Bill Text: NJ A1573 | 2018-2019 | Regular Session | Introduced
Bill Title: Requires insurance coverage in the individual and small employer markets and SHBP and SEHBP for "off-label" uses of certain drugs.
Spectrum: Partisan Bill (Democrat 8-0)
Status: (Introduced - Dead) 2018-01-09 - Introduced, Referred to Assembly Health and Senior Services Committee [A1573 Detail]
Download: New_Jersey-2018-A1573-Introduced.html
STATE OF NEW JERSEY
218th LEGISLATURE
PRE-FILED FOR INTRODUCTION IN THE 2018 SESSION
Sponsored by:
Assemblyman HERB CONAWAY, JR.
District 7 (Burlington)
Assemblywoman VALERIE VAINIERI HUTTLE
District 37 (Bergen)
Assemblywoman SHAVONDA E. SUMTER
District 35 (Bergen and Passaic)
Assemblywoman PAMELA R. LAMPITT
District 6 (Burlington and Camden)
Assemblyman RAJ MUKHERJI
District 33 (Hudson)
Co-Sponsored by:
Assemblywomen Tucker, Pinkin and McKnight
SYNOPSIS
Requires insurance coverage in the individual and small employer markets and SHBP and SEHBP for "off-label" uses of certain drugs.
CURRENT VERSION OF TEXT
Introduced Pending Technical Review by Legislative Counsel.
An Act concerning "off-label" uses of certain drugs, amending various parts of the statutory law and supplementing P.L.1992, c.161 (C.17B:27A-2 et seq.), P.L.1992, c.162 (C.17B:27A-17 et seq.), P.L.1961, c.49 (C.52:14-17.25 et seq.), and P.L.2007, c.103 (C.52:14-17.46.1 et seq.).
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. (New section) a. No individual health benefits plan which provides benefits for expenses incurred in prescribing drugs approved by the federal Food and Drug Administration shall be delivered, issued, executed or renewed in this State, or approved for issuance or renewal in this State on or after the effective date of this act, unless the plan provides benefits to a covered person for expenses incurred in prescribing a drug for a treatment for which it has not been approved by the Food and Drug Administration if the drug is recognized as being medically appropriate for the specific treatment for which it has been prescribed in one of the following established reference compendia:
(1) the American Hospital Formulary Service Drug Information; or
(2) the United States Pharmacopoeia Drug Information;
or, it is recommended by three clinical studies that have been published in peer-reviewed professional journals or one review article in a peer-reviewed professional journal.
b. Notwithstanding the provisions of this section, coverage shall not be required for any experimental or investigational drug or any drug which the Food and Drug Administration has determined to be contraindicated for the specific treatment for which the drug has been prescribed. The benefits provided pursuant to this section shall be provided to the same extent as other benefits under the health benefits plan for drugs prescribed for a treatment approved by the Food and Drug Administration.
c. This section shall apply to all individual health benefits plans in which the carrier has reserved the right to change the premium.
d. Any coverage of a drug required by this section shall also include medically necessary services associated with the administration of the drug.
2. (New section) a. No small employer health benefits plan which provides benefits for expenses incurred in prescribing drugs approved by the federal Food and Drug Administration shall be delivered, issued, executed or renewed in this State, or approved for issuance or renewal in this State on or after the effective date of this act, unless the plan provides benefits to a covered person for expenses incurred in prescribing a drug for a treatment for which it has not been approved by the Food and Drug Administration if the drug is recognized as being medically appropriate for the specific treatment for which it has been prescribed in one of the following established reference compendia:
(1) the American Hospital Formulary Service Drug Information;
or
(2) the United States Pharmacopoeia Drug Information;
or, it is recommended by three clinical studies that have been published in peer-reviewed professional journals or one review article in a peer-reviewed professional journal.
b. Notwithstanding the provisions of this section, coverage shall not be required for any experimental or investigational drug or any drug which the Food and Drug Administration has determined to be contraindicated for the specific treatment for which the drug has been prescribed. The benefits provided pursuant to this section shall be provided to the same extent as other benefits under the health benefits plan for drugs prescribed for a treatment approved by the Food and Drug Administration.
c. This section shall apply to all small employer health benefits plans in which the carrier has reserved the right to change the premium.
d. Any coverage of a drug required by this section shall also include medically necessary services associated with the administration of the drug.
