NY State Senate Bill 2015-S280

Senate Bill S280

2015-2016 Legislative Session

Includes nurse practitioners as a provider of services for purposes of collaborative drug therapy management and makes the authorization for pharmacists to perform such management permanent

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Archive: Last Bill Status - In Senate Committee Higher Education Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 06, 2016	referred to higher education
Jan 07, 2015	referred to higher education

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2015-S280 (ACTIVE) - Details

Current Committee:: Senate Higher Education
Law Section:: Education Law
Laws Affected:: Amd §6801-a, Ed L; amd §5, Chap 21 of 2011
Versions Introduced in Other Legislative Sessions:: 2013-2014: S5400
2017-2018: S4296
2021-2022: S4689
2023-2024: S4043

2015-S280 (ACTIVE) - Summary

Includes nurse practioners as a provider of services for purposes of collaborative drug therapy management and makes the authorization for pharmacists to perform such management permanent.

2015-S280 (ACTIVE) - Sponsor Memo

                                 BILL NUMBER:  S280

 TITLE OF BILL :  An act to amend the education law, in relation to
including nurse practitioners as a provider of services for purposes
of 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 management with
physicians in certain settings, in relation to making the
authorization for pharmacists to perform collaborative drug therapy
management permanent

 PURPOSE :  To extend and expand provisions enacted in 2011 that
permit pharmacists to collaborate with physicians in the provision of
collaborative drug therapy.

 SUMMARY OF PROVISIONS :  The bill would extend and make permanent the
Collaborative Drug Therapy Demonstration Project and expand the scope
of the authorization for collaborative drug therapy management (CDTM)
as follows:

Section one of the bill would amend section 6801-a of the Education
Law as follows:

* Deletes reference to a "demonstration program" in the title of the
section;

* Adds nurse practitioners (NPs) to the legislation to allow NPs to
enter into collaborative agreements with pharmacists by which drug
therapies would be reviewed, evaluated and managed;

* Authorizes CDTM to occur in all hospitals and other Article 28
facilities, such as nursing homes and clinics; and

* Permits the State Education Department in consultation with the
Department of Health, to include up to fifteen community practice
sites as authorized locations for the provision of CDTM.

Section two of the bill would repeal the expiration date of the prior
statute and make the provisions permanent.

 EXISTING LAW :

Section 6801-a established the CDTM Demonstration Program and
authorized physicians and pharmacists in teaching hospitals (including
clinics associated with them) to engage in collaborative drug therapy
management. The existing law authorizes pharmacists and physicians,
pursuant to protocols entered into between them, to adjust and manage
a drug regimen of a patient, including adjusting drug strength,
frequency of administration and route of administration. If authorized
by the protocol, the substitution of a different drug may also be
permitted. In addition, requirements relating to follow up with the
patient's treating physicians, the qualifications of the pharmacists
and various other requirements and limitations exist in the current
law.

 JUSTIFICATION :  Legislation was enacted in 2011 to establish the
Collaborative Drug Therapy Management Demonstration Program, by which
pharmacists, working in collaborative agreements with physicians,
could adjust, manage, evaluate and implement drug therapies for
patients in certain settings. The current law only applies to teaching
hospitals and their affiliated outpatient and freestanding clinics A
report on the results of the current statute will be issued in late
2013 or early 2014 but all preliminary reports have indicated that the
legislation has been successfully implemented by eligible facilities
and the collaboration between pharmacists and physicians has been very
much in the interest of promoting the best interests of their
patients.  This bill would extend the current program to all Article
28 licensed health care facilities (hospitals, clinics and residential
health care facilities) as well as permit the practice on a more
limited basis in certain community based settings. The bill would also
permit nurse practitioners to engage in the collaborative agreements
with pharmacists.

Adverse drug reactions or adverse drug events (ADRs or ADEs) are
reported to be among the leading causes of death in the United States,
behind only heart disease, cancer and stroke. The most updated
information on ADRs suggests that these earlier estimates may actually
understate the problem. A recent comprehensive study of medication
errors, estimated that as many as 2.7 million medication errors occur
each year in hospitals in the United States, adversely affecting
130,000 patients. Studies have shown that at least 28% of these errors
were preventable. Nearly half of the errors made were the result of
errors in the prescribing process. These errors are not only
potentially dangerous to patients, they are extremely costly to the
health care system, resulting in additional and unnecessary
expenditures of as much as $177 billion per year. Of this amount,
seventy percent was attributed to unnecessary hospital admissions or
prolonged hospital stays due to medication errors.

Virtually every other state permits CDTM, most of which authorize the
practice in many more settings than permitted under the current New
York State law and the results have been uniformly positive: CDTM
along with pharmacist provided drug information services, adverse drug
reaction monitoring, drug protocol management and medial rounds
participation by pharmacists have all shown to make a statistically
significant contribution to the reduction of medication errors. The
expansion of the statute to additional settings and the authorizing of
Nurse Practitioners as collaborating practitioners is warranted not
only by the success of the New York State initiative, but based on the
records of other states.

 LEGISLATIVE HISTORY : Chapter 21 of the Laws of 2011

 FISCAL IMPLICATIONS : None

 EFFECTIVE DATE : The one hundred twentieth day after which it shall
have become law.

