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<chapter num="12" heading="Disposable Medical Supplies and Durable Medical Equipment" title_num="10" subtitle_num="09">
  <regulation prefix="Regulation" num=".01" heading="Definitions.">
    <paragraph num="A.">
      <text>In this chapter, the following terms have the meanings indicated.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Terms Defined.</text>
      <paragraph num="(1)">
        <text>“Customary charge” means the uniform amount that the provider charges in the majority of cases for a specific supply or piece of equipment, excluding token charges for charity patients and substandard charges for welfare and other low income patients.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>“Customized equipment” means durable medical equipment which is uniquely constructed or substantially modified by the provider from the standard product:</text>
        <paragraph num="(a)">
          <text>For a specific recipient according to the description and orders of a physician; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>In such a way that the equipment can only be used by the specific recipient.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>“Department” means Maryland Department of Health as defined in COMAR 10.09.36.01.</text>
      </paragraph>
      <paragraph num="(4)">
        <text>“Disposable medical supplies” means consumable or disposable items with minimal or no potential for reuse which are used to serve a medically necessary purpose and, with the exception of disposable gloves and incontinence supplies, have no practical use in the absence of illness, injury, disability, or health condition.</text>
      </paragraph>
      <paragraph num="(5)">
        <text>“Durable medical equipment” means equipment which satisfies all of the following requirements:</text>
        <paragraph num="(a)">
          <text>It can withstand repeated use;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>It is used to serve a medically necessary purpose; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>It has no practical use in the absence of illness, injury, disability, or health condition.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(6)">
        <text>“Home” means that place of residence occupied by the recipient, including an assisted living facility, but other than a hospital, nursing facility, or other medical institution.</text>
      </paragraph>
      <paragraph num="(7)">
        <text>“Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, 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.</text>
      </paragraph>
      <paragraph num="(8)">
        <text>“Incontinence” means the inability to refrain from yielding to the urge to urinate or defecate for persons previously having bowel or bladder control or individuals who are lacking bowel or bladder control due to congenital anomalies or postnatal insult.</text>
      </paragraph>
      <paragraph num="(9)">
        <text>“Invoice” means a form designated by the Department for use by providers in submitting bills for payment.</text>
      </paragraph>
      <paragraph num="(10)">
        <text>“Maximum allowable reimbursement” means the payment limitation established by the Department.</text>
      </paragraph>
      <paragraph num="(11)">
        <text>“Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01.</text>
      </paragraph>
      <paragraph num="(12)">
        <text>“Medically necessary” means that the service or benefit is:</text>
        <paragraph num="(a)">
          <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Consistent with current accepted standards of good medical practice;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Not primarily for the convenience of the consumer, family, or provider.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(13)">
        <text>“Medicare” means Medicare as defined in COMAR 10.09.36.01.</text>
      </paragraph>
      <paragraph num="(14)">
        <text>“Nursing facility” means a facility licensed as a comprehensive care or extended care facility pursuant to COMAR 10.07.02.</text>
      </paragraph>
      <paragraph num="(15)">
        <text>“Orthotic device” means rigid and semi-rigid devices used for the purpose of supporting a weak or misaligned body member or restricting or eliminating motion in a diseased or injured part of the body.</text>
      </paragraph>
      <paragraph num="(16)">
        <text>“Physical therapy program” means an established program that outlines the prescribed equipment and treatment, along with frequency, duration, and goals or expected outcome of the recipient.</text>
      </paragraph>
      <paragraph num="(17)">
        <text>“Prepayment authorization” means the approval required from the Department or its designee before services can be reimbursed.</text>
      </paragraph>
      <paragraph num="(18)">
        <text>“Prescriber” means a physician, dentist, podiatrist, physician’s assistant, clinical nurse specialist, or nurse practitioner licensed in the state in which the prescriber's practice is maintained who has examined the recipient.</text>
      </paragraph>
      <paragraph num="(19)">
        <text>“Prescriber order” means a document on the prescriber's letterhead or prescription form which details the:</text>
        <paragraph num="(a)">
          <text>Patient name and Medical Assistance number;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Item needed including the accessories, adaptions, modifications, and attachments considered medically necessary and medically appropriate by the prescriber;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Estimated quantity of the item;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Length of time of need;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Date of face-to-face encounter and how the health status of the recipient at the time of the face-to-face encounter is related to the items prescribed; and</text>
        </paragraph>
        <paragraph num="(f)">
          <text>Prescriber’s signature.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(20)">
        <text>“Prescription” means a written order for medical supplies or equipment, signed by the prescriber.</text>
      </paragraph>
      <paragraph num="(21)">
        <text>“Program” means program as defined in COMAR 10.09.36.01.</text>
      </paragraph>
      <paragraph num="(22)">
        <text>“Prosthetic device” means:</text>
        <paragraph num="(1)">
          <text>An artificial device to replace, in whole or in part, a leg, arm, or eye; or</text>
        </paragraph>
        <paragraph num="(2)">
          <text>An artificial breast, including surgical brassiere.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(23)">
