Accreditation, competitive bidding and comprehensive product lists
by Mary Ellen Conway

There has been a bit of concern lately regarding the connection between accreditation, bids submitted in Round Two of Competitive Bidding and your Comprehensive Product List.

Effective March 2008, well before the accreditation deadline of 2009, the Centers for Medicare & Medicaid Services (CMS) created requirements that their approved accreditors had to meet before a supplier could become accredited. One is that the supplier proves to the accreditor that they are capable of providing the product(s) by actually providing them to customers before the accreditor comes onsite to perform the unannounced survey. The onsite accreditation surveyor validates that the supplier has adequate and quality stock and stores, delivers, sets up and maintains the equipment appropriately. The surveyor must also ensure that the supplier completes the proper paperwork and instructs and educates the customer effectively as well as obtains complete physician orders and patient signatures.

CMS does not allow the accreditor to simply review that these processes are in place, it requires that the onsite survey validates that all of these items are being performed correctly. CMS decided that it is not possible to demonstrate this process without observing actual patient records and, where appropriate, making home visits and interviewing customers.

CMS’s requirement for new suppliers is that they have provided equipment to at least 10 customers, so that the accreditation representative has at least that many records to review. These 10 customers need to include all of the items the supplier wishes to be accredited for, not 10 of each item. Typically a new supplier will provide each type of equipment they want to provide. New suppliers cannot bill CMS for the equipment that they may be providing to Medicare beneficiaries during this process until they are accredited and have received an NPI number. CMS doesn’t care whether the supplier is billing another third-party payer during this time or if they are providing the item(s) for free.

CMS also created a document known as the Comprehensive Product List. This is a list of every piece of medical equipment CMS provides to beneficiaries under Part B, from routine durable medical equipment and supplies, to orthotics, prosthetics, speech-generating devices, dialysis equipment and more. The supplier must make sure that every item they are accredited to provide is noted on this list from their accreditor. The accreditor then submits the list to the NSC, which then must match the information submitted by the supplier. Invoices sent by the supplier to the DMEMAC for items provided must match the Comprehensive Product List received by the accreditor in order to be reimbursed. Suppliers will not receive reimbursement for items billed that are not also included on the Comprehensive Product List submitted by the accreditor.

The same requirement exists when adding new items and product categories for suppliers who are already accredited. A supplier who decides to add new products to those they are currently accredited to provide—everything from oxygen and supplies to therapeutic shoes—needs to first provide those items to customers and prove that all of the accreditor’s requirements have been met. These can be customers with other payer sources, or in the case of Medicare beneficiaries, provided for free. Once they notify their accreditor that they are ready, the accreditor must come onsite to observe their process and then these items, or these product categories, can be added to the list.

Suppliers must contact their accreditor when they are planning to add new equipment and product categories to obtain their guidance on requirements and be aware that not all of the approved accreditors are able to accredit in every product category. For example, NABP was not recognized to accredit oxygen or rental items.

Now we address the current problem. This year, many suppliers submitted bids in Round Two for equipment and product categories that the supplier has never provided. Many suppliers hope to expand their businesses in the new Competitive Bidding landscape and thus win the bids for multiple product categories. The problem arises when the supplier is not accredited for the new product line and these items are not included on the Comprehensive Product List provided by the accreditor on file with the NSC. As the CBIC reviews the bids submitted for each category, they will check to make sure that the supplier is accredited to provide all of the bid items in that category. For suppliers who are not accredited in that product category and whose Comprehensive Product List does not include those items, the bid will be disqualified.

If you are in this unfortunate situation, contact your accreditor and find out what you need to do. Hopefully you can get your Comprehensive Product List up to date before the CBIC reviews your bid.