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S05464 Summary:

BILL NOS05464
 
SAME ASNo Same As
 
SPONSORCOMRIE
 
COSPNSR
 
MLTSPNSR
 
Amd §280-a, Pub Health L
 
Amends provisions governing reimbursement practices of pharmacy benefit managers to ensure that pharmacies are not reimbursed an amount less than the cost of procuring the drugs.
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S05464 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          5464
 
                               2025-2026 Regular Sessions
 
                    IN SENATE
 
                                    February 21, 2025
                                       ___________
 
        Introduced  by  Sen.  COMRIE -- read twice and ordered printed, and when
          printed to be committed to the Committee on Health
 
        AN ACT to amend the public health law, in relation to  pharmacy  benefit
          managers
 
          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:

     1    Section 1. Section 280-a of the public health law, as added by chapter
     2  828 of the laws of 2021, subdivisions 1, 2 and 3 as amended  by  chapter
     3  128  of  the laws of 2022 and subdivision 5 as amended by chapter 396 of
     4  the laws of 2024, is amended to read as follows:
     5    § 280-a. Pharmacy benefit managers.  1. Definitions. As used  in  this
     6  section, the following terms shall have the following meanings:
     7    (a) "Health plan" means an entity for which a pharmacy benefit manager
     8  provides pharmacy benefit management services and that is a health bene-
     9  fit  plan or other entity that approves, provides, arranges for, or pays
    10  or reimburses in whole or in part for health care items or services,  to
    11  include at least prescription drugs, for a substantial number of benefi-
    12  ciaries  who  work  or  reside  in  this state. The superintendent shall
    13  determine, in [his or her] their sole discretion, by regulation how  the
    14  phrase "a substantial number of beneficiaries who work or reside in this
    15  state" shall be interpreted.
    16    (b)  "Pharmacy  benefit  management  services" means the management or
    17  administration of prescription drug benefits for a health plan, directly
    18  or through another entity, and regardless of whether the pharmacy  bene-
    19  fit manager and the health plan are related, or associated by ownership,
    20  common  ownership,  organization or otherwise; including the procurement
    21  of prescription drugs to be dispensed to patients, or the administration
    22  or management of prescription drug benefits, including but  not  limited
    23  to, any of the following:
    24    (i) mail service pharmacy;
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD09728-01-5

        S. 5464                             2
 
     1    (ii)  claims  processing,  retail  network  management,  or payment of
     2  claims to pharmacies for dispensing prescription drugs;
     3    (iii)  clinical  or other formulary or preferred drug list development
     4  or management;
     5    (iv) negotiation or  administration  of  rebates,  discounts,  payment
     6  differentials,  or  other  incentives,  for  the inclusion of particular
     7  prescription drugs in a particular category or to promote  the  purchase
     8  of particular prescription drugs;
     9    (v)  patient  compliance, therapeutic intervention, or generic substi-
    10  tution programs;
    11    (vi) disease management;
    12    (vii) drug utilization review or prior authorization;
    13    (viii) adjudication of appeals or grievances related  to  prescription
    14  drug coverage;
    15    (ix) contracting with network pharmacies; and
    16    (x) controlling the cost of covered prescription drugs.
    17    (c) "Pharmacy benefit manager" means any entity that performs pharmacy
    18  benefit management services for a health plan.
    19    (d)  "Maximum  allowable  cost  price"  means  a maximum reimbursement
    20  amount set by the pharmacy benefit manager  for  therapeutically  equiv-
    21  alent multiple source generic drugs.
    22    (e) "Controlling person" means any person or other entity who or which
    23  directly  or  indirectly has the power to direct or cause to be directed
    24  the management, control or activities of a pharmacy benefit manager.
    25    (f)  "Covered  individual"  means  a  member,  participant,  enrollee,
    26  contract holder or policy holder or beneficiary of a health plan.
    27    (g)  "License" means a license to be a pharmacy benefit manager, under
    28  article twenty-nine of the insurance law.
    29    (h) "Spread pricing" means the practice of a pharmacy benefit  manager
    30  retaining  an  additional amount of money in addition to the amount paid
    31  to the pharmacy to fill a prescription.
    32    (i) "Superintendent" means the superintendent of financial services.
    33    (j) "Pharmacy acquisition cost" means the amount that a pharmaceutical
    34  wholesaler charges for a pharmaceutical product as listed on the pharma-
    35  cy's billing invoice.
    36    (k) "Pharmacy benefit manager affiliate" means a pharmacy  or  pharma-
    37  cist  that  directly  or  indirectly, through one or more intermediaries
    38  owns or controls, is owned or controlled by, or is under  common  owner-
    39  ship or control with a pharmacy benefit manager.
    40    (l)  "Pharmacy  benefits plan or program" means a plan or program that
    41  pays for, reimburses, covers the cost  of,  or  otherwise  provides  for
    42  pharmacist services to individuals who reside in or are employed in this
    43  state.
    44    2. Duty, accountability and transparency. (a) (i) The pharmacy benefit
    45  manager  shall  have  a  duty and obligation to perform pharmacy benefit
    46  management services with care, skill, prudence, diligence,  and  profes-
    47  sionalism.
    48    (ii)  In  addition  to  the  duties as may be prescribed by regulation
    49  pursuant to article twenty-nine of the insurance law:
    50    (1) A pharmacy benefit manager interacting with a  covered  individual
    51  shall  have the same duty to a covered individual as the health plan for
    52  whom it is performing pharmacy benefit management services.
    53    (2) A pharmacy benefit manager shall have a duty  of  good  faith  and
    54  fair  dealing  with  all  parties,  including but not limited to covered
    55  individuals and pharmacies, with whom it interacts in the performance of
    56  pharmacy benefit management services.