        <text>“Provider” means provider as defined in COMAR 10.09.36.01.</text>
      </paragraph>
      <paragraph num="(24)">
        <text>“Recipient” means recipient as defined in COMAR 10.09.36.01.</text>
      </paragraph>
      <paragraph num="(25)">
        <text>Wholesale cost.</text>
        <paragraph num="(a)">
          <text>“Wholesale cost” means the price paid by the provider to the manufacturer or any other supplier for disposable medical supplies or durable medical equipment after consideration of both primary discounts and secondary volume and prompt payment discounts applicable at the time the manufacturer's invoice is paid.</text>
        </paragraph>
        <paragraph num="(b)">
          <text>“Wholesale cost” includes, but is not limited to:</text>
          <paragraph num="(i)">
            <text>Shipping;</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>Handling; and</text>
          </paragraph>
          <paragraph num="(iii)">
            <text>Insurance costs.</text>
          </paragraph>
        </paragraph>
        <paragraph num="(c)">
          <text>“Wholesale cost” does not include associated costs such as:</text>
          <paragraph num="(i)">
            <text>Evaluation;</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>Assembly by the provider;</text>
          </paragraph>
          <paragraph num="(iii)">
            <text>Fitting and adjustment; and</text>
          </paragraph>
          <paragraph num="(iv)">
            <text>Delivery to the recipient.</text>
          </paragraph>
        </paragraph>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="License Requirements.">
    <text>Providers of services shall meet the licensing requirements as set forth in COMAR 10.09.36.02.</text>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Conditions for Participation.">
    <text>To participate in the Program, the provider:</text>
    <paragraph num="A.">
      <text>Effective January 1, 2018, shall be in an approved status with Medicare;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Effective April 1, 2012 through December 31, 2017, shall, unless exempt from Medicare accreditation requirements:</text>
      <paragraph num="(1)">
        <text>Be accredited by a Medicare-approved accreditation organization;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Provide documentation of:</text>
        <paragraph num="(a)">
          <text>Accreditation; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Having submitted an application for accreditation; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>Be accredited or terminated from the Program;</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>Shall meet the conditions for participation as set forth in COMAR 10.09.36.03;</text>
    </paragraph>
    <paragraph num="D.">
      <text>Shall be prepared to furnish necessary service and repairs to equipment dispensed by the provider;</text>
    </paragraph>
    <paragraph num="E.">
      <text>Shall certify residential service agency status as set forth in COMAR 10.07.05 by submitting either a:</text>
      <paragraph num="(1)">
        <text>Copy of the license; or</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Form supplied by the Department which documents exempt status;</text>
      </paragraph>
    </paragraph>
    <paragraph num="F.">
      <text>May not charge the recipient any fee or deposit;</text>
    </paragraph>
    <paragraph num="G.">
      <text>Shall collect and report as a collection any and all possible rebates or other third-party reimbursement;</text>
    </paragraph>
    <paragraph num="H.">
      <text>Shall mark durable medical equipment with an identification tag as specified and provided by the Program, noting the tag number on all appropriate delivery tickets; and</text>
    </paragraph>
    <paragraph num="I.">
      <text>Shall participate in the Program's recycling efforts as set forth in Regulation .07O of this chapter.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Covered Services.">
    <paragraph num="A.">
      <text>The following medically necessary items are covered when ordered by an individual who is enrolled as a provider in the Program on the date of service:</text>
      <paragraph num="(1)">
        <text>Disposable medical supplies;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Durable medical equipment;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Repairs to purchased durable medical equipment;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>All disposable medical supplies and durable medical equipment for home kidney dialysis purchased or rented for Medical Assistance recipients;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Orthotic devices;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Repair of orthotic devices;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Replacement of orthotic devices;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Prosthetic devices which include:</text>
        <paragraph num="(a)">
          <text>Artificial eyes;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Breast prostheses, including surgical brassiere;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Upper and lower extremity, full and partial, to include stump cover or harnesses where necessary; and</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Custom-designed, fabricated, fitted, or modified devices to treat partial or total limb loss for purposes of restoring physiological function;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(9)">
        <text>Repair of prosthetic devices;</text>
      </paragraph>
      <paragraph num="(10)">
        <text>Replacement of prosthetic devices;</text>
      </paragraph>
      <paragraph num="(11)">
        <text>Individually form-fitted support stockings, leg or arm, including all fitting, dispensing, and follow-up care, for recipients for whom these supports are medically necessary, not to exceed two at one time, three times in a 12-month period for recipients 21 years old or older;</text>
      </paragraph>
      <paragraph num="(12)">
        <text>Evaluation for equipment that was subsequently provided through the Department's recycling program as described in Regulation .07O of this chapter;</text>
      </paragraph>
      <paragraph num="(13)">
        <text>Speech generating, augmentative, and alternative communication devices for recipients enrolled under fee-for-service or a Managed Care Organization; and</text>
      </paragraph>
      <paragraph num="(14)">
        <text>Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>The items in §A of this regulation are covered when medically necessary for use in the recipient's:</text>
