Amd 3217-b & 4325, Ins L; amd 4406-c, Pub Health L
Establishes patient safety and quality assurance measures regarding the distribution of patient-specific medication from an insurer-designated pharmacy; prohibits certain "brown bagging" and "white bagging" policies regarding pharmacy provided medications.
STATE OF NEW YORK
________________________________________________________________________
7413
2023-2024 Regular Sessions
IN SENATE
May 23, 2023
___________
Introduced by Sen. BRESLIN -- read twice and ordered printed, and when
printed to be committed to the Committee on Insurance
AN ACT to amend the insurance law and the public health law, in relation
to establishing patient safety and quality assurance measures regard-
ing the distribution of patient-specific medication from an insurer-
designated pharmacy
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Section 3217-b of the insurance law is amended by adding a
2 new subsection (p) to read as follows:
3 (p) (1) No insurer subject to this article shall by contract, written
4 policy or written procedure allow or require an insurer-designated phar-
5 macy to dispense a medication directly to a patient with the intention
6 that such patient will transport such medication to a physician's
7 office, hospital or clinic for administration.
8 (2) An insurer subject to this article may offer coverage for, but
9 shall not require the use of a home infusion pharmacy to dispense ster-
10 ile intravenous drugs ordered by physicians to patients in their homes
11 or the use of an infusion site external to a patient's provider office
12 or clinic.
13 (3) An insurer subject to this article, in order to require the
14 distribution of patient-specific medication from an insurer-designated
15 pharmacy to a physician's office, hospital or clinic for administration,
16 shall establish an agreement with the physician, hospital or clinic
17 responsible for receiving and administering such medications to ensure
18 proper receipt, transfer, handling, and storage of the medication prior
19 to administration that includes, but is not limited to, the following
20 provisions:
21 (A) provide at least ninety days' notice to providers and insurers
22 prior to the implementation of such a requirement;
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD05796-01-3
S. 7413 2
1 (B) have a patient-specific expedited exception process for cases in
2 which a provider certifies that it is unsafe for a patient to receive
3 medication from an insurer-designated pharmacy;
4 (C) provide same day delivery of medications;
5 (D) make available on-call access to a pharmacist or nurse twenty-four
6 hours per day, seven days per week;
7 (E) utilize cold chain logistics or other means to ensure a drug
8 remains at the appropriate temperature through all stages of supply and
9 storage;
10 (F) provide a medication's pedigree to certify to the physician's
11 office, hospital or clinic that the drug was handled appropriately
12 through the supply chain;
13 (G) demonstrate expertise and reliability in risk evaluation and miti-
14 gation strategy to comply with United States food and drug adminis-
15 tration reporting requirements;
16 (H) demonstrate the insurer-designated pharmacy is accredited by a
17 national accreditation organization;
18 (I) demonstrate ability to deliver medications to a physician's
19 office, hospital or clinic in a clinically appropriate dosage and in a
20 ready-to-administer dosage form; and
21 (J) offer site neutral payment for such medications to the physician's
22 office, hospital or clinic administering the medication, which payment
23 shall include the costs for the providers to intake, store and dispose
24 of such medications.
25 (4) No insurer subject to this article shall by contract, written
26 policy or written procedure require (A) a medication requiring sterile
27 compounding by the provider, or (B) a medication with a patient-specific
28 dosage requirement to be based upon lab or test results on the day of
29 the patient visit, to be distributed from an insurer-designated pharmacy
30 to a physician's office, hospital or clinic for administration.
31 § 2. Section 4325 of the insurance law is amended by adding a new
32 subsection (p) to read as follows:
33 (p) (1) No corporation organized under this article shall by contract,
34 written policy or written procedure allow or require an insurer-desig-
35 nated pharmacy to dispense a medication directly to a patient with the
36 intention that the patient will transport the medication to a physi-
37 cian's office, hospital or clinic for administration.
38 (2) A corporation organized under this article may offer coverage for,
39 but shall not require the use of a home infusion pharmacy to dispense
40 sterile intravenous drugs ordered by physicians to patients in their
41 homes or the use of an infusion site external to a patient's provider
42 office or clinic.
