Bill Details - HB703 (2019)

HB 703-FN - AS AMENDED BY THE HOUSE

 

19Mar2019... 0908h

2019 SESSION

19-0806

01/05

 

HOUSE BILL 703-FN

 

AN ACT relative to providing notice of the introduction of new high-cost prescription drugs.

 

SPONSORS: Rep. Butler, Carr. 7; Rep. Knirk, Carr. 3; Sen. Sherman, Dist 24

 

COMMITTEE: Commerce and Consumer Affairs

 

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AMENDED ANALYSIS

 

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Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.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

01/05

 

STATE OF NEW HAMPSHIRE

 

In the Year of Our Lord Two Thousand Nineteen

 

AN ACT relative to providing notice of the introduction of new high-cost prescription drugs.

 

Be it Enacted by the Senate and House of Representatives in General Court convened:

 

1  New Subdivision; New High-Cost Prescription Drugs.  Amend RSA 318 by inserting after section 66 the following new subdivision:

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.

2  Effective Date.  This act shall take effect January 1, 2020.

 

LBAO

19-0806

Amended 4/10/19

 

HB 703-FN- FISCAL NOTE

AS AMENDED BY THE HOUSE (AMENDMENT #2019-0908h)

 

AN ACT relative to providing notice of the introduction of new high-cost prescription drugs.

 

FISCAL IMPACT:      [ X ] State              [    ] County               [    ] Local              [    ] None

 

 

 

Estimated Increase / (Decrease)

STATE:

FY 2020

FY 2021

FY 2022

FY 2023

   Appropriation

$0

$0

$0

$0

   Revenue

$0

$0

$0

$0

   Expenditures

Indeterminable Increase

Indeterminable Increase

Indeterminable Increase

Indeterminable Increase

Funding Source:

  [ X ] General            [    ] Education            [    ] Highway           [    ] Other

 

METHODOLOGY:

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.  

 

AGENCIES CONTACTED:

Departments of Justice and Insurance

 

Docket

Date Status
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
Majority Committee Report: Ought to Pass with Amendment # 2019-0908h (Vote 13-7; RC)
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
Minority Committee Report: Inexpedient to Legislate
March 19, 2019 Amendment # 2019-0908h: AA VV 03/19/2019 HJ 10 P. 77
March 19, 2019 Ought to Pass with Amendment 2019-0908h: MA RC 206-141 03/19/2019 HJ 10 P. 77
March 28, 2019 Introduced 03/28/2019 and Referred to Commerce; SJ 12
May 7, 2019 Hearing: 05/07/2019, Room 100, SH, 02:15 pm; SC 21
May 15, 2019 Committee Report: Rereferred to Committee, 05/15/2019; Vote 5-0; CC; SC 22
May 15, 2019 HB 703-FN was Removed from the Consent Calendar; 05/15/2019; SJ 16
May 15, 2019 Sen. Sherman Moved to Remove HB 703-FN from the Consent Calendar; 05/15/2019; SJ 16
May 15, 2019 Rereferred to Committee, MA, VV; 05/15/2019; SJ 16

Action Dates

Date Body Type
Feb. 19, 2019 House Hearing
Feb. 21, 2019 House Exec Session
March 8, 2019 House Exec Session
March 8, 2019 House Exec Session
House Floor Vote
March 19, 2019 House Floor Vote
May 7, 2019 Senate Hearing

Bill Text Revisions

HB703 Revision: 4985 Date: Jan. 17, 2019, 2:54 p.m.
HB703 Revision: 5617 Date: April 11, 2019, 2:06 p.m.