      <paragraph num="(1)">
        <text>Home;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>School; or</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Place of employment.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>The items in §A(8)—(10) of this regulation are covered once annually when medically necessary for the purpose of performing physical activities including running, biking, swimming, strength training and other activities to maximize overall health.</text>
    </paragraph>
    <paragraph num="D.">
      <text>Repairs under §A(3) of this regulation are also covered for recipients in hospitals, nursing facilities, and other medical institutions for equipment that was purchased for the recipient while the recipient lived in the community.</text>
    </paragraph>
    <paragraph num="E.">
      <text>Items in §A(8)—(10) of this regulation are also covered for recipients in hospitals, nursing facilities, and other medical institutions.</text>
    </paragraph>
    <paragraph num="F.">
      <text>Replacements under §A(10) are covered:</text>
      <paragraph num="(1)">
        <text>Once annually for devices less than 3 years old if the replacement is for the following reasons:</text>
        <paragraph num="(a)">
          <text>A change in the physiological condition of the patient;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Unless necessitated by misuse, because of an irreparable change in the condition of the prosthetic device or the component of the prosthetic device; or</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Unless necessitated by misuse, because the condition of the prosthetic device or the component of the prosthetic device requires repairs and the cost of the repairs would be more than 60 percent of the cost of replacing the prosthetic device or the component of the prosthetic device; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>For devices more than 3 years old subject to §§B and C of this regulation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="G.">
      <text>Documentation Required.</text>
      <paragraph num="(1)">
        <text>Items in §A of this regulation are covered only when adequate documentation is obtained by the provider and kept on file as part of the permanent business records of the provider. This documentation includes, but is not limited to the:</text>
        <paragraph num="(a)">
          <text>Signed and dated prescriber order including documentation that a face-to-face encounter occurred within 6 months before ordering services;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Recertifications of continuous medical need;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Delivery ticket signed by the recipient or the recipient's representative where the identification of the person signing and the exact nature of the items delivered is clearly evident on the delivery ticket;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Make, model, and serial number of the item, as applicable; and</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Cost of the item to the provider for individually considered items reimbursed under a cost-plus methodology.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>For purchased equipment, the delivery ticket shall note the identification tag number and also include a statement which notifies the recipient that the equipment has been purchased by the State of Maryland and remains the property of the Department of Health.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Documentation shall be retained for 6 years and be made available upon request by the Department.</text>
      </paragraph>
    </paragraph>
    <paragraph num="H.">
      <text>The Department may arrange for the provision of any covered service listed in §A of this regulation under an exclusive contract with a vendor or vendors that has been awarded in accordance with State regulations and policies governing contracts and procurements.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Limitations.">
    <text>The Program does not cover:</text>
    <paragraph num="A.">
      <text>Incontinency pants and disposable underpads unless the following conditions are met:</text>
      <paragraph num="(1)">
        <text>The incontinence supplies are medically necessary for medical conditions associated with prolonged urinary or bowel incontinence;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>For pull-on underwear type garments, the recipient is capable of independently putting on and removing the garment; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Disposable incontinence supplies meet, at a minimum, the following absorbent capacity standards:</text>
        <paragraph num="(a)">
          <text>For children's diapers and underwear, not less than 800cc;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>For youth diapers and underwear, not less than 1,000cc;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>For small adult diapers and underwear, not less than 1,200cc;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>For medium adult diapers and underwear, not less than 1,750cc;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>For large, extra large, and bariatric adult diapers and underwear, not less than 2,000cc; and</text>
        </paragraph>
        <paragraph num="(f)">
          <text>For disposable underpads, not less than 1,000 cc;</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>Osteogenesis stimulators unless the following criteria are met:</text>
      <paragraph num="(1)">
        <text>The use is for noninvasive therapy;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>The bone fracture is at least 6 months old, except when used for pseudarthrosis; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>The space gap of the fracture measures 1/2 centimeter or less, except when used for pseudarthrosis;</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>Osteogenesis stimulators beyond the first 6 weeks of use unless evaluations at the 6-week and 3-month intervals after initial date of service verify recipient use of at least 50 percent of the time prescribed, on a form designated by the Program;</text>
    </paragraph>
    <paragraph num="D.">
      <text>The following durable medical equipment:</text>
      <paragraph num="(1)">
        <text>Equipment prescribed primarily to provide comfort or convenience, including, but not limited to, emesis basins, posture support chairs, over-the-bed tables;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Self-help devices including, but not limited to, grab bars, shower stools, and commode seats;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Abdominal supports;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Bed boards;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Enema bags;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Environmental controls;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Exercise equipment and devices, unless home use of such equipment is a necessary component of an active physical therapy program;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Geriatric chairs;</text>
