AMARILLO, TX – The Centers for Medicare & Medicaid Services (CMS) has recently initiated a surge in off-cycle, unannounced site visits nationwide. This proactive enforcement effort has already resulted in a noticeable increase in revocations of supplier billing privileges. Now is the time to ensure your locations—and your staff—are fully prepared. 

Understanding CMS Site Visits
CMS site visits are a routine part of supplier oversight, occurring during initial enrollment, revalidation, when requesting a change in address, or when adding a new location. However, suppliers may also be subject to unannounced inspections at any time. The primary objective of these visits is to confirm that a supplier’s operations align with the information on file and comply with Medicare enrollment requirements, specifically that the supplier is in compliance with the DMEPOS supplier standards.

A failed site visit—whether due to inaccurate enrollment data, inaccessible locations, or non-compliance with standards—can lead to application denials, revocation of billing privileges, and even a bar on future enrollment.

Three Keys to Site Visit Readiness
To mitigate the risk of revocation, suppliers should take a proactive, three-pronged approach: validate enrollment data, ensure compliance with supplier standards, and train employees to effectively support site inspections. 

1) Validate Your Enrollment Profile

Start by reviewing your enrollment records in PECOS (Provider Enrollment, Chain, and Ownership System) to confirm. Pay close attention to:

• Business Hours: Site visits occur during the hours listed in your enrollment record. If staff are unavailable during these times—even temporarily—CMS may consider the visit obstructed, which could trigger enforcement action. If a supplier has limited staff and needs to make deliveries during the day, adjust operating hours to allow for time for the staff to make those deliveries. For example, business hours could be Monday, Wednesday, and Friday from 9:00 to 5:00 and on Tuesday and Thursday the hours could be from 9:00 to 3:00 with deliveries taking place after 3:00 on these days. The key is that if business hours are reported to the enrollment contractor, someone must be in the location and the location must be open to the public.
• Location and Contact Information: An incorrect address, inactive phone number, or unmonitored email can cause critical communications to go undelivered or prevent the inspector from locating or contacting the facility—each of which could result in revocation.
• States Where Items are Provided: It is important that all states in which a supplier is providing services be disclosed on the 855S and all required licensure is in place. Failure to update this information or to not have the required licensure could result in a retroactive revocation.
• Products and Accreditation: Be sure that if the company makes any changes to the products and services it is providing, not only has the company been appropriately accredited for the new items, but the new items must be included on the 855S. The NPEs will often run a report, and if an item that is being provided has not been added or accreditation is not present, this is another scenario that could result in a retroactive revocation.
• Updated Licenses, Bonds, and Insurance: If this information has changed or has been renewed, it should be updated via PECOS. This is often a reason for revocation and simply submitting the updated information can save the supplier from a lot of stress and pain as it will avoid revocations.

Keeping all information current is essential to avoiding administrative revocations that are preventable with routine data maintenance.

2) Confirm Compliance with Supplier Standards

Suppliers must meet all applicable requirements under 42 C.F.R. § 424.57(c)—which outlines 30 individual DMEPOS supplier standards. While not all standards apply universally, every supplier is responsible for knowing which do and ensuring ongoing compliance.

Examples of commonly scrutinized standards include:

• Visible Signage: Your location must display a permanent sign in plain view, showing the business name and posted hours.
• Operational Telephone Line: A working telephone number must be listed under the supplier’s name in a local directory and operational at the physical site.
• Inventory Requirements: Suppliers must either maintain inventory on-site or provide evidence of contractual arrangements with third-party vendors. If you fill orders through partnerships, have those contracts readily available.

Even seemingly minor deficiencies—such as a faded sign or incorrectly listed phone number—can result in failed inspections and revoked billing privileges.

3) Train and Equip Employees for Site Visits

Your front-line staff are critical to the success of any CMS site visit. Employees should be trained to:

• Understand the purpose and protocol of a site inspection from CMS.
• Greet inspectors professionally and facilitate their access to the facility.
• Provide documentation quickly and accurately.

All employees need to understand the importance of responding to a site inspection. Any employee who is left alone at the location should be trained to respond to a site inspection.

Each location should maintain a comprehensive site visit binder, easily accessible to staff and readily shared with inspectors. This binder should include:

• Accreditation certificates
• State/local business licenses
• Surety bond and liability insurance documents
• Complaint log, return policy, warranty policy
• Intake and proof-of-delivery forms
• Documentation of inventory sources

For standards that are not applicable, include a written explanation. For example, if your business dispenses supplies that are not subject to a warranty, state this explicitly in the binder, along with the company’s policy on how to handle the replacement of defective supplies, to preempt confusion or false assumptions.

When standards allow multiple compliance paths (e.g., inventory fulfillment), choose one, document it thoroughly, and have all related contracts or evidence on hand for inspection.

Conclusion: Proactive Preparation Saves Time and Revenue
CMS’s recent escalation of unannounced site visits underscores the need for preparedness. By validating enrollment data, ensuring compliance with all applicable supplier standards, and training staff to handle inspections confidently, suppliers can protect their Medicare billing privileges and avoid unnecessary disruptions. A failed inspection can result in months of costly appeals and interrupted cash flow. Investing time now in preparation is not just advisable—it’s essential.

Denise M. Leard, Esq., is an attorney with the Health Care Group of Brown & Fortunato, a law firm with a national health care practice based in Texas. Leard represents HME companies, pharmacies, and other health care providers throughout the United States. Leard has authored numerous articles and is a frequent lecturer throughout the country. She is licensed in Idaho, Oklahoma, Oregon, Texas, and Washington and is Board Certified in Health Law by the Texas Board of Legal Specialization. Leard earned a B.A. from the University of Washington and received her law degree from the University of Oklahoma College of Law. She can be reached at (806)345-6318 or [email protected].

Jordan T. Vogel, JD, is an attorney with the Health Care Group at Brown & Fortunato, PC, a law firm with a national health care practice based in Texas. He represents pharmacies, infusion companies, HME companies, manufacturers and other health care providers throughout the United States. Vogel can be reached at (806) 345-6351 or [email protected].