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Medicaid Contract Purchasing Specifications

Childhood Lead Poisoning
November, 1998

These sample purchasing specifications for childhood lead poisoning (elevated blood lead levels 1) have been prepared by the George Washington University Center for Health Policy Research in consultation with officials from the Centers for Disease Control and Prevention, state Medicaid agencies, state and local health agencies, representatives of managed care organizations and other experts. This document should be viewed as a tool to help managed care purchasers in the public and private sector identify key issues and decision points as they prepare their purchasing agreements. The specifications provide a broad menu of draft provisions for contracts, RFPs, and intergovernmental agency agreements. They can be used singly or in combination with one another.

Certain provisions are identified in bold and italics as alternative provisions for inclusion in contracts and service agreements. Because federal Medicaid law establishes specific standards for lead poisoning services for children, certain alternatives have been prepared specifically for Medicaid purchasers. Additional alternatives are provided to accommodate the variety of legal, policy and programmatic approaches to childhood lead poisoning among and within state and local jurisdictions. Italic insertions in certain provisions identify provisions where a drafter may wish to insert state or local laws, regulations, ordinances, programs or agencies that pertain to childhood lead poisoning. Explanatory drafter's notes are provided as footnotes.

These specifications, which are part of a Sample Purchasing Specifications Series, may be obtained in diskette format from:

The George Washington University Medical Center
Center for Health Policy Research
2021 K Street N.W. #800
Washington D.C. 20006

For a related study, see Medicaid Managed Care Contracting for Childhood Lead Poisoning Prevention Services

Table of Contents

§ 001. Lead-Related Definitions: Defines lead-related specialized terms used in the sample specifications.
§ 002. Lead-Related Sample Specifications of General Applicability: Describes provisions that apply generally throughout the specifications.
§ 003. Lead-Related Service and Coverage Activities: Describes the basic scope of coverage for lead-related screening and clinical management services as well as rules on coverage.
§ 004. Lead-Related Enrollment and Disenrollment Standards: Describes standards for coverage, notification, and record transfers relating to enrollees who, at the time of enrollment or disenrollment, are receiving clinical management services for elevated blood lead level or for whom a blood lead level screening test has indicated an elevated blood lead level.
§ 005. Lead-Related Network Provider Qualifications: Describes lead-related qualification standards for network providers and evaluation of provider performance.
§ 006. Lead-Related Access Standards: Sets forth sample specifications for lead-related service time frames and outreach for families of certain enrolled children.
§ 007. Lead-Related Agreements with State or Local Public Health Agencies: Sets forth sample lead-related issues that may be addressed in a memorandum of understanding between a Contractor and a state or local public health agency with a childhood lead poisoning prevention program.
§ 008. Lead-Related Quality Measurement and Improvement: Sets forth sample lead-related performance standards that may be incorporated into a Contractor's quality measurement and improvement activities.
§ 009. Lead-Related Data and Reporting: Specifies elements of lead-related data collection and reporting arrangements that Contractors may be expected to maintain.

Endnotes

§ 001. Lead-Related Definitions

  1. Case management -- services furnished in conjunction with clinical management of a child diagnosed with elevated blood lead level (EBLL), which shall include: (1) assessing the environmental, social, educational, housing and other needs of the child and developing a written case management plan based on the assessment; (2) assisting the child (and child's family) in gaining access to covered and non-covered services in the case management plan; (3) coordinating services in the case management plan with the clinical management of the child: (4) monitoring provision of services in the plan; and (5) providing technical assistance to the provider furnishing clinical management for the child. 2, 3

  2. Case management plan -- a multidisciplinary plan of services for a child diagnosed with an EBLL, which shall address the provision and coordination of one or more of the following classes of services, whether or not such services are covered under this Part: clinical management of EBLL; environmental lead services; nutrition services; family lead education; housing; early intervention services; social services and other services or programs that are indicated by the child's clinical status and environmental, social, educational, housing and other needs.

  3. CDC lead poisoning guidelines 4 -- Centers for Disease Control and Prevention. Screening Young Children for Lead Poisoning: Guidance for State and Local Public Health Officials. Atlanta: CDC, 1997, and any later revisions, amendments or successor lead poisoning guidelines. 5

  4. Childhood lead poisoning prevention program (CLPPP) -- [drafter insert name of each program that is responsible for one or more of the following lead-related services in the Contractor's service area: case management of children with EBLL; childhood lead poisoning surveillance; environmental lead services; individualized family lead education; development and implementation of a statewide childhood lead screening plan.] 6

[Alternative A] 7

  1. EBLL (elevated blood lead level) -- a concentration of lead in whole blood (capillary or venous sample) that is equal to or exceeds 10 micrograms per deciliter.

[Alternative B] 8

  1. EBLL (elevated blood lead level) -- [drafter insert the EBLL specified in applicable state or local law, regulation or public health policy]

[Alternative C] 9

  1. EBLL (elevated blood lead level) -- the concentration of lead in whole blood (capillary or venous sample) that is identified in CDC lead poisoning guidelines as a concentration that requires medical and other interventions for the child.

