S T A T E O F N E W Y O R K
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364
2011-2012 Regular Sessions
I N A S S E M B L Y
(PREFILED)
January 5, 2011
___________
Introduced by M. of A. CAHILL, GOTTFRIED, GUNTHER, JACOBS, ROSENTHAL,
COLTON, PAULIN, CLARK, BROOK-KRASNY, MAISEL, JAFFEE, ENGLEBRIGHT,
WEINSTEIN, CYMBROWITZ, WEPRIN, BURLING, MONTESANO -- Multi-Sponsored
by -- M. of A. BOYLAND, CROUCH, GALEF, GLICK, LATIMER, McENENY,
PEOPLES-STOKES, PHEFFER, RAIA, SCHIMEL, SWEENEY, TITONE, TITUS, WEIS-
ENBERG -- read once and referred to the Committee on Health
AN ACT to amend the public health law and part C of chapter 58 of the
laws of 2005, amending the public health law and other laws relating
to implementing the state fiscal plan for the 2005-2006 fiscal year,
in relation to prescription privacy
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Legislative findings and intent. Prescribing health care
professionals should have a reasonable expectation that when they
prescribe a medication for a patient, that decision will not be made
available to an outside third party. However, disclosure of individual
identifying information about patients and prescribers enables pharma-
ceutical companies to track the prescribing practices of physicians to
target them for marketing, including gifts and payments. This marketing
can distort prescribing practices to increase health care costs and
undermine patient safety. The National Institutes of Health has found
that nearly one-third of the increase in prescription drug prices over
the last decade was attributable to marketing-induced shifts in
prescribing practices. Published evidence shows that prescribers are
often encouraged by sales representatives to prescribe medications in a
manner that has not been approved by the Federal Food and Drug Adminis-
tration.
Neither the state nor any other entity has the resources to effec-
tively counter targeted marketing campaigns that exceed hundreds of
millions of dollars.
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD01177-01-1
A. 364 2
The legislature finds that this legislation is necessary to protect
health care professionals and their patients from the abuses of targeted
marketing that are made possible by the disclosure of individual identi-
fying information.
S 2. Section 270 of the public health law is amended by adding two new
subdivisions 15 and 16 to read as follows:
15. "INDIVIDUAL IDENTIFYING INFORMATION" MEANS INFORMATION IDENTIFYING
OR TENDING TO IDENTIFY A PRESCRIBER OR PATIENT, WHERE THE INFORMATION IS
DERIVED FROM OR RELATES TO A PRESCRIPTION FOR ANY DRUG OR DEVICE.
16. "MARKETING" MEANS, BUT IS NOT LIMITED TO, ADVERTISING, DETAILING,
MARKETING, PROMOTION, OR ANY ACTIVITY THAT COULD BE USED TO INFLUENCE
SALES OR MARKET SHARE OF A DRUG OR DEVICE, INFLUENCE OR EVALUATE THE
PRESCRIBING PRACTICES OF A PRESCRIBER, OR EVALUATE THE EFFECTIVENESS OF
MARKETING PRACTICES OR PERSONNEL.
S 3. The public health law is amended by adding a new section 276-c to
read as follows:
S 276-C. PRESCRIPTION PRIVACY. 1. NO PRESCRIBER, PHARMACIST, PHARMACY,
PHARMACY BENEFITS MANAGER, HEALTH PLAN, INSURER, THIRD PARTY PAYER, DATA
TRANSFER INTERMEDIARY, DRUG MANUFACTURER OR WHOLESALER OR THEIR AGENTS
SHALL DISCLOSE, SELL, TRANSFER, EXCHANGE OR USE ANY INDIVIDUAL IDENTIFY-
ING INFORMATION TO ANY PERSON OR ENTITY FOR THE PURPOSE OF MARKETING ANY
DRUG OR DEVICE.
2. NOTWITHSTANDING SUBDIVISION ONE OF THIS SECTION, INDIVIDUAL IDENTI-
FYING INFORMATION, SUBJECT TO APPLICABLE LAW MAY BE DISCLOSED, SOLD,
TRANSFERRED OR EXCHANGED TO: (A) THE PATIENT TO WHOM THE ORIGINAL
PRESCRIPTION WAS ISSUED OR A PERSON TO WHOM THE PRESCRIBED DRUG OR
DEVICE MAY BE DELIVERED;
(B) A PERSON LEGALLY AUTHORIZED TO ISSUE OR FILL A PRESCRIPTION FOR
THE PATIENT, A PERSON WHO TREATS THE PATIENT, OR A PERSON WHO PROVIDES
DISEASE MANAGEMENT OR CASE MANAGEMENT TO THE PATIENT;
(C) AN OFFICER, INSPECTOR OR INVESTIGATOR FOR A GOVERNMENT HEALTH,
LICENSING OR LAW ENFORCEMENT AGENCY ACTING UNDER APPROPRIATE LEGAL
AUTHORITY, WHERE THE REQUEST IS MADE IN WRITING.
