Okla. Admin. Code § 535:20-10-3

Current through Vol. 42, No. 4, November 1, 2024

Section 535:20-10-3 - DME Suppliers and combined DME+MGD Suppliers

(a)Licensing requirement. Before conducting interstate and/or intrastate transactions in Oklahoma, a Durable Medical Equipment supplier (DME) or a combined DME Supplier and Medical Gas Distributor (DME+MGD) shall register annually with the Board.

(1) A DME or DME+MGD license is only valid for the name, ownership and location listed on the license. Changes of name, ownership or location shall require a new DME supplier license.

(2) Changes in any information required for licensure must be reported to the Board within ten (10) days (e.g., manager, contact person, phone, etc.).

(3) Each location shall possess a DME or DME+MGD license. A DME or DME+MGD license entitles the license holder to store and supply DME at the licensed location.

(4) Each facility at which DME is stored, warehoused, handled, held, offered, marketed, or displayed shall be licensed by the Board and be of suitable size and construction to facilitate cleaning, maintenance, and proper operations.

(5) As allowed under 59 OS Section 375.3 (D) an out-of-state DME supplier will not be required to maintain a physical office or place of business within Oklahoma or within one hundred (100) miles of a resident of Oklahoma being served by the DME supplier if the following conditions are met,

(A) They are supplying a specialized DME product/device,

(B) The specialized DME product/device is not available through standard local DME channels, and

(C) They are accredited by an organization that is recognized by the Centers for Medicare and Medicaid Services.

(6) A DME supplier shall not operate from a place of residence.

(7) A DME supplier shall not operate from a storage unit.

(b)License issuance. Licenses shall be issued only to those DME or DME+MGD who satisfy the provisions of 59 O.S. Section 375.1 through 375.5, and the requirements under the Act, this Title, and the rules in 535:25 for applicants.

(c)Compliance with federal requirements. DME or DME+MGD applicants and registrants must comply with all applicable federal, state, or local laws and regulations. DME+MGD applicants and registrants shall be registered with the federal Food and Drug Administration (FDA), if required.

(d)Minimum required information for licensure. The minimum required information for DME or DME+MGD licensure shall be as follows, applicants must submit a satisfactorily completed application together with the required fee annually. This application shall include, at least, the following:

(1) The name, full business address, and telephone number.

(2) All trade or business names used by the applicant.

(3) Address, telephone numbers, and the names of contact persons for the facility.

(4) The type of ownership or operation (e.g., partnership, corporation, or sole proprietorship).

(5) The name(s) of the owner and/or operator of the applicant; and

(6) Any other information the Board deems necessary to protect the public health.

(e)Minimum qualifications. DME and DME+MGD must conform to all applicable federal, state, or local laws and regulations.

(1) The minimum qualifications shall be the same as those set forth in 535:25 and this Chapter. The Board shall consider, at a minimum, the following factors in reviewing the qualifications of persons who engage in the supplying of DME:

(A) Any convictions of the applicant under any federal, state, or local laws relating to DME, devices, drugs, drug samples, manufacture, packager, wholesale or retail drug distribution, or distribution of controlled substances.

(B) Any felony convictions of the applicant under federal, state, or local laws.

(C) The applicant's past experience in the handling, manufacture, packaging, or distribution of DME, devices, drugs, including controlled substances.

(D) The furnishing by the applicant of false or fraudulent material in any application made in connection with DME, device, or drug handling, manufacturing, packing, or distribution.

(E) Suspension, sanction, or revocation by federal, state, or local government of any license currently or previously held by the applicant for the handling, manufacture, packaging, or distribution of any DME, devices, drugs, including controlled substances; or by any of its owners for violation of state or federal laws regarding DME, devices, or drugs.

(F) Compliance with licensing requirements under previously granted licenses, if any.

(G) Compliance with requirements to maintain and/or make available to the State Board or to federal, state, or local law enforcement officials those records required under this section; and,

(H) Any other factors or qualifications the Board considers relevant to and consistent with the public health and safety.

(2) The Board shall have the right to deny a license to an applicant if it determines that the granting of such a license would not be consistent with the public health and safety.

(f)Personnel. Personnel employed by DME or DME+MGD suppliers shall have sufficient education, training, and/or experience to perform assigned functions and comply with federal, state, and local licensing requirements. Personnel involved with the delivery, maintenance, and repair of DME shall complete annual continuing education.

(g)Minimum requirements for storage, handling, and records. DME or DME+MGD suppliers must meet minimum requirements for storage and handling, and for the establishment and maintenance of distribution records for DME. The following shall describe the minimum requirements for the storage and handling of DME, and for the establishment and maintenance of DME records by DME or DME+MGD suppliers and their officers, agents, representatives, and employees.

(1)Security. Each facility used for DME shall be secure from unauthorized entry.

(A) Access from outside the premises shall be kept to a minimum and be well controlled.

(B) The outside perimeter of the premises shall be well-lighted.

