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As HME businesses rapidly adapted their policies and procedures to respond to the COVID-19 public health emergency, Congress and CMS implemented relief programs and altered the funding environment to help providers keep serving patients. How much of this change will be permanent?

CoronavirusBetween March 3 and 5, HME providers in the western states traveled to and from Las Vegas for Medtrade West — and they likely noticed things were a bit strange. The airports were pretty empty; fiights were sparsely attended; not as many people were at the Mandalay Bay; and Sin City looking a bit like a ghost town.

The week after the show, most events of any kind were going on hiatus. States would soon shut down, and before providers could really think about it, they would be dealing with COVID-19, a disease that up until then had seen like it was affecting other people in other places, far away.

COVID-19’s spread was surprisingly fast. The Wuhan, China outbreak began in December 2019 and by Jan. 20 the first case in the United States was identified. On Jan. 30, the World Health Organization declared COVID-19 a Public Health Emergency of International Concern, and on Jan. 31, the Trump Administration declared a Public Health Emergency. On Feb. 29, the first U.S. COVID-19 fatality was reported, and on March 11, as Medtrade West attendees were probably still working their way through their show follow-ups, WHO officially declared COVID-19 a pandemic.

Suddenly, providers had to think about how they would implement measures to mitigate the spread of the disease; how they would interact with patients; how they would drop off and pick up equipment; how they would work with referral partners; how they would protect their staff; how they would comply with state stay-at-home guidelines; how they would maintain their supply chains; and how they would keep their businesses running in all this unforeseen chaos.


With some states already implementing stay-at-home policies by mid-March, Congress quickly moved to pass the Coronavirus Aid, Relief and Economic Security (CARES) Act, which was signed into law in late March, as well as the Paycheck Protection Program and HealthCare Enhancement Act, which was signed into law in late April. The two pieces of legislation contained billions of dollars in relief that healthcare providers and businesses could tap into, as well as a series of provisions that relaxed or changed to help HME providers serve Medicare beneficiaries.

All told, the CARES Act was a $2 trillion dollar stimulus package that allocated $100 billion to the Public Health and Social Services Emergency Fund (PHSSEF). Of that, $50 billion was earmarked for general distribution to Medicare facilities and providers impacted by COVID-19.

The first $30 billion was distributed proportionately to providers’ share of 2019 Medicare fee-for-service reimbursements, with $26 billion paid out on April 10 and the remaining $4 billion on April 17. Then at the end of April, HHS began distribution the final $20 billion of the general distribution to providers to augment their allocation so that the whole $50 billion general distribution was allocated proportionally to providers’ share of 2018 net patient revenue.

Additionally, the CARES Act included various HME provisions:

An extension of the 50/50 blended rate for rural suppliers through the COVID-19 public health emergency (PHE).

It also provides better rates (a blend using 75 percent current adjusted rates and 25 percent unadjusted rates) for suppliers in non-rural, non-bid areas during that period.

Those rates are retroactive to March 6.

An elimination of the 2 percent Medicare sequester reduction that went into effect in 2013. This relief will be effective May 1 to Dec. 31. An elimination of the three-year established patient relationship requirement from the telehealth provisions in earlier COVID-19 relief legislation.

Then the Paycheck Protection Program and Health Care Enhancement Act added a total of $484 billion in relief, with $75 billion going to healthcare providers via the PHSSEF that was established by the CARES Act.

The relief bill also included $310 billion for the Paycheck Protection Program (PPP) and added $50 billion for Economic Injury Disaster Loans (EIDL) and $10 billion for EIDL Advance grants.


While Congress was passing those two important pieces of legislation, CMS issued two Interim Final Rules (IFRs), one in late March and one in late April, that covered various healthcare issues related to COVID-19 includes policy recommendations that industry advocates had been pressing the Centers to implement.

