SAMPLE PURCHASING SPECIFICATIONS FOR REPRODUCTIVE HEALTH SERVICES

Transcription

1 SAMPLE PURCHASING SPECIFICATIONS FOR REPRODUCTIVE HEALTH SERVICES 1 This document sets forth illustrative language in the form of sample specifications for the purchase of reproductive health services from managed care organizations (MCOs). The specifications address a range of clinical concerns in reproductive health, including male and female family planning services and preconceptional and perinatal services. Separate documents setting out sample specifications for sexually transmitted disease and HIV services are identified below and may be used in conjunction with this document. These specifications are intended for use in health care service purchasing agreements with managed care organizations (MCOs) that either for a preset fee (i.e., a premium) or under an administrative services agreement (ASO) arrange for the delivery of comprehensive health care through a network of participating providers. The specifications have been developed for use by both public sector Purchasers (e.g., state Medicaid agencies) and private sector entities (e.g., employers and employer purchasing coalitions). The specifications were drafted by the Center for Health Services Research and Policy (CHSRP) of the George Washington School of Public Health and Health Services to reflect nationally recognized clinical guidelines and were prepared under the direction of experts in the field of reproductive health. The Centers for Disease Control and Prevention (CDC) provided guidance on clinical and policy issues addressed in the sample specifications and financial support for their development. The specifications were reviewed in draft by officials in state Medicaid agencies and the Health Care Financing Administration (HCFA) and the Health Resources and Services Administration (HRSA) and also by health care providers, consumers, and managed care officials. As a publication of CHSRP, however, the specifications do not represent agency policy, guidance or any other official agency act. Any use of this document is optional for state policymakers. These sample specifications are illustrative. They are designed to function as one of many tools that Purchasers employ to develop and oversee managed care systems for their enrollees. The specifications may be used in negotiating with a managed care Contractor on the range of reproductive health issues that the Purchaser wishes to address. Individual specifications may be added to appropriate sections in a purchasing agreement or a package of specifications may be added to an agreement as a reproductive health appendix or attachment. Because of variations in Purchasers' financing options, policy preferences and legal duties, there is no single correct method for covering and delivering reproductive health services. However, it is possible to identify the critical decision points that Purchasers may face and to suggest approaches to each. The specifications offer illustrative options for purchasing

2 including key issues in coverage, delivery and quality of care. It is anticipated that Purchasers would tailor them to the laws of the state(s) in which the contract is in operation. (Purchasers should consult with the public health agency in a state to ensure consistency with state laws regarding reporting, confidentiality, consent of minors to clinical services, and other matters addressed in state public health and other relevant statutes and regulations.) In the case of Medicaid Purchasers, the specifications have been drafted to be consistent with federal Medicaid law pertaining to reproductive health services and managed care purchasing. A Purchaser may elect to remain silent with respect to a particular matter for which illustrative language has been prepared. In such a case, rules of contract construction would mean that the Purchaser would effectively elect to defer resolution of the particular issue to Contractor discretion. The specifications are accompanied by Commentaries to aid in reading and interpretation. Commentaries reference the clinical practice guidelines cited in the text of specifications and, for certain provisions, summarize the public health or clinical reasons for including a specification. Commentaries specifically for Medicaid Purchasers provide references to federal Medicaid law. The specifications are designed to be used in conjunction with other specialized sample specifications, under development by CHSRP, which relate to reproductive health issues not addressed in detail in this document. Cross-references to the relevant sections of the other specifications are shown in Commentaries as follows: STDSPECS refers to Sample Purchasing Specifications for Services for Sexually Transmitted Diseases; HIV/AIDSSPECS refers to Sample Purchasing Specifications for HIV Infection, AIDS and HIV-Related Conditions; IMMUNIZESPECS refers to Sample Purchasing Specifications:Immunizations; and MEDICAIDSPECS refers to Sample Medicaid Pediatric Purchasing Specifications: A Technical Assistance Document. All the sample specifications are available at ( While MEDICAIDSPECS was drafted specifically for Medicaid Purchasers of services for adolescent (as well as younger) program beneficiaries, other Purchasers of managed care may also wish to consider the clinical and policy issues relating to reproductive health services that are cross-referenced in this document.) All specifications will be hyperlinked to numerous related government and private agency website addresses. The specifications are part of a series of sample purchasing specifications in preparation and posted at CHSRP s website address At the time this draft was prepared, specifications had been posted for pediatric Medicaid Services, immunizations, tuberculosis, HIV/AIDS, sexually transmitted diseases, prevention of lead poisoning, and pediatric dental and oral health care. Other CHSRP specifications under preparation addressed: diabetes; asthma; health care for the homeless; adults with mental illness and addiction disorders; memoranda of understanding between MCOs and public health agencies; data and information; pharmaceuticals and pharmaceutical services;

3 3 The reproductive health and other sample purchasing specifications in the series also may be obtained in diskette form from: Center for Health Services Research and Policy School of Public Health and Health Services The George Washington University Medical Center 2021 K Street N.W. #800 Washington D.C (202) access to health care services; and cultural competence. Support for the specifications projects was provided by CDC, HRSA,the Substance Abuse and Mental Health Administration (SAMHSA), the David and Lucile Packard Foundation, Center on the Future of Children, The Commonwealth Fund, and Glaxo Wellcome Inc.

