In this chapter, the following terms have the meanings indicated. Terms Defined. “Department” means the Maryland Department of Health. “Dietitian or nutritionist” means an individual who: Meets the licensing requirements in Regulation .02D of this chapter; Meets the conditions of participation in Regulation .03A and D of this chapter; and Has a provider agreement with the Department as a Program provider of dietary and nutrition services. “Enriched maternity service” means direct counseling, educational, case coordination, and referral services provided to a pregnant or postpartum recipient by or under the supervision of a physician or nurse midwife in conjunction with the clinical services provided by the physician or nurse midwife during the prenatal or postpartum visit. “Family support center” means a community-based and operated center which provides parenting education, health education, child development assessment services, education and job skill development services, and social support services to families. “Healthy Start High-Risk Nutrition Instrument” means the form designated by the Department for the purpose of identifying pregnant participants in need of high-risk nutrition counseling services. “Healthy Start Prenatal Risk Assessment Instrument” means the form furnished by the Department to the provider for the purposes of documenting the results of the prenatal risk assessment and developing the participant's plan of care. “Healthy Start Program” means a program designed to identify and address medical, nutritional, and psychosocial predictors of poor birth outcomes and poor child health by providing enhanced prenatal and postpartum services to pregnant and postpartum recipients. “High-risk nutrition counseling services” means educational services provided to nutritionally high-risk pregnant participants by a dietitian or nutritionist. “Local health department” means the local agency responsible for ensuring the availability of basic public health services in each local jurisdiction, and for administering and enforcing certain State and local health laws and regulations. “Maternal and Child Health Services Block Grant” means funds allotted by the federal government under Title V of the Social Security Act. “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Nurse” means an individual who is licensed as a registered nurse in the state in which services are provided. “Nurse midwife” means an individual who: Meets the licensing requirements of Regulation .02A of this chapter; Meets the conditions of participation in Regulation .03A—C of this chapter; and Has a provider agreement with the Department as a Program provider of nurse midwife services. “Participant” means a pregnant or postpartum recipient who: Enters the Healthy Start Program during a medically verified pregnancy, or up to 60 days after delivery; May continue in the program receiving postpartum family planning services up to 60 days after the delivery; and Elects to receive the services available under these regulations. “Physician” means a doctor of medicine or osteopathy who: Is licensed to practice medicine in the state in which services are provided; Has a provider agreement with the Department as a Program provider of physician services; and Meets the conditions of participation in Regulation .03A—C of this chapter. “Program” means the Maryland Medical Assistance Program. “Provider” means a qualified provider of services under the Healthy Start Program who meets the conditions of participation in Regulation .03 of this chapter. “Provider agreement” means a contract between the Department and the provider. “Recipient” means an individual who is certified for and is receiving Medical Assistance benefits. “Risk assessment—plan of care” means a package of services provided to a pregnant participant by or under the supervision of a physician or nurse midwife in conjunction with the clinical services provided by the physician or nurse midwife, to include: A comprehensive risk assessment appraising the participant's medical history and current health, nutritional, psychological, and social status; and An individualized plan of care developed by the provider in consultation with the participant. “Social worker” means a person who is licensed as a social worker in the state in which services are provided. “Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)” means the federally funded program authorized under an amendment to the Child Nutrition Act of 1966 (PL 94-105) to provide supplemental foods and nutrition education to pregnant and postpartum women, infants, and young children from families with low incomes who are at risk by reason of inadequate nutrition or health care. “Tertiary care maternity center” means a facility with all necessary equipment and personnel specifically trained to care for high-risk obstetrical patients and with the capability to perform all necessary tests and obstetrical procedures 24 hours a day. A certified nurse midwife providing Healthy Start services shall be: Licensed as a registered nurse in the state in which services are provided; Certified as a nurse midwife by the American College of Nurse-Midwives; and In compliance with requirements to practice nurse midwifery in the state in which services are provided. Physicians providing Healthy Start services shall be licensed and legally authorized to practice medicine in the state in which the services are provided. Dietitians or nutritionists providing Healthy Start Program services shall be licensed in the state in which the services are provided. General requirements for participation in the Medical Assistance Program are that providers shall: Meet the licensure requirements in Regulation .02 of this chapter, and verify the licenses and credentials of all professionals employed by the provider; Apply for participation in the Program using an application form designated by the Department; Be approved for participation by the Department; Have a provider agreement with the Department in effect; Be identified as a Program provider by issuance of an individual provider number; Verify the eligibility of recipients; Accept payment