Pharmacy Accreditation

There are many questions about the recently passed health care reform act and how it affects pharmacies and accreditation. We do not know how CMS will implement the components of this law, but we do know what changes the new law provides.

The Affordable Care Act provides an exemption from the accreditation requirement for pharmacies that can meet certain criteria:

• The volume of DMEPOS billings are 5 percent or less of total pharmacy sales;

• There have been no adverse fraud or abuse determinations against the pharmacy for the last five years; and

• Submission to randomly selected on-site Medicare audits to confirm attestation.

Additionally, the exempted pharmacy will be required to:

• Submit an attestation (possibly certified financial statements, notarized documents, etc.) that its total Medicare DMEPOS billings are, and continue to be, less than a rolling three year average of 5 percent of total pharmacy sales; and

• Submit documentation on an ongoing, rolling basis that would verify this information.

The legislation also states that the Health and Human Services Secretary may apply alternative accreditation requirements deemed appropriate for those seeking the exemption.

One very important item to know is that there is no exemption for a new pharmacy. Providers who wish to open a new pharmacy must be accredited, whether or not they currently have an exempted site.

The law also postpones the current deadline for pharmacy accreditation to be effective until January 2011. This affects pharmacies that are not yet accredited and do not meet the exemption criteria listed.

Owners and managers of pharmacies that are currently accredited need to be aware of and think about these items if they are considering not renewing their accreditation:

• Pharmacies that wish to participate in competitive bidding at any time are not exempt from accreditation.

• Medicare is not the only payer that requires accreditation. There are many state Medicaid programs as well as many HMOs, PPOs and third-party payers that currently require accreditation. Accreditation applies to all of a pharmacy's customers, not just Medicare beneficiaries.

• There are processes and procedures in place. An accredited provider does not need to reinvent the wheel in order to maintain accreditation.

• If a currently accredited pharmacy chooses to open a new location, the accreditation applies to a new location automatically.