4 TABLE OF CONTENTS 4 PART 1. REPRODUCTIVE HEALTH BENEFITS 101. In General 102. Scope of Benefit 103. Prevention, Counseling and Education Services 104. Family Planning Services 105. Preconceptional Services 106. Perinatal Services 107. Other Reproductive Health Services 108. Laboratory Services and Other Screening and Diagnostic Procedures 109. Prescription Drugs and Biologicals 110. Guidelines 111. Coverage Determinations 112. Definitions 113. Availability to Purchaser of Certain Documents PART 2. REPRODUCTIVE HEALTH SERVICE DELIVERY AND QUALITY OF CARE 201. Enrollee Access to Health Care Providers 202. Enrollment and Disenrollment 203. Provider Network Requirements 204. Public Health and Other Reporting 205 Quality Measurement and Improvement 206. Confidentiality 207. Information for Enrollees

5 EXPANDED TABLE OF CONTENTS 5 PART 1. REPRODUCTIVE HEALTH BENEFITS 101. In General (a) Contractor Duties 102. Scope of Benefit (a) Reproductive Health Services 103. Prevention, Counseling and Education Services (a) Prevention Services (b) Counseling and Education (c) Delivery of Prevention, Counseling and Education services 104. Family Planning Services (a) Family Planning Services (b) Delivery of Family Planning Services 105. Preconceptional Services (a) Preconceptional Services (b) Delivery of Preconceptional Services 106. Perinatal Services (a) Perinatal Services (b) Delivery of Perinatal Services 107. Other Reproductive Health Services (a) Other Reproductive Health Services (b) Delivery of Other reproductive health Services 108. Laboratory Services and Other Screening and Diagnostic Procedures (a) In General (b) Delivery of Laboratory Services and Other Screening and Diagnostic Procedures 109. Prescription Drugs and Biologicals (a) In General (b) Delivery of Prescription Drugs and Biologicals Guidelines 111. Coverage Determinations (a) Use of Prior Authorization Procedures for Certain Services (b) Determinations of Medical Necessity (c) Prohibited Bases for Denial of Coverage of Reproductive Halth Services (d) Formulary May Not Restrict Contraceptive Choice 112. Definitions 113. Availability to Purchaser of Certain Documents

6 6 PART 2. REPRODUCTIVE HEALTH SERVICE DELIVERY AND QUALITY OF CARE 201. Enrollee Access to Health Care Providers (a) Self-referral for Certain Covered Services (b) Access to Reproductive Health Services by Minor Enrollees (c) Cost-sharing Not Permitted for Certain Services 202. Enrollment and Disenrollment (a) Enrollees Receiving Reproductive Health Services at the Time of Enrollment (b) Enrollment of Infants Born to Enrollees (c) Disenrollment of Enrollees Receiving Reproductive Health Services (d) Transfer of Medical and Related Records (e) Individual Enrollment cards or Other Evidence of Coverage 203. Provider Network Requirements (a) Providers of Reproductive Health Services in Contractor s Provider Network (b) Consultation Agreements with Specialist and Subspecialist Physicians (c) Inclusion of Publicly Supported Providers in Contractor Network (d) Inclusion of Birthing Centers in Contractor Network (e) Selection of Primary Care Pediatric Provider by Pregnant Enrollees (f) Criteria for Provider Credentialing and Compensation (g) Provider and Subcontractor Compliance 204. Public Health and Other Reporting (a) Public Health and Other Reporting 205. Quality Measurement and Improvement (a) Development and Dissemination of Practice Guidelines (b) Focused Quality Review (c) Performance Reporting 206. Confidentiality (a) Maintenance of Confidentiality of Information Relating to Enrollee Reproductive Health Status and Receipt of Reproductive Health Services (b) Omission of Information from Communications Relating to Enrollee Reproductive Health status and Receipt of Reproductive Health services (c) Informing Enrollees Regarding Confidentiality Protections 207. Information for Enrollees

7 In General (a) Contractor Duties -- Contractor shall, for female and male enrollees (including minor enrollees), cover and furnish, or arrange for the furnishing of, reproductive health services enumerated in Part 1 in accordance with: (1) guidelines covering prevention, testing, health counseling and education, family planning, preconceptional care, infertility, other reproductive health and perinatal services that are enumerated in 110 (and any subsequent editions of such guidelines); 2 and (2) coverage determination standards and procedures enumerated in 111 of this Part. [ALTERNATIVE A] 3 (3) in the case of a Medicaid enrollee, reproductive health services covered under this Part shall be furnished as part of the Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit and shall be subject to all standards and requirements which apply to the EPSDT program Scope of Benefit (a) Reproductive Health Services -- Reproductive health services are: (1) services relating to prevention, counseling and education about reproductive health enumerated in 103; (2) family planning services enumerated in 104; (3) preconceptional services enumerated in 105; (4) perinatal services enumerated in 106; 2 Commentary: The clinical practice guidelines that are incorporated into these sample specifications state that they are intended to support clinical decision-making and not to override the clinical judgment of a provider with regard to the appropriate services for an individual patient. 3 Commentary: This alternative is provided for consideration by Medicaid Purchasers. 4 Commentary: Medicaid Purchasers may wish to consider the complete description of the EPSDT benefit at MEDISPECS Part I, 102. (

