S T A T E O F N E W Y O R K
________________________________________________________________________
8609
2011-2012 Regular Sessions
I N A S S E M B L Y
September 21, 2011
___________
Introduced by M. of A. TITONE, BENEDETTO, DINOWITZ, MILLMAN, COOK,
GIBSON, JACOBS, SPANO, MARKEY, N. RIVERA, MAISEL, JAFFEE, HOOPER,
O'DONNELL, CASTRO, LINARES, ZEBROWSKI, M. MILLER, P. RIVERA, COLTON,
BROOK-KRASNY, WEPRIN, LAVINE, SCHROEDER -- Multi-Sponsored by -- M. of
A. BOYLAND, BRENNAN, HIKIND, McENENY, PRETLOW, SIMOTAS, TOBACCO --
read once and referred to the Committee on Insurance
AN ACT to amend the insurance law, in relation to the prohibition on
first fail policies
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. The insurance law is amended by adding a new article 33 to
read as follows:
ARTICLE 33
PROHIBITION ON FIRST FAIL POLICIES AND
UNAUTHORIZED THERAPEUTIC SUBSTITUTION
SECTION 3301. DEFINITIONS.
3302. PRESCRIPTION DRUG DENIALS.
3303. SWITCH COMMUNICATIONS/CONSUMER RIGHT TO KNOW.
3304. PENALTIES.
3305. PRESCRIPTION DRUG RESTRICTION OVERRIDES.
S 3301. DEFINITIONS. AS USED IN THIS ARTICLE:
(A) "INSURER" SHALL MEAN ANY PERSON OR ENTITY WHO OFFERS A POLICY OF
ACCIDENT AND/OR HEALTH INSURANCE PURSUANT TO SECTION THREE THOUSAND TWO
HUNDRED SIXTEEN, THREE THOUSAND TWO HUNDRED TWENTY-ONE, OR FOUR THOUSAND
THREE HUNDRED THREE OF THIS CHAPTER OR ARTICLE FORTY-FOUR OF THE PUBLIC
HEALTH LAW; EXCEPT WHEN SUCH HEALTH CARE SERVICES ARE PROVIDED, DELIV-
ERED, ARRANGED FOR, PAID FOR, OR REIMBURSED BY ANY STATE, DEPARTMENT OR
AGENCY;
(B) "PHARMACY BENEFITS MANAGER" OR "PBM", MEANS A PERSON OR ENTITY
OTHER THAN A PHARMACY OR PHARMACIST ACTING AS AN ADMINISTRATOR IN
CONNECTION WITH PHARMACY BENEFITS;
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD06098-03-1
A. 8609 2
(C) "SWITCH COMMUNICATION", MEANS A WRITTEN COMMUNICATION FROM ANY
INSURER OR PBM TO A PATIENT OR THE PATIENT'S PHYSICIAN THAT RECOMMENDS A
PATIENT'S MEDICATION BE SWITCHED BY THE ORIGINAL PRESCRIBING HEALTH CARE
PROFESSIONAL TO A DIFFERENT MEDICATION THAN THE MEDICATION ORIGINALLY
PRESCRIBED BY THE PRESCRIBING HEALTH CARE PROFESSIONAL.
(D) "GENERIC EQUIVALENT" MEANS A DRUG THAT IS THE SAME CHEMICAL
COMPOUND AS ANOTHER DRUG AND IS THE SAME DOSAGE FORM, STRENGTH, ROUTE OF
ADMINISTRATION, AND INTENDED USE, AND IS LISTED AS EQUIVALENT IN FDA'S
APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS (ORANGE
BOOK).
(E) "THERAPEUTIC SUBSTITUTION" MEANS THE DISPENSING OF A CHEMICALLY
DIFFERENT DRUG IN THE PLACE OF THE DRUG ORIGINALLY PRESCRIBED BY THE
PATIENT'S PHYSICIAN OR OTHER PRESCRIBING HEALTH CARE PROFESSIONAL,
INCLUDING BIOLOGICS AND PLASMA-DERIVED THERAPIES. THERAPEUTIC SUBSTI-
TUTION DOES NOT INCLUDE SUBSTITUTION OF A GENERIC EQUIVALENT.
S 3302. PRESCRIPTION DRUG DENIALS. (A) A POLICY OF ACCIDENT AND/OR
HEALTH INSURANCE THAT COVERS PRESCRIPTION DRUGS SHALL NOT LIMIT, REDUCE,
OR DENY COVERAGE FOR ANY DRUG IF, PRIOR TO THE LIMITATION, REDUCTION, OR
DENIAL OF COVERAGE:
(1) ANY INSURED WAS USING THE DRUG;
(2) SUCH INSURED OR INSUREDS WERE COVERED UNDER THE POLICY; AND
(3) THE DRUG WAS COVERED UNDER THE POLICY FOR SUCH INSURED INDIVIDUAL
OR INDIVIDUALS.
