New Tech Gets New Focus at CMS With Recent Restructure

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The Medicare agency is reorganizing staff to establish a starting place and clearer pathway for innovators seeking coverage, coding, and payment for new technologies. Jason Bennett, CMS’ point person on the effort, unveiled the strategy this week at AdvaMed’s annual meeting, Market Pathways reports.

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CMS has added a new permanent office and launched a six-month pilot program to simplify how new innovative medical technologies can interact with the multi-faceted Medicare reimbursement process.

The new structure comes amid a rapidly evolving medtech-focused policy framework at CMS, including reforms advanced last year to streamline bonus payments to FDA-designated Breakthrough Devices and, more recently, the agency’s proposal to automatically grant temporary national coverage to Breakthrough Devices (Medicare Coverage for Innovative Technology, or MCIT, program). These reforms are highly praised by industry, but companies have nonetheless called for a more fundamental organizational shift in how CMS operates in the realm of new technology.

The Technology, Coding, and Pricing Group launched last month within CMS’ Center for Medicare. It puts under one roof functions relating to medical technology that have previously been housed in disparate parts of CMS. In conjunction, the agency has brought together a smaller, dedicated team of “navigators” who, for the next six months at least, will be focused on helping shepherd medtech innovators through what can be a byzantine reimbursement process that wasn’t necessarily structured with next-generation technologies in mind.

“Part of navigating CMS is knowing who to engage with, when to engage with them, and in what order.”

Jason Bennett, CMS

“The pace of innovation continues to accelerate. We have had an increase in volume and complexity that has driven us to think differently about how we have organized our work,” said Jason Bennett, a veteran HHS official who was recently tapped as acting director of the new group. Bennett introduced the Technology, Coding, and Pricing Group October 5 during a live session at The Virtual MedTech Conference, AdvaMed’s annual meeting. “It really spoke to us at CMS that it was time to structure ourselves differently, to have a focal area where we would have leadership and staff who are working on innovative technologies on a daily basis.”

Bennett has served in multiple roles within the Center of Medicare for the past three years, and before that was an official at the Health Resources and Services Administration. CMS posted a vacancy in September to fill the Technology, Coding, and Pricing director role on a permanent basis.

Tech Teams Together

CMS consists of dozens of centers, offices, and groups organized around the operations of the US healthcare system, the agency’s distinct roles in establishing coverage, coding, and payment for health care services, and other functions. But there has been no single starting point for developers of new technologies trying to figure out how to get their products appropriately recognized by the Medicare system. That makes the transition from the very technology-focused FDA process to the CMS realm complicated, for smaller, inexperienced companies, in particular.

The Technology, Coding, and Pricing Group is now the single home for several parts of CMS that are often key stop-off points for device makers. In particular, the group’s newly formed Division of New Technology is now in charge of Medicare’s multiple add-on payment programs that offer medtech developers the opportunity to qualify for temporary bonus payments for their new technology to support adoption while CMS figures out longer term reimbursement policies. This includes hospital inpatient new-technology add-on payments (NTAP), outpatient pass-through payments, and the recently established new technology payments for end stage renal disease.

The new group also includes divisions focused on policies for durable medical equipment, prosthetics, and supplies, including the DMEPOS competitive bidding program, and the new Division of Coding and Diagnosis Related Groups. The latter unit is focused on Healthcare Common Procedure Coding System (HCPCS) codes, the ICD-10 system, and inpatient Diagnosis-Related Group (DRG) Categories. “It’s a team of professionals who are thinking about coding day in and day out,” Bennett explained. 

Navigators Point the Way?

But there are also CMS segments critical to the device industry that have not been folded into the new group, most notably the Coverage and Analysis Group, run by Tamara Syrek Jensen. And the Hospital and Ambulatory Policy Group, which develops the annual Medicare payment rules, also continues under the separate leadership of Carol Blackford.

“I know that we are not the only ones you may engage with,” Bennett told the audience of the CMS Townhall at the AdvaMed Meeting. “Part of navigating CMS is knowing who to engage with, when to engage with them, and in what order.”

Addressing that long-standing puzzle is the goal of the six-month “navigator” pilot project that CMS quietly announced in conjunction with the release of its MCIT proposal at the end of August. The program is now getting off the ground, with at least one company leveraging the framework so far.

The navigator team, Bennett said, is tasked essentially with “connecting the dots” for innovators by bringing together expertise and information from different parts of CMS in cases where the coverage, coding, and payments pathway for a new technology may not be immediately obvious.

This isn’t the first attempt by CMS to try to connect the reimbursement dots for medtech start-ups. The agency first published its “Innovators’ Guide to Navigating Medicare” in 2008 and has since updated the document multiple times. And former agency officials have told Market Pathways that they had informally made efforts to bringing the necessary staff from different parts of CMS to help address an individual company’s project. But this is the most significant organizational restructuring that has been carried out to address the issue.

“We really are trying to get a sense as to whether...we can organize our processes in a more efficient way and a more customer-focused way, so that we can really get the right information at the right time both within CMS, but also with innovator companies,” Bennett said.

Because it is a pilot project, the agency will regularly assess the approach and whether the navigator team has the resources to effectively address the issues that arise. The agency will also be looking to learn what types of information it can proactively make more accessible and easily understandable to stakeholders to reduce the number of circumstances in which companies feel they need to seek special assistance.

“We realize not everyone reads every one of the rules we put out,” Bennett said. “Recognizing you might have missed a key piece of information on, say, page 114 of a rule, someone may be able to help point that out. But if there was a way we could have organized that differently to bring it to the forefront, that is part of what we’re doing.”

At least one company has already scheduled a meeting with the navigator team, according to industry stakeholders, but the identity of the firm has not been made public.

The firm, which is an AdvaMed member, will be the first company that will be assisted via the new navigator pilot, Richard Price, AdvaMed’s Senior VP, Payment and Health Care Delivery Policy, told Market Pathways. The major issue for the company, Price explained, “is it is unclear exactly how their technology would fit into the existing benefits structure of Medicare.”

The company will be meeting with CMS soon, he said, which is a “really important sign that Medicare is serious about helping companies find pathways to coverage for their innovative technologies.”

Bennett affirmed that the team of liaisons is open for business; interested companies should email medicareinnovation@cms.hhs.govto seek assistance.

[Pictured above: Bennett, along with CMS officials Tamara Syrek Jensen and Carol Blackford, and AdvaMed's Don May, on the October 5 MedTech Conference CMS Townhall]

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