The following terms have the meanings indicated. Terms Defined. “Concentrator” means a device which removes nitrogen from ambient air, thus increasing the percentage of oxygen, and delivers the resulting oxygen-enhanced air to the patient. “Current stable arterial blood gas results” means stable arterial blood gas results on room air within 1 month before the requested date of submission of the form designated by the Department. “Demurrage” means a charge imposed by a provider for the detention of an oxygen cylinder or other equipment. “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. “Emergency services” means unscheduled deliveries or maintenance visits to the home or nursing home by the provider because of a threat to the patient's life caused by insufficient supply of oxygen or equipment malfunction. “Home” means the place of residence occupied by the recipient, other than a hospital or a nursing facility. “Hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-301 et seq., Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the State in which the service is provided. “Intermittent Positive Pressure Breathing (IPPB) Equipment” means an apparatus designed to force a combination of ambient air or medication, or both, into a patient's respiratory system. “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. “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. “Nasal continuous positive airway pressure (NCPAP) system” means a noninvasive apparatus designed to maintain air or oxygen, or both, under constant positive pressure through the nose during sleep. “Nursing facility” means a Comprehensive Care Facility which falls within the jurisdiction of the Health-General Article, §19-301 et seq., Annotated Code of Maryland, or other applicable standards established by the State in which the service is provided. “Oxygen” means pure liquid or gaseous oxygen, not in combination with other medical gases, packaged in suitable safe containers for administration to patients. “Prepayment authorization” means the approval required from the Department or its designee before services can be rendered. “Prescriber” means a physician licensed to prescribe oxygen and related respiratory equipment in the state in which the service is provided. “Program” means the Maryland Medical Assistance Program. “Provider” means an individual, association, partnership, or incorporated or unincorporated group of individuals who, through an appropriate agreement with the Department, has been identified as a Program supplier of oxygen and related respiratory equipment by the issuance of an individual account number. “Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. “Related respiratory equipment” means accessories used to move, direct, measure, or control the flow of oxygen from its container, or from a concentrator, to the patient. To participate in the Program, the provider shall: Unless exempt from Medicare accreditation requirements: Be accredited by a Medicare-approved accreditation organization; Effective November 1, 2011, provide documentation of: Accreditation; or Having submitted an application for accreditation; and Effective April 1, 2012, be accredited or terminated from the Program; Apply for participation in the Program using the application form designated by the Department; If located more than 25 miles from the border of Maryland, shall provide to the Program documentation demonstrating that the enrollment and screening requirements of 42 CFR Part 455, Subpart E have been performed within the 12 months preceding the application for initial enrollment or revalidation of enrollment by: A Medicare contractor; or The Medicaid agency or the Children’s Health Insurance Program of another state; Be approved for participation by the Department; Verify the recipient's eligibility; Maintain for a minimum of 6 years adequate records which are sufficient in detail to support the invoices submitted for payment, and make these records available upon request to the Department or its designee; Provide service without discrimination as to race, creed, color, age, sex, national origin, marital status, or physical or mental handicap; Not knowingly employ a former Medicaid provider, or a former employee of a Medicaid provider, to provide service to Medical Assistance patients after that provider or employee has been disqualified from the Program, unless prior approval has been received from the Department; Accept payment by the Department as payment in full for services rendered, and make no additional charge to any person for covered services; Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or preauthorized, the provider may not seek payment for that service from the recipient; Agree that if the Program denies payment due to late billing, he may not seek payment from the recipient; Place no restriction on a recipient's right to select providers of the recipient's choice; Have emergency services available on a 24 hour-a-day basis; Be prepared to furnish necessary maintenance and repairs to oxygen and related respiratory equipment; Insure on every visit to the patient that all oxygen and related respiratory equipment functions properly; Provide suitable identification, including a recent photograph, which employees who visit patients at home will carry on their person and display on request; Agree to discontinue billing or remove equipment promptly, if the patient dies, is institutionalized, or otherwise ceases to require the oxygen; Provide an ancillary source of oxygen to last at least 24 hours when the primary source is a concentrator. The following medically necessary items and services are covered for pulmonary use in the patient's home or nursing facility