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S00438 Summary:

BILL NOS00438A
 
SAME ASNo Same As
 
SPONSORMYRIE
 
COSPNSRLIU, WEBB
 
MLTSPNSR
 
Add Art 30 §§3001 - 3010, Ins L; amd §99-oo, St Fin L
 
Establishes the prescription drug supply chain transparency act; requires pharmacy services administrative organizations, pharmacy switch companies and rebate aggregators to register with the insurance department and to provide certain disclosures relating to the ownership and activities of such entities; relates to deposits into the pharmacy benefit manager regulatory fund.
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S00438 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         438--A
            Cal. No. 296
 
                               2025-2026 Regular Sessions
 
                    IN SENATE
 
                                       (Prefiled)
 
                                     January 8, 2025
                                       ___________
 
        Introduced  by Sens. MYRIE, LIU, WEBB -- read twice and ordered printed,
          and when printed to be committed to  the  Committee  on  Insurance  --
          recommitted  to  the  Committee on Insurance in accordance with Senate
          Rule 6, sec. 8 -- reported favorably from said committee,  ordered  to
          first  and second report, ordered to a third reading, passed by Senate
          and delivered to the Assembly, recalled, vote  reconsidered,  restored
          to  third  reading, amended and ordered reprinted, retaining its place
          in the order of third reading
 
        AN ACT to amend the insurance law,  in  relation  to  prescription  drug
          supply  chain  transparency;  and  to  amend the state finance law, in
          relation to deposits into the pharmacy benefit manager regulatory fund
 
          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
 
     1    Section  1.  This  act  shall  be  known  and  may  be  cited  as  the
     2  "prescription drug supply chain transparency act".
     3    § 2. The insurance law is amended by adding a new article 30  to  read
     4  as follows:
     5                                 ARTICLE 30
     6                 PRESCRIPTION DRUG SUPPLY CHAIN TRANSPARENCY
     7  Section 3001. Definitions.
     8          3002. Electronic filing requirement.
     9          3003. Special reports and other powers.
    10          3004. Registration of pharmacy services administrative organiza-
    11                  tions.
    12          3005. Required  disclosures  by pharmacy services administrative
    13                  organizations.
    14          3006. Registration of pharmacy switch companies.
    15          3007. Required disclosures by pharmacy switch companies.
    16          3008. Registration of rebate aggregators.
    17          3009. Required disclosures by rebate aggregators.

