Bill Text: NY A10219 | 2009-2010 | General Assembly | Amended
Bill Title: Relates to insurance coverage for drugs used in cancer treatment; updates the established reference compendia which are used as authoritative sources for use in the determination of off-label drugs and biologicals used in an anticancer chemotherapeutic regimen.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Passed) 2010-08-13 - signed chap.357 [A10219 Detail]
Download: New_York-2009-A10219-Amended.html
S T A T E O F N E W Y O R K
________________________________________________________________________
10219--A
I N A S S E M B L Y
March 11, 2010
___________
Introduced by M. of A. JACOBS -- read once and referred to the Committee
on Insurance -- committee discharged, bill amended, ordered reprinted
as amended and recommitted to said committee
AN ACT to amend the insurance law, in relation to insurance coverage for
drugs used in cancer treatment
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
1 Section 1. Paragraph 12 of subsection (i) of section 3216 of the
2 insurance law, as added by chapter 853 of the laws of 1990, is amended
3 to read as follows:
4 (12) (A) Every policy which provides coverage for prescribed drugs
5 approved by the food and drug administration of the United States
6 government for the treatment of certain types of cancer shall not
7 exclude coverage of any such drug on the basis that such drug has been
8 prescribed for the treatment of a type of cancer for which the drug has
9 not been approved by the food and drug administration. Provided, howev-
10 er, that such drug must be recognized for treatment of the specific type
11 of cancer for which the drug has been prescribed in one of the following
12 established reference compendia:
13 [(i) the American Medical Association Drug Evaluations;
14 (ii) the American Hospital Formulary Service Drug Information; or
15 (iii) the United States Pharmacopeia Drug Information; or recommended
16 by review article or editorial comment in a major peer reviewed profes-
17 sional journal.]
18 (I) THE AMERICAN HOSPITAL FORMULARY SERVICE-DRUG INFORMATION (AHFS-
19 DI);
20 (II) NATIONAL COMPREHENSIVE CANCER NETWORKS DRUGS AND BIOLOGICS
21 COMPENDIUM;
22 (III) THOMSON MICROMEDEX DRUGDEX;
23 (IV) ELSEVIER GOLD STANDARD'S CLINICAL PHARMACOLOGY; OR OTHER AUTHORI-
24 TATIVE COMPENDIA AS IDENTIFIED BY THE FEDERAL SECRETARY OF HEALTH AND
25 HUMAN SERVICES OR THE CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS); OR
26 RECOMMENDED BY REVIEW ARTICLE OR EDITORIAL COMMENT IN A MAJOR PEER
27 REVIEWED PROFESSIONAL JOURNAL.
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD16275-04-0
A. 10219--A 2
1 (B) Notwithstanding the provisions of this paragraph, coverage shall
2 not be required for any experimental or investigational drugs or any
3 drug which the food and drug administration has determined to be
4 contraindicated for treatment of the specific type of cancer for which
5 the drug has been prescribed. The provisions of this paragraph shall
6 apply to cancer drugs only and nothing herein shall be construed to
7 create, impair, alter, limit, modify, enlarge, abrogate or prohibit
8 reimbursement for drugs used in the treatment of any other disease or
9 condition.
10 S 2. Paragraph 12 of subsection (1) of section 3221 of the insurance
11 law, as added by chapter 853 of the laws of 1990, is amended to read as
12 follows:
13 (12) (A) Every insurer delivering a group or blanket policy or issuing
14 a group or blanket policy for delivery in this state which provides
15 coverage for prescribed drugs approved by the food and drug adminis-
16 tration of the United States government for the treatment of certain
17 types of cancer shall not exclude coverage of any such drug on the basis
18 that such drug has been prescribed for the treatment of a type of cancer
19 for which the drug has not been approved by the food and drug adminis-
20 tration. Provided, however, that such drug must be recognized for treat-
21 ment of the specific type of cancer for which the drug has been
22 prescribed in one of the following established reference compendia:
23 [(i) the American Medical Association Drug Evaluations;
24 (ii) the American Hospital Formulary Service Drug Information; or
25 (iii) the United States Pharmacopeia Drug Information; or recommended
26 by review article or editorial comment in a major peer reviewed profes-
27 sional journal.]
28 (I) THE AMERICAN HOSPITAL FORMULARY SERVICE-DRUG INFORMATION (AHFS-
29 DI);
30 (II) NATIONAL COMPREHENSIVE CANCER NETWORKS DRUGS AND BIOLOGICS
31 COMPENDIUM;
32 (III) THOMSON MICROMEDEX DRUGDEX;
33 (IV) ELSEVIER GOLD STANDARD'S CLINICAL PHARMACOLOGY; OR OTHER AUTHORI-
34 TATIVE COMPENDIA AS IDENTIFIED BY THE FEDERAL SECRETARY OF HEALTH AND
35 HUMAN SERVICES OR THE CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS); OR
36 RECOMMENDED BY REVIEW ARTICLE OR EDITORIAL COMMENT IN A MAJOR PEER
37 REVIEWED PROFESSIONAL JOURNAL.
38 (B) Notwithstanding the provisions of this paragraph, coverage shall
39 not be required for any experimental or investigational drugs or any
40 drug which the food and drug administration has determined to be
41 contraindicated for treatment of the specific type of cancer for which
42 the drug has been prescribed. The provisions of this paragraph shall
43 apply to cancer drugs only and nothing herein shall be construed to
44 create, impair, alter, limit, modify, enlarge, abrogate or prohibit
45 reimbursement for drugs used in the treatment of any other disease or
46 condition.
