed in above in clause (i) of this subparagraph.

(B) enters this information in the provider reminder or prompt system and on the enrollee's chart; and

(C) documents current tobacco use on the encounter or claims form using an ICD-9-CM Diagnostic Code of 305.1.

(4) ensure that as part of each routine hospital admission or visit to another clinical site (regardless of the reason for the admission or visit):7

(A) an enrollee is asked: (i) if the enrollee uses tobacco products, and (ii) if the current tobacco user wants to quit tobacco use;

(B) this information is entered in the provider reminder or prompt system of the hospital or site and on the enrollee's chart; and

(C) current tobacco use is documented on the encounter or claims form using an ICD-9-CM Diagnostic Code of 305.1;

(5) ensure that each enrollee who uses tobacco is offered at least one of the treatments described in subsection (f) during each provider encounter or visit to a hospital or other clinical site; 8

(6) ensure that each enrollee who uses tobacco or is a recent quitter be given appropriate follow-up treatment and/or referrals to other providers necessary to identify and monitor any medical conditions arising as a result of the physical effect of tobacco use or that are related or complicating medical conditions, such as asthma, emphysema, cardiovascular disease, periodontal disease or cancer;

(7) ensure that each enrollee has access to at least two of the three tobacco dependence counseling therapies listed in subsection (f)(2); and

(8) ensure that if an enrollee receives treatment related to the enrollee's tobacco use from anyone other than the enrollee's primary care provider, a description of the treatment is communicated to the individual's primary care provider as soon as possible after treatment is provided.

(b) Initial Assessment — Contractor shall require each provider participating in Contractor's provider network to:

(1) take a medical history of each enrollee at the first encounter to determine whether and the extent to which the enrollee currently uses tobacco or has used tobacco in the past;

(2) conduct a physical examination to evaluate the enrollee for any physical effects of the enrollee's current or past tobacco use;

(3) document the information obtained by questioning and examining the enrollee in the provider reminder or prompt system and on the enrollee's chart, and

(4) document current tobacco use on the encounter or claims form using an ICD-9-CM Diagnostic Code of 305.1.

(c) Treatment of Tobacco Use and Tobacco Use-Related Conditions — If the enrollee has been identified as a tobacco user or a recent quitter, Contractor shall ensure that care for each such enrollee is provided in accordance with the Guideline described in §111.

(d) Treatment of Other Conditions That Are Aggravated by Tobacco Use — If the treating provider determines that other medical conditions are present that are aggravated by tobacco use, Contractor shall ensure that referrals to appropriate providers of specialty services, in accordance with the Guideline described in §111, are expedited. [Drafter: Insert a time reference]

(e) Treatment of Other Conditions and Environmental Factors That Interfere With Tobacco Counseling Treatment — Contractor shall ensure that referrals to appropriate health professionals (including mental health specialists) for counseling and treatment are offered to enrollees with significant psychiatric, psychosocial, or family problems that interfere with their tobacco-use counseling treatment. In addition, when enrollees who use tobacco live with others who use tobacco, a brief counseling intervention must be offered to all members of the household who use tobacco if they are also enrollees. 9

(f) Covered Diagnostic and Treatment Items and Services — In addition to the pharmacotherapy services described in §108 and the tobacco-use counseling services described in §109, and consistent with the Guideline described in §111, the following items and services necessary for the identification and treatment of tobacco use are covered:

(1) brief tobacco dependence treatment, consisting of the following elements:

(A) ask the enrollee about tobacco use;

(B) advise the tobacco user to quit;

(C) assess a willingness on the part of the tobacco user to make an attempt to quit;

(D) assist the tobacco user who is willing to make an attempt to quit to do so;

(E) arrange a follow-up encounter, preferably within one week of the quit date, and make tobacco users aware of the services available to them (i.e., individual counseling, group counseling, telephone quit line counseling program (as defined in §§109 and 113 and pharmacotherapy (as described in §108) and encouraging their use:

(F) (i) offer tobacco dependence counseling and pharmacotherapy services enrollees who indicate a willingness to undertake a quit attempt (unless such pharmacotherapy is contraindicated or special circumstances exist (e.g., if the enrollee is an adolescent (see services described in §106) or pregnant/breastfeeding (see services described in §105));

(ii) arrange for enrollees who are unwilling to make a quit attempt a brief motivational intervention, including the following components:

(I) relevance: why quitting is important to the enrollee's physical well-being;

(II) risk: the long and short-term risks of continuing to use tobacco;

(III) reward: the rewards to the enrollee of stopping tobacco use;

(IV) roadblocks: the potential barriers to the enrollee's attempt to quit and the elements of a treatment plan that could address these roadblocks, and

(V) repetition: this intervention should be repeated every time the enrollee visits a clinical setting if the enrollee is still unwilling to undertake a quit attempt; and

(2) consistent with the Guideline described in §111 and delivered by approved providers (as defined in §113(a)), tobacco dependence counseling, including person-to-person contact (via individual, group or a proactive telephone quit line counseling program as defined in §113(f));

(3) special tobacco-use counseling programs for pregnant enrollees (as described in §105) 10 and adolescent and pre-teen enrollees (as described in §106) 11; and

(4) relapse prevention interventions, including scheduled clinic visits and telephone calls. 12

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§104. Diagnostic and Treatment Services for Enrollees Who Are Recent Quitters

(a) Identification of Newly Enrolled Individuals Who Are Recent Quitters — Contractor shall:

(1) determine whether an enrollee presents with an history of tobacco use at the first encounter between a newly enrolled individual and a provider participating in Contractor's provider network;

(2) ensure that each provider, hospital or other clinical site at which the enrollee may receive medical care 13 establishes a provider reminder or prompt system (as defined in §113(e))for tobacco users and determines at each encounter the extent of current and/or past tobacco use in the following categories: current tobacco user, recent quitter (ceased using tobacco within the past year), former tobacco user (ceased using tobacco more than a year ago) or non-user (never used tobacco);

(3) ensure that each provider:

(A) enters the information obtained by the determination required under paragraph (2) in the provider reminder or prompt system (as defined in §113(e)) and on the patient's chart; and

(B) if a recent quitter, documents this status on the encounter or claim form using the ICD-9-CM Diagnostic Code of 305.1.

