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STATE OF NEW YORK
________________________________________________________________________

8320

2011-2012 Regular Sessions

IN ASSEMBLY

June 13, 2011
___________

Introduced  by  M. of A. CUSICK -- (at request of the Department of Law)
  -- read once and referred to the Committee on Health

AN ACT to amend the public  health  law,  in  relation  to  creating  an
  on-line real time controlled substance reporting system to monitor the
  prescribing and dispensing of certain controlled substances

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. This act shall be known and may be cited as  the  "Internet
System for Tracking Over-Prescribing (I-STOP) Act".
  S  2.  The public health law is amended by adding a new section 3343-a
to read as follows:
  S 3343-A. ON-LINE REAL-TIME CONTROLLED SUBSTANCE REPORTING SYSTEM.  1.
ESTABLISHMENT  OF SYSTEM. THE COMMISSIONER SHALL, IN ACCORDANCE WITH THE
PROVISIONS OF THIS SECTION, ESTABLISH AND MAINTAIN A SYSTEM FOR COLLECT-
ING, MONITORING  AND  REPORTING  DATA  CONCERNING  THE  PRESCRIBING  AND
DISPENSING  OF  SCHEDULE II, III, IV, OR V CONTROLLED SUBSTANCES, OR ANY
OTHER SUBSTANCES SPECIFIED BY THE COMMISSIONER, THAT ARE  PRESCRIBED  OR
DISPENSED.  SUCH  SYSTEM  SHALL  ALLOW  PRACTITIONERS AND PHARMACISTS TO
MONITOR AND REPORT SUCH DATA BY  MEANS  OF  AN  INTERNET  PORTAL  AND  A
WEBSITE AND ANY OTHER ELECTRONIC MEANS DEEMED APPROPRIATE BY THE COMMIS-
SIONER.  SUCH SYSTEM SHALL ENABLE PRACTITIONERS AND PHARMACISTS TO MONI-
TOR AND REPORT SUCH DATA AT THE TIME A PRESCRIPTION IS  ISSUED  OR  SUCH
SUBSTANCE  IS  DISPENSED.  THE  COMMISSIONER SHALL ADOPT AND SUCH SYSTEM
SHALL MAINTAIN PROCEDURES AND  SAFEGUARDS  TO  ENSURE  THE  PRIVACY  AND
CONFIDENTIALITY  OF  PATIENT  INFORMATION  AND  TO  ENSURE THAT ANY DATA
COLLECTED OR REPORTED IS  NOT  UNLAWFULLY  ACCESSED  OR  DISCLOSED.  THE
COMMISSIONER  SHALL  ALSO ESTABLISH ACCEPTABLE ERROR TOLERANCE RATES FOR
DATA AND PROCEDURES FOR PRACTITIONERS AND PHARMACISTS TO FOLLOW  IN  THE
EVENT OF A TECHNOLOGICAL FAILURE.
  2.  REPORTING OBLIGATIONS. EVERY PRACTITIONER OR PHARMACIST WITHIN THE
STATE OR ANY OTHER DISPENSER WHO HAS OBTAINED A LICENSE, PERMIT OR OTHER

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD11782-01-1
A. 8320                             2

