Bill Text: NY A01193 | 2019-2020 | General Assembly | Introduced

NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Requires optometrists to meet certain standards, including the completion of a course, to prescribe oral medications.

Spectrum: Slight Partisan Bill (Democrat 76-26)

Status: (Engrossed - Dead) 2020-07-21 - REFERRED TO RULES [A01193 Detail]

Download: New_York-2019-A01193-Introduced.html


                STATE OF NEW YORK
        ________________________________________________________________________
                                          1193
                               2019-2020 Regular Sessions
                   IN ASSEMBLY
                                    January 14, 2019
                                       ___________
        Introduced  by  M.  of  A.  PAULIN, COOK, CYMBROWITZ, ABINANTI, GUNTHER,
          WEPRIN, HEVESI, RYAN, TITUS,  STIRPE,  BUCHWALD,  DiPIETRO,  BRABENEC,
          BLAKE,  FAHY, ORTIZ, COLTON, NORRIS, BARRETT, PHEFFER AMATO, DINOWITZ,
          LALOR, ZEBROWSKI, STECK,  HUNTER,  BRONSON,  SOLAGES,  PEOPLES-STOKES,
          DE LA ROSA,  B. MILLER, RAIA, GARBARINO, MORINELLO, FITZPATRICK, DICK-
          ENS, MAGNARELLI, PICHARDO, SANTABARBARA,  GIGLIO,  D. ROSENTHAL,  KIM,
          RODRIGUEZ,  ABBATE,  JONES, ARROYO, VANEL, McDONOUGH, AUBRY, L. ROSEN-
          THAL,  ENGLEBRIGHT,  LAVINE,  D'URSO,   JAFFEE,   JOYNER,   SEAWRIGHT,
          M. L. MILLER  --  Multi-Sponsored by -- M. of A. BARCLAY, BLANKENBUSH,
          CAHILL, CROUCH, CUSICK, EPSTEIN, FRIEND,  GALEF,  GOODELL,  GOTTFRIED,
          HAWLEY,  LENTOL,  LIFTON,  LUPARDO,  PALMESANO,  RIVERA,  STEC, TAGUE,
          THIELE, WALSH, WOERNER, WRIGHT  --  read  once  and  referred  to  the
          Committee on Higher Education
        AN  ACT to amend the education law, in relation to the use of oral medi-
          cations by optometrists; and  providing  for  the  repeal  of  certain
          provisions upon expiration thereof
          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:
     1    Section 1. Paragraph (e) of subdivision 1 of  section  7101-a  of  the
     2  education  law,  as added by chapter 517 of the laws of 1995, is amended
     3  to read as follows:
     4    (e) [Phase one] Topical therapeutic pharmaceutical agents. [Phase one]
     5  Topical therapeutic pharmaceutical agents shall mean those  drugs  which
     6  shall  be  limited  to topical application to the surface of the eye for
     7  therapeutic purposes and shall be limited to:
     8    (i) antibiotic/antimicrobials;
     9    (ii) decongestants/anti-allergenics;
    10    (iii) non-steroidal anti-inflammatory agents;
    11    (iv) steroidal anti-inflammatory agents;
    12    (v) antiviral agents;
    13    (vi) hyperosmotic/hypertonic agents;
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD01275-01-9

