Senate Bill S5409A

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

                                 5409--A

                       2011-2012 Regular Sessions

                            I N  S E N A T E

                              May 18, 2011
                               ___________

Introduced  by  Sen. KENNEDY -- read twice and ordered printed, and when
  printed to be committed to the Committee on Health --  recommitted  to
  the  Committee  on  Health in accordance with Senate Rule 6, sec. 8 --
  committee discharged, bill amended, ordered reprinted as  amended  and
  recommitted to said committee

AN  ACT to amend the public health law, in relation to requiring pharma-
  cists and practitioners to check the controlled substance abuse regis-
  try before prescribing analgesics

  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 "Michael
David Israel controlled substance registry reform act".
  S 2. Section 3308 of the public health law is amended by adding a  new
subdivision 7 to read as follows:
  7.  THE  COMMISSIONER SHALL DEVELOP A SYSTEM TO ENSURE COMPLIANCE WITH
SECTION THIRTY-THREE HUNDRED TWENTY-THREE OF THIS ARTICLE.  SUCH  SYSTEM
SHALL, AT A MINIMUM:
  (A)  CROSS-CHECK  THE  PRESCRIPTIONS SUBMITTED BY PHARMACISTS WITH THE
PRACTITIONERS CONSULTING THE REGISTRY PURSUANT TO  SECTION  THIRTY-THREE
HUNDRED TWENTY-THREE OF THIS ARTICLE.
  (B) ESTABLISH AN APPROPRIATE FINE SCALE FOR PRACTITIONERS FOUND BY THE
DEPARTMENT  TO  NOT  BE  CONSULTING THE REGISTRY IN VIOLATION OF SECTION
THIRTY-THREE HUNDRED TWENTY-THREE OF THIS ARTICLE FOLLOWED BY MORE SERI-
OUS PUNISHMENTS FOR REPEAT OFFENSES.
  S 3. The public health law is amended by adding a new section 3323  to
read as follows:
  S  3323.  PRACTITIONERS'  AND PHARMACISTS' DUTIES PRIOR TO PRESCRIBING
ANALGESICS.  EVERY PRACTITIONER AND PHARMACIST SHALL, PRIOR TO PRESCRIB-
ING ANY ANALGESIC, CONSULT THE CENTRAL REGISTRY ESTABLISHED PURSUANT  TO
THIS ARTICLE TO DETERMINE:

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD11567-06-1

              

S. 5409--A                          2

  1. WHAT OTHER PRESCRIPTIONS THE PATIENT BEING PRESCRIBED SUCH ANALGES-
IC IS CURRENTLY TAKING;
  2.  WHETHER  SUCH  PATIENT  MAY BE UNDER TREATMENT WITH A PRESCRIPTION
ANALGESIC BY ANOTHER PRACTITIONER; AND
  3. WHETHER SUCH PATIENT'S PRESCRIPTION HISTORY INDICATES A POSSIBILITY
OF DRUG ABUSE, ADDICTION OR DIVERSION.
  S 4. Paragraphs (d) and (e) of subdivision 1 of section  3371  of  the
public  health  law,  as amended by chapter 178 of the laws of 2010, are
amended and a new paragraph (f) is added to read as follows:
  (d) to a central registry established pursuant to this article; [and]
  (e) to a practitioner to inform him or her that a patient may be under
treatment with a controlled substance by another practitioner[.]; OR
  (F) TO A PHARMACIST  TO  INFORM  THE  PHARMACIST  THAT  A  PERSON  WHO
PRESENTS  OR  HAS  PRESENTED A PRESCRIPTION FOR ONE OR MORE PRESCRIPTION
ANALGESICS  AT  THE  PHARMACY  MAY  HAVE  ALSO  OBTAINED  ONE  OR   MORE
PRESCRIPTION ANALGESICS FROM ANOTHER PHARMACY.
  S  5.  The public health law is amended by adding a new section 3323-a
to read as follows:
  S 3323-A. PAIR REPORTING PROGRAM.   1. ESTABLISHMENT  OF  SYSTEM.  THE
COMMISSIONER  SHALL,  IN ACCORDANCE WITH THE PROVISIONS OF THIS SECTION,
ESTABLISH AND MAINTAIN A SYSTEM FOR COLLECTING, 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 COMMISSIONER. SUCH SYSTEM SHALL ENABLE PRACTI-
TIONERS  AND  PHARMACISTS  TO MONITOR 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 TOLER-
ANCE  RATES FOR DATA AND PROCEDURES FOR PRACTITIONERS AND PHARMACISTS TO
FOLLOW IN THE EVENT OF A TECHNOLOGICAL FAILURE.
  2. DEFINITIONS. FOR PURPOSES OF THIS SECTION,  THE  MEANING  GIVEN  TO
TERMS  IN  SECTION  THIRTY-THREE  HUNDRED  TWO  OF THIS ARTICLE SHALL BE
CONTROLLING, PROVIDED THAT:
  (A) "PAIR" SHALL MEAN PRESCRIPTION ANALGESICS INFORMATION REGISTRY.
  (B) PATIENT IDENTIFIER SHALL MEAN A PATIENT'S:
  (1) FULL NAME;
  (2) ADDRESS;
  (3) DATE OF BIRTH; AND
  (4) SOCIAL SECURITY NUMBER OR  AN  ALTERNATIVE  IDENTIFICATION  NUMBER
ESTABLISHED BY THE COMMISSIONER.
  3. REPORTING REQUIREMENTS. A PRACTITIONER OR PHARMACIST THAT DISPENSES
SCHEDULE II, III, IV OR V CONTROLLED SUBSTANCES SHALL REPORT THE FOLLOW-
ING  INFORMATION REGARDING EACH DISPENSATION IN A MANNER CONSISTENT WITH
SUBDIVISION FOUR OF THIS SECTION:
  (A) PATIENT IDENTIFIER;
  (B) NATIONAL DRUG CODE OF THE DRUG DISPENSED;
  (C) METRIC QUANTITY OF DRUG DISPENSED;
  (D) DATE OF DISPENSING;
  (E) ESTIMATED DAY'S SUPPLY DISPENSED;
  (F) DRUG ENFORCEMENT ADMINISTRATION REGISTRATION NUMBER OF  THE  PRES-
CRIBER;

