10 Questions
What is the term used to define a selected drug for which at least 16 years have elapsed since the date of approval or licensure?
Long-monopoly drug
What type of drug would not fall under the category of 'long-monopoly drug'?
Vaccine licensed under section 351 of the Public Health Service Act and marketed pursuant to such section
What does the term 'average non-Federal average manufacturer price' refer to?
The average of the non-Federal average manufacturer price for the 4 calendar quarters of the year involved
What is the minimum percentage for the maximum fair price negotiated for a qualifying single source drug in the initial price applicability year 2029 or 2030?
66 percent
What factors does the Secretary consider for negotiating the maximum fair price of a selected drug?
Manufacturer-specific information, market data, unit costs of production, prior Federal financial support, patents and exclusivity, national sales data, clinical trials, information on alternative treatments.
What specific information about the manufacturer's costs is considered for negotiating drug prices?
Research and development costs and the extent of recouped costs
How many calendar quarters are considered for calculating the average non-Federal average manufacturer price?
4
What percentage increase is considered in the consumer price index for determining the maximum fair price for a selected drug?
Percentage increase in the consumer price index for all urban consumers (all items; United States city average) from specific dates
Which year is used as a reference point for the consumer price index increase in determining the maximum fair price for a selected drug?
September of the year prior to the selected drug publication date with respect to the initial price applicability year
What is the term used to define a selected drug that is a qualifying single source drug in a specific price applicability year?
Temporary floor for small biotech drugs
Test your knowledge on the amendments made to various sections of the tax code. Identify the correct amendments and placements within the sections mentioned in the quiz text.
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