In this chapter, the following terms have the meanings indicated. Terms Defined. “Activities of daily living” means functions normally associated with mobility, eating, elimination, body hygiene and dressing. “Attending” means the role of an individual who establishes the plan of treatment and certifies the necessity for home health services for a participant following a hospitalization. “Case coordinator” means a licensed health professional designated by a home health agency to coordinate the care of a participant. “Certified nurse midwife (CNM)” means an individual who meets licensure requirements and conditions for participation as a certified nurse midwife set forth in COMAR 10.09.01. “Certified nurse practitioner” means an individual who meets the licensing requirements and conditions for participation as a nurse practitioner set forth in COMAR 10.09.01. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. 1396 et seq. “Electronic Visit Verification (EVV)” has the meaning stated in COMAR 10.09.36.03-2. “Face-to-face” means contact with a participant that occurs in person or via audio-visual telehealth in accordance with COMAR 10.09.49. “Health team” means the physician or nonphysician practitioner and the home health agency personnel who render services listed in Regulation .04B of this chapter to a participant. “Home” means the place of residence occupied by the participant, including a domiciliary level facility, but other than a hospital, nursing facility, or other medical institution. “Home health agency” means a public or private agency or organization, or part of an agency or organization, that meets the requirements for participation in Medicare. “Home health aide” means a person who meets the requirements of COMAR 10.07.10, and has received instruction from, and renders services under the supervision of, a registered nurse. “In person” means contact with a participant that occurs in the physical presence of the participant and the provider. “Intermittent” means services which are furnished on a medically predictable recurring basis. “Licensed nurse” means a person who is licensed as a registered nurse or as a licensed practical nurse in the jurisdiction in which the service is provided. “Medicaid average rate” means the average projected per diem rate established for the Department's fiscal year as specified in COMAR 10.09.10.07B(2) multiplied by 30. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Medical supplies” means items which are generally recognized under accepted standards of medical practice as serving a therapeutic or diagnostic purpose and are medically necessary to enable home health agency personnel to carry out effectively the care the physician has ordered for the treatment or diagnosis of the patient's illness or injury, and which are accounted for in billing records. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. 1395 et seq. “Newborn early discharge assessment” means a visit to the newborn infant and postpartum mother to observe and assess the health status of both the newborn and the mother. “Nonphysician practitioner” means an individual who: Is licensed as a certified nurse practitioner, clinical nurse specialist, a certified nurse-midwife, or a physician assistant in the jurisdiction in which the service is provided; and Works in collaboration with or under the supervision of the ordering practitioner. “Occupational therapist” means a person who is licensed or registered as an occupational therapist in the jurisdiction in which the service is provided. “Participant” means a person who is certified as eligible for and is receiving Medical Assistance benefits. “Part-time” means services, usually furnished during several visits per week, but not exceeding one visit per discipline per day, unless unusual circumstances are documented by the physician, which are reasonable and necessary to the treatment of an illness or injury. “Physical therapist” means a person who is licensed or registered as a physical therapist in the jurisdiction in which the service is provided. “Physician” means an individual who meets the licensure requirements and conditions for participation set forth in COMAR 10.09.02. “Physician assistant” means an individual who meets license requirements and conditions for participation set forth in COMAR 10.09.55. “Program” means the Maryland Medical Assistance Program. “Progress note” means a dated, written notation by a member of the health team which summarizes facts about the care given and the patient's response during a given period of time, specifically addresses the established goals of treatment, is consistent with the patient plan of care, is written immediately following each visit, and is part of the provider's permanent record for the participant. “Provider” means a person or an organization who meets the requirements of Regulations .03 and .04 of this chapter and who, through an appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. “Speech-language pathologist” means a person who is licensed as a speech-language pathologist in the jurisdiction in which the service is provided. “Supervision” means authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic evaluation of the act of accomplishing the function or activity. “Support system” means a family