(B) A LIMITATION, REDUCTION, OR DENIAL OF COVERAGE INCLUDES REMOVING A
DRUG FROM THE FORMULARY OR OTHER DRUG LIST, IMPOSING NEW PRIOR AUTHORI-
ZATION OR OTHER UTILIZATION MANAGEMENT TOOLS, OR PLACING THE DRUG ON A
FORMULARY TIER THAT INCREASES THE PATIENT'S COST-SHARING OBLIGATIONS OR
OTHERWISE INCREASES THE PATIENT'S COST-SHARING OBLIGATIONS.
(C) NOTHING IN THIS SECTION SHALL PROHIBIT AN INSURER FROM MAKING
UNIFORM CHANGES IN ITS BENEFIT DESIGN THAT APPLY TO ALL COVERED DRUGS,
UNIFORMLY REMOVING A DRUG FROM THE FORMULARY LIST FOR ALL INSUREDS, OR
INCREASING COST-SHARING OBLIGATIONS MERELY DUE TO A PERCENTAGE COINSU-
RANCE PAYMENT THAT NECESSARILY INCREASES WITH AN INCREASE IN THE UNDER-
LYING DRUG PRICES.
(D) NO THERAPEUTIC SUBSTITUTION OF A MEDICATION BY ANYONE AUTHORIZED
TO DISPENSE MEDICATIONS FOR SELF OR HOME ADMINISTRATION BY A CONSUMER
SHALL BE ALLOWED WITHOUT THE EXPRESS AUTHORIZATION OF THE ORIGINAL
PRESCRIBING PHYSICIAN OR HEALTH CARE PROFESSIONAL AND NOTICE TO THE
PATIENT AND THE POLICY SPONSOR AS PROVIDED FOR IN SECTION THIRTY-THREE
HUNDRED THREE OF THIS ARTICLE. PRIOR TO MAKING A THERAPEUTIC SUBSTI-
TUTION IN A PATIENT'S PRESCRIPTION INCLUDING BUT NOT LIMITED TO CHANGES
IN PRODUCT SELECTION AND CHANGES IN DOSAGE, THE DISPENSING PHARMACIST
SHALL:
(1) VERBALLY REQUEST THE PATIENT TO AGREE TO A CHANGE TO THE
PRESCRIPTION, AND EXPLAIN THAT THE CHANGE CANNOT BE MADE UNLESS BOTH THE
PATIENT AND THE PRESCRIBING PHYSICIAN (OR OTHER PRESCRIBING HEALTH CARE
PROFESSIONAL) EXPRESSLY AGREE TO THE CHANGE;
(2) VERBALLY DESCRIBE THE PROPOSED CHANGE THAT WOULD BE MADE TO THE
PRESCRIPTION, INCLUDING CLEARLY IDENTIFYING THE ORIGINALLY PRESCRIBED
MEDICATION AND THE MEDICATION THAT WOULD BE SUBSTITUTED FOR THE
ORIGINALLY PRESCRIBED MEDICATION; AND
(3) VERBALLY INFORM THE PATIENT OF THE IMPACT, IF ANY, ON THE
PATIENT'S OUT-OF-POCKET COST.
S 3303. SWITCH COMMUNICATIONS/CONSUMER RIGHT TO KNOW. (A) ANY TIME A
PATIENT'S PRESCRIBED MEDICATION IS RECOMMENDED TO BE SWITCHED TO A MEDI-
A. 8609 3
CATION OTHER THAN THAT ORIGINALLY PRESCRIBED BY THE PRESCRIBING PRACTI-
TIONER, A SWITCH COMMUNICATION SHALL BE SENT TO:
(1) THE PATIENT AND SHALL PROVIDE INFORMATION ABOUT WHY THE SWITCH IS
PROPOSED AND THE PATIENT'S RIGHTS FOR REFUSING THE RECOMMENDED CHANGE IN
TREATMENT; AND
(2) THE POLICY SPONSOR AND SHALL INFORM SUCH SPONSOR OF THE PHARMACEU-
TICAL WHOLESALE ACQUISITION COST, SHOWN IN CURRENCY FORM, OF THE RECOM-
MENDED MEDICATION AND THE WHOLESALE ACQUISITION COST, SHOWN IN CURRENCY
FORM, OF THE ORIGINALLY PRESCRIBED MEDICATION.
