Drug pricing expert witness must comprehend drug classifications as well as the care settings where drugs are prescribed administered and billed. A drug pricing expert witness must be able to have a strong basis for their opinion regarding the market charges nationally and regionally without considering insurance payments where a collateral source rule is in effect. When collateral source rules apply in litigation, a drug pricing expert or pharmaceutical pricing expert should be able to articulate Usual Customary and Reasonable charges (UCR) whether drug prices alone or other data for medical procedures are part of the equation.
When various care models are considered, inpatient (using the Inpatient Prospective Payment System or IPPS) and outpatient (Outpatient Prospective Payment System or OPPS), dialysis, home care etc. not only prescribes payments but methods for calculating charges which is an important differentiator. There is a trend toward increased outpatient administration of drugs including pain medicine injections in ambulatory surgery centers (ASCs). In this context, a drug pricing expert witness should understand the Ambulatory Payment Classification System (APC).
A drug pricing expert witness should be able to discuss drug formularies which impact clinical decision support, drug-drug interactions in electronic health record clinical decision support and other safety and quality measures. Drug pricing analysis may also include multi-payor and Medicare provider data by individual physician, drug classification, manufacturer, dosage and other factors.
Data standards such as NDC, RxNorm and GPI should be well understood by a Drug pricing expert witness. RxNorm includes the National Drug File – Reference Terminology (NDF-RT) from the Veterans Health Administration. NDF-RT is a terminology used to code clinical drug properties, including mechanism of action, physiologic effect, and therapeutic category. GPI includes codified drug dictionary, drug vocabulary, and drug pricing for prescription drugs and medication-based over-the-counter products in the United States. The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)).
A drug pricing expert witness should also be able to produce source data for any calculations as a basis for their opinions with a detailed discussion of their methodology.