Amendments to Tax Code Sections Quiz
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Questions and Answers

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?

<p>66 percent</p> Signup and view all the answers

What factors does the Secretary consider for negotiating the maximum fair price of a selected drug?

<p>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.</p> Signup and view all the answers

What specific information about the manufacturer's costs is considered for negotiating drug prices?

<p>Research and development costs and the extent of recouped costs</p> Signup and view all the answers

How many calendar quarters are considered for calculating the average non-Federal average manufacturer price?

<p>4</p> Signup and view all the answers

What percentage increase is considered in the consumer price index for determining the maximum fair price for a selected drug?

<p>Percentage increase in the consumer price index for all urban consumers (all items; United States city average) from specific dates</p> Signup and view all the answers

Which year is used as a reference point for the consumer price index increase in determining the maximum fair price for a selected drug?

<p>September of the year prior to the selected drug publication date with respect to the initial price applicability year</p> Signup and view all the answers

What is the term used to define a selected drug that is a qualifying single source drug in a specific price applicability year?

<p>Temporary floor for small biotech drugs</p> Signup and view all the answers

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