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A03048 Summary:

BILL NOA03048
 
SAME ASNo Same As
 
SPONSORSeawright
 
COSPNSR
 
MLTSPNSR
 
Amd 6801-a, Ed L; amd 5, Chap 21 of 2011
 
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.
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A03048 Actions:

BILL NOA03048
 
01/28/2019referred to higher education
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A03048 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A3048                   Revised Memo 2/4/19
 
SPONSOR: Seawright
  TITLE OF BILL: 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 amending the education law relating to authorizing pharmacists to perform colla- borative drug therapy management with physicians in certain settings, in relation to making the authorization for pharmacists to perform collabo- rative drug therapy management permanent   PURPOSE OR GENERAL IDEA OF BILL: 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.   DIFFERENCE BETWEEN ORIGINAL AND AMENDED VERSION (IF APPLICABLE): 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 manage- ment. 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 proto- col, 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, eval- uate 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 under- state 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 cost- ly to the health care system, resulting in additional and unnecessary expenditures of as much as $177 billion per year. Of this amount, seven- ty 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 addi- tional settings and the authorizing of Nurse Practitioners as collab- orating practitioners is warranted not only by the success of the New York State initiative, but based on the records of other states.   PRIOR LEGISLATIVE HISTORY: 2017-18 A10196 (Seawright) Referred to Higher Education Committee/ S4296 (LaValle) Ordered to Third Reading 2015-16 S280 (LaValle) Referred to Higher Education Committee 2011 Chapter 21 of the Laws of 2011   FISCAL IMPLICATIONS FOR STATE AND LOCAL GOVERNMENTS: None.   EFFECTIVE DATE: This act shall take effect on the one hundred twentieth day after it shall have become a law; provided that, effective immediately, the addi- tion, amendment and/or repeal of any rule or regulation necessary for the implementation of this act on its effective date are authorized and directed to be made and completed on or before such effective date.
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A03048 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          3048
 
                               2019-2020 Regular Sessions
 
                   IN ASSEMBLY
 
                                    January 28, 2019
                                       ___________
 
        Introduced  by  M.  of  A.  SEAWRIGHT  --  read once and referred 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:
 
     1    Section  1. Section 6801-a of the education law, as amended by chapter
     2  238 of the laws of 2015, is amended to read as follows:
     3    §  6801-a.  Collaborative  drug  therapy   management   [demonstration
     4  program].    1.  As used in this section, the following terms shall have
     5  the following meanings:
     6    a. "Board" shall mean the state board of pharmacy  as  established  by
     7  section sixty-eight hundred four of this article.
     8    b. "Clinical services" shall mean the collection and interpretation of
     9  patient  data  for  the  purpose of initiating, modifying and monitoring
    10  drug therapy  with  associated  accountability  and  responsibility  for
    11  outcomes in a direct patient care setting.
    12    c.  "Collaborative drug therapy management" shall mean the performance
    13  of clinical services by a pharmacist relating to the review,  evaluation
    14  and  management  of drug therapy to a patient, who is being treated by a
    15  physician or nurse practitioner for a  specific  disease  or  associated
    16  disease  states, in accordance with a written agreement or protocol with
    17  a voluntarily participating  physician  or  nurse  practitioner  and  in
    18  accordance with the policies, procedures, and protocols of the facility.
    19  Such  agreement  or  protocol  as entered into by the physician or nurse
    20  practitioner and a pharmacist, may include, and shall be limited to:
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD04907-01-9