pursuant to §§B, C, D, and E of this regulation: Rental or purchase for use in patient's home or nursing facility of: Oxygen, gaseous (tank contained); Oxygen, liquid. Rental of concentrators. Rental or purchase of the following related respiratory equipment: Rental of equipment included in complete oxygen set-up: Flow meter; Humidity jar; Nasal cannula; Oxygen face mask; Regulator; Safety stand; Tubing; Rental of portable oxygen unit; Rental or purchase of the following tracheostomy equipment: Trach tubes; Tracheostomy trays; Humidity system, complete set-up to include tracheostomy collar or T-tube, tubing, humidity jar, and compressor; Heater; Water trap; Other related equipment: Rental or purchase of aerosol compressor (complete set-up) to include compressor unit, medication cup, connector fitting, tubing, hand-held nebulizer, and mouthpiece, face mask, or tracheostomy collar or T-tube; Rental or purchase of ultrasonic nebulizer (complete set-up) to include ultrasonic aerosol chamber with blower, medication cup, connector fitting, corrugated tubing, and mouthpiece, face mask, or tracheostomy collar or T-tube; Resuscitator bag, manual. Rental or purchase of an intermittent positive pressure breathing (IPPB) machine (complete set-up) to include: Compressor; Medication cup; Nebulizer; Connector fitting; Corrugated tubing; Nebulizer hose; Exhalation hose; Exhalation valve; and Mouthpiece. Rental or purchase of a nasal continuous positive airway pressure (NCPAP) system (complete set-up) to include: Flow generating device; Valve mechanism to maintain pressure; Nasal mask and headgear; and Tubing and reservoir. Repairs to purchased respiratory equipment. Replacement items for purchased equipment. The items in §A(1), (2), and (3)(a) and (b) of this regulation are covered when: The patient's current stable arterial blood gas results (at rest, using room air) for PaO2 are 60 mm Hg or less after optimal treatment; or The patient’s saturation level is 88 percent or less on room air or less than 93 percent for patients younger than 21 years old; or The patient's: Baseline study demonstrates sleep apnea or disordered breathing events, or both, (hourly rates >30 episodes/hour) with oxygen desaturation (oxyhemoglobin desaturation <85 percent by ear oximetry which is the equivalent to PaO2 <50 mm Hg); and Repeat study on supplemental oxygen demonstrates either a 30 percent reduction in the number of apneic episodes or disordered breathing events, or both, or improved oxyhemoglobin saturation (>85 percent by ear oximetry which is equivalent to PaO2 >50 mm Hg) throughout the night. The items in §A(5) of this regulation are covered when the patient's: Baseline study demonstrates more than 30 episodes per hour of obstructive sleep apnea (OSA), each lasting 10 seconds or more, or other disordered breathing events (DBE's), with evidence of clinical impairment (that is, daytime hypersomnolence or cor pulmonale); and Study of NCPAP demonstrates a greater than 90 percent reduction in frequency of OSA or other DBE's, with improvement in clinical symptoms. The items in §A(4) of this regulation are covered when the patient's pulmonary function studies show: A vital capacity of less than 1.5 liters (with a normal FEV1; or An absolute FEV1 of 1.5 liters or less. The items in §A(3)(d)(i) and (ii) of this regulation are covered when: The patient's pulmonary function studies show an FEV1/FVC percentage of 45 or less (calculated as FEV1 divided by FVC); or Unable to test for §E(1), of this regulation, other objective signs/symptoms of severe airway obstruction. The items in §A(1)—(5) of this regulation are covered when they are ordered in writing, by a physician, including documentation that a face-to-face encounter occurred within 6 months before ordering prescribed services, as follows: The physician's initial order and plan of treatment shall include: When prescribing oxygen: Diagnosis and indication for oxygen use; Liter flow rate per minute (at rest, and when exercising if prescribing portable oxygen); Number of hours to be used during a 24-hour period; Description of equipment to include route of administration; Rehabilitative goals; Hospital discharge or clinical summary; Current stable arterial blood gas results to include PaO2, PaCO2, and Ph on room air and on oxygen at rest, and, if prescribing portable oxygen, when exercising, or sleep apnea study results. When prescribing aerosol equipment: Diagnosis and indication for use; Number of hours to be used during a 24-hour period; Description of equipment to include route of administration; Rehabilitative goals; Hospital discharge or clinical summary; Pulmonary function study results. When prescribing tracheostomy equipment: Diagnosis and indication for use; Description of equipment to include quantity requested, period of time required, and approximate cost; Rehabilitative goals. When prescribing an NCPAP system: Diagnosis and indication for use; Specification of NCPAP fixed level; Rehabilitative goals; Clinical summary, including appropriate sleep studies. The physician's subsequent orders shall include: When prescribing oxygen for other than sleep apnea, an update of the items listed in §F(1)(a) of this regulation if the patient's condition regarding the need for oxygen has changed since the previous orders; When prescribing oxygen for sleep apnea, an update of the items listed in §F(1)(a) of this regulation; When prescribing aerosol equipment, an update of the items listed in §F(1)(b) of this regulation; When prescribing tracheostomy equipment, an update of the items listed in §F(1)(c) of this regulation; When prescribing an NCPAP system, an update of the items listed in §F(1)(d) of this regulation. The physician's