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD01699-03-6

        S. 438--A                           2
 
     1          3010. Deposit of penalties and fees.
     2    §  3001.  Definitions. (a) For the purposes of this article, the defi-
     3  nitions contained in section two hundred eighty-a of the  public  health
     4  law shall apply to this article as if specifically set forth herein.
     5    (b)  For  the purposes of this article, the following words or phrases
     6  shall  have  the  following  meanings,  unless  the  context   otherwise
     7  requires:
     8    (1)  "Manufacturer"  means  an  entity  engaged  in the manufacture of
     9  prescription drugs sold in this state.
    10    (2) "Pharmacy services administrative organization" or "PSAO" means an
    11  entity that is operating in this state and that contracts with a pharma-
    12  cy for the purpose of conducting business on the pharmacy's behalf  with
    13  wholesalers, distributors, health plans or pharmacy benefit managers.
    14    (3) "Rebate aggregator" means an entity that provides formulary rebate
    15  administrative services for pharmacy benefit managers or otherwise nego-
    16  tiates  rebates  with manufacturers on behalf of pharmacy benefit manag-
    17  ers.
    18    (4) "Switch company" means an entity  that  acts  as  an  intermediary
    19  between a pharmacy and a pharmacy benefit manager or health plan for the
    20  purpose of routing insurance claims data to or from a pharmacy.
    21    §  3002. Electronic filing requirement. Notwithstanding any law to the
    22  contrary, any filing or submission required under this article shall  be
    23  made  electronically  unless  the entity required to make such filing or
    24  submission demonstrates undue hardship, impracticability or  good  cause
    25  as required by section three hundred sixteen of this chapter.
    26    §  3003.  Special reports and other powers. (a) The superintendent may
    27  address to any entity required to register or report  information  under
    28  this  article,  or  its  officers,  or any agent or employee thereof any
    29  inquiry in relation to its business or any matter  connected  therewith.
    30  Every  individual  or entity so addressed shall reply in writing to such
    31  inquiry promptly and truthfully, and such reply shall be, if required by
    32  the superintendent, subscribed by such individual, or by such officer or
    33  officers of the entity, or by such agent or employee of  the  entity  as
    34  the  superintendent  shall designate, and affirmed by them as true under
    35  the penalties of perjury.
    36    (b) In the event any individual or entity does not submit a good faith
    37  response to an inquiry from the superintendent  pursuant  to  subsection
    38  (a) of this section within a time period specified by the superintendent
    39  of not less than fifteen business days, the superintendent is authorized
    40  to  levy  a civil penalty, after notice and hearing, against such person
    41  not to exceed one thousand dollars per day for each day beyond the  date
    42  specified by the superintendent for response to the inquiry.
    43    (c) In addition to all other powers granted by law, the superintendent
    44  is  hereby  empowered to order any person or entity required to register
    45  or report information under  this  article  to  cease  and  desist  from
    46  violations of this article and, following issuance of such an order, may
    47  bring  and maintain an action in any court of competent jurisdiction for
    48  an injunction or other appropriate relief to enjoin threatened or exist-
    49  ing violations of this article, or of  the  superintendent's  orders  or
    50  regulations.  Such action may specifically seek restitution on behalf of
    51  persons aggrieved by a violation of this  article  or  orders  or  regu-
    52  lations of the superintendent.
    53    (d)  In addition to all other powers granted by law, whenever it shall
    54  appear to the superintendent, either upon complaint or  otherwise,  that
    55  in  the course of its business within or from this state that any entity
    56  shall have employed, or employs, or is  about  to  employ  any  business

        S. 438--A                           3
 
     1  practice  or  shall  have  performed,  or  is performing, or is about to
     2  perform any act in violation of this article or orders or regulations of
     3  the superintendent, or the superintendent  believes  it  to  be  in  the
     4  public  interest  that an investigation be made, the superintendent may,
     5  in the superintendent's discretion, either require or permit such entity
     6  or any agent or employee thereof, to file with the department  a  state-
     7  ment  in writing under oath or otherwise as to all the facts and circum-
     8  stances concerning the subject matter that the  superintendent  believes
     9  is  in  the  public  interest  to  investigate  and for such purpose may
    10  prescribe forms upon which such statements shall  be  made.  The  super-
    11  intendent may also require such other data and information as the super-
    12  intendent  may  deem  relevant and may make such special and independent
    13  investigations as the superintendent may deem  necessary  in  connection
    14  with  the  matter.  It  shall  be the duty of all public officers, their
    15  deputies, assistants, subordinates, clerks or employees  and  all  other
    16  persons  to  render and furnish to the superintendent, when requested in
    17  connection with an investigation under this subsection, all  information
    18  and assistance in their possession or within their power.
    19    (e)  Any  entity  who violates an order under subsection (c) or (d) of
    20  this section shall be subject to a civil penalty,  after  notice  and  a
    21  hearing,  of not more than ten thousand dollars per act in violation, in
    22  addition to any other penalty provided by law.
    23    (f) Any communications or documents sent  or  received  in  connection
    24  with  an investigation under this article and any materials referring to
    25  such information in the possession of the superintendent shall be confi-
    26  dential and not subject to disclosure.   Notwithstanding the  foregoing,
    27  the superintendent may release such confidential communications or docu-
    28  ments  to  the  extent  necessary  to address criminal or other unlawful
    29  behavior. This subsection shall not apply to information, documents  and
    30  materials  in  the  possession  and under the control of an entity other
    31  than the superintendent.
    32    § 3004. Registration of  pharmacy  services  administrative  organiza-
    33  tions. (a) No PSAO shall operate in this state after March thirty-first,
    34  two thousand twenty-seven without first registering with the department.
    35    (b)  A  PSAO  seeking  registration  shall  file, in a form and manner
    36  determined by the superintendent, information that includes at  a  mini-
    37  mum:
    38    (1) the legal name of the entity;
    39    (2) any trade or other names used by the entity;
    40    (3) the organizational structure of the entity;
    41    (4)  the  pharmacies  located  within this state with which the entity
    42  provides services;
    43    (5) the persons who exercise control of the entity;
    44    (6) a primary point of contact for the entity;
    45    (7) an agent for service of process;
    46    (8) a set of audited financials for the prior fiscal year; and
    47    (9) such other information as the superintendent shall require.
    48    (c) The superintendent shall accept a registration only if the  super-
    49  intendent determines that all the required information has been provided
    50  in  a  satisfactory  form  and  has  received payment of a nonrefundable
    51  registration fee of five thousand dollars.  Notwithstanding the require-
    52  ments  of  this  subsection  the  superintendent  may,  in  their   sole
    53  discretion  and  upon  good cause shown, reduce the registration fee for
    54  any PSAO to an amount not less than one-tenth of one percent of the fees
    55  earned by the PSAO from all pharmacies located in New York in the  prior
    56  calendar year.

