December 2017 will mark an important change in to US Medicare reimbursement for drug-coated balloons (DCBs) which could create an access barrier to DCB treatment and reduced therapy adoption in patients with peripheral artery disease (PAD).
The recently-released CY 2018 Hospital Outpatient Proposed Rule CMS (Centers for Medicare and Medicaid Services) has confirmed that the existing add-on payment for DCBs will expire on 31 December, 2017. Furthermore, CMS has decided that the costs of DCB devices will be packaged into the payments for associated procedures as of 1 January,2018.
CMS approved the creation of an add-on payment in the outpatient hospital setting effective to facilitate beneficiary access and ensure adequate hospital payment for DCBs in April 2015. These temporary payments were designed to support access to new and promising technologies for two to three years after market entry, while collecting cost data for future rate-setting.
The CY 2018 OPPS proposed rule does not include a provision to create new coding or differentiate payment for procedures involving DCB. CMS has proposed to package the device costs of DCB into the costs of the procedures with which the device is utilised, as of 1 January, 2018, meaning angioplasty procedures with DCB and plain balloons will receive the same payment amount.
As part of the rulemaking process, the OPPS proposed rule is open to public commenting until 11 September. Comments can be submitted here.
Chairman of the NCVH, Craig Walker, voiced his opposition on the change, and encouraged physicians to submit public comments. He said, “I am concerned that the proposed payment structure would not adequately reflect the added costs of DCB and could adversely impact access for Medicare beneficiaries given the difference in costs between a plain balloon and DCB. The clinical benefits and cost effectiveness of DCB angioplasty have been well-established through randomised controlled trials and large-scale, population based observational studies. CMS’ approval of both inpatient and outpatient temporary add-on payments for DCB was in recognition that DCBs represent a significant clinical improvement in the treatment of PAD relative to plain balloon angioplasty catheters when compared to drug coated balloon therapy.”
“I believe an appropriate payment structure after the expiration of these add-on payments is important to avoid patient access barriers to a technology that reduces repeat interventions for patients and health care costs to Medicare.”