California Code of Regulations › Title 22 - Social Security › Division 7 - Health Planning and Facility Construction › Chapter 9.5 - Prescription Drug Pricing for Purchasers › Article 2 - Prescription Drug Cost Increase Notification and Report Requirements › Section 96070 - Wholesale Acquisition Cost Increase Report

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) For
				  each drug product wholesale acquisition cost increase for which a notice was
				  required pursuant to Section
				  96065, a manufacturer shall file a
				  report with the Department.
(b) The
				  report shall include the following information:
(1) The NDC. The NDC shall be reported in
				  numeric form.
(2) A description of
				  the drug product to include the following:
(A)
				  The drug product name.
(B) The drug
				  product strength.
(C) The drug
				  product dosage form.
(D) The drug
				  product package size.
(3) Effective date of wholesale acquisition
				  cost increase.
(4) Amount of
				  wholesale acquisition cost increase.
(5) The wholesale acquisition cost resulting
				  from the reported cost increase.
(6) If the drug is under patent, the patent
				  expiration date. For a drug under multiple patents, the patent expiration date
				  shall be the date on which all of the patents will have expired.
(7) Indicate whether the drug product is one
				  of the following as defined in subparagraph (A) of paragraph (7) of subdivision
				  (k) of Section
				  1396r-8 of Title 42 of the United States
				  Code:
(A) An innovator
				  multiple source drug;
(B) A
				  noninnovator multiple source drug; or
(C) A single source drug.
(8) Total volume of gross sales in
				  United States dollars of the drug product sold in the United States during the
				  one year period prior to the effective date of the cost increase.
(9) A narrative description of the specific
				  financial and nonfinancial factors used to make the decision to increase the
				  wholesale acquisition cost of the drug product and to decide on the amount of
				  the increase. The description shall include, but shall not be limited to, an
				  explanation of how these factors explain the increase in the wholesale
				  acquisition cost of the drug product.
(10) A narrative description of the change or
				  improvement in the drug product, if any, that necessitates the price
				  increase.
(11) A schedule of
				  wholesale acquisition cost increases for the drug product for any period during
				  the previous five year period in which the drug product was manufactured by the
				  reporting manufacturer. The schedule shall list the date of each wholesale
				  acquisition cost increase, the amount of each wholesale acquisition cost
				  increase, and the wholesale acquisition cost resulting from each wholesale
				  acquisition cost increase.
(12) If
				  the drug product was acquired by the manufacturer within the previous five year
				  period, all of the following information:
(A)
				  The name of the company from which the drug product was acquired.
(B) The date acquired.
(C) The purchase price.
(D) The wholesale acquisition cost of the
				  drug product at the time of acquisition.
(E) The wholesale acquisition cost of the
				  drug product one year prior to the date of acquisition.
(F) The year the drug product was introduced
				  to market.
(G) The wholesale
				  acquisition cost of the drug product at the time it was introduced to
				  market.