Medicaid Contract Purchasing Specifications

Part 1. HIV/AIDS Benefits

Table of Contents

§101. In General
§102. Scope of Benefit
§103. Prevention, Testing, Counseling, Education, and Referral Services
§104. Medical Management Services
§105. Laboratory Services
§106. Prescribed Drugs and Biologicals
§107. Home and Community-based Services
§108. Case Management and Adherence Services
§109. Guidelines
§110. Coverage Determinations and Utilization Management
§111. Consumer Protections
§112. Definitions
§113. Information for Purchaser

Note: As used throughout this document, the term "HIV/AIDS" shall mean "HIV, AIDS, and HIV-related conditions (e.g., opportunistic infections)."

Note on symbols that appear alongside sample purchasing specifications: In order to provide additional guidance to Medicaid purchasers, these sample purchasing specifications contain applicable symbols that are designed to identify the basis (or bases) for the sample specification. The meaning of each symbol is as follows:

L: The provision is based in whole or in part on federal Medicaid law, as articulated in the Medicaid statute, a federal regulation, or other written HCFA policy such as an Action Transmittal, State Medicaid Directors Letter, Regional Office Memorandum, or other formal HCFA transmittal. Just because an item is marked "L" does not mean that the service or activity is mandatory either for state agencies or for managed care contractors. Where the legal basis in question identifies a required service or activity, a footnote will so indicate. Law-related provisions that relate to optional services and activities also will be identified in a footnote. "L" is also used to indicate provisions that are based on and may incorporate non-Medicaid laws such as those relating to confidentiality of patient information.

G: The provision is based on whole or in part on formal guidelines issued by, or under the auspices of, a government agency (e.g., Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents), a professional society, or a formally convened, impartial deliberative body (e.g., the Institute of Medicine)..

K: The provision is based in whole or in part on the best judgment and opinions of persons knowledgeable in a particular area of health care practice, health care delivery, or health services organization and management. This symbol is used to signify sample specifications that do not reflect a formal legal policy or that are not part of a formal practice guideline but that are recommended for consideration because they reflect good practice in the opinion of experts.

The following section sets forth the general duties of Contractors in the case of HIV/AIDS for Purchasers who desire to articulate general service duties in this specific area.

§101. In General

^G (a) Contractor duties - Contractor shall, for each enrollee, cover and furnish, or arrange for the furnishing of, HIV/AIDS services enumerated in this Part in accordance with:

^G (1) Guidelines covering prevention, testing, counseling, medical management, health education, and health care coverage that are enumerated in §109 (or any subsequent editions of such Guidelines); and

^K(2) the coverage determination standards and procedures enumerated in this Part.

The following section sets forth illustrative language addressing the overall range of benefits that have been identified as both relevant and necessary by experts in the field and that Purchasers may wish to consider for inclusion in their Agreements.

§102. Scope of Benefit

(a) HIV/AIDS services¹, ² - HIV/AIDS services are:

^{L, G} (1) services enumerated in §103 (relating to prevention, testing, counseling, education, and referral);

^{L, G, K} (2) services enumerated in §104 (relating to medical management);

^{L, G, K} (3) laboratory services enumerated in §105;

^{L, G, K} (4) prescribed drugs and biologicals enumerated in §106;

^L,K (5) home and community-based services enumerated in §107; and

^{L,G, K} (6) case management and adherence services enumerated in §108.

The following section provides an illustrative enumeration of services that experts consider relevant and necessary to HIV prevention, testing, counseling, education and referral.

§103. Prevention, Testing, Counseling, Education, and Referral Services

^L,G (a) Prevention services - Services relating to prevention of HIV are the following items and services:³

^{L, G} (1) risk assessment to determine the presence of risk factors for HIV as defined in §112;⁴

^{L, G} (2) education concerning HIV and HIV risk reduction;⁵

^{L, G} (3) testing and counseling as defined in subsection (b) of this section; ⁶

^{L, G} (4) prescribed drugs:

^G (A) to prevent transmission in the case of perinatal exposure;⁷

^G (B) for occupational exposure to HIV⁸; and

^G (C) for exposed infants beginning at birth;⁹

^{L, G} (5) family planning services and supplies¹⁰; and

^G (6) referral services described in subsection (c) of this section.

^L,G(b) Testing and counseling services - Testing and counseling services are the following services:¹¹

^{L, G} (1) laboratory services described in §105 to determine the presence of HIV/AIDS, as set forth in applicable guidelines enumerated in §109;

^{L, G} (2) counseling services¹², consisting of:

^G (A) counseling at the time of testing and at the time of receipt of test results regarding HIV/AIDS and risk reduction;

^G (B) individualized, multi-session HIV risk-reduction counseling to assist an enrollee initiate or sustain behaviors or practices that eliminate or reduce the risk of acquiring or transmitting HIV;

^G (C) counseling HIV-infected enrollees regarding notifying sex and needle-sharing partners of the risk of infection and the need to seek counseling and testing services;

^G (D) counseling regarding decreasing the risk of perinatal transmission; and

^G (E) counseling HIV-infected enrollees regarding treatment options.

^G (c) Referral Services - Referral services are referrals:

(1) to providers of substance abuse and mental illness treatment and prevention services that are either:

(A) members of Contractor's provider network; or

(B) maintain a contractual affiliation status with Contractor as referral providers, regardless of their network membership status;¹³

(2) to appropriate and available sources of care in the community for treatment in the case of substance abuse and mental health services that are not covered under this Agreement; and

(3) of HIV-infected enrollees to partner services programs if offered by the public health agency in Contractor's service area.

The following section sets forth the range of medical management services for persons with HIV/AIDS that have been identified by experts and that Purchasers may wish to consider for inclusion.

