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A09089 Summary:

BILL NOA09089
 
SAME ASSAME AS S07214
 
SPONSORClark
 
COSPNSRSimon, Stirpe
 
MLTSPNSR
 
Amd §§6611 & 6612, add §§6610-a, 6614 & 6615, Ed L
 
Relates to dental laboratories; defines terms; requires any dental laboratory operating, doing business, or intending to operate or do business in this state to register with the department of education; makes related provisions.
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A09089 Actions:

BILL NOA09089
 
02/06/2024referred to higher education
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A09089 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A9089
 
SPONSOR: Clark
  TITLE OF BILL: An act to amend the education law, in relation to dental laboratories   PURPOSE: The purpose of this bill is to provide for increased safety and trans- parency for New Yorkers and their dentists related to dental prostheses, devices or appliances, and to provide for the registration of dental laboratories.   SUMMARY OF PROVISIONS: Section 1: Amends subdivision 1 of § 6611 of the education law to clari- fy that prescriptions for dental impressions shall include digital intraoral scans and analog impression, and to require dental laboratory registration information to be included with dental laboratory prescriptions. Section 2: Amends § 6612 of the education law to clarify that dental laboratories must comply with prosthetic identification marking require- ments. Section 3: Adds § 6610-A, to provide for definitions relating to the provision of this act; adds § 6614, to provide for the registration of dental laboratories doing business or intending to do business in New York state and the requirements for such registrations; adds § 6615 to provide for the registration of non-resident dental laboratories provid- ing products into New York state and the requirements for such registra- tion. Section 4: provides that this act shall take effect one year after becoming law, and provides the State Education Department with the authority to promulgate rules and regulations and to implement such other measures upon the act becoming a law   JUSTIFICATION: The dental laboratory industry produces and provides dentures, crowns, bridges, orthodontic appliances and other dental restorations for thou- sands of New Yorkers each year. These important products and services are integral to the improvement of patient health and the quality of life for New Yorkers, every day. While New Yorkers and their dentists assume the quality of these products and their constituent materials are safe to use, there are few statutory protections in place to ensure they are, in fact, manufactured in a safe environment and use quality materi- als. Currently, there is no requirement that a dental laboratory inform the dentist of the materials used in a restoration or the point of origin of manufacture. Because poorly made dental restorations can lead to a range of health consequences for patients, and negative treatment and profes- sional outcomes for their dentists, it is critical that there be greater oversight and accountability and that dentists receive the information they need to ensure the standard of care for their patients. Moreover, growing demand for dental work in the United States has helped create a robust market for both high-end as well as more economically priced dental restoration products. Recenthave shown that nationwide approximately. 25 percent of domestic dental laboratory sales, and 38 percent of dental restorations are manufactured overseas, evidenced by the fact that there are foreign dental laboratories from 42 countries currently registered with the U.S. Food and Drug Administration. While the global market to provide these services and products has expanded, awareness of the sourcing of dental restorations and their component materials has not kept pace with the rate of change. The ability to have a full understanding and confidence in the origin of dental restoration materials is therefore vital to patients and dentists in ensuring better health outcomes and safer restorations. This legislation promotes modest, yet important, measures to improve public health and consumer safety. By providing for improved product transparency practitioners, establishing reasonable registration stand- ards and accountability for dental laboratories and their products, this legislation will ensure that dentists receive the information needed to strengthen patient and health provider confidence and improve health outcomes.   FISCAL IMPACT ON THE STATE: None.   LEGISLATIVE HISTORY: New bill.   EFFECTIVE DATE: This act shall take effect one year after it shall have become law.
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A09089 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          9089
 
                   IN ASSEMBLY
 
                                    February 6, 2024
                                       ___________
 
        Introduced  by M. of A. CLARK -- read once and referred to the Committee
          on Higher Education
 