(4) ensure that as part of each routine hospital admission or visit to another clinical site (regardless of the reason for the admission or visit)14:

(A) the information obtained by the determination required under paragraph (2) is entered in the provider reminder or prompt system of the hospital or site (as defined in §113(e)) and on the patient's chart; and

(B) if a recent quitter, this status is documented on the encounter or claim form using the ICD-9-CM Diagnostic Code of 305.1.

(5) ensure that each enrollee who is a recent quitter (as defined in §113(g)) be given appropriate follow-up treatment and/or referrals to other providers necessary to identify and monitor any medical conditions arising as a result of the physical effect of tobacco use or that are related or complicating medical conditions, such as asthma, emphysema, cardiovascular disease, periodontal disease, or cancer; and

(6) ensure that each enrollee who is a recent quitter as defined in §113(g)) has access to at least two of the three types of tobacco dependence counseling therapies listed in subsection (f)(2) and ensure that each recent quitter is offered at least one of those therapies during each provider encounter or visit to a hospital or other clinical site 15;

(b) Initial Assessment — Contractor shall require each provider participating in Contractor's provider network to:

(1) take a medical history of each enrollee at the first encounter to determine whether the enrollee is a recent quitter (as defined in §113(g)), the extent to which the enrollee has used tobacco products in the past and whether the enrollee is concerned about a relapse;

(2) conduct a physical examination to evaluate the enrollee for any physical effects from the enrollee's tobacco use;

(3) incorporate the information obtained by this questioning and examination of the enrollee in the reminder or prompt system and on the patient's chart; and

(4) document recent quitter status on the encounter or claim form using an ICD-9-CM Diagnostic Code of 305.1.

(c) Treatment of Tobacco Use and Tobacco Use-Related Conditions — If the enrollee has been identified as a recent quitter (as defined in §113(g)), Contractor shall ensure that relapse prevention services for each such enrollee are provided in accordance with the Guideline described in §111.

(d) Treatment of Other Conditions That Are Aggravated by Tobacco Use — If the treating provider determines that other medical conditions are present that are or have been aggravated by tobacco use, Contractor shall ensure that timely referrals to appropriate providers of specialty services, in accordance with the Guideline described in §111, are expedited. [Drafter: Insert time frames]

(e) Treatment of Other Conditions and Environmental Factors That Interfere With the Continuance of Tobacco Counseling — Contractor shall ensure that referrals to appropriate health professionals (including mental health specialists) for counseling and treatment are provided for enrollees with significant psychiatric, psychosocial, or family problems that interfere with their recent cessation of tobacco use. 16 In addition, when enrollees who are recent quitters (as defined in §113(g)) live with others who use tobacco, a brief counseling intervention must be offered to all members of the household who use tobacco if they are enrollees. 17

(f) Covered Treatment Items and Services — Consistent with the Guideline described in §111, the following items and services necessary for the treatment of enrollees who are recent quitters (as defined in §113(g)) are covered:

(1) relapse prevention interventions, including scheduled clinic visits and telephone calls; 18

(2) relapse prevention counseling, including access to at least two of the following person-to-person contacts: individual, group or telephone quit line counseling programs (as defined in §113(f)); and

(3) pharmacotherapy, if indicated.

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§105. Services for Pregnant Enrollees Who Use Tobacco

(a) Identification of Pregnant Enrollees Who Use Tobacco — In addition to the services described in §103 and §104 and consistent with the Guideline described in §111, Contractor shall:

(1) ensure that each pregnant enrollee is assessed regarding her tobacco usage at the first prenatal visit 19 using the techniques recommended in the Guideline described in §111;

(2) ensure that tobacco usage information is entered in the provider reminder or prompt system (as defined in §113(e)) and on the enrollee's chart; and

(3) document current tobacco use on the encounter or claims form using an ICD-9-CM Diagnostic Code of 305.1.

(b) Pregnant Enrollees Who Use Tobacco — Consistent with the Guideline described in §111, Contractor shall ensure that pregnant enrollees who use tobacco be offered:

(1) effective smoking cessation interventions at the first prenatal visit (including a brief cessation counseling session of 5-15 minutes with the provision of pregnancy-specific self-help written materials);

(2) follow-up assessments throughout the pregnancy, including further encouragement of cessation;

(3) and encouraged to use:

(A) extended or augmented psychosocial interventions that exceed the minimal advice to quit; and

(B) intensive counseling (individual, group or proactive telephone quit line counseling programs as defined in §113(f));

(4) if a quit attempt is undertaken, follow-up visits and monitoring;

(5) throughout pregnancy and in the early postpartum period, relapse assessment and relapse prevention counseling;

(6) pharmacotherapy, if considered an appropriate intervention by the treating clinician 20; and

(7) access to at least two of the three tobacco dependence counseling therapies listed in subsection (f)(2).

(c) Pregnant enrollees who are recent quitters — Consistent with the Guideline described in §111, pregnant enrollees who are recent quitters (as defined in §113 (f)) shall be offered throughout pregnancy and in the early postpartum period, relapse assessment and relapse prevention counseling, including those described in §104(f), and have access to at least two of the three tobacco dependence counseling therapies listed in subsection (f)(2). Offering these interventions shall be documented on the encounter or claims form and entered into the system using an ICD-9-CM Diagnostic Code of 305.1.

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§106. Services for Adolescent and Pre-Teen Enrollees Who Use Tobacco

(a) Identification of Adolescent and Pre-Teen Enrollees Who Use Tobacco — In addition to the services described in §103 and §104 and consistent with the Guideline described in §111, Contractor shall ensure that providers:

(1) ask whether an adolescent or pre-teen enrollee uses tobacco at every encounter;

(2) if so, assess the extent of tobacco usage and enter the information in the provider reminder or prompt system (as defined in §113(e)) and on the patient's chart;

(3) document current tobacco use or recent quitter status on the encounter or claims form using an ICD-9-CM Diagnostic Code of 305.1;

(4) counsel all adolescent and pre-teen enrollees regarding the importance of totally abstaining from tobacco use whether current users or not.

