DMEPOS Competitive Bidding Program Round 2021 Announcement

On March 7, 2019, the Centers for Medicare & Medicaid Services (CMS) announces plans to consolidate the competitive bidding areas (CBAs) included in the Round 2 Recompete and Round 1 2017 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program into a single round of competition named Round 2021. Round 2021 contracts are scheduled to become effective on January 1, 2021, and extend through December 31, 2023.

CMS is incorporating some important changes in the DMEPOS Competitive Bidding Program for Round 2021. These changes include several initiatives that are part of CMS' ongoing process improvements for the program, many of which are outlined in the revised federal regulations at 42 CFR subsections 414.414 and 414.416.

To ensure bidders have ample time to understand the new bidding rules and prepare for Round 2021, CMS has provided detailed fact sheets on the Competitive Bidding Implementation Contractor (CBIC) website and will be offering additional educational resources. Refer to the timeline for the Round 2021 bidding schedule. Bidders may contact the CBIC customer service center at 877-577-5331 between 9 a.m. and 5:30 p.m. prevailing Eastern Time if they have questions or need assistance.

CBAs
CMS is consolidating the CBAs included in Round 1 2017 and Round 2 Recompete by conducting Round 2021 in the same geographic areas for a total of 130 CBAs. Please refer to the CBIC website for more information about the CBAs. 

PRODUCT CATEGORIES
CMS is shifting some items to different, smaller product categories to accommodate the lead item pricing methodology. As a result, the 16 product categories listed below are included in Round 2021. Items that are newly included in the DMEPOS Competitive Bidding Program are off-the-shelf (OTS) back braces, OTS knee braces, and non-invasive ventilators. A list of the specific items in each product category is available on the CBIC website.

1. Commode Chairs
2. Continuous Positive Airway Pressure (CPAP) Devices and Respiratory Assist Devices (RADs)
3. Enteral Nutrition
4. Hospital Beds
5. Nebulizers
6. Negative Pressure Wound Therapy (NPWT) Pumps
7. Non-Invasive Ventilators
8. OTS Back Braces*
9. OTS Knee Braces*
10. Oxygen and Oxygen Equipment
11. Patient Lifts and Seat Lifts
12. Standard Manual Wheelchairs
13. Standard Power Mobility Devices
14. Support Surfaces (Groups 1 and 2)
15. Transcutaneous Electrical Nerve Stimulation (TENS) Devices and Supplies
16. Walkers

* The law requires that OTS orthotics or braces be included in the DMEPOS competitive bidding program, specifically "orthotics which require minimal self-adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit to the individual." Medicare Regulations define "minimal self-adjustment" as "an adjustment that the beneficiary, caretaker for the beneficiary, or supplier of the device can perform and does not require the services of a certified orthotist or an individual who has specialized training." In cases where a beneficiary is not physically able to adjust the brace, the adjustment may be performed by the caretaker for the beneficiary or the supplier of the brace. The adjustment has to be one that a beneficiary, in general, could make themselves, following education and training on the proper use of the device, but the individual beneficiary does not always have to make the adjustment in order for the brace to be classified as OTS. When the beneficiary has a medical need for a brace that requires more than minimal self-adjustment and the brace has to be trimmed, bent, molded, assembled, or customized by an individual with expertise, the brace is not an OTS brace. The same back or knee brace may have separate codes in the event that the beneficiary needs the brace to be custom fitted. Payment for custom fitting is included in the separate code for the custom fitted brace. Please contact the Pricing, Data, Analysis, and Coding (PDAC) contractor with any questions regarding product classification or to submit a request for reconsideration.

NATIONAL MAIL-ORDER
As a result of Section 50414 of the Bipartisan Budget Act (BBA) of 2018, CMS is not including a national mail-order (NMO) program for diabetes testing supplies in Round 2021. Section 50414 of the BBA of 2018 mandates several changes to the NMO program, and CMS is working on making these required changes.

