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

                                 7521--A

                       2013-2014 Regular Sessions

                          I N  A S S E M B L Y

                              May 23, 2013
                               ___________

Introduced  by M. of A. McDONALD, WEPRIN, RA -- Multi-Sponsored by -- M.
  of A. BRENNAN, SCHIMEL -- read once and referred to the  Committee  on
  Higher  Education  -- recommitted to the Committee on Higher Education
  in accordance with Assembly Rule 3, sec. 2  --  committee  discharged,
  bill  amended,  ordered  reprinted  as amended and recommitted to said
  committee

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 REVIEW, EVALUATION AND  MANAGE-
MENT OF DRUG THERAPY TO A PATIENT.
  B.  "Collaborative drug therapy management" shall mean the performance
of CLINICAL services by a pharmacist 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 agree-
ment or protocol with a voluntarily participating  physician,  PHYSICIAN
ASSISTANT,  NURSE  PRACTITIONER  OR  FACILITY and in accordance with the
policies, procedures, and protocols of [the]  A  facility  OR  PRACTICE.
Such  agreement  or protocol as entered into by the physician, PHYSICIAN

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD10244-03-4

              

A. 7521--A                          2

ASSISTANT OR NURSE PRACTITIONER and  a  pharmacist,  may  include[,  and
shall be limited to]:
  (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, NURSE PRACTITIONER, OR FACILITY, which may  include
adjusting  drug strength, frequency of administration or route of admin-
istration[. 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 substi-
tution  is  expressly],PHYSICIAN  ASSISTANT  OR  NURSE  PRACTITIONER  AS
authorized  in  the  written  order or protocol. The pharmacist 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] PRACTICE to notify [any of] the patient's  other  treating  physi-
cians [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 FACILITY OR THE COLLABORATIVE PRACTICE
AGREEMENT;
  (ii) evaluating and, [only  if  specifically]  AS  authorized  by  the
protocol  and only to the extent necessary to discharge the responsibil-
ities set forth in this section, ordering [clinical] DISEASE STATE labo-
ratory tests related to the drug therapy  management  for  the  specific
disease or disease [state] STATES specified within the protocol; and
  (iii) [only if specifically] AS authorized by the protocol and only to
the extent necessary to discharge the responsibilities set forth in this
section,  ordering or performing routine patient monitoring functions as
may be necessary in the drug therapy management[, including the collect-
ing and reviewing of patient histories, and ordering or checking patient
vital signs, including pulse, temperature, blood pressure  and  respira-
tion].
  [b.] C. "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] STATES and
that describes the  nature  and  scope  of  collaborative  drug  therapy
management to be undertaken by the pharmacist, in collaboration with the
participating  physician,  PHYSICIAN  ASSISTANT,  NURSE  PRACTITIONER OR
FACILITY, in accordance with the provisions of this section.
  [c.] D. "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.
  [d.] E. "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.  IN ADDITION, A PRACTICE SHALL
MEAN A PLACE OR SITUATION IN WHICH PHYSICIANS, PHYSICIAN ASSISTANTS  AND
NURSE  PRACTITIONERS EITHER ALONE OR IN GROUP PRACTICES PROVIDE DIAGNOS-
TIC AND TREATMENT CARE FOR PATIENTS. [For the purposes of this  section,