(D) A PERSON AUTHORIZED BY A COURT ORDER TO RECEIVE SUCH INFORMATION;
(E) A HEALTH RESEARCHER WHO IS OTHERWISE AUTHORIZED TO HAVE ACCESS TO
HEALTH RECORDS OF THE PATIENT THAT INCLUDE THE INDIVIDUAL IDENTIFYING
INFORMATION, FOR REASONS INCLUDING, BUT NOT LIMITED TO, CONDUCTING CLIN-
ICAL TRIALS OR RESEARCH REGARDING THE EFFECTS OF HEALTH CARE PRACTITION-
ER PRESCRIBING PRACTICES;
(F) CONDUCT DRUG SAFETY EVALUATIONS, PRODUCT RECALLS AND SPECIFIC RISK
MANAGEMENT PLANS, AS IDENTIFIED OR REQUESTED BY THE FEDERAL FOOD AND
DRUG ADMINISTRATION, OR ITS SUCCESSOR AGENCY;
(G) ALLOW FOR THE APPROPRIATE TRANSFER OF RECORDS THAT MAY TAKE PLACE
WHEN OWNERSHIP OF A PHARMACY IS CHANGED OR TRANSFERRED;
(H) THE PATIENT'S HEALTH PLAN, INSURER, OR THIRD PARTY PAYER, OR AN
AGENT, FOR THE PURPOSE OF PAYMENT OR REIMBURSEMENT FOR HEALTH CARE
SERVICES, INCLUDING DETERMINING COMPLIANCE WITH THE TERMS OF COVERAGE OR
MEDICAL NECESSITY, OR UTILIZATION REVIEW;
(I) A PERSON OR ENTITY TO WHOM, AND FOR A PURPOSE FOR WHICH, DISCLO-
SURE OR TRANSFER IS OTHERWISE EXPLICITLY AUTHORIZED OR REQUIRED BY LAW;
OR
(J) A PERSON OR ENTITY ACTING AS AN EMPLOYEE OR AGENT OF A PERSON OR
ENTITY UNDER ANY PRECEDING PARAGRAPH OF THIS SUBDIVISION, FOR THE
PURPOSE OF AND CONSISTENT WITH THAT PARAGRAPH.
3. NOTHING IN THIS SECTION SHALL PROHIBIT THE COLLECTION, USE, TRANS-
FER, OR SALE OF PATIENT AND PRESCRIBER DATA BY ZIP CODE, GEOGRAPHIC
A. 364 3
REGION, OR MEDICAL SPECIALTY FOR MARKETING PURPOSES, PROVIDING IT DOES
NOT CONTAIN INDIVIDUAL IDENTIFYING INFORMATION.
4. THIS SECTION SHALL NOT PREVENT ANY PERSON FROM DISCLOSING, SELLING,
TRANSFERRING, OR EXCHANGING FOR VALUE INDIVIDUAL IDENTIFYING INFORMATION
PERTAINING TO THAT PERSON, FOR ANY PURPOSE; PROVIDED THAT THE INFORMA-
TION DOES NOT INCLUDE INDIVIDUAL IDENTIFYING INFORMATION PERTAINING TO
ANY OTHER PERSON.
5. NOTHING IN THIS SECTION SHALL PROHIBIT A PHARMACY FROM USING
PATIENT INFORMATION TO PROVIDE CARE MANAGEMENT EDUCATIONAL COMMUNI-
CATIONS TO A PATIENT ABOUT THE PATIENT'S HEALTH CONDITION, ADHERENCE TO
A PRESCRIBED COURSE OF THERAPY OR OTHER INFORMATION ABOUT THE DRUG BEING
DISPENSED, TREATMENT OPTIONS, OR CLINICAL TRIALS.
6. NO PERSON OR ENTITY TO WHOM OR WHICH INDIVIDUAL IDENTIFYING INFOR-
MATION IS DISCLOSED, SOLD, TRANSFERRED OR EXCHANGED SHALL DISCLOSE,
SELL, TRANSFER OR EXCHANGE IT TO ANY PERSON OR ENTITY OTHER THAN FOR THE
LAWFUL PURPOSE FOR WHICH IT WAS DISCLOSED, SOLD, TRANSFERRED OR
EXCHANGED TO THE PERSON OR ENTITY, AND WITHOUT SATISFACTORY ASSURANCE
THAT THE RECIPIENT WILL SAFEGUARD THE RECORDS FROM BEING DISCLOSED OR
USED IN THE STATE FOR MARKETING PURPOSES.
7. THIS SECTION SHALL NOT BE CONSTRUED TO AUTHORIZE ANY DISCLOSURE,
SALE, TRANSFER, OR EXCHANGE OF INDIVIDUAL IDENTIFYING INFORMATION THAT
IS NOT OTHERWISE AUTHORIZED OR REQUIRED BY LAW.
8. IN ADDITION TO THE COMMISSIONER'S AUTHORITY TO ENFORCE THIS SECTION
UNDER SECTION TWELVE OF THIS CHAPTER, THE ATTORNEY GENERAL SHALL HAVE
THE AUTHORITY TO BRING AN ACTION TO ENFORCE COMPLIANCE WITH THIS SECTION
WITHOUT REFERRAL BY THE COMMISSIONER.
S 4. Subdivision 1 of section 79 of part C of chapter 58 of the laws
of 2005, amending the public health law and other laws relating to
implementing the state fiscal plan for the 2005-2006 fiscal year, is
amended to read as follows:
1. sections ten through fifteen of this act shall expire and be deemed
repealed on and after June 15, 2012; PROVIDED, HOWEVER, THAT SECTION 270
OF THE PUBLIC HEALTH LAW, AS ADDED BY SECTION TEN OF THIS ACT, SHALL NOT
EXPIRE OR BE DEEMED REPEALED;
S 5. This act shall take effect on the one hundred eightieth day after
it shall have become a law; provided, however, that the amendments to
article 2-A of the public health law made by section three of this act
shall survive the repeal of such article as provided in section 79 of
part C of chapter 58 of the laws of 2005, as amended; and provided
further that section four of this act shall take effect immediately.