§104. Medical Management Services

^{L,G, K} (a) Medical management services - Services relating to the medical management of HIV/AIDS are:¹⁴

^L (1) services of medical and health professionals;

^L (2) inpatient and outpatient hospital care including hospital emergency room services;

^L (3) federally qualified health center services and other ambulatory services offered by federally qualified health centers;¹⁵

^L (4) services of nursing facilities and rehabilitation institutions;

^L (5) laboratory services enumerated in §105;

^L (6) prescribed drugs and biologicals in accordance with §106;

^L (7) FDA approved vitamin supplements;

^L,G (8) vaccines enumerated in guidelines set forth in §109(j) to prevent opportunistic infections as well as other vaccines recommended by the Advisory Committee on Immunization Practices under guidelines set forth in §109(k);

^L (9) home and community-based services enumerated in §107;

^L (10) case management services enumerated in §108(a);

^G (11) adherence services enumerated in §108(b);

^L (12) medical nutrition services;

^K (13) services and benefits that are covered under this Agreement, when furnished as part of a clinical trial relating to HIV/AIDS;¹⁶

(14) services for the treatment of mental illness and addiction disorders (reserved);

^L (15) hospice and palliative services;

^L (16) durable medical equipment;

^L (17) home health care and private duty nursing care;

^L (18) preventive, restorative and emergency dental care;

^L (19) vision care; ¹⁷

^L (20) hearing care, including hearing aids and devices to aid hearing;

^L (21) intravenous and aerosolized therapy;

^{L, G} (22) individualized counseling services described in §103(b);

^L (23) habilitative and rehabilitative services, including occupational, speech, and physical therapy;

^L (24) medical devices for the administration of therapies; and

^L (25) other medical, remedial, and palliative care permitted under state law.¹⁸

The following section identifies laboratory testing services that have been identified by experts as relevant and necessary for the diagnosis, treatment and management of HIV/AIDS

§105. Laboratory Services

^L,G,K (a) Covered services - The following laboratory services for the testing, diagnosis and medical management of HIV/AIDS covered under this Agreement are¹⁹:

^L (1) tests to:

^G (A) determine the presence of HIV, and

^G (B) monitor the progression of HIV/AIDS and the effectiveness of medical management in accordance with the guidelines enumerated in §109; and

^{G, K} (2) Such other laboratory tests deemed appropriate under the guidelines enumerated in §109 or in the opinion of experienced HIV providers, as defined in §112.

The following section provides illustrative language for coverage of prescribed drugs and biologicals identified by experts as necessary for the treatment and management of HIV/AIDS.

§106. Prescribed Drugs and Biologicals

^L (a) In general ²⁰,²¹ - A prescribed drug and biological is covered under this Agreement regardless of whether Contractor covers the drug for members enrolled by other Purchasers if the drug or biological is one that is:

(1) approved by the Food and Drug Administration (FDA); and

(2) prescribed:

(A) for the indication for which it is approved by the FDA; or

(B) for an indication for which it is listed in one of the following compendia:

(i) American Hospital Formulary Service Drug Information;

(ii) United States Pharmacopeia-Drug Information;

(iii) American Medical Association Drug Evaluations; or

(iv) the DRUGDEX Information System.

^K (b) Additional coverage - Drugs not described under subsection (a)(2)(A) or (B) will be considered covered under this Agreement if certified as medically necessary by an individual who conducts utilization review and who is an experienced HIV provider, as defined in §112.

^{G, K} (c) Substitution prohibited -

^{G, K} (1) Contractor shall ensure that drugs prescribed under this section are dispensed as prescribed unless the prescribing physician expressly authorizes modification of the prescription.

^K (2) Notwithstanding subparagraph (1) of this subsection, Contractor may substitute generic drugs where available.

The following section sets forth illustrative language enumerating home and community-based services identified as relevant and necessary by persons with expertise in the care and management of HIV/AIDS.

§107. Home and Community-based Services

^L (a) Home and community-based services²² - Home and community-based services are the following services furnished to an enrollee in the enrollee's home or in a community setting:²³

(1) personal care services;²⁴

(2) homemaker/home health aide services;²⁵

(3) respite care for the enrollee's partner or family caretaker; and²⁶

(4) transportation necessary to enable an enrollee to obtain prevention or medical management services.²⁷

The following section provides illustrative language relating to case management and adherence services, which have been identified by experts as relevant and necessary to the proper care and management of HIV/AIDS.

§108. Case Management and Adherence Services

^L,G,K (a) Case management services²⁸-- Case management services for enrollees with HIV/AIDS, or perinatally exposed infants, are the following items and services:²⁹

^K (1) an initial and periodic³⁰ assessment of an enrollee's medical, prevention, social, substance abuse, mental health, transportation, housing, and other needs conducted on a face-to-face basis by a case manager in consultation with the enrollee's primary care physician and other providers involved in the care of the enrollee and in consultation with the enrollee or enrollee's representative;

^K (2) development and maintenance of a written case management plan for the enrollee based on the assessment under paragraph (1) that is made available to the enrollee and any treating or consulting provider;

^K (3) arranging necessary referrals;

^L (4) assistance to an enrollee in gaining timely access to necessary medical, social, and preventive health services regardless of coverage under this Agreement;

^K (5) assistance to an enrollee in applying for federal, state, or local benefits or assistance for needed services not covered under this Agreement;

^K (6) assistance to an enrollee in initiating and sustaining practices that prevent the transmission of HIV; and

^G (7) assistance to family members involved in the care of an individual with HIV/AIDS.³¹

^G (b) Adherence services³² - Adherence services for enrollees with HIV/AIDS are:

(1) monitoring enrollee adherence to a prescribed course of treatment; and

(2) counseling an enrollee about adherence to a prescribed treatment, and activities that assist an enrollee initiate and sustain practices that promote adherence to a course of treatment.³³

^G§109. Guidelines³⁴

(a) U. S. Preventive Services Task Force. Guide to Clinical Preventive Services, 2d ed. (Virginia: International Medical Publishing, 1996.³⁵

(b) Centers for Disease Control and Prevention. HIV Counseling, Testing, and Referral Standards and Guidelines. (Atlanta, Georgia, May 1994).³⁶

(c) Centers for Disease Control and Prevention. U.S. Public Health Service Recommendations for Human Immunodeficiency Virus Counseling and Voluntary Testing for Pregnant Women. MMWR 1995;44(RR-7): 1-14. ³⁷

