NABP’s DMEPOS Pharmacy Accreditation standards are inclusive of the CMS quality standards. The quality standards are guidelines used by the CMS-approved accrediting organizations to which suppliers must comply to attain DMEPOS Pharmacy Accreditation.
Drugs Associated with Durable Medical Equipment
Drugs used with durable medical equipment (DME), for example, inhalation drugs, drugs infused with a DME pump, are not subject to CMS quality standards. If a pharmacy supplies drugs used with DME but does not supply items subject to CMS quality standards, it will not need DMEPOS Pharmacy Accreditation. Medicare Part B drugs identified in section 1861(s) of the Social Security Act (eg, immunosuppressive drugs, oral anti-emetic drugs) are not subject to the quality standards.
However, home dialysis supplies, nutrients furnished using enteral or parenteral devices, blood products, and transfusion medicine are subject to the quality standards. Suppliers of these products will need to attain DMEPOS Pharmacy Accreditation if they wish to maintain Medicare billing privileges.
Items Subject to CMS Quality Standards
All DME described in section 1834(a)(13) of the Social Security Act and paid in accordance with section 1834(a), excluding drugs or implantable items furnished by an outpatient hospital department that are not paid for in accordance with section 1861(n) of the Act. The term DME is defined in section 1861(n) of the Act.
Prosthetic devices, orthotics, and prosthetics described in section 1834(h)(4).
Orthotics (braces), prosthetics (artificial limbs), and diabetic shoes, but not intraocular lenses or medical supplies (eg, catheters, catheter suppliers, ostomy bags, and supplies) furnished by a home health agency (HHA). (Note: These items are bundled into the HHA prospective payment system.)
Additional items referenced in section 1842(s)(2):
a. Medical supplies
b. Home dialysis supplies and equipment
c. Therapeutic shoes
d. Parenteral and enteral
e. Electromyogram devices (currently not covered)
f. Salivation devices (currently not covered)
g. Blood products
h. Transfusion medicine
DMEPOS Products Approved for Accreditation by NABP
NABP’s DMEPOS Pharmacy Accreditation program is best suited to pharmacies that distribute DMEPOS products that fall within the program’s scope of accreditation.
NABP is currently approved by CMS to accredit the following product categories from the Medicare Enrollment Application:
Devices & Equipment
- Continuous Positive Airway Pressure (CPAP) Devices and/or Supplies
- Enteral Equipment and/or Supplies
- Insulin Infusion Pumps & Pump Supplies
- Nebulizer Equipment and/or Supplies
- Parenteral Equipment and/or Supplies
- Respiratory Assist Devices
- External Infusion Pumps & Pump Supplies
Mobility Assistance Equipment
- Seat Lift Mechanisms
Prosthetics & Orthotics
- Diabetic Shoes/Inserts (Custom & Non-custom)
- Breast Prostheses and/or Accessories
- Blood Glucose Monitors and/or Supplies (mail order & non-mail order)
- Enteral Nutrients
- Heat & Cold Applications
- Ostomy Supplies
- Parenteral Nutrients
- Surgical Dressings
Contact the National Supplier Clearinghouse (NSC) or your DME Medicare Administrative Contractor for information on product category-specific information and billing questions. When selecting product categories, facilities must consider the applicable licensure requirements and know which product categories are included in the competitive bidding programs of their service area.
The DMEPOS competitive bidding program is designed to help lower out-of-pocket costs and improve access to certain high-quality DMEPOS products for Medicare beneficiaries. The competitive bidding program was mandated through the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 through a statute that requires Medicare to replace its fee schedule with a competitive bid process.
The competitive bid payment amounts are determined by using bids submitted by DMEPOS suppliers. The intent of the competitive bidding program is to set more appropriate payment amounts for DMEPOS items, which will result in reduced beneficiary out-of-pocket expenses and savings to taxpayers and the Medicare program. To participate in the Medicare DMEPOS competitive bidding program, suppliers must be accredited by a CMS-approved accreditation organization, meet licensing requirements, and, if applicable, become bonded; additional requirements may apply. Please note that DMEPOS Pharmacy Accreditation is required to participate in the DMEPOS competitive bidding program.
Learn More About Competitive Bidding
Information about competitive bidding changes frequently. For up-to-date information, including the bidding timeline and rules, user guides, frequently asked questions, and policy fact sheets and checklists, visit the Competitive Bidding Implementation Contractor website.