Cms-10169

DESCRIPTION OF TECHNICAL CHANGES TO OMB CONTROL #0938-1016

The Centers for Medicare & Medicaid Services (CMS) has identified a small number of clarifications to the previously approved Form A (CMS-10169A) and Form B (CMS-10169B) of the Request for Bids for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program information collection (OMB # 0938-1016). These clarifications represent nonmaterial or non-substantive changes to a currently approved collection and are designed to improve the instructions and streamline the information collection.

Form A (CMS-10169A) Section 1 – 1a:

Previous collections via Form A required reporting of certain information at both the organization level as well as the location-specific level. Based on our experience during the Round 1 Rebid, we found that over 65% of bidders had a single business location. This common business structure made the existing form duplicative in the information collected and frequently created confusion among users. Therefore, the modifications to this form delete a small number of duplicative questions about the organization that are fully addressed by existing collection requirements at the location level. This modification removes unnecessary duplication and presents the questions in a more logical and simple manner, providing clarity and ease for the end-user.

The RFB instructions inform bidders of the regulatory requirement to have all required state licenses and remind them that they must ensure that copies of licenses are on file with the National Supplier Clearinghouse (NSC). (These are pre-existing information collections that are accounted for in a separate OMB approval.) Based on our experience during the Round 1 Rebid, a large number of suppliers did not understand the requirement to submit current licenses to the NSC. This put suppliers at great risk of being disqualified from the competition. To help clarify the rules for suppliers, we have included two affirmation statements in Form A. The first affirmation statement asks each bidder to affirm that its organization as a whole meets licensure requirements. The second affirmation statement asks each bidder to affirm that each of its locations has the specific licensures required for the state or states it serves. We do not believe that these affirmations constitute an information collection because they simply serve to clarify and reinforce existing requirements that are a standard business practice.

We have also reordered some of the questions to enhance the logical flow of the collection.

A spreadsheet is attached to assist in evaluating the modifications. The spreadsheet identifies the topics from Form A in the left column and uses the rows to provide a cross-reference between the current and new forms in the subsequent columns to the right. The reader can cross-reference the topic from the section, page and item number in the current form to the same information in the clarified form. Comments have been added where needed to provide further explanation.

Summary of Items in CMS-10169A
	Duplicative Items	Items Relocated & Renumbered	Clarifications
Row Number	4-6, 10-12, 20	2, 7, 9, 13-16, 18-19, 21	1, 3, 8, 17, 19

Form A (CMS-10169A) Section 2 – 2a:

Section 2 & 2a pertain to suppliers organized and bidding as a network. This section of the form mirrors section 1 & 1a and includes one additional attestation statement regarding the presence of a legal agreement for the formation of the network. This attestation statement is designed to reinforce and clarify existing instructions that are included in the current collection.

Form B (CMS10169B)

A small number of questions have been removed from Form B. CMS has determined that this information is either obsolete, duplicates information collected in Form A, or can be adequately obtained through other processes. We have also deleted an unnecessary optional field and reordered some of the questions to enhance the logical flow of the collection.

CMS is reporting one clarification to the technology used to collect an existing requirement. DMEPOS suppliers are currently required to report the brand information (Manufacturer, Make, and Model) of competitively bid items, including diabetic test strips, they plan to provide to Medicare beneficiaries. This information is collected during the bidding process through DBidS, the online bidding system, and has previously received PRA approval. The Medicare Improvements for Patients and Providers Act of 2008 mandated that suppliers ensure their bid for diabetic test strips cover at least 50% of the products by brand that are available in the market. The requirements to comply with this mandate were finalized after the deadline to make coding changes in the DBidS system; therefore, CMS has developed an online form to collect this information for diabetic testing supplies. The form will clarify the rules by automatically calculating the percentage of market share for diabetic testing supplies as suppliers enter their information. Accessing this portion of the collection will be seamless for suppliers because they will access the form via a link from DBidS to the Competitive Bidding Implementation Contractor website. The modification in reporting method will further assist in clarifying the specific information that must be reported by allowing suppliers to select Manufacturer, Make, and Model information from a pre-populated list rather than the free text format in DBidS. Suppliers will mail the form with other required hardcopy documents that are already part of the approved collection.

Summary of Items in CMS-10169B
	Obsolete / Duplicative Items	Items Relocated & Renumbered	Clarifications
Row Number	1-3, 9-10, 14	4-5, 7-8, 13, 15	6, 11-12