(b) [Drafter: Select one of the following options]

Option #1:

Adolescent and Pre-Teen Enrollees Who Use Tobacco — Contractor shall ensure that providers offer developmentally appropriate counseling and behavioral interventions for adolescent and pre-teen enrollees who use tobacco, including pharmacotherapy services described in §108 (if considered appropriate by the treating clinician), tobacco-use counseling services described in §109, and other services described in §103.

Option #2: 21

Adolescent and Pre-Teen Enrollees Who Use Tobacco — Contractor shall ensure that providers offer developmentally appropriate counseling and behavioral interventions for adolescent and pre-teen enrollees who use tobacco, including pharmacotherapy services described in §108 (if considered appropriate by the treating clinician), a brief tobacco-use counseling intervention, and other services described in §103.

(c) Adolescents and Pre-Teens Who Are Recent Quitters — Contractor shall ensure that adolescents and pre-teens who are recent quitters (as defined in §113(f)) are offered relapse prevention and other services described in §104 on a developmentally appropriate basis.

(d) Adolescents and Pre-Teens Who Live in Households With Enrollees Who Use Tobacco — Contractor shall ensure that providers offer smoking cessation advice and interventions as described in §103 to parents and other enrolled individuals who use tobacco in households with adolescents and pre-teens.

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§107. Preventive Services to Reduce Tobacco-Use Initiation — Consistent with the Guideline described in §111:

(a) Smoke-free Facilities — Contractor shall ensure that each provider's office or clinic and each health care site at which enrollees may receive health care services within Contractor's provider network is smoke-free.

(b) Public Education and Outreach — Contractor shall ensure that each primary care provider and health care site is involved in on-site public education and outreach efforts to prevent the initiation of tobacco use and to encourage cessation of tobacco use.22

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§108. Pharmacotherapy Services for Enrollees Who Use Tobacco

(a) Enrollees Who Indicate a Willingness to Undertake a Quit Attempt — As determined by the treating provider in accordance with the Guideline described in §111, all enrollees who indicate a willingness to undertake a quit attempt must be offered pharmacotherapy unless contraindicated or special circumstances are present (e.g., enrollee is an adolescent or is pregnant/breastfeeding). For enrollees who are adolescents, pre-teens or pregnant/breastfeeding women, pharmacotherapy is provided at the discretion of the treating clinician.

(b) First-Line Pharmacotherapies — As determined by the treating provider in accordance with the Guideline described in §111, the following FDA-approved pharmacotherapies must be covered:

(1) bupropion SR;

(2) nicotine gum;

(3) nicotine inhaler;

(4) nicotine nasal spray;

(5) nicotine patches; and

(6) any other pharmaceutical with the approval of the Food and Drug Administration (FDA) for treatment of tobacco use.

Contractor must include at least one type of pharmaceutical from each class of FDA-approved pharmaceuticals for tobacco-use treatment. For example, Contractor must ensure that its formulary includes at least one type of nicotine patch, nicotine inhaler, nicotine nasal spray, etc. [Drafter: Insert any other additional requirements]

(c) Second-Line Pharmocotherapies — As determined by the treating provider in accordance with the Guideline described in §111, if all first-line pharmocotherapies have been tried and were found unsuccessful or contraindicated, the following second-line pharmocotherapies must be covered:

(1) clonidine;

(2) nortriptyline; and

(3) any other drugs, whether or not on the Contractor's formulary, that are prescribed by the treating clinician as recommended by the Guideline described in §111 or are subsequently approved by the FDA for smoking cessation treatment.

(d) Monitoring Safety and Side Effects of Medications — Contractor shall establish a program to monitor the use of covered pharmacotherapy to ensure that first and second line pharmocotherapies are prescribed in accordance with the Guideline described in §111.

(e) Drug Formulary Updates — Contractor shall assess the sufficiency of its drug formulary in the area of pharmacotherapy treatment for tobacco use and shall update the formulary no less frequently than [Drafter: Insert time frame] in accordance with appropriate clinical guidelines.

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§109. Tobacco-Use Counseling Programs

(a) In General — Consistent with the Guideline described in §111, Contractor shall ensure that tobacco-use counseling programs are available and accessible to (1) enrollees who use tobacco; (2) family members of enrollees who use tobacco if they are enrolled with Contractor; and (3) other individuals enrolled in the plan whose tobacco use might interfere with the tobacco-use counseling treatment for an enrollee who uses tobacco.

(b) Information on Availability of Tobacco-Use Counseling Programs — Contractor shall provide information on the availability and coverage of tobacco-use counseling programs in materials furnished to new enrollees. In addition, Contractor shall ensure that the availability and coverage of tobacco-use counseling programs is advertised and promoted to enrollees and providers participating in Contractor's provider network at least annually, either as part of any general communication to enrollees or providers or as a separate communication.

(c) Referrals to Tobacco-Use Counseling Program — In the initial encounter with an enrollee who uses tobacco, the treating providershall determine whether other family members use tobacco. If so, the treating provider shall offer treatment to such individual (if the individual is an enrollee), including referral to a tobacco-use counseling program.

(d) [Drafter: Chose one of the following options]

Option #1:

Contracting With and Payment To State or Local Health Departments — Contractor shall contract with [Drafter: Insert name of state or local health department program] that offers telephone quit line counseling programs (as defined in §113(f)) to ensure access and availability for enrollees described in subsection (a) who use tobacco and shall reimburse such department for the costs associated with the enrollment in such programs of enrollees" under Contractor's plan.

Option #2:

Contracting With State or Local Health Departments — Contractor shall include in Contractor's provider network [Drafter: Insert name of state or local health department program that offers telephone quit line counseling programs as defined in §113(f)] to ensure access and availability for enrollees described in subsection (a) who use tobacco. 23

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§110. Tobacco-Related Disease Management Services

(a) Tobacco-Use Disease Management Strategy Initiatives — Contractor shall include tobacco use as one of its disease management services and operate or contract with a program designed to manage proactively adult and pediatric enrollees who use tobacco. At a minimum, components of this program shall include, but not be limited to:

(1) educational programming for providers in Contractor's provider network on the treatment of enrollees who use tobacco;

(2) ensuring that every enrollee who uses tobacco in the program receives care consistent with the Guideline described in §111;

(3) a proactive approach to encouraging cessation of tobacco use;

(4) periodic assessment and monitoring to establish on a [Drafter: Insert time frame] basis whether the goal of cessation for individuals who use tobacco has been achieved; and

(5) measurement of the tobacco-use disease management service's effectiveness in improving the management of tobacco use consistent with the requirements of §§205 (regarding quality measurement) and 206 (regarding data collection and reporting).