8 8 (5) other reproductive health services enumerated in 107; (6) laboratory procedures and other screening and diagnostic procedures enumerated in 108; (7) prescription drugs and biologicals enumerated in 109; (8) services related to HIV infection, AIDS and HIV-related conditions (hereinafter HIV/AIDS); 5 and (9) services related to sexually transmitted disease Prevention, Counseling and Education Services 7 (a) Prevention Services -- Prevention services relating to reproductive health are the following items and services delivered in accordance with subsection (c) of this Section: (1) risk assessments, to determine: 8 (A) the presence of one or more reproductive health risk factors as defined in 112; and (B) enrollee intentions with regard to pregnancy; (2) medical and sexual history(ies) and examination(s) which, in the case of female enrollees, shall include breast and gynecological examinations; 5 Commentary: For a comprehensive package of sample specifications relating to HIV/AIDS, Purchasers may wish to consider HIVAIDSSPECS ( This document cross-references specific sections of HIV/AIDSSPECS where both documents address the same or related issues (e.g., prevention and medical mangement of perinatal exposure to HIV infection). 6 Commentary: For a comprehensive package of sample specifications relating to sexually transmitted disease, Purchasers may wish to consider STDSPECS ( This document cross-references specific sections of STDSPECS where both documents address the same or related issues (e.g., self-referral for sexually transmitted disease services). 7 Commentary: Purchasers may wish to consider HIV/AIDS Prevention, Testing, Counseling, Education and Referral Services at HIV/AIDSSPECS 103 and sexually transmitted disease Prevention, Counseling and Education Services at STDSPECS 103. ( 8 Commentary: Medicaid Purchasers may wish to consider EPSDT risk assessment and counseling for adolescent Medicaid enrollees at MEDICAIDSPECS 102(a),(b) (

9 9 (3) laboratory services and other screening and diagnostic procedures enumerated in 108; (4) immunizations; 9 (5) condoms; (6) referrals to: (A) family planning services enumerated in 104; (B) preconceptional services enumerated in 105; (C) perinatal services enumerated in 106; (D) other reproductive health services enumerated in 107; (E) HIV/AIDS services; (F) services for sexually transmitted diseases; (G) acute and chronic care services for cancer and other medical conditions (other than HIV/AIDS or sexually transmitted diseases); (H) smoking cessation services which; (i) in the case that smoking cessation services are covered under this Agreement, are available from: (I) members of Contractor s network; or (II) providers that maintain a contractual affiliation status with Contractor as referral providers, regardless of their network membership status; 10 or 9 Commentary: For applicable guidelines, see 110(d). 10 Commentary: Models for such affiliations could include memoranda of understanding or, in the case of a staffmodel HMO, a limited contract with, for example, a community mental health center for provision of services not available from the HMO s medical staff.

10 10 (ii) in the case that smoking cessation services are not covered under this Agreement, providers in the community to the extent that such providers are available in Contractor s service area; (I) addiction disorder services which: 11 (i) in the case that addiction disorder services are covered under this Agreement, are available from: (I) members of Contractor s network; or (II) providers that maintain a contractual affiliation status with Contractor as referral providers, regardless of their network membership status; 12 or (ii) in the case that addiction disorder services are not covered under this Agreement, providers in the community to the extent that such providers are available in Contractor s service area; (J) mental health services, which: 13 (i) in the case that mental health services are covered under this Agreement, are available from: (I) members of Contractor s network; or (II) providers that maintain a contractual affiliation status with Contractor as referral providers, regardless of their network membership status; or 11 Commentary: As they become available at the CHSRP web site, Medicaid Purchasers may wish to consider the following sample specifications under development at the time the reproductive health specifications were drafted: Optional Specifications: Purchasing Medicaid Managed Care for Children s Behavioral Health: A Technical Assistance Document (forthcoming) and sample specifications relating to mental health and addiction services for adults (forthcoming). 12 Commentary: Models for such affiliations could include memoranda of understanding or, in the case of a staffmodel HMO, a limited contract with, for example, a community mental health center or substance abuse gtreatment center for provision of services not available from the HMO s medical staff. 13 Commentary: Medicaid Purchasers may wish to consider the following sample specifications under development by CHSRP: Optional Specifications: Purchasing Medicaid Managed Care for Children s Behavioral Health: A Technical Assistance Document and sample specifications relating to mental health and addiction services for adults (

