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

                                  5805

                       2015-2016 Regular Sessions

                          I N  A S S E M B L Y

                              March 5, 2015
                               ___________

Introduced by M. of A. McDONALD -- read once and referred to the Commit-
  tee on Higher Education

AN  ACT  to  amend the education law, in relation to authorizing pharma-
  cists to perform collaborative drug therapy management, and  to  amend
  chapter  21 of the laws of 2011 amending the education law relating to
  authorizing pharmacists to perform collaborative drug therapy  manage-
  ment  with  physicians in certain settings, in relation to making such
  provisions permanent

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

  Section 1. Section 6801-a of the education law, as added by chapter 21
of the laws of 2011, is amended to read as follows:
  S  6801-a.    Collaborative  drug  therapy  management  [demonstration
program].  1. As used in this section, the following  terms  shall  have
the following meanings:
  a.    "CLINICAL SERVICES" SHALL MEAN THE COLLECTION AND INTERPRETATION
OF PATIENT DATA FOR THE PURPOSE OF INITIATING, MODIFYING AND  MONITORING
DRUG  THERAPY  WITH  ASSOCIATED  ACCOUNTABILITY  AND  RESPONSIBILITY FOR
OUTCOMES IN A DIRECT PATIENT CARE SETTING.
  B. "Collaborative drug therapy management" shall mean the  performance
of  CLINICAL  services  by  [a  pharmacist]  PHARMACISTS relating to the
review, evaluation and management of drug therapy to a patient,  who  is
being  treated by a physician, PHYSICIAN ASSISTANT OR NURSE PRACTITIONER
for a specific disease or disease [state] STATES, in accordance  with  a
written   agreement   or   protocol  with  a  voluntarily  participating
physician, PHYSICIAN ASSISTANT OR NURSE PRACTITIONER and  in  accordance
with  the  policies,  procedures,  and  protocols of [the] A facility OR
MEDICAL PRACTICE. Such agreement or protocol  as  entered  into  by  the
physician,  PHYSICIAN ASSISTANT OR NURSE PRACTITIONER and [a pharmacist]
PHARMACISTS, may include[, and shall be limited to]:

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD06620-05-5

              