(b) Integration of Tobacco-Use with Disease Management Services — Contractor shall include the treatment of tobacco dependence as part of any disease management service offered by Contractor where tobacco use is a cause of the disease or significantly increases the risk of complication from the disease (e.g., cardiovascular disease, asthma, diabetes, hypertension, chronic obstructive pulmonary disease (COPD), congestive heart failure, cerebrovascular disease, peripheral vascular disease, or cancer).

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§111. Guideline

(a) In General — Contractor shall structure its coverage of tobacco-use-related treatment to conform with the most recent version of the following Consensus Public Health Service Guideline: Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. June 2000 which can be found at: www.surgeongeneral.gov/tobacco/default.htm;

(b) Discretion to Consider More Recent Evidence — In instances in which more recent evidence of effectiveness exists with respect to proposed treatment not already incorporated in the most recent version of the Consensus Public Health Service Guideline described in subsection(a), Contractor shall ensure that such proposed treatment is covered, notwithstanding the fact that it is not included in the Guideline described in subsection (a). In proposing such treatment, the provider may take into consideration professional standards of medical care practice related to the coverage determination that is being made, as reflected in scientific literature published in peer-reviewed journals, results of relevant clinical trials, government-sponsored studies; professional consensus statements; and other sources of valid and reliable clinical evidence regarding the standard of care for individuals who use tobacco (providing that such sources are free from conflicts of interest).

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§112. Coverage Determination Standards and Procedures

(a) In General — Contractor shall comply with the requirements of this section relating to the determination of whether an item or service enumerated under §102 is covered with respect to an enrollee. Coverage of each item and service enumerated under §102 shall be consistent with the Guideline described in §111.

(b) Limitations — Contractor may limit:

(1) pharmacotherapy treatment to two (2) 90-day courses of treatment per enrollee per plan year, and

(2) tobacco-use counseling programs (as defined in §113(i)) to:

(A) four counseling sessions and at least 90 minutes total contact time over all sessions, with sessions concentrated around the quit date and the first month after the quit date, 24 and

(B) two programs per enrollee per year.

(c) Use of Prior Authorization Procedures — Contractor shall not impose any requirement for prior authorization or otherwise limit coverage with respect to:

(1) tobacco-use counseling services described in §103(f)(2) and special tobacco-use counseling programs for pregnant, adolescent and pre-teen enrollees as described in §103(f)(3); or

(2) emergency or urgent care services [Drafter: Insert reference to definition of these services] related to an enrollee's treatment for tobacco-use cessation.

(d) Evidence Used to Determine Medical Necessity by Contractor — Contractor shall determine the medical necessity of items and services enumerated in §102 as covered services for the diagnosis and treatment of tobacco use based on the following evidence:

(1) the Guideline described in §111;

(2) the opinion and recommendation of the clinician furnishing diagnostic and treatment services;

(3) evidence and information provided by the enrollee;

(4) the enrollee's medical record and accompanying supporting documents;

(5) the enrollee's health status;

(6) opinions of medical practitioners who are experienced in the treatment of tobacco use or other conditions similar to that of the enrollee with respect to whom a coverage determination is being made; and

(7) professional standards of medical care practice related to the coverage determination that is being made, as reflected in scientific literature published in peer-reviewed journals, results of relevant clinical trials, government-sponsored studies; professional consensus statements; and other sources of valid and reliable clinical evidence regarding the standard of care for individuals who use tobacco (providing that such sources are free from conflicts of interest).

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§113. Tobacco-Use-Related Definitions

(a) An "approved provider of intensive tobacco-use counseling services" (or "approved provider") means a program (or an individual who is a counselor in such program) that is described in §203(b).

(b) In determining whether an enrollee has "ceased" using tobacco products, the point prevalence method should be used. In other words, an enrollee may only be classified as having "ceased" using tobacco products if, at the time of the measurement (e.g., 6 months after the end of the treatment described in §§102, 103, 104, 105 or 106), the enrollee has not used tobacco products for at least 7 days prior to that date.

(c) A "former tobacco user" or "former user" means an individual who has not used tobacco products for at least one year.

(d) "Adolescents" and "pre-teens" are individuals from age 10-17.

(e) A "provider reminder or prompt system" means a method for reminding the provider or health care institution at every visit or admission of the tobacco-use status of the patient. This does not have to be an electronic reminder system. For instance, the provider reminder system could entail a color-coded notation prominent on the patient's chart or medical record that indicates whether the enrollee is a current tobacco user, a recent quitter (ceased using tobacco products within the past year), former tobacco user (ceased using tobacco products more than a year ago) or non-user (never used tobacco). Alternatively, an enrollee's vital signs could be expanded to include a notation of tobacco-use status. Each encounter in which the enrollee is found to be a tobacco user or recent quitter must be documented on the encounter or claims form using the ICD-9-CM Diagnostic Code of 305.1.

(f) A "quit line" or "telephone quit line counseling program" means a pro-active telephone counseling service for enrollees who are seeking intensive tobacco-use counseling or wish to engage in a quit attempt and which provides tobacco-use counseling for enrollees undergoing a quit attempt or who need follow-up counseling. A "quit line" must:

(1) operate with one or more counselors trained in tobacco-use counseling available at a minimum in the late afternoon and evening hours each weekday and one weekend day each week 25;

(2) have the capacity to receive counseling requests and other messages on a 24-hour a day basis and respond to those requests and messages within 48 hours; and

(3) meet the criteria for intensive tobacco-use counseling programs described in subsection (i).

(g) A "recent quitter" means an enrollee who has ceased using tobacco products within the past year.

(h) "Tobacco products" or "tobacco" includes one or more of the following:

(1) cigarettes (including roll-your-own (RYO) or handmade cigarettes);

(2) bidis;

(3) kreteks;

(4) cigars (including little cigars, cigarillos, regular cigars, premium cigars, cheroots, chuttas, and dhumti);

(5) pipe;

(6) smokeless tobacco (including snuff, chewing tobacco and bettle nut); and

(7) novel tobacco products, such as Eclipse and Accord.