(d) Centers for Disease Control and Prevention. HIV Prevention Case Management: Guidance. Atlanta, Georgia. September 1997.³⁸

(e) Centers for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), National Institute on Drug Abuse (NIDA), Substance Abuse and Mental Health Services Administration (SAMSHA). HIV Prevention Bulletin: Medical Advice for Persons who Inject Illicit Drugs, May 9, 1997. ³⁹

(f) Centers for Disease Control and Prevention. Public Health Service Task Force Recommendations for the Use of Antiretroviral Drugs in Pregnant Women Infected with HIV-1 for Maternal Health and for Reducing Perinatal HIV-1 Transmission in the United States. MMWR 1998:47 (RR-2).⁴⁰

(g) Centers for Disease Control and Prevention. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. MMWR 1998; 47 (RR-4).⁴¹

(h) Centers for Disease Control and Prevention. Public Health Service Guidelines for the Management of Health-Care Worker Exposures to HIV and Recommendations for Post-Exposure Prophylaxis. MMWR 1998; 47 (RR-7).⁴²

(i) Centers for Disease Control and Prevention. Report of the NIH Panel to Define Principles of Therapy of HIV Infection and Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents. MMWR 1998;47 (RR-5).⁴³

(j) Centers for Disease Control and Prevention. 1999 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with Human Immunodeficiency Virus. MMWR 1999;48 (RR-10).⁴⁴

(k) Centers for Disease Control and Prevention. Recommendations of the Advisory Committee on Immunization Practices (ACIP): Use of Vaccines and Immune Globulins in Persons with Altered Immunocompetence MMWR 1993; 42 (RR-4)⁴⁵

(l) Centers for Disease Control and Prevention. Prevention and Treatment of Tuberculosis Among Patients Infected with Human Immunodeficiency Virus: Principles of Therapy and Revised Recommendations, MMWR 1998; 47 (RR-20).⁴⁶

(m) Centers for Disease Control and Prevention. HIV Partner Counseling and Referral Services: Guidance. Atlanta, Georgia. December 1998.⁴⁷

(n) Centers for Disease Control and Prevention, 1993 Revised Classification System for HIV Infection and Expanded Surveillance Case Definitions for AIDS Among Adolescents and Adults MMWR 1992; 41 (RR-17)⁴⁸

The following section sets forth illustrative language regarding coverage decision-making in the case of persons with HIV/AIDS, which Purchasers may wish to include in whole or in part in their Agreements.

§110. Coverage Determinations and Utilization Management

^K (a) Medical necessity of services for prevention, testing, counseling, referral and medical management of HIV/AIDS - In making coverage determinations under this Part, Contractor shall utilize medical and health professionals with training and expertise in the prevention and medical management of HIV/AIDS and shall make determinations in a manner that is consistent with the requirements of this section.

^K (b) Determinations of medical necessity

(1) Basic rule -- In determining whether an item or service covered under this Agreement will be covered as medically necessary for the prevention or medical management of HIV/AIDS, Contractor shall base such determinations on the guidelines enumerated in §109, using personnel who have expertise in the prevention, and medical management of HIV/AIDS; and

(2) Determinations - In the case of coverage determinations involving conditions and procedures that are not addressed in the guidelines enumerated in §109, Contractor shall rely on the following evidence:

(A) the enrollee's health status and health-related behaviors;⁴⁹

(B) clinical evidence of HIV/AIDS;

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

(D) the opinion of any medical or health professional responsible for the care and management of the enrollee;

(E) findings from clinical drug trials or from studies published in journals which have been reviewed by relevant experts in the field of HIV/AIDS; and

(F) the opinions of peer reviewers with expertise in the medical management of persons with HIV and HIV-related conditions.

^K (c) Services considered medically necessary without additional pre- or post-utilization review - The following items and services shall be considered medically necessary and therefore exempt from both pre- and post-service utilization review procedures otherwise employed by Contractor to determine medical necessity:

(1) services enumerated in §103 (a)(1)-(5) (certain prevention services);⁵⁰

(2) drugs prescribed in accordance with the provisions of §106; and

(3) consultation by an enrollee (under a standing order of the primary care provider) or provider on the enrollee's behalf with an experienced HIV provider who has in effect a consultation Agreement with the enrollee's primary care provider as described in §202(a)(2).

^L,G,K (d) Use of prospective utilization management and prior authorization - In reviewing the medical necessity of care and services furnished under this Part, Contractor shall exempt care and services from prospective utilization management or prior authorization in cases involving:

^L (1) emergency medical conditions;⁵¹

^K (2) urgent medical conditions;⁵² and

^G (3) post-exposure prophylaxis for enrollees who are health care workers.⁵³

^K,L (e) Prohibited bases for denial of coverage of HIV medical management services - Contractor shall not deny, terminate or reduce coverage of items and services enumerated under this Part solely on the grounds that such services are:

^K (1) available:

(A) free of charge or at a discount through a public or private provider that is legally obligated to furnish such service either free of charge or in accordance with a schedule of charges that has been adjusted for family income; or

(B) from a provider described in §202(f);

^L (2) ordered by a court or administrative agency with jurisdiction over the enrollee;

^K (3) for an enrollee with co-occurring conditions or living in adverse social circumstances or living arrangements; ⁵⁴

^K (4) for an enrollee who is participating in a clinical trial or is under treatment with a drug available under an FDA Treatment Investigational New Drug Application (or similar application for expanded access distribution); or

^L (5) specified in a plan of care developed for a child or adolescent by a child welfare agency under Title IV-B the Social Security Act or by an education agency or early intervention agency under the Individuals with Disabilities Education Act (IDEA).

§111. Consumer Protections: Timelines for Review of Requests for Treatment, Grievances and Appeals of Adverse Coverage or Treatment Determinations, and Other Matters (Reserved)

The following section provides illustrative definitions.