CMS’s March IFR included various provisions, starting with CMS stating that it wouldn’t enforce clinical indications for coverage for respiratory, home anticoagulation management and infusion pump National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs), including articles. CMS will resume enforcement of these clinical indications for coverage once the COVID-19 emergency has ended.

The LCDs and NCDs include:

  • NCD 240.2 Home Oxygen. NCD 240.4 Continuous Positive Airway Pressure for Obstructive Sleep Apnea.
  • LCD L33800 Respiratory Assist Devices (ventilators for home use).
  • NCD 240.5 Intrapulmonary Percussive Ventilator.
  • LCD L33797 Oxygen and Oxygen Equipment (for home use).
  • NCD 190.11 Home Prothrombin Time/International Normalized Ratio (PT/INR) Monitoring for Anticoagulation Management.
  • NCD 280.14 Infusion Pumps.
  • LCD L33794 External Infusion Pumps.

The March IFR also stated that face-to-face exams would not be not required for items that otherwise require them due to NCD or LCD. This does not apply to power mobility devices (PMDs), but telehealth is already allowed to be used to meet the face-to-face requirements of PMDs.

The rule also ensured that Medicare and Medicaid regulations are the same in terms of who can order medical supplies, equipment, and appliances. And, advance payments With CMS’s April IFR, one section reviewed the CARES Act’s provisions regarding reimbursement rates rural and other non-bid-area and affirmed it would extend the 50/50 blended rate for rural suppliers through Dec. 31 or the end of the COVID-19 public health emergency (PHE), if that lasts longer.

CMS also said it will use the blended rate of 75 percent current adjusted rates and 25 percent unadjusted rates for suppliers in non-rural, non-bid areas during that period, as well. Both of those rate structures are retroactive to March 6.

Additionally, CMS stated in the April IFR that it wouldn’t enforce certain clinical criteria in local coverage determinations governing therapeutic continuous glucose monitors to give diabetes patients more flexibility to monitor their glucose and adjust insulin doses at home.

Also, the duration of the COVID-19 PHE, CMS said it is waiving any limitations on the types of clinical practitioners that can furnish Medicare telehealth services. This means CMS has broadened its telehealth list to include both two key clinical partners/staff for HME providers: Physical Therapists (PTs) and Occupational Therapists (OTs).

But those IFRs weren’t all that CMS did. Citing the COVID-19 pandemic, CMS also decided in mid-April to remove non-invasive ventilators (NIV) from Round 2021 of competitive bidding — a policy change AAHomecare and industry advocates had been fighting for a year to stop.

In March of 2019, CMS announced that part of the changes brought with Round 2021 would be the addition of NIVs to the round, which immediately drew industry concern. This was followed by Congressional sign-on letters calling on CMS to reverse the addition, but CMS essentially turned a deaf ear to those concerns. This led to the introduction of H.R. 4945, which called for the removal of NIVs from competitive bidding.

By removing NIVs from Round 2021 of competitive bidding, any Medicare-enrolled DMEPOS supplier can provide any of the types of ventilators covered under the Medicare program, including NIVs.

In addition to the COVID-19 pandemic, CMS also said its decision was due to President Trump’s exercise of the Defense Production Act; the public concern over access to ventilators; and the NIV product category being new to competitive bidding.


Perhaps one of the top relaxed policy guidelines is that signature requirements have been completed suspended on any document that a supplier might need a patient to sign, according to Kim Brummett, the vice president of Regulatory Affairs for AAHomecare. Be that an ABN or a delivery tick, a signature isn’t necessarily required.

Moreover, prior authorization for HME claims is suspended as well. Right now, that procedure is entirely voluntary.

“You don’t have to do it,” Brummett says. “You can do it if you’d like to do it. We have many suppliers that really want to continue getting prior authorization because it keeps them from being audited in the future.

“And then the other option is the suspending all face-to-face requirements for any of the policies, except of course for PMD, which is statutory,” she adds. “But CMS is allowing telehealth and audio-only telehealth to meet those requirements as well.”