(i) A "tobacco-use counseling program" means a program (individual, group, or proactive telephone quit line counseling program (as defined in subsection (f)) approved by the state which meets the following criteria:

(1) provides a minimum of four counseling sessions and at least 90 minutes of counseling.26 These sessions should be designed to build positive behavior change practices, including counseling at a minimum on all of the following topics 27:

(A) Establishment of reasons for quitting;

(B) Understanding nicotine addition;

(C) Various techniques for quitting and remaining a non- smoker;

(D) Discussion of stages of change;

(E) Overcoming the problems of quitting (withdrawal symptoms, depression, etc.);

(F) Short-term goal setting;

(G) Setting a quit date;

(H) Relapse prevention information; and

(I) Follow-up;

(2) operates under a written program/service outline, which at a minimum should include: (A) overview of service; (B) service objectives and key topics covered; (C) general teaching/learning strategies, (D) clearly stated methods of assessing participant success; (E) description of audio or visual materials that will be used; (F) distribution plan for patient education materials; and (G) method for verifying enrollee attendance;

(3) employs counselors who have formal training and experience in smoking cessation programming and are active in relevant continuing education activities; and

(4) utilizes a formal evaluation process, including mechanisms for data collection and measuring the participant rate and impact of the program. The data should include

(A) the number starting the program, the number completing the program, and the average number attending each session, and

(B) the number and percentage of participants who ceased using tobacco products and who maintained their tobacco cessation at 6 months after completion of the program [Drafter: Extraordinarily high turnover of Medicaid enrollees may justify the use of a 3-month reporting period].

In calculating each of the percentages described in subparagraph (B), the number of participants in each category must be divided by the number of participants who started the program. 28 In addition, in determining whether a participant "ceased" using tobacco products, only those participants who did not use tobacco products for at least a week at the time of the measurement should be treated as having "ceased" using tobacco products.

(5) reports back to the referring provider on each referred enrollee who uses tobacco within a month of the end of each program indicating whether the enrollee entered the program, completed the program, and ceased tobacco use at the end of the program, and

(6) reports the data described in paragraph (4) to Contractor on an monthly basis.

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Part 2. Service Delivery for Enrollees Who Use Tobacco Or Formerly Used Tobacco

§201. Enrollee Access to Health Care Providers

§202. Enrollment and Disenrollment

§203. Provider Network

§204. Relationship with State (or Local) Public Health Agency

§205. Quality Measurement and Improvement

§206. Data Collection and Reporting

§201. Enrollee Access to Health Care Providers

(a) Services of Specialists — Contractor shall ensure that each enrollee who uses tobacco has access to a provider experienced in tobacco cessation treatment.

(b) Services of Non-Network Providers — Contractor shall ensure access to a non-network provider for an enrollee who uses tobacco who obtains medically necessary covered items or services related to such tobacco use on an emergency or urgent basis [Drafter: Insert reference to definitions of emergency or urgent care], if a provider participating in Contractor's provider network is not reasonably available to the enrollee. 29

(c) Cost-Sharing Prohibited — Contractor may not impose co-payments on an enrollee's participation in intensive treatment and counseling programs described in §103(f)(3) or special tobacco-use counseling sessions for pregnant, adolescent or pre-teen enrollees described in §103(f)(4). In addition, Contractor may not impose a copayment in connection with pharmacotherapy treatment described in §109 that is in excess of the copayment for other types of covered drugs under the plan.

(d) Other Limits — Consistent with §112(b), Contractor may limit:

(1) pharmacotherapy treatment to two (2) 90-day courses of treatment per enrollee per plan year, and

(2) tobacco-use counseling programs (as defined in §113(i)) to:

(A) four counseling sessions and at least 90 minutes total contact time over all sessions, with sessions concentrated around the quit date and the first month after the quit date; 30 and

(B) two (2) courses of treatment per enrollee per plan year.

(e) Right to Self-Referral — An enrollee shall have the right to self-refer to a provider participating in Contractor's provider network for the following services:

(1) tobacco-use counseling programs as described in §103(f)(2) and (3); and

(2) telephone quit line counseling programs (as defined in §113(f)) that are part of Contractor's provider network or funded by [Drafter: Insert name of state or local health department].31

(f) Service Waiting Times — Contractor shall ensure that an enrollee who is interested in making a quit attempt or who is in the process of making a quit attempt must be seen by a provider within 48 hours of the request or must have access to a telephone quit line counseling program (as defined in §113(f)) that responds to the quit attempt request within 48 hours of the request. Contractor shall also ensure that an enrollee who is interested in making a quit attempt is offered receive the items and services described in §102, during the visit in which the desire to quit is expressed.

(g) Payment to Out-Of-Network Providers — If an enrollee obtains medically necessary covered items or services from a non-network provider consistent with subsection (b), Contractor shall reimburse the provider for such items or services in at least the same amounts and on terms at least as favorable as apply to a provider providing such items and services participating in Contractor's network. In addition, Contractor shall ensure that the enrollee may not be asked to pay a greater amount than the enrollee would have had to pay had the items or services been furnished by a provider participating in Contractor's provider network.32

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§202. Enrollment and Disenrollment

(a) Enrollees Receiving Treatment for Tobacco Use at the Time of Enrollment — In the case of an enrollee who, at the time of enrollment, is receiving pharmacotherapy or other diagnosis and treatment services relating to tobacco use, Contractor shall adhere to any diagnosis and treatment plan (if consistent with the Guideline described in §111) that has been developed for the enrollee prior to enrollment until the course of treatment is completed or until the enrollee's status is evaluated on the basis of a medical history, examination and any indicated laboratory or other tests, and an alternative course of treatment is developed in accordance with §110.

(b) Individuals Disenrolled While Receiving Treatment for Tobacco Use — In the case of an individual who ceases to be an enrollee and who, at the time of disenrollment, is receiving pharmacotherapy or counseling treatment services for tobacco use, Contractor shall:

(1) continue to provide the services to the individual until the earliest of the following:

(A) the day on which an enrollee's coverage under the terms of this Part ends; or,

(B) the day on which the enrollee finishes the course of treatment in progress.