        S. 5464                             3
 
     1    (b) All funds received by the pharmacy benefit manager in relation  to
     2  providing  pharmacy benefit management services shall be received by the
     3  pharmacy benefit manager in trust and shall be used or distributed  only
     4  pursuant to the pharmacy benefit manager's contract with the health plan
     5  or  applicable  law;  including any administrative fee or payment to the
     6  pharmacy benefit manager expressly  provided  for  in  the  contract  to
     7  compensate  the  pharmacy  benefit  manager  for its services. Any funds
     8  received by the pharmacy benefit manager through spread pricing shall be
     9  subject to this paragraph. In addition to any other power  conferred  by
    10  law  the  superintendent  shall  have  the  authority to prescribe rules
    11  concerning pharmacy benefit manager administrative fees, including limi-
    12  tations on their form and use.
    13    (c) The pharmacy benefit  manager  shall  account,  annually  or  more
    14  frequently  to the health plan for any pricing discounts, rebates of any
    15  kind, inflationary payments, credits, clawbacks, fees,  grants,  charge-
    16  backs,  reimbursements, or other benefits received by the pharmacy bene-
    17  fit manager. The health plan shall have  access  to  all  financial  and
    18  utilization  information  of the pharmacy benefit manager in relation to
    19  pharmacy benefit management services provided to the health plan.
    20    (d) The pharmacy benefit manager shall  disclose  in  writing  to  the
    21  health  plan  the  terms  and  conditions of any contract or arrangement
    22  between the pharmacy benefit manager and any party relating to  pharmacy
    23  benefit  management  services  provided to the health plan including but
    24  not limited to, dispensing fees paid to the pharmacies.
    25    (e) The pharmacy benefit manager shall  disclose  in  writing  to  the
    26  health  plan  any activity, policy, practice, contract or arrangement of
    27  the pharmacy benefit manager that directly or  indirectly  presents  any
    28  conflict  of  interest  with the pharmacy benefit manager's relationship
    29  with or obligation to the health plan.
    30    (f) Any information required to be disclosed  by  a  pharmacy  benefit
    31  manager  to  a  health plan under this section that is reasonably desig-
    32  nated by the pharmacy benefit manager as  proprietary  or  trade  secret
    33  information  shall  be  kept  confidential by the health plan, except as
    34  required or permitted by law, including disclosure necessary  to  prose-
    35  cute  or  defend  any legitimate legal claim or cause of action.  Desig-
    36  nation of information as proprietary or trade secret  information  under
    37  this subdivision shall have no effect on the obligations of any pharmacy
    38  benefit  manager  or  health  plan  to  provide  that information to the
    39  department of health or the department of financial services.
    40    (g) The superintendent, in consultation with the commissioner may make
    41  regulations defining, limiting, and relating to the duties, obligations,
    42  requirements and other provisions relating to pharmacy benefit  managers
    43  under this subdivision.
    44    3.  Prescriptions.  A  pharmacy  benefit manager may not substitute or
    45  cause the substituting of one prescription drug for another in  dispens-
    46  ing  a  prescription,  or  alter or cause the altering of the terms of a
    47  prescription, except with the approval of the prescriber or as explicit-
    48  ly required or permitted by law, including regulations of the department
    49  of financial services or the department of  health.  The  superintendent
    50  and  commissioner,  in  coordination  with each other, are authorized to
    51  promulgate regulations to determine when  substitution  of  prescription
    52  drugs may be required or permitted.
    53    4.  Appeals.  A  pharmacy  benefit  manager  shall,  with  respect  to
    54  contracts between a pharmacy benefit manager and a pharmacy or, alterna-
    55  tively, a pharmacy benefit manager and a pharmacy's  contracting  agent,
    56  such  as  a  pharmacy  services  administrative  organization, include a

