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Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)
Frequently Asked Questions

1. What is the NABP DMEPOS Accreditation Program? How long is DMEPOS accreditation valid?
It is an accreditation program offered by the NABP for licensed pharmacies that distribute certain DMEPOS products and services and bill Medicare Part B for these products and services. The NABP DMEPOS accreditation program is approved by the US Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS).  DMEPOS accreditation is valid for three years. Accredited suppliers will submit a renewal application to NABP every three years.

2. Who is eligible to apply for NABP DMEPOS accreditation?
The NABP DMEPOS accreditation program can only service suppliers who:

  • possess a current valid state pharmacy license, and
  • distribute only DMEPOS products and services that fall within NABP’s scope

3. What are the steps required for a pharmacy to become DMEPOS accredited? What is the time frame for the accreditation process?

  • Suppliers submit application materials and all required documentation to NABP.
  • NABP staff members assess application materials to ensure that CMS quality standards are met.
  • Unannounced survey of pharmacy is held to compare the pharmacy’s written policies and procedures to its actual practices.
  • When capacity permits, the NABP goal is to complete the DMEPOS accreditation process within 90 days from verified submission of all required documentation.

4. Is DMEPOS accreditation mandatory? 
On December 19, 2007, CMS announced that the deadline by which all DMEPOS suppliers need to be accredited is on or before September 30, 2009. However, several additional criteria exist, including:

  • Suppliers who already have a Medicare Billing number, also known as the National Supplier Clearinghouse (NSC) number, who are not participating in the competitive bid, will need to be accredited on or before September 30, 2009.  If not accredited by that date, the supplier's NSC DMEPOS billing privileges will be revoked.
  • Suppliers with lapsed NSC numbers must be accredited before the NSC number can be reactivated.
  • New DMEPOS suppliers must be accredited before an NSC number can be obtained.
  • DMEPOS suppliers participating in Round Two of the competitive bid must either be accredited or have applied for accreditation by May 14, 2008, in order to register for the second round of competitive bidding. CMS cannot accept a bid from any supplier that is not accredited or that has not applied for accreditation by May 14, 2008.
  • DMEPOS suppliers will need to be accredited by October 31, 2008, in order to be awarded a contract.  The accreditation deadline for the second round of competitive bidding is October 31, 2008.  Suppliers must be accredited before this date to be awarded a contract.  Suppliers should apply for accreditation immediately to allow adequate time to process their applications.

5. What is the cost for DMEPOS accreditation through NABP?
The cost of accreditation for a single pharmacy is shown below.

Single Pharmacy (small supplier)

 

Application Fee

$1,250

NABP Survey Fee

$1,500

Annual Accreditation Participation Fee (Year 2)

$150

Annual Accreditation Participation Fee (Year 3)

$150

Total 3-year cost    

$3,050

The Annual Accreditation Participation Fee is the fee incurred after an entity’s first year of DMEPOS accreditation.
The first year’s annual participation fee is included in the application fee.
There is a separate fee structure for suppliers with more than one facility; please email your information to NABP at custserv@nabp.net.

6. How do I apply for NABP DMEPOS accreditation?
The application for DMEPOS accreditation for a single pharmacy is only available online and is accessible here. There are different application instructions for suppliers with more than one facility; please email your information to NABP at custserv@nabp.net.

7. What products has CMS approved for NABP accreditation? What are my options if my pharmacy carries products or provides services in addition to those NABP is approved to accredit?
NABP is authorized by CMS to accredit only non-custom, off-the-shelf DMEPOS products and services. More information on NABP’s scope of products is available here. If you have more products or services than those CMS has approved NABP to accredit, another accrediting organization might be better equipped to serve your needs.

8.  I only dispense Medicare Part B drugs, no DMEPOS products or services. Do I need to be accredited to keep my provider number?
Drugs used with DME (eg, inhalation drugs, drugs infused with a DME pump) are not subject to CMS quality standards or accreditation. Likewise, other Part B drugs identified in section 1861(s) of the Act (eg, immunosuppressive drugs, oral anti-emetic drugs) are not subject to the quality standards or accreditation, either. Thus, pharmacies that dispense only Part B drugs and do not furnish any DMEPOS subject to the CMS quality standards do not need to be accredited.
More information on the items subject to CMS quality standards, including drugs and pharmaceuticals, is accessible here.

9. Do I need to prepare a manual in order to become accredited by NABP?
A manual, per se, is not required. However, all supporting documentation requested with the application must be submitted to NABP for review. NABP believes the pharmacy should have flexibility in crafting a product that suits its needs while at the same time provides NABP with the necessary information to ensure the pharmacy is in compliance with the CMS quality standards. For more information about required supported documentation, please review the application instructions.

10. How often will surveys be performed?
NABP conducts an unannounced survey of the accredited DMEPOS-pharmacy once every three years, in accordance with the following comprehensive schedule, to review, evaluate, and monitor the pharmacy supplier, its performance, and compliance with CMS quality standards. Complaints (from any beneficiary, regulatory agency, or CMS) and/or a change in critical operations or business structure, such as a change in ownership, could prompt an announced on-site survey at other times.

