Finding a way to “yes” can take some imagination and hard work


Medical device manufacturer


Medicare reimbursement


Strategy to influence Centers for Medicare and Medicaid Services (CMS) regulators to use statutory authority to adjust the payment or create a new code for this service

What We Did

A large multi-national conglomerate with a subsidiary devoted to manufacturing a subset of medical devices for home infusion sought our help  in developing a Medicare reimbursement strategy to obtain coverage for their product in the home setting. Access to the product would mitigate patients’ risk for opioid addiction after undergoing a medical procedure in the hospital. Given its otherwise focus on non-health industries, the company needed assistance with engaging the federal health care payor in a meaningful way to ensure payment.

At the outset, we sat down with the company’s internal teams to gain a clear understanding of their outreach to Department of Health and Human Services (HHS) and CMS.  We learned that the client had only engaged the agencies via correspondence with regional offices in reaction to an unfavorable coverage decision. As the top DC healthcare lobbying firm, our review of the lobbying activity to date indicated that we needed to build a nuanced strategy on a very complicated reimbursement issue.  

While some companies may want to go straight to the top and engage the CMS Administrator, knowing CMS as well as we do, we recognized that a better course of action would be to work the agency process from the ground up. We arranged meetings in a matter of days with all key stakeholders at CMS — both career and political — to brief them on the issue.  We first engaged the career staff within the coverage and payment teams at CMS’ headquarters to better explain the product and its value to Medicare beneficiaries in improving outcomes. We then engaged political appointees at both CMS and the HHS Office of the Secretary to reinforce our message and get their feedback on how best to proceed. 

Based on those meetings, we determined three options with a high likelihood of success from which the client could choose to offer to CMS to address their coverage concern.   First, CMS could address the issue through a national coverage determination for the product.  Alternatively, the client could request a new payment code that would capture all components of the products used across settings of care.  Finally, the client could work with the Center for Medicare and Medicaid Innovation (CMMI) within CMS to develop a targeted multi-site demonstration project to address barriers to payment and access for the product. All of these approaches could have been done independently or in concert to achieve the company’s goal. 

We helped the client evaluate these options in light of their need for expediency for a solution to address their lack of coverage issue.  We presented pros and cons of a multi-year national coverage process that if unsuccessful would not be able to be undone or removed from the public sphere. Additionally, we spent weeks developing the structure and data collection models necessary to propose an innovative project to CMMI that would target the population most in need of this product. Ultimately, the client elected to seek a new code under the annual rulemaking process as this was the fastest route to differential reimbursement.


CMS finalized a new billing code

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