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2018 Trends in Medical Device Reimbursement

Telehealth: improvements in coverage and access
No one can ignore telehealth and remote patient monitoring as hot topics for 2018. This year we saw innovation in digital and telehealth technology and the necessary improvements to coverage from Medicare, Medicaid, and private payers that will allow for easier patient access and provider billing for these types of services. The caveat is that much of this coverage is still bound by a variety of parameters including particular diagnoses and treatment, as well as amounts of time and timing associated with the telehealth service. This means that companies should be cautious in resting business plans solely on telehealth reimbursements, but things seem to be moving in a positive direction as consumers continue to request virtual access to healthcare.

Expediting coverage for breakthrough devices
In June of this year, bipartisan legislation was introduced to help streamline the CMS review process for breakthrough technologies. While little movement has been made on the Ensuring Patient Access to Critical Breakthrough Products Act of 2018 , many device sponsors have chosen to leverage the FDA’s Parallel Review Program that continues to enable FDA and CMS review to determine clinical evidence that supports both the approval and coverage of a new medical device. Introduction of the Private Payor Program in 2018 gave manufacturers the opportunity to receive feedback from non-governmental health technology assessment groups or private payors through a similar parallel review approach.

Keeping up with innovation: modernization of payor policies
Many payors, CMS included, took steps to modernize policies in 2018 in an effort to keep up with the rapid pace of advancing technology. Reforms to the Medicare Local Coverage Determination aimed to improve long requested transparency and review consistency to the decision-making process by Medicare contractors. In July, CMS proposed changes to the payment rules for DMEPOS that would simplify Medicare’s Competitive Bidding Program with the aim to drive competition and increase affordability for consumers.

What to look for in 2019

Cost reduction measures: cost comparison tools and value-based purchasing
Continuation of programs like the Value-Based Bundled Payment Model and new programs, like the CMS Hospital Value-Based Purchasing Program, will have an effect on pricing considerations for hospital purchasing of new technology and devices. The Hospital VBP Program will affect payment for inpatient stays at approximately 2,800 hospitals in the United States based on how well they performed compared to peers and how much they have improved quality of care provided to patients over time. CMS has launched Procedure Price Lookup, similar to tools already in place by private payors, that aims to help Medicare beneficiaries consider potential cost differences when making decisions.

Innovation fueled by funds for critical healthcare needs will require coverage for patient access
Many funding opportunities (i.e. Aetna, FDA) announced in 2018 to fuel sorely needed innovation in technology and programs to prevent and treat opioid addiction will have breakthroughs coming to fruition in 2019. To keep up, payors will be looking for ways to expand coverage for new treatments and technologies to ensure access for consumers.


This year end blog was written by Cassie Brugger, MA, Simbex Senior Program Administrator.  A story’s inclusion does not imply endorsement by Simbex, LLC.

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