member, friend, neighbor, or any person who renders services, which would otherwise be covered under Regulation .04 of this chapter, to the participant. “Telehealth” has the meaning stated in COMAR 10.09.49.02. “Visit” means the time spent rendering a covered service to a participant at home by an individual employed by a home health agency. “Witness” means a person who on behalf of the participant is able to personally verify at the time of service that the participant received home health care. A home health agency shall be licensed pursuant to Health-General Article, §§19-401—19-408, Annotated Code of Maryland, or shall be part of a hospital or related institution licensed pursuant to Health-General Article, §§19-301—19-359, Annotated Code of Maryland, or shall be legally authorized to provide home health services in the jurisdiction in which the service is provided. To be a provider, a home health agency shall be a participating home health agency under Medicare. To participate in the Program, the home health agency shall: Apply for participation in the Program using the form designated by the Department; Be approved for participation by the Department; Have in effect a provider agreement with the Department; Accept payment by the Department as payment in full for covered services rendered and make no additional charge to any person for covered services; Provide verification to the Department, in the manner prescribed by the Department, of all changes in the provider's charges within 10 days of the occurrence of the changes; Maintain all patient care, medical supply, timesheets, official agency recipient or witness signature records, and billing records for a minimum of 6 years after completion of an audit by the Department and make them available, upon request, to the appropriate State and federal personnel or their designees during office hours; Secure from the participant's physician, physician assistant, certified nurse midwife, or certified nurse practitioner a written plan of treatment which relates the items and services to the participant's medical condition; Maintain a participant's plan of care based on the physician's, physician assistant's, certified nurse midwife's, or certified nurse practitioner's plan of treatment for the participant; Provide services without regard to race, color, age, sex, national origin, marital status, or physical or mental handicap; Verify the participant's eligibility; Place no restriction on a participant's right to select his choice of providers under this subtitle; Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary, the provider may not seek payment for that service from the participant; Agree that if the Program denies payment due to late billing, the provider may not seek payment from the participant; Provide services in person unless expressly authorized by the Department to render services via telehealth; and If not rendering services in person, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. Plan of Treatment. The plan of treatment under §B(8) shall include: Prognosis; Diagnoses; Treatment goals; Frequency of visits for each type of service ordered; Duration of treatment of each type of service ordered; Rehabilitation potential; Functional limitations; Permitted and prohibited activities; Diet; Medications; Treatments; Mental status; Medical supplies; Durable medical equipment; Safety measures to protect against injury; and Other appropriate items. The plan of treatment shall be reviewed, updated, and signed at least every 60 days by the participant's physician, physician assistant, certified nurse midwife, or certified nurse practitioner, in consultation with the registered nurse or the case coordinator. The physician, physician assistant, certified nurse midwife, or certified nurse practitioner shall: Sign and date the initial plan of treatment; and Document that the physician or nonphysician practitioner, who is not employed by the home health agency, has had a face-to-face encounter with the participant no more than 90 days before the home health start of care date or within 30 days of the start of the home health care, including the date of the encounter. For participants admitted immediately to home health upon discharge from a hospital or post-acute setting, the attending acute or post-acute physician shall document the clinical findings of the face-to-face encounter. The plan of treatment shall be part of the provider's permanent record for the participant. Plan of Care. For each type of service ordered, the plan of care under §C(9) shall, at a minimum, include: Goals of treatment; Actions or procedures needed to meet the goals; Dates the goals are expected to be achieved; Problems encountered, if any; Revision of goals and actions or procedures, whenever necessary; and Appropriate discharge activities. The plan of care shall be reviewed, dated, and signed at least every 60 days by the registered nurse or the case coordinator upon consultation with the appropriate health team. The plan of care is a part of the provider's permanent record for the participant. The Program covers the services listed in §§B and C of this regulation when the services are: Provided upon the written order of a physician, physician assistant, certified nurse midwife, or certified nurse practitioner; Furnished