        A. 1193                             2
     1    (vii) cycloplegics;
     2    (viii) artificial tears and lubricants; and
     3    (ix) immunosuppressive agents.
     4    § 2. Paragraph (f) of subdivision 1 of section 7101-a of the education
     5  law,  as added by chapter 517 of the laws of 1995, is amended to read as
     6  follows:
     7    (f) [Phase two  therapeutic]  Therapeutic  pharmaceutical  agents  for
     8  treatment  of glaucoma and ocular hypertension.  [Phase two] Therapeutic
     9  pharmaceutical agents for treatment of glaucoma and ocular  hypertension
    10  shall  mean those drugs which shall be limited to topical application to
    11  the surface of the eye and shall be limited to:
    12    (i) beta blockers;
    13    (ii) alpha agonists;
    14    (iii) direct acting cholinergic agents;
    15    (iv) prostaglandin analogs; and
    16    (v) carbonic anhydrase inhibitors.
    17    § 3. Subdivision 1 of section 7101-a of the education law  is  amended
    18  by adding a new paragraph (g) to read as follows:
    19    (g)  Oral  therapeutic pharmaceutical agents. Oral therapeutic pharma-
    20  ceutical agents shall mean those  orally  administered  drugs  used  for
    21  therapeutic purposes solely for the treatment of diseases of the eye and
    22  adnexa and shall be limited to:
    23    (i) the following antibiotics, including, where applicable, the gener-
    24  ic equivalent of any of the listed drugs:
    25    (1) augmentin;
    26    (2) keflex;
    27    (3) azithromycin;
    28    (4) bactrim;
    29    (5) doxycycline; and
    30    (6) tetracycline;
    31    (ii)   the   following   decongestants/anti-allergenic/antihistamines,
    32  including the generic equivalents of the listed drugs:
    33    (1) clarinex;
    34    (2) xyzal; and
    35    (3) singulair;
    36    (iii) the following antiglaucoma agents, including the generic  equiv-
    37  alents  of  such  agents,  used for the management of acute increases in
    38  intraocular pressure; provided,  however,  an  optometrist  may  use  or
    39  prescribe a maximum of one twenty-four hour prescription and shall imme-
    40  diately  refer  the  patient  to  a  licensed  physician specializing in
    41  diseases of the eye:
    42    (1) diamox; and
    43    (2) neptazane;
    44    (iv) the following antiviral agents, including the generic equivalents
    45  of such agents, used for herpes zoster ophthalmicus; provided an optome-
    46  trist shall  use  or  prescribe  in  maximum,  seven-day  prescriptions;
    47  provided, however, if a patient is diagnosed with herpes zoster ophthal-
    48  micus  and  has not already been examined by a primary care physician or
    49  other appropriate physician for such  viral  condition,  an  optometrist
    50  shall  refer  the patient to a licensed primary care physician, licensed
    51  physician specializing in diseases of  the  eye,  or  other  appropriate
    52  physician within three days of such diagnosis:
    53    (1) valacyclovir; and
    54    (2) acyclovir; and
    55    (v) the following non-steroidal anti-inflammatory agents:
    56    (1) cox-2 inhibitors;

        A. 1193                             3
     1    (2) ibuprofen; and
     2    (3) naproxen.
     3    §  4.  The  subdivision  heading and paragraph (a) of subdivision 4 of
     4  section 7101-a of the education law, as added by chapter 517 of the laws
     5  of 1995, are amended to read as follows:
     6    [Phase one] Topical  therapeutic  pharmaceutical  agents.  (a)  Before
     7  using  or  prescribing  [phase  one]  topical therapeutic pharmaceutical
     8  agents, each optometrist shall have completed  at  least  three  hundred
     9  hours of clinical training in the diagnosis, treatment and management of
    10  patients  with  ocular  disease other than glaucoma and ocular hyperten-
    11  sion, not fewer than twenty-five hours of such training shall have  been
    12  completed  subsequent  to  June thirtieth, nineteen hundred ninety-three
    13  and additionally shall either have taken  and  successfully  passed  the
    14  treatment  and  management  of  ocular  diseases portion of the National
    15  Board of Examiners in Optometry test  or  have  taken  and  successfully
    16  passed an examination acceptable to the board.
    17    § 5. Paragraph (b) of subdivision 4 of section 7101-a of the education
    18  law,  as added by chapter 517 of the laws of 1995, is amended to read as
    19  follows:
    20    (b) Before using or prescribing [phase two] therapeutic pharmaceutical
    21  agents for treatment of glaucoma and ocular hypertension, an optometrist
    22  must be certified for diagnostic and  [phase  one]  topical  therapeutic
    23  agents  and  have  completed an additional one hundred hours of clinical
    24  training in the diagnosis, treatment and  management  of  patients  with
    25  glaucoma  and  ocular  hypertension, not fewer than twenty-five hours of
    26  such training shall have been completed subsequent to July first,  nine-
    27  teen  hundred  ninety-four, and shall have taken and successfully passed
    28  an oral or written examination acceptable by the board.
    29    § 6. Paragraphs (c) and (d) of subdivision 4 of section 7101-a of  the
    30  education  law are relettered paragraphs (d) and (e) and a new paragraph
    31  (c) is added to read as follows:
    32    (c)  Before  using  or  prescribing  oral  therapeutic  pharmaceutical
    33  agents, an optometrist must be certified to prescribe diagnostic pharma-
    34  ceutical  agents  and topical therapeutic and therapeutic pharmaceutical
    35  agents for treatment of glaucoma and ocular hypertension, have completed
    36  an oral therapeutic pharmaceutical agent certification course  and  have
    37  passed  an examination within five years of the department's approval of
    38  the initial certification course or the initial  examination,  whichever
    39  is later.
    40    (i)  The  curriculum  for the course shall include, but not be limited
    41  to, instruction in pharmacology and drug interaction in treating  ocular
    42  disease  and  be  taught  through  clinical case scenarios and emphasize
    43  clinical decision making and shall be no less than forty hours, of which
    44  no less than twenty-four hours shall be live instruction.
    45    (ii) Such course shall qualify towards meeting the  continuing  educa-
    46  tion  per  triennial  registration  requirement  pursuant to subdivision
    47  seven of this section.
    48    (iii) The examination shall test the knowledge  of  materials  in  the
    49  curriculum  and  reflect  the provisions of paragraph (g) of subdivision
    50  one of this section, and shall be acceptable to the  department.  If  an
    51  optometrist  fails  to pass the examination, such optometrist may retake
    52  the examination; provided, however, that if an optometrist fails to pass
    53  the examination  after  three  attempts,  such  optometrist  must  again
    54  complete the certification course in order to retake the examination. An
    55  optometrist shall be required to complete the certification course after
    56  each subsequent failure to pass the examination three times. If an opto-

