Unannounced CMS Site Visits
PAAS National® has recently seen an uptick in the number of unannounced CMS site visits related to Medicare enrollment or revalidation. These visits are currently being conducted by Novitas Solutions, the contracted National Provider Enrollment East (NPEast) contractor and Palmetto GBA® for the NPWest. Site visits are performed to verify the business location and ensure that suppliers meet DME supplier standards.
Pharmacies will typically receive a notice that indicates a site visit will be forthcoming and that they cannot provide specific information on when the visit will be conducted. The notice includes a list of items to be examined by personnel including, but not limited to, the following:
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- Licenses
- General Liability Insurance
- Inventory (physically in stock or credit agreement with wholesaler)
- Complaints (Logs and Resolution Protocol)
- Warranty Coverage Notification
- Rent/Purchase Option Notification
- Surety Bond Agreement
- Accreditation Information (if applicable)
- Patient Instructions for Use
- Oxygen Licensure (if applicable)
Pharmacies often have questions about requirements for the inventory, complaints, warranty coverage notification, rent/purchase option notification, and patient instructions for use.
- For inventory, the site inspectors will take pictures of the DME items you have in stock, and if something is out-of-stock, they will request proof of where you will purchase the out-of-stock item from.
- Model forms for the (i) warranty coverage notification, (ii) rent/purchase option notification, and (iii) complaint log/resolution protocol can be found on the Palmetto GBA® website.
- For the patient instructions for use request, the site inspector will ask to see a patient label from a claim you have previously billed.
Create a resource folder with all the applicable documents to help your pharmacy be prepared. Staff should be made aware of an impending visit and where to locate the resource folder. Auditors will conduct the audit whether or not the pharmacy is prepared (and regardless of whether the owner is present). PAAS has seen these audits go awry because staff were unaware and ill-equipped, failing to provide the auditor with any documentation.
Site visits are typically short. If you do not have all the required documents for the site inspectors during the visit, or if you fail the site visit for any other reason, you may receive a non-compliance notice and revocation letter which typically requires a Corrective Action Plan (CAP) and Reconsideration Request for appeal.
PAAS Tips:
- Create a resource folder with all the necessary documentation and educate staff on its location
- Review the CMS-R-263 form site inspectors use when conducting a site visit
- Review the DMEPOS Supplier Standards to ensure adherence
- Visit the Novitas Solutions FAQs page for an array of answers to other questions you may have
- Visit the Palmetto GBA® Suggested Templates page to download any missing forms
- Read the September 2024 Newsline article, Rethink Corrective Action Plans
I have a Bachelor of Arts in Communications from the University of Wisconsin – Madison. Prior to joining PAAS in 2017, I worked for Walgreens for 19 years.
As an Analyst at PAAS, I really enjoy being able to help independent pharmacies succeed. I have always been a fan of the underdog and am excited to be able to give you the tools you need to take on the giants of the PBM industry.