(2) arrange at Contractor's expense for the transfer of the enrollee's medical records to the successor (if any) managed care plan or provider assuming responsibility for the care of the enrollee within [Drafter: Insert number of days] of a request by the enrollee, the successor managed care plan, or provider.

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§203. Provider Network

(a) Providers Experienced in Tobacco Use-Related Services Required in Contractor's Provider Network — Contractor shall include providers experienced in tobacco use-related services in Contractor's provider network.

(b) Tobacco-Use Training for Providers — Contractor shall ensure that providers participating in the Contractor's provider network receive training in:

(1) the diagnosis and treatment of enrollees who use tobacco and the current medical management of tobacco use, consistent with the Guideline described in §111;

(2) the techniques necessary to establish and use a chart documentation and a provider reminder or prompt system (as defined in §113(e)) and utilize the appropriate coding of tobacco-use status in encounter or claims systems which is required under §102;

(3) basic counseling strategies on how to provide social support and problem solving skills consistent with the Guideline described in §111;

(4) appropriate use of pharmacotherapies consistent with the Guideline described in §111 in treating enrollees who use tobacco;

(5) the available tobacco-use cessation resources available to enrollees through the plan, including how to obtain information about approved providers of intensive counseling services.

(c) Access to Specialists by Network Providers — Contractor shall ensure that a provider who is treating an enrollee who uses tobacco shall be able to consult, on a timely basis and without prior authorization, an approved provider of tobacco-use counseling services (as defined in §113(a)), who participates in Contractor's provider network. Such consultations shall not be taken into account by Contractor in determining provider network participation or provider compensation (including participation in financial incentive programs).

(d) Payment to Out-Of-Network Specialists — In the case of a consultation described in subsection (c), if Contractor's provider network does not contain sufficient approved providers of intensive tobacco-use counseling services to permit timely consultation, a provider participating in Contractor's network who is treating such an enrollee may consult with an experienced non-network specialist. Contractor shall reimburse such out-of-network specialist for the consultation in at least the same amounts and on terms at least as favorable as apply to an approved provider of intensive tobacco-use counseling services providing such consultations.

(e) Distribution of Clinical Practice Guideline to Providers — Contractor shall make available the Guideline described in §111 and any other appropriate clinical practice guidelines regarding tobacco use and cessation to each provider participating in Contractor's provider network.33

(f) Criteria for Provider Network Participation — To the extent that the actions of the provider are consistent with the Guideline described in §111, Contractor shall not, solely on the grounds of the amount, duration, or scope of one or more items or services described in §102 that a provider furnishes, prescribes or otherwise arranges for an enrollee who uses tobacco:

(1) exclude the provider from participation in Contractor's provider network; or

(2) reduce or withhold compensation from, or otherwise impose financial penalties upon a provider participating in Contractor's provider network.

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§204. Relationship with State (or Local) Public Health Agency — If a state or local public health agency has established a telephone quit line counseling program (as defined in §113(f)) or a state-funded local tobacco counseling services program, Contractor shall encourage its use and reimburse the state or local program for the reasonable costs of such services in treating plan enrollees.

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§205. Quality Measurement and Improvement

(a) Focused Quality Review — Contractor shall include in each quality review conducted by Contractor a focused study on the continuous quality improvement of care provided to enrollees who use tobacco. If statewide criteria or standards exist, Contractor shall use them.

(b) Measurement of Effectiveness of Tobacco-Use Management Program — Contractor shall measure the effectiveness of the Tobacco-Use Disease Management Services described in §110 and analyze and assess the outcomes and encounter data required to be reported under §206.

(c) Compliance Measures — Upon request, Contractor shall make available to the Purchaser the most recent version of the following:

(1) Contractor's provider manuals and any other directives, guidelines, or protocols transmitted in writing or electronically by Contractor to providers (including case managers) participating in Contractor's provider network relating to the provision of items and services under [Drafter: Insert the name of the purchasing document];

(2) any subcontracts or other written agreements between Contractor and providers (including case managers) participating in Contractor's provider network;

(3) Contractor's enrollee handbook and other written information given to enrollees regarding:

(A) covered items and services;

(B) access to primary care providers, experienced tobacco-use specialists and telephone quit line counseling programs;

(C) the circumstances under which enrollees who use tobacco may have access to non-network providers and under which recent quitters have access to relapse prevention services; and

(D) enrollee rights, including confidentiality protections, and grievance and appeal procedures;

(4) Contractor's operations manual and any other directive, guideline or protocol setting forth the standards and procedures used by Contractor relating to coverage and medical necessity determinations and to prior authorization determinations; and

(5) the names and practice sites of providers participating in Contractor's provider network who furnish specialized tobacco-use screening, diagnosis, or treatment services under §§102, 103, 104, 105, and 106.

(d) Drug Formulary Updates — Contractor shall assess the sufficiency of its drug formulary in the area of tobacco-use treatment and shall update the formulary no less frequently than [Drafter: Insert time frame, preferably 1 or 2 years] in accordance with the appropriate clinical guidelines.

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§206. Data Collection and Reporting

(a) Data Relating to Outcomes and Encounters — Contractor shall collect and annually report on outcomes and encounter data with respect to enrollees who use tobacco, including, but not limited to, the following information:

(1) the percentage of enrollees for whom the ICD-9 Diagnostic Code 305.1 was utilized and how this compares to the estimated percentage of Medicaid tobacco users enrolled with Contractor;

(2) based on a random sample of chart audits, the percentage of enrollees whose medical records reflect their tobacco usage;

(3) based on a random sample of chart audits of enrollees who are tobacco users: 35

(A) the percentage of enrollees using tobacco who were advised to quit;

(B) the percentage of enrollees using tobacco who were encouraged to use pharmacotherapy (unless contraindicated or special circumstances (i.e., adolescents, pre-teens or pregnant/breastfeeding));

(C) the percentage of enrollees using tobacco who filled their prescriptions 36;

(D) the percentage of enrollees using tobacco who were scheduled for follow-up visits;

(E) the percentage of enrollees using tobacco who were referred to the telephone quit line counseling program (if available);

(F) the percentage of enrollees using tobacco that were referred to intensive tobacco-use counseling programs.