        A. 1193                             4
     1  metrist  requires more time to pass the examination and to become certi-
     2  fied than the five-year period provided  for  in  this  paragraph,  such
     3  optometrist  may  be  authorized to retake the examination and to become
     4  certified  beyond  such period upon application by the optometrist and a
     5  showing of good cause as may be acceptable to the commissioner.
     6    (iv) The initial, and any subsequent, curriculum and examination shall
     7  be subject to review and approval by the department.
     8    (v) The requirement for  the  oral  therapeutic  pharmaceutical  agent
     9  certification  course  and  examination shall not apply to those optome-
    10  trists who graduated from an accredited college of optometry  subsequent
    11  to  January  first,  two  thousand seven and have taken and successfully
    12  passed the National Board of Examiners in Optometry test or an  examina-
    13  tion acceptable to the department.
    14    § 7. Subdivision 5 of section 7101-a of the education law, as added by
    15  chapter 517 of the laws of 1995, is amended to read as follows:
    16    5.  Suspension  of  certification.  The  department  shall suspend the
    17  certification for the use and prescribing of [phase one] topical  thera-
    18  peutic  agents of any optometrist who fails to receive certification for
    19  [phase two] therapeutic pharmaceutical agents for treatment of  glaucoma
    20  and  ocular hypertension within three years of having been certified for
    21  [phase one] topical therapeutic pharmaceutical agents.
    22    § 8. The subdivision heading of subdivision 6 of section 7101-a of the
    23  education law, as added by chapter 517 of the laws of 1995,  is  amended
    24  to read as follows:
    25    Consultation  with  use  of certain topical therapeutic pharmaceutical
    26  agents for treatment of glaucoma and ocular hypertension.
    27    § 9. Subdivision 7 of section 7101-a of the education law, as added by
    28  chapter 517 of the laws of 1995, is amended to read as follows:
    29    7. Continuing education. Each optometrist certified to use [phase  one
    30  or  phase two] topical therapeutic pharmaceutical agents and therapeutic
    31  pharmaceutical agents for treatment of glaucoma and ocular hypertension,
    32  shall complete a minimum of thirty-six hours of continuing education  in
    33  the  area  of ocular disease and pharmacology per triennial registration
    34  period. [The education shall be in the area of ocular disease and  phar-
    35  macology  and  may  include both didactic and clinical components.] Each
    36  optometrist certified to  use  oral  therapeutic  pharmaceutical  agents
    37  shall,  in addition to the minimum thirty-six hours of continuing educa-
    38  tion provided for in this subdivision, complete an additional minimum of
    39  thirty-nine hours of continuing education related  to  systemic  disease
    40  and therapeutic treatment per triennial registration period. Such educa-
    41  tional  programs  may  include both didactic and clinical components and
    42  shall be approved in advance by  the  department  and  evidence  of  the
    43  completion  of this requirement shall be submitted with each application
    44  for license renewal as required by section  sixty-five  hundred  two  of
    45  this chapter.
    46    § 10. The subdivision heading and subparagraph (i) of paragraph (a) of
    47  subdivision  8 of section 7101-a of the education law, as added by chap-
    48  ter 517 of the laws of 1995, are amended to read as follows:
    49    Notice to patient with the use or prescription of topical  therapeutic
    50  pharmaceutical  agents  and therapeutic pharmaceutical agents for treat-
    51  ment of glaucoma and ocular hypertension.
    52    (i) An optometrist prescribing topical steroids or  antiviral  medica-
    53  tion  shall inform each patient that in the event the condition does not
    54  improve within five days, a physician of the patient's  choice  will  be
    55  notified.