11 (ii) in the case that mental health services are not covered under this Agreement, providers in the community to the extent that such providers are available in Contractor s service area; 14 and (K) social, shelter, legal, mental health and other services indicated for sexual abuse or domestic violence; (i) to the extent that such services are available in Contractor s service area; or (ii) in the case that such services are not available in Contractor s service area, referral to local, regional or national hotlines for information about such services outside Contractor s service area. (b) Enrollee Counseling, Information and Education -- Enrollee counseling, information and education services are such services relating to the following topics and delivered in accordance with subsection (c) of this Section: (1) reproductive health risks as defined at 112; (2) in the case of a female enrollee of child-bearing age, breast self-examination; and (3) topics addressed at 104(a)(1)(A) (relating to contraceptive services); 104(a)(2)(A) (relating to tubal ligation and vasectomy services); 105(a)(2) (relating to preconceptional care); 105(a)(3)(B) (relating to genetic testing); 107(a)(1)(A) (relating to voluntary termination of pregnancy; 107(a)(2)(A) (relating to hormone replacement therapy); and 106(a)(2),(12)(D) (relating to perinatal services). 15 (c) Delivery of Prevention, Counseling and Education Services -- In delivering the prevention, counseling and education services covered under this Section, Contractor shall: (1) ensure that services enumerated in this Part are offered and delivered in accordance Commentary: See Commentary Commentary: For sample specifications relating to HIV/AIDS counseling and enrollee education, Purchasers may wish to consider the following, which address promoting risk reduction (including risk of perinatal HIV infection), safe sexual practices and treatment options for HIV infected enrollees at HIV/AIDSSPECS 103(a)(2), (b)(2) and 204(b)(1),(2)(B). For specifications relating to sexually transmitted disease counseling to promote risk reduction and safe sexual practices, Purchasers may wish to consider STDSPECS 103(b)(1),(2). For sample specifications relating to counseling adolescent Medicaid enrollees with regard to reduction of risk of HIV, sexually transmitted disease and unintended pregnancy, Medicaid Purchasers may wish to consider MEDICAIDSPECS 102B(b).(

12 with appropriate clinical guidelines; (2) ensure provision of a risk assessment described in (a)(1) of this subsection for each enrollee of childbearing age (whether or not the enrollee is symptomatic) at the initial encounter by an enrollee with a provider participating in Contractor s provider network (and when appropriate in the opinion of the provider at any subsequent encounter) in connection with: [Alternative A] 17 (A) preventive health assessments for adult and adolescent enrollees; [Alternative B] 18 (A) preventive health assessments for adult and adolescent enrollees which, in the case of adolescent enrollees, shall be periodic and interperiodic Early Diagnostic, Treatment and Screening (EPSDT) assessments ( screens ); (B) gynecological examinations; (C) family planning; (D) sexually transmitted disease; (E) HIV/AIDS; 19 (F) addiction disorder, in the case that addiction disorder services are covered under this Agreement; (G) mental illness, in the case that mental health services are covered under this Agreement; and (H) pregnancy. (3) ensure that each enrollee of childbearing age is offered an appointment for an initial 16 Commentary: For applicable guidelines, see 110(a)-(c) and (f). 17 Commentary: This alternative is provided for consideration by non-medicaid Purchasers. 18 Commentary: This alternative is provided for consideration by Medicaid Purchasers. 19 Commentary: HIV/AIDS means infection with the Human Immunodeficiency Virus, AIDS and conditions associated with HIV infection.

13 risk assessment: (i) within [drafter insert timeline for risk assessment] of the effective date of the individual s enrollment; or (ii) in the case of an enrollee who is pregnant, within [drafter insert timeline for risk assessment] of the effective date of the individual's enrollment; (4) ensure that immunizations are furnished in accordance with appropriate clinical guidelines; 21 (5) ensure that condoms: 22 (A) are available to providers participating in Contractor s network for dispensing in connection with: [Alternative A] 23 (i) preventive health assessments for adult and adolescent enrollees; [Alternative B] 24 (i) preventive health assessments for adult and adolescent enrollees which, in the case of adolescent enrollees, shall be and interperiodic Early Diagnostic, Treatment and Screening (EPSDT) examinations ( screens ); (ii) gynecological examinations; 20 Commentary: While guidelines do not specifically address the number of days or weeks within which an enrollee should be seen for reproductive health services, early access to clinical services for reproductive health services and especially perinatal care is strongly recommended by experts in reproductive health. Early access is considered to minimize the risks of unintended pregnancy, poor pregnancy outcomes resulting from such factors as maternal infection with HIV or a sexually transmitted organism, and other desired outcomes. See guidelines at 110. Medicaid Purchasers may wish to review timelines for first appointments for new enrollees and for pregnant enrollees in certain Medicaid managed care contract documents in Rosenbaum, S, et al. Negotiating the New Health System: A Nationwide Study of Medicaid Managed Care Contracts. 3rd ed., Table 3.7. (Center for Health Services Research and Policy, 1999) 21 Commentary: For applicable guidelines, see 110(d). For sample specifications relating to immunizations, Purchasers may wish to consider IMMUNIZESPECS.003(b), (c) ( 22 Commentary: Purchasers may also wish to consider sample specifications relating to dispensing condoms at HIV/AIDSSPECS 204(b)(3) and at STDSPECS 103(c)(2) ( 23 Commentary: This alternative is provided for consideration by non-medicaid Purchasers. 24 Commentary: This alternative is provided for consideration by Medicaid Purchasers.