(b) Annual Report to State Medicaid Agency — Contractor shall:

(1) compile the following data for each intensive tobacco-use counseling program, broken out by type of counseling (i.e., individual, group or telephone quit line counseling programs as defined in §113(f)):

(A) the number and percentage of enrollees who use tobacco who entered the program;

(B) the number and percentage of enrollees who use tobacco who called the telephone quit line counseling program and agreed to proactive counseling;

(C) the number and percentage of tobacco users who completed the program or telephone quit line counseling program;

(D) the number and percentage of tobacco users who ceased (as defined in §113(b)) using tobacco at the end of the program or telephone quit line counseling program; and

(E) the number and percentage of tobacco users who ceased (as defined in §113(b)) using tobacco for 6 months after the completion of the program or telephone quit line counseling program.37

In calculating each of the percentages described in subparagraphs (A), (C), (D), and (E) the number of participants in each category must be divided by the number of participants who started the program. Participants who are unable to be reached for follow-up must be counted as smokers for purpose of this reporting.

(2) On an annual basis, Contractor shall submit the data described in paragraph (1) to [Drafter: Insert name of State Medicaid agency].

(c) HEDIS — Contractor shall report in accordance with the HEDIS measure for tobacco use and report the tobacco measure score to [Drafter: Insert name of State Medicaid agency].38

(d) Patient Satisfaction — In addition to the requirements of the existing HEDIS measure, Contractor shall also include questions related to the diagnosis and treatment of tobacco use in its annual patient satisfaction survey. These questions shall include:

(1) whether the enrollee knows that cessation treatment options are offered under the plan and, if so, how the enrollee was informed of these options, and

(2) whether the enrollee was offered assistance in quitting, whether the enrollee was offered pharmacotherapy, and/or offered access to a proactive telephone quit line counseling program (as defined in §113(f))(if available) or counseling services.

This survey shall be made available to the Purchaser upon request.