[Alternative A] 11

  1. Emergency medical condition -- Under this Part, emergency medical conditions shall include an EBLL at a concentration that requires initiation of lead-related services within emergency care timelines established in [drafter insert applicable state or local law, regulation or ordinance or public health agency policy].

[Alternative B] 12

  1. Emergency medical condition -- Under this Part, emergency medical conditions shall include an EBLL at a concentration that requires initiation of lead-related services immediately in accordance with CDC lead poisoning guidelines.

  2. Environmental lead services -- services to reduce exposure to lead of a child diagnosed with EBLL, which shall include investigation of the child's living environment to determine the source(s) of exposure and enforcement of environmental lead remediation. The living environment of a child with EBLL includes, but is not limited to, the child's residence, residence(s) of frequently visited caretakers, relatives and playmates and day care site.

  3. EPSDT -- the Medicaid Early and Periodic Screening, Diagnostic and Treatment program, which is a specific set of benefits set forth in sect;sect;1905(d)(a)(4)(B) and1905(r) of the Social Security Act and implementing regulations and guidelines, to which all Medicaid enrollees under age 21 are entitled.

  4. Interim blood lead screening recommendations -- [drafter identify interim blood lead screening recommendations]; 13

  5. Lead-related anticipatory guidance -- education and information for families of enrolled children and pregnant enrollees about prevention of childhood lead poisoning prevention that addresses the following topics: the importance of lead screening tests and where and how to obtain such tests; identifying lead hazards in the home; housekeeping, nutritional and other measures to minimize the risk of childhood lead poisoning; and rights of families under the federal Residential Lead-Based Paint Hazard Reduction Act of 1992 14 to disclosure of information about lead paint hazards in residences that they buy or rent.

[Alternative A] 15

  1. Qualified laboratory -- a laboratory that is certified under the federal Clinical Laboratories Improvement Act (CLIA) 16, participates in a federal or state blood lead testing proficiency program and is experienced in blood lead level testing as evidenced by a history of compliance with the blood lead level reporting regulations of all states whose residents it serves.

[Alternative B]

  1. Qualified laboratory -- a laboratory that is certified under the federal Clinical Laboratories Improvement Act (CLIA) and that has not been cited for violations under the Act.

[Alternative C]

  1. Qualified laboratory -- a laboratory that is certified under [drafter insert the state law and regulations establishing standards for medical laboratories doing business in the state].

  2. Qualified pediatric lead care center -- [drafter insert name(s) of children's hospital, academic medical center, other institutional provider that offers at a minimum the following inpatient and outpatient services relating to EBLLs: age-appropriate pediatric intensive care; and specialist and subspecialist providers with experience in furnishing multidisciplinary medical services for children with EBLLs. Such providers shall include specialists and subspecialists in: critical care; developmental pediatrics; nephrology; neurology; neurosurgery and toxicology].

  3. Qualified pediatric lead care provider -- a health care provider licensed under [drafter insert applicable state law] with demonstrated experience in furnishing diagnostic and treatment services relating to EBLL in children. 17

  4. Statewide childhood lead screening plan -- [drafter identify statewide childhood lead screening plan].18

[Alternative A] 19

  1. Urgent medical condition -- Under this Part, urgent medical conditions shall include an EBLL at a concentration that requires initiation of lead-related services within urgent care timelines established in [drafter insert applicable state or local law, regulation or ordinance or public health agency policy].

[Alternative B]

  1. Urgent medical condition -- Under this Part, urgent medical conditions shall include an EBLL at a concentration that requires initiation of lead-related services within 48 hours in accordance with CDC lead poisoning guidelines.

Back to Top § 002. Lead-Related Sample Specifications of General Applicability

  1. Contractor shall ensure that employees and subcontractors furnishing medical, health, administrative, or other services under this Part shall comply with all service, data, reporting and other standards set out in this Part.

  2. For Medicaid enrollees under age 21 years, services under this Part shall be considered to be furnished as part of the EPSDT benefit package and shall be subject to all standards and requirements which apply to the EPSDT program. 20

Back to Top § 003. Lead-Related Service and Coverage Activities

If, as a purchaser, you are interested in addressing childhood lead poisoning services in your purchasing specifications and wish to adopt detailed specifications regarding the elements of childhood lead poisoning services, this language is for your consideration. This language covers the basic amount and scope of services, allowable limitations and exclusions relating to childhood lead poisoning services and individual determinations of coverage for such services.

  1. Coverage defined -- For enrollees under age 21 years and enrollees who are pregnant, Contractor shall cover and arrange or provide for services related to screening and clinical management of EBLLs that are described in this section.

  2. Anticipatory guidance -- Contractor shall furnish anticipatory guidance about lead hazards and their control in accordance with CDC lead poisoning guidelines as part of

    1. prenatal services; and

    [Alternative A] 21

    1. EPSDT periodic and interperiodic health assessments.

    [Alternative B] 22

    1. routine pediatric preventive services.

  3. Screening services related to EBLLs -- Contractor shall cover and provide for the following screening services for asymptomatic children who are enrollees: 23

    [Alternative A] 24

    1. In the case of enrolled children who are Medicaid enrollees, screening blood lead level (BLL) tests (capillary or venous sample) to determine the presence of EBLL which shall at a minimum be furnished to each enrolled child at the following ages: twelve (12) months; twenty-four (24) months; and to each enrolled child who has not previously received such tests, between the ages of thirty-six (36) and seventy-two (72) months; and at such other times (including earlier ages) as are required under [Drafter insert any additional standards set forth in state's EPSDT periodicity schedule].