S. 5409--A                          3

  (G) SERIAL NUMBER ASSIGNED BY THE DISPENSER; AND
  (H)  THE  DRUG  ENFORCEMENT  ADMINISTRATION REGISTRATION NUMBER OF THE
DISPENSER.
  4. DATA REPORTED. EVERY PRACTITIONER OR PHARMACIST WITHIN THE STATE OR
ANY OTHER DISPENSER WHO HAS OBTAINED A LICENSE, PERMIT OR OTHER AUTHORI-
ZATION TO OPERATE FROM THE COMMISSIONER OF EDUCATION, OR ANY AGENT THER-
EOF, SHALL REPORT TO THE PAIR SYSTEM THE DATA SPECIFIED IN PARAGRAPH (A)
OR (B) OF THIS SUBDIVISION THROUGH AN INTERNET PORTAL AND WEBSITE  MAIN-
TAINED  BY  THE  COMMISSIONER AND ANY OTHER METHOD DEEMED APPROPRIATE BY
THE COMMISSIONER, UPON ISSUING A PRESCRIPTION OR DISPENSING  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  THOUSAND  THREE  HUNDRED
THIRTY-FOUR, THREE THOUSAND THREE HUNDRED THIRTY-SEVEN OR THREE THOUSAND
THREE  HUNDRED  FORTY-TWO  OF  THIS  ARTICLE  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;  PATIENT'S
SOCIAL  SECURITY  NUMBER;  DATE  PRESCRIPTION  ISSUED;  METRIC QUANTITY;
NATIONAL DRUG CODE NUMBER OF THE DRUG; NUMBER OF  DAYS  SUPPLY;  PRACTI-
TIONER  DRUG  ENFORCEMENT ADMINISTRATION NUMBER; DATE PRESCRIPTION WRIT-
TEN; 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;  PATIENT'S
SOCIAL  SECURITY  NUMBER;  DATE  PRESCRIPTION  FILLED;  METRIC QUANTITY;
NATIONAL DRUG CODE NUMBER OF THE DRUG; NUMBER OF  DAYS  SUPPLY;  PRACTI-
TIONER  DRUG  ENFORCEMENT ADMINISTRATION NUMBER; DATE PRESCRIPTION WRIT-
TEN; SERIAL NUMBER OF  OFFICIAL  PRESCRIPTION  FORM,  OR  AN  IDENTIFIER
DESIGNATED  BY  THE  COMMISSIONER;  PAYMENT  METHOD;  NUMBER  OF REFILLS
AUTHORIZED; AND REFILL NUMBER.
  (C) DATA TO BE REPORTED BY FACILITIES. UPON A PATIENT'S  ADMISSION  TO
AN  INPATIENT  OR  OUTPATIENT TREATMENT FACILITY FOR DRUG ABUSE, OR UPON
SUCH PATIENT'S ADMISSION TO A DETOXIFICATION CENTER OR ANY OTHER FACILI-
TY, INCLUDING A GENERAL HOSPITAL, THAT TREAT SUCH PATIENT'S  DRUG  ABUSE
OR ADDICTION, SUCH HOSPITAL, DETOXIFICATION CENTER OR TREATMENT FACILITY
SHALL  REPORT  SUCH  PATIENT'S  TREATMENT TO THE DEPARTMENT WITHIN SEVEN
DAYS OF ADMISSION. THE  HOSPITAL,  DETOXIFICATION  CENTER  OR  TREATMENT
FACILITY  SHALL  REPORT  THROUGH  THE  PAIR  SYSTEM  THE FOLLOWING DATA:
PATIENT NAME; PATIENT ADDRESS, INCLUDING STREET, CITY, STATE, ZIP  CODE;
PATIENT  DATE OF BIRTH; PATIENT'S SEX; PATIENT'S SOCIAL SECURITY NUMBER;
LENGTH OF PATIENT'S STAY; THE TYPE OF TREATMENT PATIENT RECEIVES AND THE
CONTROLLED SUBSTANCE PATIENT WAS ADMITTED  FOR;  AND  DATE  PATIENT  WAS
RELEASED.  SUCH  INFORMATION  SHALL  BE  SUBMITTED TO THE ASPIRIN SYSTEM
WITHIN SEVEN DAYS OF PATIENT'S  ADMISSION.  SUCH  INFORMATION  SHALL  BE
TRANSMITTED IN A MANNER CONSISTENT WITH THE PROVISIONS OF THIS SECTION.