AUTHORIZATION TO OPERATE FROM THE  COMMISSIONER  OF  EDUCATION,  OR  ANY
AGENT  THEREOF,  SHALL  REPORT TO THE COMMISSIONER THE DATA SPECIFIED IN
PARAGRAPH A OR B OF THIS SUBDIVISION  THROUGH  AN  INTERNET  PORTAL  AND
WEBSITE  MAINTAINED  BY  THE  COMMISSIONER  AND  ANY OTHER METHOD DEEMED
APPROPRIATE BY THE COMMISSIONER, UPON ISSUING A PRESCRIPTION OR DISPENS-
ING A SCHEDULE II, III, IV, OR  V  CONTROLLED  SUBSTANCE  OR  ANY  OTHER
SUBSTANCE  SPECIFIED  BY  THE COMMISSIONER; PROVIDED THAT SUCH REPORTING
SHALL NOT BE REQUIRED FOR ANY SUCH SUBSTANCE ADMINISTERED DIRECTLY TO  A
PATIENT, OR FOR SUCH SUBSTANCE DISPENSED PURSUANT TO SECTION THREE THOU-
SAND THREE HUNDRED THIRTY-FOUR, THREE THOUSAND THREE HUNDRED THIRTY-SEV-
EN OR THREE THOUSAND THREE HUNDRED FORTY-TWO OF THIS CHAPTER OR ANY RULE
OR REGULATION PROMULGATED UNDER THOSE SECTIONS.
  A.  DATA TO BE REPORTED BY PRACTITIONERS. DATA CONCERNING SCHEDULE II,
III, IV, OR V CONTROLLED SUBSTANCES OR ANY OTHER SUBSTANCES SPECIFIED BY
THE COMMISSIONER THAT ARE PRESCRIBED SHALL INCLUDE BUT NOT BE LIMITED TO
THE FOLLOWING: PRACTITIONER PRESCRIPTION NUMBER;  PRACTITIONER  NATIONAL
IDENTIFICATION  NUMBER; PATIENT NAME; PATIENT ADDRESS, INCLUDING STREET,
CITY, STATE, ZIP CODE;  PATIENT  DATE  OF  BIRTH;  PATIENT'S  SEX;  DATE
PRESCRIPTION  ISSUED;  METRIC QUANTITY; NATIONAL DRUG CODE NUMBER OF THE
DRUG; NUMBER OF DAYS  SUPPLY;  PRACTITIONER  DRUG  ENFORCEMENT  ADMINIS-
TRATION  NUMBER;  DATE  PRESCRIPTION  WRITTEN; SERIAL NUMBER OF OFFICIAL
PRESCRIPTION FORM,  OR  AN  IDENTIFIER  DESIGNATED  BY  THE  DEPARTMENT;
PAYMENT METHOD, AND NUMBER OF REFILLS AUTHORIZED.
  B.  DATA  TO  BE REPORTED BY PHARMACISTS. DATA CONCERNING SCHEDULE II,
III, IV, OR V CONTROLLED SUBSTANCES OR ANY OTHER SUBSTANCES SPECIFIED BY
THE COMMISSIONER THAT ARE DISPENSED SHALL INCLUDE BUT NOT BE LIMITED  TO
THE  FOLLOWING:  PHARMACY PRESCRIPTION NUMBER; PHARMACY'S NATIONAL IDEN-
TIFICATION NUMBER; PATIENT  NAME;  PATIENT  ADDRESS,  INCLUDING  STREET,