§112. Definitions

^G (a) Adolescent - an individual aged 11 through 20.⁵⁵

^G (b) AIDS - Acquired Immunodeficiency Syndrome, which is a specific group of diseases, conditions or laboratory findings that are indicative of severe immunosuppression related to infection with the human immunodeficiency virus (HIV)).⁵⁶

^G (c) HIV infection - infection with the Human Immunodeficiency Virus, the etiologic agent for AIDS.

^G (d) HIV-related condition - conditions associated with HIV infection, as enumerated in the CDC guidelines under §109.

^K (e) Experienced HIV provider⁵⁷ - a licensed physician, nurse practitioner, or physician assistant who has:

(1) maintained an active HIV/AIDS medical practice by providing continuous and direct medical care to at least ___ individuals with a full spectrum of HIV/AIDS; and

(2) has completed at least __ hours of continuing medical education on topics related to the care and management of individuals with HIV/AIDS.⁵⁸

^G (f) HIV risk factor - the presence or history in an individual of one or more of the following factors:⁵⁹

(1) injection drug use;

(2) for men, sex with other men;

(3) failure to use condoms whenever engaged in sexual activity that poses a risk of transmission of HIV and that involves an individual whose HIV infection status is positive or unknown;

(4) exchange of sex for money or drugs;

(5) a sexually transmitted disease;

(6) exposure to the blood or body fluids of an individual with HIV infection;

(7) participation in sexual activity with multiple sex partners;

(8) participation in sexual activity with an individual with one or more of the risk factors enumerated in this subsection;

(9) any other behavior, condition or circumstance that is recognized by the Centers for Disease Control and Prevention as providing a route of transmission of HIV; or

(10) for women, sex with men with a known risk factor.⁶⁰

^K (g) Medically necessary - a service or benefit that is necessary to prevent, diagnose, treat or manage HIV/AIDS or, in an individual with HIV/AIDS, to maintain an optimal health and functional level.

^L (h) Minor enrollee - an enrollee who has not attained [drafter insert the legal age of majority under state law].

^K (i) Specialist - a licensed physician who, as measured by added education and training, has a demonstrated expertise in one or more areas of health and medical care practice and relevant experience in the care and management of HIV/AIDS.

The following section provides illustrative language regarding information that Purchasers may wish to consider specifying in their Agreements.

§113. Information for Purchaser

^K (a) Submissions required - Upon request, Contractor shall make available to the Purchaser the current version of each of the following documents:

(1) Contractor's provider manual and any other directives, guidelines, or protocols relating to the provision or coverage of items or services under this Agreement;

(2) the subcontract or other written Agreement between Contractor and participating laboratories, pharmacies, providers and case managers;

(3) Contractor's enrollee handbook or other written information given to enrollees regarding items and services covered under this Agreement; and