A. 5805                             2

  (i) [adjusting or managing] PRESCRIBING IN ORDER TO ADJUST OR MANAGE a
drug regimen of a patient, pursuant  to  a  patient  specific  [written]
order, or NON-PATIENT-SPECIFIC protocol made by the patient's physician,
PHYSICIAN  ASSISTANT  OR NURSE PRACTITIONER, which may include adjusting
drug  strength, frequency of administration or route of administration[.
Adjusting the drug regimen shall not include substituting or selecting a
different] OR  SELECTING  A  drug  which  differs  from  that  initially
prescribed  by  the  patient's  physician  [unless  such substitution is
expressly], PHYSICIAN ASSISTANT OR NURSE PRACTITIONER AS  authorized  in
the  written  order  or  protocol. [The pharmacist] PHARMACISTS shall be
required to [immediately enter into] DOCUMENT IN the patient record [any
change or] changes made to the patient's drug therapy and shall use  any
reasonable  means  or method established by the facility or [the depart-
ment] MEDICAL PRACTICE to notify [any of] the patient's  other  treating
physicians  [with  whom  he  or she does not have a written agreement or
protocol regarding such changes. The patient's physician  may  prohibit,
by  written  instruction, any adjustment or change in the patient's drug
regimen by the pharmacist], PHYSICIAN  ASSISTANTS,  NURSE  PRACTITIONERS
AND  OTHER  PROFESSIONALS  AS  REQUIRED  BY  THE  WRITTEN  AGREEMENT  OR
PROTOCOL;
  (ii) evaluating and, [only if specifically] AS authorized by  the  NEW
WRITTEN  AGREEMENT  OR  protocol  and  only  to  the extent necessary to
discharge the responsibilities  set  forth  in  this  section,  ordering
[clinical]  DISEASE  STATE  laboratory tests related to the drug therapy
management for the specific disease or disease [state] STATES  specified
within the WRITTEN AGREEMENT OR protocol; and
  (iii) [only if specifically] AS authorized by the WRITTEN AGREEMENT OR
protocol  and only to the extent necessary to discharge the responsibil-
ities set forth in this section, ordering or performing routine  patient
monitoring  functions  as  may  be necessary in the drug therapy manage-
ment[, including the collecting and reviewing of patient histories,  and
ordering  or checking patient vital signs, including pulse, temperature,
blood pressure and respiration].
  [b. "Written agreement or protocol" shall  mean  a  written  document,
pursuant to and consistent with any applicable state or federal require-
ments,  that  addresses  a  specific  disease  or disease state and that
describes the nature and scope of collaborative drug therapy  management
to  be  undertaken  by the pharmacist, in collaboration with the partic-
ipating physician, in accordance with the provisions of this section.
  c. "Physician" shall mean the physician, selected by or assigned to  a
patient,  who  has  primary responsibility for the treatment and care of
the patient for the disease or disease state that is the subject of  the
collaborative drug therapy management.
  d.]  C.  "Facility"  shall mean a [teaching] hospital, [including any]
diagnostic  center,  treatment  center,  or  hospital-based   outpatient
department,  [however,  for  the  purposes of this section,] residential
health care facilities [and] OR nursing [homes shall be  excluded]  HOME
OR  ANY  FACILITY  AS DEFINED IN SECTION TWENTY-EIGHT HUNDRED ONE OF THE
PUBLIC HEALTH LAW OR OTHER ENTITY  THAT  PROVIDES  DIRECT  PATIENT  CARE
UNDER THE AUSPICES OF A MEDICAL DIRECTOR.
  D.  "MEDICAL PRACTICE" SHALL MEAN A PLACE OR SITUATION IN WHICH PHYSI-
CIANS, PHYSICIAN ASSISTANTS AND NURSE PRACTITIONERS EITHER ALONE  OR  IN
GROUP PRACTICES PROVIDE DIAGNOSTIC AND TREATMENT CARE FOR PATIENTS. [For
the  purposes of this section, a "teaching hospital" shall mean a hospi-
tal licensed pursuant to article twenty-eight of the public  health  law
that  is  eligible to receive direct or indirect graduate medical educa-