CITY,  STATE,  ZIP  CODE;  PATIENT  DATE  OF  BIRTH; PATIENT'S SEX; DATE
PRESCRIPTION FILLED; METRIC QUANTITY; NATIONAL DRUG CODE NUMBER  OF  THE
DRUG;  NUMBER  OF  DAYS  SUPPLY;  PRACTITIONER DRUG ENFORCEMENT ADMINIS-
TRATION NUMBER; DATE PRESCRIPTION WRITTEN;  SERIAL  NUMBER  OF  OFFICIAL
PRESCRIPTION  FORM,  OR  AN  IDENTIFIER  DESIGNATED BY THE COMMISSIONER;
PAYMENT METHOD; NUMBER OF REFILLS AUTHORIZED; AND REFILL NUMBER.
  3.   DUTY TO CONSULT DATABASE;  PROHIBITIONS.  EVERY  PRACTITIONER  OR
PHARMACIST  WITHIN  THE  STATE,  INCLUDING  ANY  OTHER DISPENSER WHO HAS
OBTAINED A LICENSE, PERMIT, OR OTHER AUTHORIZATION TO OPERATE  FROM  THE
COMMISSIONER  OF EDUCATION, SHALL MAKE INQUIRY TO THE ON-LINE CONTROLLED
SUBSTANCE REPORTING SYSTEM ESTABLISHED PURSUANT TO  SUBDIVISION  ONE  OF
THIS  SECTION  PRIOR  TO PRESCRIBING OR DISPENSING ANY SCHEDULE II, III,
IV, OR V CONTROLLED SUBSTANCE OR ANY OTHER SUBSTANCE  SPECIFIED  BY  THE
COMMISSIONER;  PROVIDED THAT THIS SUBDIVISION AND PARAGRAPHS (A) AND (B)
HEREOF, SHALL NOT APPLY TO ANY SUCH SUBSTANCE ADMINISTERED DIRECTLY TO A
PATIENT OR FOR ANY SUCH SUBSTANCE DISPENSED PURSUANT TO  SECTIONS  THREE
THOUSAND  THREE  HUNDRED THIRTY-FOUR, THREE THOUSAND THREE HUNDRED THIR-
TY-SEVEN OR THREE THOUSAND THREE HUNDRED FORTY-TWO OF THIS  CHAPTER  AND
ANY RULE PROMULGATED THEREUNDER.
  A.  NO  PRACTITIONER  SHALL  PRESCRIBE  ANY SCHEDULE II, III, IV, OR V
CONTROLLED SUBSTANCE OR ANY OTHER SUBSTANCE SPECIFIED BY THE COMMISSION-
ER WITHOUT  REVIEWING  A  PATIENT'S  CONTROLLED  SUBSTANCE  PRESCRIPTION
HISTORY  AS  SET  FORTH  IN  THE  ON-LINE CONTROLLED SUBSTANCE REPORTING
SYSTEM TO DETERMINE THAT SUCH PRESCRIPTION IS  MEDICALLY  NECESSARY  AND
WOULD  NOT  OTHERWISE VIOLATE SECTION THREE THOUSAND THREE HUNDRED FIFTY
OF THIS ARTICLE, OR, FOR PRESCRIPTIONS ELIGIBLE FOR REIMBURSEMENT BY THE
MEDICAID  PROGRAM,  SECTION  ONE  HUNDRED  FORTY-FIVE-B  OF  THE  SOCIAL
SERVICES LAW.
A. 8320                             3

