Business Solutions

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

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 this year?

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 Team (thecomplianceteam.org).

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 the waivers.”

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 change.

“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 pandemic.”

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 braces categories.

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 without contracts.

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 categories.

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.