Section 409.430 - Recordkeeping RequirementsThe DME provider must keep a record, either paper or electronic, at the service facility for each member. The record must include all purchases, rentals, and repairs of DME provided for each member in accordance with the recordkeeping requirements set forth in 130 CMR 450.205: Recordkeeping and Disclosure. The DME provider must make all records retained in accordance with 130 CMR 409.430 and 450.205 available to the MassHealth agency, or its designee upon request. Payment for services is conditioned upon the complete documentation in the member's record. In addition to fulfilling the requirements of 130 CMR 450.205, the DME provider must ensure that each member's record includes the following, except where noted that the record must be available upon request:
(A) a completed, signed, and dated prescription and letter of medical necessity that meets the requirements set forth in 130 CMR 409.416, and 42 CFR 440.70, and any other applicable state or federal law or regulation;(B) a copy of the prior-authorization request submitted to the MassHealth agency, or its designee, including a copy of the MassHealth agency decision;(C) the face-to-face encounter related to the primary reason the member requires DME must be documented in the member's record either on the plan of care or in other medical notes sufficient to make the link between the member's health conditions, the DME ordered, and an appropriate face-to-face encounter that occurred within six months of the start of services of DME consistent with 42 CFR 440.70. This documentation must include the name of the practitioner and date of the encounter;(D) if the member has third-party liability, including Medicare, the DME provider must also maintain a copy of all documentation of their efforts to diligently seek prior authorization and payment from other liable parties;(E) a copy of all documentation submitted with a member's prior authorization request, including any MassHealth agency or its designee's correspondence and decisions related to such requests;(F) written confirmation of receipt of the prescribed DME, including refills, signed by the member or the member's designee, except as permitted by 130 CMR 409.419(D) regarding signed delivery tickets, that includes(1) the date the equipment or medical supplies were delivered to the member;(2) the manufacturer, brand name, model number, and, if applicable, the serial number of the equipment or medical supplies; and(3) if the delivery slip is signed by the member's designee, an explanation of the designee's relationship to the member. This individual cannot be associated with either the DME provider or the delivery service.(G) a copy of the invoice showing the cost to the DME provider of the items delivered must be available to the MassHealth agency upon request;(H) for repair services, a complete description of all repair services, including the manufacturer, brand name, model number, and serial number of the repaired item;(I) copies of written warranties and any discounts;(J) documentation of any oral or written complaints received by the member in accordance with 130 CMR 409.405(P). The documentation must include, at a minimum(1) the name, address, and telephone number of the member;(2) the name, address, and telephone number of the person filing the complaint (if not the member);(3) a summary of the complaint;(4) the date the complaint was received by the provider;(5) the name of the person receiving the complaint;(6) a summary of any investigation or actions taken by the DME provider to resolve the complaint; and(7) if the DME provider determined that an investigation of the complaint or further action was not necessary, the name of the person making this decision and the reason for the decision.(K) confirmation that a written description of any instruction or orientation provided to the member or the member's caregiver on the proper use of the equipment in accordance with 130 CMR 409.405(R), signed and dated by the provider staff who provided the instruction or orientation with the exception of items delivered by a shipping service 130 CMR 409.419(D);(L) a written description or an electronically dated note of all contacts the provider has had with the member or the member's caregiver, including member or authorized representative approval for refills, signed and dated by the provider staff who had the contact; and(M) a written description of any action taken by the provider in response to a recall notice, including any communication with members and repair/replacement of equipment, signed and dated by the technician or clinician responsible for implementing the instructions in the recall notice.Amended by Mass Register Issue 1449, eff. 8/6/2021.Amended by Mass Register Issue 1472, eff. 7/1/2022.