  B.  NO  PHARMACIST  SHALL  DISPENSE  ANY  SCHEDULE  II,  III, IV, OR V
CONTROLLED SUBSTANCE OR ANY OTHER SUBSTANCE SPECIFIED BY THE COMMISSION-
ER WITHOUT CONFIRMING THE EXISTENCE OF A MATCHING REPORT PROVIDED  BY  A
PRACTITIONER THROUGH THE ON-LINE CONTROLLED SUBSTANCE REPORTING SYSTEM.
  4.  LIMITATIONS ON USE; DISCLOSURE RESTRICTIONS. A. NO PRACTITIONER OR
PHARMACIST SHALL DISCLOSE OR BE REQUIRED TO DISCLOSE ANY DATA VIEWED  OR
RECEIVED  THROUGH  THE  ON-LINE  CONTROLLED  SUBSTANCE  REPORTING SYSTEM
UNLESS SO REQUIRED BY A PROVISION OF LAW SPECIFICALLY  RELATING  TO  THE
TREATMENT  OF  A  PATIENT  OR  RELATING TO THE MANDATORY REPORTING OF AN
ILLEGAL USE OR ABUSE OF A CONTROLLED SCHEDULE II, III, IV OR V SUBSTANCE
OR ANY OTHER SUBSTANCE SPECIFIED BY THE COMMISSIONER.   DISCLOSURE BY  A
PRACTITIONER  OR  PHARMACIST  TO  ANY  OTHER PERSON OR ENTITY, INCLUDING
DISCLOSURE IN THE CONTEXT OF A CIVIL  ACTION  WHERE  THE  DISCLOSURE  IS
SOUGHT EITHER FOR THE PURPOSE OF DISCOVERY OR FOR EVIDENCE, IS PROHIBIT-
ED.
  B.  THE  COMMISSIONER  MAY NOT DISCLOSE DATA COLLECTED FOR THE ON-LINE
CONTROLLED SUBSTANCE REPORTING SYSTEM UNLESS SPECIFICALLY SO  AUTHORIZED
BY LAW.
  C.  THE COMMISSIONER SHALL BE AUTHORIZED TO REVIEW BY ELECTRONIC MEANS
OR OTHERWISE THE DATE COLLECTED OR PUBLISHED FOR THE ON-LINE  CONTROLLED
SUBSTANCE  REPORTING  SYSTEM.  THE  COMMISSIONER  SHALL BE AUTHORIZED TO
DISCLOSE DATA COLLECTED FOR  OR  PUBLISHED  ON  THE  ON-LINE  CONTROLLED
SUBSTANCE  REPORTING  SYSTEM, WITHOUT NECESSITY OF SUBPOENA, TO: (I) THE
DIRECTOR OF THE OFFICE OF THE PROFESSIONS OF THE DEPARTMENT OF EDUCATION
OR HIS OR HER DESIGNEE WHO IS RESPONSIBLE FOR THE LICENSURE, REGULATION,
OR DISCIPLINE OF PRACTITIONERS OR PHARMACISTS; (II) THE DEPUTY  ATTORNEY
GENERAL  FOR  MEDICAID  FRAUD  CONTROL OR HIS OR HER DESIGNEE; (III) THE
MEDICAID INSPECTOR GENERAL OR HIS OR HER DESIGNEE; (IV)  A  JUDGE  OR  A
PROBATION  OR  PAROLE  OFFICER  ADMINISTERING  A  DIVERSION OR PROBATION
PROGRAM OF A CRIMINAL DEFENDANT WHO IS  ELIGIBLE  TO  PARTICIPATE  IN  A
COURT-ORDERED DRUG DIVERSION OR PROBATION PROGRAM; OR (V) A PRACTITIONER
OR  PHARMACIST,  OR  THEIR AGENT, WHO REQUESTS INFORMATION AND CERTIFIES
THAT THE REQUESTED INFORMATION IS FOR THE PURPOSE OF  PROVIDING  MEDICAL
OR PHARMACEUTICAL TREATMENT TO A CURRENT PATIENT. ANY PERSON TO WHOM THE
COMMISSIONER  DISCLOSES  SUCH  DATA PURSUANT TO THIS PARAGRAPH SHALL NOT
PROVIDE SUCH DATA TO ANY OTHER PERSON OR ENTITY EXCEPT BY  COURT  ORDER,
WHICH  SHALL  BE  GRANTED  ONLY UPON APPLICATION BY SUCH PERSON AND ONLY
UPON A SHOWING THAT SUCH AN ORDER IS NECESSARY FOR SUCH PERSON TO  CARRY
OUT  HIS OR HER DUTIES AS A PUBLIC OFFICER OR AS A PRACTITIONER OR PHAR-
MACIST; PROVIDED THAT THE COMMISSIONER OF THE  DEPARTMENT  OF  EDUCATION
MAY SUBMIT THE DATA AS EVIDENCE IN ANY ADMINISTRATIVE HEARING AS AUTHOR-
IZED BY LAW.
  D.  THE  COMMISSIONER SHALL BE AUTHORIZED TO PROVIDE THE DATA REPORTED
TO OR COLLECTED FOR THE ON-LINE CONTROLLED  SUBSTANCE  REPORTING  SYSTEM
UPON  RECEIPT  OF A SUBPOENA ISSUED TO A POLICE OFFICER, DISTRICT ATTOR-
NEY, OR GRAND JURY, OR ANY FEDERAL OR STATE LAW ENFORCEMENT AGENCY.
  E. THE COMMISSIONER MAY USE ANY  DATA  OR  REPORTS  COLLECTED  FOR  OR
REPORTED  TO  THE  ON-LINE CONTROLLED SUBSTANCE REPORTING SYSTEM FOR THE
PURPOSE OF IDENTIFYING MEDICAID RECIPIENTS  WHOSE  USAGE  OF  CONTROLLED
SUBSTANCES  MAY BE APPROPRIATELY MANAGED BY A SINGLE OUTPATIENT PHARMACY
OR PRIMARY CARE PRACTITIONER.
  F. NOTHING IN THIS SUBDIVISION SHALL BE INTERPRETED TO ALLOW A DISCLO-
SURE OF INFORMATION OTHERWISE PROHIBITED BY FEDERAL LAW.
  5. IMMUNITY. NO PUBLIC OFFICER ACTING IN GOOD FAITH NOR THE  STATE  OF
NEW  YORK  NOR  ANY  DEPARTMENT,  BUREAU, BOARD OR POLITICAL SUBDIVISION
THEREOF SHALL BE SUBJECT TO  CIVIL  LIABILITY  ARISING  FROM  ANY  FALSE
A. 8320                             4

