Game Changes: Accreditation in 2021
This year marks a renewal cycle for DMEPOS accreditation, but COVID-19 had changed this typically routine process. Also, other developments might impact renewal choices in 2021. What do providers need to know to ensure a smooth, timely renewal?
- By David Kopf
- Feb 01, 2021
Photo © BrianAJackson/depositphotos.com
It’s 2021, and the New Year means
an accreditation renewal cycle for most
DMEPOS providers — but they might
not recognize the process. The game has
changed quite a bit.
Every three years, providers must renew
their Medicare accreditation in order to
continue billing for DMEPOS claims, but
due to the COVID-19 public health emergency,
the process has changed. Moreover,
there are other reasons — such as
CMS’s decision to opt of issuing contracts
for 13 Round 2021 categories, thus leaving
those categories open — why a provider
might want to add new lines of businesses
and expand their accreditation.
So, bearing all that in mind, how should
providers approach accreditation renewal
FIRST, SOME BACKGROUND
Well, before we get into how’s accreditation
has changed due to the PHE, let’s
first review why we’re here. Why? Because
there are a lot of new entrants to the
market due to mergers and acquisition activity.
Also, reviewing the renewal process
will help underscore the changes.
For starters, let’s review the importance
of accreditation. Any Medicare supplier
wishing to file DMEPOS claims is required
to have Medicare accreditation — by law.
“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
The Act gave DMEPOS suppliers a
deadline of 2009 to get accredited so
that any provider that was going to bill
Medicare Part B DMEPOS was required
to get accredited by one of the approved
agencies. Since then, every three years,
providers must renew.
Since 2009, Medicare accreditation has
taken on even more importance. Now,
DMEPOS accreditation isn’t just for Medicare;
it has become a gold standard with
other funding sources. Even if a provider
doesn’t derive the majority of its revenue
from Medicare funding, various payers
and referral partners want to see that they
are working with HME/DME providers that
have secured that accreditation.
“Accreditation is 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 [provider] itself
is looking for other avenues of revenue, such as third-party payers,
or even Medicaid, some of those still require accreditation.”
THE TYPICAL RENEWAL PROCESS
Renewal starts by internally reviewing the internal policies and
procedures manual to see if there’s any need for revisions. This
is important because it helps the provider ensure that they are
living up to Medicare’s expectations for how they should be provisioning
products and services for the categories they are supplying.
Moreover, if they have new staff that has come on board
since the last renewal and the provider wants to ensure they are
living up to those policies and procedures.
“Even if the policies remain the same, create a document that
states that the policies were reviewed and approved by whomever
it is on a particular date, so that they can show they reviewed
it when [the provider] is up for renewal, any accreditor is going to
say, ‘Okay, show me where your policies have been reviewed,’”
Canally explains. “And that’s a simplified way of performing that
review: Check it off, write it, document it, and put it in the front of
your policy manual.”
And once the policies and procedures are in place, the AO will
conduct an unscheduled site survey with the provider.
“When they’re finished doing their work and are 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 site survey, 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
Form 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.
However, thanks to COVID-19, things have changed. Certain
elements of policies and procedures are more emphasized, and
the site survey is now virtual, which represents a major change
from the past. Let’s take a closer look.
SITE SURVEYS UNDER COVID-19
The major impact COVID-19 has had on the accreditation process
is with 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 changes and exceptions post-COVID
that were outlined in specific 1135 waivers issued by CMS, which
expire when the PHE is lifted. Those waivers are available at cms.gov.
“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,” says Matt Gruskin,
MBA, BOCO, BOCPD, CDME, credentialing director for the
Board of Certification/Accreditation (bocusa.org). “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
Early into the PHE, CMS’s waivers initially included a waiver
from accreditation and reaccreditation activities for DMEPOS
suppliers. Then, effective July 6, CMS resumed all those activities.
It even allowed site surveys to be conducted on-site.
However, the 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 customers.
When it comes to virtual site surveys and virtual accreditation
processes, the AOs have become practiced hands at accrediting
DMEPOS suppliers remotely, and there continues to be much
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 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 DME and
actually say, ‘Okay, let’s look at that shelf. Let’s look at this and
so forth,’” Canally explains (TCT was the first AO out of the gate
with a virtual process when COVID-19 hit). “So it’s very comprehensive.