A. Class I – Independent Community DMEPOS-pharmacy supplier: State License Approved or Renewed and State Board of Pharmacy Inspection Conducted within the Prior 12 Months

a. Review of application and submission materials for the DMEPOS-pharmacy supplier.
b. Review of state board of pharmacy report for applicability of compliance to CMS quality standards.
c. If the pharmacy is in compliance with CMS quality standards, NABP issues the accreditation and schedules an unannounced survey sometime during the three-year accreditation period.
d. If the pharmacy is not in compliance with CMS quality standards, NABP conducts an unannounced on-site survey prior to action on accreditation status.

B. Class II - Independent Community DMEPOS-pharmacy supplier: State License Inspection Greater than 12 Months or a New Pharmacy that has not yet been Inspected

a. Review of application and submission materials for the DMEPOS-pharmacy supplier.
b. Review of state board of pharmacy report, if available, for applicability of compliance to CMS quality standards.
c. Unannounced on-site survey, prior to action on accreditation status.

C. Class III – Community Chain (chain defined as 25 or more DMEPOS-pharmacy suppliers under common ownership) DMEPOS-pharmacy supplier

a. Review of application and submission materials for the DMEPOS-pharmacy supplier designated by the chain to provide DMEPOS.
b. On-site meeting with corporate chain personnel responsible for the DMEPOS-pharmacy suppliers designated by the chain to provide DMEPOS. (Chain is responsible for the costs associated with this meeting.)
c. Review of state board of pharmacy reports for applicability of compliance to CMS quality standards for the prior year for all DMEPOS-pharmacy suppliers designated by the chain to provide DMEPOS.
d. Review of policies and procedures, corporate quality control, and monitoring systems for the DMEPOS-pharmacy suppliers designated by the chain to provide DMEPOS.
e. Unannounced survey of representative sample and statistically valid number (determined by NABP) of DMEPOS-pharmacy suppliers within the chain designated to provide DMEPOS. 

11. What is the NABP procedure for addressing disputes?
The Appeals Procedure is available on the NABP Web site here.

12. Where can I access the list of accredited DMEPOS pharmacies?
A list of accredited DMEPOS pharmacies is accessible on the NABP Web site here.

13. Whom can I contact at NABP regarding DMEPOS accreditation questions?
 DMEPOS staff is available at custserv@nabp.net to answer any questions for which you did not find an answer on our Web site.

14. What are the responsibilities of NABP as an accrediting organization?

    • Prioritize surveys for those suppliers in the70 Metropolitan Statistical Areas (MSAs) that are eligible to participate in Round Two of the competitive bid in 2008.
    • Consider any previous accreditation, certification, and/or licensure findings that indicate that DMEPOS quality standards are being met at the time the accreditation organization surveys the supplier.
    • Use a streamlined process that considers only compliance with CMS’s DMEPOS quality standards.
    • Notify CMS, in writing, of any supplier that has had its accreditation revoked, withdrawn, revised, or any other remedial or adverse action taken against it by the accreditation organization within 30 calendar days of any such action taken.
    • Notify all accredited suppliers within 10 calendar days of CMS’s withdrawal of the organization’s approval of deeming authority.
    • Notify CMS, in writing, at least 30 calendar days in advance of the effective date of any proposed changes in accreditation requirements.
    • Submit to CMS, within 30 calendar days of a change in CMS requirements, an acknowledgement of CMS’s notification of the change, as well as a revised crosswalk reflecting the new requirements, and inform CMS about how the organization plans to alter its requirements to conform to CMS’s new requirements.
    • Permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings.
    • Notify CMS, in writing, within two calendar days of a deficiency identified in any accreditation entity where the deficiency poses an immediate jeopardy to the entity’s beneficiaries or a hazard to the general public.
    • Provide, on an annual basis, summary data specified by CMS that relates to the past years’ accreditations and trends.
    • Attest that the organization will not perform any DMEPOS accreditation surveys of Medicare participating suppliers with which it has a financial relationship or interest.
    • Conform accreditation requirements to changes in Medicare requirements.

15. What are the responsibilities of pharmacies seeking accreditation through NABP?

As an applicant, the pharmacy’s responsibilities include:

    • Prepare and submit all required documentation within 90 days of creating application.
    • Inform NABP of all DMEPOS products and services provided to beneficiaries.
    • Advise NABP in writing within 30 calendar days of changes to your submitted application that include:
      • Change in ownership
      • Change in pharmacist-in-charge
      • Major change in physical structure of facility
      • Change in location

16. What is the competitive bid? Do I have to participate in the bid?
The Competitive Bidding Program lets Medicare use competitive bids submitted by suppliers to determine the amount Medicare pays for certain medical equipment and supplies.  More information about the Competitive Bidding Program is available here.
Or, you can go to the Competitive Bidding Implementation Contractor (CBIC) Web site.

17. Does NABP administer other types of accreditation programs?
NABP currently administers two other accreditation programs.  These are:

For more information click on the links above.

 

  National Association of Boards of Pharmacy
  1600 Feehanville Drive • Mount Prospect, IL 60056 Tel: 847/391-4406 Fax: 847/391-4502
  Carmen A. Catizone, MS, RPh, DPh, Executive Director/Secretary

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This web page was last updated 05/09/2008 09:43:25