      </paragraph>
      <paragraph num="(9)">
        <text>Heating pads or lamps;</text>
      </paragraph>
      <paragraph num="(10)">
        <text>Hot water bottles;</text>
      </paragraph>
      <paragraph num="(11)">
        <text>Hydrocollators;</text>
      </paragraph>
      <paragraph num="(12)">
        <text>Ice bags;</text>
      </paragraph>
      <paragraph num="(13)">
        <text>Knee cages;</text>
      </paragraph>
      <paragraph num="(14)">
        <text>Nasal atomizers;</text>
      </paragraph>
      <paragraph num="(15)">
        <text>Restraints;</text>
      </paragraph>
      <paragraph num="(16)">
        <text>Sitz baths;</text>
      </paragraph>
      <paragraph num="(17)">
        <text>Soft collars;</text>
      </paragraph>
      <paragraph num="(18)">
        <text>Whirlpools;</text>
      </paragraph>
      <paragraph num="(19)">
        <text>Whirlpool bath equipment;</text>
      </paragraph>
    </paragraph>
    <paragraph num="E.">
      <text>Disposable medical supplies and durable medical equipment provided in a facility or by a group when reimbursement is covered by another segment of the Program;</text>
    </paragraph>
    <paragraph num="F.">
      <text>Items which are investigational or experimental in nature;</text>
    </paragraph>
    <paragraph num="G.">
      <text>Nutritional supplements supplied by a DMS/DME provider under this chapter if the provider is also a licensed pharmacy and has a Medicaid Pharmacy provider number;</text>
    </paragraph>
    <paragraph num="H.">
      <text>Food supplements or infant formulas, including enteral nutritional products and supplemental vitamin and mineral products, when administered orally;</text>
    </paragraph>
    <paragraph num="I.">
      <text>Purchase of used equipment, except as approved by the Department as per Regulation .07L of this chapter;</text>
    </paragraph>
    <paragraph num="J.">
      <text>Equipment if the recipient owns or otherwise has access to useable equipment that serves the same purpose as the requested equipment;</text>
    </paragraph>
    <paragraph num="K.">
      <text>Replacement of equipment or a device while the item is still under warranty or before having met the Department’s life expectancy schedule unless prepayment authorization has been obtained.</text>
    </paragraph>
    <paragraph num="L.">
      <text>Replacement of a prosthetic device or component if necessary due to misuse.</text>
    </paragraph>
    <paragraph num="M.">
      <text>Rental of any equipment not in good working condition for the entire length of rental;</text>
    </paragraph>
    <paragraph num="N.">
      <text>Rental of equipment for any period longer than 90 days without renewed documentation of continued medical need from the prescriber for each 90-day period;</text>
    </paragraph>
    <paragraph num="O.">
      <text>Modifications to motor vehicles;</text>
    </paragraph>
    <paragraph num="P.">
      <text>Disposable medical supplies and durable medical equipment ordered by an individual who is not enrolled as a provider in the Program on the date of service; and</text>
    </paragraph>
    <paragraph num="Q.">
      <text>Disposable medical supplies and durable medical equipment ordered by an entity, facility, or other provider that is not an individual.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".06" heading="Prepayment Authorization Requirements.">
    <paragraph num="A.">
      <text>Prepayment authorization is required for:</text>
      <paragraph num="(1)">
        <text>Disposable medical supplies with a charge exceeding $500, except as specified in §B(1) and (4) of this regulation and durable medical equipment on the approved list of items as individual consideration (I/C);</text>
      </paragraph>
      <paragraph num="(2)">
        <text>All incontinency pants for recipients 3 through 15 years old in excess of 240 in any 30-day period, and disposable underpads for recipients 3 through 15 years old in excess of 135 in any 30-day period;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>All incontinency pants for recipients 16 years old or older in excess of 180 in any 30-day period, and disposable underpads for recipients 16 years old or older in excess of 100 in any 30-day period;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>All disposable incontinency pants and all disposable underpads for recipients younger than 3 years old;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Disposable medical supplies and durable medical equipment not on the approved list of items;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Any rental of durable medical equipment after 3 months of rental;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>All repairs to purchased durable medical equipment exceeding $500;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Durable medical equipment with a purchase price of $1,000 or more except as specified in §B(1) and (4) of this regulation;</text>
      </paragraph>
      <paragraph num="(9)">
        <text>Prosthetics and orthotics with a charge exceeding $1,000 except as specified in §B(1) and (4) of this regulation; and</text>
      </paragraph>
      <paragraph num="(10)">
        <text>Medical equipment, supplies not listed on the approved list of items.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>Prepayment authorization is not required for:</text>
      <paragraph num="(1)">
        <text>Any disposable medical supplies and durable medical equipment for home kidney dialysis purchased or rented for Medical Assistance recipients;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Prosthetic devices under $1,000;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Orthotic equipment under $1,000; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Enteral and parenteral supplies not exceeding one unit per day.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>For the rental of durable medical equipment, the following prepayment authorization requirements apply:</text>
      <paragraph num="(1)">
        <text>For durable medical equipment below $1,000:</text>
        <paragraph num="(a)">
