Don Goffena

Coding and Reimbursement

Don’s career in the medical device industry has spanned 40+ years: ranging from the design and construction of Class 100 cleanrooms for device manufacturing, product development, technical support for field clinical sales teams, and market access/healthcare economics.

For the past 20 years Don worked with AMA’s CPT, Medicare’s HCPCS & ICD coding systems, and Medicare’s inpatient and outpatient payments; helping to guide new cardiovascular technologies through required stages of market access. This included involvement commencing with new product concept evaluation and continuing through clinical trial data collection and eventual payment in commercialized clinical use. These activities involved close collaboration with internal teams focused on product development, legal, regulatory, marketing, and clinical sales; providing a broad, hands-on appreciation of and familiarity with the entire spectrum of work required for successful commercialization. These internal activities were complemented by coordinated work with medical societies and Medicare payers to develop coverage policy, strategic coding initiatives, and rate setting, including successful submissions for Medicare’s Inpatient New Technology add-on payments.

With the increasing importance of economics in healthcare, Don’s focus expanded to the application of healthcare datasets and health economic outcomes research (HEOR) to help inform value decisions affecting product development choices, clinical trial designs, and informing “right patient, right time, right treatment” decisions.

His expertise in health economics and reimbursement continues to be focused on improving the lives of patients while optimizing the efficiencies of healthcare.