        A. 1193                             5
     1    §  11. Subdivision 10 of section 7101-a of the education law, as added
     2  by chapter 517 of the laws of 1995, is amended to read as follows:
     3    10.  Pharmaceutical  agents.  Optometrists  who have been approved and
     4  certified by the department shall be  permitted  to  use  the  following
     5  drugs:
     6    (a) Diagnostic pharmaceuticals.
     7    (b)  Those  optometrists having been certified for [phase one] topical
     8  therapeutic pharmaceutical agents shall be authorized [(i)  to  use  and
     9  recommend all nonprescription medications appropriate for ocular disease
    10  whether intended for topical or oral use; and (ii)] to use and prescribe
    11  all  [phase  one] topical therapeutic pharmaceutical agents specified in
    12  paragraph (e) of subdivision one of this section, which are FDA approved
    13  and commercially available for topical use.
    14    In the event an optometrist treats a patient with topical antiviral or
    15  steroidal drugs and the patient's condition either fails to  improve  or
    16  worsens  within  five  days,  the  optometrist  shall notify a physician
    17  designated by the patient or, if none, by the treating optometrist.
    18    (c) Those optometrists having been certified for [phase two] therapeu-
    19  tic pharmaceutical agents for treatment of glaucoma and ocular hyperten-
    20  sion shall be authorized to use and prescribe  [phase  two]  therapeutic
    21  pharmaceutical  agents for treatment of glaucoma and ocular hypertension
    22  specified in paragraph (f) of subdivision one of this section, which are
    23  FDA approved and commercially available.
    24    (d) Those optometrists having  been  certified  for  oral  therapeutic
    25  pharmaceutical  agents  shall  be  authorized  to use and prescribe oral
    26  therapeutic pharmaceutical agents specified in paragraph (g) of subdivi-
    27  sion one of this section, which are FDA approved and commercially avail-
    28  able and shall comply with all safety information  and  side-effect  and
    29  warning advisories contained in the most current physicians' desk refer-
    30  ence.
    31    (e)  Those  optometrists having been certified for topical therapeutic
    32  pharmaceutical agents, therapeutic pharmaceutical agents  for  treatment
    33  of  glaucoma  and ocular hypertension or oral therapeutic pharmaceutical
    34  agents shall be authorized to  use  and  recommend  all  nonprescription
    35  medications,  whether  intended for topical or oral use, appropriate for
    36  the treatment of the eye and adnexa.
    37    § 12. Subdivision 8 of section 7104 of the education law,  as  amended
    38  by chapter 517 of the laws of 1995, is amended to read as follows:
    39    (8)  Fees:  pay  a fee of two hundred twenty dollars to the department
    40  for admission to a department conducted examination and for  an  initial
    41  license,  a fee of one hundred fifteen dollars for each reexamination, a
    42  fee of one hundred  thirty-five  dollars  for  an  initial  license  for
    43  persons  not  requiring admission to a department conducted examination,
    44  [and] a fee of two hundred ten dollars for each  triennial  registration
    45  period,  [and] for additional authorization for the purpose of utilizing
    46  diagnostic pharmaceutical agents,  a  fee  of  sixty  dollars,  and  for
    47  certification  to  use  or  prescribe  oral  therapeutic  pharmaceutical
    48  agents, a fee of two hundred fifty dollars.
    49    § 13. Oral therapeutic pharmaceutical agent implementation review.  1.
    50  For  purposes  of  this  section, the term "commissioner" shall mean the
    51  commissioner of the state education department; and  the  term  "depart-
    52  ment" shall mean the state education department.
    53    2.   Each optometrist certified to use oral therapeutic pharmaceutical
    54  agents pursuant to paragraph (c) of subdivision four of  section  7101-a
    55  of the education law shall provide the department with information, on a
    56  form  prescribed by the commissioner, related to the prescription or use