        S. 438--A                           4

     1    (d)  If  any  of  the  information contained in the registration shall
     2  change, the PSAO shall notify the department of such change  in  a  form
     3  and  manner  prescribed  by  the  superintendent for such purpose within
     4  twenty-one days of the change.  The requirement to update shall  include
     5  the  filing  of  a  new set of audited financials upon adoption. For any
     6  change other than new audited financials, the filing shall not be deemed
     7  complete unless accompanied by a payment of a fee of fifty dollars.
     8    (e) Every PSAO registration issued  pursuant  to  this  section  shall
     9  expire  twelve  months  after  the  date  of issue. A PSAO may renew its
    10  registration for another twelve months upon the filing of an application
    11  in conformity with this section.
    12    (f) Before a PSAO registration shall be renewed, the PSAO  shall  file
    13  an application for renewal in such form as the superintendent prescribes
    14  and pay a fee of five thousand dollars. Notwithstanding the requirements
    15  of this subsection, the superintendent may, in their sole discretion and
    16  upon  good  cause  shown, reduce the registration fee for any PSAO to an
    17  amount not less than one-tenth of one percent of the fees earned by  the
    18  PSAO from all pharmacies located in New York in the prior calendar year.
    19    (g)  If  a PSAO files a renewal application with the superintendent at
    20  least one month before its expiration, then the registration  sought  to
    21  be  renewed  shall  continue  in  full force and effect either until the
    22  issuance by the superintendent of the renewal registration  applied  for
    23  or  until five days after the superintendent shall have refused to issue
    24  such renewal registration and given notice of such refusal to the appli-
    25  cant, otherwise the PSAO registration shall expire  and  the  registrant
    26  shall have no expectation of renewal.
    27    §  3005.  Required  disclosures  by  pharmacy  services administrative
    28  organizations. (a) (1) Each PSAO  shall  at  the  time  of  registration
    29  pursuant  to section three thousand four of this article disclose to the
    30  department the extent of any ownership or control of the PSAO or by  the
    31  PSAO of any parent company, subsidiary, or affiliate that:
    32    (A) provides pharmacy services;
    33    (B) provides prescription drug or device services; or
    34    (C)  manufactures,  sells,  or distributes prescription drugs, biolog-
    35  icals, or medical devices.
    36    (2) A PSAO shall furnish a copy of the disclosure made at the time  of
    37  registration to all pharmacies located in this state with which it has a
    38  contract  in  place  at  the  time of the registration. A PSAO shall not
    39  collect any fee for any services provided to a pharmacy for  any  period
    40  beginning  five days after the filing of a registration with the depart-
    41  ment until such disclosure is sent to the pharmacy.
    42    (3) Not later than April first, two thousand twenty-eight, the depart-
    43  ment shall publish all disclosures received  under  this  section  on  a
    44  publicly  accessible online database, which shall be searchable at least
    45  by PSAO name. All disclosures shall be posted not later than  ten  busi-
    46  ness days after a registration is accepted and shall remain on the data-
    47  base for the duration of the registration of the PSAO.
    48    (b)  (1) Prior to entering into any contract with any pharmacy located
    49  in this state, including a contract with a group of pharmacies at  least
    50  one  of  which  is in this state, a PSAO shall furnish to the pharmacy a
    51  written disclosure of  the  information  required  to  be  disclosed  in
    52  subsection  (a)  of  this  section. No contract with a pharmacy shall be
    53  enforceable against the pharmacy by a PSAO unless such PSAO  makes  such
    54  disclosure  prior  to  the  agreement.  In  addition  to any other power
    55  conferred by law, the superintendent may prescribe the form  and  manner
    56  of such disclosures.