        AN ACT to amend the education law, in relation to dental laboratories
 
          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
 
     1    Section  1.  Subdivision  1  of  section 6611 of the education law, as
     2  amended by chapter 576 of the laws  of  2001,  is  amended  to  read  as
     3  follows:
     4    1.  Except  upon  the  written  dental  laboratory  prescription  of a
     5  licensed dentist and except by the use of impressions, including but not
     6  limited to digital intraoral scans or analog impressions, or casts  made
     7  by  a  licensed  dentist,  no  dental  laboratory shall furnish, supply,
     8  construct, reproduce, place, adjust, or repair  any  dental  prosthesis,
     9  device, or appliance. A dental laboratory prescription shall be made out
    10  in  duplicate.  It  shall  contain the registration number issued by the
    11  department and such other data as may be prescribed by  the  commission-
    12  er's  regulations.  One  copy  shall  be retained by the practitioner of
    13  dentistry for a period of one year. The other copy shall  be  issued  to
    14  the  person,  firm  or  corporation engaged in filling dental laboratory
    15  prescriptions, who or which shall each retain and file in their  respec-
    16  tive  offices or places of business their respective copies for a period
    17  of one year.
    18    § 2. Section 6612 of the education law, as added by chapter 332 of the
    19  laws of 1985, is amended to read as follows:
    20    § 6612. Identification  of  removable  full  or   partial   prosthetic
    21  devices.   1. Except as provided [herein] in this section, every dentist
    22  licensed in this state making or directing to be made a removable  pros-
    23  thetic denture, bridge, appliance or other structure to be used and worn
    24  as  a  substitute for natural teeth, shall offer to the patient for whom
    25  the prosthesis is intended  the  opportunity  to  have  such  prosthesis
    26  marked  with  the  patient's  name  or  initials. Such markings shall be
    27  accomplished at the time the prosthesis is made  and  the  location  and
    28  methods used to apply or implant them shall be determined by the dentist
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD11541-01-3

        A. 9089                             2
 
     1  or  the  person  acting  on behalf of the dentist. Such marking shall be
     2  permanent, legible and cosmetically acceptable.
     3    2. Notwithstanding the foregoing, if in the judgment of the dentist or
     4  the  [person]  dental laboratory making the prosthesis, such identifica-
     5  tion is not practicable or clinically safe, the identification marks may
     6  be omitted entirely.
     7    3. The commissioner shall adopt  rules  and  regulations  and  provide
     8  standards necessary to carry out the provisions of this section.
     9    § 3. The education law is amended by adding three new sections 6610-a,
    10  6614, and 6615 to read as follows:
    11    §  6610-a. Dental laboratories. For the purposes of sections sixty-six
    12  hundred eleven, sixty-six hundred twelve,  sixty-six  hundred  fourteen,
    13  and sixty-six hundred fifteen of this article, the following terms shall
    14  have the following meanings:
    15    1.  "Certified dental technician" shall mean a dental laboratory tech-
    16  nician who is certified by  the  national  board  for  certification  in
    17  dental laboratory technology.
    18    2.  "Prescribing  dentist"  shall mean a licensed dentist who issues a
    19  dental laboratory  prescription  or  any  other  written  or  electronic
    20  instrument  directing  the  manufacture  of or work to be performed on a
    21  dental prosthesis, device, or appliance.
    22    3. "Dental laboratory" shall mean  a  facility  that  engages  in  the
    23  designing,  making,  repairing,  altering,  or  supplying  of artificial
    24  restorations, substitutions, appliances, or materials for the correction
    25  of disease, loss, deformity, malposition, dislocation, fracture,  injury
    26  to the jaws, teeth, lips, gums, cheeks, palate, or associated tissues or
    27  parts.
    28    4.  "Material content disclosure" shall mean a notice to the prescrib-
    29  ing dentist that contains the name, physical address,  and  registration
    30  number  of  the  dental  laboratory  that received a prescription or any
    31  other written or electronic instrument from a licensed dentist directing
    32  the manufacture of or work to  be  performed  on  a  dental  prosthesis,
    33  device,  or  appliance, and the city, state, and country of origin where
    34  the work on the prosthesis, device or appliance was performed  in  whole
    35  or  in  part  or  laboratories  that manufactured or repaired the dental
    36  prosthesis, either directly or indirectly,  and  the  complete  material
    37  content information of all patient contact materials used in such dental
    38  prosthesis,  device  or  appliance,  including whether the United States
    39  food and drug administration cleared materials were  used.  Such  notice
    40  must  be  provided in a manner that can be easily entered into a patient
    41  record.
    42    5. "Work authorization" shall mean a written  instrument  by  which  a
    43  dental laboratory delegates to another dental laboratory to perform work
    44  on  a  dental  prosthesis, device, or appliance, in whole or in part, as
    45  authorized by a dental laboratory prescription from a licensed dentist.
    46    § 6614. Dental laboratory registrations. 1. (a) Any dental  laboratory
    47  operating,  doing  business,  or  intending to operate or do business in
    48  this state must register with the department in a manner  acceptable  to
    49  the department and in accordance with the commissioner's regulations.
    50    (b)  A  dental laboratory shall be considered operating or doing busi-
    51  ness within this state if its work product is prepared for a prescribing
    52  dentist pursuant to a prescription  or  work  authorization  originating
    53  from an entity located within this state.
    54    2.  Any  dental  laboratory operating, doing business, or intending to
    55  operate or do business within this state must submit an application  for
    56  registration  of  dental laboratory or renewal of registration of dental

