Perspectives on Medical Reimbursement
By JR Associates
The Medical Device Manufacturers Association’s annual Coverage, Reimbursement and Health Policy Conference is always a high point on our firm’s schedule. That’s because our President, Judy Rosenbloom, and our VP of Global Health Policy, Jo Ellen Slurzberg, work hand-in-hand with MDMA each year to develop and deliver this educational event.
Our relationship with MDMA began 22 years ago, when the medical device market was much different in size, scope and complexity. But despite profound change across the reimbursement landscape, this conference continues to focus on the same overarching mission – empowering manufacturers to improve patient access to innovative technologies they produce.
In recent years, this forum focused on the shift from volume-based care (fee for service) to value-based reimbursement (fee for value), and its impact on device commercialization. Yet a vast gap still remains between novel products and the patients they’re designed to help. So in 2019, topics built on the “volume-to-value” transition, with special emphasis on the role that Medicare and payer coverage play in improving patient access to innovative technologies.
Below are snapshot summaries of the three sessions our consultants led:
DAY 1
- Reimbursement Strategic Planning
DAY 2
- SESSION 1: Industry Reaction to CMS Coverage Process and Reforms
- SESSION 2: Navigating CPT and RUC: Implications for Access
DAY 1
Reimbursement Strategic Planning: Challenges and Cases
In this interactive session, Jo Ellen and Judy examined the importance of coverage in establishing market access and how to incorporate coverage in successful business strategies. Specifically, they explored practical ways to assess opportunities, mitigate risks, develop appropriate milestones and manage timelines on the road to reimbursement.
While leading a spirited discussion with participants, Judy and Jo Ellen explained how thoughtfully designed strategic assessments can lay a foundation that helps medical device innovators anticipate potential roadblocks and prepare to address those barriers.
Throughout the session, Judy and Jo Ellen underscored the importance of communicating effectively with board members and executives. For example, it’s vital to help these stakeholders understand the relationship between reimbursement and business strategy and the timeline for obtaining reimbursement, as well as their roles in advancing this agenda.
Top Takeaway: Keep in Mind That Clinical Evidence Is Key
Regardless of the regulatory path, manufacturers should aim to develop clinical evidence. In other words, rather than analyzing coverage, coding and payment separately, think of them a “whole” comprised of interdependent parts. This holistic approach helps innovators avoid choosing a more narrow path that might unnecessarily restrict market access.
DAY 2
SESSION 1 of 2
Industry Reaction to CMS Coverage Process and Reforms
In this expert roundtable, Jo Ellen joined other expert panelists to discuss timely coverage policy issues. This discussion paid specific attention to the unique coverage challenges that smaller companies face.
Some panelists suggested that most technologies still lack enough evidence to satisfy criteria for coverage – even when TPT (transitional pass-through payment) and NTAP (new technology add-on payment) are included. Jo Ellen and many members of the audience agreed that this was true for some past cases. However, they countered with several current examples where the evidence supports coverage and is commensurate with other covered technologies and services.
In addition, Jo Ellen presented examples involving Medicare Administrative Contractors (MACs) that misinterpreted criteria for TPT, NTAP and the 21st Century Cures Act. Most audience members agreed that, despite the diligence of MACs, criteria to gain coverage was not transparent. Also because new technologies weren’t reviewed in a fair and clear way, coverage and patient access were negatively influenced. Panelist Tamara Syrek Jensen JD, Director of the CMS Coverage and Analysis Group (CAG), and audience member Laurence Clark MD, Medical Director at Noridian, actively contributed to this discussion.
TOP TAKEAWAY: Focus on developing clinical evidence that supports coverage
As the session ended, participants agreed that it’s essential for device innovators to focus on developing clinical evidence that supports coverage. In addition, they should advocate for industry efforts that minimize barriers to coverage for beneficial new technologies and procedures.
Specifically, it’s important to consider mechanisms that help the clinical community – and patients above all – to gain access to medical innovation without having to overcome non-coverage barriers. This will be a key focus area for MDMA in 2020.
DAY 2
SESSION 2 of 2
Navigating CPT and RUC: Implications for Access
In this joint presentation with Susan Clark, Physician Payment Operations Manager, American Medical Association, Judy advised device manufacturers to think carefully before simply requesting a new CPT code, because that can lead to serious negative business consequences.
Planning and preparation sometimes require a multi-year effort to ensure that CPT criteria are met and that stakeholder and company goals are aligned. Judy indicated that new technology-driven procedures continue to be plagued by issues surrounding ambiguous utilization criteria. This makes securing a Category I CPT code particularly difficult.
It’s important for the CPT panel to have more visibility into the necessary data, as well as clarification from the CPT RUC representative about the kind of survey numbers needed to determine the value of a new code. Judy noted that if a medical society can assure that survey numbers are attainable, then utilization issues should not be a barrier for gaining a Category I CPT code.
Specifically, she recommended that organizations investigate Category I and Category III CPT code options, benefits and coverage risks, in conjunction with RUC code valuation and payment considerations. She also recommended considering MDMA goals for achieving greater transparency in the process and utilization criteria for Category I CPT coding.
TOP TAKEAWAY: Choose CPT Code Strategy Wisely
Pursuing CPT coding in isolation can impede market access. This risk can be reduced by including coverage and payment considerations in the equation.
Our consultants believe that CPT strategy is critical and should be tailored, accordingly. This sets us apart from those who recommend the same code path for all technologies or procedures, because it minimizes long-term reimbursement problems that are difficult or impossible to reverse.
For best results, we suggest that medical innovators begin strategic reimbursement planning in the early stages of clinical and product development.
Are you a medical device innovator? Do you need guidance to prepare a reimbursement strategy and action plan that will help you obtain reimbursement and market access?
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