    [Alternative B]

    1. In the case of enrolled children who are not Medicaid enrollees and who reside in an area where [drafter identify applicable statewide childhood lead screening plan] is in effect, administration of lead level risk-assessment questionnaires and screening BLL tests in accordance with the plan

    [Alternative C]

    1. In the case of enrolled children who are not Medicaid enrollees and who reside in an area where [drafter identify applicable interim blood lead screening recommendations] are in effect, administration of lead level risk-assessment questionnaires and screening BLL tests in accordance with the recommendations.

    [Alternative D]

    1. In the case of enrolled children who are not Medicaid enrollees and who reside in an area where neither a statewide blood lead screening plan nor interim blood lead screening recommendations are in effect, screening blood lead level (BLL) tests (capillary or venous sample) to determine the presence of EBLL which shall at a minimum be furnished to each enrolled child at the following ages: twelve (12) months; twenty-four (24) months; and to each enrolled child who has not previously received such tests, between the ages of thirty-six (36) and seventy-two (72) months;

    2. In the case of enrolled children (Medicaid and non-Medicaid), screening BLL tests shall be furnished to each enrolled child (regardless of timelines set forth in this subsection) when such a test is indicated for a child by a risk assessment; clinical signs or symptoms in the child that are consistent with EBLL; or other evidence indicating possible exposure of the child to lead. 25

  1. Clinical Management Services -- In the case of enrolled children for whom a screening BLL test indicates an EBLL, Contractor shall cover and provide or arrange for the following clinical management services: 26 27

    1. Individualized family education which shall address at a minimum the following topics: factors associated with a child's EBLL; consequences of EBLLs; housekeeping, nutritional and other measures to minimize an enrolled child�s risk for lead exposure; the child's need for medically indicated repeat BLL tests and clinical management services; environmental services; and a family's rights under [drafter insert applicable state or local law or ordinance that pertains to lead-safe housing]. 28

    2. Diagnostic blood lead level (BLL) tests (venous sample) which shall be furnished to confirm an EBLL indicated by a screening BLL test. 29

    3. In the case of an enrolled child with an EBLL confirmed by a diagnostic BLL test:

      1. A clinical assessment including a physical examination and medically indicated tests (in addition to diagnostic BLL tests) and other diagnostic procedures (e.g., x-rays) to determine the child's developmental, neurological, nutritional and hearing status and the extent, duration and possible source of the child's exposure to lead;

      2. Repeat BLL tests (venous sample) which shall be furnished when medically indicated for purposes of monitoring blood lead concentrations in the child;

      3. Pharmaceutical services including chelation agents and other drugs, vitamins and minerals prescribed for treatment of EBLL;

      4. Medically indicated inpatient services including pediatric intensive care; and emergency services;

      [Alternative A] 30

      1. Medical nutrition therapy when medically indicated by a nutritional assessment, which shall be furnished by a dietitian or other nutrition specialist who is registered or licensed under [Drafter insert applicable state law].

      [Alternative B] 31

      1. Referral to [Drafter insert the name of the WIC program Contractor's service area] when medically indicated by a nutritional assessment and coordination of clinical management services with WIC program services;

      2. Referral for [Drafter insert the name of each agency with responsibility for early intervention and special education programs under the federal Individuals with Disabilities Education Act (IDEA) 32 in Contractor's service area] when medically indicated by a clinical assessment;

      [Alternative A] 33

      1. Case management as described in §001b, which shall be furnished by case managers with a demonstrated capacity to develop and oversee multi-disciplinary plans for children with EBLLs; 34

      [Alternative B]

      1. Referral to [Drafter insert the name of the childhood lead poisoning prevention program that furnishes case management services in Contractor's service area] for case management services;

      [Alternative A] 35

      1. In home environmental investigation 36 which shall be furnished in accordance with [drafter insert applicable state or local laws, regulations or ordinances that pertain to such investigations] by environmental health specialists that are certified or registered to perform such investigations under [drafter insert applicable state or local laws, regulations or ordinances that pertain to such certification or registration];

      [Alternative B]

      1. Referral for an environmental investigation to the state or local public health or other agency that furnishes such investigations under [drafter insert applicable state or local laws, regulations or ordinances that pertain to such investigations]. Such referral shall be in accordance with the Memorandum of Understanding (MOU) described in §108;

    [Alternative A] 37

    1. Standards for clinical management services -- Contractor shall furnish the clinical management services described in this section in accordance with CDC lead poisoning guidelines. 38

    [Alternative B] 39

    1. Standards for clinical management services -- Contractor shall furnish the clinical management services described in this section in accordance with [Drafter insert the state or local law, regulation, ordinance or agency policy pertaining to clinical management of elevated blood lead level].