        S. 438--A                           5
 
     1    (2)  A  PSAO  that owns, is owned by, in whole or in part, or controls
     2  any entity that manufactures, sells, or distributes prescription  drugs,
     3  biologicals,  or  medical  devices shall not, as a condition of entering
     4  into a contract with a pharmacy, require that the pharmacy purchase  any
     5  drugs or medical devices from an entity with which the PSAO has a finan-
     6  cial interest, or an entity with an ownership interest in the PSAO.
     7    (3)  No PSAO shall enter into a contract with a pharmacy in this state
     8  unless such contract shall  provide  that  all  remittances  for  claims
     9  submitted  by  a pharmacy benefit manager or third-party payer on behalf
    10  of a pharmacy to the PSAO shall be passed through by  the  PSAO  to  the
    11  pharmacy  within  a  reasonable  amount  of  time,  established  in  the
    12  contract, after receipt of the remittance by the PSAO from the  pharmacy
    13  benefit manager or third-party payer.
    14    (c)  (1)  A  PSAO  that  provides,  accepts,  or processes a discount,
    15  concession, or product voucher, to reduce,  directly  or  indirectly,  a
    16  covered  individual's  out-of-pocket  expense for the order, dispensing,
    17  substitution, sale, or purchase of a prescription drug shall make avail-
    18  able to each pharmacy in this state that it contracts with or  which  it
    19  contracted  with  in  the  prior  calendar  year,  an annual report that
    20  includes:
    21    (A) an aggregated total of all such transactions, by the pharmacy; and
    22    (B) an aggregated total of any payments received by  the  PSAO  itself
    23  for  providing,  processing,  or  accepting any discount, concession, or
    24  product voucher on behalf of a pharmacy.
    25    (2) A pharmacy in this state that is a party to a contract with a PSAO
    26  shall have a right to an accounting of the funds received  by  the  PSAO
    27  for  goods  or services provided by the pharmacy to patients and custom-
    28  ers.
    29    § 3006. Registration of  pharmacy  switch  companies.  (a)  No  switch
    30  company may do business in this state after June thirtieth, two thousand
    31  twenty-seven without first registering with the department.
    32    (b)  A switch company seeking registration shall file with the depart-
    33  ment, in a form and manner determined by the superintendent, information
    34  including but not limited to:
    35    (1) the legal name of the entity;
    36    (2) any trade or other names used by the entity;
    37    (3) the organizational structure of the entity;
    38    (4) the pharmacies located within this state and the pharmacy  benefit
    39  managers licensed in this state with which the entity provides services;
    40    (5) the persons who exercise control of the entity;
    41    (6) a primary point of contact for the entity;
    42    (7) an agent for service of process;
    43    (8) a set of audited financials for the prior fiscal year; and
    44    (9)  such  other  information or documents as the superintendent shall
    45  require.
    46    (c) The superintendent shall accept a registration only if  they  deem
    47  that  all  the  required information has been provided in a satisfactory
    48  form and manner and has received payment of a nonrefundable registration
    49  fee of one thousand dollars.
    50    (d) If any of the information  contained  in  the  registration  shall
    51  change,  the switch company shall notify the department of the change in
    52  a form and manner prescribed by  the  superintendent  for  such  purpose
    53  within  twenty-one days of the change.  Such requirement to update shall
    54  include the filing of a new set of audited financials upon adoption. For
    55  any change other than new audited financials, the filing  shall  not  be

