SB 91 – VERSION ADOPTED BY BOTH BODIES
01/30/14 0121s
30Apr2014… 1357h
2013 SESSION
01/05
SENATE BILL 91
AN ACT relative to drug use not approved by the Food and Drug Administration.
SPONSORS: Sen. Carson, Dist 14; Rep. Emerson, Ches 11
This bill prohibits insurers from requiring use of a prescription drug for an indication not approved by the Food and Drug Administration unless certain circumstances exist.
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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Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
01/30/14 0121s
30Apr2014… 1357h
13-0878
01/05
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Thirteen
AN ACT relative to drug use not approved by the Food and Drug Administration.
Be it Enacted by the Senate and House of Representatives in General Court convened:
1 Off-Label Prescription Drugs. Amend RSA 415:6-g, I to read as follows:
I. No insurer that issues or renews any individual policy of accident or health insurance providing benefits for medical or hospital expenses and providing coverage for prescription drugs shall:
(a) Exclude coverage for any such drug for a particular indication on the ground that the drug has not been approved by the Food and Drug Administration (FDA) for that indication, if such drug is recognized for treatment of such indication in one of the standard reference compendia or in the medical literature [as recommended by current American Medical Association (AMA) policies]; or
(b) As a condition of coverage, impose use of an alternative drug not approved by the FDA for the indication being treated, unless such alternative drug is recognized for treatment of such indication in one of the standard reference compendia or in the medical literature. An override of such condition of coverage shall be expeditiously granted consistent with RSA 420-J:7-b, II whenever the prescriber can demonstrate that the alternative drug:
(1) Has been ineffective in the treatment of the insured’s medical condition in the past;
(2) Is expected to be ineffective based on the known relevant physical or mental characteristics of the insured and the known characteristics of the drug regimen;
(3) Will cause or will likely cause an adverse reaction or other physical harm to the insured; or
(4) Is not in the insured’s best interest, based on medical necessity consistent with RSA 420-J:7-b, II.
2 Off-Label Prescription Drugs. Amend RSA 415:18-j, I to read as follows:
I. No insurer that issues or renews any policy of group accident or health insurance providing benefits for medical or hospital expenses and providing coverage for prescription drugs shall:
(a) Exclude coverage for any such drug for a particular indication on the ground that the drug has not been approved by the Food and Drug Administration (FDA) for that indication, if such drug is recognized for treatment of such indication in one of the standard reference compendia or in the medical literature [as recommended by current American Medical Association (AMA) policies]; or
(b) As a condition of coverage, impose use of an alternative drug not approved by the FDA for the indication being treated, unless such alternative drug is recognized for treatment of such indication in one of the standard reference compendia or in the medical literature. An override of such condition of coverage shall be expeditiously granted consistent with RSA 420-J:7-b, II whenever the prescriber can demonstrate that the alternative drug:
(1) Has been ineffective in the treatment of the insured’s medical condition in the past;
(2) Is expected to be ineffective based on the known relevant physical or mental characteristics of the insured and the known characteristics of the drug regimen;
(3) Will cause or will likely cause an adverse reaction or other physical harm to the insured; or
(4) Is not in the insured’s best interest, based on medical necessity consistent with RSA 420-J:7-b, II.
3 Effective Date. This act shall take effect 60 days after its passage.
LBAO
13-0878
Amended 05/02/14
SB 91 FISCAL NOTE
AN ACT relative to drug use not approved by the Food and Drug Administration.
FISCAL IMPACT:
The New Hampshire Insurance Department states this bill, as amended by the House (Amendment #2014-1357h), may increase state revenue, and county and local expenditures by indeterminable amounts in FY 2015 and each year thereafter. There will be no fiscal impact on state expenditures, or county and local revenue.
METHODOLOGY:
The New Hampshire Insurance Department states this bill prohibits the carriers from requiring use of a prescription drug for an indication that has not been approved by the FDA, unless the drug is recognized for treatment in standard reference compendia or in the medical literature. As amended, the bill requires carriers to provide an expeditious exception process to allow access to the FDA approved drug if the prescriber can demonstrate certain conditions. The Department states, to the extent that coverage is currently provided for certain indications with lower cost drugs not approved by the FDA, this requirement will increase claims costs. The Department states insurance premiums are a function of claims costs and premiums may increase. The Department collects premium tax based on insurance premiums and indicates state revenue may increase by an indeterminable amount. The Department further states, to the extent local governments buy fully insured products; their health benefit plan costs may be impacted.
The Department of Administrative Services states this bill would prohibit insurers from issuing individual or group policies that require use of a prescription drug for an indication not approved by the FDA. The Department states the bill would apply only to insurers and the state employee and retiree health benefit program, which is self-funded, would not be subject to the provisions of this bill. The Department states the bill would have no fiscal impact on the state employee and retiree health benefit program.
The Department of Health and Human Services states the proposed amendments to RSA 415 regulate private insurers and would have no impact on New Hampshire’s Medicaid program.