In this chapter, the following terms have the meanings indicated. Terms Defined. “Acute hospital” means an institution that provides active, short-term medical diagnosis, treatment, and care. “Administrative day” means a day of medical services delivered to a participant who no longer requires the level of care that the provider is licensed to deliver. “Admission” means the formal acceptance by a hospital of a participant who is to be provided with room, board, and medically necessary services in an area of the hospital where individuals stay at least overnight. “Ancillary services” means diagnostic and therapeutic services including but not limited to radiology, laboratory tests, pharmacy, and physical therapy services, provided exclusive of room and board. “Appropriate facility” means: A facility located within a 25-mile radius of the participant’s residence; or If acceptable to the participant, a more distant facility, which is licensed and certified to render the participant’s required level of care, except when the only facility or facilities that provide the level of care and specialized services required by the participant exceed that distance. “Brain injury” means an injury or insult to the brain that occurs after birth and is not related to congenital or degenerative disease, which results in cognitive, physical, behavioral, or emotional disability that is documented in the medical record. “Brain injury community integration program” means a program located on the campus of a licensed chronic hospital and approved by the Department to treat individuals with primary diagnoses of brain injury resulting in functional limitations and disability, who need services designed to transition to home or a community-based program of services and supports. Chronic Hospital. “Chronic hospital” means an institution licensed by the Maryland Department of Health in accordance with COMAR 10.07.01.03B, which provides services to patients with complex medical needs who do not require hospitalization in an acute hospital, but whose treatment needs exceed the capabilities of a nursing facility. “Chronic hospital” does not mean a: Long-term care hospital, as defined at 42 CFR §412.23(e); or Long-term care facility, as defined at 42 CFR §483.5(a). “Concurrent review” means a periodic reauthorization of continued medical eligibility for the level of services provided by a chronic hospital which allows for close monitoring of the participant’s progress, treatment goals, and objectives, performed during an inpatient hospitalization. “Date of service” means: For inpatient hospitalizations, the date of admission into a chronic hospital up to, but not including, the date of discharge; or For outpatient services, the date services are rendered in the outpatient department of the hospital. “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Designee” means any entity designated to act on behalf of the Department. “Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record or transaction. “Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. “Interdisciplinary team” means a physician-led multidisciplinary clinical team consisting of, at a minimum: The participant or an individual of the participant’s choice; A physician; A registered nurse; A social worker; The participant’s case manager; and Any other clinical professional indicated by an individual’s specific needs, including but not limited to: A psychologist; A behavioral analyst; A dietitian or nutritionist; and Licensed therapists in other disciplines. “Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with 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 participant, family, or provider. “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Neuro-behavioral” means the discipline within medical rehabilitation that focuses on behavioral impairments seen in association with brain injury resulting from trauma, hypoxia, or ischemia. “Out-of-State hospital” means any hospital outside of Maryland, except for hospitals located in the District of Columbia. “Outpatient services” means services provided to the participant on the hospital campus that do not require hospital admission. “Participant” means an individual who is enrolled with the Department to receive Medical Assistance services. “Program” means the Maryland Medical Assistance Program. “Provider” means a chronic hospital which, through agreement with the Department, has been identified as a Program provider by the issuance of a provider number. In order to participate in the Program, a provider shall: Be licensed by the Department pursuant to Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, as a hospital; and Obtain any other licenses required by COMAR 10.07.01. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: If located in Maryland, comply with requirements of: Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and COMAR 10.10.01; or If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided and with the requirements of COMAR 10.09.09.02. The provider shall obtain accreditation by the Commission on Accreditation of Rehabilitation Facilities if it provides neuro-behavioral rehabilitation or brain injury services. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. To participate in the Program as a chronic hospital services provider, the provider shall: Meet the requirements of Title XIX of the Social Security Act for participation as a hospital, as issued by the U.S. Department of Health and Human Services; 24 hours per day, 7 days per week, meet the following staffing requirements: On-call or on-site physician services; On-site registered nurses; On-site respiratory therapist services; and On-site advanced cardiac life support services; Directly provide or make available through contractual arrangements or transfer agreements, medically necessary covered services; Accept payment by the Program as payment in full for the covered service; Make available to the Department or its designee the participant’s medical record for review and certification of medical necessity for admission and continuation of stay; and Maintain documentation of each contact with the participant as part of the complete medical record, which, at