        S. 438--A                           6
 
     1  deemed  complete  unless  accompanied  by  a  payment  of a fee of fifty
     2  dollars.
     3    (e)  Every  pharmacy switch company's registration shall expire twelve
     4  months after the date of issue. Every registration  issued  pursuant  to
     5  this section may be renewed for the ensuing period of twelve months upon
     6  the filing of an application in conformity with this section.
     7    (f)  Before a pharmacy switch company's registration shall be renewed,
     8  the pharmacy switch company shall properly file in  the  office  of  the
     9  superintendent  an  application  for  renewal in such form as the super-
    10  intendent prescribes and pay a fee of one thousand dollars.
    11    (g) If an application for a renewal registration shall have been filed
    12  with the superintendent at least one month before its  expiration,  then
    13  the  registration  sought to be renewed shall continue in full force and
    14  effect either until the issuance by the superintendent  of  the  renewal
    15  registration  applied  for  or  until five days after the superintendent
    16  shall have refused to issue such renewal registration and  given  notice
    17  of  such  refusal  to  the  applicant,  otherwise the registration shall
    18  expire and the registrant shall have no expectation of renewal.
    19    § 3007. Required disclosures by pharmacy switch  companies.  (a)  Each
    20  switch  company shall annually disclose to the department, in a form and
    21  manner prescribed by the superintendent, such information as the  super-
    22  intendent  deems  necessary  for the proper supervision of the industry.
    23  Such information shall include:
    24    (1) a list of services the switch company provides and the  industries
    25  to which they are provided;
    26    (2)  information on electronic voucher services provided by the switch
    27  company, including:
    28    (A) a list of manufacturers that the switch company has contracts with
    29  or for which it transmits electronic vouchers;
    30    (B) a list of medications and the National Drug Codes (NDCs) for which
    31  the switch company may apply electronic vouchers; and
    32    (C) the total amount of money collected from manufacturers related  to
    33  transmission of electronic vouchers; and
    34    (3)  the  number of transactions processed in this state and the total
    35  amount of revenue attributable to those transactions.
    36    (b) A switch company shall disclose to each pharmacy  benefit  manager
    37  with  which it does business any instance in which an electronic voucher
    38  was applied in the course of routing the claim.
    39    § 3008. Registration of rebate aggregators. (a) No  rebate  aggregator
    40  may  do  business  in this state after September thirtieth, two thousand
    41  twenty-seven without first registering with the department.
    42    (b) A rebate aggregator seeking registration shall file, in a form and
    43  manner determined by the superintendent, information including  but  not
    44  limited to:
    45    (1) the legal name of the entity;
    46    (2) any trade or other names used by the entity;
    47    (3) the organizational structure of the entity;
    48    (4)  the  health  plans  and the pharmacy benefit managers licensed in
    49  this state for which the entity provides services;
    50    (5) the persons who exercise control of the entity;
    51    (6) a primary point of contact for the entity;
    52    (7) an agent for service of process;
    53    (8) a set of audited financials for the prior fiscal year; and
    54    (9) such other information or documents as  the  superintendent  shall
    55  require.

