Active Summer in State Drug Pricing Transparency Laws

Foley Hoag LLP - Drug Pricing Policy Watch
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During the summer of 2019, a number of states enacted new drug price transparency laws, swelling the number of states with such laws to 11.  Colorado, Maine, Maryland, Texas, and Washington joined California, Connecticut, Louisiana, Nevada, and Oregon with transparency laws.  Oregon also supplemented its transparency laws with an advance notice requirement for certain price increases.

Washington: On May 9, Washington enacted HB 1224.  Under this law, drug manufacturers would have to provide at 60 days’ advance notice and report transparency information in the event of a WAC increase of at least 1) 20% cumulatively over one calendar year before the date of the proposed increase, or 2) 50% cumulatively over 3 calendar years prior to the date of the proposed increase.  HB 1224 also imposes launch notification and transparency requirements triggered by new drugs introduced at a WAC of $10,000 or more per course of treatment or 30-day supply, whatever is longer.  Finally, the law also puts in place further reporting requirements triggered by certain filings with the FDA.

Colorado: On May 16, Colorado enacted HB 19-1131.  This legislation requires drug manufacturers to inform prescribers of the WAC of a prescription drug when the manufacturer provides the prescriber with information about the drug.

Maryland: On May 25, Maryland enacted HB 768.  HB 768 allows the state to conduct a cost review and require certain information from manufacturers of brand drugs with a launch WAC of at least $30,000 per year or course of treatment or that experience a WAC increase of at least $3,000 per 12-month period or course of treatment, as well as certain biosimilars and generics.

Texas: On June 14, Texas enacted H.2536.  This law imposes transparency reporting for manufacturers of drugs experiencing a WAC increase of at least 40% over the preceding three calendar years, or at least 15% over the preceding calendar year.

Oregon: On June 20, Oregon enacted HB 2658.  This legislation supplements Oregon’s existing price transparency laws by imposing a 60-day advance notice requirement for 1) branded drugs experiencing a cumulative WAC increase of 10% or more or $10,000 or more within a 12-month period and 2) generic drugs experiencing a cumulative WAC increase of 25% or more and an increase of $300 or more within a 12 month period.

Maine: On June 24, Maine enacted LD 1162.  This law imposes transparency reporting requirements on drugs that experienced an increase in WAC exceeding 20% in the preceding year.  The legislation also requires manufacturers to notify the state of new drugs introduced at a WAC in excess of the Medicare Part D Specialty Drug Threshold, and report transparency data about such drugs.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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