a minimum, includes: Date of service; The participant’s chief medical complaint or reason for admission; A description of the services provided, including: Progress notes; Imaging studies; Laboratory results; Medication administration records; and Discharge summary; and A signature, electronic or handwritten, along with the printed or typed name of the individual providing care, with the appropriate title. To participate in the Program as a provider operating a brain injury community integration program, the provider shall be: Accredited by the Commission on Accreditation of Rehabilitation Facilities; and Approved by the Department to provide the Program. Staff Requirements. In addition to the requirements in Regulation .03 of this chapter, a brain injury community integration program shall meet staffing requirements, as approved by the Program, necessary to provide the neuro-behavioral management programming set forth in Regulation .05D of this chapter. At least annually, in a form specified by the Program, a provider operating a brain injury community integration program shall report on the individuals admitted to and participating in the program, including: Length of stay; Discharge setting; and Any other data specified by the Program. Chronic hospitals shall provide the following services: Complex respiratory care services; Complex wound care services; Services for participants with multiple co-morbidities, including but not limited to services necessary to care for: Ventilator-assisted individuals who have been ventilator dependent for less than 6 months and who need further medical stabilization or are candidates for weaning from ventilator assistance; Tracheostomy participants who require suctioning more frequently than every 2 hours or are candidates for decannulation; More than two extensive stage IV decubiti which require daily intensive treatment that is not available in a nursing facility; or Extensive post-operative or post-traumatic care with multiple drains or extensive dressing change or therapies beyond the capabilities of a nursing facility; For participants admitted for medically necessary rehabilitation services, physical therapy, occupational therapy, or speech therapy, directed by an interdisciplinary team; and Ancillary services. Treatment Plan. Within 24 hours of a participant’s admission, a physician shall perform a documented face-to-face evaluation of the participant and begin developing an individualized treatment plan designed to meet the participant’s assessed needs. By the 7th day of a participant’s admission, an interdisciplinary team shall establish a written, individualized treatment plan for the participant, which shall include, at a minimum: Diagnoses; Treatment goals; Frequency of interventions for each type of service ordered; Duration of treatment of each type of service ordered; and Prognosis. The physician-led interdisciplinary team shall update the individualized treatment plan weekly until discharge. The Program covers outpatient hospital services provided by a chronic hospital when the services are: Medically necessary; and Provided to individuals who are eligible for Medical Assistance and who are not current inpatients at the chronic hospital, except when payment for certain outpatient services provided to a participant on the date of inpatient admission or within 3 calendar days before the date of an inpatient admission are bundled, in accordance with 42 CFR §412.2(c)(5). The program covers the following brain injury community integration program services: Neuro-behavioral management programming, which includes, but is not limited to: Assessment of maladaptive behaviors using valid and reliable behavioral measurement tools; Pharmacologic intervention provided to manage maladaptive behaviors related to brain injury; Neuro-behavioral programming created, implemented, overseen, and revised as needed; Incorporation of neuro-behavioral programming into therapy and care for participants in the community integration program; and Referral to a neuro-psychiatrist, as needed, if a neuro-psychiatrist is not a member of the facility staff; Cognitive skills adaptation and compensation programming, including: Specific programming dedicated to cognitive skills adaptation and compensation; and Incorporation of cognitive compensatory strategies into community integration program participant’s interdisciplinary team treatment; Community re-entry programming, including specific programming dedicated to social or pragmatic skills, leisure skills, and life skills; and According to the participant’s needs: The services of a psychiatrist or psychiatric nurse; Services and supports related to substance use disorders and other addictions; Speech therapy, which includes but is not limited to: Cognitive skills; Communication skills; Swallowing ability; and Linguistic programming that assists the patient to connect the meaning of words to their context; Occupational therapy, which includes but is not limited to: Instrumental activities of daily living; and Community re-entry activities; Physical therapy, which includes but is not limited to: Ambulation; and Motor planning and coordination; Dietary services, which includes but is not limited to nutritional needs assessment and monitoring; and Case management, which includes but is not limited to: Treatment planning; and Discharge planning. The Program covers administrative days approved by the Department or its designee according to the conditions set forth in Regulation .08C of this chapter. The Program does not cover: Services for individuals who are not eligible for Medicaid; Services for individuals who are not medically eligible for chronic hospital services; Services identified by the Department or its designee as not medically necessary; Hospital services, procedures, drugs, or hospital admissions that are investigational or experimental; Duplicated care or services; Interpretation of laboratory tests or panels; Inpatient and outpatient diagnostic and laboratory services not ordered by the attending physician or other practitioner involved in the participant’s care; or Telephones, televisions, or personal comfort items or services. General