        S. 438--A                           7
 
     1    (c)  The  superintendent shall accept a registration only if they deem
     2  that all the required information has been provided  in  a  satisfactory
     3  form and manner and has received payment of a nonrefundable registration
     4  fee of one thousand dollars.
     5    (d)  If  any  of  the  information contained in the registration shall
     6  change the rebate aggregator shall notify the department of such  change
     7  in  a  form and manner prescribed by the superintendent for such purpose
     8  within twenty-one days of the change. Such requirement to  update  shall
     9  include the filing of a new set of audited financials upon adoption. For
    10  any  change  other  than new audited financials, the filing shall not be
    11  deemed complete unless accompanied by  a  payment  of  a  fee  of  fifty
    12  dollars.
    13    (e)  Every rebate aggregator's registration shall expire twelve months
    14  after the date of issue. Every  registration  issued  pursuant  to  this
    15  section  may be renewed for the ensuing period of twelve months upon the
    16  filing of an application in conformity with this section.
    17    (f) Before a rebate aggregator's registration shall  be  renewed,  the
    18  rebate  aggregator  shall properly file in the office of the superinten-
    19  dent an application for renewal  in  such  form  as  the  superintendent
    20  prescribes and pay a fee of one thousand dollars.
    21    (g) If an application for a renewal registration shall have been filed
    22  with  the  superintendent at least one month before its expiration, then
    23  the registration sought to be renewed shall continue in full  force  and
    24  effect  either  until  the issuance by the superintendent of the renewal
    25  registration applied for or until five  days  after  the  superintendent
    26  shall  have  refused to issue such renewal registration and given notice
    27  of such refusal to  the  applicant,  otherwise  the  registration  shall
    28  expire and the registrant shall have no expectation of renewal.
    29    §  3009.  Required  disclosures by rebate aggregators. (a) Each rebate
    30  aggregator that has a contract or arrangement with  a  pharmacy  benefit
    31  manager  serving  a  health  plan shall, on an annual basis, disclose in
    32  writing to the health plan the following:
    33    (1) fee structure provisions of any contract  or  arrangement  between
    34  the rebate aggregator and pharmacy benefit manager or drug manufacturer,
    35  including:
    36    (A) fees collected for aggregating rebates due to the health plan; and
    37    (B)  such other information as the superintendent may require by regu-
    38  lation; and
    39    (2)  quantification  of  inflationary   payments,   credits,   grants,
    40  reimbursements,  other  financial  or  other reimbursements, incentives,
    41  inducements, refunds or other benefits received by the rebate aggregator
    42  from the drug manufacturer and retained by the rebate aggregator, wheth-
    43  er referred to as a rebate, a discount, or otherwise.
    44    (b) (1) Each rebate aggregator shall, at  the  time  of  registration,
    45  disclose to the department the extent of any ownership or control of the
    46  rebate  aggregator  or  by  the rebate aggregator of any parent company,
    47  subsidiary, or other  affiliated  organization  that  provides  pharmacy
    48  benefit management services.
    49    (2)  Each  rebate  aggregator shall on an annual basis disclose to the
    50  department the information requested by the superintendent, including:
    51    (A) any payments made to a rebate aggregator by  a  drug  manufacturer
    52  relating to a drug's utilization, including inflationary payments, cred-
    53  its,  grants,  reimbursements,  other financial or other reimbursements,
    54  incentives, inducements, refunds  or  other  benefits  received  by  the
    55  rebate  aggregator,  whether  referred  to  as  a rebate, a discount, or
    56  otherwise;

        S. 438--A                           8
 
     1    (B) any payments made, including those described in  subparagraph  (A)
     2  of this paragraph and subsequently retained by a rebate aggregator;
     3    (C)  any fees charged by the rebate aggregator to the pharmacy benefit
     4  manager or drug manufacturer relating to a drug's utilization;
     5    (D) any payments made to a rebate aggregator from a  program  adminis-
     6  tered  by a drug manufacturer for the purpose of assisting patients with
     7  the cost of prescription drugs, including copayment assistance programs,
     8  discount cards, and coupons; and
     9    (E) the terms and conditions of any contract  or  arrangement  between
    10  the rebate aggregator and a pharmacy benefit manager or drug manufactur-
    11  er.
    12    §  3010.  Deposit  of penalties and fees. Penalties and fees collected
    13  pursuant to this article shall be deposited into  the  pharmacy  benefit
    14  manager  regulatory  fund established pursuant to section ninety-nine-oo
    15  of the state finance law.
    16    § 3. Subdivision 3 of section 99-oo of the state finance law, as added
    17  by chapter 128 of the laws of 2022, is amended to read as follows:
    18    3. Such fund shall consist of money received  by  the  state  as  fees
    19  under  [article] articles twenty-nine and thirty of the insurance law or
    20  penalties ordered under [article] articles twenty-nine and thirty of the
    21  insurance law and all other monies  appropriated,  credited,  or  trans-
    22  ferred thereto from any other fund or source pursuant to law. All monies
    23  shall remain in such fund unless and until directed by statute or appro-
    24  priation.
    25    §  4. This act shall take effect on the one hundred fiftieth day after
    26  it shall have become a law.
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