          <text>Months 1 through 3, the rental does not require a prepayment authorization;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Months 4 through 10, the rental does require a prepayment authorization; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Month 10 is the final rental month, after which the item is considered purchased.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>For durable medical equipment above $1,000, and items requiring individual consideration:</text>
        <paragraph num="(a)">
          <text>Months 1 through 10, the rental does require prepayment authorization; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Month 10 is the final rental month, after which the item is considered purchased.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>The prescriber shall submit requests for prepayment authorization, when required, using the format and procedures designated by the Department.</text>
    </paragraph>
    <paragraph num="E.">
      <text>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 shall be followed by a request for prepayment authorization, which shall be submitted immediately to the Department. Providers shall call the Program before making a request via facsimile.</text>
    </paragraph>
    <paragraph num="F.">
      <text>Except as provided in §H of this regulation, providers shall submit prepayment authorization requests to the Program not later than 30 days following the first date of service.</text>
    </paragraph>
    <paragraph num="G.">
      <text>Prepayment authorization is issued when:</text>
      <paragraph num="(1)">
        <text>Program procedures are met;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>The prescriber submits to the Department adequate documentation demonstrating that the service to be authorized is medically necessary; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>A request for supplies or equipment on the list of approved items, or on the list but without a specified maximum Program price, is accompanied by the manufacturer's suggested retail price or an invoice or other documentation of the wholesale cost, whichever is applicable under Regulation .07 of this chapter.</text>
      </paragraph>
    </paragraph>
    <paragraph num="H.">
      <text>Prepayment authorization normally required by the Program is waived when the service is 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—G of this regulation.</text>
    </paragraph>
    <paragraph num="I.">
      <text>The Department is not responsible for any reimbursement to a provider for any service provided which requires prepayment authorization unless the authorization has been granted by the Program.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".07" heading="Payment Procedures.">
    <paragraph num="A.">
      <text>Payment procedures shall be as set forth in COMAR 10.09.36.04.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The provider’s billed charges to the Program may not exceed the provider’s customary charge. If the item is free to individuals not covered by Medicaid:</text>
      <paragraph num="(1)">
        <text>The provider:</text>
        <paragraph num="(a)">
          <text>May charge the Program; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Shall be reimbursed in accordance with the provisions of this regulation; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>The provider’s reimbursement is not limited to the provider’s customary charge.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>The provider shall give the Program the full advantage of any and all manufacturer's warranty offered on the item.</text>
    </paragraph>
    <paragraph num="D.">
      <text>Effective July 1, 2022, the Department shall pay providers 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare rate established January 1 of each year for prosthetic devices. For prosthetic devices for which Medicare has not established a rate, the Department shall pay providers the manufacturer’s suggested retail price of the item, less 26.5 percent. The payment shall include all fitting, dispensing, and follow-up care.</text>
    </paragraph>
    <paragraph num="E.">
      <text>Charges for osteogenesis stimulators shall include all follow-up care, batteries, repairs, and replacement parts within the limitations of Regulation .05E and F, at the following times:</text>
      <paragraph num="(1)">
        <text>Initial date of service;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>After 6-week evaluation;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>After 3-month evaluation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="F.">
      <text>With the exception of items free to individuals not covered by Medicaid, the Department shall reimburse providers for the purchase of covered services at the lesser of the provider’s customary charge or:</text>
      <paragraph num="(1)">
        <text>For the purchase of items for which Medicare has established a rate:</text>
        <paragraph num="(a)">
          <text>Disposable medical supplies and durable medical equipment other than enteral nutritional products and enteral and parenteral therapy supplies at 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare purchase reimbursement rate established January 1 of each year;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home as established in §F-1(1) of this regulation;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Enteral and parenteral therapy supplies as established in §F-1(2) of this regulation; and</text>
        </paragraph>
        <paragraph num="(d)">
          <text>For medical equipment for which Medicare has established a rental rate, the purchase price shall be 10 times the lowest rural, non-rural, or competitive bidding area (CBA) Medicare monthly rental rate.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>For the purchase of items for which Medicare has not established a rate:</text>
        <paragraph num="(a)">
          <text>Disposable medical supplies not otherwise specified in this section are reimbursed 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;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home as established in §F-1(3) of this regulation;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Enteral and parenteral therapy supplies as established in §F-1(4) of this regulation;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Incontinence supplies at the provider's wholesale cost plus 25 percent;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Customized equipment at the provider's choice of the manufacturer's suggested retail price minus 30 percent or provider's wholesale cost plus 40 percent; and</text>
        </paragraph>
        <paragraph num="(f)">
          <text>Durable medical equipment, not otherwise specified in this section, are reimbursed at the provider’s choice of the manufacturer’s suggested retail price minus 41.2 percent or provider’s wholesale cost plus 27.4 percent.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="F-1.">
