Bill Text: NY A02939 | 2017-2018 | General Assembly | Introduced
Bill Title: Relates to prescription drug cost transparency.
Spectrum: Bipartisan Bill
Status: (Introduced - Dead) 2018-01-03 - referred to health [A02939 Detail]
Download: New_York-2017-A02939-Introduced.html
STATE OF NEW YORK ________________________________________________________________________ 2939 2017-2018 Regular Sessions IN ASSEMBLY January 23, 2017 ___________ Introduced by M. of A. McDONALD -- read once and referred to the Commit- tee on Health AN ACT to amend the public health law, in relation to prescription drug cost transparency The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Legislative intent. It is the intent of the legislature to 2 make information available to the public about the cost and utilization 3 of pharmaceutical drugs. To fulfill this goal, the legislature finds 4 that there should be annual reporting of drug costs and use that would 5 be of use by policymakers, government agencies and others to understand 6 pharmacy cost trends. 7 § 2. The public health law is amended by adding a new section 278-a to 8 read as follows: 9 § 278-a. Prescription drug cost transparency. 1. Each manufacturer of 10 a brand and generic medication that is made available in New York state 11 shall file a report on pharmaceutical costs as outlined in this section. 12 2. The manufacturer of a pharmaceutical drug that has a wholesale 13 acquisition cost of one thousand dollars for a thirty day supply shall 14 file a report pursuant to this section on the costs for each qualifying 15 drug. Wholesale acquisition cost shall have the same meaning as found in 16 subsection (c) of 42 U.S. Code Section 1395w-3a. 17 3. The manufacturer of a pharmaceutical drug which during a three 18 month period has a cumulative price increase of three times the consumer 19 price index shall file a report pursuant to this section on the costs 20 for each qualifying drug. 21 4. The report shall include the following for each drug described in 22 subdivisions two and three of this subdivision: 23 (a) the total costs for the production of the drug including all of 24 the following: EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD07661-01-7A. 2939 2 1 (1) the total research and development costs including but not limited 2 to: 3 (i) the total costs of any study drug manufactured during this report- 4 ing period in support of the U.S. food and drug administration approved 5 use of the drug; 6 (ii) the total costs of any preclinical studies conducted during this 7 reporting period; 8 (iii) the total costs of any clinical trials conducted during this 9 reporting period; 10 (iv) the total costs associated with the preparation and submission of 11 any regulatory documents submitted to the U.S. food and drug adminis- 12 tration during this reporting period; 13 (v) the total costs of post approval clinical studies mandated by the 14 U.S. food and drug administration during this reporting period; and 15 (vi) the total costs of post approval studies earmarked for publica- 16 tion using external providers of data during this reporting period; 17 (2) the total costs for materials, manufacturing and administration 18 attributable to the drug for this reporting period; 19 (3) the total costs paid by any entity other than the manufacturer or 20 predecessor for research and development, including an itemized list of 21 any amount from federal, state, or other governmental programs or any 22 form of subsidies, grants, or other support for this reporting period; 23 and 24 (4) any other costs to acquire the drug, including costs for the 25 purchase of patents, licensing or acquisition of any corporate entity 26 owning any rights to the drug while in development. 27 (b) The total administrative costs for the promotion of the drug, 28 including but not limited to: 29 (i) marketing and advertising costs; 30 (ii) direct to consumer advertising costs; 31 (iii) prescriber education costs; 32 (iv) professional education costs; 33 (v) lobbying costs; and 34 (vi) financial assistance to patient groups, disease associations, or 35 other consumer organizations. 36 (c) The total profit as represented in total dollars and a percentage 37 of total company profit derived from the sale of the drug. 38 (d) The total amount of financial assistance the manufacturer has 39 provided through patient prescription assistance programs if such 40 programs are available, including but not limited to: 41 (i) costs associated with direct to consumer coupons and amount 42 redeemed; 43 (ii) costs associated with copayment assistance programs; and 44 (iii) costs associated with sample doses, trial doses, or where the 45 drug product is provided but not sold. 46 (e) The wholesale acquisition cost of the drug as publicly reported 47 for each drug, including a five-year history of wholesale acquisition 48 cost price increases, expressed as a percentage, and the month or months 49 each increase took effect and any explanation for the price increase. 50 5. Information shall be filed with the department annually, consistent 51 with subdivisions two and three of this section, on a form prescribed by 52 the department and shall be submitted no later than May first, two thou- 53 sand eighteen. Such information shall be updated quarterly. 54 6. The department shall issue a report outlining the information 55 submitted pursuant to this section by December thirty-first, two thou- 56 sand eighteen and issue addendums on a quarterly basis reflecting theA. 2939 3 1 requirements of paragraph (d) of subdivision four of this section to the 2 legislature. Such information shall be made publicly available on the 3 department's website. 4 7. The department shall convene an advisory workgroup to develop the 5 forms required by this section. The workgroup shall include, but is not 6 limited to, representatives from the pharmaceutical industry, health 7 insurance plans, pharmacy benefit managers, governmental agencies, 8 consumer advocates, and physicians. 9 8. The department shall maintain the confidentiality of any informa- 10 tion submitted pursuant to this section that the commissioner deems to 11 be confidential, proprietary information of the prescription drug 12 manufacturer and the disclosure of which would cause the manufacturer 13 competitive harm. This confidential proprietary information shall not be 14 made public by the department and is exempt form disclosure under the 15 state freedom of information law. 16 § 3. This act shall take effect immediately.