Achieving Trust Through Accreditation
Why Medicare accreditation plays an essential role in providing DME, how to get accredited, and how COVID-19 has impacted the process.
- By David Kopf
- Dec 01, 2020
Photo © depositedhar/depositphotos.com
There are many community pharmacies
that offer durable medical
equipment and home medical
equipment (DME and HME) on
a retail basis. Items such as bath
safety products, orthopedic braces, pain management
offerings, and standing and walking
aids can really help drive revenue.
Moreover, those items also ensure that the
pharmacy can serve as a single healthcare product
source for its local marketplace. That role
can be particularly important if the pharmacy is
in a rural area where finding in-person access to
those types of products can be difficult.
However, many DME items are funded under
Medicare, and that puts the DME pharmacy in a
tough position. If one of its many Medicare beneficiaries
comes in to pick up a prescription and
also is interested in a DME item he or she knows is
funded by Medicare, the pharmacy is going to be
in the difficult position of only being able to offer
it on a cash basis.
And besides running the risk of alienating
steady clients, many DME pharmacies want
to become a supplier for Medicare’s Durable
Medical Equipment, Prosthetics, Orthotics and
Supplies (DMEPOS) benefit because that lets
them access a new revenue stream. However,
to bill Medicare as a DMEPOS supplier, a pharmacy
must be accredited.
Accreditation is both important and imperative
for being a DMEPOS supplier for Medicare beneficiaries.
First off, if you plan to derive more than
5 percent of your revenue from DMEPOS, then
you must have Medicare accreditation.
“The easy answer is that, going back to the
Medicare Modernization Act of 2003, it was mandated
that anybody that wanted to bill Medicare
for DME items had to be accredited by one of the
approved agencies,” says Sandra Canally, RN, the
founder and CEO of accreditation organization
The Compliance Team (thecomplianceteam.org).
“… What I tell pharmacists is that you want to have
a Medicare part B number to be able to bill and
service your Medicare beneficiaries for everything
that they need.
“If, for example, diabetes patients are coming
to your pharmacy right now for scripts, you want
to be able to give them the diabetic strips, to give
them the diabetic shoes, or give them walkers, or
whatever,” she continues. “Because if you’re not
able to do that, it gives them the opportunity to
go down the street to your competition, or go to
the big box stores. And not only will they go for
that, but they’ll take their strips with them. Why
It’s also important to note that while DMEPOS
accreditation is for Medicare, it has become a
gold standard with other funding sources.
“It’s not all about CMS,” says Tim Safley, program
director for the Accreditation Commission
for Health Care (ACHC; achc.org). “And that’s one
of the things that people forget. There are other
payers. … If the pharmacy itself is looking for
other avenues of revenue, such as third-party payers,
or even Medicaid, some of those still require
And that means that when a customer comes
into the accredited DME pharmacy, they know
they have a one-stop-shop.
“When the patient comes in, the pharmacy has
a full line of availability, they can service everything,”
Safley says. “The pharmacy is building that
relationship with the patient, and can eventually
serve him for everything.”
THE PHARMACY EXEMPTION
First off, when considering accreditation for
DMEPOS, it’s important to note that pharmacies
can apply for an exemption with Medicare when it
comes to DMEPOS accreditation.
“There are really three things you need to have
to apply for that exemption,” says Matt Gruskin,
MBA, BOCO, BOCPD, CDME, credentialing director
for the Board of Certification/Accreditation
(bocusa.org). “You need to be enrolled for five
years with a PTAN number. You have to have no
adverse actions against you. And then you have
to have less than 5 percent of your revenue come
from DMEPOS. So for example, if you are dispensing
nebulizers to everyone that comes in for
albuterol, and you look at your finances and you’re
at 7 percent of your revenue is coming from those
nebulizers, you’re not going to qualify for it. So
you’re going to need that accreditation still.”
This is important for a community pharmacy
offering DME to consider. Even a pharmacy
initially starts providing DME not necessarily from
a profit perspective, but more in terms of trying to
provide a community health service, It could still
quickly eclipse that 5 percent, given the reimbursement
on some of these items.
“It’s something that we focus on when we
speak with customers that are pharmacies,”
Gruskin says. “You want to provide continuity of
care, especially for the community-based pharmacies.
So, when the physician refers them to your
business, they can ask you questions about their
nebulizer. And you know what? Their mother-in-law
Might be an insulin-dependent diabetic, and
she may get the insulin from you. Well, now you
can also dispense the pump as well, right?