14 (iii) family planning services; 14 (iv) sexually transmitted disease services; (v) HIV/AIDS services; (vi) addiction disorder services, in the case that such services are covered under the Agreement; (vii) mental illness services, provided that such services are covered under the Agreement; and (viii) perinatal services; and (B) are dispensed with, when appropriate, provider instruction on how to use a condom; (6) ensure that referrals described in subsection (a) of this Section are furnished when indicated by a risk assessment, medical or sexual history or laboratory service or other screening or diagnostic procedure enumerated in this Section or elsewhere in this Part; (7) in the case of an enrollee in whom referral to addiction disorder services is indicated, referral shall: 25 (A) be provided [drafter insert timeline for referral] as permitted by the availability of addiction disorder services from network, referral or communitybased providers, as described in subsection (a)(6)(i) of this Section; 25 Commentary: Experts in public health and reproductive health consider early access to services for addiction disorder and for mental illness to be especially important in interrupting the progression of HIV and or sexually transmitted disease and in preventing or minimizing poor pregnancy outcomes associated with maternal use of moodaltering drugs, alcohol or tobacco and with maternal mental illness. For that reason, the specifications address referrals and assistance in scheduling appointments for services for addiction disorder and for mental illness, even when such services are not covered under an Agreement that includes reproductive health services. See guidelines at 110. While guidelines do not specifically address the time within which enrollees with these conditions should be seen for treatment, Medicaid Purchasers may wish to review timelines for access to substance abuse and mental health services in certain Medicaid managed care contract documents in Rosenbaum, S, et al. Negotiating the New Health System: A Nationwide Study of Medicaid Managed Care Contracts. 3rd ed., Table 3.7. (Center for Health Services Research and Policy, 1999) Purchasers also may wish to consider sample specifications that address referrals of enrollees either to mental health and addiction disorder providers within a Contractor s network or, if such services are not covered services under the Purchasing Agreement, to appropriate and available community providers of such services who are not network providers, at HIV/AIDSSPECS 103(c) and, for an HIV-infected woman who is pregnant and has an addiction disorder, HIV/AIDSSPECS 204(d)(6). (

15 15 (B) include assistance in scheduling an appointment with available providers of addiction disorder services, whether or not such providers are network, referral or community-based providers; and (C) be made, when appropriate because of the age or condition of the enrollee, to providers of addiction disorder services who are trained and experienced in furnishing services for adolescents, women who are pregnant and individuals diagnosed with both addiction disorder and mental illness, provided that such providers are available as network, referral or community-based providers; (8) in the case of an enrollee for whom referral to mental illness services is indicated, referral shall: 26 (A) be provided [drafter insert timeline for referral] as permitted by the availability of mental health services from network, referral or community-based providers, as described in subsection (a)(6)(j) of this Section; (B) include assistance in scheduling an appointment with available providers of mental health providers, whether or not such providers are network, referral or community-based providers; (C) be made, when appropriate because of the age or condition of the enrollee, to providers of mental health services who are trained and experienced in furnishing services for adolescents, women who are pregnant and individuals diagnosed with both mental illness and addiction disorder, provided that such providers are available as network, referral or community-based providers; (9) in the case of an enrollee at risk of or subject to sexual abuse or domestic violence, referral 27 shall: (A) be provided on an emergency basis as permitted by the availability in Contractor s service area of services and programs identified in subparagraph (B); and (B) include assistance in scheduling an appointment or other assistance with social, shelter, legal, mental health and other services for sexual abuse or domestic 26 Commentary: See preceding Commentary. 27 Commentary: Experts in reproductive health recommend such referrals, even though non-medical services for victims of sexual abuse or violence would not be covered services under this Agreement, because of the substantial risks to the health of the victims of such abuse or violence. These risks include: transmission of sexually transmitted disease or HIV, unintended pregnancy, injuries and death.

16 violence that are available in Contractor s service area; or 16 (C) in the case that there are no services in Contractor s service area for individuals who are subject to sexual abuse or domestic violence, include telephone numbers and other available information about local, regional or national telephone hot line services for such individuals Family Planning Services (a) Family Planning Services Services relating to family planning are the following items and services delivered in accordance with subsection (c) of this Section: (1) contraceptive services which shall include: (A) enrollee counseling, instruction and written information with regard to contraceptive methods, which shall include; (i) initial counseling, instruction and written information; and (ii) followup counseling with the provider prescribing contraceptives for purposes of monitoring the acceptability of the contraceptive method chosen by the enrollee; (B) a medical and sexual patient history and examination for purposes of prescribing contraceptive interventions; (C) prescription drugs, devices and supplies enumerated in 109; (D) medical and surgical procedures relating to contraception including: (i) injection of contraceptive drugs; 28 Commentary: Medicaid Purchasers may wish to consider sample specifications for family planning services for Medicaid enrollees who are adolescents at MEDICAIDSPECS 101(g) and 104 ( Under federal Medicaid law, family planning services are a mandatory benefit that state Medicaid programs must offer to categorically eligible beneficiaries including sexually active minors who desire such services. 42 U.S.C. 1396d(a)(4)(c). Federal Medicaid law does not provide a definition of family planning services; however, many Medicaid managed care contracts define this service broadly to include contraceptive services, screening and treatment for sexually transmitted diseases and HIV infection and other services relating to individual choices with regard to reproduction.

