ASSEMBLY, No. 1830

STATE OF NEW JERSEY

215th LEGISLATURE

 

PRE-FILED FOR INTRODUCTION IN THE 2012 SESSION

 


 

Sponsored by:

Assemblyman  HERB CONAWAY, JR.

District 7 (Burlington)

Assemblywoman  VALERIE VAINIERI HUTTLE

District 37 (Bergen)

Assemblyman  RUBEN J. RAMOS, JR.

District 33 (Hudson)

 

Co-Sponsored by:

Assemblyman Fuentes and Assemblywoman Tucker

 

 

 

 

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

     As reported by the Assembly Health and Senior Services Committee with technical review.

  


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 a clinical study or 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 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 a clinical study or 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 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 a clinical study or 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.     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 a clinical study or 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.     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 clinical study or 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 clinical study or 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 clinical study or 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 clinical study or 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;

     (1)   the American Medical Association Drug Evaluations;

     (2)   the American Hospital Formulary Service Drug Information;

     (3)   the United States Pharmacopoeia Drug Information;      or, it is recommended by a clinical study or 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 clinical study or 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.