“So I do think it’s super relevant for these
pharmacies to look at the product categories under
the DMEPOS benefit and take a look at what
they’re doing from a Part D perspective and see if
any of that complements it,” he adds.
STEPS TO ACCREDITATION
So, assuming the pharmacy is going to exceed
that 5 percent, what is the accreditation process
like? It starts with the pharmacy submitting an
application, Canally says. What happens next
depends on the accreditation organization (AO).
Some AOs will be out of touch until about six
months later, when it conducts a site survey (this
has traditionally been done on-site, but during
COVID-19 they have been conducted virtually).
In those instances, Canally says, “There’s
nothing in between with assistance or preparation.
The pharmacy usually hires an outside
consultant that helps them develop policies and
procedures and so forth.”
In the case The Compliance Team and AOs
like it, there’s more of an effort to provide a
turnkey solution. “We assign them an educator,
who is going to walk them through the standards;
what they need to do on their end; and
more or less keep monitoring them via teleconferences,”
Canally says. “Also, we give them a
toolbox. In that toolbox, they have assessment
checklist, and they have templates of policies,
so they don’t need to start from scratch.”
Safley echoes that point: providers should
seek out AOs that will help them chart a path
through the process.
“The pharmacy needs to research as to which AO is going to help them through the process,” he says. “It could
help them with policy and procedures. It could help them by giving them
“After that, I would pick up the phone and see how the application is,”
Safley continues. “Is it a friendly application process? How quickly do they
answer the phone? And how quickly do they respond to your needs? All
of those important, because if you’re just getting started, you want an AO
that’s going to help you through the process.”
In the instances where a consultant is involved, there are AOs that train
and certify independent consultants. Of course, hiring a consultant costs
money; roughly $3,000 to $5,000.
“Can you get through accreditation without a consultant? Yes, you
can,” Safley says. “The problem is that for small pharmacies, it’s a struggle
because they don’t have time. The pharmacists or the pharm techs are too
busy filling the scripts or working behind the counter.”
Besides hiring a certified consultant, Safley advises that providers ensure
that the consultant has experience specifically with community pharmacies
and pharmacies that carry DME.
And once the policies and procedures are in place, the AO will conduct
an unscheduled site survey with the pharmacy. As mentioned, this is typically
on-site, but is now virtual during the COVID-19 public health emergency
“When they’re finished doing their work and through the call series, they
complete the form saying, ‘I’m ready; I’ve done all of my implementation
work,’” Canally says. “Then, one of our other on-site advisors is the one that
verifies and validates that they meet the quality standards.
“Once they complete the on-site — or now during COVID, we’re able to
do the virtual — we’re going to send them a scoring report, a certificate of
accreditation and a letter of accreditation,” she continues. “At that point,
they then put in their 855S, and list The Compliance Team as the accreditor.”
“On a weekly basis, we send a report to CMS that includes all of the
companies that are accredited and the Medicare items that they’re accredited
for and can bill for,” she adds.
As mentioned, COVID-19 has impacted the accreditation process, starting
with the site surveys, which are now handled remotely.
Now, it’s important to acknowledge that you might have heard that,
around the time of HHS’s initial COVID-19 PHE declaration, CMS implemented
a waiver from accreditation and reaccreditation activities for DMEPOS
suppliers. However, effective July 6, CMS resumed all those activities.
It even allowed site surveys to be conducted on-site, but most AOs are
continuing with virtual site survey services, to comply with local guidelines,
their own internal infection control policies, and the preferences and policies
of their supplier and pharmacy customers.
So, moving on, how else is COVID-19 impacting the accreditation
“There have been no specific changes or guidance to DMEPOS facilities
in regards to use of PPEs,” Gruskin says. “That being said, per Supplier
Standard 1, ‘A supplier must be in compliance with all applicable federal
and state licensure and regulatory requirements.’ This puts the responsibility
on the facility as they should be aware of the CDC guidelines for patient
care and proper PPE use. I can confidently say that, BOC surveyors have
been noting compliance with the CDC guideline in their survey reports.”
There have been certain changes and exceptions post-COVID that were
outlined in specific 1135 waivers issued by CMS, Gruskin says. Those waivers
are available at cms.gov/files/document/covid-dme.pdf.
“These waivers will expire once the public health emergency (PHE) is
lifted,” Gruskin explains. “From an accreditation process perspective, our
surveyors, as well as BOC internal facility accreditation staff, are aware of
these waivers and are operating in accordance. It is clear that these waivers
are temporary and in no way affect the ability for facilities to still meet the
quality and supplier standards not addressed the waivers.”