A. 5805                             3

tion payments pursuant to article  twenty-eight  of  the  public  health
law.]
  E.  "PHYSICIAN,  PHYSICIAN ASSISTANT OR NURSE PRACTITIONER" SHALL MEAN
THE PHYSICIAN, PHYSICIAN ASSISTANT OR NURSE PRACTITIONER SELECTED BY  OR
ASSIGNED  TO A PATIENT, WHO HAS PRIMARY RESPONSIBILITY FOR THE TREATMENT
AND CARE OF THE PATIENT FOR THE DISEASE OR DISEASE  STATE  THAT  IS  THE
SUBJECT OF THE COLLABORATIVE DRUG THERAPY MANAGEMENT.
  F.  "WRITTEN  AGREEMENT  OR  PROTOCOL"  SHALL MEAN A WRITTEN DOCUMENT,
PURSUANT TO AND CONSISTENT WITH ANY APPLICABLE STATE OR FEDERAL REQUIRE-
MENTS, THAT ADDRESSES A SPECIFIC DISEASE  OR  DISEASE  STATES  AND  THAT
DESCRIBES  THE NATURE AND SCOPE OF COLLABORATIVE DRUG THERAPY MANAGEMENT
TO BE UNDERTAKEN BY THE PHARMACISTS, IN COLLABORATION WITH  THE  PARTIC-
IPATING  PHYSICIAN, PHYSICIAN ASSISTANT, NURSE PRACTITIONER OR FACILITY,
IN ACCORDANCE WITH THE PROVISIONS OF THIS SECTION.
  2. a. [A pharmacist who meets the experience requirements of paragraph
b of this subdivision and who is employed  by  or  otherwise  affiliated
with  a facility shall be permitted to enter into a written agreement or
protocol with a physician authorizing collaborative drug therapy manage-
ment, subject to the limitations set forth in this section,  within  the
scope of such employment or affiliation.
  b. A participating pharmacist] PARTICIPATING PHARMACISTS must:
  [(i)(A) have been awarded either a master of science in clinical phar-
macy or a doctor of pharmacy degree;
  (B)] (I) maintain a current unrestricted license; and
  [(C)  have  a  minimum  of two years experience, of which at least one
year of such experience shall include clinical experience  in  a  health
facility,  which  involves  consultation with physicians with respect to
drug therapy and may include a residency at a  facility  involving  such
consultation; or
  (ii)(A) have been awarded a bachelor of science in pharmacy;
  (B) maintain a current unrestricted license; and
  (C) within the last seven years, have a minimum of three years experi-
ence,  of which at least one year of such experience shall include clin-
ical experience in a health facility, which involves  consultation  with
physicians with respect to drug therapy and may include a residency at a
facility involving such consultation.
  c.] (II) SATISFY ANY TWO OF THE FOLLOWING CRITERIA:
  (A)  BOARD  CERTIFICATION FROM A NATIONAL ACCREDITING BODY AS APPROVED
BY THE DEPARTMENT IN CONSULTATION WITH THE STATE BOARD  OF  PHARMACY  OR
OTHER CREDENTIAL OR PROGRAM IN PHARMACY CLINICAL SERVICES AS APPROVED BY
THE DEPARTMENT, IN CONSULTATION WITH THE STATE BOARD OF PHARMACY;
  (B)  POSTGRADUATE RESIDENCY THROUGH AN ACCREDITED POSTGRADUATE PROGRAM
REQUIRING AT LEAST FIFTY PERCENT OF THE EXPERIENCE BE IN DIRECT  PATIENT
CARE SERVICES WITH INTERDISCIPLINARY TERMS; OR
  (C)  HAVE PROVIDED CLINICAL SERVICES TO PATIENTS FOR AT LEAST ONE YEAR
EITHER:
  (1) UNDER A COLLABORATIVE PRACTICE AGREEMENT OR PROTOCOL WITH A PHYSI-
CIAN, PHYSICIAN ASSISTANT, NURSE PRACTITIONER OR FACILITY; OR
  (2) HAS DOCUMENTED EXPERIENCE IN THE PROVISION OF CLINICAL SERVICES TO
PATIENTS FOR AT LEAST ONE YEAR OR ONE THOUSAND HOURS, OR AS APPROVED  BY
THE DEPARTMENT, IN CONSULTATION WITH THE STATE BOARD OF PHARMACY.
  B. NOTWITHSTANDING ANY PROVISION OF LAW, NOTHING IN THIS SECTION SHALL
PROHIBIT  A LICENSED PHARMACIST FROM ENGAGING IN CLINICAL SERVICES ASSO-
CIATED WITH COLLABORATIVE DRUG THERAPY  MANAGEMENT,  IN  ORDER  TO  GAIN
EXPERIENCE NECESSARY TO QUALIFY UNDER ITEM TWO OF CLAUSE (C) OF SUBPARA-
GRAPH  (II) OF PARAGRAPH A OF THIS SUBDIVISION, PROVIDED THAT SUCH PRAC-

