AMARILLO, TX – As of January 1, 2024, the Centers for Medicare & Medicaid Services (CMS) is codifying its policies regarding automatic refills for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). In the past CMS has had policies regarding the refills of DMEPOS but it has now codified those policies.

Durable medical equipment (DME) is covered under Part B as a benefit category under medical or other health services. It is defined as equipment that can withstand repeated use, is primarily and customarily used to serve a medical purpose, is not generally useful to a person in the absence of illness or injury, is appropriate for use in the home, and has an expected life of at least three years. There are some DME items that require supplies for effective use. These supplies require refills.

DMEPOS items and supplies may be furnished on a recurring basis to beneficiaries with chronic or long-term conditions. A practitioner may be able to anticipate the need for later dates of service for the beneficiary receiving these items and supplies. The practitioner may write an order for immediate use and refills for later dates of service in that case.

There were initial concerns related to auto-shipments and delivery of supplies that may no longer be needed or not needed at the same level of frequency. Therefore, CMS instituted policies that required suppliers to contact the beneficiary prior to dispensing a refill. Initially the rule was that contact with the beneficiary (or his/her designee) regarding the refill needed to occur no sooner than seven days prior to the delivery/shipping date. The subsequent delivery of refills was not to occur sooner than five days prior to the end of the usage for the current product.

The Medicare Program Integrity Manual stated that contact with the beneficiary regarding refills must take place no sooner than 14 days prior to the delivery/shipping date and the delivery of the product could not occur any sooner than 10 calendar days. This has been the policy since 2011.

The OIG conducted a national study demonstrating that suppliers did not maintain sufficient refill documentation as recently as 2019. Due to compliance concerns CMS proposed to codify the refill policies contained in the Medicare Program Integrity Manual.

CMS now requires documentation indicating that a beneficiary must confirm his/her need for a refill within the 30-day period prior to the end of the current supply period. CMS has codified the requirement that the delivery of a resupply item be no sooner than 10 calendar days before the expected end of the current supply.

According to the Final Rule, CMS will require DME suppliers to document contact with the beneficiary to verify that the refill is needed. The documentation must include:

• Evidence of the beneficiary’s affirmative response to the need for supplies; and
• For shipped items, the beneficiary’s name, date of contact, the item requested, and the affirmative response from the beneficiary indicative of the need for refill, prior to dispensing the product or for items obtained in-person from a retail store, the delivery slip signed by the beneficiary can be sufficient documentation of a request for refill.

Based on comments submitted, CMS is finalizing the documentation requirements for products supplied as refills to the original order as initially proposed. The refill rules will be officially codified as of January 1, 2024.

Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato, a law firm based in Texas with a national health care practice. He represents pharmacies, infusion companies, HME companies, manufacturers, and other health care providers throughout the United States. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or [email protected].

Jacque K. Steelman, JD is a member of the Health Care Group at Brown & Fortunato, 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. Steelman can be reached at (806) 345-6316 or [email protected].