When will the Department of Health and Human Services (HHS) end the COVID-19 public health emergency (PHE)?

It’s an important question that persists because so many temporary rules and reimbursement

60-Day Notice?

You may have heard – and many industry stakeholders assume – that HHS will announce plans to expire the PHE at least 60 days before doing so. But with only informal sources to rely on, suppliers still worry the PHE will end abruptly and leave them scrambling to:

• Requalify existing patients no longer covered by pandemic waivers and flexibilities,
• Retrieve equipment from patients that no longer qualify, and
• Prepare for audits that may come in the aftermath.

I have some good news.

After doing a bit of research, I found a January 2021 letter from Acting HHS Secretary Norris Cochran to state governors committing to the 60-day heads up. Though the letter was written in the early days of Biden’s presidency, it still represents his administration’s position. According to Route-Fifty, a digital news publication for government executives, an HHS spokesman re-affirmed the agency’s 60-day promise as recently as May 20, 2022. While not law, it is certainly more concrete than rumor mill.

The Rationale

I believe the rationale for giving states advance notice of PHE expiration is what makes this promise reliable for suppliers, too. The government pegged significant Medicaid funding and enrollment obligations to the COVID-19 PHE, and states will need time to transition back to normal operations. Ending the PHE suddenly would certainly create turbulence for state budgets and extreme difficulty for beneficiaries that will no longer qualify for Medicaid benefits when the PHE ends. The Cochran letter recognizes the implications for the beneficiary population, and I think that has more teeth than a purely aspirational statement from HHS to pacify anxious suppliers.

Going Forward

Relying on the 60-day promise, suppliers can reasonably assume HHS will:
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• Extend the COVID-19 PHE, scheduled to end July 15, 2022, for another 90 days to October 2022.
• Announce any plans to let the next extension expire in October by mid-August 2022.

Going one step further, if the agency fails to announce definitive plans by mid-August, suppliers can expect the PHE to continue through to January 2023.

SOURCE LINKS
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx
https://aspr.hhs.gov/legal/PHE/Pages/Letter-to-Governors-on-the-COVID-19-Response.aspx+
https://www.route-fifty.com/health-human-services/2022/05/national-covid-19-public-health-emergency-extending-until-least-october/367245/

In the May 5 issue of its MLN Connects Newsletter, CMS quietly announced plans to discontinue all requirements for Certificates of Medical Necessity (CMNs) and DME Information Forms (DIFs) in 2023. While we are not surprised by the complete elimination, the future implementation date only fuels the ongoing drama surrounding current CMN requirements for oxygen.

The notice was exceptionally brief, clocking in at just 77 words, but it does include a statement that continues the disconnect between coverage and claims processing:

“Suppliers must continue to submit CMN and DIF information for claims with dates of service before January 1, 2023.”

As we detailed in February, Form CMS-484, the oxygen CMN, is incompatible with revisions the agency made to its Home Use of Oxygen NCD in September 2021. In fact, the first two questions will most certainly cause oxygen claims for patients with acute diagnoses - covered broadly under the NCD – to deny. In January, we explained why MACs, QICs, and ALJs will be forced to reverse erroneously denied claims on appeal.

To avoid the onerous burden that this administrative sinkhole places on suppliers, patients, and even the DME MACs, specific guidance is needed to address claims for services started or restarted:

1. Before the NCD revision (prior to September 27, 2021).
2. During the implementation gap (September 27, 2021, to June 13, 2022).
3. Between MAC implementation and CMN elimination (June 14, 2022, to December 31, 2022).

CMS already issued a change request giving DME MACs until June 14 to process oxygen claims in accordance with the revised NCD. The change request also requires the DME MACs, upon supplier request, to reprocess denied claims that should have paid under the revised NCD. Still, these requirements do not speak to the incompatibility of the CMN or how suppliers should manage renewals for patients that started therapy before September 27.

There are a number of stop-gap measures the DME MACs can implement to remedy the issue until January 1, 2023:
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1. Provide a pathway for suppliers to administratively complete the CMN in a manner that clearly identifies it as something other than a medical record prepared by the referring physician.
2. Automatically add a “dummy” CMN to all oxygen claims to effectively bypass the obsolete processing logic.
3. Adopt a modifier bypass similar in effect to the CR modifier and COVID-19 narratives used to bypass oxygen CMN requirements during the PHE.

The continued disparity in coverage and processing benefits no one, and unfortunately, the future elimination of the CMN doesn’t do much to solve the problem.

SOURCE LINKS
https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2022-05-05-mlnc#_Toc102553739

In the ongoing battle for who decides what is medically necessary, doctors often order supplies in excess of Medicare coverage. Medicare considers any item that goes beyond the covered quantity an upgrade, even when prescribed. Suppliers caught in the middle have two choices when filling orders for excess supplies: charge the patient or give them away for free.