        A. 3048                             2
 
     1    (i) adjusting or managing a drug regimen of a patient, pursuant  to  a
     2  patient  specific  order  or protocol made by the patient's physician or
     3  nurse practitioner, which may include adjusting drug strength, frequency
     4  of administration or route of administration. Adjusting the drug regimen
     5  shall  not  include  substituting  or  selecting  a different drug which
     6  differs from that initially prescribed by  the  patient's  physician  or
     7  nurse  practitioner  unless such substitution is expressly authorized in
     8  the written order or protocol. The pharmacist shall be required to imme-
     9  diately document in the patient record changes  made  to  the  patient's
    10  drug therapy and shall use any reasonable means or method established by
    11  the  facility to notify the patient's other treating physicians or nurse
    12  practitioners with whom he or she does not have a written  agreement  or
    13  protocol  regarding such changes. The patient's physician or nurse prac-
    14  titioner may prohibit, by written instruction, any adjustment or  change
    15  in the patient's drug regimen by the pharmacist;
    16    (ii)  evaluating  and, only if specifically authorized by the protocol
    17  and only to the extent necessary to discharge the  responsibilities  set
    18  forth  in  this section, ordering disease state laboratory tests related
    19  to the drug therapy management for the specific disease or disease state
    20  specified within the written agreement or protocol; and
    21    (iii) only if specifically authorized  by  the  written  agreement  or
    22  protocol  and only to the extent necessary to discharge the responsibil-
    23  ities set forth in this section, ordering or performing routine  patient
    24  monitoring functions as may be necessary in the drug therapy management,
    25  including  the collecting and reviewing of patient histories, and order-
    26  ing or checking patient vital signs, including pulse, temperature, blood
    27  pressure and respiration.
    28    d. "Facility" shall mean: (i) a [teaching hospital or general]  hospi-
    29  tal,  [including  any  diagnostic center, treatment center, or hospital-
    30  based outpatient department] as defined in subdivision  one  of  section
    31  twenty-eight  hundred  one  of  the public health law; or (ii) a nursing
    32  home  with  an  on-site  pharmacy  staffed  by  a  licensed  pharmacist;
    33  provided,  however, for the purposes of this section the term "facility"
    34  shall not  include  dental  clinics,  dental  dispensaries,  residential
    35  health care facilities and rehabilitation centers.
    36    [For  the purposes of this section, a "teaching hospital" shall mean a
    37  hospital licensed pursuant to article twenty-eight of the public  health
    38  law  that  is  eligible  to  receive direct or indirect graduate medical
    39  education payments pursuant to article twenty-eight of the public health
    40  law.] In addition, a facility may also include up to fifteen  community-
    41  practice  sites,  selected  by  the  department in consultation with the
    42  department of health, where pharmacists and physicians or nurse  practi-
    43  tioners  may  propose to enter into collaborative arrangements, pursuant
    44  to the provisions of this section. Such sites shall  be  selected  based
    45  upon  a review of applications submitted to the department by such phar-
    46  macists and physicians or nurse practitioners,  which  demonstrate  that
    47  the applicants can satisfy the requirements of this section.
    48    e.  "Physician"  or  "nurse  practitioner" shall mean the physician or
    49  nurse practitioner selected by or assigned to a patient, who has primary
    50  responsibility for the treatment and care of the patient for the disease
    51  and associated disease states that are the subject of the  collaborative
    52  drug therapy management.
    53    f.  "Written  agreement  or  protocol"  shall mean a written document,
    54  pursuant to and consistent with any applicable state or federal require-
    55  ments, that addresses a specific disease or  associated  disease  states
    56  and  that  describes  the nature and scope of collaborative drug therapy