3. (New section) Notwithstanding any other provision of law to the contrary, the State Health Benefits Commission shall ensure that every contract purchased by the commission on or after the effective date of this act shall provide coverage pursuant to the provisions of this section.
a. The contract shall provide benefits for expenses incurred in prescribing a drug for a treatment for which it has not been approved by the Food and Drug Administration if the drug is recognized as being medically appropriate for the specific treatment for which it has been prescribed in one of the following established reference compendia:
(1) the American Hospital Formulary Service Drug Information;
or
(2) the United States Pharmacopoeia Drug Information;
or, it is recommended by three clinical studies that have been published in peer-reviewed professional journals or one review article in a peer-reviewed professional journal.
b. Notwithstanding the provisions of this section, coverage shall not be required for any experimental or investigational drug or any drug which the Food and Drug Administration has determined to be contraindicated for the specific treatment for which the drug has been prescribed. The benefits provided pursuant to this section shall be provided to the same extent as other benefits under the contract for drugs prescribed for a treatment approved by the Food and Drug Administration.
c. Any coverage of a drug required by this section shall also include medically necessary services associated with the administration of the drug.
4. (New section) Notwithstanding any other provision of law to the contrary, the School Employees' Health Benefits Commission shall ensure that every contract purchased by the commission on or after the effective date of this act shall provide coverage pursuant to the provisions of this section.
a. The contract shall provide benefits for expenses incurred in prescribing a drug for a treatment for which it has not been approved by the Food and Drug Administration if the drug is recognized as being medically appropriate for the specific treatment for which it has been prescribed in one of the following established reference compendia:
(1) the American Hospital Formulary Service Drug Information;
or
(2) the United States Pharmacopoeia Drug Information;
or, it is recommended by three clinical studies that have been published in peer-reviewed professional journals or one review article in a peer-reviewed professional journal.
b. Notwithstanding the provisions of this section, coverage shall not be required for any experimental or investigational drug or any drug which the Food and Drug Administration has determined to be contraindicated for the specific treatment for which the drug has been prescribed. The benefits provided pursuant to this section shall be provided to the same extent as other benefits under the contract for drugs prescribed for a treatment approved by the Food and Drug Administration.
c. Any coverage of a drug required by this section shall also include medically necessary services associated with the administration of the drug.
5. Section 2 of P.L.1993, c.321 (C.17:48-6h) is amended to read as follows:
2. a. [Except as provided in P.L.1992, c.161 (C.17B:27A-2 et al.) and P.L.1992, c.162 (C.17B:27A-17 et seq.), no] No group or individual hospital service corporation contract which provides benefits for expenses incurred in prescribing drugs approved by the federal Food and Drug Administration shall be delivered, issued, executed or renewed in this State, or approved for issuance or renewal in this State on or after the effective date of this act, unless the contract provides benefits to any subscriber or other person covered thereunder for expenses incurred in prescribing a drug for a treatment for which it has not been approved by the Food and Drug Administration if the drug is recognized as being medically appropriate for the specific treatment for which it has been prescribed in one of the following established reference compendia:
(1) [the American Medical Association Drug Evaluations;
(2)] the American Hospital Formulary Service Drug Information;
[(3)] or
(2) the United States Pharmacopoeia Drug Information;
or, it is recommended by [a] three clinical [study] studies that have been published in peer-reviewed professional journals or one review article in a [major] peer-reviewed professional journal.
b. Notwithstanding the provisions of this section, coverage shall not be required for any experimental or investigational drug or any drug which the Food and Drug Administration has determined to be contraindicated for the specific treatment for which the drug has been prescribed. The benefits provided pursuant to this section shall be provided to the same extent as other benefits under the contract for drugs prescribed for a treatment approved by the Food and Drug Administration.
c. This section shall apply to all hospital service corporation contracts in which the hospital service corporation has reserved the right to change the premium.
d. Any coverage of a drug required by this section shall also include medically necessary services associated with the administration of the drug.
(cf: P.L.1993, c.321, s.2)
6. Section 3 of P.L.1993 c.321 (C.17:48A-7g) is amended to read as follows:
3. a. [Except as provided in P.L.1992, c.161 (C.17B:27A-2 et al.) and P.L.1992, c.162 (C.17B:27A-17 et seq.), no] No group or individual medical service corporation contract which provides benefits for expenses incurred in prescribing drugs approved by the federal Food and Drug Administration shall be delivered, issued, executed or renewed in this State, or approved for issuance or renewal in this State on or after the effective date of this act, unless the contract provides benefits to any subscriber or other person covered thereunder for expenses incurred in prescribing a drug for a treatment for which it has not been approved by the Food and Drug Administration if the drug is recognized as being medically appropriate for the specific treatment for which it has been prescribed in one of the following established reference compendia:
(1) [the American Medical Association Drug Evaluations;
(2)] the American Hospital Formulary Service Drug Information;
[(3)] or
(2) the United States Pharmacopoeia Drug Information;
or, it is recommended by [a] three clinical [study] studies that have been published in peer-reviewed professional journals or one review article in a [major] peer-reviewed professional journal.