      <text>Enteral Nutritional Product and Enteral and Parenteral Supply Reimbursement Rates Effective February 1, 2021.</text>
      <paragraph num="(1)">
        <text>Effective February 1, 2021, enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home shall be reimbursed at the following rates per unit:</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Effective February 1, 2021, enteral and parenteral therapy supplies shall be reimbursed at the following rates per unit:</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Effective February 1, 2021, enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home shall be reimbursed at the following rates per unit:</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Effective February 1, 2021, enteral and parenteral therapy supplies shall be reimbursed at the following rates per unit:</text>
      </paragraph>
    </paragraph>
    <paragraph num="G.">
      <text>The Department shall reimburse providers for the monthly rental of covered services as follows:</text>
      <paragraph num="(1)">
        <text>For items for which Medicare has established a purchase rate, 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare purchase reimbursement rate divided over 10 months;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>For items for which Medicare has not established a purchase rate, items will be rented at the provider’s choice of:</text>
        <paragraph num="(a)">
          <text>The manufacturer’s suggested retail price minus 41.2 percent, divided over 10 months; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>The provider’s wholesale cost plus 27.4 percent, divided over 10 months; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>After 10 months of monthly rental, the item will be considered purchased.</text>
      </paragraph>
    </paragraph>
    <paragraph num="H.">
      <text>The Department reserves the right to prorate the monthly rental amount for daily rentals.</text>
    </paragraph>
    <paragraph num="I.">
      <text>The Department shall pay for repairs to purchased durable medical equipment according to the following:</text>
      <paragraph num="(1)">
        <text>The provider's choice of wholesale cost plus 37.2 percent or the manufacturer's suggested retail price minus 31.4 percent to the provider for all materials;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Labor costs shall be billed in quarter hour increments using the appropriate procedure code and shall be reimbursed the lesser of:</text>
        <paragraph num="(a)">
          <text>The supplier’s customary charge unless the service is free to individual not covered by Medicaid; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>The reimbursement rate specified in the Medicaid Durable Medical Equipment Program's approved list of items.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="J.">
      <text>The determination to purchase or rent medical equipment shall be based on the prescriber's best faith estimate of length of time the equipment will be needed by the recipient. When the equipment is ordered for:</text>
      <paragraph num="(1)">
        <text>10 or more months, the provider shall charge the Program for a purchase, unless:</text>
        <paragraph num="(a)">
          <text>The items cannot be purchased, in which case the items shall continue to be rented for the duration of their need at the amount determined on the fee schedule or elsewhere in this chapter; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>There is justification to request a rental rather than a purchase of the item, and a request for prepayment authorization is submitted to and approved by the Program before the submission of the invoice for the item; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Less than 10 months, the provider shall charge the Program for rental of the item for the duration of the medical necessity except that:</text>
        <paragraph num="(a)">
          <text>If the equipment is still medically necessary after 10 months of rental and the equipment is purchasable,  the tenth rental payment is the final rental payment, and the equipment is considered purchased by the Program; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>If there is justification to request a purchase rather than a rental of the item, a request for prepayment authorization shall be submitted to the Program and approved by the Program before the submission of the invoice.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="K.">
      <text>Medical equipment that is determined by the Department to require frequent and substantial servicing in order to avoid risk to the recipient's health shall be reimbursed at the rental rate in accordance with §G of this regulation until either the equipment is no longer medically necessary or the recipient is no longer eligible for Medical Assistance fee-for-service benefits.</text>
    </paragraph>
    <paragraph num="L.">
      <text>Every 90 days during the rental term the provider shall obtain recertification from the prescriber and keep in the provider's records a recertification of continuous medical need that the equipment is still medically necessary.</text>
    </paragraph>
    <paragraph num="M.">
      <text>The Department shall review purchase prices and rental charges for items for which Medicare has not established a rate at least every 3 years.</text>
    </paragraph>
    <paragraph num="N.">
      <text>If services are provided under a contract pursuant to Regulation .04F of this chapter, the Department shall reimburse the contracted vendor or vendors at rates and under conditions in accordance with the contract or contracts.</text>
    </paragraph>
    <paragraph num="O.">
      <text>Once an item has been purchased in full, then title to the equipment shall remain with the Department, and the equipment, after use by the recipient, shall be recovered by the Department or its designee. The Department may arrange for the provision of recycled equipment under an exclusive contract with a vendor or vendors that have been awarded in accordance with State regulations and policies governing contracts and procurement. The Department also may determine the geographical scope and the types of equipment, or both, to be included under the contract. The vendor or vendors shall be reimbursed at a rate and under terms established in the contract.</text>
    </paragraph>
    <paragraph num="P.">
