Industry revisits clinical data elements

BALTIMORE – A new national coverage determination that eliminates the certificate of medical necessity requirement for home oxygen therapy provides an opening to revisit standardized clinical data elements, industry stakeholders say. 

Through Aug. 3, stakeholders are urging members in the House of Representatives to sign on to a Dear League letter that asks CMS to adopt CDEs for home oxygen equipment and supplies. 

“The industry has taken this opportunity to pull out those clinical data elements, dust them off and update them to the new requirements,” said Kim Brummett, senior vice president of regulatory affairs for AAHomecare. “So, it’s interesting timing to have the folks on the Hill advocate for, ‘Hey, it’s a good idea to make them a requirement.’” 

Former CMS official Melanie Combs-Dyer was a big proponent of an e-clinical template with CDEs going back to 2015, but when she left the agency, they were largely shelved. 

Stakeholders say standardized CDEs would ensure records properly substantiate medical necessity, in turn ensuring access to care and a streamlined audit review process.  

“I can see how it could be construed as a replacement to the CMN,” Brummett said. “But if CMS creates a form, be it a CMN or something else, it has to go through the Office of Management and Budget to be approved, so these are more clinical data elements that should exist in the record. As it stands right now, when the DME MACs turn off the CMN requirement in their system in January, there will no longer be any data points that you have to put in.” 

But the rub today, just as it was several years ago, is the need for e-prescribing platforms to adopt the CDEs and for CMS to accept documentation with CDEs, stakeholders say. 

“Where the CDEs would make the most meaningful impact for suppliers is if we had the biggest e-prescribers incorporating them into their platforms, so when the device is ordered, doctors would be provided with a series of questions that must be answered or considered, so they don’t forget something,” said Andrea Stark, a Medicare consultant and reimbursement specialist for Mira Vista. “Until we have a more forceful push from CMS to require that, I think the CDEs are going to have limited utility.” 

Even without CDEs and without, at press time, companion local coverage determinations and policy articles from the DME MAC, providers should feel more secure today about providing home oxygen equipment and supplies, stakeholders say. 

“Suppliers are in the best position they’ve ever been in on the oxygen front,” Stark said.