(C) Entry into areas where DME are held shall be limited to authorized personnel.

(D) All DME suppliers shall establish and maintain controls and systems that protect against, detect, and document any instances of theft, diversion, or counterfeiting. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

(E) All DME suppliers shall establish and maintain a suspicious order monitoring program for DME.

(i) The DME or DME+MGD supplier must not ship the customer's order if the order is confirmed as suspicious.

(ii) Each DME or DME+MGD supplier shall notify the Board, within ten (10) days, if an order is confirmed as suspicious; and,

(iii) DME or DME+MGD suppliers shall establish guidelines and procedures for identifying suspicious orders.

(2)Storage. All DME shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such DME.

(A) If no storage requirements are established for DME, the DME may be held at "controlled" room temperature, as defined in an official compendium, to help ensure that it is not adversely affected.

(B) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of DME, if required.

(C) Storage areas should be designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions.

(D) Storage areas must have a quarantine area for storage of DME that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened.

(E) Storage areas must be maintained in a clean and orderly condition and, be free from infestation by insects, rodents, birds, or vermin of any kind.

(F) The recordkeeping requirement in this Chapter for DME suppliers shall be followed for all stored DME.

(3)Examination of materials. Upon receipt, each shipment of DME shall be visually examined for identity and to prevent the acceptance of damaged DME. This examination shall be adequate to reveal damage to the DME.

(A) Each outgoing shipment shall be carefully inspected for identity of the DME and to ensure that there is no delivery of DME that have been damaged in storage or held under improper conditions.

(B) The recordkeeping requirement in this Chapter shall be followed for all incoming and outgoing DME.

(4)Returned, damaged, and outdated DME. DME that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other DME until they are destroyed.

(A) If the conditions under which DME has been returned cast doubt on the DME's safety or quality, then the DME shall be destroyed, unless examination or other investigation proves that the DME meets appropriate standards of safety and quality. In determining whether the conditions under which DME has been returned cast doubt on the DME's safety and quality, the DME supplier shall consider, among other things:

(i) The conditions under which the DME has been held, stored, or shipped before or during its return; and,

(ii) The condition of the DME carton, or labeling, as a result of storage or shipping.

(B) The recordkeeping requirements for DME or DME+MGD suppliers in this Chapter shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated DME.

(5)Recordkeeping. DME or DME+MGD suppliers shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of DME.

(A) Inventories and records shall be made available for inspection and photocopying by authorized federal, state, or local law enforcement agency officials for a period of two (2) years following disposition of the DME.

(B) Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two (2) working days of a request by an authorized official of a federal, state, or local law enforcement agency.

(C) Each DME or DME+MGD supplier should maintain an ongoing list of persons with whom they do business.

(6)Written policies and procedures. DME or DME+MGD suppliers shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of DME, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories.

(A) DME or DME+MGD suppliers shall include in their written policies and procedures the following: A procedure to be followed for handling recalls and withdrawals of DME. Such procedure shall be adequate to deal with recalls and withdrawals due to any:

(i) Action initiated at the request of the Food and Drug Administration (FDA) or other federal, state, or local law enforcement or other government agency, including the Board,

(ii) Voluntary action by the DME or DME+MGD supplier to remove defective or potentially defective DME from the market; or

(iii) Action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design.

(B) A procedure to ensure that DME or DME+MGD suppliers prepare for, protect against, and handle a crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state or national emergency.

(C) A procedure to ensure that any outdated DME shall be segregated from other DME and destroyed.

(i) This procedure shall provide for written documentation of the disposition of outdated DME.

(ii) This documentation shall be maintained for two (2) years after disposition of the outdated DME.

(7)Responsible persons. DME or DME+MGD suppliers shall establish and maintain lists of officers, directors, managers, and other persons in charge of DME distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

(8)Compliance with federal, state and local laws. DME or DME+MGD suppliers shall operate in compliance with applicable federal, state, and local laws and regulations. DME suppliers shall permit the Board and authorized federal, state, and local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures and to confiscate records, to the extent authorized by law and rule.

(9)Salvaging and reprocessing. DME or DME+MGD suppliers shall be subject to the provisions of any applicable federal, state, or local laws or regulations that relate to DME product salvaging or reprocessing.

(h)Prescription requirement. DME or DME+MGD suppliers shall not supply DME without a prescription order.

(1) An original or copy of a prescription order must be kept at the licensed location supplying the DME.

(2) A prescription DME order is only valid for one (1) year. Prescription DME orders shall be maintained for five years and be readily retrievable and available at inspection.

(i)DME+MGD Compliance. All DME+MGD must comply with the requirements in 535:20-9-4 for medical gas distributors.

Okla. Admin. Code § 535:20-10-3

Adopted by Oklahoma Register, Volume 40, Issue 12, March 1, 2023, eff. 1/27/2023

Adopted by Oklahoma Register, Volume 40, Issue 22, August 1, 2023, eff. 9/1/2023