Requirements. An admission to a chronic hospital is medically necessary for a participant whose: Medical condition is not stabilized subsequent to a course of treatment at an acute hospital, or whose deteriorating medical condition resulted in a readmission to an acute hospital from a nursing facility or community setting; and Service and care needs require active and continuing medical treatment at an intensity and frequency not provided in a nursing facility, as defined in COMAR 10.09.10.01B, such as: 24-hour availability of a physician, physician assistant, or nurse practitioner, and associated nursing staff; and Active and continuing medical treatment by a physician at least three times per week as documented in the medical record, physician orders, and physician progress notes. An admission to a chronic hospital is medically necessary for a participant who: Requires rehabilitation services of a lesser intensity or frequency than the acute inpatient rehabilitation services provided in a special rehabilitation hospital; and May have comorbidities or a level of medical complexity that preclude admission to a special rehabilitation hospital. A participant who may not be able to fully participate in a chronic hospital rehabilitation program may be admitted for a brief trial period of inpatient care after review by the Department or its designee and approval by the Program. If no progress on rehabilitative goals occurs, the participant shall be discharged to a lower level of care. Medical Criteria for Brain Injury Community Integration Programs. In order to be preauthorized by the Program for services in a brain injury community integration program, a participant: Shall have a primary diagnosis of brain injury; Shall be at low risk of potential medical instability; May not require acute inpatient physical rehabilitation services; Shall require an intensive neuro-behavioral or neuro-cognitive rehabilitation program at a chronic level of care as described in §A of this regulation in order to: Address pervasive and persisting maladaptive behaviors, or behavioral health risk factors, that preclude a safe discharge to the community or to a less restrictive setting; and Relearn basic living and adaptive skills; Shall have potential for achievement of specific functional outcomes with the potential of improving functional ability so that discharge to a less restrictive setting is a reasonable goal; Shall need rehabilitative programming, which may include: Recreation therapy; Speech language pathology; Occupational therapy; Physical therapy; and Neuro-psychology; Shall require at least two contacts daily within the rehabilitative programming that address the neuro-behavioral or neuro-cognitive needs of the participant; Shall require active and continued clinical treatment by a physician who is experienced in neuro-rehabilitation and in psychopharmacology for a minimum of three contacts per week; Shall require a structured and integrated environment of care that provides on-going behavioral programming designed to reduce maladaptive behaviors that are reinforced by clinical support and administrative staff; Shall make progress toward the achievement of specified functional outcomes; and Shall have the ability to participate in the required number of therapy sessions. Admission and Prior Approval. For participants and individuals who have applied for Medical Assistance, the provider shall request a determination from the Department or its designee at the time of admission, or at the time of application for Medical Assistance, that the individual meets the medical eligibility criteria set forth in Regulation .07A of this chapter. For a participant to be preauthorized for services in a brain injury community integration program, a provider that meets the requirements of Regulation .04 of this chapter shall request a determination from the Department or its designee that the participant meets the criteria set forth in Regulation .07B of this chapter. If the provider obtains the determination set forth in §A(1) or (2) of this regulation after admission, the eligibility determination shall be effective on the date that the determination was requested. Concurrent Review. On a monthly basis, the provider shall notify the Department or its designee of all persons who have: Received an initial determination of medical eligibility for chronic hospital services; Been determined to continue to meet medical eligibility criteria for chronic hospital services; Been discharged; or Been determined to no longer be medically eligible. Concurrent review shall be conducted every 14 days as long as the participant remains hospitalized to ensure the medical necessity of the participant’s inpatient stay. The Department or its designee may conduct on-site reviews. Administrative Days. To be paid for administrative days, the provider shall document, in a form designated by the Department, information which satisfies the conditions listed below: The participant who was initially eligible has been determined to no longer require chronic hospital services, and the provider has: Received a determination from the Department or its designee that the participant requires the level of service provided by a nursing facility but an appropriate facility is not available; Established a plan for discharge during the period of administrative days, is actively pursuing placement at an appropriate level of care for the participant, and has documented this activity in the participant’s record; and Submitted documentation to the Department or its designee that placement activity was conducted no fewer than 3 days per week during the period for which payment is requested for administrative days; or The participant is no longer medically eligible to receive chronic hospital services but cannot be moved, and the following conditions are met: The medical reason the participant cannot be moved is documented by the attending physician in the participant’s medical record; The attending physician reevaluates the medical cause of the participant’s inability to be moved at least once every 7 days; and The provider documents the active treatments used to resolve the medical cause of the