A pharmacy location can skip DMEPOS accreditation by attesting that it has been enrolled for 5 calendar years and that its DMEPOS billings requiring accreditation are under 5 percent of total pharmacy sales over the prior 3 years. New chain locations and pharmacies with a TIN-changing ownership change in 5 years do not qualify. Contractors audit attestations.
Pharmacies are among the most common DMEPOS suppliers, and most of them need accreditation like any other supplier. CMS offers one way around it: "Pharmacies may also apply for an accreditation exemption by submitting an accreditation exemption attestation to the NPECs" (MLN905710, December 2025). The attestation is narrow, and the details live in the CMS Program Integrity Manual rather than the fact sheet.
Who qualifies for the attestation?
The manual (chapter 10, section 10.2.5.5) describes a letter that lets a pharmacy location attest "that they are exempt from the requirement to be accredited because their total durable medical equipment, prosthetics orthotics and supplies (DMEPOS) billings subject to accreditation are less than 5 percent of their total pharmacy sales, as determined based upon the total pharmacy sales of the pharmacy for the previous 3 calendar or fiscal years." The letters go to pharmacy locations that have been enrolled for 5 calendar years.
So the tests are:
- Enrollment history. The practice location has been enrolled as a DMEPOS supplier for 5 calendar years.
- Sales share. DMEPOS billings for items that require accreditation are less than 5 percent of total pharmacy sales over the previous 3 calendar or fiscal years.
- Each location separately. "For pharmacies with more than one practice location, the letters shall cite the need for each individually enrolled practice location to attest."
Two situations disqualify a location outright. "New locations of enrolled chain pharmacies shall not be considered to have been enrolled for 5 calendar years." And pharmacies "that have had a change of ownership in the prior 5 years which resulted in a change in their legal business entity, including a change in their tax identification number (TIN), shall not qualify."
A newly opened pharmacy therefore cannot use the attestation for equipment that requires accreditation. Neither can a pharmacy bought by a new legal entity within the past five years.
Who signs the attestation?
The pharmacy's own officials. The manual says "the attestation requires the signature of the authorized or delegated official of the entity," as those terms are defined in section 15 of the CMS-855S. A delegated official must be an owner or a W-2 managing employee (42 CFR 424.502), so an outside consultant or a billing company cannot sign it.
What happens after a pharmacy attests?
Contractors audit. The manual tells them to sample at least 10 percent of the pharmacies with accepted attestations and request evidence, which "at a minimum ... shall include a certification by an accountant on behalf of the pharmacy or the submission of tax returns filed by the pharmacy during the relevant periods." The contractor compares the answer with the pharmacy's DMEPOS billing data for products that require accreditation. Pharmacies that cannot substantiate the attestation receive a notice of revocation "for a lack of required accreditation." The manual tells contractors to repeat the attestation and audit process in later years.
The practical advice: before attesting, have your accountant compute the ratio from the same records a tax return would use, and keep that workpaper. The test counts only DMEPOS billings for items that require accreditation, so drug-only lines are left out of the numerator.
Is there a second pharmacy exemption on the 855S?
Yes. Section 2E2 of the CMS-855S offers two pharmacy boxes: "The supplier location is previously enrolled pharmacy with attestation on file," and "The supplier is a pharmacy providing only non-accredited products." The second covers a pharmacy whose only Medicare DMEPOS items are on the non-accredited list in section 2E3: epoetin, immunosuppressive drugs, infusion drugs, nebulizer drugs, oral anticancer drugs and oral antiemetic drugs. The manual's caution applies: "suppliers that provide equipment to administer drugs or pharmaceuticals must be accredited."
What does an exempt pharmacy still need?
- The surety bond. Pharmacies are not among the bond exceptions in 42 CFR 424.57(d)(15). Each location needs $50,000 of coverage. See the DMEPOS surety bond.
- The supplier standards. A pharmacy may be a "closed door" business under standard 7, but it must meet every other requirement of the standard, including the 30-hours-a-week rule in standard 30.
- State licensing. A pharmacy permit does not always cover medical equipment. Some states regulate equipment separately from dispensing; check the state DME license requirements for each state you ship to.
- Enrollment and revalidation on the 855S for each location, with the application fee, and reporting of changes within 30 days.
Was the 2026 moratorium a problem for pharmacies?
Not directly. The nationwide moratorium CMS imposed on February 27, 2026 (CMS-6099-N) covered seven "medical supply company" supplier types, and CMS said a pharmacy's principal function "is typically not the provision of DMEPOS," so the moratorium "would generally not apply" to it. CMS also warned that it would screen applications closely and that enrolling as another supplier type to get around the moratorium could bring a reapplication bar. See DMEPOS enrollment for pharmacies.
How do we help a pharmacy decide?
The $149 DMEPOS Readiness Review checks enrollment history, ownership changes and product lines against the attestation tests and tells you which products push you into accreditation. If you qualify, we prepare the attestation for your authorized or delegated official to sign. If you do not, Accreditation Readiness ($2,495) prepares you for a survey; NABP is one of the CMS-approved accreditors and its approved scope is narrower than the others, as choosing an accrediting organization explains.
Common questions
- Can a new pharmacy use the accreditation exemption?
- Not for equipment that requires accreditation. The attestation requires 5 calendar years of enrollment, and the CMS manual says new locations of chain pharmacies do not count as enrolled for 5 years.
- How is the 5 percent test calculated?
- DMEPOS billings for items subject to accreditation divided by total pharmacy sales, using the previous 3 calendar or fiscal years. Contractors may ask for an accountant's certification or tax returns to prove it.
- Does an exempt pharmacy still need a surety bond?
- Yes. Pharmacies are not among the bond exceptions, so each enrolled location needs $50,000 of bond coverage, more if there are adverse legal actions.
- Who signs the pharmacy accreditation attestation?
- The pharmacy's authorized or delegated official. A delegated official must be an owner or W-2 managing employee, so a consultant cannot sign it.
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