b. Notwithstanding the provisions of this section, coverage shall not be required for any experimental or investigational drug or any drug which the Food and Drug Administration has determined to be contraindicated for the specific treatment for which the drug has been prescribed. The benefits provided pursuant to this section shall be provided to the same extent as other benefits under the contract for drugs prescribed for a treatment approved by the Food and Drug Administration.
c. This section shall apply to all medical service corporation contracts in which the medical service corporation has reserved the right to change the premium.
d. Any coverage of a drug required by this section shall also include medically necessary services associated with the administration of the drug.
(cf: P.L.1993, c.321, s.3)
7. Section 4 of P.L.1993, c.321 (C.17:48E-35.5) is amended to read as follows:
4. a. [Except as otherwise provided in P.L.1992, c.161 (C.17B:27A-2 et al.) and P.L.1992, c.162 (C.17B:27A-17 et seq.), no] No group or individual health service corporation contract which provides benefits for expenses incurred in prescribing drugs approved by the federal Food and Drug Administration shall be delivered, issued, executed or renewed in this State, or approved for issuance or renewal in this State on or after the effective date of this act, unless the contract provides benefits to any subscriber or other person covered thereunder for expenses incurred in prescribing a drug for a treatment for which it has not been approved by the Food and Drug Administration if the drug is recognized as being medically appropriate for the specific treatment for which it has been prescribed in one of the following established reference compendia:
(1) [the American Medical Association Drug Evaluations;
(2)] the American Hospital Formulary Service Drug Information;
[(3)] or
(2) the United States Pharmacopoeia Drug Information;
or, it is recommended by [a] three clinical [study] studies that have been published in peer-reviewed professional journals or one review article in a [major] peer-reviewed professional journal.
b. Notwithstanding the provisions of this section, coverage shall not be required for any experimental or investigational drug or any drug which the Food and Drug Administration has determined to be contraindicated for the specific treatment for which the drug has been prescribed. The benefits provided pursuant to this section shall be provided to the same extent as other benefits under the contract for drugs prescribed for a treatment approved by the Food and Drug Administration.
c. This section shall apply to all health service corporation contracts in which the health service corporation has reserved the right to change the premium.
d. Any coverage of a drug required by this section shall also include medically necessary services associated with the administration of the drug.
(cf: P.L.1993, c.321, s.4)
8. Section 5 of P.L.1993, c.321 (C.17B:26-2.1g) is amended to read as follows:
5. a. [Except as otherwise provided in P.L.1992, c.161 (C.17B:27A-2 et al.), no] No individual health insurance policy which provides benefits for expenses incurred in prescribing drugs approved by the federal Food and Drug Administration shall be delivered, issued, executed or renewed in this State, or approved for issuance or renewal in this State on or after the effective date of this act, unless the policy provides benefits to any policyholder or other person covered thereunder for expenses incurred in prescribing a drug for a treatment for which it has not been approved by the Food and Drug Administration if the drug is recognized as being medically appropriate for the specific type of treatment for which the drug has been prescribed in one of the following established reference compendia:
(1) [the American Medical Association Drug Evaluations;
(2)] the American Hospital Formulary Service Drug Information;
[(3)] or
(2) the United States Pharmacopoeia Drug Information;
or, it is recommended by [a] three clinical [study] studies that have been published in peer-reviewed professional journals or one review article in a [major] peer-reviewed professional journal.
b. Notwithstanding the provisions of this section, coverage shall not be required for any experimental or investigational drug or any drug which the Food and Drug Administration has determined to be contraindicated for the specific treatment for which the drug has been prescribed. The benefits provided pursuant to this section shall be provided to the same extent as other benefits under the policy for drugs prescribed for a treatment approved by the Food and Drug Administration.
c. This section shall apply to all individual health insurance policies in which the insurer has reserved the right to change the premium.
d. Any coverage of a drug required by this section shall also include medically necessary services associated with the administration of the drug.