        A. 9089                             3
 
     1  laboratory to the department in a form provided by  the  department  and
     2  accompanied  by  a  registration  or  renewal  fee  as  provided in this
     3  section.  Applications for registration or renewals of registration must
     4  include:
     5    (a)  The name, mailing address, phone number, and email address of the
     6  dental laboratory;
     7    (b) The physical address of the dental laboratory, if  different  from
     8  the mailing address of the dental laboratory;
     9    (c)  The name, mailing address, phone number, and email address of the
    10  responsible person, or, the name and license number of  the  supervising
    11  dentist who is licensed under this article;
    12    (d)  A  statement  that the dental laboratory meets accepted infection
    13  control precaution practices as established by the department of  health
    14  pursuant to section two hundred thirty-a of the public health law;
    15    (e)  An  acknowledgment  by  the responsible person or the supervising
    16  dentist that the dental  laboratory  will  provide  a  material  content
    17  disclosure  to  the prescribing dentist of all patient contact materials
    18  that contain both the manufacturer and brand name, or the United  States
    19  food  and drug administration registration number of all patient contact
    20  materials contained in  each  restoration  such  that  the  dentist  may
    21  include those in the patient's record;
    22    (f)  An  acknowledgment  by  the responsible person or the supervising
    23  dentist who is licensed in this state that he or she  will  disclose  to
    24  the  prescribing  dentist  the point of origin of the manufacture of the
    25  restoration. If the restoration was partially or  entirely  manufactured
    26  by  a third-party provider, the point of origin disclosure must identify
    27  the portion manufactured by a third-party provider and the city,  state,
    28  and country of the provider;
    29    (g) Materials documenting that the applicant or one of the applicant's
    30  employees  who  works  at least thirty hours per week in the applicant's
    31  dental laboratory:
    32    (i) Has successfully completed at least thirty-six hours of continuing
    33  education in dental laboratory technology approved by the national board
    34  for certification in dental laboratory technology or another  certifying
    35  body  having  certification  or registration standards acceptable to the
    36  commissioner during the thirty-six months  immediately  preceding  their
    37  application  or  renewal  for  registration, provided however, that such
    38  education must be completed by an individual who works on the laboratory
    39  premises; or
    40    (ii) Is a certified dental technician in good standing;
    41    (h) An acknowledgment by the responsible  person  or  the  supervising
    42  dentist that the laboratory will continuously maintain a qualified owner
    43  or  employee  satisfying  the  requirements  of  paragraph  (g)  of this
    44  section; and
    45    (i) A registration or renewal fee, not to exceed one hundred and fifty
    46  dollars, as determined by the department.
    47    3. Upon approval of  a  registration  for  a  dental  laboratory,  the
    48  department  shall  assign  the  dental laboratory a registration number.
    49  Such registration number must appear on any invoice from and  all  other
    50  correspondence by a dental laboratory to the prescribing dentist.
    51    4. Dental laboratory registrations shall require renewal on a trienni-
    52  al  basis  from  the date of issuance. Registrations may be renewed with
    53  the department upon receipt and approval  of  application  materials  as
    54  required by subdivision two of this section.
    55    5.  (a)  This section shall not apply to a dental laboratory operating
    56  under the supervision of a practicing dentist licensed under this  arti-