        A. 3048                             3
 
     1  management to be undertaken by the pharmacists,  in  collaboration  with
     2  the participating physician or nurse practitioner in accordance with the
     3  provisions of this section.
     4    2.  a. A pharmacist who meets the experience requirements of paragraph
     5  b of this subdivision and who is either employed by or otherwise  affil-
     6  iated with a facility or is participating with a community-practice site
     7  selected  pursuant  to  paragraph  d  of subdivision one of this section
     8  shall be permitted to enter into a written agreement or protocol with  a
     9  physician  or  nurse practitioner authorizing collaborative drug therapy
    10  management, subject to the limitations set forth in this section, within
    11  the scope of such employment [or], affiliation or participation.
    12    b. A participating pharmacist must:
    13    (i)(A) have been awarded either a master of science in clinical  phar-
    14  macy or a doctor of pharmacy degree;
    15    (B) maintain a current unrestricted license; and
    16    (C) have a minimum of two years experience, of which at least one year
    17  of such experience shall include clinical experience in a health facili-
    18  ty,  which  involves consultation with physicians or nurse practitioners
    19  with respect to drug therapy and may include a residency at  a  facility
    20  involving such consultation; or
    21    (ii)(A) have been awarded a bachelor of science in pharmacy;
    22    (B) maintain a current unrestricted license; and
    23    (C) within the last seven years, have a minimum of three years experi-
    24  ence,  of which at least one year of such experience shall include clin-
    25  ical experience in a health facility, which involves  consultation  with
    26  physicians  or  nurse practitioners with respect to drug therapy and may
    27  include a residency at a facility involving such consultation; and
    28    (iii) meet any additional education, experience, or other requirements
    29  set forth by the department in consultation with the board.
    30    c. Notwithstanding any provision of law, nothing in this section shall
    31  prohibit a licensed pharmacist from engaging in clinical services  asso-
    32  ciated  with  collaborative  drug  therapy  management, in order to gain
    33  experience necessary to qualify under clause (C) of subparagraph (i)  or
    34  (ii)  of paragraph b of this subdivision, provided that such practice is
    35  under the supervision of a pharmacist that currently  meets  the  refer-
    36  enced  requirement, and that such practice is authorized under the writ-
    37  ten agreement or protocol with the physician or nurse practitioner.
    38    d. Notwithstanding any provision of this section, nothing herein shall
    39  authorize the pharmacist to diagnose disease. In the event that a treat-
    40  ing physician or nurse practitioner may disagree with  the  exercise  of
    41  professional  judgment  by  a  pharmacist,  the judgment of the treating
    42  physician or nurse practitioner shall prevail.
    43    3. The physician or nurse practitioner who is a  party  to  a  written
    44  agreement  or protocol authorizing collaborative drug therapy management
    45  shall be employed by or otherwise affiliated with the same facility with
    46  which the pharmacist is also employed or affiliated.
    47    4. The existence of a written agreement or protocol  on  collaborative
    48  drug therapy management and the patient's right to choose to not partic-
    49  ipate in collaborative drug therapy management shall be disclosed to any
    50  patient  who  is  eligible to receive collaborative drug therapy manage-
    51  ment. Collaborative drug therapy management shall not be utilized unless
    52  the patient or the  patient's  authorized  representative  consents,  in
    53  writing,  to such management. If the patient or the patient's authorized
    54  representative consents, it shall be  noted  on  the  patient's  medical
    55  record.  If  the  patient or the patient's authorized representative who
    56  consented to collaborative drug therapy management chooses to no  longer

        A. 3048                             4
 
     1  participate  in  such  management, at any time, it shall be noted on the
     2  patient's medical record. In addition,  the  existence  of  the  written
     3  agreement or protocol and the patient's consent to such management shall
     4  be  disclosed  to  the patient's primary physician or nurse practitioner
     5  and any other treating physician or  nurse  practitioner  or  healthcare
     6  provider.
     7    5. Participation in a written agreement or protocol authorizing colla-
     8  borative  drug  therapy  management  shall be voluntary, and no patient,
     9  physician or  nurse  practitioner,  pharmacist,  or  facility  shall  be
    10  required to participate.
    11    6. Nothing in this section shall be deemed to limit the scope of prac-
    12  tice of pharmacy nor be deemed to limit the authority of pharmacists and
    13  physicians  or  nurse  practitioners  to engage in medication management
    14  prior to the effective date of this section and to the extent authorized
    15  by law.
    16    § 2. Section 5 of chapter 21 of the laws of 2011 amending  the  educa-
    17  tion  law  relating  to authorizing pharmacists to perform collaborative
    18  drug therapy management with physicians in certain settings, as  amended
    19  by section 5 of part DD of chapter 57 of the laws of 2018, is amended to
    20  read as follows:
    21    § 5. This act shall take effect on the one hundred twentieth day after
    22  it  shall  have become a law[, provided, however, that the provisions of
    23  sections two, three, and four of this act shall  expire  and  be  deemed
    24  repealed July 1, 2020]; provided, however, that the amendments to subdi-
    25  vision  1  of  section  6801 of the education law made by section one of
    26  this act shall be subject to the expiration and reversion of such subdi-
    27  vision pursuant to section 8 of chapter 563 of the laws  of  2008,  when
    28  upon  such  date  the provisions of section one-a of this act shall take
    29  effect; provided, further, that  effective  immediately,  the  addition,
    30  amendment  and/or  repeal  of  any  rule or regulation necessary for the
    31  implementation of this act on its  effective  date  are  authorized  and
    32  directed to be made and completed on or before such effective date.
    33    § 3. This act shall take effect on the one hundred twentieth day after
    34  it  shall have become a law. Effective immediately, the addition, amend-
    35  ment and/or repeal of any rule or regulation necessary for the implemen-
    36  tation of this act on its effective date are authorized to be  made  and
    37  completed on or before such effective date.
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