A. 7521--A                          3

a "teaching hospital" shall mean a hospital licensed pursuant to article
twenty-eight of the public health law that is eligible to receive direct
or  indirect  graduate  medical  education  payments pursuant to article
twenty-eight of the public health law.]
  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] CERTIFIED BY THE DEPARTMENT TO ENGAGE IN COLLABORATIVE
DRUG THERAPY MANAGEMENT AND WHO  IS  EITHER  EMPLOYED  BY  OR  OTHERWISE
AFFILIATED  WITH A FACILITY OR IS PARTICIPATING WITH A PRACTICING PHYSI-
CIAN, PHYSICIAN ASSISTANT OR NURSE PRACTITIONER shall  be  permitted  to
enter  into  a written agreement or protocol with a physician, PHYSICIAN
ASSISTANT, NURSE PRACTITIONER OR FACILITY authorizing collaborative drug
therapy management,  subject  to  the  limitations  set  forth  in  this
section,  within  the  scope  of  such  employment  [or], affiliation OR
PARTICIPATION.  ONLY PHARMACISTS SO CERTIFIED MAY ENGAGE  IN  COLLABORA-
TIVE DRUG THERAPY MANAGEMENT AS DEFINED IN THIS SECTION.
  b. A participating pharmacist must:
  (i)(A) [have been awarded either a master of science in clinical phar-
macy or a doctor of pharmacy degree;
  (B)] 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.] (B) SATISFY ANY TWO OF THE FOLLOWING CRITERIA:
  (I)  CERTIFICATION  IN  A  RELEVANT AREA OF PRACTICE INCLUDING BUT NOT
LIMITED TO AMBULATORY CARE, CRITICAL CARE, GERIATRIC  PHARMACY,  NUCLEAR
PHARMACY, NUTRITION SUPPORT PHARMACY, ONCOLOGY PHARMACY, PEDIATRIC PHAR-
MACY,  PHARMACOTHERAPY, OR PSYCHIATRIC PHARMACY, FROM A NATIONAL ACCRED-
ITING BODY AS APPROVED BY THE DEPARTMENT;
  (II) 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
  (III)  HAVE  PROVIDED  CLINICAL  SERVICES TO PATIENTS FOR AT LEAST ONE
YEAR EITHER:
  (A) UNDER A COLLABORATIVE PRACTICE AGREEMENT OR PROTOCOL WITH A PHYSI-
CIAN, PHYSICIAN ASSISTANT, NURSE PRACTITIONER OR FACILITY; OR
  (B) HAS DOCUMENTED EXPERIENCE IN PROVISION  OF  CLINICAL  SERVICES  TO
PATIENTS FOR AT LEAST ONE YEAR OR ONE THOUSAND HOURS, AND DEEMED ACCEPT-
ABLE TO THE DEPARTMENT UPON RECOMMENDATION OF THE BOARD OF PHARMACY.
  (C)  NOTWITHSTANDING  ANY  PROVISION  OF  LAW, NOTHING IN THIS SECTION
SHALL PROHIBIT A LICENSED PHARMACIST FROM ENGAGING IN CLINICAL  PRACTICE
ASSOCIATED  WITH COLLABORATIVE DRUG THERAPY MANAGEMENT, IN ORDER TO GAIN
EXPERIENCE NECESSARY TO QUALIFY UNDER ITEM (B) OF CLAUSE (III)  OF  THIS
SUBPARAGRAPH,  PROVIDED THAT SUCH PRACTICE IS UNDER THE SUPERVISION OF A
PHARMACIST THAT CURRENTLY MEETS THE  REFERENCED  REQUIREMENT,  AND  THAT
SUCH PRACTICE IS AUTHORIZED UNDER THE COLLABORATIVE DRUG THERAPY MANAGE-

A. 7521--A                          4

MENT  PROTOCOL  WITH  THE INVOLVED PHYSICIAN, PHYSICIAN ASSISTANT, NURSE
PRACTITIONER OR FACILITY.
  3. Notwithstanding any provision of this section, nothing herein shall
authorize the pharmacist to diagnose disease. In the event that a treat-
ing  physician,  PHYSICIAN  ASSISTANT OR NURSE PRACTITIONER may disagree
with the exercise of professional judgment by the pharmacist, the  judg-
ment of the treating physician, PHYSICIAN ASSISTANT OR NURSE PRACTITION-
ER 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. A PHARMACIST WHO IS CERTIFIED BY THE DEPARTMENT TO ENGAGE IN COLLA-
BORATIVE  DRUG THERAPY MANAGEMENT MAY ENTER INTO A WRITTEN COLLABORATIVE
PRACTICE AGREEMENT OR PROTOCOL WITH A  PHYSICIAN,  PHYSICIAN  ASSISTANT,
NURSE PRACTITIONER OR PRACTICE AS AN INDEPENDENT HEALTH CARE PROVIDER OR
AS AN EMPLOYEE OF A PHARMACY OR OTHER HEALTH CARE PROVIDER. IN A FACILI-
TY,  THE  PHYSICIAN,  PHYSICIAN  ASSISTANT OR NURSE PRACTITIONER AND THE
PHARMACIST WHO ARE PARTIES TO A WRITTEN AGREEMENT OR PROTOCOL  AUTHORIZ-
ING  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]  PHYSICIAN  ASSISTANT, NURSE PRACTITIONER,
facility 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, 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 3 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
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,

A. 7521--A                          5

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.