        A. 9089                             4
 
     1  cle  in a dental office or as a part of a dental practice, provided that
     2  the laboratory does not perform work  for  a  prescribing  dentist  from
     3  outside  of  the  supervising  dentist's  dental practice or supervising
     4  dentist's office, or in an educational institution as part of the insti-
     5  tution's  educational  program, provided that the dental laboratory does
     6  not routinely perform work for prescribing dentists from outside of  the
     7  educational institution.
     8    (b) A responsible person or employee of a dental laboratory may engage
     9  in  onsite  consultation  with a licensed dentist during a dental proce-
    10  dure.
    11    § 6615. Nonresident dental  laboratories.  1.  The  term  "nonresident
    12  dental laboratory" shall mean any dental laboratory as defined in subdi-
    13  vision  three of section sixty-six ten-a of this article located outside
    14  of this state  which  has  its  work  product  prepared  pursuant  to  a
    15  prescription  or  any  other  written  or  electronic  instrument from a
    16  licensed dentist  or  work  authorization  originating  from  an  entity
    17  located within this state.
    18    2.  Any  nonresident  dental laboratory that ships, mails, or delivers
    19  dental prostheses, devices or appliances to any other dental laboratory,
    20  dental office, licensed dentist, and/or patient in this  state  pursuant
    21  to  a  prescription or any other written or electronic instrument from a
    22  licensed dentist  or  work  authorization  originating  from  an  entity
    23  located within this state shall be registered with the department.
    24    3.  Each  nonresident dental laboratory that ships, mails, or delivers
    25  dental prostheses, devices or appliances into this state shall designate
    26  a resident agent in this state for service of process pursuant  to  rule
    27  three hundred eighteen of the civil practice law and rules.
    28    4.  As  a  condition  of registration, a nonresident dental laboratory
    29  shall comply with the following requirements:
    30    (a) Be in good standing in the state of residence;
    31    (b) Maintain, in readily retrievable form,  records  of  work  product
    32  shipped into this state;
    33    (c)  Supply, upon request, all information needed by the department to
    34  carry out the department's responsibilities under the laws and rules and
    35  regulations pertaining to nonresident dental laboratories;
    36    (d) Comply with all statutory and regulatory requirements of the state
    37  where the nonresident dental laboratory is located;
    38    (e) Apply in the manner and form prescribed by the department pursuant
    39  to the requirements of subdivision  two  of  section  sixty-six  hundred
    40  fourteen of this article.
    41    5. The commissioner may adopt such regulations as appropriate to eval-
    42  uate  registrations  from  dental laboratories that hold valid licenses,
    43  registrations, certifications or their equivalent in  another  state  or
    44  country, provided the standards for granting licenses, registrations, or
    45  certifications  to  such  facilities  are  not  less  than the standards
    46  required of dental laboratories otherwise registered  pursuant  to  this
    47  section.
    48    §  4. This act shall take effect one year after it shall have become a
    49  law. Effective immediately, the addition, amendment and/or repeal of any
    50  rule or regulation necessary for the implementation of this act  on  its
    51  effective date are authorized to be made and completed on or before such
    52  effective date.
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