      <text>For equipment that is not covered under a contract awarded under §O of this regulation, the provider that originally furnished the equipment to the recipient shall recover the equipment after it is no longer required by the recipient. After recovery of the equipment, the provider shall determine the viability of recycling the item and, upon its reissue, bill the Program 75 percent of the Program's original payment.</text>
    </paragraph>
    <paragraph num="Q.">
      <text>To the extent that the Department chooses to use an exclusive contract to provide recycled equipment under §O of this regulation, the Department shall reimburse providers for evaluation of a recipient for equipment that is subsequently provided through the Department's recycling program at 11.5 percent of the reimbursement rate established under §§AH of this regulation.</text>
    </paragraph>
    <paragraph num="R.">
      <text>The Department will authorize payment on Medicare claims if:</text>
      <paragraph num="(1)">
        <text>The provider accepts Medicare assignments;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Medicare makes direct payment to the provider;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Medicare has determined that services were medically justified;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>The services are covered by the Program;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text>
      </paragraph>
    </paragraph>
    <paragraph num="S.">
      <text>Supplemental payments on Medicare claims are made subject to the following provisions:</text>
      <paragraph num="(1)">
        <text>Deductible insurance will be paid in full;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Coinsurance will be paid in full;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Services not covered by Medicare, but by the Program, will be paid in accordance with the limitations of §I of this regulation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="T.">
      <text>The provider may not bill the Department for:</text>
      <paragraph num="(1)">
        <text>Completion of forms and reports;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Broken or missed appointments;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Professional services rendered by mail or telephone; or</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Fitting, dispensing, or follow-up care except as set forth in §D of this regulation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="U.">
      <text>The methodology in §§F and G of this regulation shall be used to establish a list of approved items with the corresponding procedure code, maximum allowable reimbursement amount, useful life expectancy, and maximum number allowed. This list shall be made available to the providers for ease of administration of the Program. When the approved list of items contains a price for a procedure code, the Department shall reimburse providers the lesser of the price listed in the approved list or the provider’s customary charge unless the service is free to individuals not covered by Medicaid.</text>
    </paragraph>
    <paragraph num="V.">
      <text>The provider shall ensure that the equipment is in good working condition both throughout the rental of the equipment and at the end of the rental term.</text>
    </paragraph>
    <paragraph num="W.">
      <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text>
    </paragraph>
    <paragraph num="X.">
      <text>Durable medical 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 medical equipment and supplies.</text>
    </paragraph>
    <paragraph num="Y.">
      <text>Refills.</text>
      <paragraph num="(1)">
        <text>For durable medical equipment or disposable supplies, or both 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.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>The provider shall maintain documentation of contact and confirmation of any changes and modifications of the order for audit purposes.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>The provider shall contact the recipient or designee regarding refills no earlier than 7 business days before the anticipated delivery date or anticipated shipping date.</text>
      </paragraph>
      <paragraph num="(4)">
        <text>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.</text>
      </paragraph>
    </paragraph>
    <paragraph num="Z.">
      <text>The disposable medical supplies or durable medical equipment provider shall identify the individual who ordered the disposable medical supplies and durable medical equipment by recording the individual practitioners National Provider Identifier (NPI) number on the claim.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".08" heading="Recovery and Reimbursement.">
    <text>Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07.</text>
  </regulation>
  <regulation prefix="Regulation" num=".09" heading="Cause for Suspension or Removal and Imposition of Sanctions.">
    <text>Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08.</text>
  </regulation>
  <regulation prefix="Regulation" num=".10" heading="Appeal Procedures.">
    <text>Appeal procedures shall be as set forth in COMAR 10.09.36.09.</text>
  </regulation>
  <regulation prefix="Regulation" num=".11" heading="Interpretive Regulation.">
    <text>State Regulations shall be interpreted as set forth in COMAR 10.09.36.10.</text>
  </regulation>
  <annotations>
    <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, 15-105, and 15-129, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: January 1, 1976 (2:29 Md. R. 1740)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .04A amended effective February 8, 1980 (7:3 Md. R. 264)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05 amended effective February 8, 1980 (7:3 Md. R. 264) and April 4, 1980 (7:7 Md. R. 708)</annotation>
    <annotation type="History" subtype="Administrative History">Chapter revised effective June 26, 1981 (8:13 Md. R. 1139)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 11, 1988 (15:13 Md. R. 1553)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03J adopted effective January 6, 1983 (9:26 Md. R. 2572); May 29, 1989 (16:10 Md. R. 1108)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .04A amended effective July 1, 1987 (14:13 Md. R. 1473); May 29, 1989 (16:10 Md. R. 1108)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .04B amended effective July 2, 1984 (11:13 Md. R. 1176); July 11, 1988 (15:13 Md. R. 1553); May 29, 1989 (16:10 Md. R. 1108)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .04E amended effective July 2, 1984 (11:13 Md. R. 1176); August 12, 1985 (12:16 Md. R. 1606)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .04F G adopted effective June 2, 1986 (13:11 Md. R. 1273)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .04H adopted effective March 23, 1987 (14:6 Md. R. 