under the current plan of treatment; Ordered by an individual who is enrolled as a provider in the Program with an active status on the date of service; Consistent with the current diagnosis and treatment of the participant's condition; In accordance with accepted standards of medical practice; Required by the medical condition rather than the convenience or preference of the participant; Considered under accepted standards of medical practice to be a specific and effective treatment for the participant's condition; Required on a part-time, intermittent basis; Rendered in the participant's home, or other setting when normal life activities take the participant outside the home, by an approved provider; Received by the participant as documented by the participant's signature or the signature of the participant's witness on the home health agency's official forms; and Adequately described in the signed and dated progress notes. The Program covers the following services: Skilled nursing services provided by a licensed nurse when the complexity of the services, or the condition of a participant, requires the judgment, knowledge, and skills of a licensed nurse; Home health aide services provided by a home health aide, that include: Assistance with activities of daily living as defined in Regulation .01B of this chapter when performed in addition to other home health services; Other health care services properly delegated by the registered nurse pursuant to the Maryland Nurse Practice Act as set forth in Health Occupations Article, Title 8, Annotated Code of Maryland, that may include, but are not limited to: Noninvasive parts of ostomy or catheter care; Nonsterile dressing changes; Procedures; Exercises; Reporting of the participant's condition and needs; and Completion of appropriate records; Physical therapy services, provided by a physical therapist: When the condition of a participant requires the judgment, knowledge, and skills of a licensed or registered physical therapist; When the services are directly related to the physician's, physician assistant's, certified nurse midwife's, or certified nurse practitioner's plan of treatment, which specifies: Body part or parts to be treated; Type of modalities or treatments to be rendered; Expected results of physical therapy treatments; Frequency and duration of treatment; When the services are of a diagnostic, rehabilitative, or therapeutic nature and: Are provided with the expectation, based on the assessment made by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner, that a participant will improve significantly in physical functioning in a reasonable and generally predictable period of time; or Are necessary to the establishment of a safe and effective maintenance program required in connection with a specific disease state; Occupational therapy services, provided by an occupational therapist: When the condition of the participant requires the judgment, knowledge, and skills of a licensed occupational therapist; When the services are provided with the expectation that there will be a significant practical improvement in a participant's level of physical functioning within a reasonable period of time; and When the services fall within one or more of the following categories: Evaluation and reevaluation of a participant's level of functioning by administering diagnostic and prognostic tests; Selection and teaching of task-oriented therapeutic activities designed to restore physical function; Teaching of compensatory techniques to improve the level of independence in the activities of daily living; Training in the use of supportive and adaptive equipment, and assistive devices required for independent performance; Improvement of mobility skills; and Speech-language pathology services performed by a licensed speech-language pathologist when the: Services are of a diagnostic, rehabilitative, or therapeutic nature and: Are provided with the expectation, based on the assessment made by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner, that a participant will improve significantly in a reasonable and generally predictable period of time; or Are necessary to the establishment of a safe and effective maintenance program required in connection with a specific disease state; and The condition of a recipient requires the judgment, knowledge, and skills of a speech-language pathologist. The Program covers a provider's newborn early discharge assessment visit to a participant when the assessment: Is 4 hours or less; Is ordered by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner; Is delivered to a participant and a participant's mother who have been discharged within 48 hours after delivery; Occurs within 36 hours after discharge; Includes: An evaluation of the presence of immediate problems of dehydration, sepsis, infection, jaundice, respiratory distress, cardiac distress, or other adverse physical symptoms of the infant; An evaluation of the presence of immediate problems of dehydration, sepsis, infection, bleeding, pain, or other adverse physical symptoms of the mother; Collection of a blood specimen for newborn screening as described in COMAR 10.52.12; An evaluation of risk factors that identify biological factors for the infant, maternal health behaviors, psychosocial environmental