S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                   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.