(B) SUCH SWITCH COMMUNICATION SHALL:
(1) CLEARLY IDENTIFY THE ORIGINALLY PRESCRIBED MEDICATION AND THE
MEDICATION TO WHICH IT HAS BEEN PROPOSED THAT THE PATIENT SHOULD BE
SWITCHED;
(2) PROVIDE INFORMATION WHICH IS TRUTHFUL, ACCURATE, AND NOT MISLEAD-
ING, WITH APPROPRIATE FAIR BALANCE, CONSISTENT WITH THE UNITED STATES
FOOD AND DRUG ADMINISTRATION FOR MEDICATIONS;
(3) INCLUDE CURRENT APPROVED PRODUCT LABELING AND INFORMATION ABOUT
RISKS ASSOCIATED WITH THE RECOMMENDED MEDICATION;
(4) CLEARLY ACKNOWLEDGE THAT NO THERAPEUTIC SUBSTITUTION SHALL BE
ALLOWED WITHOUT THE EXPRESS AUTHORIZATION OF THE ORIGINAL PRESCRIBING
PHYSICIAN OR OTHER ORIGINAL PRESCRIBING HEALTH CARE PROFESSIONAL;
(5) ADVISE THE PATIENT OF HIS OR HER RIGHTS TO DISCUSS THE PROPOSED
CHANGE IN TREATMENT BEFORE SUCH A SWITCH TAKES PLACE, INCLUDING A
DISCUSSION WITH THE PATIENT'S PRESCRIBING PRACTITIONER, THE FILING OF A
GRIEVANCE WITH THE INSURER TO PREVENT THE SWITCH IF SUCH A SWITCH IS
BASED ON A FINANCIAL INCENTIVE AND THE FILING OF A GRIEVANCE WITH THE
DEPARTMENT; AND
(6) EXPLAIN ANY COST-SHARING CHANGES FOR WHICH THE PATIENT IS RESPON-
SIBLE.
(C) A COPY OF ANY SWITCH COMMUNICATION SENT TO A PATIENT SHALL ALSO BE
SENT TO THE PRESCRIBING PRACTITIONER.
(D) HEALTH INSURANCE PAYERS, INCLUDING EMPLOYERS RESPONSIBLE FOR
PAYING THE HEALTH CARE PREMIUM OR PORTIONS THEREOF, SHALL BE NOTIFIED OF
THERAPEUTIC SUBSTITUTIONS AMONG POLICY PARTICIPANTS AND OF ANY THERAPEU-
TIC SUBSTITUTION PROGRAMS ADOPTED BY HEALTH PLANS AND PHARMACY BENEFIT
MANAGERS IN ANY PLAN OFFERED BY SUCH PREMIUM PAYER OR EMPLOYER.
(E) THE DEPARTMENT SHALL CREATE ONE FORM FOR INSURERS AND PHARMACY
BENEFIT MANAGERS TO USE IN SWITCH COMMUNICATIONS TO PATIENTS, PRESCRIB-
ING PRACTITIONERS, AND HEALTH INSURANCE PAYERS INCLUDING EMPLOYERS.
(F) THE DEPARTMENT SHALL PROMULGATE RULES GOVERNING SWITCH COMMUNI-
CATIONS. SUCH RULES SHALL INCLUDE, BUT NOT BE LIMITED TO THE FOLLOWING:
(1) PROCEDURES FOR VERIFYING THE ACCURACY OF ANY SWITCH COMMUNICATIONS
FROM POLICIES OF ACCIDENT AND/OR HEALTH INSURANCE AND PHARMACY BENEFIT
MANAGERS TO ENSURE THAT SUCH SWITCH COMMUNICATIONS ARE TRUTHFUL, ACCU-
RATE, AND NOT MISLEADING BASED ON COST TO THE PATIENT AND POLICY SPON-
SOR, THE PRODUCT PACKAGE LABELING, MEDICAL COMPENDIA RECOGNIZED BY THE
DRUG UTILIZATION REVIEW BOARD, AND PEER-REVIEWED MEDICAL LITERATURE,
WITH APPROPRIATE REFERENCES PROVIDED;
(2) EXCEPT FOR A SUBSTITUTION DUE TO THE FOOD AND DRUG ADMINIS-
TRATION'S WITHDRAWAL OF A DRUG FOR PRESCRIPTION, A REQUIREMENT THAT ALL
SWITCH COMMUNICATIONS BEAR A PROMINENT LEGEND ON THE FIRST PAGE THAT
STATES: "THIS IS NOT A PRODUCT SAFETY NOTICE. THIS IS A PROMOTIONAL
ANNOUNCEMENT FROM YOUR HEALTH CARE INSURER OR PHARMACY BENEFITS MANAGER
ABOUT ONE OF YOUR CURRENT PRESCRIBED MEDICATIONS.";
(3) A REQUIREMENT THAT, THE NOTIFICATION OF REQUEST FOR MEDICATION
CHANGE (I) EXPRESSLY STATES THAT THE CHANGE INVOLVES A THERAPEUTIC
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SUBSTITUTION, NOT A GENERIC SUBSTITUTION; (II) EXPLAIN THE DIFFERENCE
BETWEEN THERAPEUTIC SUBSTITUTION AND GENERIC SUBSTITUTION; AND (III)
PROVIDE A TRUTHFUL, FAIR, AND BALANCED EXPLANATION REGARDING THE POTEN-
TIAL, RAMIFICATIONS OF THE THERAPEUTIC SUBSTITUTION, INCLUDING BUT NOT
LIMITED TO, THAT MEDICATIONS IN THE SAME THERAPEUTIC CLASS ARE ASSOCI-
ATED WITH DIFFERENT RISKS AND BENEFITS AND MAY WORK DIFFERENTLY IN
DIFFERENT PATIENTS.