43 (3) A corporation organized under this article, in order to require
44 the distribution of patient-specific medication from an insurer-desig-
45 nated pharmacy to a physician's office, hospital or clinic for adminis-
46 tration, shall establish an agreement with the physician, hospital or
47 clinic responsible for receiving and administering such medications to
48 ensure proper receipt, transfer, handling, and storage of the medication
49 prior to administration that includes, but is not limited to, the
50 following provisions:
51 (A) provide at least ninety days' notice to providers and insureds
52 prior to the implementation of such a requirement;
53 (B) have a patient-specific expedited exception process for cases in
54 which a provider certifies that it is unsafe for a patient to receive
55 medication from an insurer-designated pharmacy;
56 (C) provide same day delivery of medications;
S. 7413 3
1 (D) make available on-call access to a pharmacist or nurse twenty-four
2 hours per day, seven days per week;
3 (E) utilize cold chain logistics or other means to ensure a drug
4 remains at the appropriate temperature through all stages of supply and
5 storage;
6 (F) provide a medication's pedigree to certify to the physician's
7 office, hospital or clinic that the drug was handled appropriately
8 through the supply chain;
9 (G) demonstrate expertise and reliability in risk evaluation and miti-
10 gation strategy to comply with United States food and drug adminis-
11 tration reporting requirements;
12 (H) demonstrate the insurer-designated pharmacy is accredited by a
13 national accreditation organization;
14 (I) demonstrate ability to deliver medications to a physician's
15 office, hospital or clinic in a clinically appropriate dosage and in a
16 ready-to-administer dosage form; and
17 (J) offer site neutral payment for such medications to the physician's
18 office, hospital or clinic administering the medication, which payment
19 shall include the costs for the providers to intake, store and dispose
20 of such medications.
21 (4) No corporation organized under this article shall by contract,
22 written policy or written procedure require (A) a medication requiring
23 sterile compounding by the provider, or (B) a medication with a
24 patient-specific dosage requirement to be based upon lab or test results
25 on the day of the patient visit, to be distributed from an insurer-de-
26 signated pharmacy to a physician's office, hospital or clinic for admin-
27 istration.
28 § 3. Section 4406-c of the public health law is amended by adding a
29 new subdivision 13 to read as follows:
30 13. (a) No health care plan shall by contract or written policy or
31 written procedure allow or require a plan-designated pharmacy to
32 dispense a medication directly to a patient with the intention that the
33 patient will transport the medication to a physician's office, hospital
34 or clinic for administration.
35 (b) A health care plan may offer coverage for, but shall not require
36 the use of a home infusion pharmacy to dispense sterile intravenous
37 drugs ordered by physicians to patients in their homes or the use of an
38 infusion site external to a patient's provider office or clinic.
39 (c) A health care plan, in order to require the distribution of
40 patient-specific medication from an insurer-designated pharmacy to a
41 physician's office, hospital or clinic for administration, shall estab-
42 lish an agreement with the physician, hospital or clinic responsible for
43 receiving and administering such medications to ensure proper receipt,
44 transfer, handling, and storage of the medication prior to adminis-
45 tration that includes, but is not limited to, the following provisions:
46 (i) provide at least ninety days' notice to providers and enrollees
47 prior to the implementation of such a requirement;
48 (ii) have a patient-specific expedited exception process for cases in
49 which a provider certifies that it is unsafe for a patient to receive
50 medication from a plan-designated pharmacy;
51 (iii) provide same day delivery of medications;
52 (iv) make available on-call access to a pharmacist or nurse twenty-
53 four hours per day, seven days per week;
54 (v) utilize cold chain logistics or other means to ensure a drug
55 remains at the appropriate temperature through all stages of supply and
56 storage;
S. 7413 4
1 (vi) provide a medication's pedigree to certify to the physician's
2 office, hospital or clinic that the drug was handled appropriately
3 through the supply chain;
4 (vii) demonstrate expertise and reliability in risk evaluation and
5 mitigation strategy to comply with United States food and drug adminis-
6 tration reporting requirements;
7 (viii) demonstrate the insurer-designated pharmacy is accredited by a
8 national accreditation organization;
9 (ix) demonstrate ability to deliver medications to a physician's
10 office, hospital or clinic in a clinically appropriate dosage and in a
11 ready-to-administer dosage form; and
12 (x) offer site neutral payment for such medications to the physician's
13 office, hospital or clinic administering the medication, which payment
14 shall include the costs for the providers to intake, store and dispose
15 of such medications.
16 (d) No health care plan shall by contract, written policy or written
17 procedure require (i) a medication requiring sterile compounding by a
18 provider, or (ii) a medication with a patient-specific dosage require-
19 ment to be based upon lab or test results on the day of the patient
20 visit, to be distributed from a plan-designated pharmacy to a physi-
21 cian's office, hospital or clinic for administration.
22 § 4. This act shall take effect immediately.
