Handling Regulatory and Process Changes During the Pandemic

The COVID-19 pandemic has ushered in a variety of regulatory changes from CMS. How do HME providers manage all of them?

• By Kris Ravotti, RRT, RCP
• Jan 12, 2021

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The COVID-19 pandemic has challenged providers to rethink the way we do what we do and to implement new practices to continue meeting the needs of patients. 

Because of the pandemic, the industry has seen many changes to − or the loosening of − regulatory requirements, especially those from the Centers for Medicare & Medicaid Services (CMS). Among the CMS changes are:

• Waiving signature and proof-of-delivery requirements for Durable Medical Equipment when a signature could not be obtained
• Allowing the provision of DMEPOS items based on a verbal order
• Not enforcing clinical indications for coverage for respiratory items and infusion pumps
• Waiving two DMEPOS supplier standards − 9 (primary business phone) and 30 (open 30 hours/week)

Although these changes were implemented to ensure continued services to Medicare beneficiaries, providers should not become relaxed on CMS signature, documentation, and national coverage determination (NCD) and local coverage determination (LCD) requirements. If you can obtain a signature, a written order prior to delivery, or documentation to verify that clinical coverage requirements have been met, it is best to continue to obtain it. We have already seen CMS rescind some waivers, and, at some point, we can expect CMS to rescind most or all waivers. Also, we must consider that while clinical indications for coverage are not being enforced for some products, there has been no further clarification about how that will affect subsequent claims for supplies or replacements once CMS begins enforcing the coverage criteria again.

Not only have we seen changes in regulatory requirements, but also we’ve seen that providers have had to make changes to their own practices, procedures, and processes to continue to provide services. Even under pandemic-forced implementation, providers still should consider how they document such changes. It is understood that many organizations do not want to alter their formal policies and procedures for these pandemic-related practice, procedure, or process changes; however, this does not mean that there should not be a documented record of the changes implemented. The provider should create a document that references the date of the change, the reason for the change, and the proof of staff education about the change, as well as a plan to revisit the change to determine when it is appropriate to return to the organization’s formal policy and procedure.

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