HB 703-FN - AS AMENDED BY THE HOUSE
HOUSE BILL 703-FN
SPONSORS: Rep. Butler, Carr. 7; Rep. Knirk, Carr. 3; Sen. Sherman, Dist 24
COMMITTEE: Commerce and Consumer Affairs
This bill requires prescription drug manufacturers to provide certain notice to the insurance department if they are introducing a new prescription drug to market at a wholesale acquisition cost that exceeds the threshold set for a specialty drug under the Medicare Part D program.
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Explanation: Matter added to current law appears in bold italics.
Matter removed from current law appears [in brackets and struckthrough.]
Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
19Mar2019... 0908h 19-0806
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Nineteen
Be it Enacted by the Senate and House of Representatives in General Court convened:
New High-Cost Prescription Drugs
318:67 Definitions. In this subdivision:
I. "Department" means the insurance department.
II. “Manufacturer” means any entity which is engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drugs, whether directly or indirectly by extraction from substances of natural origin, independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, or any entity engaged in the packaging, repackaging, labeling, relabeling, or distribution of prescription drugs. The term shall not include a wholesale distributor of prescription drugs, a retailer, or a pharmacist licensed under the board.
III. “Prescription drug” means a drug defined in 21 U.S.C. section 321.
318:68 Notice Required.
I. A prescription drug manufacturer shall notify the department in writing if it is introducing a new prescription drug to market at a wholesale acquisition cost that exceeds the threshold set for a specialty drug under the Medicare Part D program. The manufacturer shall provide the written notice within 3 calendar days following the release of the drug in the commercial market. A manufacturer may make the notification pending approval by the United States Food and Drug Administration (FDA) if commercial availability is expected within 3 calendar days following the approval.
II. No later than 30 calendar days following notification required under paragraph I, the manufacturer shall provide the following information to the department in a format that the department prescribes:
(a) A description of the marketing and pricing plans used in the launch of the new drug in the United States and internationally.
(b) The estimated volume of patients who may be prescribed the drug.
(c) Whether the drug was granted breakthrough therapy designation or priority review by the FDA prior to final approval.
(d) The date and price of acquisition if the drug was not developed by the manufacturer.
III. The manufacturer may limit the information required under paragraph II to that which is otherwise in the public domain or publicly available.
IV. The department shall publish on its Internet website, at least quarterly, the information reported to it under this section. The information shall be published in a manner that identifies the information that is disclosed on a per-drug basis and shall not be aggregated in a manner that would not allow identification of the drug.
V. The attorney general may bring a civil action for injunctive relief, costs, and attorney’s fees and impose on a manufacturer that fails to provide the information required under paragraph II, a civil penalty of not more than $1,000 per day for every day after the notification period described in paragraph II that the required information is not reported. In any action brought under this section, the attorney general shall have the same authority to investigate and obtain remedies as if the action were brought under the RSA 358-A.
HB 703-FN- FISCAL NOTE
AS AMENDED BY THE HOUSE (AMENDMENT #2019-0908h)
FISCAL IMPACT: [ X ] State [ ] County [ ] Local [ ] None
Estimated Increase / (Decrease)
[ X ] General [ ] Education [ ] Highway [ ] Other
This bill requires prescription drug manufacturers to provide written notice to the Insurance Department if they introduce a new prescription drug to the market at a wholesale acquisition cost that exceeds the threshold set for a specialty drug under the Medicare Part D program. The bill requires the Department to publish the reported information on its website at least quarterly. The Department assumes this bill would have no impact on insurance premium tax revenue and further assumes it would be able to handle the additional responsibilities within it existing operating budget.
The bill allows the Attorney General to bring a civil action against a manufacturer that fails to provide the requisite information. Since the Department of Justice has no way to predict the number of civil actions that may occur as a result of the bill, the fiscal impact on the Department is indeterminable.
Departments of Justice and Insurance
|Jan. 3, 2019||Introduced 01/03/2019 and referred to Commerce and Consumer Affairs HJ 3 P. 27|
|Feb. 19, 2019||Public Hearing: 02/19/2019 02:00 pm LOB 302|
|Feb. 21, 2019||Subcommittee Work Session: 02/21/2019 10:30 am LOB 302|
|Feb. 21, 2019||==RECESSED== Executive Session: 02/21/2019 02:00 pm LOB 302|
|March 6, 2019||Subcommittee Work Session: 03/06/2019 08:30 am LOB 302|
|March 8, 2019||Subcommittee Work Session: 03/08/2019 09:00 am LOB 302-304|
|March 8, 2019||==CONTINUED== Executive Session: 03/08/2019 01:30 pm LOB 302-304|
|March 19, 2019||Majority Committee Report: Ought to Pass with Amendment # 2019-0908h for 03/19/2019 (Vote 13-7; RC) HC 16 P. 22|
|Majority Committee Report: Ought to Pass with Amendment # 2019-0908h (Vote 13-7; RC)|
|Minority Committee Report: Inexpedient to Legislate|
|March 19, 2019||Amendment # 2019-0908h: AA VV 03/19/2019|
|March 19, 2019||Ought to Pass with Amendment 2019-0908h: MA RC 206-141 03/19/2019|
|March 28, 2019||Introduced 03/28/2019 and Referred to Commerce; SJ 12|
|Feb. 19, 2019||House||Hearing|
|Feb. 21, 2019||House||Exec Session|
|March 8, 2019||House||Exec Session|
|March 8, 2019||House||Exec Session|
|March 19, 2019||House||Floor Vote|