Billing Patients for Upgrades

In addition to billing Medicare for the covered supplies, suppliers can charge the beneficiary directly for excess supplies provided they obtain a properly executed Advance Beneficiary Notice (ABN) from the patient. The supplier then includes two lines on the Medicare claim:

1. Line 1 includes the total number of units provided and the GA modifier.
2. Line 2 includes the covered number of units provided and the GK modifier.

For example, assume a doctor orders a non-insulin dependent diabetic patient to test two times per day. Because Medicare only covers one test per day, the patient needs twice the allowed testing strips over the same testing period. In this scenario, the patient needs four boxes of testing strips, not two, for a 90-day period. If the supplier cannot find coverage justification for the higher testing frequency, they can still dispense all four boxes, billing Medicare for two and charging the patient directly for the extra.

After obtaining an ABN from the patient, the supplier will include the following on the Medicare claim:

• Line 1 – A4253NUKSGA; QTY = 4.
• Line 2 – A4253NUKSGK; QTY = 2.

The GA modifier indicates the supplier has a signed ABN from the patient for excess quantities; this line must be reported on the claim first. The GK modifier identifies the covered items or quantities.
The patient pays the following amounts:

1. 20 percent copay for the allowed units on line 2, and
2. The difference between the usual and customary charge on line 1 and line 2.

Suppliers cannot pass the contractual write-off amount for the covered supplies to the patient.

Free Upgrades

Alternatively, the supplier can provide the excess items or quantities at no additional charge to the beneficiary. Medicare does not require ABNs for free upgrades. The supplier includes a single line on the claim including the covered quantity of supplies and the GL modifier. The supplier also needs to include a claim narrative telling Medicare auditors how many units the patient actually received.

Using the same example as above, the supplier will include the following on the Medicare claim:

1. Line 1 - A4253NUKSGL; QTY = 2, and
2. Claim narrative disclosing the patient received four boxes of strips.

The GL modifier indicates the beneficiary received an upgrade ‑ a luxury item, or in this example, a more liberal supply.

In all cases, the proof of delivery must reflect the actual quantities delivered to the patient.

These upgrade protocols apply to virtually any supply HCPCS with a set limit on quantity (e.g., urological, surgical, ostomy, CPAP, and diabetic supplies). They do not apply to supply allowances which are based on units of time instead of quantity. Supply allowances cannot be limited by quantity when Medicare pays a fixed amount to cover whatever the patient needs for a given day or week or month as is the case for enteral administration kits, infusion sets, CGM supplies, and the like.

SOURCE LINKS
https://cgsmedicare.com/jc/pubs/news/2022/01/cope24725.html
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Communication between patients entering hospice with active DME rentals, the DME supplier, and the hospice provider is not great. The patient is usually in no condition to keep everyone informed, the hospice does not have access to the patient’s complete medical history, and the DME supplier is usually the last to know about the hospice care.

When CMS released the Patient Notification of Hospice Non-Covered Items, Services, and Drugs form (the Form) in November 2020, they indirectly provided an excellent tool to coordinate care and get everyone on the same page.

The Form

The Form is a beneficiary notice CMS requires hospice providers to complete, but only if the beneficiary requests it. In doing so, the hospice provider explicitly lists terminal diagnoses, unrelated illnesses and conditions, and items and services unrelated to the terminal illness.

That last part is important because it is a clear declaration of which services are not included in hospice reimbursement. If DME items are listed, suppliers have a strong foundation for continued billing. Suppliers may need to pick up equipment or contract separately with the hospice provider for items not listed.
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Using the Form to Improve Health Care Coordination

CMS requires the hospice to complete this form, but only when the beneficiary specifically requests it. Beneficiaries – and many hospice providers – probably don’t know it exists. To maximize the benefit, DME suppliers will have to assume the role of unofficial educator.

DME suppliers should proactively check eligibility monthly for active rental patients. Once alerted to a hospice stay, the supplier should fax the hospice agency a list of all active equipment and supplies with a blank copy of CMS’s Hospice Non-Covered Items form, asking them to complete the form, provide a copy to the beneficiary, and provide a copy for the DME supplier’s patient file. Doing so benefits hospice providers, too, because it is a straight-forward way to coordinate care and ensure they are not responsible for items not covered in their own reimbursement rates.

Suppliers should continue to bill to Medicare with a “GW” modifier for any item the hospice lists on the form as excluded. Absent payment arrangements from the hospice, suppliers should discontinue service and schedule the pick-up of any item the hospice deems related (and therefore does not appear on the Form).

By using the Hospice Non-Covered Items form as a tool to clearly document the hospice’s assessment specific to equipment and supplies, DME suppliers can avoid cash flow disruptions and improve overall care coordination.

SOURCE LINKS
MLN Article on the Implementation of the Election Statement
https://www.cms.gov/files/document/mm12015.pdf 
Model Statement Form
https://www.cms.gov/files/document/model-hospice-election-statement-addendum-july-2021.pdf