CMS Pub. 100-08, ch. 10, § 10.2.5.5

(Refer to section 10.2.2.7 of this chapter for a discussion of pharmacy enrollment via the Form

CMS-855B (i.e., pharmacy not enrolling as a DMEPOS supplier).)

The contractor shall not require that a pharmacy be accredited as a condition of enrollment

before January 1, 2011.

The contractor shall determine which enrolled suppliers are pharmacies that are not accredited

and who will be enrolled for 5 calendar years prior to January 1 of the next calendar year. The

contractor shall then send a notice of revocation by January 10, 2011, to all enrolled pharmacies

that are not accredited and who will not be enrolled for 5 calendar years as of January 1, 2011.

The contractor shall prepare a letter which enables all individually enrolled practice locations of

pharmacies who have been enrolled for 5 calendar years prior to January 1, 2011, to 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 letter shall cite that the

attestation requires the signature of the authorized or delegated official of the entity. The

authorized and delegated officials are defined in Section 15, of the Medicare Enrollment

Application (Form CMS-855S), and as described in the internet enrollment application version

of PECOS. Before mailing the letters, contractor shall obtain the contractor project officer’s

approval of the letter. The mailing shall be in the form of an endorsement letter with an enclosed

stamped self-addressed envelope. The mailing should be performed between October 1, 2010

and October 31, 2010. For pharmacies with more than one practice location, the letters shall cite

the need for each individually enrolled practice location to attest that they are exempt from the

accreditation requirements. New locations of enrolled chain pharmacies shall not be considered

to have been enrolled for 5 calendar years. 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 for an attestation accreditation exemption

and therefore shall not be sent the attestation letter.

The contractor shall review the attestations received from pharmacies. Pharmacies that properly

signed the attestation letter shall be given an accreditation status of exempt. The contractor shall

make attempts to assist and follow-up with pharmacy suppliers that have not submitted or

properly completed their attestations. The contractor shall send a notice of revocation by

January 10, 2011, to all enrolled pharmacies who were sent an attestation letter and have not

properly completed it as of the date of the notice of revocation. The notice of revocation shall

cite that the revocation is for a lack of required accreditation.

Between April 1, 2011 and April 30, 2011, the contractor shall compile a sample listing of at

least 10 percent of the pharmacies that have submitted a contractor-accepted attestation

exempting them from accreditation. The contractor shall develop a letter to be sent to

pharmacies that will be audited to determine if their accreditation exemption attestations are

correct. The letter shall request submission of evidence substantiating that the validity of the

pharmacy supplier’s attestation. At a minimum, requested materials for this evidence 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 shall obtain contractor

project officer approval of the letter. Within 45 days after project officer approval of the letter,

the contractor shall mail a copy of the letter to the random sample of pharmacies that claimed

exemption through an attestation. The contractor shall determine the acceptability of the replies

received in response to the audit verification random sample mailing. The contractor shall use

DMEPOS billing data for only products and services requiring accreditation to assist in the

determination. The contractor shall make attempts to assist and follow-up with pharmacy

suppliers that have not submitted or properly completed their audit verifications. The contractor

shall consult with the contractor project officer in cases where it is uncertain as to the

acceptability of the supplier’s response to the audit request. By June 30, 2011, the contractor

shall send a notice of revocation to all enrolled pharmacies that were sent an audit verification

letter who did not submit satisfactory evidence that they were compliant with the requirements to

obtain an accreditation exemption. The notice of revocation shall cite that the revocation is for a

lack of required accreditation.

The contractor shall follow the procedures shown above concerning issuance of attestation letters

and audit survey letters for all succeeding years after they have been performed for the first time.