17 (ii) insertion and removal of contraceptive devices; 17 (iii) insertion and removal of implantable contraceptives; and (iv) diagnosis and treatment of medical complications resulting from the use of contraceptives. (2) tubal ligation and vasectomy services which shall include: 29 [ALTERNATIVE A] 30 (A) enrollee counseling and written information; (B) medical and surgical services and procedures for tubal ligation and vasectomy, which shall include: (i) physician services; (ii) inpatient services; (iii) outpatient services; (iv) prescription drugs enumerated in 109; (v) whole blood and blood products; and (vi) anesthesia services; except that in the case of a Medicaid enrollee, tubal ligation or vasectomy is not a covered service if the enrollee is: (i) under age twenty-one (21); 29 Commentary: Federal law permits the use of federal matching funds to finance voluntary sterilization as a family planning service, if certain conditions are met. 42 C.F.R et seq. 30 Commentary Federal Medicaid law prohibits the use of federal funds for sterilization of Medicaid beneficiaries under age 21; of beneficiaries who are involuntarily institutionalized under criminal or civil law; of beneficiaries who are voluntarily committed to mental health treatment institutions; or of beneficiaries who have been declared mentally incompetent. Federal law also prohibits the use of federal funds for hysterectomies that are performed for the purpose (or primary purpose) of sterilization except in limited circumstances (e.g., medical emergency). Otherwise, federal funds may be used for sterilization procedures (and hysterectomies) if informed consent, physician certification and other requirements are met. 42 C.F.R State laws and regulations may establish similar restrictions on access to these services (whether or not for Medicaid beneficiaries).

18 18 (ii) involuntarily or voluntarily institutionalized; or (iii) declared to be mentally incompetent. (3) infertility services which shall include: 31,32 (A) laboratory services and other screening and diagnostic procedures enumerated in 108; and (B) pre- and post-test counseling about such services and procedures and their results. (b) Delivery of Family Planning Services -- In delivering the family planning services covered under 104(a)(1) (relating to contraceptive services), 104(a)(2) (relating to tubal ligation and vasectomy) and 104(a)(3) (relating to infertility services), Contractor shall: (1) ensure that enrollee counseling, instruction and written information about family planning services: (A) is non-directive with regard to an enrollee s choice of contraceptive method, tubal ligation or vasectomy; (B) is provided on an individualized basis to enrollees; (C) includes information about the benefits, potential risks, methods and effectiveness of: (i) contraceptive methods, including abstinence; natural family planning; contraceptive drugs, devices and procedures; and (ii) emergency contraceptive services following unprotected intercourse, which information shall include availability of emergency contraceptive services; (D) in the case of an enrollee who is pregnant, addresses: 31 Commentary: At state option, infertility services may be covered for Medicaid beneficiaries as a family planning service. HCFA State Medicaid Manual, 4270B. 32 Commentary: For applicable guidelines, see 110(f).

19 (i) planning for future pregnancies and contraception; and 19 (ii) risks of poor birth outcomes associated with smoking; (F) in the case of an enrollee who is a woman age 35 or older, risks associated with smoking and use of oral contraceptives; (2) in the case of an enrollee (including a sexually active minor enrollee) who uses contraceptive services: (A) deliver such services in accordance with the covered method chosen by the individual enrollee unless contraindicated for that enrollee; and 33 (B) ensure that an enrollee is not required to undergo a gynecological examination before an oral contraceptive may be prescribed or dispensed; 34 (3) ensure that an enrollee who requests contraceptive services is offered an appointment for such services to occur with in ten (10) working days of the request, except that: (A) in the case of an enrollee who requests emergency contraceptive services, provide drugs, devices and procedures indicated for this purpose shall be provided within seventy-two (72) hours of unprotected intercourse as reported by the enrollee; 35 (4) in the case of an enrollee who is pregnant, ensure that counseling about family planning is offered during the third trimester of the pregnancy and that contraceptive services are provided post partum at the request of the enrollee; (5) ensure that enrollee counseling and written information about tubal ligation and vasectomy includes information about the benefits, potential risks and effectiveness (including comparative risks and effectiveness) of the two procedures; (6) ensure that providers and subcontractors who provide tubal ligation and vasectomy 33 Commentary: Under federal guidance for administration of Medicaid, a beneficiary ust be free to choose the method of family planning that she or he uses. 34 Commentary: 35 Commentary: At the time these specifications were drafted, multiple regimens of oral contraceptives and the use of certain contraceptive devices had been reported to be effective in postcoital contraception if initiated within 72 hours of unprotected intercourse. Prescription Drug Products: Certain Combined Oral Contraceptives for Use as Postcoital Emergency Contraception (62 Fed. Reg (1997). (Department of Health and Human Services, Food and Drug Administration Notice (Docket no. 96N-0492)). As with all prescription drugs, emergency contraceptives may be dispensed only in accordance with the law of the state in which the dispensing occurs.