    [Alternative C]

    1. Standards for clinical management services -- Contractor shall furnish the clinical management services described in this section in accordance with the policy statement of the American Academy of Pediatrics. 40

  2. Coverage determinations -- in administering a prior authorization program and making medical necessity determinations, Contractor shall comply with the following standards and procedures:

    1. Contractor shall not require prior authorization for:

      1. screening and diagnostic BLL tests; or

      2. clinical management services that are indicated for an EBLL that is an emergency medical condition as defined in §001.

    2. In making determinations regarding the medical necessity of coverage and provision of clinical management services for EBLL in children (including determinations regarding the modification of an oral or written clinical management plan that is in effect at the time of a enrollee's enrollment), the Contractor shall comply with the guidelines and standards incorporated into this Part and shall take into account the following:

      1. The enrollee's overall health status including evidence of disorders and other health and social factors (including living arrangements) that could adversely affect or complicate treatment of the enrollee;

      2. Clinical evidence of an EBLL;

      3. The opinion of the provider who is clinically managing the case of EBLL and;

      4. The opinion of officials at [Drafter insert the name of the childhood lead poisoning prevention program that furnishes services in Contractor's service area].

    3. In the case of a enrollee receiving clinical management services for an EBLL on an inpatient basis, Contractor may only discharge the enrollee if Contractor ensures, in consultation with officials at [Drafter insert the name of the childhood lead poisoning prevention program that furnishes services in Contractor's service area], that the enrollee can be discharged to an environment that is deemed "lead safe" in accordance with [Drafter insert state or local law, regulation or ordinance that pertains to lead-safe housing] by an environmental health specialist that is certified or registered under [Drafter insert applicable state or local law, regulation or ordinance].

    4. In the case of an enrollee receiving treatment with chelating agents, Contractor may only furnish this service on an outpatient basis if the Contractor ensures, in consultation with officials at [Drafter insert the name of the childhood lead poisoning prevention program that furnishes services in Contractor's service area] that the enrollee will reside in an environment during treatment that is deemed "lead safe" in accordance with [Drafter insert applicable state or local law, regulation or ordinance] by an environmental health specialist that is certified or registered to perform such investigations under [Drafter insert state or local law, regulation or ordinance that pertains to lead-safe housing].

    5. Free or discounted care not a factor in coverage determinations -- In making coverage determinations under this part, the Contractor shall not deny or reduce coverage for covered services or refer an enrollee out of network for such services on the ground that such services are available at a substantial discount or free-of-charge through the [Drafter insert the name of the childhood lead poisoning prevention program that furnishes services in Contractor's service area] or other program, provider or agency.

    6. Drug substitution -- In the case of pharmaceutical services that are prescribed for an enrollee with EBLL, the Contractor shall engage in drug substitution practices only if substitution is approved by the provider furnishing clinical management of the case.

    7. Treatment ordered by a public agency or court -- Contractor shall not deny access to the screening or clinical management services covered under this Part because such services are requested or ordered by a childhood lead poisoning prevention program or other unit of a state or local public health agency; a court; a child welfare agency; an early intervention program, an education agency or other agency with legal authority to prescribe or order provision of services.

Compliance measure: Contractor shall make available to purchaser copies of all memoranda, instructions and other documents sent to network providers about the scope of services covered under this Part, standards used to determine medical necessity, content of anticipatory guidance and individualized family lead education, and coverage or referral sources for case management and environmental investigation services. Provide the list of all qualified laboratories, pediatric lead treatment providers, pediatric lead treatment centers and providers of environmental lead services disseminated to providers. Provide copies of all materials furnished to families regarding EBLLs, including information on recognizing lead exposure risks, recognizing symptoms of EBLL, the preventive, diagnostic and treatment services covered under this Part and the pediatric lead treatment providers and pediatric lead treatment centers that are network providers.

[Additional option] 41

Provide information prepared for childhood lead poisoning prevention programs and other units of state or local public health agencies, courts, public health agencies, education agencies, early intervention agencies, and other public agencies as well as publicly-assisted providers of social, health, nutritional, child care, child development services and other providers in Contractor's service area regarding services covered under this Part.

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§ 004. Lead-Related Enrollment and Disenrollment Standards

If, as a purchaser, you are interested in addressing childhood lead poisoning services in your purchasing specifications and wish to adopt detailed specifications regarding enrollment and disenrollment of children receiving clinical management services for EBLLs or who have had a screening blood lead level test that indicates an EBLL, the following language is for your consideration.

  1. Enrollment of children receiving clinical management for EBLL or for whom a screening BLL test has indicated an EBLL -- In the event that the Contractor enrolls a child who, at the time of enrollment, is receiving clinical management for EBLL or for whom a screening BLL test has indicated an EBLL, the Contractor shall, without requiring an initial assessment by a network provider, comply with any written or oral clinical management or diagnostic testing plan for the child that was developed prior to enrollment, from the effective date of the child's enrollment until the clinical management services or the diagnostic testing is completed or until a provider with demonstrated experience 42 in the clinical management of EBLL has evaluated the clinical status of the child and the child's plan. The Contractor may modify the clinical management plan and any case management plan only in accordance with the terms of this Part.