LEAD ITEM PRICING
In Round 2021, suppliers will bid for a lead item within a product category. This means that rather than submitting individual bids for each item within a product category, bidders will submit one bid for the lead item and that bid will be used to determine the single payment amounts (SPAs) for the other items in the product category. Refer to the Lead Item Pricing Calculator and Lead Item Pricing fact sheet for more information.

BID SURETY BONDS
Bidders must obtain a $50,000 bid surety bond from an authorized surety on the Department of the Treasury’s List of Certified Companies for each CBA for which a bid is submitted. A copy of the bid surety bond(s) must be uploaded in Connexion, the DMEPOS Competitive Bidding Program’s secure portal, by the deadline for bid submission. Refer to the CBIC website for more information. 

SUPPLIERS INTERESTED IN BIDDING: PREPARE NOW – DON’T WAIT!

GET BONDED: Bidders must provide proof of having obtained the required bond(s) by uploading a copy of the bond(s) in Connexion by the close of the bid window. It is important to note, however, that bid surety bonds required for bidding in the DMEPOS Competitive Bidding Program are NOT the same as the surety bonds required for DMEPOS supplier enrollment purposes. 

GET LICENSED: Contracts are only awarded to bidders that meet all licensing requirements by the close of the bid window. Licensing requirements change periodically, and it remains the responsibility of the bidder to identify, obtain, and have all current, non-expired required licenses reflected in the Provider Enrollment, Chain, and Ownership System (PECOS) by the close of the bid window. Each supplier location on the bid must be licensed for all lead and non-lead items in the product category by the state in which it furnishes or plans to furnish if awarded a DMEPOS competitive bidding contract. It is up to the bidder to confirm which states require a license(s). For additional information, please see the Licensure for Bidders fact sheet.

The National Supplier Clearinghouse (NSC) provides a DMEPOS State License Directory for each state, the District of Columbia, and the U.S. territories. This directory provides general licensing requirements for DMEPOS product categories and contact information for each state’s licensing board or agency. This is only a guide. Licensing requirements change periodically and it remains the responsibility of the bidder to identify, obtain, and have all current, non-expired required licenses reflected in PECOS by the close of the bid window. For more information about licensing requirements, please consult the appropriate licensing board/agency listed in the directory.

GET ACCREDITED: Each supplier location on a bid must be accredited by a CMS approved accrediting organization for the lead and non-lead items in a product category. Any supplier who is interested in bidding for a product category but its location(s) is not currently accredited for that product category must take action NOW to get it accredited for that product category. Accrediting organizations report any accreditation updates to the NSC, so it is important that bidders get their locations accredited early so their information will be up to date. CMS cannot contract with suppliers that are not accredited by a CMS approved accrediting organization. Further information on the DMEPOS accreditation requirements along with a list of the accrediting organizations and those professionals and other persons exempted from accreditation are available on the CMS website.

REVIEW AND UPDATE ENROLLMENT: Each supplier must maintain accurate information on its CMS-855S with the NSC and in PECOS including:

• Contact information (name, Social Security number, and date of birth) for authorized official(s)
• Products and services furnished by the enrolled location(s)
• Each state in which the enrolled location(s) furnishes items and services

It is also important that the NSC has your current liability insurance policy information on file. Without this information, the NSC cannot process any changes to your enrollment record(s). As a reminder, licenses and insurance documents may be uploaded directly to the NSC using the NSC Web Form Submission tool on the NSC website.

NOTE: Bidders with only one authorized official (AO) listed on their enrollment file should consider adding one or more eligible AOs to help with registration and bidding. It is important to note that if bidders' files are not current at the time of registration, they may experience delays and/or be unable to register and bid.

The CBIC is the official information source for bidders and the focal point for bidder education. The CBIC website contains important and helpful resources to ensure that bidders have the necessary information to prepare for Round 2021. To sign up to receive important competitive bidding announcements and reminders, bidders and others are encouraged to subscribe to Email Updates on the CBIC website.