There are many questions about the recently passed health care reform act and how it affects pharmacies and accreditation.
by Mary Ellen Conway, RN, BSN
May 1, 2010

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

  • 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

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

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

When a pharmacy is approaching renewal, management should be
cognizant of the following:

  • CMS is vigorously enforcing accreditation dates and deadlines.
    Ideally, all providers need to budget for a minimum of six months'
    lead time to be prepared for the unannounced, onsite survey. You
    must be re-accredited before your actual accreditation expiration
    date so that your accreditation does not lapse.

  • The National Supplier Clearinghouse (NSC) will deactivate a
    non-exempt supplier's billing privileges if its accreditation
    lapses. If the NSC revokes privileges, there is a one-year
    mandatory waiting period for re-application to reinstate

We will have to wait and see over the next few months what
additional specifications CMS will require for pharmacies choosing
not to become accredited. If this affects you and you have
questions, contact your accreditor for clarifications.

Are you watching your accreditation timeline?

Accreditation from most organizations generally lasts for three
years, and CMS is closely watching providers' accreditation dates.
Providers who were accredited in 2007 are now going through their
re-accreditation, or will be shortly. Accrediting organizations are
coming out to visit providers well in advance (generally about six
months out) of their accreditation expiration date. Having your
survey six months ahead of expiration allows adequate time to
address any deficiencies found on survey, correct those
deficiencies and file an accepted plan of correction in advance of
your expiration date. Providers who were accredited in 2008 are due
for re-accreditation in 2011. NOW is the time to start

Read more Accreditation Now

Mary Ellen Conway, RN, BSN, is president of Capital
Healthcare Group, LLC
, Bethesda, Md., which provides health
care management expertise in accreditation preparation and survey
follow-up, operations assistance, design of quality improvement
programs and outcome measures. She can be contacted by phone at
301/896-0193 or through