20 services comply with all federal and state laws and regulations relating specifically to sterilization; and 20 (7) offer infertility services to enrollees who identify themselves as intending to become pregnant and who are infertile as defined in Preconceptional Services (a) Preconceptional Services -- Preconceptional services are the following items and services delivered in accordance with subsection (b) of this Section: (1) risk assessment described in 103(a)(1); (2) enrollee counseling and education that addresses: (A) nutrition counseling, including the benefits of preconceptional and prenatal use of folic acid; (B) reproductive health risk factors as defined in 112. (C) risks to the fetus and infant during pregnancy: (D) childbirth education, which shall be provided as classes for the enrollee and enrollee s spouse or partner; 36 (E) breastfeeding; (F) counseling and education in parenting skills for the enrollee and enrollee s spouse and partner; 37 (G) counseling described in ( 104(a)(1)(A) (relating to contraceptive services); and (3) in the case of an enrollee for whom a risk assessment indicates a risk of genetic 36 Commentary: Experts in reproductive health recommend that both a pregnant woman s spouse or other partner attend childbirth education classes with her. This provision assumes that the spouse or partner is also an enrollee in Contractor s plan. In the case of Medicaid Purchasers, childbirth education may be covered as anticipatory guidance for enrollees eligible for EPSDT services. 42 U.S.C. 1396d(r)(1)(A)(v) 37 Commentary: Experts in child health recommend parenting skills classes for both parents. See preceding commentary for Medicaid coverage option.

21 disorder(s) in a child born to the enrollee: 21 (A) laboratory tests and other screening and diagnostic procedures enumerated in 108(a); and (B) enrollee counseling about such tests and procedures and results; before and after these interventions. (b) Delivery of Preconceptional Services -- In delivering the preconceptional services covered in this Section, Contractor shall: (1) offer and provide preconceptional services to enrollees who identify themselves as intending to become pregnant; (2) ensure that enrollee counseling and education addresses: (A) the benefits of preconceptional and prenatal use of folic acid, as part of nutrition counseling; (B) reproductive health risks as defined in 112; and (C) the benefits, methods and contraindications for breastfeeding, in accordance with appropriate guidelines; Perinatal Services (a) Perinatal Services -- Perinatal services are the following items and services furnished during pregnancy, delivery and postpartum in accordance with subsection (b) of this Section: (1) a medical and sexual history, examination and assessment to determine risk of poor pregnancy outcome as defined in 112; (2) counseling and education described in 105(a)(2)(C),(E) (relating to childbirth education and parenting skills education and training); 105(a)(3)(B) (relating to genetic tests and procedures); and reproductive health risk factors as defined in Commentary: For applicable guidelines, see 110(a).

22 (3) physician services which shall include: 22 (A) routine and acute care visits; (B) in the case of an enrollee determined to be at risk for a poor pregnancy outcome, clinical management by specialist and subspecialist physicians described in 203(a)(4),(5) when indicated; (C) in the case of an enrollee s newborn infant: (i) physical examination; (ii) laboratory services and other screening and diagnostic procedures described in 108; (iii) prophylactic treatments required by state law or regulation; and (iv) in the case of a newborn, prophylactic treatment as indicated for metabolic disorders, perinatal exposure to maternal infection or other conditions for which intervention beginning during delivery or immediately upon birth is indicated; 39,40 (4) nurse-midwife services 41 which shall include the services enumerated in paragraph (3) of this subsection to the extent permitted under [drafter insert applicable state law]; (5) birthing center services; (6) inpatient services which shall include: (A) medically necessary inpatient services for pregnant and newborn enrollees; (B) newborn nursery services; and 39 Commentary: Purchasers may wish to consider sample specifications addressing prevention of perinatallytransmitted HIV infection at HIVAIDSSPECS 103(a)(4)(A), (C) and medical management of HIV in a pregnant woman at HIV/AIDSSPECS 104 ( 40 Commentary: Purchasers may wish to consider sample specifications addressing the time within which a primary care provider appointment must be provided for newborns receiving prophylactic drug therapies to prevent perinatal transmission of HIV at HIVAIDSSPECS 204(d)(7) ( 41 Commentary: Medicaid Purchasers may wish to consider coverage of nurse-midwife services for Medicaid enrollees who are adolescents at MEDICAIDSPECS 101(j) (

23 (C) medically necessary neonatal intensive care services. 23 (7) outpatient services; (8) laboratory services and other screening and diagnostic procedures enumerated in 108; (9) prescription drugs enumerated in 109; (10) whole blood and blood products; (11) anesthesia services; (12) immunizations for the pregnant enrollee and enrollee's newborn in accordance with appropriate clinical guidelines; 42 (13) nutrition services when indicated for pregnant and breastfeeding enrollees and their newborns, which shall include: (A) nutritional assessment; (B) laboratory services and other screening and diagnostic procedures enumerated in 108; (C) dietary counseling and education described in 105(a)(2) (relating to preconceptional services); and (D) in the case of an enrollee who is pregnant or breastfeeding or a newborn infant and who is eligible for the program, referral to a Women, Infants and Children (WIC) supplemental food program; 43 (14) breastfeeding services which shall include enrollee education and training; (15) in the case of a pregnant enrollee at risk of a poor pregnancy outcome as defined at 112: 42 Commentary: For applicable guidelines, see 110(d). For sample specifications relating to immunization, Purchasers may wish to consider IMMUNIZESPECS.003(b)( 43 Commentary: WIC eligibility is based on an individual's income and nutritional status. Medicaid Purchasers may also wish to consider sample specifications addressing WIC services at MEDICAIDSPECS 005 (