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

Endnotes

Commentary: There is no standard definition of HIV/AIDS services either in the Medicaid or Medicare programs or under private insurance or employee health benefit laws. This definition has been fashioned by experts in the field of HIV/AIDS to guide Purchasers. It draws upon the opinions of expert panels and data evaluation reflected in clinical guidelines referenced throughout the document and the prevention and medical management experience of clinicians and community-based supportive service providers supported by the Centers for Disease Control and Prevention (CDC), and the Health Resources and Services Administration (HRSA) as administrator of the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act ( PL 104-146).
Commentary for Medicaid Purchasers: Medicaid law makes special provision for HIV/AIDS in two instances: optional eligibility of certain low-income infants and young children exposed perinatally to HIV (42 U.S.C.§1396n(e)) and optional targeted case management for individuals with AIDS (42 U.S.C. §1396n(g). However, a broad range of health related items and services which either must or may be covered under Medicaid is enumerated and described in the federal Medicaid statute and regulations, Health Care Financing Administration (HCFA) guidance and opinions, and judicial rulings. Consequently, most if not all of the HIV/AIDS-specific items and services enumerated in this document are either in one or more classes of "mandatory" Medicaid services (which states must cover at least for categorically eligible individuals) or "optional" services (which a state may cover). In the case of Medicaid beneficiaries under age 21, the mandatory Early and Periodic Screening, Diagnosis and Treatment (EPSDT) benefit requires coverage of comprehensive well-child assessments and any diagnostic or treatment service found to be necessary in an assessment, including optional services that the state does not otherwise offer. (42 U.S.C. §§1396a(a)(10), 1396d(r)). State Medicaid agencies may reasonably limit the amount, scope and duration of covered services through utilization review or "medical necessity" determinations; but even with such limits, coverage must be sufficient for an item or service to achieve the purpose for which it was prescribed. (42 U.S.C. §440.230(d),(c)). In certain instances, (e.g., optional community-supported living arrangements, which include homemaker, home health aide, habilitation and respite care (§1396d(a)(23), 1396(t)) a waiver may be needed to offer specific services described in this document to individuals with HIV/AIDS, if the services are reserved in statute to specific diagnostic or age-specific classes of Medicaid beneficiaries. The following list identifies the mandatory and optional Medicaid services identified in the federal statute at 42 §1396d(a). It does not capture all of the coverage options for state Medicaid programs, such as specialized ("targeted") case management services for individuals with AIDS (42 U.S.C. 1396n(g)(1), or state duties such as mandatory coverage of physical therapy as an outpatient service. (Physical therapy claimed as such is, however, an optional Medicaid service (§1396d(a)(11), 42 C.F.R. §440.110). The statute also includes certain broadly-worded benefits which may be interpreted to cover a range of specific servics. For example, the comprehensive health assessments and health education that are required elements of EPSDT would require coverage of virtually all the prevention, testing, counseling and patient education services enumerated at §103. For adult enrollees, these services as well as certain medical management services (e.g. adherence services) enumerated at §104 could be covered under the optional benefit, "other diagnostic, screening, preventive, and rehabilitative" services (42 U.S.C. §1396d(a)(13), 42 C.F.R. §440.130)), to the extent that such services would not be covered otherwise as physician services, or other more specific Medicaid benefits. Finally, states may include in their state Medicaid managed care programs benefits that are not otherwise included in a state's Medicaid plan. (42 U.S.C. §§1396n(a)(,(b), 1396a(a)(1),(10)). Federal financial participation for such benefits may require a waiver or states may finance them with state dollars. Mandatory Medicaid items and services are: inpatient hospital services (42 U.S.C. §1396d, 42 C.F.R. 440.10)); outpatient hospital services (42 U.S.C. §1396(a)(2)(A), 42 C.F.R. §440.20); Federally Qualified Health Center services as defined in federal law and other ambulatory services offered by Federally Qualified Health Centers and included in a state's Medicaid plan (42 U.S.C. §1396d(a)(2)(c), 42 U.S.C. 440.20(b)); rural health clinic services as defined in federal law and other ambulatory services offered by a rural health clinic and included in a state's Medicaid plan (42 U.S.C. §1396d(a)(2)(b), 1365x(aa)(1), 42 C.F.R. §440.20(b); laboratory and x-ray services (42 U.S.C. §1396d(a0(3), 42 C.R.R. §440.30); Early and Periodic Screening, Diagnosis and Treatment (EPSDT) services for enrollees under age 21 (42 U.S.C. §1396d(a)(4)(B), 1396d(r), 42 C.F.R. §440.40); physician services and medical and surgical services of a dentist (42 U.S.C. §1396d(a)(5)(A)); family planning services and supplies (42 U.S.C. §1396d(a)(4)(C), 42 C.F.R. §440.40(c)) home health services (which include parttime or intermittent nursing, home health aides and medical supplies and equipment)(§1396a(a)(7), 42 C.F.R. 440.70); nurse-midwife services (42 U.S.C. ?1396d(a)(17), 42 C.F.R. ?440.165); services of certified pediatric nurse practitioners and certified family nurse practitioners (42 U.S.C. ?1396d(a)(21), 42 C.F.R. ?440.166)). Optional Medicaid items and services are: prescribed drugs, dentures; prosthetic devices and eyeglasses (42 U.S.C. ?1396d(a)(12), 1396r-8(g), 42 C.F.R. ?440.120(a)); transportation services that are necessary for a beneficiary to receive diagnostic and treatment services (42 C.F.R. §170(a)); skilled nursing facility services for enrollees under age 21 (42 C.F.R. §440.170(d)); medical and "other remedial care recognized under state law" if furnished by a licensed practitioner (§1396d(a)(6), 42 C.F.R. §440.60); private duty nursing (42 U.S.C. §1396d(a)(8), 42 C.F.R. §440.80); "clinic" services, which may be preventive, diagnostic, therapeutic, rehabilitative or palliative services furnished on an outpatient basis (42 C.F.R. §440.90); physical, occupational and related therapies including necessary equipment and supplies for treatment of speech, hearing and language disorders (42 U.S.C. §1396d(a)(11), 42 C.F.R. §440.110); "other diagnostic, screening, preventive, and rehabilitative" services (42 U.S.C. §1396d(a)(13), 42 C.F.R. §440.130); hospice services (42 U.S.C. §1396(o)); durable medical equipment and prosthetic devices (42 C.F.R. §440.120(c)); case management services, which are defined broadly to cover multi-disciplinary patient assistance in "gaining access" not only to covered medical and health services but also needed educational, social or other services that may not in themselves be reimbursable Medicaid services (42 U.S.C. §§1396d(a)(19), 1396n(g)(2)); a specialized package of services for individuals diagnosed with tuberculosis (42 U.S.C. §1396(a)(19)), respiratory care services (§1396d(a)(20), 1396(e)(9), 42 C.F.R. §440.185); personal care services (42 C.F.R. §440.167); and home and community-based services (§1396d(a)(23), 42 C.F.R. §440.180).
Commentary: The services enumerated in this section are considered to be primary preventive services to the extent that they prevent transmission of HIV infection (e.g., through promotion of condom use or timely diagnosis and treatment of HIV infection in pregnant women). The services are also considered to be secondary preventive services to the extent that they promote diagnosis early in the course of HIV infection and initiation of treatment to achieve and maintain maximum viral load reduction and delay and mitigate opportunistic infections and other AIDS-defining conditions. For applicable Medicaid law, see Commentary 3.

