Legal: Perform due diligence

Q. How can DME suppliers mitigate legal risks associated with telehealth arrangements?

A. As telehealth technologies have become more widely used and accepted as a means of delivering health care services, regulators have increased their scrutiny of arrangements involving these services. Although the enforcement landscape continues to evolve as novel telehealth models and related fraud schemes emerge, DME suppliers can help mitigate legal risk by learning from the compliance concerns highlighted in recent enforcement actions by the U.S. Department of Justice (DOJ) and the Department of Health and Human Services Office of Inspector General (HHS OIG).

A significant – and perhaps the most common – compliance risk is relying too heavily on prescriptions without performing any additional due diligence such as taking steps to confirm that the supporting documentation and surrounding circumstances substantiate the medical necessity and the coverage requirements related to the treatment prescribed. For example, to satisfy Medicare’s conditions of payment for products on the “Required Face-to-Face and Written Order Prior to Delivery List,” DME suppliers must be able to provide CMS with documentation of the face-to-face encounter (which must meet the requirements of 42 CFR 410.78 and 42 CFR414.65), including the patient’s history, physical examination, diagnostic tests, summary of findings, progress notes, treatment plans and other relevant information. Before dispensing a product, suppliers should review the documentation carefully to confirm that it supports both the medical necessity of the DME and satisfies the related documentation requirements for reimbursement.

Suppliers should also consider the broader context of the telehealth encounter, including whether a genuine prescriber-patient relationship was established and medical necessity was appropriately evaluated. For example, DME suppliers may ask:

• Does the ordered product align with the prescriber’s specialty?; and
• Was the telehealth visit sufficiently thorough and individualized to support patient-specific clinical decision-making?

A negative or inconclusive response to either of these questions should prompt further investigation by the DME supplier to confirm that all applicable Medicare conditions of payment have been met.

Telehealth can be a legitimate and effective way to deliver health care services. Even so, DME suppliers should continue to conduct their own due diligence to confirm that Medicare’s conditions of payment are met and adequately supported by the documentation.

Kianna L. Sitarski, Esq., is a member of the Health Care Group at Brown & Fortunato, PC, a law firm with a national health care practice based in Texas. She represents pharmacies, infusion companies, HME companies, manufacturers, and other health care providers throughout the United States. Ms. Sitarski can be reached at (972) 684-5788 or ksitarski@bf-law.com.