problems, or any other concerns or problems perceived by the nurse that are identified on a form specified by the Department; and Referrals for any continuing health care services, including skilled nursing services under COMAR 10.09.53 or home health services under this chapter; and Is conducted by a registered nurse. A provider may deliver services in §B of this regulation via telehealth if: The Department expressly authorizes the provider to render services via telehealth; and The patient's plan of care specifies that the service may be delivered via telehealth. The Program does not cover the following: Nonskilled services rendered by licensed nurses, physical therapists, occupational therapists and speech pathologists; Services and medical supplies that are not medically necessary and appropriate; Durable medical equipment except as covered under COMAR 10.09.12; Services primarily for the purpose of housekeeping, including but not limited to: Cleaning of floor and furniture; Laundry; and Shopping; Home health aide services unless biweekly supervisory visits by a registered nurse in the participant’s home are made, every second visit of which shall include observations of the delivery of services by the aide to the participant; Home health aide services rendered to participants with chronic conditions when those participants require only assistance with activities of daily living as defined in Regulation .01B of this chapter unless preauthorized as specified in Regulation .06 of this chapter; Meals; More than one visit per type of service per day, unless preauthorized as specified in Regulation .06 of this chapter; Any service or combination of services specified in Regulation .04 of this chapter and rendered during any 30-day period for which payments by the Program to the provider exceed the Medicaid average nursing facility rate unless preauthorized as specified in Regulation .06 of this chapter; Four or more hours of care per day whether the 4-hour limit is reached in one visit or in several visits in one day unless preauthorized as specified in Regulation .06 of this chapter; Services for investigational and experimental purposes; Services specified in Regulation .04 of this chapter to persons eligible for Medicare coverage of those services; A service not documented as received by the participant as indicated by the participant’s signature or the signature of a witness on the home health agency's official form; Supervisory visits by a registered nurse to monitor services of a home health aide; Initial assessments by a therapist or a registered nurse; Services provided for the convenience or preference of the participant or primary caregiver rather than as required by the participant’s medical condition; Services specified in Regulation .04 of this chapter which duplicate or supplant services performed by the participant and those services rendered by the participant’s family; Services which are covered by other insurance or entitlement programs; Newborn early discharge services provided more than one time to a participant; A newborn early discharge visit provided on the same day as another skilled nursing visit billed under this chapter; and Home health services ordered by an: Individual who is not enrolled as a provider in the Program with an active status on the date of service; and Entity, facility, or another provider that is not an individual. Preauthorization is required for: More than one visit per type of service per day; Any service or combination of services specified in Regulation .04 of this chapter and rendered during any 30-day period for which the provider anticipates payments from the program in excess of the Medicaid average nursing facility rate; Four or more hours of care per day whether the 4-hour limit is reached in one visit or in several visits in one day; and Any instances in which home health aide services without skilled nursing services are provided. Preauthorization may be: Issued by telephone when the provider submits to the Department or its designee adequate documentation demonstrating that the service or services are medically necessary. Denied when the Department, after taking into consideration the particular circumstances of the participant, determines the payments to the provider for any service or combination of services rendered during any 30-day period would exceed the cost to the program of any alternative services which could be used for the same purpose. The provider shall submit his request for payment on the form designated by the Department. To receive payment for services under Regulation .04 of this chapter, a provider and its workers shall use the Electronic Visit Verification method and data management system approved by the Department to document time and submit claims in accordance with COMAR 10.09.36.03-2. The provider shall submit requests for payment for supplies on the same invoice which requests payment for the visit during which the supplies were used. The Department reserves the right to return to the provider, before payment, all invoices not properly completed. Payment Rates. The provider shall be paid the lesser of: The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The rate in accordance with the Department's fee schedule. For out-of-State providers, rates shall