S. 5409--A                          4

  5. DUTY TO CONSULT DATABASE; PROHIBITIONS. EVERY PRACTITIONER OR PHAR-
MACIST  WITHIN THE STATE, INCLUDING ANY OTHER DISPENSER WHO HAS OBTAINED
A LICENSE, PERMIT, OR OTHER AUTHORIZATION TO OPERATE  FROM  THE  COMMIS-
SIONER  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 ARTICLE 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.
  (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.
  6. REPORTING PERIOD. THE DATA IDENTIFIED IN SUBDIVISION THREE OF  THIS
SECTION  SHALL  BE  TRANSMITTED  IMMEDIATELY  ON  THE DATE OF DISPENSING
UNLESS THE DEPARTMENT GRANTS AN EXTENSION. SUCH AN  EXTENSION  SHALL  BE
GRANTED  BY THE DEPARTMENT FOR ELECTRONIC OR MECHANICAL FAILURES AND FOR
ANY OTHER REASON PROMULGATED BY THE COMMISSIONER.
  7. WAIVERS. A PRACTITIONER OR PHARMACIST WHO DOES NOT  HAVE  AN  AUTO-
MATED  RECORDKEEPING SYSTEM CAPABLE OF PRODUCING AN ELECTRONIC REPORT IN
THE FORMAT ESTABLISHED BY "ASAP TELECOMMUNICATIONS FORMAT FOR CONTROLLED
SUBSTANCES", SHALL BE GRANTED A WAIVER  FROM  THE  ELECTRONIC  REPORTING
REQUIREMENT IF THE DISPENSER:
  (A)  MAKES A WRITTEN REQUEST TO THE BRANCH WITHIN TWENTY-FOUR HOURS OF
DISCOVERY AND OF THE CIRCUMSTANCES NECESSITATING THE REQUEST, OR ON  THE
NEXT DATE THAT STATE OFFICES ARE OPEN FOR BUSINESS FOLLOWING THE DISCOV-
ERY; AND
  (B)  AGREES  IN  WRITING  TO  IMMEDIATELY  BEGIN REPORTING THE DATA BY
SUBMITTING A COMPLETED "PAIR  REPORTING  FORM"  OR  COMPARABLE  DOCUMENT
APPROVED IN WRITING AND PROMULGATED BY THE DEPARTMENT.
  8.  PATIENT IDENTIFICATION NUMBER. (A) A PATIENT OR THE PERSON OBTAIN-
ING THE CONTROLLED SUBSTANCE ON BEHALF OF THE PATIENT SHALL DISCLOSE  TO
THE  DISPENSER  THE PATIENT'S SOCIAL SECURITY NUMBER FOR PURPOSES OF THE
DISPENSER'S MANDATORY REPORTING TO PAIR.
  (B) IF A PATIENT IS AN ADULT WHO  DOES  NOT  HAVE  A  SOCIAL  SECURITY
NUMBER, THE PATIENT'S DRIVER'S LICENSE NUMBER SHALL BE DISCLOSED.
  (C)  IF A PATIENT IS AN ADULT WHO HAS NOT BEEN ASSIGNED A SOCIAL SECU-
RITY NUMBER OR A DRIVER'S LICENSE NUMBER, THE NUMBER  000-00-0000  SHALL
BE USED.
  (D) IF A PATIENT IS A CHILD WHO DOES NOT HAVE A SOCIAL SECURITY NUMBER
OR  A  DRIVER'S  LICENSE  NUMBER,  THE  SOCIAL SECURITY NUMBER, DRIVER'S
LICENSE NUMBER, OR THE  NUMBER  "000-00-0000",  AS  APPLICABLE,  OF  THE
PARENT OR GUARDIAN SHALL BE USED.

S. 5409--A                          5

  (E)  IF  A  PATIENT  IS AN ANIMAL, THE OWNER'S SOCIAL SECURITY NUMBER,
DRIVER'S LICENSE NUMBER, OR THE  NUMBER  "000-00-0000",  AS  APPLICABLE,
SHALL BE USED.
  9.  THE  COMMISSIONER  SHALL   HAVE THE POWER TO ISSUE RULES AND REGU-
LATIONS REGARDING THE USE OF SUCH ELECTRONIC SYSTEMS AND  SHALL  PROMUL-
GATE SUCH POLICIES AND REGULATIONS AS NECESSARY TO ENSURE THE PRIVACY OF
PATIENT INFORMATION AND INTEGRITY OF DATA TRANSMISSION.
  S  6.  This act shall take effect immediately; provided, however, that
section three of this act shall take effect on the one hundred twentieth
day after it shall have become a law.