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DMEPOS Enrollment

DMEPOS Accreditation

In November 2006, the Centers for Medicare & Medicaid Services (CMS) approved 10 national accreditation organizations that will accredit suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) as meeting new quality standards under Medicare Part B.

In order to enroll or maintain Medicare billing privileges, all DMEPOS suppliers (except for exempted professionals and other persons as specified by the Medicare Improvement for Patients and Providers Act of 2008) must comply with the Medicare program's supplier standards (found at 42 CFR §424.57 (c)) and quality standards to become accredited. The accreditation requirement applies to suppliers of durable medical equipment, medical supplies, home dialysis supplies and equipment, therapeutic shoes, parenteral/enteral nutrition, transfusion medicine and prosthetic devices, and prosthetics and orthotics.

For more information regarding the DMEPOS Quality Standards, please click here.

On March 23, 2010, the President signed HR 3590 into Public Law no: 111-148, which amends title XVII of the Social Security Act to exempt a pharmacy from accreditation if it meets all of the following criteria:

  • The total billings by the pharmacy for DMEPOS are less than 5 percent of total pharmacy sales; 
  • The pharmacy has been enrolled as a supplier of durable medical equipment, prosthetics, orthotics and suppliers, as has been issued a provider number for at least 5 years; 
  • No final adverse action has been imposed on the pharmacy in the past 5 years;
  • The pharmacy submits an attestation, as determined by CMS, that the pharmacy meets the first three criteria; 
  • The pharmacy agrees to submit materials as requested during the course of an audit conducted on a random sample of pharmacies selected annually.

Further information on the DMEPOS accreditation requirements along with a list of the accreditation organizations and the guidance regarding the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) for DMEPOS suppliers can be found on the Downloads section below.

DMEPOS Supplier Standards

All Medicare DMEPOS suppliers must be in compliance with these Supplier Standards in order to obtain and retain their billing privileges. These standards, in their entirety, are listed in 42 Code of Federal Regulations (CFR), part 424, section 57.

On August 27, 2010, the Centers for Medicare & Medicaid Services published a proposed rule titled, "Medicare Program; Establishing Additional Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Suppliers (DMEPOS) Supplier Enrollment Safeguards" (CMS-6036-F) in the Federal Register. The new supplier standards are effective on September 27, 2010.

In order to obtain a full version of the DMEPOS Supplier Standards, please visit the electronic Code of Federal Regulations (e-CFR).

DMEPOS Surety Bond

The Centers for Medicare & Medicaid Services (CMS) published a final rule titled, "Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)" in the Federal Register on January 2, 2009.  This final rule implemented Section 4312(a) of the Balanced Budget Act of 1997 and requires certain DMEPOS suppliers to obtain and maintain surety bond on continuing basis.  Section 4312(b) requires that a surety bond be in amount of not be less than $50,000.   

Enrolled DMEPOS suppliers, subject to the bonding requirement, are required to obtain and submit $50,000 bond for each National Provider Identifier (NPI) by October 2, 2009 to the National Supplier Clearinghouse (NSC). Since DMEPOS suppliers must obtain an NPI by practice location, except for sole proprietorships.  For example, an organizational DMEPOS supplier with 20 practice locations would be required to secure a $1 million surety bond.

DMEPOS suppliers exempt from bonding requirement: (1) Government-owned suppliers that have provided CMS with a comparable surety bond under state law. The surety bond shall state that CMS is an obligee and cover obligations concerning claims, (2) State-licensed orthotic and prosthetic personnel in private practice making custom made orthotics and prosthetics if the business is solely-owned and operated by said personnel and is billing only for orthotic and prosthetics, and supplies, (3) Physicians and non-physician practitioners if the DMEPOS items are furnished only to his or her patients as part of his or her professional service, and (4) Physical and occupational therapists if: (1) the business is solely-owned and operated by the therapist, and (2) if the DMEPOS items are furnished only to his or her patients as part of his or her professional service.

Medicare Program; Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom Fabricated Orthotics

Section 1834(h)(1)(F)(ii)(I) of the Act requires the Secretary to develop a list of items to which the requirements of Section 1834(h)(1)(F) would apply. On August 19, 2005, CMS issued program instructions (Transmittal 656, CR 3959) implementing the list of HCPCS codes describing items subject to the requirements of section 1834(h)(1)(F) of the Act. 

The list of HCPCS codes is found below in the Downloads box.
For additional information regarding DMEPOS accreditation, please return to the main provider enrollment web page and select DMEPOS accreditation from list of topics on the left side of the screen.
When submitting your DMEPOS surety bond to the National Supplier Clearinghouse (NSC), you are required to complete sections 1, 6, 7, 11 (Optional), 12, and either 14 or 15 of the Medicare enrollment application (CMS-855S).  By completing and submitting the required sections of the CMS-855S, you will help to ensure that the NSC is able to correctly associate your DMEPOS surety bond to your enrollment record.

If your pharmacy is enrolled as a DMEPOS supplier with the NSC and bills the DME MAC (formerly a DMERC) for non-accredited products, including Epoetin, immunosuppressive drugs, infusion drugs, nebulizer drugs, or oral anticancer drugs, you are required to have a surety bond.
Note:  The DMEPOS Surety Bond final rule did not establish an exception to the bonding requirement for pharmacies.  Accordingly, pharmacies continuing to participate in the Medicare program as a DMEPOS supplier must have a surety bond.  Any supplier enrolled with the NSC is considered a DMEPOS supplier.