        A. 1193                             6
     1  of oral therapeutic pharmaceutical agents provided for in section 7101-a
     2  of the education law. Such information shall include  the  optometrist's
     3  license  number  and  the national provider identifier as established by
     4  the  centers  for  medicare  and  medicaid  services,  whether  no  oral
     5  prescriptions have been issued and in the event that oral  prescriptions
     6  have been issued, then the following information shall be required:  the
     7  prescribed  or used oral therapeutic pharmaceutical agent, the dosage of
     8  such agent, the date of the prescription, the diagnosis of  the  patient
     9  for  which  the agent was prescribed or used, and whether a referral was
    10  made in accordance with paragraph (g) of subdivision  one  of    section
    11  7101-a  of  the  education law.   Such information shall not include any
    12  patient identifying information and must otherwise be in compliance with
    13  all state and federal requirements related to protected health  informa-
    14  tion.  Each  form  shall be submitted by mail or electronic means to the
    15  department on a quarterly basis.  If a database of all oral  therapeutic
    16  pharmaceutical agents prescribed or used by optometrists is, or becomes,
    17  available  to  the committee provided for in this act, then optometrists
    18  shall be advised by the commissioner that quarterly reporting forms will
    19  no longer be required.  The requirements of this section shall remain in
    20  effect for five years  following  approval  by  the  department  of  the
    21  initial  oral  therapeutic pharmaceutical agent certification course and
    22  examination pursuant to paragraph (c) of  subdivision  four  of  section
    23  7101-a  of  the education law, after which time these requirements shall
    24  expire and no longer have effect.
    25    3. The commissioner shall appoint a committee to advise and assist the
    26  commissioner in evaluating compliance with  the  provisions  of  section
    27  7101-a  of  the education law and to identify any necessary enhancements
    28  to the curriculum provided for in such  section  and  other  educational
    29  materials  and to assist in ensuring patient safety. The committee shall
    30  consist of one pharmacist, one optometrist upon the recommendation of  a
    31  statewide  professional  organization  consisting  of  optometrists, one
    32  ophthalmologist upon the  recommendation  of  a  statewide  professional
    33  organization consisting of ophthalmologists, and one expert in the field
    34  of public health who shall be designated as chair by the commissioner in
    35  consultation  with  the commissioner of the department of health and who
    36  shall be neither an ophthalmologist nor an optometrist.
    37    4. The commissioner shall submit each form received pursuant  to  this
    38  section  to the committee, except as otherwise provided in this subdivi-
    39  sion.  The committee shall review the forms and  shall  randomly  cross-
    40  check  such  submissions  with  a  publicly  available or other database
    41  containing electronic prescriber information. Should a database  of  all
    42  oral  therapeutic  pharmaceutical  agents  prescribed or used by optome-
    43  trists pursuant to section 7101-a of the education law become available,
    44  and the commissioner determines and advises optometrists that  quarterly
    45  reports  are  no  longer  necessary, then the committee shall review the
    46  database and ascertain the prescribing information for all  optometrists
    47  consistent  with  section  7101-a  of the education law.   The committee
    48  shall advise the commissioner as to compliance with  the  provisions  of
    49  section  7101-a  of  the  education  law  for  the purpose of evaluating
    50  compliance with the provisions of section 7101-a of  the  education  law
    51  including the applicable referrals and dosing limitations and to identi-
    52  fy  any  necessary  enhancements to the curriculum provided for in para-
    53  graph (c) of subdivision 4 of section 7101-a of the  education  law  and
    54  other  educational  materials  and to assist in ensuring patient safety.
    55  Upon finding evidence of non-compliance by any optometrist, the  commit-
    56  tee  shall  refer such information to the commissioner and to the office

        A. 1193                             7
     1  of professions within the department for investigation and, if  applica-
     2  ble,  disciplinary  action.  Nothing  in this subdivision is intended to
     3  modify or otherwise limit the department's authority  or  discretion  to
     4  review,  investigate  and  refer  matters  related  to  the professional
     5  conduct of a licensed provider.
     6    § 14. This act shall take effect eighteen months after it  shall  have
     7  become a law; provided that:
     8    (a)  section  thirteen of this act shall expire and be deemed repealed
     9  five years following the approval by the department of education of  the
    10  initial  certification  course  or the initial examination, whichever is
    11  later, pursuant to paragraph (c) of subdivision 4 of section  7101-a  of
    12  the education law as added by section six of this act;
    13    (b)  the  commissioner  of education shall notify the legislative bill
    14  drafting commission upon approval of the  initial  certification  course
    15  and  examination  required  in section six of this act in order that the
    16  commission may maintain an accurate and timely effective  data  base  of
    17  the official text of the laws of the state of New York in furtherance of
    18  effectuating  the  provisions  of  section 44 of the legislative law and
    19  section 70-b of the public officers law; and
    20    (c) any rule or regulation necessary for the timely implementation  of
    21  this  act  on  its effective date shall be promulgated on or before such
    22  effective date.
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