S 3304. PENALTIES. (A) ISSUING OR DELIVERING OR CAUSING TO BE ISSUED
OR DELIVERED A SWITCH COMMUNICATION THAT HAS NOT BEEN APPROVED AND IS
NOT IN COMPLIANCE WITH THE REQUIREMENTS OF SECTION THREE THOUSAND THREE
HUNDRED THREE OF THIS ARTICLE IS PUNISHABLE BY A FINE NOT TO EXCEED
TWENTY-FIVE THOUSAND DOLLARS.
(B) PROVIDING A MISREPRESENTATION OR FALSE STATEMENT IN A SWITCH
COMMUNICATION UNDER SECTION THREE THOUSAND THREE HUNDRED THREE OF THIS
ARTICLE IS PUNISHABLE BY A FINE NOT TO EXCEED TWENTY-FIVE THOUSAND
DOLLARS.
(C) ANY OTHER MATERIAL VIOLATION OF SECTION THREE THOUSAND THREE
HUNDRED THREE OF THIS ARTICLE IS PUNISHABLE BY A FINE NOT TO EXCEED
TWENTY-FIVE THOUSAND DOLLARS.
S 3305. PRESCRIPTION DRUG RESTRICTION OVERRIDES. (A) WHEN MEDICATIONS
FOR THE TREATMENT OF ANY MEDICAL CONDITION ARE RESTRICTED FOR USE BY AN
INSURER OR PBM BY A STEP THERAPY OR FAIL FIRST PROTOCOL, A PRESCRIBER
SHALL HAVE ACCESS TO A CLEAR AND CONVENIENT PROCESS TO OVERRIDE SUCH
RESTRICTIONS FROM THE INSURER AND MAY EXPEDITIOUSLY OVERRIDE SUCH
RESTRICTION IF:
(1) THE PREFERRED TREATMENT BY THE INSURER OR THE PBM HAS BEEN INEF-
FECTIVE IN THE TREATMENT OF THE COVERED PERSON'S DISEASE OR MEDICAL
CONDITION; OR
(2) BASED ON SOUND CLINICAL EVIDENCE AND MEDICAL AND SCIENTIFIC
EVIDENCE:
(A) THE PREFERRED TREATMENT IS EXPECTED TO BE INEFFECTIVE BASED ON THE
KNOWN RELEVANT PHYSICAL OR MENTAL CHARACTERISTICS OF THE COVERED PERSON
AND KNOWN CHARACTERISTICS OF THE DRUG REGIMEN, AND IS LIKELY TO BE INEF-
FECTIVE OR ADVERSELY AFFECT THE DRUG'S EFFECTIVENESS OR PATIENT COMPLI-
ANCE; OR
(B) THE PREFERRED TREATMENT HAS CAUSED OR IS LIKELY TO CAUSE AN
ADVERSE REACTION OR OTHER HARM TO THE COVERED PERSON.
(B) THE DURATION OF ANY STEP THERAPY OR FAIL FIRST PROTOCOL SHALL NOT
BE LONGER THAN THE PERIOD DEEMED NECESSARY BY THE PRESCRIBING PHYSICIAN
OR HEALTH CARE PROFESSIONAL TO DETERMINE THE TREATMENT'S CLINICAL EFFEC-
TIVENESS OR A PERIOD OF FOURTEEN DAYS.
(C) FOR MEDICATIONS WITH NO GENERIC EQUIVALENT AND FOR WHICH THE
PRESCRIBING PHYSICIAN IN THEIR CLINICAL JUDGMENT FEELS THAT NO APPROPRI-
ATE THERAPEUTIC ALTERNATIVE IS AVAILABLE AN INSURER OR PBM SHALL PROVIDE
ACCESS TO UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) LABELED MEDI-
CATIONS WITHOUT RESTRICTION TO TREAT SUCH MEDICAL CONDITIONS FOR WHICH
AN FDA LABELED MEDICATION IS AVAILABLE.
(D) NOTHING IN THIS SECTION SHALL REQUIRE COVERAGE FOR AN ADDITIONAL
CONDITION NOT ALREADY COVERED BY THE POLICY OR WHICH IS NOT OTHERWISE
COVERED BY LAW.
S 2. This act shall take effect on the one hundred twentieth day after
it shall have become a law.