Commentary: For applicable guidelines see §§109(a) and (b).
Commentary: For applicable guidelines, see §§109(a)-(e). There is a growing body of evidence based on randomized controlled trials that personalized one-on-one counseling aimed at risk reduction reduces high-risk behaviors and reduces new infection among high-risk persons. Commentary for Medicaid Purchasers: In the case of Medicaid-eligible enrollees under age 21, this education and counseling would be considered an element of the health education and anticipatory guidance that are part of mandatory Early and Periodic Screening, Diagnosis and Treatment (EPSDT) services (42 U.S.C. §1396d).
Commentary: For applicable guidelines see §§109(a)-(d).
Commentary: For applicable guidelines see §109(f).
Commentary: For applicable guidelines see §109(h).
Commentary: Assumes coverage at the time of birth of infants born to HIV-infected women, to permit antiretroviral prophylaxis for the infant to begin as soon as possible after birth, preferably within 12-24 hours. For applicable guidelines see §109(f).
Commentary: For a definition of family planning services and supplies see forthcoming sample purchasing specifications for reproductive health services. Additional Commentary for Medicaid Purchasers: In the case of Medicaid, condoms would be included in the term "family planning services and supplies." Other purchasers may wish to specify condoms separately.
Commentary: For applicable Medicaid law, see Commentary 3.
Commentary: For applicable guidelines see §§109(a)-(e) and (h).
Commentary: Certain providers may not have network membership status but may nonetheless maintain a formal contractual affiliation with a Contractor for purposes of referral services.
Commentary: "Medical management" refers to the diagnostic, treatment, ancillary medical and supportive social services that are needed, in the view of experts in HIV/AIDS, to manage HIV infection as a chronic condition. The services enumerated in this section constitute the minimum elements of medical management of HIV infection. When offered as a continuum of care that is tailored to the HIV/AIDS status and psychosocial circumstances of an HIV-infected individual, these services promote desired treatment outcomes (delaying and mitigating loss of immune function, suppressing or delaying emergence of drug-resistance strains of HIV virus, and delaying and mitigating severity of opportunistic infections and other AIDS-defining conditions.) For a comprehensive reference and clinician's practice guideline on medical management of HIV/AIDS, see John Bartlett, 1998 Medical Management of HIV Infection (1998 Johns Hopkins University, Department of Infectious Diseases, Baltimore, MD.) (http://www.hopkins-aids.edu). The website should be consulted regularly for updates.
Commentary for Medicaid Purchasers: For applicable Medicaid law, see Commentary 3. Commentary for Medicaid Purchasers: Federally Qualified Health Centers (FQHCs) are community-based, multi-disciplinary ambulatory health care centers that provide primary and certain specialty health care services to medically underserved communities and populations. FQHCs include centers in medically underserved urban and rural areas and health care services for individuals who are homeless. FQHC services are a mandatory service under federal Medicaid and Medicare law. 42 U.S.C. §§1395x(aa)(3); §1396a(a)(10) and §1396d(a)(2)(C). The term "federally qualified health center services" (FQHC) refers to physicians services and ancillary services, services of nurse practitioners and physicians assistants and ancillary services, services of clinical psychologists and social workers when furnished by a federally qualified health center as defined in §1395x(aa)(4). FQHC services in the case of Medicare also include preventive primary services that a Center is required to furnish under §§329,330 and 340 of the Public Health Service Act. §1395x(aa)(3). In certain cases FQHC services also include home health services.
Commentary: Access to investigational HIV/AIDS drugs and combination therapies is considered by experts in HIV/AIDS to be an important option. While the drugs used in such trials are provided without cost to participants, enrollee access to trials may be impeded if they are denied other covered services simply because they are participating in a trial. The guidelines identified at §109(g) include a toll-free telephone number (1-800-874-2572) that may be called to determine availability of drug trials that would be appropriate for an HIV-infected enrollee.
Additional Commentary for Medicaid Purchasers: In the case of Medicaid, eyeglasses are a mandatory benefit for children under age 21. Most states cover eyeglasses at least to some extent in the case of adults. Medicaid purchasers may wish to include eyeglasses in their purchasing agreements or may wish to continue direct coverage for eyeglasses outside of their managed care contracts.
Commentary for Medicaid and other Purchasers Under Medicaid, "any other medical care permitted under state law" is an optional service for categorically needy adults but would be a mandatory service for enrollees under age 21 if medically necessary. (42 U.S.C. §1396d). This service would include such alternative therapies (e.g., acupuncture) as may be furnished under the medical practice laws of the state in which the Agreement is in effect. In the case of other public and private Purchasers, this subsection should be viewed as a placeholder for the enumeration of other services.
For applicable Medicaid law, see Commentary 3.
Commentary: The pharmacy benefit described in this section is drafted to respond to the well-recognized need for maximum flexibility in prescribing antiretroviral combination drug therapies and other medications for HIV-infected individuals on a case-by-case basis, taking into consideration the stage of infection in the individual (or exposure in the case of perinatally- or occupationally-exposed individuals); evidence of treatment failure or drug resistance, variations in pharmacokinetics, the multiplicity of combination drug therapy options and emerging new drug therapies.
Commentary for Medicaid Purchasers: The extent to which the full scope of coverage described in this section is required under Medicaid law for all Medicaid beneficiaries is unclear. Under Medicaid law, "prescribed drugs" are an optional benefit for categorically needy individuals except that any drug found to be medically necessary for a beneficiary under age 21 would be mandatory. (42 U.S.C. 1396a(10), 42 U.S.C. §1396d(a)(12), §1396d(r)). All states now include prescribed drugs in their state Medicaid plans. Medicaid law requires that all FDA-approved drugs available under rebate agreements (which are virtually all currently-approved drugs) be covered; a state may exclude only drugs in certain named categories and drugs that are not prescribed for "medically indicated" uses, defined as either uses approved by the FDA or "off-label" uses that are supported in at least one of the four named compendia. (42 U.S.C. §1396r-8(d), 1396(a)). The Health Care Financing Administration (HCFA) has advised state Medicaid directors that states must cover AZT (now referred to as Zidovudine, ZDV) for the prevention of perinatal transmission of HIV. (Letter of Sally K. Richardson, Director, Center for Medicaid and State Operations, to state Medicaid directors, Dec. 5, 1994). HCFA has also advised state Medicaid directors that FDA-approved protease inhibitors must be covered. In the same advisory letter, HCFA also advised states that if Medicaid beneficiaries who are HIV-infected are enrolled in managed care and if the state's managed care contract includes drugs, "these [protease inhibitor] drugs must be available in managed care formularies." State Medicaid agencies are also advised to determine what benefit restrictions might apply to the drugs and to consider whether "capitation rates should be adjusted to account for the introduction of new drugs such as protease inhibitors." (Letter of Sally K. Richardson, Director, Center for Medicaid and State Operations to state Medicaid directors, June 19, 1996). At least one court that has considered this issue has enjoined a state from failing to cover HIV-related drugs used in accordance with accepted medical practice (Reagan v. Weaver, 886 F.2d.194 (8th Cir., 1989). This specification is drafted to follow Medicaid law (coverage for FDA-approved uses or uses supported by one of the four compendia) except that an additional basis for coverage has been added, i.e., certification of a drug's "medical necessity" by a Contractor or an experienced HIV provider.