be paid at the lower of the following: The home state's Medicaid rate for the same service rendered by the same provider if the provider participates in its home state Medicaid Program; or The rate paid for the same service rendered by a provider in the nearest Maryland county. The Department shall pay home health providers for medical and other supplies which are used during a covered home health visit as part of the treatment ordered by the participant's physician, physician assistant, certified nurse midwife, or certified nurse practitioner at a rate that is the lesser of the: Provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or Medicaid rate for the supply or pharmaceutical under COMAR 10.09.12 and 10.09.03. Subject to the limitations of the State budget, the fee schedule rates shall be adjusted annually by the same factor used by the Centers for Medicare and Medicaid Services in updating Medicare's prospective payment system rates. The annual fee schedule rate adjustment shall be limited to a maximum of 5 percent and be effective the date on which Medicare's rate changes are implemented. The fee schedule effective January 1, 2025 is as follows: Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. The Department shall reimburse for supervision of home health aide services by a registered nurse as part of the home health aide reimbursement. Payment to a provider of newborn early discharge services may not exceed the rate for one skilled nursing visit. The Department shall reimburse for preauthorized home health services upon verification that a face-to-face encounter with the participant was performed as described under Regulation .03C of this chapter. The home health provider shall identify the individual who ordered the home health services by recording the individual practitioner's National Provider Identifier (NPI) number on the claim. Recovery and reimbursement regulations are set forth in COMAR 10.09.36. Cause for suspension or removal and imposition of sanctions are set forth in COMAR 10.09.36. Appeal procedures are set forth in COMAR 10.09.36. State regulations are interpreted as set forth in COMAR 10.09.36. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland Effective date: July 1, 1985 (12:11 Md. R. 1048) Regulations .01B and .05L amended, and .05M adopted as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); adopted permanently effective November 1, 1990 (17:20 Md. R. 2427) Regulation .01B amended effective November 12, 1990 (17:22 Md. R. 2656) Regulation .03C amended effective November 12, 1990 (17:22 Md. R. 2656) Regulation .04B amended effective April 4, 1988 (15:7 Md. R. 849); November 12, 1990 (17:22 Md. R. 2656) Regulation .05F, I amended effective November 12, 1990 (17:22 Md. R. 2656) Regulation .05F, J amended effective April 4, 1988 (15:7 Md. R. 849) Regulation .06A amended effective April 4, 1988 (15:7 Md. R. 849); November 12, 1990 (17:22 Md. R. 2656) Regulation .07E amended effective April 4, 1988 (15:7 Md. R. 849) Regulation .07F 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 .07F 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 .08B amended effective November 12, 1990 (17:22 Md. R. 2656) Regulation .10A amended effective May 12, 1986 (13:9 Md. R. 1029) Chapter revised as an emergency provision effective October 1, 2000 (28:1 Md. R. 21); emergency status extended at 28:7 Md. R. 687 and 28:22 Md. R. 1931 (see 28:24 Md. R. 2125); emergency status expired October 28, 2001 Chapter revised effective October 29, 2001 (28:21 Md. R. 1856) Chapter revised effective March 12, 2007 (34:5 Md. R. 560) Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787); September 30, 2013 (40:19 Md. R. 1544); June 14, 2021 (48:12 Md. R. 470); November 27, 2023 (50:23 Md. R. 1004) Regulation .02 amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .03 amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .03B amended effective June 14, 2021 (48:12 Md. R. 470); November 27, 2023 (50:23 Md. R. 1004) Regulation .03C amended effective September 30, 2013 (40:19 Md. R. 1544); June 14, 2021 (48:12 Md. R. 470) Regulation .04 amended effective June 14, 2021 (48:12 Md. R. 470) Regulation .04A amended effective January 1, 2018 (44:26 Md. R. 1214) Regulation .04B amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .04C repealed effective September 26, 2016 (43:19 Md. R. 1072) Regulation .04D amended effective March 10, 2008 (35:5 Md. R. 641) Regulation .04D adopted effective November 27, 2023 (50:23 Md. R. 1004) Regulation .05 amended effective December 27, 2010 (37:26 Md. R. 1787); January 1, 2018 (44:26 Md. R. 1214); June 14, 2021 (48:12 Md. R. 470) Regulation .05W amended effective March 10, 2008 (35:5 Md. R. 641) Regulation .06 amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .06B amended effective June 14, 2021 (48:12 Md. R. 470) Regulation .07 amended effective December 27, 2010 (37:26 Md. R. 1787); November 27, 2023 (50:23 Md. R. 1004) Regulation .07D amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .07D, H amended effective June 14, 2021 (48:12 Md. R. 470) Regulation .07E amended effective June 14, 2010 (37:12 Md. R. 800); May 11, 2026 (53:9 Md. R. 412) Regulation .07H adopted effective September 30, 2013 (40:19 Md. R. 1544) Regulation .07I adopted effective January 1, 2018 (44:26 Md. R. 1214)