Then at the end, the accreditation goes through scoring
and our usual process.”
Assuming the provider passes, it is officially accredited by
its AO, which reports that to CMS, according to TCT’s 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 onsite
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.”
POLICIES AND PROCEDURES UNDER COVID-19
As providers review their policies and procedures, one of the
things they need to keep in mind is how the pandemic has
impacted what they do and how they carry out tasks in relation to
their policies and procedures.
“One of the things in reviewing the policies that you want to
pay close attention to infection control and emergency preparedness,
mainly because of the pandemic,” Canally says, adding that
this includes how they meet the needs of their employees during
this public health emergency, as well as quality improvement.”
This can get a little tricky. While there might not be specific
federal requirements, providers need to ensure they are working
within all guidelines, including those at the state and local level.
So, for instance, while CMS might not have specific requirements
related to provisioning a particular product during the PHE, a provider’s
state could, and that could still impact their accreditation.
“There have been no specific changes or guidance to DMEPOS
facilities in regards to the use of PPEs,” BOC’s 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.”
Also, how a provider actually carries out tasks that are required
in policies in procedures related to a product category might
“For example, we need to verify and validate that they are
giving instruction to the patient,” Canally explains. “So that, how
that instruction is being delivered might have changed because
of the pandemic.
For instance, the provider’s delivery tech might be out on the
doorstep, and the family member comes and picks up the concentrator,
takes it back in, and via FaceTime or even the front window,
the tech can actually show them how to adjust the settings.
“But the end of the day, the requirements are still there with
ensuring that the patient understands how to operate the equipment,
how to use it correctly,” she says. “The importance of
appropriate and comprehensive instruction is really key. We don’t
want Joe the delivery guy to have to go back, especially during a
And, of course, controlling any and all bloodborne pathogens
is particularly important right now. COVID-19 has underscored
the importance of any and all infection control.
“If providers offer services where their employees are at risk for
exposure, they do annual training on that issue,” Canally advises.
“This includes offering the hepatitis B vaccination, if those folks
are at risk, like delivery people, or people in the warehouse that
are cleaning dirty equipment on a regular basis. You have postings
that need to be taken care of and training on that. Hazardous
material. There are all sorts of things that come under this
annual training umbrella.”
ANOTHER CHANGE: CMS’S ROUND 2021 PUNT
Of course, accreditation isn’t static. When DMEPOS suppliers
renew their accreditation every three years, they might want to
add product categories, and 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.
And this year might see a big proliferation
in adding categories. Why? CMS’s
pause on competitive bidding continues.
At the end of October, CMS announced
that after originally taking bids for 16
product categories in the 130 competitive
bid areas of Round 2021 of its competitive
bidding program, it was only awarding contracts
for the off-the-shelf back and knees
As for the 13 remaining categories (CMS
had already removed the non-invasive
ventilator category due to the COVID-19
public health emergency), CMS announced
it would not issue contracts because it “did
not achieve expected savings.” In other
words, CMS decided to punt.
That means that given the last competitive
bidding contracts expired on Dec. 31,
2018, and that the bidding program has
since been dormant, DMEPOS providers
can continue to provide these 13 categories
Even though CMS’s announcement also
implied that it had reached a bid floor
with DMEPOS reimbursement essentially
frozen at 2018 rates, the ability for
providers to serve new categories without
a contract is proving attractive. The key?
They need to be accredited for those
There is a huge opportunity for the HMEs
to add products that maybe they used to
cover,” Canally says. “Maybe it’s years that
they haven’t carried oxygen because they
didn’t win a bid, and now they’re able to.
They still have the understanding of how to
utilize oxygen and provide oxygen as a service;
they would need to redo their training
and make sure that any new employees are
up to speed with manufacturer’s guidelines
and so forth and so on.
“But I see it as an opportunity. … We’ve
had a few providers that have added
products,” she adds.
When adding a new category, the accreditation
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 be in need of 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 an HME/DME
provider delivers solid product category
knowledge so that their referral partners
and their patients are going to feel that
they are working with an expert resource.
As a result, 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 start by coordinating
with their AO.
“Any products that they add they need
to be accredited for by their AO,” Canally
explains. “It is connected to any kind of
additional billing opportunity. They need to
make sure that they contact their accreditor
and see what needs to be done.”
This article originally appeared in the Jan/Feb 2021 issue of HME Business.