by the Program as payment in full for services rendered and make no additional charge to any person for the covered services specified in Regulation .04 of this chapter; Provide services without discrimination on the basis of race, color, sex, national origin, marital status, physical or mental handicap; Maintain adequate records concerning service provision for a minimum of 6 years and make them available, upon request, to the Department or its designee; Not knowingly employ or contract with any person, partnership, or corporation which has been disqualified from the Program to provide or supply service to Medical Assistance recipients, unless prior written approval has been received from the Department; Agree that claims rejected for payment due to late billing may not be billed to the participant; Not place a restriction on the recipient's right to choose the provider; Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or has not been preauthorized, the provider may not seek payment for that service from the participant; and Be selected by the participant from among qualified providers. Specific requirements for providers of risk assessment-plan of care services are that providers shall: Be physicians or nurse midwives; Provide the covered services as specified in Regulation .04A of this chapter in conjunction with the pregnant participant's initial clinical prenatal visit or, otherwise, as early as possible in the pregnancy; Maintain the participant's consolidated medical record; and Agree to on-site visits by Department staff to monitor adherence to Regulation .04A of this chapter. Specific requirements for providers of enriched maternity services are that providers shall: Be physicians or nurse midwives or be under the supervision of a physician or nurse midwife; Provide the covered services as specified in Regulation .04B of this chapter in conjunction with each prenatal clinical visit of the pregnant participant and each postpartum clinical visit of the postpartum participant up to 60 days after the delivery; and Agree to on-site visits by Department staff to monitor adherence to Regulation .04B of this chapter. Specific requirements for participation in the provision of high-risk nutrition counseling services are that providers shall: Be a dietician or nutritionist as specified in Regulation .02C of this chapter; Contact the recipient within 10 working days of the receipt of a referral from a local health department or private prenatal care provider, unless client-related extenuating circumstances are documented; and Agree to on-site visits by Department staff to monitor adherence to Regulation .04C of this chapter. Effective July 1, 2006, the Program shall reimburse for the following services: Risk Assessment — Plan of Care. One unit of service is to be reimbursed for each pregnancy. A risk assessment is an appraisal of the participant's medical history and current health, nutritional, psychological, and social status, as specified in the Healthy Start Risk Assessment Instrument. It results in the identification of problems having an impact on the outcome of the pregnancy and the subsequent health care status of the child. Based on the assessment, an appropriate plan of care is drafted and appropriate referrals are made. A copy of the completed Healthy Start Risk Assessment Instrument will be sent by the provider to the participant's local health department within 10 working days of the risk assessment. A plan of care is a description of the services and resources required to meet the participant's needs identified through the risk assessment. An individual participant's plan of care: Includes a description of the specific action steps necessary to address each identified need; Matches the risk status of the participant to the appropriate intensity and breadth of care; Describes the elements of care, provider or providers, and facilities to be utilized by the participant; Is subject to modification as new information arises during the course of care, including information communicated from the provider of home-visiting services; Is individualized and is developed in consultation with the participant; and Encompasses the continuum of care from the prenatal period through postpartum. Enriched Maternity Service. A maximum of one unit of service is to be reimbursed in conjunction with each prenatal and postpartum clinical visit of the participant. The following components comprise enriched maternity service: Prenatal and postpartum counseling and education. This component shall include, but not be limited to, the following topics: The benefits and recommended schedule of prenatal visits, including routine laboratory and radiological services; Danger signs of pre-term labor, including how to differentiate between normal and abnormal signs and symptoms related to pregnancy and what actions the individual should take; Preparation for labor and delivery, including hospital registration procedures; The risks of using prescription and over-the-counter medicines during pregnancy; The risks of alcohol, tobacco, and controlled substance use; The benefits of proper dental care; The benefits of seat belt and infant car seat use; The importance of postpartum care and continuing family planning services; and Arrangements for pediatric care. Nutrition education for pregnant and postpartum participants. This component shall include, but not be limited to, the following topics: The relation of proper nutrition to a healthy pregnancy and to a successful pregnancy outcome; Kinds and amounts of foods needed to meet nutritional requirements during pregnancy; Appropriate weight gain during pregnancy, and components of gain; Early decisions about infant feeding practices; Benefits of, and preparation for, breastfeeding; Appropriate use of nutritional supplements, if prescribed; A postpartum woman's nutritional needs; and The benefits of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Case coordination and referral for pregnant participants. This component shall include, but not be limited to, the following activities: Telephone reminders before prenatal and postpartum appointments and follow-up