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

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.

THE ACCREDITATION IMPERATIVE

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 wouldn’t they?”

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 accreditation.”

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 education.

“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 (PHE).

“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.

COVID-19’S IMPACT

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 process?

“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 communities.

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 credentialing.

This article originally appeared in the DME Pharmacy December 2020 issue of HME Business.