Requires covered entities report to the department of health regarding certain 340B drug discounts and what percentage of patients benefit from such discounts.
STATE OF NEW YORK
________________________________________________________________________
6987--A
2025-2026 Regular Sessions
IN ASSEMBLY
March 18, 2025
___________
Introduced by M. of A. SEPTIMO, ALVAREZ, TAPIA, GRIFFIN, BICHOTTE HERME-
LYN, REYES, YEGER, HEVESI -- read once and referred to the Committee
on Health -- recommitted to the Committee on Health in accordance with
Assembly Rule 3, sec. 2 -- committee discharged, bill amended, ordered
reprinted as amended and recommitted to said committee
AN ACT to amend the public health law, in relation to requiring trans-
parency requirements for certain 340B drugs
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. The public health law is amended by adding a new section
2 280-e to read as follows:
3 § 280-e. Accountability to safeguard benefits for vulnerable patients.
4 1. For the purposes of this section, the following terms shall have the
5 following meanings:
6 (a) "340B drug" shall mean a covered outpatient drug, as defined by 42
7 USC § 1396r-8(k)(2), that has been subject to any offer for reduced
8 prices by a manufacturer pursuant to 42 USC § 256b(a)(1), and is
9 purchased by a covered entity.
10 (b) "340B profits" shall mean the difference between aggregated
11 payments received from insurers, payors, or self-paying patients for all
12 340B drugs and the aggregate acquisition cost pay for all 340B drugs.
13 (c) "340B program" shall mean the federal drug pricing program
14 described in 42 USC § 256b.
15 (d) "Charity care" shall have the same meaning as ascribed to such
16 term as is found in line twenty-three of the S-10 Medicare cost work-
17 sheet or any successor form.
18 (e) "Contract pharmacy" shall mean a pharmacy with which a covered
19 entity has contracted to dispense 340B drugs on behalf of such covered
20 entity to patients of such covered entity, whether distributed in
21 person, via mail, or by other means.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD10744-02-6
A. 6987--A 2
1 (f) "Covered entity" shall have the same meaning as under 42 USC §
2 256b(a)(4). Provided, however, a covered entity shall not include a
3 federally qualified health center.
4 (g) "Low-income patient" shall mean a patient of a covered entity with
5 a family income below two hundred percent of the federal poverty guide-
6 lines.
7 2. Beginning April first, two thousand twenty-seven, each covered
8 entity shall report to the department with respect to such covered enti-
9 ty and separately for each offsite outpatient facility associated with
10 such covered entity, in a form and manner as determined by the depart-
11 ment, the following information about the prior year:
12 (a) Delineated by form of insurance or payor type, including but not
13 limited to Medicaid, Medicare, commercial insurance, and uninsured to
14 include:
15 (i) aggregated acquisition costs paid for all 340B drugs;
16 (ii) aggregated payments received from insurers, payors, and self-pay-
17 ing patients for all 340B drugs;
18 (iii) the total number of prescriptions and percentage of the covered
19 entity's prescriptions that were filled with 340B drugs; and
20 (iv) the percentage of patients served by a sliding fee scale for 340B
21 drugs at the point of sale for low-income patients.
22 (b) The total operating costs for such covered entity, and itemized
23 costs for:
24 (i) implementing direct pass through of 340B profits to patients in
25 the form of lower cost sharing for 340B drugs at the point of dispensing
26 or administration;
27 (ii) implementing a sliding fee scale for 340B drugs at the point of
28 sale for low-income patients; and
29 (iii) charity care.
30 (c) The total payments made to:
31 (i) contract pharmacies for 340B program related services and other
32 functions;
33 (ii) third-party administrators for managing any components of such
34 covered entity's 340B program; and
35 (iii) any other third parties in connection with 340B program-related
36 compliance, legal, educational, and/or administrative costs.
37 (d) The total number of contract pharmacies, including:
38 (i) the number of contract pharmacies located out-of-state and the
39 states in which such out-of-state pharmacies are located;
40 (ii) the total number of prescriptions and the percentage of the
41 covered entity's prescriptions that were filled at contract pharmacies,
42 delineated by in-state and out-of-state contract pharmacies;
43 (iii) the total remuneration paid to or retained by contract pharma-
44 cies or their affiliates for any 340B program-related services performed
45 on behalf of the covered entity; and
46 (iv) the percentage change in total remuneration paid to or retained
47 by contract pharmacies or their affiliates as described in subparagraph
48 (iii) of this paragraph compared to the prior year.
49 3. An officer of a covered entity shall certify the completeness and
50 accuracy of the report submitted pursuant to subdivision two of this
51 section.
52 4. The department shall post all reports submitted by covered entities
53 pursuant to subdivision two of this section on a publicly accessible
54 website.
55 § 2. This act shall take effect immediately.