  2. Disenrollment of children receiving clinical management for EBLL or for whom a screening BLL test has indicated an EBLL -- In the event that a child is disenrolled at a time when the child is receiving clinical management for EBLL or for whom a screening BLL test has indicated an EBLL, Contractor shall immediately notify the childhood lead poisoning prevention program and shall continue to furnish services (including diagnostic testing for a child with a screening EBLL) until the clinical management services or diagnostic testing is completed or until the end of the period for which a premium has been paid for the child, whichever occurs first.

  3. Transfer of medical and related records -- In the case of a child described in subsections (a) or (b) of this section, Contractor shall arrange for the timely transfer of the child's medical records including clinical management plan and any case management plan as follows:

    1. In the case of a newly enrolled child, transfer shall be arranged from the child's former provider(s) to the child's primary care provider and, where necessary, to the case manager;

    2. In the case of a child who has been disenrolled, transfer shall be arranged from the child's primary care provider and any case manager to the successor provider(s). Contractor shall also ensure that network providers furnishing treatment and case management services to the child at the time of disenrollment make themselves available to the successor providers for review of the former enrollee's treatment and case management plans.

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§ 005. Lead-Related Network Provider Qualifications

If, as a purchaser, you are interested in addressing childhood lead poisoning services in your purchasing specifications and wish to adopt detailed specifications regarding the qualifications of network providers relating to such services, the following language is for your consideration.

  1. Network requirements -- The Contractor's provider network shall include sufficient providers in the following classes of providers to ensure timely and reasonable access to services covered under this Part:

    1. Primary care practitioners including pediatric providers who shall be trained in pediatric blood lead level screening techniques and clinical management of children with EBLLs; 43

    2. Qualified laboratories;

    3. Qualified pediatric lead treatment providers;

    4. Qualified pediatric lead care centers;

    5. Registered dietitians or other licensed or certified nutrition specialists;

    [Alternative] 44

    1. Case managers who have a demonstrated capacity to develop and oversee a multi-disciplinary plan for children with lead poisoning; 45 and

    [Alternative] 46

    1. Environmental health specialists that are certified or registered under [Drafter insert applicable state or local law, regulation or ordinance.] 47

If, as a purchaser, you are interested in addressing childhood lead poisoning services in your purchasing specifications and wish to adopt detailed specifications to address provider disincentives that may inappropriately limit an enrolled child's access to covered services, the following language is for your consideration.

  1. Evaluation of provider performance 48 -- In evaluating provider performance for purposes of determining financial or other disincentives for provider overuse of covered services, Contractor shall not count screening or diagnostic BLL tests or referrals, pharmacy or inpatient services for children with EBLLs, whether such services are furnished directly or through referral or prescription.

Compliance measure: Contractor shall make available to purchaser a list of participating health providers that conforms to this section.

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§ 006. Lead-Related Access Standards

If, as a purchaser, you are interested in addressing childhood lead poisoning services in your purchasing specifications and wish to adopt detailed specifications regarding enrollee access to such services, the following language is for your consideration.

  1. Time lines for access -- In covering and providing for services relating to childhood lead poisoning under this Part, Contractor shall comply with the following timelines and timelines specified elsewhere in the Part:

    1. Visits for screening services described in this Part shall be scheduled to occur within six (6) weeks of the date of a request by the family of an enrolled child for such services;

    2. Clinical management services for children for whom there is evidence 49 of an EBLL that is an emergency medical condition as defined in §001g shall not be delayed for confirmation of the EBLL by an additional laboratory test.

If, as a purchaser, you are interested in addressing childhood lead poisoning services in your purchasing specifications and wish to adopt detailed specifications regarding outreach to enrolled families in specified circumstances, the following language is for your consideration.

  1. Outreach for families -- Contractor shall maintain procedures for contacting the family of each:

    1. enrolled child for whom a screening or diagnostic BLL test indicates EBLL and who has not returned to the child's provider for medically indicated BLL diagnostic testing or other clinical management services; and

    2. enrolled child who resides in community where there is a heightened risk of lead poisoning as determined by [Drafter insert the childhood lead poisoning prevention program that furnishes services in Contractor's service area or other state or local program or agency with responsibility for determining areas where there is a heightened risk of lead poisoning].

Such procedures shall include informing the families of the importance of blood lead screening, diagnostic BLL testing and other indicated clinical management services [for EBLLs].

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§ 007. Lead-Related Agreements with State or Local Public Health Agencies

If, as a purchaser, you are interested in addressing childhood lead poisoning services in your purchasing specifications and wish to adopt detailed specifications regarding the relationship between a managed care organization (MCO) furnishing services under the specifications and state or local public health agencies that maintain childhood lead poisoning prevention programs, the following language is for your consideration.

  1. Memorandum of understanding required -- For [Drafter identify each state or local public health agency with a childhood lead poisoning prevention program that furnishes services in Contractor's service area] the Contractor shall enter into a written memorandum of understanding (MOU) which shall address the following matters:

    1. Roles and responsibilities of the agency and the Contractor in furnishing and coordinating the following services for enrolled children with EBLLs: clinical management; medical treatment; environmental investigation; case management; outreach; and liaison with [Drafter identify the agency that is responsible for enforcement of state or local law or ordinances that pertain to lead-safe housing].