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  1. Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. June 2000 [hereinafter known as the Consensus Public Health Service Guideline or the Guideline described in § 111].
  2. Marks, JS, Koplan, JP, Hogue, CJR, et al., A Cost-Benefit/Cost Effectiveness Analysis of Smoking Cessation for Pregnant Women. A. J. Prev. Med. 1990;6:282-291. In addition, it has been projected that a decline of one percentage point in smoking prevalence among pregnant women each year would prevent 1,300 low birth weight births a year, and, based on numbers from 1995, would save $21 million. Lightwood, JM, Phibbs, CS, Glantz, SA, et al, Short-Term Health and Economic Benefits of Smoking Cessation: Low Birth Weight. Pediatrics 1999:104(6): 1312-1320.
  3. Provider reminder systems have been determined to be effective in increasing patient receipt of provider advice to quit when applied in individual practice settings and in health-care systems. This recommendation appears as Systems Strategy 1 in the Consensus Public Health Service Guideline: Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. June 2000, page 44 [hereinafter referred to as the Consensus Public Health Service Guideline or the Guideline described in §111]. In addition, provider reminder or prompt systems were recommended in a report entitled "Strategies for Reducing Exposure to Environmental Tobacco Smoke, Increasing Tobacco-Use Cessation, and Reducing Initiation in Communities and Health-Care Systems": A Report on Recommendations of the Task Force on Community Preventive Services" MMWR 2000;49 (No. RR-12):5 & 8, Table 2. These systems do not have to be electronic — for example, a provider reminder or prompt system can be created simply by adding tobacco-use status as a fifth vital sign to a patient's chart or identifying the individual's smoking status (e.g., current, former, never) with a distinctive stamp or sticker reflecting each status.
  4. The purpose of recording this information on the encounter or claims form is so that an administrative data base can be developed to identify individuals who use tobacco within the plan's enrolled population. There needs to be a single consistent place where this data is recorded using the ICD-9-CM Diagnostic Code of 305.1 so that information regarding tobacco use can be readily accessed for outreach efforts, quality control or HEDIS purposes.
  5. These requirements are not intended to apply when an enrollee is seeking purely diagnostic services (such as x-ray or laboratory services). However, in each of these settings where a clinician is involved in providing medical services, these requirements are expected to be carried out.
  6. See footnote 17.
  7. These requirements are not intended to apply when an enrollee is seeking purely diagnostic services (such as x-ray or laboratory services). However, in each of these settings where a clinician is involved in providing medical services, these requirements are expected to be carried out.
  8. See footnote 5.
  9. In counseling the enrollee about quitting, the clinician should stress the benefit to the success of the enrollee's quit attempt if others around the enrollee avoid tobacco use. The Contractor and/or clinician is only required to treat other tobacco users in the household who (1) are enrolled in the plan, and (2) interested in quitting. However, the clinician should make it clear to the enrollee that it would be helpful if the enrollee urged other enrollees in the household who use tobacco to participate in the smoking cessation interventions that are covered by the plan. Since tobacco use by others in the household may interfere with treatment of tobacco use by the enrollee, it is important that referrals for others in the household occur as quickly as possible, preferably within 48 hours of the counseling session.
  10. An expert panel has reviewed the published literature for evidence relating to cessation counseling during pregnancy. The panel concluded that pregnancy is an important time to achieve smoking cessation and that successful interventions produce clear, short term, and cost-saving benefits. They also concluded that a brief cessation counseling session is more likely to improve cessation rates than simple advice to quit, as generally recommended by the Guideline described in §111. Melvin, CL, et al. "Recommended Cessation Counseling for Pregnant Women Who Smoke: A Review of the Evidence. Tobacco Control 2000;9 (Suppl III) iii80-iii84.
  11. Evidence of effectiveness of adolescent cessation interventions is less well-defined, but brief advice by a clinician can be highly cost effective even with low success rates. Coffield, AB, et al., "Priorities Among Recommended Clinical Preventive Services," Am J.Prev. Med. 2001:21(1), page 5, Table 2 and page 7, Figure 3. The Guideline described in §111 recommends that adolescents receive the same types of interventions as adults (with the possible exception of pharmacotherapy) but using developmentally appropriate techniques. See Consensus Public Health Service Guideline, page 101.
  12. The report described above in footnote 1 also assessed the evidentiary support for the effectiveness of multi-component interventions, including telephone support for persons who want to stop using tobacco. These interventions were strongly recommended as effective in both clinical and community settings. The minimum effective combination was proactive telephone quit line counseling programs plus patient education materials. Proactive telephone support includes multiple provider-maintained contacts. Mass media efforts were also found to be effective in increasing use of telephone quit line counseling programs and other support services and increasing cessation rates. See "Strategies for Reducing Exposure to Environmental Tobacco Smoke, Increasing Tobacco-Use Cessation, and Reducing Initiation in Communities and Health-Care Systems: A Report on Recommendations of the Task Force on Community Preventive Services." MMWR 2000;49 (No. RR-12) 5 & 8, Table 2.
  13. These requirements are not intended to apply when an enrollee is seeking purely diagnostic services (such as x-ray or laboratory services). However, in each of these settings where a clinician is involved in providing medical services, these requirements are expected to be carried out.
  14. These requirements are not intended to apply when an enrollee is seeking purely diagnostic services (such as x-ray or laboratory services). However, in each of these settings where a clinician is involved in providing medical services, these requirements are expected to be carried out.
  15. These requirements are not intended to apply when an enrollee is seeking purely diagnostic services (such as x-ray or laboratory services). However, in each of these settings where a clinician is involved in providing medical services, these requirements are expected to be carried out.
  16. Since this referral is triggered by the presence of other problems that interfere with treatment for tobacco use, it is important that referrals occur as quickly as possible, preferably within 48 hours of the initial assessment in which the other problem is identified.
  17. In counseling the enrollee about quitting, the clinician should stress the benefit to the success of the enrollee's quit attempt if others around the enrollee avoid tobacco use. The Contractor and/or clinician is not required to treat everyone in the household who uses tobacco. However, the clinician should make it clear to the enrollee that it would be helpful if the enrollee urged other enrollees in the household who use tobacco to participate in the smoking cessation interventions that are covered by the plan.
  18. See discussion in footnote 8, above.
  19. Because many pregnant women are reluctant to disclose their smoking status, clinicians have developed a multiple choice question to probe smoking status. Use of this question, in either written or oral form, has been shown to improve disclosure in comparison with a yes or no question, such as "Do you smoke?" Under this approach, the enrollee is asked to choose which of the following best describes her smoking status: (A) I smoke regularly now — about the same as before finding out I was pregnant; (B) I smoke regularly now, but I"ve cut down since I found out I was pregnant; (C) I smoke every once in a while: (D) I quit smoking after I found out I was pregnant and I am not smoking now; (E) I wasn't smoking around the time I found out I was pregnant and I don"t smoke now. See Consensus Public Health Service Guideline, page 95, Table 43. For pregnant women, this question should be used in place of the question described in §103(a)(3)(i)(I). However, the other questions in §103(a)(3)(i) should be asked of pregnant women.
  20. Once a woman is post-partum, if she is not breast-feeding, pharmacotherapy should be offered.
  21. At the moment, the evidence that more intensive counseling interventions are more effective for adolescents and pre-teens is not as strong as the evidence of their effectiveness for adults. However, studies are currently in progress to test this issue. If an easily accessible telephone quit line counseling program is available, States may want to require Contractors to provide this type of counseling, but States may not want to require intensive counseling programs for adolescents and pre-teens until more evidence is available regarding their effectiveness.
  22. States are encouraged to define more specifically any public education and outreach activities to be required of Contractors. For instance, these efforts could reflect a special focus on prevention of tobacco use by adolescents, pre-teens and pregnant women.
  23. In this option, the explicit requirement for reimbursement is omitted to provide flexibility to states that have already established (or want to establish) counseling programs that involve cost-sharing arrangements between the states and managed care organizations.
  24. See footnote 8.
  25. These times were chosen because they afford accessibility during peak demand time for many working individuals. Of course, a state may define the Contractor's responsibility in alternative ways, for instance, requiring the Contractor to make the service available "at times that are likely to provide convenient access for the majority of enrollees" or "for at least four hours at a minimum during weekday evening hours and on at least one weekend day.
  26. Most relapses occur during the first four weeks after the quit attempt. Therefore, ideally, relapse counseling should be concentrated during that period. The Guideline described in §111 suggests counseling beyond 300 minutes per program provides incrementally diminishing returns. See Consensus Public Health Service Guideline, page 59. States may want to closely examine the effectiveness of any programs exceeding that length.
  27. Counseling on other issues, such as weight management (including the importance of exercise) and stress management, might also be beneficial but are not required.
  28. Those participants not completing the program and those participants unable to be reached for follow-up at the end of the program, or at the 6-month and 12-month mark must be considered tobacco users for purposes of calculating the percentages of those who ceased tobacco use under the program.
  29. If a State does not permit enrollees to obtain any services outside of the network, this provision can be omitted.
  30. See footnote 8.
  31. For example, Oregon currently provides state-funded telephone counseling services for both Medicaid enrollees and the uninsured population in the state.
  32. See footnote 25.
  33. States may want to post this information on their websites or require Contractors to post it on their websites, either in addition to requiring distribution to participating providers or in lieu of the distribution requirement.
  34. The states of Washington and Oregon currently have such arrangements in place.
  35. Wherever possible, charts selected for audit should be drawn from the administrative data base established by using the ICD-9-CM Diagnostic Code of 305.1 on each encounter or claims form. Using this technique would reduce the cost of chart audits substantially.
  36. This information is expected to be captured through the plan's pharmacy data base.
  37. Extraordinarily high turnover of Medicaid enrollees may justify the use of a 3-month reporting period.
  38. The new HEDIS measure for smoking includes the following questions: (1) On how many visits was medication recommended or discussed to assist your with quitting smoking (for example: nicotine gum, patch, nasal spray, inhaler, prescription medication)?, and (2) On how many visits did your doctor or health care provider recommend or discuss methods and strategies (other than medication) to assist you with quitting smoking? The response categories are the following: None; 1 visit; 2-4 visits; 5-9 visits; 10 or more visits; and I had no visits in the last 12 months. HEDIS® 2003, Volume 3: Specifications for Survey Measures

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