715)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 2, 1984 (11:13 Md. R. 1176); July 11, 1988 (15:13 Md. R. 1553); July 25, 1988 (15:14 Md. R. 1655); May 29, 1989 (16:10 Md. R. 1108)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05A-3 and A-4 adopted, B amended effective July 1, 1987 (14:13 Md. R. 1473)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05B and D amended effective June 2, 1986 (13:11 Md. R. 1273); March 23, 1987 (14:6 Md. R. 715)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06 amended effective July 2, 1984 (11:13 Md. R. 1176); October 29, 1984 (11:21 Md. R. 1812); June 2, 1986 (13:11 Md. R. 1273);</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06A amended effective March 23, 1987 (14:6 Md. R. 715); July 1, 1987 (14:13 Md. R. 1473); May 30, 1988 (15:11 Md. R. 1331); July 11, 1988 (15:13 Md. R. 1553)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06D amended effective May 30, 1988 (15:11 Md. R. 1331)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06D-1 amended effective August 12, 1985 (12:16 Md. R. 1606)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07 amended effective July 2, 1984 (11:13 Md. R. 1176); October 29, 1984 (11:21 Md. R. 1812); June 2, 1986 (13:11 Md. R. 1273); May 29, 1989 (16:10 Md. R. 1108)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07 amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2392); amended permanently effective February 9, 1987 (14:2 Md. R. 129)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07B-1 adopted effective August 12, 1985 (12:16 Md. R. 1606)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07C-1 repealed effective August 12, 1985 (12:16 Md. R. 1606)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07C-1 adopted effective June 2, 1986 (13:11 Md. R. 1273); amended effective March 23, 1987 (14:6 Md. R. 715)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07C-2 adopted effective July 1, 1987 (14:13 Md. R. 1473)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07D amended effective October 1, 1983 (10:19 Md. R. 1691); June 2, 1986 (13:11 Md. R. 1273); March 23, 1987 (14:6 Md. R. 715); July 1, 1987 (14:13 Md. R. 1473); July 1, 1988 (15:13 Md. R. 1554); July 11, 1988 (15:13 Md. R. 1553); July 25, 1988 (15:14 Md. R. 1655)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); emergency status expired October 28, 1984</annotation>
    <annotation type="History" subtype="Administrative History">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)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07D, F-1 adopted effective August 12, 1985 (12:16 Md. R. 1606)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07F amended effective April 9, 1984 (11:7 Md. R. 625); June 2, 1986 (13:11 Md. R. 1273)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07F-2 adopted effective June 2, 1986 (13:11 Md. R. 1273); amended effective March 23, 1987 (14:6 Md. R. 715)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07L amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07Q 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))</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07Q 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)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2105)</annotation>
    <annotation type="History" subtype="Administrative History">Chapter revised effective March 16, 1992 (19:5 Md. R. 577)</annotation>
    <annotation type="History" subtype="Administrative History">Chapter revised effective November 16, 1998 (25:23 Md. R. 1696)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .01B amended effective September 29, 2003 (30:19 Md. R. 1331); August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); April 30, 2012 (39:8 Md. R. 533); June 9, 2025 (52:11 Md. R. 532)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03 amended effective April 16, 2012 (39:7 Md. R. 491); April 13, 2015 (42:7 Md. R. 568); January 1, 2018 (44:26 Md. R. 1214)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03G amended effective September 11, 2006 (33:18 Md. R. 1505)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .04 amended effective August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); June 9, 2025 (52:11 Md. R. 532)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .04A amended effective April 19, 2010 (37:8 Md. R. 615); January 1, 2018 (44:26 Md. R. 1214); June 14, 2021 (48:12 Md. R. 470); June 9, 2025 (52:11 Md. R. 532)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .04E amended effective April 30, 2012 (39:8 Md. R. 533)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05 amended effective August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); January 1, 2018 (44:26 Md. R. 1214)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05A amended effective February 9, 2009 (36:3 Md. R. 208)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05D amended effective April 19, 2010 (37:8 Md. R. 615)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05K amended effective June 9, 2025 (52:11 Md. R. 532)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05L adopted effective June 9, 2025 (52:11 Md. R. 532)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation05M-Q amended effective June 9, 2025 (52:11 Md. R. 532)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06 amended effective January 7, 2002 (28:26 Md. R. 2272); August 1, 2005 (32:15 Md. R. 1320); October 16, 2023 (50:20 Md. R. 887)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06A amended effective February 9, 2009 (36:3 Md. R. 208)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06A,B amended effective June 9, 2025 (52:11 Md. R. 532)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06D amended effective June 9, 2025 (52:11 Md. R. 532)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06E amended effective September 29, 2003 (30:19 Md. R. 1331); June 9, 2025 (52:11 Md. R. 532)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07 amended effective September 29, 2003 (30:19 Md. R. 1331); August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); April 19, 2010 (37:8 Md. R. 615); April 30, 2012 (39:8 Md. R. 534); July 4, 2016 (43:13 Md. R. 712); October 16, 2023 (50:20 Md. R. 887)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07D amended effective February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 470)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07F amended effective February 9, 2009 (36:3 Md. R. 208); February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 470)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07F-1 adopted effective June 14, 2021 (48:12 Md. R. 470)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .07Z adopted effective January 1, 2018 (44:26 Md. R. 1214)</annotation>
  </annotations>
</chapter>