A. 5805                             4

TICE IS UNDER THE SUPERVISION OF A PHARMACIST THAT CURRENTLY  MEETS  THE
REFERENCED  REQUIREMENT,  AND THAT SUCH PRACTICE IS AUTHORIZED UNDER THE
COLLABORATIVE DRUG THERAPY MANAGEMENT PROTOCOL WITH THE INVOLVED  PHYSI-
CIAN, PHYSICIAN ASSISTANT, NURSE PRACTITIONER OR FACILITY.
  3. Notwithstanding any provision of this section, nothing herein shall
authorize [the pharmacist] PHARMACISTS to diagnose disease. In the event
that a treating physician, PHYSICIAN ASSISTANT OR NURSE PRACTITIONER may
disagree  with  the exercise of professional judgment by [the] A pharma-
cist, the judgment of the treating  physician,  PHYSICIAN  ASSISTANT  OR
NURSE PRACTITIONER shall prevail.
  [3.  The  physician  who is a party to a written agreement or protocol
authorizing collaborative drug therapy management shall be  employed  by
or otherwise affiliated with the same facility with which the pharmacist
is also employed or affiliated.
  4.  The  existence of a written agreement or protocol on collaborative
drug therapy management and the patient's right to choose to not partic-
ipate in collaborative drug therapy management shall be disclosed to any
patient who is eligible to receive collaborative  drug  therapy  manage-
ment. Collaborative drug therapy management shall not be utilized unless
the  patient  or  the  patient's  authorized representative consents, in
writing, to such management. If the patient or the patient's  authorized
representative  consents,  it  shall  be  noted on the patient's medical
record. If the patient or the patient's  authorized  representative  who
consented  to collaborative drug therapy management chooses to no longer
participate in such management, at any time, it shall be  noted  on  the
patient's  medical  record.  In  addition,  the existence of the written
agreement or protocol and the patient's consent to such management shall
be disclosed to the patient's primary physician and any  other  treating
physician or healthcare provider.]
  4. PHARMACISTS WHO ARE CERTIFIED BY THE DEPARTMENT TO ENGAGE IN COLLA-
BORATIVE  DRUG  THERAPY MANAGEMENT MAY ENTER INTO A WRITTEN AGREEMENT OR
PROTOCOL WITH A PHYSICIAN, PHYSICIAN ASSISTANT OR NURSE PRACTITIONER  AS
AN  INDEPENDENT  HEALTH CARE PROVIDER OR AS AN EMPLOYEE OF A PHARMACY OR
OTHER HEALTH CARE PROVIDER. IN  A  FACILITY,  THE  PHYSICIAN,  PHYSICIAN
ASSISTANT  OR NURSE PRACTITIONER AND THE PHARMACIST WHO ARE PARTIES TO A
WRITTEN AGREEMENT OR PROTOCOL  AUTHORIZING  COLLABORATIVE  DRUG  THERAPY
MANAGEMENT  SHALL  BE  EMPLOYED  BY  OR BE OTHERWISE AFFILIATED WITH THE
FACILITY.
  5. Participation in a written agreement or protocol authorizing colla-
borative drug therapy management shall be  voluntary,  and  no  patient,
physician,  [pharmacist, or facility] PHYSICIAN ASSISTANT, NURSE PRACTI-
TIONER OR PHARMACIST shall be required to participate.
  [6. Nothing in this section shall be deemed  to  limit  the  scope  of
practice of pharmacy nor be deemed to limit the authority of pharmacists
and physicians to engage in medication management prior to the effective
date of this section and to the extent authorized by law.]
  S  2. Section 5 of chapter 21 of the laws of 2011, amending the educa-
tion law relating to authorizing pharmacists  to  perform  collaborative
drug  therapy management with physicians in certain settings, as amended
by chapter 125 of the laws of 2014, is amended to read as follows:
  S 5. This act shall take effect on the one hundred twentieth day after
it shall have become a law [and shall expire 4 years after  such  effec-
tive date when upon such date the provisions of this act shall be deemed
repealed];  provided,  however,  that the amendments to subdivision 1 of
section 6801 of the education law made by section one of this act  shall
be  subject to the expiration and reversion of such subdivision pursuant

A. 5805                             5

to section 8 of chapter 563 of the laws of 2008, when upon such date the
provisions of section one-a of this act  shall  take  effect;  provided,
further,  that  effective  immediately,  the  addition, amendment and/or
repeal  of  any  rule  or regulation necessary for the implementation of
this act on its effective date is authorized and directed to be made and
completed on or before such effective date.
  S 3. This act shall take effect immediately, provided that section one
of this act shall take effect on the one hundred twentieth day after  it
shall have become a law; provided, further, that, effective immediately,
the  addition,  amendment and/or repeal of any rule or regulation neces-
sary for the implementation of this act on its effective date is author-
ized and directed to be made and completed on or before  such  effective
date.