Bill Text: NJ A3868 | 2010-2011 | 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 5-0)
Status: (Engrossed - Dead) 2011-07-08 - Reviewed by the Pension and Health Benefits Commission Recommend to not enact [A3868 Detail]
Download: New_Jersey-2010-A3868-Introduced.html
Sponsored by:
Assemblyman HERB CONAWAY, JR.
District 7 (Burlington and Camden)
SYNOPSIS
Requires insurance coverage in the individual and small employer markets for "off-label" uses of certain drugs; imposes reporting requirement on physicians who prescribe off-label drugs in certain circumstances.
CURRENT VERSION OF TEXT
As introduced.
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.), and chapter 9 of Title 45 of the Revised Statutes.
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 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 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 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 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. 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) 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.
(P.L.1993, c.321, s.2)
4. 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) 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.
(P.L.1993, c.321, s.3)
5. 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) 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.
(P.L.1993, c.321, s.4)
6. 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) 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)
7. 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) 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)
8. 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) 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)
9. (New section) A physician who prescribes a drug for which insurance coverage is required pursuant to sections 1 and 2 of P.L. , c. (pending before the Legislature as this bill), section 2 of P.L.1993, c.321 (C.17:48-6h), section 3 of P.L.1993, c.321 (C.17:48A-7g), section 4 of P.L.1993, c.321 (C.17:48E-35.5), section 5 of P.L.1993, c.321 (C.17B:26-2.1g), section 6 of P.L.1993, c.321 (C.17B:27-46.1g), and section 7 of P.L.1993, c.321 (C.26:2J-4.5), in cases in which the drug is the subject of a clinical trial to evaluate the use of that drug for the specific treatment for which the physician prescribes the drug, shall report the treatment results that are attributed to the drug to the manufacturer of the drug, on a form and in a manner to be prescribed by the State Board of Medical Examiners.
10. This act shall take effect on the 90th day following enactment.
STATEMENT
This bill requires health benefits plans offered in the individual and small employer markets in New Jersey, which provide coverage for drugs that are approved by the federal Food and Drug Administration, to also provide coverage for certain "off-label" uses of those drugs.
Off-label use of a drug - use for a specific treatment for which the drug has not been approved by the Food and Drug Administration - is legal when prescribed in a medically appropriate way. The bill requires carriers that participate in the New Jersey Individual Health Coverage Program and the Small Employer Health Benefits Program to provide coverage for off-label use of a drug if the drug is recognized as being medically appropriate for the specific treatment for which it has been prescribed in one of the three established reference compendia (the American Medical Association Drug Evaluations, the American Hospital Formulary Service Drug Information, or the United States Pharmacopeia Drug Information) or is recommended by a clinical study or review article in a major peer-reviewed professional journal.
The bill also requires a physician who prescribes an off-label drug for which insurance coverage is required under this bill or pursuant to existing law, in cases in which the drug is also the subject of a clinical trial to evaluate the use of the drug on an off-label basis, to report the treatment results that are attributed to the drug to the manufacturer of the drug, on a form and in a manner to be prescribed by the State Board of Medical Examiners.
The bill also makes technical changes.