subsequent orders for oxygen when prescribing for sleep apnea shall be made within: One year of the effective date of the initial preauthorization; or At the time the patient's condition is changed by significant intervention, as follows, not to exceed that 1-year period: Significant weight loss of more than 10—15 percent; Surgical intervention on upper airway; Tracheostomy; Positive airway pressure. The Program does not cover: Any service or items not identified in Regulation .04 of this chapter; Demurrage; Charges for delivery; Equipment prescribed primarily to provide comfort or convenience, including, but not limited to, air conditioners and room humidifiers; Items which are investigational or experimental in nature; Oxygen and related equipment not for pulmonary use; Pre-set oxygen for emergency use; Trach string or tape. The Program places the following limitations upon covered services: Reimbursement for aerosol equipment will only be provided if a hand held nebulizer has been tried and is not successful, as indicated in the clinical summary; Reimbursement for IPPB machine will only be authorized if the aerosol compressor with the nebulizer kit has been tried and is not successful, as indicated in the clinical summary; Reimbursement may not be made for: Repairs or replacement parts for rented items; Oxygen prescribed on an as-needed basis (PRN); Oxygen prescribed for stand-by purposes; Piped-in oxygen; Oxygen and related respiratory equipment and services provided in a facility or by a group when reimbursement is covered by another segment of the Program; and Payment for portable oxygen will be made only when: It is required in the pursuit of medical treatment; and The medical necessity is indicated for this type of system. The following items require a written prepayment authorization: Nasal continuous positive pressure (NCPAP) system; Custom made tracheostomy tubes; and Intermittent positive pressure breathing (IPPB) machine. Prepayment authorization is issued when: Program procedures are met; Program limitations are met; and The Prescriber submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary. The prescriber shall submit requests for prepayment authorization in writing using the format and procedures designated by the Department. Prepayment authorization, when required, may be requested via a facsimile machine to expedite hospital, nursing facility, or other medical institutional discharge or in emergency situations approved by the Program. In this case, the facsimile of the completed prepayment authorization form shall be followed by a written request, using the original of the form, which shall be submitted immediately to the Department. Written prepayment authorization is valid for a period to be determined by the Program but not to exceed a maximum of 365 days beginning with the date of issue by the Program, and is contingent on the recipient's continuing eligibility. Prepayment authorization normally required by the Program is waived when the services are covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require prepayment authorization according to §§A—E of this regulation. The provider shall submit request for payment on the forms designated by the Department, with attachments when applicable. The Department reserves the right to return to the provider, before payment, all invoices not properly signed and completed and those submitted without required documentation. The provider shall charge the Program the provider’s customary charge to the general public for similar items. If the item is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with §D of this regulation; and The provider’s reimbursement is not limited to the provider’s customary charge. The Department shall reimburse providers for the purchase of covered services at the lowest of the provider’s customary charge: For items for which Medicare has established a rate: The Department shall pay providers 80 percent of the Medicare rates established on January 1 of each year for oxygen and respiratory equipment and supplies, which shall include all fitting, dispensing, and follow-up care; and For respiratory equipment for which Medicare has established a capped rental rate, the purchase price shall be 9 times the current Medicare monthly rental rate; and For items for which Medicare has not established a rate: Oxygen and respiratory supplies at the provider's choice of the manufacturer's suggested retail price minus 41.2 percent or the provider's wholesale cost plus 37.2 percent; Customized equipment or supplies at the provider's choice of the manufacturer's suggested retail price minus 30 percent or the provider's wholesale cost plus 40 percent; and Other oxygen and respiratory equipment at the provider's choice of the manufacturer's suggested retail price minus 41.2 percent or of the provider's wholesale cost plus 27.4 percent. The Department shall pay for repairs to purchased oxygen and respiratory equipment in accordance with the following: The provider's choice of wholesale cost plus 37.2 percent or manufacturer's suggested retail price minus 31.4 percent for all materials; and Reasonable charges for labor, not to exceed the customary charges for similar services in the provider’s area unless the service is free to individuals not covered by Medicaid; or Actual charges for repairs done by other than the provider as evidenced by an invoice attached to the bill. The Department shall only pay separately for the following replacement items for purchased respiratory equipment, and all other replacement items shall be included in repairs and will be reimbursed according to §E of this regulation: Mouthpiece; Face mask; Tracheostomy collar or T-tube. When