24 (A) pregnancy-related case management; 44 and 24 (B) prenatal and post-partum home nursing visits, when indicated; (16) in the case of a newborn infant for whom such referral is indicated, referral to: (A) early intervention programs under the federal Individuals with Disabilities Education Act (IDEA); 45 and/or (B) programs for children with special health care needs under Title V of the Social Security Act; 46 (17) family planning services enumerated in 104(a). (b) Delivery of Perinatal Services -- In delivering the perinatal services covered in this Section, Contractor shall ensure that: (1) perinatal services described in this Section are delivered in accordance with appropriate clinical guidelines; 47 (2) risk assessments are repeated during the pregnancy when indicated; (3) medical examinations are provided; (A) at the pregnant enrollee s initial encounter with the provider delivering perinatal services to her; and (B) periodically during the pregnancy and postpartum. (4) enrollee counseling and education relating to breastfeeding is offered to enrollees before delivery and delivered to enrollees electing to breast feed following delivery; and 44 Commentary: Purchasers may also wish to consider sample specifications addressing case management services for individuals with HIV/AIDS at HIV/AIDSSPECS 108(a) ( 45 Commentary: Purchasers may wish to consider sample specifications addressing arrangements for referrals to Early Intervention Programs at MEDICAIDSPECS 706 ( These sample specifications may be of interest to non-medicaid as well as Medicaid Purchasers because eligibility for early intervention services is based on diagnosis of developmental delay or risk of developmental delay in newborns and children to age three. 46 Commentary: Purchasers may wish to consider sample specifications addressing arrangement for referrals to Title V programs (for children with special health care needs) at MEDICAIDSPECS 703(c) ( These sample specifications may be of interest to non-medicaid as well as Medicaid Purchasers because eligibility for Title V services is based on diagnosis of special health care needs. 47 Commentary: For applicable guidelines, see 110(a).

25 25 (5) parenting skills counseling and education: 48 (A) are offered and provided during pregnancy and following delivery; and (B) are provided as classes, as a component of post-partum home visiting or by other means. (6) medical nutrition services described in this Section are furnished by a registered dietitian or other certified or licensed nutrition professional; (7) the first postpartum visits for an enrollee and enrollee s newborn are scheduled to occur within six (6) weeks of birth; 49 (8) referral to a WIC program, an IDEA early intervention program or a Title V program for children with special health care needs shall include, at the request of such programs and with the written authorization of the newborn enrollee s parent or caregiver, transfer relevant medical records and results of any diagnostic tests or procedures that indicate such a referral Other Reproductive Health Services (a) Other Reproductive Health Services -- Other reproductive health services are the following items and services delivered in accordance with subsection (b) of this Section: (1) services relating to voluntary termination of pregnancy, which shall include: 50 (A) enrollee counseling and written information about: (i) the risks and benefits of voluntary termination of pregnancy; and 48 Commentary: Federal financial participation may be available for parenting skills counseling and education that is provided to a child s parent(s) or caretaker(s) as part of EPSDT anticipatory guidance (Section 1905(r) of the Social Security Act), nurse midwife, certified pediatric or family nurse practitioner services (Section 1905(a)(17) of the Social Security Act; or home health services (Section 1905(a)(7) of the Social Security Act.) 49 Commentary: Purchasers may wish to consider specifications addressing appointments with primary care providers following discharge from a hospital or birthing center at HIVSPECS 204(d)(7) ( 50 Commentary: Under Federal Medicaid law, federal matching funds (federal financial participation) may be used to finance a voluntary termination of pregnancy (an abortion) only if continuing a pregnancy would endanger the life of the mother, as certified by her physician. Documentation and certain other requirements also apply to this procedure. 42 U.S.C et seq. However, a state may elect to use state funds only to finance abortions for other indications for Medicaid beneficiaries.

26 (ii) in the case of an enrollee whose pregnancy is unintended, prevention of future unintended pregnancies; (B) medical and surgical services and procedures for purposes of voluntary termination of pregnancy, which shall include: 51 (i) physician services; (ii) inpatient services; (iii) outpatient services; (iv) prescription drugs enumerated in 109; (v) whole blood and blood products; and (vi) anesthesia services. (2) services relating to hormone replacement therapy which shall include the following: 52 (A) enrollee counseling and written information about the benefits and potential risks of such therapy; and (B) prescription drugs enumerated in 109. (3) services relating to the clinical management of HIV/AIDS; 53 (4) services relating to the clinical management of sexually transmitted disease. 54 (b) Delivery of Other Reproductive Health Services -- In delivering the other reproductive health services covered in this Section, Contractor shall: Commentary: For applicable guidelines, see 110(f). 52 Commentary: Drug therapies that are therapeutically equivalent to hormone replacement therapy include nonhormonal medications that are indicated for relief of menopausal symptoms and for osteoporosis associated with menopause. 53 Commentary: Purchasers may wish to consider sample specifications addressing medical management of HIV/AIDS at HIV/AIDSSPECS 104 ( 54 Commentary: Purchasers may wish to consider sample specifications addressing medical management of sexually transmitted disease at STDSPECS 104 (