2015-S280 (ACTIVE) - Bill Text download pdf

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

                                   280

                       2015-2016 Regular Sessions

                            I N  S E N A T E

                               (PREFILED)

                             January 7, 2015
                               ___________

Introduced  by  Sen. LAVALLE -- read twice and ordered printed, and when
  printed to be committed to the Committee on Higher Education

AN ACT to amend the education law, in relation to including nurse  prac-
  titioners as a provider of services for purposes of collaborative drug
  therapy management; and to amend chapter 21 of the laws of 2011 amend-
  ing  the  education law relating to authorizing pharmacists to perform
  collaborative drug  therapy  management  with  physicians  in  certain
  settings,  in  relation to making the authorization for pharmacists to
  perform collaborative drug therapy management 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. "Collaborative drug therapy management" shall mean the  performance
of  services  by  a  pharmacist  relating  to the review, evaluation and
management of drug therapy to a patient,  who  is  being  treated  by  a
physician OR NURSE PRACTITIONER for a specific disease or disease state,
in  accordance  with  a written agreement or protocol with a voluntarily
participating physician OR NURSE PRACTITIONER and in accordance with the
policies, procedures, and protocols of the facility. Such  agreement  or
protocol  as  entered  into by the physician OR NURSE PRACTITIONER and a
pharmacist, may include, and shall be limited to:
  (i) adjusting or managing a drug regimen of a patient, pursuant  to  a
patient  specific written order or protocol made by the patient's physi-
cian 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

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

                                                           LBD03272-01-5

S. 280                              2

drug  which  differs  from  that  initially  prescribed by the patient's
physician OR NURSE PRACTITIONER unless such  substitution  is  expressly
authorized  in  the  written  order or protocol. The pharmacist shall be
required  to  immediately  enter  into  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 department to notify
any of the patient's other treating physicians  OR  NURSE  PRACTITIONERS
with  whom  he  or  she  does  not  have a written agreement or protocol
regarding such changes. The patient's physician  OR  NURSE  PRACTITIONER
may  prohibit,  by  written instruction, any adjustment or change in the
patient's drug regimen by the pharmacist;
  (ii) evaluating and, only if specifically authorized by  the  protocol
and  only  to the extent necessary to discharge the responsibilities set
forth in this section, ordering clinical laboratory tests related to the
drug therapy management for the specific disease or disease state speci-
fied within the protocol; and
  (iii) only if specifically 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.  "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  OR  NURSE  PRACTITIONER,  in  accordance  with  the
provisions of this section.
  c. "Physician OR NURSE PRACTITIONER" shall mean the physician 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. "Facility" shall mean a [teaching] hospital, [including  any  diag-
nostic  center,  treatment  center, or hospital-based outpatient depart-
ment, however, for the purposes of this section, residential health care
facilities and nursing homes shall be excluded] AS DEFINED  BY  SUBDIVI-
SION  ONE  OF SECTION TWENTY-EIGHT HUNDRED ONE OF THE PUBLIC HEALTH LAW.
[For the purposes of this section, 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.]  IN ADDITION, A FACILITY MAY ALSO INCLUDE UP TO FIFTEEN COMMUNITY-
PRACTICE SITES, SELECTED BY THE  DEPARTMENT  IN  CONSULTATION  WITH  THE
DEPARTMENT  OF HEALTH, WHERE PHARMACISTS AND PHYSICIANS OR NURSE PRACTI-
TIONERS MAY PROPOSE TO ENTER INTO COLLABORATIVE  ARRANGEMENTS,  PURSUANT
TO  THE  PROVISIONS  OF THIS SECTION. SUCH SITES SHALL BE SELECTED BASED
UPON A REVIEW OF APPLICATIONS SUBMITTED TO THE DEPARTMENT BY SUCH  PHAR-
MACISTS  AND  PHYSICIANS  OR NURSE PRACTITIONERS, WHICH DEMONSTRATE THAT
THE APPLICANTS CAN SATISFY THE REQUIREMENTS OF THIS SECTION.
  2. a. A pharmacist who meets the experience requirements of  paragraph
b  of this subdivision and who is EITHER employed by or otherwise affil-
iated with a facility OR IS PARTICIPATING WITH A COMMUNITY-PRACTICE SITE
SELECTED PURSUANT TO PARAGRAPH D OF  SUBDIVISION  ONE  OF  THIS  SECTION

S. 280                              3

shall  be permitted to enter into a written agreement or protocol with a
physician OR NURSE PRACTITIONER authorizing collaborative  drug  therapy
management, subject to the limitations set forth in this section, within
the scope of such employment [or], affiliation OR PARTICIPATION.
  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 facili-
ty, which involves consultation with physicians OR  NURSE  PRACTITIONERS
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 OR NURSE PRACTITIONERS with respect to drug therapy  and  may
include a residency at a facility involving such consultation.
  c. Notwithstanding any provision of this section, nothing herein shall
authorize the pharmacist to diagnose disease. In the event that a treat-
ing  physician  OR  NURSE PRACTITIONER may disagree with the exercise of
professional judgment by the pharmacist, the judgment  of  the  treating
physician OR NURSE PRACTITIONER shall prevail.
  3.  The  physician  OR  NURSE PRACTITIONER who is a party to a written
agreement or protocol authorizing collaborative drug therapy  management
IN  A FACILITY SETTING shall be employed by or otherwise affiliated with
the same facility with which the pharmacist is also employed  or  affil-
iated.
  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  OR  NURSE  PRACTITIONER
and  any  other  treating  physician OR NURSE PRACTITIONER or healthcare
provider.
  5. Participation in a written agreement or protocol authorizing colla-
borative drug therapy management shall be  voluntary,  and  no  patient,
physician, NURSE PRACTITIONER, pharmacist, or facility shall be required
to participate.
  6. Nothing in this section shall be deemed to limit the scope of prac-
tice of pharmacy nor be deemed to limit the authority of pharmacists and
physicians  OR  NURSE  PRACTITIONERS  to engage in medication management
prior to the effective date of this section and to the extent authorized
by law.

S. 280                              4

  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
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 on the one hundred twentieth day after
it shall have become a law; provided 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.

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Senate Bill S280

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Sponsored By

Kenneth P. LaValle