Commentary: In communities where Ryan White CARE Act-funded providers offer these services, Contractors may wish to purchase the services from these providers or consult with Ryan White Care Act grantees to identify appropriate providers. Commentary for Medicaid purchasers: For applicable Medicaid law, see Commentary 3.
Commentary: Purchasers may wish to specify that Contractors enter into agreements with Ryan White CARE Act grantees for the provision of one or more home and community care services. In the case of Medicaid agencies, on November 25th, 1998, Sally Richardson, Director of the HCFA Center for Medicaid and State Operations, sent a letter to state Medicaid directors regarding strategies to implement coordination between the Medicaid program and the Ryan White Comprehensive AIDS Resources Emergency Act (CARE). Among other options for consideration, the letter encourages the development of managed care contract language that "ensures that traditional providers such as Ryan White grantees will be considered for inclusion in managed care organizations and/or that services provided to beneficiaries be coordinated with Ryan White grantees." Letter from Sally Richardson to state Medicaid directors, November 25th, 1998. http://www.hcfa.gov/medicaid/smd11258.htm.
For applicable Medicaid law, see Commentary 3.
For applicable Medicaid law, see Commentary 3.
For applicable Medicaid law, see Commentary 3.
42 C.F.R. §§ 431.53 (transportation as an administrative cost), 440.170(a) (transportation as an optional service).
Commentary: The case management services enumerated in this section constitute an individualized, multi-disciplinary social service that is intended to promote effective care for those HIV-infected enrollees who may need assistance in coordinating complex medical management regimens or provider referrals or whose adherence to treatment may be enhanced by identifying appropriate support services (e.g., housing assistance for enrollees who are homeless or subject to domestic violence; special education and early intervention programs for HIV-infected children, state and federal public assistance programs). The case management services specified in this section are in addition to the traditional institutional discharge planning and case management done under managed care as part of utilization management. This model of case management has been developed by and evaluated for, among others, Ryan White CARE Act providers. Case management has been shown to decrease hospitalization and enhance adherence to medication regimens in individuals with severe, disabling mental illness. (CT Bush, MW Langtford, P Rosen, W Gott. Operation Outreach: intensive case management for severely psychiatrically disabled adults. Hosp. Community Psychiatry. 1990; 411:6477-649; USPHS/HRSA/HIV/AIDS Bureau, Evaluation of HIV Case Management: Invited Research and Evaluation Papers (July, 1998). HIV case management experts consider face-to-face provision of services an important quality assurance standard (as opposed to case management by telephone). Note that this language does not obligate a payor to finance services enumerated under a case management plan that are not otherwise covered services under this Agreement.) Persons who decline medical management of their conditions should be able to receive case management services. Additional Commentary for Medicaid Purchasers: Multi-disciplinary case management of this scope is an optional Medicaid service (42 U.S.C. §1396n(g)) but is mandatory when found to be medically necessary in the case of enrollees under age 21. (42 U.S.C. §1396d).
For applicable Medicaid law, see Commentary 3.
Commentary: Guidelines in §109 do not indicate the frequency for case management assessments. Experts in the medical management of persons with HIV/AIDS suggest assessments on a semi-annual basis or more often as determined by an individual's case manager, or whenever there is a major change in an individual's HIV status or psychosocial circumstances (e.g., a child's or adolescent's entry into out-of-home care).
Commentary: USDHHS, A Guide: Family Centered Comprehensive Care for Children with HIV Infections (August, 1991); Boland, Epstein and Taylor, Building Quality: Indicators for Family Centered Care in HIV Health Services for Children, Youth and Families (National Pediatric HIV Resource Center and New England SERVE, Boston, MA, 1994); Richard Conviser, Caring for Families with HIV: Case Studies of Pediatric HIV/AIDS Demonstration Projects (USDHHS, 1991).
Commentary: HIV experts consider that assistance to HIV-infected individuals as needed to promote adherence is necessary because suboptimal adherence (e.g., not taking all prescribed medicines at indicated times) may lead to treatment failure and emergence of drug resistance.
Commentary: Counseling and other strategies to promote adherence to drug treatment is considered by HIV experts to be critical to achieving acceptable treatment outcomes and avoiding or minimizing the emergence of drug-resistant HIV strains. Intensive counseling and assistance, provided on an emergency or urgent care basis by individuals with demonstrated experience in adherence services, may be needed for certain enrollees who, for psychological or other reasons, find adherence difficult.
Commentary: All guidelines enumerated in this section except those identified at subsection (a) are available at the CDC website http://www.cdc.gov/nchstp/hiv_aids/pubs.htm. The website should be consulted regularly for updates. Current treatment guidelines can be obtained at http://www.hivatis.org.
Commentary: This guide, prepared by a U.S. Public Health Service Task Force, contains evidence-based guidelines for HIV risk-assessment and for periodic HIV screening (counseling and testing) of at-risk individuals and for HIV counseling and education for all individuals. http://www.odphp.osophs.dhhs.gov/pubs/guidecps
Commentary: See Commentary 34 for website address. This two-part document was developed by CDC, with review by experts in HIV prevention, to provide standards and guidelines for CDC grantees in administering HIV counseling and testing programs and for providers of counseling and testing services in such programs.
Commentary: See Commentary 34 for website address (guidelines are located under the MMWR Index). This document contains recommendations of the U.S. Public Health Service on offering HIV counseling and testing to all pregnant women; topics addressed include test interpretation, and counseling on treatment and breastfeeding.
Commentary: See Commentary 34 for website address. This document contains CDC standards for HIV prevention grantees for provision of multi-session risk reduction counseling as a component of prevention case management. Topics addressed include indications for such counseling, screening and counseling standards and related matters.
Commentary: See Commentary 34 for website address. This document contains joint recommendations of four federal health agencies regarding counseling injection drug users (non-medical users) on methods to minimize the risk of HIV acquisition or transmission associated with injection drug use.
Commentary: See Commentary 34 for website address. This document reflects recommendations of a Public Health Service task force whose participants were clinical and public health experts on perinatal HIV transmission. Topics addressed include the use of antiretroviral therapy in pregnancy, antiretroviral chemoprophylaxis to reduce perinatal HIV transmission, and monitoring of HIV-infected women and their exposed infants.