    2. Procedures for conferring on matters related to the clinical management of EBLLs including coverage determinations and procedures for deeming environments to be "lead safe" for purposes of discharging children from inpatient services or furnishing chelation therapy on an outpatient basis;

    3. Agency responsibilities for providing to Contractor information on the following topics: state and local statutes, policies and regulations addressing EBLLs in children; a statewide childhood lead screening plan where such a plan is in effect; interim lead screening recommendations where such recommendations are in effect; and communities in the Contractor's service area that are at heightened risk for childhood lead poisoning.

    4. Exchange between Contractor and the agency of medical and case management plans for enrollees with EBLLs;

    5. Procedures to be followed by the agency and other providers, agencies, institutions and individuals when referring enrolled children to the Contractor for screening BLL tests or clinical management services for children diagnosed with or suspected of having an EBLL;

    6. Exchange between the Contractor and the agency of data relating to individuals receiving screening and clinical management services described in this agreement;

    7. Procedures for addressing issues relating to continuation of care for children who are disenrolled from the Contractor's plan at a time when they are receiving clinical management services under this agreement or for whom a screening BLL test has indicated an EBLL.

    8. Individuals who will be designated by the Contractor and the agency as liaison for matters relating to EBLLs.

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§ 008. Lead-Related Quality Measurement and Improvement

If, as a purchaser, you are interested in addressing childhood lead poisoning services in your purchasing specifications and wish to specify elements of a quality measurement and improvement program in the area of such services, this language is for your consideration.

  1. The Contractor shall develop and disseminate to network providers practice guidelines that conform with the clinical guidelines and legal standards incorporated into this agreement and that are updated to conform to such guidance and standards as are current at the time that covered services are furnished.

  2. The Contractor shall conduct [Drafter insert frequency] case record reviews which are designed to audit the timeliness and appropriateness of its services related to EBLLs. Such practice reviews shall at a minimum consider the following factors relating to enrollees from birth to age 72 months who were continuously enrolled for a period of at least twelve (12) months (allowing one break in service of up to forty-five (45) days): 50

  1. The number and percentage of enrollees who at least once received a BLL test covered under this agreement;

  2. The number and percentage of enrollees who were diagnosed with an EBLL for whom a written clinical management plan was developed;

  3. The number and percentage of enrollees who were treated for EBLLs;

  4. The number and percentage of enrollees diagnosed with an EBLL for whom a written case management plan was developed;

  5. The number of pediatric primary care providers that furnish BLL screening services and the number and percentage of enrollees screened by such providers.

Compliance measure: The Contractor shall make available to purchaser all practice guidelines and results of clinical studies.

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§ 009. Lead-Related Data and Reporting

If, as a purchaser, you are interested in addressing childhood lead poisoning services in your purchasing specifications and wish to specify minimum data and reporting standards as part of your purchasing specifications, this language is for your consideration.

  1. Integration into enrollee medical record of information on services relating to EBLLs -- The Contractor shall ensure that the medical charts of children covered under this agreement include the following: (1) a written indication of the performance of BLL tests and any verbal risk assessment(s) and the risk-assessment tool used; (2) written indications of other services related to EBLLs furnished under the agreement including referrals for specialty care services and environmental lead services.

  2. Data access for local and state public health departments -- The Contractor shall keep and make available to state and local health agencies individual and aggregate data on lead-related screening and clinical management services as required under the statutes or regulations of the jurisdiction in which screening or clinical management services are furnished.

  3. Public health reporting -- In jurisdictions with childhood lead poisoning surveillance programs, the Contractor shall assure that all laboratories analyzing blood samples for lead under this Part comply with all notification requirements (including time lines for submission of reports) of the jurisdiction in which the enrollee being tested resides.

  4. Quality assurance reporting -- The Contractor shall report data from the clinical practice studies described in this Part to the purchaser and any state or local health agencies with lead-poisoning responsibilities (CLPPP, surveillance) for all or any part of the Contractor's service area.

Compliance measure: Contractor shall make available to purchaser any childhood lead poisoning risk assessment tool used by network providers and standards for medical records kept by network providers.