any individual item or combination of items are provided as part of a complete setup, they may not be invoiced in the Program separately, but under complete setup procedure codes as listed in the fee schedule, except for replacement items as listed in §F of this regulation. The Program will approve for payment the least expensive mode of oxygen which is medically suited for the patient's condition. The Program will determine, based upon expected duration of medical need, whether oxygen related equipment will be purchased or rented. Once an item has been purchased and paid for in full, and if the Program has contributed in full or in part to the purchase, then title to the equipment shall remain with the Department, and the equipment, after use by the recipient, shall be recovered at the option of the Department. Supplemental payment on Medicare claims is made subject to the following provisions: Deductible insurance will be paid in full; Co-insurance will be paid in full; Services not covered by Medicare but by the Program will be paid in accordance with the limitations of §E of this regulation. The Department will authorize payment on Medicare claims if: The provider accepts Medicare assignments; Medicare makes direct payment to the provider; Medicare has determined that services were medically justified; The services are covered by the Program; and Initial billing is made directly to Medicare according to Medicare guidelines. The Department may not make direct payments to recipients. The provider may not bill the Program for: Services rendered by mail or telephone; Completion of forms or reports; or Broken or missed appointments. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Oxygen and respiratory equipment and disposable medical supply rates may be increased at the Program's discretion, when the Program determines in its sole discretion that the Medicare rate creates a barrier to accessing oxygen and respiratory equipment and supplies. Refills. For oxygen and respiratory equipment and supplies that are supplied as refills to the original order, providers shall contact the recipient or designee before dispensing the refill in order to ensure that the refilled item is necessary and to confirm any changes and modifications to the order. The provider shall contact recipient or designee regarding the refills no earlier than 7 days before the delivery and shipping date. For subsequent deliveries of refills, the provider shall deliver the items no earlier than 5 days before the end of usage for the current product. If the recipient has insurance or other coverage, or if any other person is obligated either legally or contractually to pay for or to reimburse the recipient for any service covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less. The provider shall reimburse the Department for any overpayment. If the Department determines that a provider, any agent or employee of a provider, or any person with an ownership interest in the provider, has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: Suspension from the Program; Withholding of payment by the Department; Removal from the Program; Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. If the Secretary of Health and Human Services suspends or removes the provider from participation in Medicare, the Department will take similar action. The Department will give the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. A provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify recipients that he no longer honors Medical Assistance cards before he renders additional services. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-129, Annotated Code of Maryland Effective date: January 1, 1984 (10:25 Md. R. 2268) Regulation .01B amended effective November 5, 1984 (11:22 Md. R. 1899); May 2, 1988 (15:9 Md. R. 1108); May 29, 1989 (16:10 Md. R. 1109); April 5, 2010 (37:7 Md. R. 570) Regulation .03 amended effective April 16, 2012 (39:7 Md. R. 491); April 13, 2015 (42:7 Md. R. 568) Regulation .03D amended effective April 5, 2010 (37:7 Md. R. 570) Regulation .03H amended effective May 29, 1989 (16:10 Md. R. 1109) Regulation .03P, .05, .06F, and .07D, F, G amended effective November 5, 1984 (11:22 Md. R. 1899) Regulation .04 amended effective November 5, 1984 (11:22 Md. R. 1899); May 2, 1988 (15:9 Md. R. 1108); May 29, 1989 (16:10 Md. R. 1109) Regulation .04B amended effective September 11, 2017 (44:18 Md. R. 866) Regulation .04B, F amended effective April 5, 2010 (37:7 Md. R. 570) Regulation .04F amended effective April 16, 2012 (39:7 Md. R. 492) Regulation .05B amended effective May 2, 1988 (15:9 Md. R. 1108); April 5, 2010 (37:7 Md. R. 570); September 11, 2017 (44:18 Md. R. 866) Regulation .06 amended effective October 27, 2003 (30:21 Md. R. 1529); April 5, 2010 (37:7 Md. R. 570) Regulation .07 amended effective April 5, 2010 (37:7 Md. R. 570) Regulation .07C, E, M amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); emergency status expired October 28, 1984 Regulation .07D amended effective August 12, 1985 (12:16 Md. R. 1606) Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 1, 1987 (14:2 Md. R. 129) Regulation .07D amended effective May 2, 1988 (15:9 Md. R. 1108); October 27, 2003 (30:21 Md. R. 1529); April 2, 2012 (39:6 Md. R. 408): February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 473) Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625) Regulation .07O amended effective September 10, 1984 (11:18 Md. R. 1584) Regulation .07O 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 .07O 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 .08A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .10 amended effective January 24, 2011 (38:2 Md. R. 84)