Getting back to virtual site surveys and virtual accreditation processes,
the AOs have become practiced hands at accrediting DMEPOS suppliers
remotely and there continues to be lots of interest in the process.
“We’ve done more than 300 virtual surveys with all of our programs,”
Safley says. “And we’ve had three town hall meetings for people in the DME
industry, with more than 1,000 people register for those three different
presentations about how virtual surveys work.”
Once the provider provides various policy and procedure documents to
the AO, it is then ready for the virtual site survey. Safely says that unlike the
typically unscheduled on-site surveys, the AO is allowed to give the supplier
pharmacy a 48-hour notice that the virtual survey is coming and that
they should be ready, since the virtual requires some additional preparation.
Once the virtual site survey process starts, it’s very much as one might
expect in the era of COVID-19 and Zoom meetings.
“We have a portal where they upload policies, and then we use Face-Time or GoTo Meeting to ‘walk’ around the actual pharmacy or the DME
or the clinic, and actually say, ‘Okay, let’s look at that shelf. Let’s look at this
and so forth,’” Canally explains. “So it’s very comprehensive. Then at the
end, the accreditation goes through scoring and our usual process.”
Assuming the pharmacy passes, it is officially accredited by its AO, which
reports that to CMS, according to Canally. That said, the virtual survey process
isn’t a closed loop. CMS still expects an in-person survey to take place.
“We still have to go back once the public health emergency is lifted or
certain states have lifted restrictions, then we can go on-site with PPE and
so forth and so on, and do the on-site evaluation,” she explains. “We are
required by CMS to do an on-site survey within six months to a year after
the virtual site survey.”
RENEWAL & ADDING CATEGORIES
Of course, accreditation isn’t static. DMEPOS suppliers must renew their
accreditation every three years, and if they want to add product categories,
it is likely they will need to work with their AO to be accredited to bill for
those items. Accreditation is an ongoing and often expanding activity for any DME pharmacy looking to be a DMEPOS supplier.
When it comes to renewal, AOs will regularly send notifications to their
suppliers roughly six months ahead to outline the steps they need to take
to renew. Things that the AO will highlight include new processes and new
people they’ve hired.
“We’re making sure that you did the appropriate orientation and training,
and set up your files correctly, because to be honest, three years later,
clients sometimes forget what they did three years before,” Canally says.
“It’s all about continuing with that continuous quality improvement aspect.”
When adding a new category, the process is similar. Providers seeking
accreditation for a new category must strive to ensure all the proper documentation
and procedural steps are in place for the DME and services they
offer, and then undergo site surveys — and possibly have to undergo them
again if they are found to need in improvement in some aspects of their
business before they can become accredited.
Also, as mentioned, accreditation has morphed into a strategic asset for
DMEPOS suppliers. Accreditation is not just a list of tasks that a provider
must fulfill in order to meet billing requirements on a state or a federal
level. Rather, it is a competitive edge that shows customers, physicians and
other funding sources that a DME pharmacy can provide solid product category
knowledge so that their referral partners and their patients are going
to feel that they are working with an expert resource.
So, we are now seeing specialized accreditation and credentialing
services emerge from the AOs to help suppliers drive home their expertise
with their local market. Examples include the Certified Durable Medical
Equipment (CDME) specialist certification from BOC, or the Patient-Centered
Respiratory Home from The Compliance Team. (Moreover, AOs such
as The Compliance Team, ACHC and BOC offer services specifically for
pharmacies as well.)
Whether it’s adding a new category or seeking an additional specialized
accreditation or credentialing, there are a few elements that our experts all
noted providers want to consider: they want to ensure that they have the
right on-staff expertise, and they want to balance their desires to drive new
revenue against how much they can enhance how they can serve their local
How do you approach that balancing act? ACHC’s Safley suggests starting
small with some retail products that are adjacent to funded categories.
“Pharmacies are finding little niches,” he says. “They’re saying ‘I’m
selling three lift chairs a month; maybe want to get into power mobility
devices.’ They’re starting with little niches and building on them, especially
with DME that their community can’t normally get, or have to mail order
when they’d rather come in and pick it up. At the pharmacy, they can see it
and touch it.”
Once a pharmacy thinks it has found the right niche? Then they can start
working with their AO to secure accreditation for that category or special
This article originally appeared in the DME Pharmacy December 2020 issue of HME Business.