Virginia Hospital & Healthcare Association, on behalf of its hospital and health system members, respectfully submits these comments on the proposed fast-track regulations to update Section 940 regarding Medicines, Drugs, Eyeglasses and Related Items (Action 2197).  An initial question is whether the documentation requirements in paragraph F.5 to certify exemption for purchases of durable medical equipment (DME) pursuant to paragraph F.1 are also intended to apply to purchases of prosthetics as those items are not specifically mentioned in paragraph F.5. 

The primary concern, however, is that the documentation requirements in paragraph F.5 are administratively burdensome, especially in the case of a hospital or nursing home that makes a large volume of these purchases on behalf of specific patients in a given time period. 

• To comply, it appears as written that the provider is required to maintain a separate “record of the transaction.”  This record would need to include a copy of the physician’s prescription or hospital’s work order, requiring duplication of patient records, which under some circumstances might otherwise be efficiently maintained within an integrated electronic record keeping system. 
• Also, vendor purchasing systems intended to improve the efficiency of DME purchases may not be capable of accommodating this documentation requirement. 
• Furthermore, this documentation requirement exposes the provider to potential retroactive tax liability arising out of the possible failure of the vendor to maintain proper documentation of signed statements by the provider. 

For these reasons, we encourage the agency to consider alternative approaches and greater flexibility in demonstrating application of the exemption to DME, and if applicable, prosthetics pursuant to paragraph F.1.

Thank you for this opportunity to comment.  Any questions or requests for additional information can be directed to Brent Rawlings, Vice President & General Counsel, brawlings@vhha.com (804)-965-1228.