        S. 5464                             4
 
     1  reasonable process to appeal, investigate and resolve disputes regarding
     2  multi-source generic drug pricing, including being  below  the  pharmacy
     3  acquisition  cost.    The  appeals  process  shall include the following
     4  provisions:
     5    (a)  the  right  to  appeal  by  the  pharmacy  and/or  the pharmacy's
     6  contracting agent shall be limited to thirty days following the  initial
     7  claim submitted for payment;
     8    (b)  a  telephone  number through which a network pharmacy may contact
     9  the pharmacy benefit manager for the purpose of filing an appeal and  an
    10  electronic  mail  address of the individual who is responsible for proc-
    11  essing appeals;
    12    (c) the pharmacy benefit manager shall send an electronic mail message
    13  acknowledging receipt of the appeal. The pharmacy benefit manager  shall
    14  respond  in  an electronic message to the pharmacy and/or the pharmacy's
    15  contracting agent filing the appeal within seven business days  indicat-
    16  ing  its  determination.  If  the  appeal is determined to be valid, the
    17  maximum allowable cost for the drug shall be adjusted for the  appealing
    18  pharmacy effective as of the date of the original claim for payment. The
    19  pharmacy benefit manager shall require the appealing pharmacy to reverse
    20  and  rebill  the  claim  in  question  in  order to obtain the corrected
    21  reimbursement;
    22    (d) if an update to the maximum allowable cost is warranted, the phar-
    23  macy benefit manager or covered entity shall adjust the  maximum  allow-
    24  able cost of the drug effective for all similarly situated pharmacies in
    25  its  network  in  the  state on the date the appeal was determined to be
    26  valid; and
    27    (e) if an appeal is denied, the pharmacy benefit manager shall identi-
    28  fy the national drug code  of  a  therapeutically  equivalent  drug,  as
    29  determined  by  the federal Food and Drug Administration, that is avail-
    30  able for purchase by pharmacies in this state  from  wholesalers  regis-
    31  tered  pursuant to subdivision four of section sixty-eight hundred eight
    32  of the education law at a price which is equal to or less than the maxi-
    33  mum allowable cost for that drug as determined by the  pharmacy  benefit
    34  manager.
    35    4-a.  Maximum  allowable  costs.  (a) If the national drug code number
    36  provided by the pharmacy benefit manager  is  not  available  below  the
    37  pharmacy  acquisition  cost from the pharmaceutical wholesaler from whom
    38  the pharmacy or pharmacist purchases the majority of prescription  drugs
    39  for  resale,  then the pharmacy benefit manager shall adjust the maximum
    40  allowable cost above the  challenging  pharmacy's  pharmacy  acquisition
    41  cost  and  permit the pharmacy to reverse and rebill each claim affected
    42  by the inability to procure the drug at a cost that is equal to or  less
    43  than the previously challenged maximum allowable cost.
    44    (b) A pharmacy benefit manager shall not reimburse a pharmacy or phar-
    45  macist  in  this  state an amount less than the amount that the pharmacy
    46  benefit manager reimburses a  pharmacy  benefit  manager  affiliate  for
    47  providing the same pharmacist services.
    48    (c)  The  amount  shall be calculated on a per unit basis based on the
    49  same generic product identified or generic code number.
    50    (d) A pharmacy or pharmacist may decline  to  provide  the  pharmacist
    51  services  to  a patient or pharmacy benefit manager if, as a result of a
    52  maximum allowable cost, a pharmacy or pharmacist is to be paid less than
    53  the pharmacy acquisition  cost  of  the  pharmacy  providing  pharmacist
    54  services.
    55    5.  Contract  provisions.  No  pharmacy  benefit  manager  shall, with
    56  respect to contracts between such pharmacy benefit manager and a pharma-

        S. 5464                             5
 
     1  cy or, alternatively, such pharmacy benefit  manager  and  a  pharmacy's
     2  contracting  agent, such as a pharmacy services administrative organiza-
     3  tion:
     4    (a)  prohibit  or penalize a pharmacist or pharmacy from disclosing to
     5  an individual purchasing a prescription medication or  service  informa-
     6  tion regarding:
     7    (i) the cost of the prescription medication or service to the individ-
     8  ual,  or the cost of the prescription medication or service to the phar-
     9  macy and the pharmacy's reimbursement for that  prescription  medication
    10  or service; or
    11    (ii)  the  availability  of any therapeutically equivalent alternative
    12  medications or alternative methods of purchasing the prescription  medi-
    13  cation, including but not limited to, paying a cash price; or
    14    (b)  charge or collect from an individual a copayment that exceeds the
    15  total submitted charges by the pharmacy for which the pharmacy is  paid.
    16  If an individual pays a copayment, the pharmacy shall retain the adjudi-
    17  cated  costs and the pharmacy benefit manager shall not redact or recoup
    18  the adjudicated cost.
    19    6. Pharmacy benefit manager  additional  duties.  A  pharmacy  benefit
    20  manager shall:
    21    (a)  provide access to its maximum allowable cost prices to each phar-
    22  macy subject to the maximum allowable cost price; and
    23    (b) update its maximum allowable cost prices on a timely basis, but in
    24  no event longer than seven calendar days from an increase of ten percent
    25  or more in the pharmacy acquisition cost from sixty percent or  more  of
    26  the pharmaceutical wholesaler doing business in the state or a change in
    27  the methodology on which the maximum allowable cost price is based or in
    28  the value of a variable involved in the methodology.
    29    § 2. This act shall take effect immediately.
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