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Endnotes

  1. Drafter's note: the term The terms "lead poisoning" and "lead toxicity" refer to concentrations of lead in an individual's blood that are associated with harmful health consequences. Because health experts differ on the level of concentration that constitutes lead "poisoning" or "toxicity", the term "elevated blood lead level" (EBLL) is used in this document in relation to Contractor's duties. Drafter' notes indicate where a specific EBLL is applicable (e.g., the level requiring provision of a diagnostic blood lead level (BLL) test for a Medicaid enrollee).
  2. Drafter's note: this description of case management services is consistent with the standard of practice in publicly funded childhood lead poisoning prevention programs.
  3. Drafter's note for Medicaid purchasers: The Medicaid definition of covered case management services permits inclusion of the activities described in this provision ("services which will assist individuals eligible under the plan in gaining access to needed Medicaid, social, educational and other services" 42 U.S.C.''1396d(a)(19).
  4. Drafter's note: the CDC guidelines address clinical management (diagnosis, treatment and follow-up care) of EBLL as well as screening.
  5. http://www.cdc.gov/nceh/lead/guide/guide97.htm
  6. Drafter's note: Agency responsibilities for these activities vary among states and may vary within a state. More than one agency may share responsibility for these activities in a Contractor's service area. In certain states and localities, these programs may not exist.
  7. Drafter's note for Medicaid purchasers: The Health Care Financing Administration (HCFA) has adopted the Centers for Disease Control and Prevention guideline that an EBLL equal to or exceeding 10 micrograms per deciliter may indicate the need for clinical and other interventions. ("If a child is found to have blood lead levels equal to or greater than 10 ug.dL [10 micrograms per deciliter], providers are to use their professional judgment, with reference to CDC guidelines covering patient management and treatment, including follow-up blood tests and initiating investigations to determine the source of lead, where indicated." HCFA, State Medicaid Manual '5132.2 (revised effective October 26, 1998))
  8. Drafter's note: this alternative is offered for consideration of non-Medicaid purchasers in an area where state or local law, regulation or ordinance or public health agency policy specifies an EBLL at which clinical and other interventions are indicated or required.
  9. Drafter's note: this provision is offered for consideration of non-Medicaid purchasers in an area there is no state or local law, regulation or ordinance or public health policy that pertains to clinical and other interventions at a specific EBLL.
  10. Drafter's note: a concentration equal to or greater than 10 micrograms per deciliter, at the time these specifications were drafted.
  11. Drafter's note: two alternative definitions of an emergency medical condition relating to lead are offered for consideration of purchaser in an area where there is a state or local, law, regulations or ordinance or public health policy that pertains to clinical and other interventions at a specific EBLL or an area without such law, regulation, ordinance or policy.
  12. Drafter's note: see note 10.
  13. Drafter's note: such recommendations may be developed by and be available from state public health officials in states that have not adopted statewide childhood lead screening plans.
  14. 42 U.S.C. '4851 et seq.
  15. Drafter's note: three alternative definitions are offered to reflect variations in state laws and policies relating to clinical laboratory qualifications.
  16. 42 U.S.C. '263
  17. Drafter's note: In states and localities where public health agencies maintain lists of pediatric providers who are experienced in the diagnosis and treatment of elevated blood lead levels, the Contractor may consult with such agencies to identify qualified pediatric lead care provider.
  18. Drafter's note: such plans are developed by and available from state public health officials in states that have adopted the plans. Statewide plans may recommend targeted screening for children residing in certain communities within Contractor's service area. Drafter's note for Medicaid purchasers: At the time these sample specifications were drafted, HCFA did not permit targeted lead screening for Medicaid children because these children are all considered to be at risk for lead toxicity. ("At this time, States may not adopt a statewide plan for screening children for lead poisoning that does not require lead screening for all Medicaid children." HCFA, State Medicaid Manual '5132.2 (revised effective October 26, 1998)
  19. Drafter's note: two alternative definitions of an urgent medical condition relating to lead are offered for consideration of purchaser in an area where there is a state or local, law, regulation or ordinance or public health policy that pertains to clinical and other interventions at a specific EBLL and for a purchaser in an area where there is not such a law, regulation or policy.
  20. Drafter's note for Medicaid purchasers: this alternative is for your consideration.
  21. Drafter's note for Medicaid purchasers: periodic screening for lead toxicity is a required element of the Medicaid EPSDT benefit. 42 U.S. C. '1396d(r)(1).
  22. Drafter's note: this alternative is offered for the consideration of non-Medicaid purchasers.
  23. Drafter's note for Medicaid and non-Medicaid purchasers: this subsection provides four alternatives which reflect variations between Medicaid law and state and local public health approaches to population-wide lead toxicity screening.
  24. Drafter's note for Medicaid purchasers: This alternative reflects Federal Medicaid law and HCFA guidance at the time it was drafted. ("�All children are considered at risk and must be screened for lead poisoning. HCFA requires that all children receive a screening blood lead test at 12 months and 24 months of age. Children between the ages of 36 months and 72 months of age must receive a blood lead test screening if they have not been previously screened for lead poisoning. A blood lead test must be used when screening Medicaid-eligible children." 42 U.S.C'1396d(r)(1); HCFA, State Medicaid Manual '5132.2 (revised effective October 26, 1998). A state may establish in its EPSDT periodicity schedule additional standards for lead screening such as use of a lead risk assessment questionnaire and provision of screening services at earlier ages. The screening schedule set out above is a minimum standard and children may receive additional screening tests at other times. ("Any additional blood lead tests continue to be covered based on a providers medical judgment, as well as any medically necessary diagnostic and treatment services coverable under Medicaid." Letter of April 13, 1998 from Sally K. Richardson, Director of the Health Care Financing Administration Center for Medicaid and State Operations to State Medicaid directors.