Commentary: See Commentary 34 for website address. This document contains guidelines developed by the Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected Children which was convened by the National Pediatric and Family HIV Resource Center (NPHRC), HRSA and the National Institutes of Health (NIH). The recommendations in the document are based on published and unpublished data on treatment of HIV infection in adults and children and where definitive data were unavailable, the clinical experience of members of the Working Group. Topics addressed include diagnostic testing, treatment recommendations (including testing for monitoring and modifying treatment) and treatment adherence for infants, children and adolescents.
Commentary: See Commentary 34 for website address. This document contains recommendations of a federal interagency working group (CDC, Food and Drug Administration, NIH, with review by expert consultants) for post-exposure prophylactic antiretroviral treatment, testing and counseling of health care workers who have been occupationally exposed to HIV.
Commentary: See Commentary 34 for website address. This two-part document consists of a statement of principles in the treatment of HIV infection, developed by a panel of experts convened by the NIH Office of AIDS Research, and clinical guidelines for antiretroviral therapy, developed by a panel convened by the Department of Health and Human Services (DHHS) and the Henry J. Kaiser Family Foundation. The clinical guidelines include indications of the strength of evidence for each guideline and also stipulate that the guidelines are not intended to substitute for the opinion of a physician "who is expert in caring for HIV-infected persons" (as primary care practitioner or through consultation). Topics addressed include considerations for initiating therapy in asymptomatic and symptomatic individuals with HIV infection (including acute HIV infection), choice of drugs and drug combinations, criteria for modifying treatment regimens, and ongoing testing associated with treatment. See http://www.hivatis.org.
Commentary: See Commentary 34 for website address. This document contains recommendations of a working group of representatives from federal agencies, universities, professional societies, community health-care providers and patient advocates, convened by the U.S. Public Health Service (USPHS) and the Infectious Diseases Society of America (IDSA). Topics addressed include disease-specific recommendations for prevention and treatment of opportunistic infections associated with HIV infection in adults, adolescents and children and in pregnant women. Recommendations are rated on the strength of published and unpublished data considered by the working group. The guidelines were made available for public comment in the Federal Register and MMWR and the final document was approved by USPHS, IDSA, the American College of Physicians, the American Academy of Pediatrics, the Infectious Diseases Society of Obstetrics and Gynecology, the Society of Healthcare Epidemiologists of America and the National Foundation for Infectious Diseases.
Commentary: See Commentary 34 for website address (guidelines are located under "HIV Prevention Guidelines , 1982-Present")
See Commentary 34 for website address (guidelines are located under the MMWR Index).
See Commentary 345 for website address. 48 Commentary: See Commentary 34 for website address (guidelines are located under "HIV Prevention Guidelines, 1982-Present).
Commentary: Experts indicate that in assessing an individual's health status and need for care, health professionals should take into account whether the individual is at risk for HIV/AIDS or presents a risk of infecting others.
Commentary: Certain services enumerated in this section are exempted from prior authorization for reasons relating to primary prevention of HIV/AIDS. Perceived delays or barriers to HIV testing could discourage earliest possible identification of the illness.
Commentary for Medicaid purchasers: In the case of Medicaid (or Medicare) contracts the term "emergency medical condition" in the managed care context means "a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent layperson, who possesses an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in (i) placing the health of the individual (or with respect to a pregnant woman, the health of the woman or the unborn child) in serious jeopardy, (ii) serious impairment of bodily functions, or (iii) serious dysfunction of any bodily organ or part. (§1852(d)(3) of the Social Security Act). According to experts in the field, in the context of HIV/AIDS, an emergency medical condition would include symptoms of serious opportunistic infection associated with AIDS. For a discussion of opportunistic infections associated with HIV infection, see §109(j). For infants born to HIV-infected pregnant women in labor who received no antiretroviral therapy during pregnancy, ZDV should be initiated as soon as possible. See guidelines at §109(f).
Commentary: There is no federal definition of the term "urgent." For illustrative approaches taken by state Medicaid agencies see S. Rosenbaum et. al., Negotiating the New Health System: A Nationwide Study of Medicaid Managed Care Contracts (2d ed.) (The George Washington University, Washington D.C., 1998).
Commentary: CDC guidelines regarding exposure of health care workers stress that occupational exposures should be considered urgent medical conditions, with immediate administration of post-exposure prophylaxis if indicated. See §109(h).
Commentary: Examples of prohibited grounds for denial would be homelessness, pregnancy, addiction, or mental illness.
Commentary: This age range for adolescence is that of the American Medical Association (Guidelines for Adolescent Preventive Medicine, GAPS). While definitions of adolescence may depend on state law, the term as it is used here is meant to identify those children whom medical experts consider to be adolescents.
Commentary: See guidelines on the AIDS case definition in §109(n).
Commentary: As used in these sample purchasing specifications, the term "experienced provider" is a term of art. It is assumed that any health care provider furnishing any covered physical or mental health benefit to an enrollee will have the requisite skill and experience to furnish competent care.
Commentary: Currently there is no uniform definition of an experienced HIV provider or any national certification for this type of provider. Moreover, the definition of an experienced provider may vary from community to community depending upon a number of factors, such as the nature of the epidemic and the population affected and the types of providers within the community's health care delivery system. However, experts suggest as minimum experience threshold an active ongoing caseload of at least 25 individuals with HIV/AIDS over the preceding 24 months, either in regular practice or as part of a supervised post-graduate training program. In the case of urban areas with a high incidence of HIV/AIDS and a delivery system that includes an academic health center, providers should be considered experienced only if they have maintained an ongoing caseload of at least 50 patients with HIV/AIDS over the preceding 24 months. The education requirement may be met if the medical or health professional has completed at least 12 hours of CME over the past 12 months. Persons interested in the definition of experienced providers may wish to consult the definitions developed by the states of Maryland, New York and Tennessee. See Negotiating the New Health System: A Nationwide Study of Medicaid Managed Care Contracts, op cit. Ch. 3. See also, J. Rawlings-Secunda and N. Kaye, op cit.
Commentary: While not factors contributing to the actual transmission of HIV, homelessness, alcohol or drug abuse, tuberculosis, hepatitis C, and history of incarceration are factors associated with HIV.
Commentary: The population at risk for HIV/AIDS is shifting from men who have sex with other men to persons who are injection drug users or who have sexual relations with drug users. This is relevant in the design of HIV prevention programs and activities by managed care organizations.