And when it comes to audits, nearly all audits have been temporarily suspended. That includes TPE audits, RACs, CERT and SMRC audits. The bottom line is that HHS is placing a whole lot of trust in the industry.

“Really, the only contractor that is not suspected is the UPIC,” Brummett adds. “And those are trickier to really fight because the theory is that they are fighting fraud as opposed to just randomly auditing to check on documentation.”


Almost as quickly as CMS began relaxing guidelines and Congress ensured the industry would be able to tap into support funds, many industry stakeholders started to realize what this meant: lawmakers, program administrators and regulators were clearly seeing HME as a key component in the nation’s front-line healthcare infrastructure.

“I think it’s elevated the HME industry,” says Mark Kassir, president and CEO of America’s HealthCare at Home and newly appointed President (Mid-Atlantic) of Spiro Health. “Now, we hear, ‘You guys have the ventilators that all these hospitals are needing?’ ‘You can put oxygen on patients in the home and get them out of the hospital?’”

And while a lot of providers were feeling warm fuzzies over the raised profile for the industry, some stakeholders were starting to get a shiver down their spine. Why? That hard-earned clout can go up in a puff of smoke if gets abused.

To that point, officials from both AAHomecare and VGM Government Relations released letters to the industry urging providers that with CMS’s relaxations of various coverage requirements, providers should judiciously apply the policy guidance and keep a sharp eye out for anyone taking advantage of the relaxed policies.

A statement from AAHomecare reminded providers that CMS’s relaxations in coverage criteria were implemented to help HME providers provide care during challenging conditions, and that providers should follow not only the “letter of the law” but the “spirit of the law,” to maintain both the goodwill, and hopefully some of the new guidelines.

Simply put, a lot is riding on how providers conduct themselves under these relaxed guidelines, according to Gary Sheehan, president and CEO of Cape Medical Supply and newly appointed CEO of Spiro Health.

“I hope HME continues to represent itself with the level of response and ethics frankly that they need to,” he says. “And if they do I think coming out of it will be thought of in a much better light than we have historically.”

And if that favorable impression continues, it could lead to some relaxed policy guidelines staying relaxed.


Bearing that in mind, one policy change that providers are betting will stick around is telehealth— so much so that they’re investing in the technology. Can you blame them? All their referral partners want increased telehealth usage, and so do their patients. It saves time and money.

“It has not been a lack of willingness for patients or a technology limitation for physicians,” Sheehan explains. “It’s been the inability of the payer and regulatory community to step up and take this in the direction it should be going and given that it’s 2020.”

So when the COVID-19 outbreak started spreading globally, Sheehan said his business started looking into implementing it.

“We made the decision very early; March 12,” he says. “We made the decision based on what we were seeing. Then, starting the following Monday, March 16, we were going to 100 percent remote setup, telehealth consults prior to setup, and post setup.”

If anything, the push toward telehealth is part of a larger “megatrend” that is being felt by many sectors of the economy: the need for social distancing has caused people to reexamine how they conduct business, not just health-related business.

“I think the entire global economy is going to look substantially different coming out of this in terms of remote work and work from home,” Sheehan says, joking, “I’m certainly glad I’m not a commercial real estate executive right now … . But in terms of HMEs specifically, the regulatory relaxation that we saw and the speed at which we saw it get adopted, I think spoke to how ridiculous some of these existing regulations were frankly.”

When it comes to HME, some of the relaxed guidelines will likely stay, Sheehan explains, while others remain. It’s a give-and-take between what will make sense after the PHE is quelled and new working methods have become rooted in place.

“I don’t think prior authorization is gone forever, and I don’t think that all of Medicare’s relaxed guidelines are going to be left in place,” he says. “I think the relaxations will be in place for quite a while as this thing comes and goes — based on what scientists are saying.”

This article originally appeared in the May/Jun 2020 issue of HME Business.

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