telephone contact if the participant misses an appointment; Referral of the participant to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); Referral of the participant to specialty services as indicated; Referral of the participant to high-risk nutrition counseling as indicated; Referral of the participant to high-risk obstetrician-gynecologist specialists, perinatologists, or other specialists based on the client's medical needs; Arrangements for hospital delivery, including delivery at a tertiary care maternity center as indicated; Arrangements for pediatric care; and Assistance in arranging for transportation to and from clinical services. High-Risk Nutrition Counseling Services. These services are provided to nutritionally high-risk pregnant participants. Nutritionally high-risk pregnant participants are identified to the high-risk nutrition counseling services provider through the Healthy Start High-Risk Nutrition Instrument. The services include, but are not limited to, the following: Making a nutritional assessment including the recording and interpretation of anthropometric measurements, clinical and laboratory findings, medical conditions, nutrient and drug interactions, diet history, and psychological, social, cultural, religious, and economic factors affecting food intake; Developing a nutritional care plan based on problems identified through the assessment and integrated into the total plan of care; Determining appropriate interventions to achieve care plan goals consistent with the participant's culture, family composition, and restrictions imposed by income, transportation availability, and neighborhood food resources, including, but not limited to, counseling for food habit and behavior change, diet modifications for medical conditions, and referral for food assistance; and Monitoring and recording participant's progress toward goal achievement. The Healthy Start Program may not restrict or otherwise affect: Eligibility for benefits under Title XIX of the Social Security Act or other available benefits or programs; and The provider's right to bill the Program for other covered program services. Request for Payment. Requests for payment of Healthy Start Program services rendered and completed shall be submitted by an approved provider according to procedures established by the Department. Payment requests which are not properly prepared or submitted may not be processed, but shall be returned unpaid to the provider. Requests for payment shall be submitted on the invoice form specified by the Department. A separate invoice shall be submitted for each participant. The completed form shall indicate the: Date or dates of service; Participant's name and Medical Assistance number; Provider's name, location, and provider number; and Nature, unit or units, and procedure code or codes of covered services provided. Providers shall bill the Program for the appropriate fee specified in §C of this regulation. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Payments shall be made: Only to a qualified provider for covered services rendered to a participant, as specified in these regulations; According to the applicable rate under COMAR 10.09.02 or 10.09.21 for risk assessment—plan of care, and enriched maternity service; According to methodology described in the memorandum of understanding between the Program and each local health department for risk assessment—plan of care; For high-risk nutrition counseling as follows: To federally qualified health centers, according to COMAR 10.09.08.05; To each local health department, according to the methodology described in the memorandum of understanding between the Program and each local health department; To Maryland qualified health centers, according to COMAR 10.09.08.06; and To all other eligible providers, according to COMAR 10.09.02.07D. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions are set forth in COMAR 10.09.36.08. Appeal procedures are as set forth in COMAR 10.09.36.09. State regulations are interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: July 1, 1989 (16:12 Md. R. 1337) Regulations .01—.05 amended as an emergency provision effective August 1, 1989 (16:16 Md. R. 1745); amended permanently effective November 29, 1989 (16:22 Md. R. 2364) Regulation .01B amended effective September 3, 1990 (17:17 Md. R. 2080); July 20, 1992 (19:14 Md. R. 1283); June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795) Regulation .02 amended effective July 20, 1992 (19:14 Md. R. 1283); November 23, 2006 (33:23 Md. R. 1795) Regulation .02G adopted effective September 3, 1990 (17:17 Md. R. 2080) Regulation .03 amended effective November 23, 2006 (33:23 Md. R. 1795) Regulation .03A, E amended effective June 2, 1997 (24:11 Md. R. 794) Regulation .03D, E amended effective July 20, 1992 (19:14 Md. R. 1283) Regulation .03F adopted effective September 3, 1990 (17:17 Md. R. 2080) Regulation .04 amended effective July 20, 1992 (19:14 Md. R. 1283); June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795) Regulation .04F adopted effective September 3, 1990 (17:17 Md. R. 2080) Regulation .04G, H adopted effective July 20, 1992 (19:14 Md. R. 1283) Regulation .05 amended effective June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795) Regulation .05B amended, C adopted effective July 20, 1992 (19:14 Md. R. 1283) Regulation .06B amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .06B amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .06C amended effective September 3, 1990 (17:17 Md. R. 2080); July 20, 1992 (19:14 Md. R. 1283); June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795) Regulations .07—.10 repealed and new Regulations .07—.10 adopted effective June 2, 1997 (24:11 Md. R. 794) Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .02D repealed effective December 27, 2010 (37:26 Md. R. 1787) Regulation .03D amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .03E repealed effective December 27, 2010 (37:26 Md. R. 1787) Regulation .04D repealed effective December 27, 2010 (37:26 Md. R. 1787) Regulation .06C amended effective December 27, 2010 (37:26 Md. R. 1787); February 27, 2017 (44:4 Md. R. 252)