47 S 3. Subsection (q) of section 4303 of the insurance law, as added by
48 chapter 853 of the laws of 1990, is amended to read as follows:
49 (q) (1) Every policy issued by a medical expense indemnity corpo-
50 ration, a hospital service corporation or a health service corporation
51 which provides coverage for prescribed drugs approved by the food and
52 drug administration of the United States government for the treatment of
53 certain types of cancer shall not exclude coverage of any such drug on
54 the basis that such drug has been prescribed for the treatment of a type
55 of cancer for which the drug has not been approved by the food and drug
56 administration. Provided, however, that such drug must be recognized for
A. 10219--A 3
1 treatment of the specific type of cancer for which the drug has been
2 prescribed in one of the following established reference compendia:
3 [(i) the American Medical Association Drug Evaluations;
4 (ii) the American Hospital Formulary Service Drug Information; or
5 (iii) the United States Pharmacopeia Drug Information; or recommended
6 by review article or editorial comment in a major peer reviewed profes-
7 sional journal.]
8 (I) THE AMERICAN HOSPITAL FORMULARY SERVICE-DRUG INFORMATION (AHFS-
9 DI);
10 (II) NATIONAL COMPREHENSIVE CANCER NETWORKS DRUGS AND BIOLOGICS
11 COMPENDIUM;
12 (III) THOMSON MICROMEDEX DRUGDEX;
13 (IV) ELSEVIER GOLD STANDARD'S CLINICAL PHARMACOLOGY; OR OTHER AUTHORI-
14 TATIVE COMPENDIA AS IDENTIFIED BY THE FEDERAL SECRETARY OF HEALTH AND
15 HUMAN SERVICES OR THE CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS); OR
16 RECOMMENDED BY REVIEW ARTICLE OR EDITORIAL COMMENT IN A MAJOR PEER
17 REVIEWED PROFESSIONAL JOURNAL.
18 (2) Notwithstanding the provisions of this subsection, coverage shall
19 not be required for any experimental or investigational drugs or any
20 drug which the food and drug administration has determined to be
21 contraindicated for treatment of the specific type of cancer for which
22 the drug has been prescribed. The provisions of this subsection shall
23 apply to cancer drugs only and nothing herein shall be construed to
24 create, impair, alter, limit, modify, enlarge, abrogate or prohibit
25 reimbursement for drugs used in the treatment of any other disease or
26 condition.
27 S 4. Subsection (g-5) of section 4900 of the insurance law, as added
28 by chapter 586 of the laws of 1998, is amended to read as follows:
29 (g-5) "Medical and scientific evidence" means the following sources:
30 (1) peer-reviewed scientific studies published in, or accepted for
31 publication by, medical journals that meet nationally recognized
32 requirements for scientific manuscripts and that submit most of their
33 published articles for review by experts who are not part of the edito-
34 rial staff;
35 (2) peer-reviewed medical literature, including literature relating to
36 therapies reviewed and approved by a qualified institutional review
37 board, biomedical compendia and other medical literature that meet the
38 criteria of the National Institute of Health's National Library of Medi-
39 cine for indexing in Index Medicus, Excerpta Medicus, Medline and
40 MEDLARS database Health Services Technology Assessment Research;
41 (3) peer-reviewed abstracts accepted for presentation at major medical
42 association meetings;
43 (4) peer-reviewed literature shall not include publications or supple-
44 ments to publications sponsored to a significant extent by a pharmaceu-
45 tical manufacturing company or medical device manufacturer;
46 (5) medical journals recognized by the secretary of Health and Human
47 Services, under section 1861 (t)(2) of the federal Social Security Act;
48 (6) the following standard reference compendia:
49 (A) the American Hospital Formulary Service - Drug Information;
50 (B) [the American Medical Association Drug Evaluation;] THE NATIONAL
51 COMPREHENSIVE CANCER NETWORK'S DRUGS AND BIOLOGICS COMPENDIUM;
52 (C) the American Dental Association Accepted Dental Therapeutics; [and
53 (D) the United States Pharmacopeia - Drug Information;] (D) THOMSON
54 MICROMEDEX DRUGDEX;
55 (E) ELSEVIER GOLD STANDARD'S CLINICAL PHARMACOLOGY; OR OTHER AUTHORI-
56 TATIVE COMPENDIA AS IDENTIFIED BY THE FEDERAL SECRETARY OF HEALTH AND
A. 10219--A 4
1 HUMAN SERVICES OR THE CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS); OR
2 RECOMMENDED BY REVIEW ARTICLE OR EDITORIAL COMMENT IN A MAJOR PEER
3 REVIEWED PROFESSIONAL JOURNAL;
4 (7) findings, studies, or research conducted by or under the auspices
5 of federal government agencies and nationally recognized federal
6 research institutes including the federal Agency for Health Care Policy
7 and Research, National Institutes of Health, National Cancer Institute,
8 National Academy of Sciences, Health Care Financing Administration,
9 Congressional Office of Technology Assessment, and any national board
10 recognized by the National Institutes of Health for the purpose of eval-
11 uating the medical value of health services.
12 S 5. This act shall take effect on the first of January next succeed-
13 ing the date on which it shall have become a law, and shall apply to all
14 policies and contracts issued, renewed, modified, altered or amended on
15 or after such effective date.