(cf: P.L.1993, c.321, s.5)
9. Section 6 of P.L.1993, c.321 (C.17B:27-46.1g) is amended to read as follows:
6. a. [Except as otherwise provided in P.L.1992, c.162 (C.17B:27A-17 et seq.), no] No group health insurance policy which provides benefits for expenses incurred in prescribing drugs approved by the federal Food and Drug Administration shall be delivered, issued, executed or renewed in this State, or approved for issuance or renewal in this State, on or after the effective date of this act unless the policy provides benefits to any policyholder or other person covered thereunder for expenses incurred in prescribing a drug for a treatment for which it has not been approved by the Food and Drug Administration if the drug is recognized as being medically appropriate for the specific treatment for which the drug has been prescribed in one of the following established reference compendia:
(1) [the American Medical Association Drug Evaluations;
(2)] the American Hospital Formulary Service Drug Information;
[(3)] or
(2) the United States Pharmacopoeia Drug Information;
or, it is recommended by [a] three clinical [study] studies that have been published in peer-reviewed professional journals or one review article in a [major] peer-reviewed professional journal.
b. Notwithstanding the provisions of this section, coverage shall not be required for any experimental or investigational drug or any drug which the Food and Drug Administration has determined to be contraindicated for the specific treatment for which the drug has been prescribed. The benefits provided pursuant to this section shall be provided to the same extent as other benefits under the policy for drugs prescribed for treatments approved by the Food and Drug Administration.
c. This section shall apply to all group health insurance policies in which the insurer has reserved the right to change the premium.
d. Any coverage of a drug required by this section shall also include medically necessary services associated with the administration of the drug.
(cf: P.L.1993, c.321, s.6)
10. Section 7 of P.L.1993, c.321 (C.26:2J-4.5) is amended to read as follows:
7. a. [Notwithstanding any provision of law to the contrary, and except as otherwise provided in P.L.1992, c.161 (C.17B:27A-2 et al.) or P.L.1992, c.162 (C.17B:27A-17 et seq.), a] A certificate of authority to establish and operate a health maintenance organization in this State shall not be issued or continued on or after the effective date of this act for a health maintenance organization which provides health care services for prescribed drugs approved by the federal Food and Drug Administration unless the health maintenance organization provides health care services to any enrollee for a drug prescribed for a treatment for which it has not been approved by the Food and Drug Administration if it is recognized to be medically appropriate for the specific treatment for which the drug has been prescribed in one of the following established reference compendia:
(1) [the American Medical Association Drug Evaluations;
(2)] the American Hospital Formulary Service Drug Information;
[(3)] or
(2) the United States Pharmacopoeia Drug Information;
or, it is recommended by [a] three clinical [study] studies that have been published in peer-reviewed professional journals or one review article in a [major] peer-reviewed professional journal.
b. Notwithstanding the provisions of this section, coverage shall not be required for any experimental or investigational drug or any drug which the Food and Drug Administration has determined to be contraindicated for the specific treatment for which the drug has been prescribed. Health care services provided pursuant to this section shall be determined and provided to the same extent as other services under the enrollee plan for drugs prescribed for treatments which have been approved by the Food and Drug Administration.
c. This section shall apply to health maintenance organization plans in which the right to change the enrollee charge has been reserved.
d. Any coverage of a drug required by this section shall also include medically necessary services associated with the administration of the drug.
(cf: P.L.1993, c.321, s.7)
11. This act shall take effect on the first day of the fourth month next following the date of enactment.
STATEMENT
This bill requires those health benefits plans offered in the individual and small employer markets in New Jersey that provide benefits for drugs that are approved by the federal Food and Drug Administration (FDA), as well as the State Health Benefits Program (SHBP) and School Employees' Health Benefits Program (SEHBP), to provide coverage for certain "off-label" uses of those drugs for which they provide benefits.
Off-label use of a drug, which is its use for a specific treatment for which the drug has not been approved by the FDA, is legal when prescribed in a medically-appropriate way.
The health insurers and programs to which the provisions of this bill apply include: health benefits plans issued pursuant to the Individual Health Coverage Program and the Small Employer Health Benefits Program; SHBP; SEHBP; hospital, medical, and health service corporations; commercial individual and group health insurers; and health maintenance organizations.
The bill requires these insurers and programs to provide coverage for the off-label use of a drug, including medically necessary services associated with the drug, if the drug is:
-- recognized as being medically appropriate for the specific treatment for which it has been prescribed in the American Hospital Formulary Service Drug Information or the United States Pharmacopeia Drug Information, which are the two established reference compendia; or
-- recommended by three clinical studies that have been published in peer-reviewed professional journals or one review article in a peer-reviewed professional journal.
Coverage would not be required under the bill if the FDA has determined that the drug is contraindicated for the specific treatment for which it has been prescribed.
