S T A T E O F N E W Y O R K
________________________________________________________________________
8253
2019-2020 Regular Sessions
I N A S S E M B L Y
June 10, 2019
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Introduced by M. of A. D. ROSENTHAL -- read once and referred to the
Committee on Health
AN ACT to amend the public health law, in relation to requiring certain
manufacturers of prescription drugs to notify the drug utilization
review board of the proposed increase of the wholesale acquisition
cost of such prescription drugs
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. The public health law is amended by adding a new section
277-a to read as follows:
§ 277-A. NOTIFICATION OF PRESCRIPTION DRUG PRICE INCREASES BY MANUFAC-
TURERS. 1. THIS SECTION SHALL APPLY TO A MANUFACTURER OF A PRESCRIPTION
DRUG THAT IS PURCHASED OR REIMBURSED BY ANY OF THE FOLLOWING:
(A) AN INSURANCE COMPANY AUTHORIZED IN THIS STATE TO WRITE ACCIDENT
AND HEALTH INSURANCE, A COMPANY ORGANIZED PURSUANT TO ARTICLE FORTY-
THREE OF THE INSURANCE LAW, A MUNICIPAL COOPERATIVE HEALTH BENEFIT PLAN
ESTABLISHED PURSUANT TO ARTICLE FORTY-SEVEN OF THE INSURANCE LAW, AN
ORGANIZATION CERTIFIED PURSUANT TO ARTICLE FORTY-FOUR OF THIS CHAPTER,
AN INSTITUTION OF HIGHER EDUCATION CERTIFIED PURSUANT TO SECTION ONE
THOUSAND ONE HUNDRED TWENTY-FOUR OF THE INSURANCE LAW, OR THE NEW YORK
STATE HEALTH INSURANCE PLAN ESTABLISHED PURSUANT TO ARTICLE ELEVEN OF
THE CIVIL SERVICE LAW; OR
(B) A PHARMACY BENEFIT MANAGER, INCLUDING AN ENTITY THAT DIRECTLY OR
THROUGH AN INTERMEDIARY, MANAGES THE PRESCRIPTION DRUG COVERAGE PROVIDED
BY A HEALTH INSURER UNDER A CONTRACT OR POLICY DELIVERED OR ISSUED FOR
DELIVERY IN THIS STATE OR A HEALTH PLAN SUBJECT TO SECTION THREE HUNDRED
SIXTY-FOUR-J OF THE SOCIAL SERVICES LAW, INCLUDING THE PROCESSING AND
PAYMENT OF CLAIMS FOR PRESCRIPTION DRUGS, THE PERFORMANCE OF DRUG UTILI-
ZATION REVIEW, THE PROCESSING OF DRUG PRIOR AUTHORIZATION REQUESTS, THE
ADJUDICATION OF APPEALS OR GRIEVANCES RELATED TO PRESCRIPTION DRUG
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD11426-01-9
A. 8253 2
COVERAGE, CONTRACTING WITH NETWORK PHARMACIES, AND CONTROLLING THE COST
OF COVERED PRESCRIPTION DRUGS.
2. (A) A MANUFACTURER OF A PRESCRIPTION DRUG WITH A WHOLESALE ACQUISI-
TION COST OF MORE THAN FORTY DOLLARS FOR A COURSE OF THERAPY SHALL NOTI-
FY THE DRUG UTILIZATION REVIEW BOARD IF THE INCREASE IN THE WHOLESALE
ACQUISITION COST OF SUCH PRESCRIPTION DRUG IS MORE THAN TEN PERCENT,
INCLUDING THE PROPOSED INCREASE AND THE CUMULATIVE INCREASES THAT
OCCURRED WITHIN THE PREVIOUS TWO CALENDAR YEARS PRIOR TO THE CURRENT
YEAR. FOR PURPOSES OF THIS SECTION, A "COURSE OF THERAPY" IS DEFINED AS
EITHER OF THE FOLLOWING:
(I) THE RECOMMENDED DAILY DOSAGE UNITS OF A PRESCRIPTION DRUG PURSUANT
TO ITS PRESCRIBING LABEL AS APPROVED BY THE FEDERAL FOOD AND DRUG ADMIN-
ISTRATION FOR THIRTY DAYS; OR
(II) THE RECOMMENDED DAILY DOSAGE UNITS OF A PRESCRIPTION DRUG PURSU-
ANT TO ITS PRESCRIBING LABEL AS APPROVED BY THE FEDERAL FOOD AND DRUG
ADMINISTRATION FOR A NORMAL COURSE OF TREATMENT THAT IS LESS THAN THIRTY
DAYS.
(B) THE NOTICE REQUIRED BY PARAGRAPH (A) OF THIS SUBDIVISION SHALL BE
PROVIDED IN WRITING TO THE DRUG UTILIZATION REVIEW BOARD AT LEAST SIXTY
DAYS PRIOR TO THE PLANNED EFFECTIVE DATE OF THE INCREASE.
(C) (I) THE NOTICE REQUIRED BY PARAGRAPH (A) OF THIS SUBDIVISION SHALL
INCLUDE THE DATE OF THE INCREASE, THE CURRENT WHOLESALE ACQUISITION COST
OF THE PRESCRIPTION DRUG, AND THE DOLLAR AMOUNT OF THE FUTURE INCREASE
IN THE WHOLESALE ACQUISITION COST OF THE PRESCRIPTION DRUG.
(II) THE NOTICE REQUIRED BY PARAGRAPH (A) OF THIS SUBDIVISION SHALL
INCLUDE A STATEMENT REGARDING WHETHER A CHANGE OR IMPROVEMENT IN THE
DRUG NECESSITATES THE PRICE INCREASE. IF SO, THE MANUFACTURER SHALL
DESCRIBE THE CHANGE OR IMPROVEMENT.
(D) IN THE EVENT THAT A MANUFACTURER OF A PRESCRIPTION DRUG SUBJECT TO
THIS SECTION DOES NOT REPORT THE INFORMATION REQUIRED IN PARAGRAPH (A)
OF THIS SUBDIVISION, THE COMMISSIONER IS AUTHORIZED TO LEVY A CIVIL
PENALTY, AFTER NOTICE AND A HEARING, AGAINST SUCH MANUFACTURER OF UP TO
ONE THOUSAND DOLLARS PER DAY FOR EVERY DAY AFTER THE REPORTING PERIOD
DESCRIBED IN THIS SECTION THAT THE REQUIRED INFORMATION IS NOT REPORTED.
§ 2. This act shall take effect immediately.