12 Va. Admin. Code § 30-50-165
A. Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise:
"Affirmative contact" means speaking, either face-to-face or by phone, with either the individual or caregiver in order to ascertain that the DME is still needed and appropriate. Such contacts shall be documented in the individual's medical record.
"Certificate of Medical Necessity" or "CMN" means the DMAS-352 form required to be completed and submitted in order for DMAS to provide reimbursement.
"Complex rehabilitation technology" or "CRT" means manual and powered wheelchairs and their accessories that are customized and individually configured to meet the specific medical, physical, and functional needs of the individual who has a primary diagnosis resulting from a congenital disorder, progressive or degenerative neuromuscular disease, or from certain types of injury or trauma.
"Designated agent" means an entity with whom DMAS has contracted to perform functions such as provider audits and prior authorizations of services.
"DMAS" means the Department of Medical Assistance Services.
"DME provider" means those entities enrolled with DMAS to render DME services.
"Durable medical equipment" or "DME" means medical equipment, supplies, and appliances suitable for use in the home consistent with 42 CFR 440.70(b)(3) that treat a diagnosed condition or assist the individual with functional limitations.
"Enteral nutrition" refers to any method of feeding that uses the gastrointestinal tract to deliver part or all of an individual's caloric requirements. "Enteral nutrition" may include a routine oral diet, the use of liquid supplements, or delivery of part or all of the daily requirements by use of a tube, which is called tube feeding.
"Expendable supply" means an item that is used and then disposed of.
"Frequency of use" means the rate of use by the individual as documented by the number of times per day, week, or month, as appropriate, a supply is used by the individual. Frequency of use must be recorded on the face of the CMN in such a way that reflects whether a supply is used by the individual on a daily, weekly, or monthly basis. Frequency of use may be documented on the CMN as a range of the rate of use. By way of example and not limitation, the frequency of use of a supply may be expressed as a range, such as four to six adult diapers per day. However, large ranges shall not be acceptable documentation of frequency of use, for example, the range of one to six adult diapers per day shall not be acceptable. The frequency of use provides the justification for the total quantity of supplies ordered on the CMN.
"Functional limitation" means the inability to perform a normal activity.
"Practitioner" means a licensed provider of physician services as defined in 42 CFR 440.50.
"Prior authorization" or "PA" means the process of approving either by DMAS or its prior authorization contractor for the purposes of DMAS reimbursement for the service for the individual before it is rendered or reimbursed.
"Quantity" means the total number of supplies ordered on a monthly basis as reflected on the CMN. The monthly quantity of supplies ordered for the individual shall be dependent upon the individual's frequency of use.
B. General requirements and conditions.
1. a. All medically necessary supplies and equipment shall be covered. Unusual amounts, types, and duration of usage must be authorized by DMAS in accordance with published policies and procedures. When determined to be cost effective by DMAS, payment may be made for rental of the equipment in lieu of purchase.
D. Supplies, equipment, or appliances that are not covered include the following:
F. Coverage of home infusion therapy.
3. The following limitations shall apply to this service:
b. In order for Medicaid to reimburse for this service, the individual shall:
I. The following criteria shall be satisfied through the submission of adequate and verifiable documentation on the CMN satisfactory to DMAS. Medically necessary DME shall be:
J. Medical documentation shall provide DMAS or the designated agent with evidence of the individual's DME needs. Medical documentation may be recorded on the CMN or evidenced in the supporting documentation attached to the CMN. The following applies to the medical justification necessary for all DME services regardless of whether prior authorization is required. The documentation is necessary to identify:
K. DME provider responsibilities. To receive reimbursement, the DME provider shall, at a minimum, perform the following:
L. Proof of delivery.
1. The delivery ticket shall contain the following information:
2. If a commercial shipping service is used, the DME provider's records shall reference, in addition to the information required in subdivision 1 of this subsection, the delivery service's package identification numbers with a copy of the delivery service's delivery ticket, which may be printed from the online record on the delivery service's website.
4. DME providers shall make affirmative contact with the individual or the individual's caregiver and document the interaction prior to dispensing repeat orders or refills to ensure that:
M. Enteral nutrition products. Coverage of enteral nutrition (EN) that does not include a legend drug shall be limited to when the nutritional supplement is administered orally or through a nasogastric or gastrostomy tube and is necessary to treat a medical condition. DMAS shall provide coverage for nutritional supplements for enteral feeding only if the nutritional supplements are not available over the counter. Additionally, DMAS shall cover medical foods that are (i) specific to inherited diseases and metabolic disorders; (ii) not generally available in grocery stores, health food stores, or the retail section of a pharmacy; and (iii) not used as food by the general population. Coverage of EN shall not include the provision of routine infant formula or feedings as meal replacement only. Coverage of medical foods shall not extend to regular foods prepared to meet particular dietary restrictions, limitations, or needs, such as meals designed to address the situation of individuals with diabetes or heart disease. A nutritional assessment shall be required for all individuals for whom nutritional supplements are ordered.
1. General requirements and conditions.
2. Service units and service limitations.
g. Prior authorization of enteral nutrition products shall not be required. The DME provider shall ensure that there is a valid CMN (i) completed every six months in accordance with subsection B of this section and (ii) on file for all Medicaid individuals for whom enteral nutrition products are provided.
3. Provider responsibilities.
d. The CMN shall include all of the following elements:
N. Reimbursement denials.
1. DMAS shall deny payment to the DME provider if any of the following occur:
O. Replacement DME following a disaster.
1. Medicaid individuals who (i) live in areas that have been declared by the Governor to be subject to a state of emergency in accordance with § 44-146.16 of the Code of Virginia, (ii) live in Virginia and were present in an area of the state that has been declared by the Governor to be subject to a state of emergency in accordance with § 44-146.16 of the Code of Virginia, or (iii) live in Virginia and can prove they were present in a state or federally declared disaster or emergency area in another state when the disaster occurred, and who need to replace DME previously approved by Medicaid that were damaged as a result of the disaster or emergency, may contact a DME provider (either enrolled in fee-for-service Medicaid or a Medicaid health plan) of their choice to obtain a replacement.
§ 32.1-325 of the Code of Virginia; 42 USC § 1396 et seq.
Derived from Virginia Register Volume 18, Issue 10, eff. February 27, 2002; amended, Virginia Register Volume 26, Issue 4, eff. January 1, 2010; Volume 28, Issue 19, eff. July 1, 2012; Volume 36, Issue 10, eff. February 21, 2020; Volume 41, Issue 10, eff. February 13, 2025.