participant’s inability to be moved; To receive reimbursement for administrative days, the provider shall document that it has met the conditions of §C(1) of this regulation, at least every 14 days. Documentation shall be submitted to the Department or its designee no later than 3 business days following the end of the 14-day period. Reimbursement of Maryland Chronic Hospitals. In-State chronic hospitals shall be reimbursed according to: Rates approved by the HSCRC pursuant to COMAR 10.37.03; or The administrative day rate as follows: For a participant who is not ventilator-dependent, payment for approved administrative days shall be the estimated Statewide average Medicaid nursing facility payment rate as determined by the Department; and For a participant who is ventilator-dependent, payment for approved administrative days shall be the estimated average Medicaid nursing facility payment rate for ventilator-dependent residents as determined by the Department. State-operated chronic hospitals shall be reimbursed according to Regulation .10 of this chapter. The Department shall make no direct reimbursement to any State-operated chronic hospital. Reimbursement of Out-of-State Hospitals. The Department shall reimburse an out-of-State hospital that provides a level of service equivalent to that provided at a chronic hospital only if: The proposed admission is first reviewed by the Department or its designee and the out-of-State placement is determined medically necessary according to Regulation .07A of this chapter; The hospital possesses the same certifications and accreditations as the Program requires for a comparable level of services and specific program in a Maryland chronic hospital; and The hospital meets one of the following conditions: The hospital proposes to provide a service or specific treatment that the participant cannot obtain in a Maryland chronic hospital; or The hospital is located geographically closer to the established residence of the participant than a Maryland chronic hospital. The Department shall reimburse an out-of-State hospital at the lesser of: The average rate established by the HSCRC for an equivalent cost center for a Maryland chronic hospital; or The rate charged by the out-of-State hospital pursuant to 42 CFR Part 412, Subpart O. The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. For hospitals who do not submit reports within 5 months, for whom an extension has not been granted, and who are reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall: Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and Refund withholdings at cost settlement. If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. The Program shall grant an extension for submission of cost reports: Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or Concurrent with any extension granted to the hospital by Medicare, but not to exceed 60 days from the due date of cost reports. In addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §B of this regulation, when a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year and the provider has not received an extension, the Department may impose one or more sanctions as provided for in Regulation .14 of this chapter. When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled. For purposes of §§A—F of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. Final settlement for services in the provider’s fiscal year shall be determined based on Medicare retrospective cost principles found at 42 CFR §413, adjusted for Program allowable costs. Allowable costs specific to the Program shall be limited to a base year cost per discharge increased by the applicable federal rate of increase times the number of Program discharges for that fiscal year. Base Year. For purposes of determining limits on the increase of cost, in accordance with Medicare regulations, the base year for an existing provider shall be the first year of entering into the Program or the first year separate rates for the unit or units of service or services are approved. The provider shall supply the Department or its designee the assurances necessary to establish that its customary charges to participants liable for payment exceed the allowable cost for these services. Revision of Interim Rates. The provider may request an interim rate revision should the actual and projected cost exceed the interim rate by 10 percent. The provider shall furnish the Department or its designee with appropriate schedules showing the reason for the increase and any other information supporting the request. The Department will lower the provider’s interim rate to closely approximate the final allowable reasonable cost based on the results of the prior year’s review. The provider may request not more than two interim rate revisions during the accounting year. Cost Settlement. The provider shall submit to the Department or its designee a Medicaid cost report based on actual data using the cost reporting forms used by Medicare for retrospective cost reimbursement. The provider shall also submit a copy of its Maryland Medical Assistance log. The submitted cost report shall be in sufficient detail to support a separate cost finding for designated Maryland Medical Assistance unique cost centers. Tentative cost settlements may not be performed on a routine basis. However, the Program reserves the right to calculate tentative settlements in limited cases, when appropriate, as determined by the Department. The provider shall furnish the Department or its designee with a finalized Medicare cost report for the cost reporting year. The Department will base final settlement on the results of the finalized Medicare cost reports. The Department or its designee shall notify each provider participating in the Program of the results of the final settlement under Regulation .11 of this chapter. Within 60 days after the provider receives the notification described in §A of this regulation, the Department shall pay the amount due to the provider regardless of whether the provider files an appeal. The provider may request review of the settlement under Regulation .11 of this chapter by filing written notice with the Program’s Appeal Board within 30 days