INFORMATION  OF  ANY  DATA  SUBMITTED  TO  OR  REPORTED  BY  THE ON-LINE
CONTROLLED SUBSTANCE REPORTING SYSTEM; OR ANY FAILURE OF THE  SYSTEM  TO
ACCURATELY  OR  TIMELY  REPORT  SUCH DATA; OR FOR DISCLOSURE OF ANY DATA
MAINTAINED  BY  THE  SYSTEM  RESULTING  FROM SUCH OFFICER ACTING IN GOOD
FAITH IN THE DISCHARGE OF HIS OR HER DUTIES.
  6. CIVIL PENALTIES. NOTWITHSTANDING ANY OTHER PROVISION OF THIS  ARTI-
CLE RELATING TO VIOLATIONS OF THIS ARTICLE:
  A. ANY PRACTITIONER OR PHARMACIST WHO KNOWINGLY FAILS TO TRANSMIT DATA
TO THE COMMISSIONER AS REQUIRED BY SUBDIVISION TWO OF THIS SECTION SHALL
BE  LIABLE  TO THE STATE FOR A CIVIL PENALTY OF FIVE HUNDRED DOLLARS FOR
THE FIRST PRESCRIPTION ISSUED WHICH IS NOT PROPERLY REPORTED; ONE  THOU-
SAND DOLLARS FOR THE SECOND PRESCRIPTION NOT PROPERLY REPORTED; AND FIVE
THOUSAND DOLLARS FOR EACH PRESCRIPTION NOT PROPERLY REPORTED THEREAFTER.
  B.  ANY  PRACTITIONER OR PHARMACIST WHO KNOWINGLY FAILS TO REVIEW DATA
PRIOR TO PRESCRIBING OR DISPENSING ANY SUBSTANCE IN VIOLATION OF  SUBDI-
VISION  THREE  OF  THIS SECTION SHALL BE LIABLE TO THE STATE FOR A CIVIL
PENALTY OF FIVE HUNDRED DOLLARS FOR THE FIRST  PRESCRIPTION  SO  ISSUED;
ONE  THOUSAND  DOLLARS  FOR  THE SECOND PRESCRIPTION SO ISSUED; AND FIVE
THOUSAND DOLLARS FOR EACH PRESCRIPTION ISSUED IN VIOLATION  OF  SUBDIVI-
SION THREE OF THIS SECTION THEREAFTER.
  C.  ANY PRACTITIONER OR PHARMACIST WHO KNOWINGLY DISCLOSES INFORMATION
IN VIOLATION OF SUBDIVISION FOUR OF THIS SECTION SHALL BE LIABLE  FOR  A
PENALTY OF NOT MORE THAN FIVE HUNDRED DOLLARS FOR THE FIRST SUCH DISCLO-
SURE;  ONE  THOUSAND  DOLLARS  FOR  THE SECOND SUCH DISCLOSURE; AND FIVE
THOUSAND DOLLARS FOR EACH SUCH DISCLOSURE ISSUED IN VIOLATION OF  SUBDI-
VISION THREE THEREAFTER.
  D. NOTHING IN THIS SECTION SHALL BE INTERPRETED TO PREEMPT OR RESTRICT
ANY CIVIL ACTION BY ANY INDIVIDUAL FOR DAMAGES RESULTING FROM AN ILLEGAL
DISCLOSURE  OF  INFORMATION  IN  VIOLATION  OF  SUBDIVISION FOUR OF THIS
SECTION, OR ANY OTHER CIVIL OR CRIMINAL ACTION BY  THE  COMMISSIONER  OR
ANY LAW ENFORCEMENT AGENCY.
  7.  EDUCATION AND OUTREACH. THE COMMISSIONER SHALL WORK WITH THE STATE
EDUCATION DEPARTMENT AND ANY OTHER GOVERNMENTAL OR PRIVATE  PROFESSIONAL
ORGANIZATION RESPONSIBLE FOR THE LICENSURE, REGULATION, OR DISCIPLINE OF
PRACTITIONERS,  PHARMACISTS,  AND  OTHER  PERSONS  WHO ARE AUTHORIZED TO
PRESCRIBE, ADMINISTER, OR DISPENSE CONTROLLED SUBSTANCES, FOR THE DEVEL-
OPMENT OF A CONTINUING EDUCATION PROGRAM ABOUT THE PURPOSES AND USES  OF
THE  ON-LINE  CONTROLLED  SUBSTANCE REPORTING SYSTEM ESTABLISHED BY THIS
SECTION. THE ATTORNEY GENERAL SHALL WORK WITH THE DEPARTMENT OF CRIMINAL
JUSTICE SERVICES FOR THE DEVELOPMENT OF A CONTINUING  EDUCATION  PROGRAM
FOR  LAW  ENFORCEMENT  OFFICERS ABOUT THE PURPOSES AND USES OF THE ELEC-
TRONIC SYSTEM FOR MONITORING ESTABLISHED IN THIS SECTION.
  8. RULES AND REGULATIONS. THE COMMISSIONER SHALL PROMULGATE RULES  AND
REGULATIONS  NECESSARY  TO  EFFECTUATE  THE  PROVISIONS OF THIS SECTION;
PROVIDED HOWEVER, THE COMMISSIONER SHALL  NOT  PROMULGATE  ANY  RULE  OR
REGULATION  THAT REQUIRES ANY PRACTITIONER OR PHARMACIST TO PAY A FEE OR
TAX SPECIFICALLY DEDICATED TO THE OPERATION OF THE SYSTEM.
  S 3. This act shall take effect immediately; provided,  however,  that
subdivisions  2, 3, 4, 5, 6 and 7 of section 3343-a of the public health
law as added by section two of this act shall take effect one year after
such effective date.