  25. Drafter's note: other evidence may include: change of a childás residence to a high-risk location; diagnosis of EBLL in a sibling, designation of the community in which a child resides as an area of heightened risk for EBLL; or a parent's report of identified lead hazards in a child's environment or diagnosis of EBLL in children residing in the same community as the child.
  26. Drafter's note: this subsection enumerates services to be furnished for the diagnosis and treatment of EBLL and related services.
  27. Drafter's note for Medicaid purchasers: the services enumerated in this section are allowable services under the HCFA guidance set forth in Notes.
  28. Drafter's note: this description of the content of individualized family education (which may be furnished as anticipatory guidance for Medicaid enrollees) is provided for your consideration; it reflects the topics that health experts have identified for prevention of childhood lead poisoning.
  29. Drafter's note for Medicaid purchasers: "A blood lead test equal to or greater than 10 [micrograms per deciliter] obtained by capillary specimen (fingerstick) must be confirmed using a venous blood sample." HCFA, State Medicaid Manual '5132.2 (revised effective October 26, 1998).
  30. Drafter's note: Medical nutrition services are identified in CDC lead poisoning guidelines as an element in clinical management of EBLL in certain children. Two alternatives are offered for consideration of purchasers.
  31. Drafter's note: eligibility for WIC services is determined on the basis of family income and a child's nutritional status.
  32. 20 U.S.C. '1401 et seq.
  33. Drafter's note: Multi-disciplinary case management, in which clinical management is coordinated with other non-clinical services is identified in CDC lead poisoning guidelines as the primary mechanism for assuring an appropriate response by multiple service systems to EBLL in certain children. Two alternatives are offered for consideration of purchasers.
  34. Drafter's note: In states and localities where public health agencies maintain lists of case managers who are experienced in provision of multi-disciplinary case management as described in '001b, the Contractor may consult with such agencies to identify case managers that meet this standard.
  35. Drafter's note: Investigation of sources of lead hazards in the home of a child diagnosed with EBLL at certain levels is identified in the CDC Lead Poisoning Guidelines as an element in the clinical management of EBLL and may be required by state or local law, regulation or ordinance.
  36. Drafter's note for Medicaid purchasers: Environmental investigation may be an allowable Medicaid service ("Determining the source of lead [in the home of a child with EBLL] may be reimbursable by Medicaid under certain circumstances. Reimbursement is limited to a health professional's time and activities during an on-site investigation of a child's home (or primary residence). The child must be diagnosed as having an elevated blood lead level. Medicaid reimbursement is not available for any testing of substances (water, paint, etc.) which are sent to a laboratory for analysis." HCFA, State Medicaid Manual '5132.2 (revised effective October 26, 1998).
  37. Drafter's note for Medicaid and non-Medicaid purchasers: The CDC guidelines identify specific EBLLs at which initiation of specified interventions may be indicated and provide other guidance on the clinical management of EBLL. This alternative is consistent with HCFA guidance relating to elevated blood lead levels. Non-Medicaid purchasers may also wish to adopt the CDC guidelines as the clinical standard for provision of lead-related services.
  38. Drafterás note: the CDC guidelines address not only screening recommendations but also clinical and other interventions that are indicated when a screening test indicates an EBLL.
  39. Drafter's note: a state or local law, regulation or ordinance may specify the concentration of lead that is considered an EBLL for certain types of non-clinical or clinical interventions.
  40. American Academy of Pediatrics Committee on Environmental Health, Screening for Elevated Blood Lead Levels, Pediatrics 101:6; June, 1998. 1072-1078. Drafter's note: this alternative is offered for consideration by non-Medicaid purchasers in an area where a state or local law, regulation or agency policy pertaining to clinical management of elevated blood lead level is not in effect. As with the CDC guidelines, the AAP recommendations address screening and clinical and non-clinical interventions for EBLL.
  41. Drafterás note: purchasers may wish to include this language, which is designed to foster coordination among providers (Contractor, other agencies and programs) that serve enrollees.
  42. Drafter's note: In states and localities where public health agencies maintain lists of pediatric providers who are experienced in the diagnosis and treatment of elevated blood lead levels, the Contractor may consult with such agencies to identify providers who are competent to review the clinical status and clinical management of such new enrollees.
  43. Drafter's note: In certain states and localities, public health agencies offer such provider training without charge.
  44. Drafter's note: this alternative is provided for consideration of purchasers that wish the Contractor to cover and provide or arrange for case management services.
  45. Drafter's note: In states and localities where public health agencies maintain lists of case managers who are experienced in provision of multi-disciplinary case management as described in this Part, the Contractor may consult with such agencies to identify case managers that meet this standard.
  46. Drafter's note: this alternative is furnished for consideration by purchasers that wish the Contractor to cover and provide or arrange for environmental investigation.
  47. Drafter's note: In states and localities where public health agencies maintain lists of environmental health specialists that meet this standard, the Contractor may consult with such agencies to identify such specialists.
  48. Drafter's note: this provision addresses a specific use of data on the enumerated services. It does not prohibit a Contractor from collecting the data and using it for other purposes such as quality measurement and improvement or provider incentives for lead screening.
  49. Drafter's note: "evidence" may include an EBLL that is identified as an emergency condition in CDC guidelines or state or local law, regulation, ordinance or public health agency policy or signs or symptoms consistent with EBLL.
  50. Drafter's note: HEDIS stipulates that studies of services for Medicaid enrollees may include enrollees for whom there has been one break in enrollment of up to 45 days, in the period covered by the study. This standard is consistent with data on interruptions in Medicaid eligibility and resulting interruptions in enrollment in a Contractor's plan.