after receipt of the notification of the results of the settlement from the Department or its designee. The Appeal Board shall be composed of the following: A representative of the hospital industry who is: Knowledgeable in Medicare and Medicaid reimbursement principles; and Appointed by the Secretary of the Department; A person who: Is employed by the State; Is knowledgeable in Medicare and Medicaid reimbursement principles; Did not participate in the verification of costs; and Is appointed by the Secretary of the Department; and A third member selected by the first two members of the Appeal Board. When the Appeal Board reviews an appeal from a provider in which an Appeal Board member is employed or in which the member has a financial or personal interest, the Secretary of the Department shall designate an alternate for the member. If the provider elects not to appeal to the Appeal Board: The provider shall pay the amount due within 60 days after the notification described in §A of this regulation; If the provider requests a longer payment schedule within 60 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule; and The Department shall establish a longer payment schedule if, in the Department’s judgment based on sufficient documentation submitted by the provider, failure to grant a longer payment schedule would: Result in financial hardship to the provider; or Have an adverse effect on the quality of participant care furnished by the facility. If the provider elects to appeal to the Appeal Board, the following provisions apply: Within 30 days after a provider appeals a determination by the Department or its designee that the provider owes money to the Program, the Department or its designee shall: Recalculate the amount due to the Program based on the verification, exclusive of the amount in controversy which is subject to the appeal; and Notify the provider of that amount; In order to enable the Department or its designee to perform this recalculation, the provider shall indicate the specific adjustment and the specific amount being appealed; Subject to the provisions of §G(4) of this regulation, payment for the amount due the Program, if any, after the recalculation, shall be made within 60 days after the provider receives notification of the recalculation; and If a provider requests a longer payment schedule within 60 days after the provider receives notification of the recalculation, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §F(3) of this regulation. Appeal Board Findings. After the Department receives the findings of the Appeal Board, the Department shall: Determine the amount that is due either to the Program or to the provider; and Notify the provider of that amount. The portion of the amount in controversy that is paid is subject to an award of interest that is: Calculated from the date the appeal was filed through the date of payment; and Based on the 6-month Treasury Bill rate in effect on the date the appeal was filed. Interest paid to a provider under §H(2) of this regulation is not subject to any offset or other reduction against otherwise allowable costs. If the provider accepted the determination made under §H(1) of this regulation, within 60 days after the provider receives the notification under §H(1) of this regulation, the Program shall pay the amount the Department determined is due the provider, if any. Subject to §H(6) of this regulation, within 60 days after the provider receives the notification, the provider shall pay the amount due the Program, if any. If a provider requests a longer payment schedule within 30 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §F(3) of this regulation. After expiration of the 60-day payment period, or longer payment schedule established by the Department as described in §§F—H of this regulation, and in addition to the sanctions provided in Regulation .14 of this chapter, the Department may recover the unpaid balance by withholding the amount due from the interim payment which would otherwise be payable to the provider. The Department or a provider aggrieved by a reimbursement decision of the Appeal Board may appeal the decision of the Appeal Board as the final decision for judicial review under the Administrative Procedure Act, State Government Article, §10-222, Annotated Code of Maryland. If the provider or the Department appeals the final decision of the Appeal Board, the provider or the Department shall place any money due from the provider or from the Program in an interest-bearing escrow account. The money due shall include the interest, based on the rate in §H(2)(b) of this regulation, calculated from the date of the administrative appeal through the date of opening the escrow account. The money shall remain in escrow until a final decision has been rendered. Upon a final determination of the dispute, the appropriate person administering the escrow account shall distribute the money in that account, including any interest accrued, in conformity with the final determination. The provider may file an appeal of the results of the settlement with the Medicare Appeal Board as a substitute for the Department’s Appeal Board, and the decision rendered by the Medicare Appeal Board will be accepted by the Department as binding. General policies governing recovery and reimbursement procedures applicable to all providers are set forth in COMAR 10.09.36.07. If refund of a payment as specified in §A of this regulation, is not made, the Department shall reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment. Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. A provider filing an appeal from an administrative decision made in connection with these regulations shall do so according to COMAR 10.09.36.09. General policies governing the interpretive regulations applicable to all providers are set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland Effective date: April 10, 2017 (44:7 Md. R. 354) Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 487) Regulation .05A amended effective May 20, 2019 (46:10 Md. R. 487) Regulation .07A amended effective May 20, 2019 (46:10 Md. R. 487) Regulation .08A, B amended effective May 20, 2019 (46:10 Md. R. 487)