Bill Text: NY A09516 | 2021-2022 | General Assembly | Introduced
Bill Title: 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.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2022-03-16 - referred to insurance [A09516 Detail]
Download: New_York-2021-A09516-Introduced.html
STATE OF NEW YORK ________________________________________________________________________ 9516 IN ASSEMBLY March 16, 2022 ___________ Introduced by M. of A. L. ROSENTHAL -- read once and referred 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 (m) to read as follows: 3 (m) (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; 23 (B) have a patient-specific expedited exception process for cases in 24 which a provider certifies that it is unsafe for a patient to receive 25 medication from an insurer-designated pharmacy; 26 (C) provide same day delivery of medications; EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD11682-01-1A. 9516 2 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 insurer subject to this article shall by contract, written 22 policy or written procedure require (A) a medication requiring sterile 23 compounding by the provider, or (B) a medication with a patient-specific 24 dosage requirement to be based upon lab or test results on the day of 25 the patient visit, to be distributed from an insurer-designated pharmacy 26 to a physician's office, hospital or clinic for administration. 27 § 2. Section 4325 of the insurance law is amended by adding a new 28 subsection (n) to read as follows: 29 (n) (1) No corporation organized under this article shall by contract, 30 written policy or written procedure allow or require an insurer-desig- 31 nated pharmacy to dispense a medication directly to a patient with the 32 intention that the patient will transport the medication to a physi- 33 cian's office, hospital or clinic for administration. 34 (2) A corporation organized under this article may offer coverage for, 35 but shall not require the use of a home infusion pharmacy to dispense 36 sterile intravenous drugs ordered by physicians to patients in their 37 homes or the use of an infusion site external to a patient's provider 38 office or clinic. 39 (3) A corporation organized under this article, in order to require 40 the distribution of patient-specific medication from an insurer-desig- 41 nated pharmacy to a physician's office, hospital or clinic for adminis- 42 tration, shall establish an agreement with the physician, hospital or 43 clinic responsible for receiving and administering such medications to 44 ensure proper receipt, transfer, handling, and storage of the medication 45 prior to administration that includes, but is not limited to, the 46 following provisions: 47 (A) provide at least ninety days' notice to providers and insureds 48 prior to the implementation of such a requirement; 49 (B) have a patient-specific expedited exception process for cases in 50 which a provider certifies that it is unsafe for a patient to receive 51 medication from an insurer-designated pharmacy; 52 (C) provide same day delivery of medications; 53 (D) make available on-call access to a pharmacist or nurse twenty-four 54 hours per day, seven days per week;A. 9516 3 1 (E) utilize cold chain logistics or other means to ensure a drug 2 remains at the appropriate temperature through all stages of supply and 3 storage; 4 (F) provide a medication's pedigree to certify to the physician's 5 office, hospital or clinic that the drug was handled appropriately 6 through the supply chain; 7 (G) demonstrate expertise and reliability in risk evaluation and miti- 8 gation strategy to comply with United States food and drug adminis- 9 tration reporting requirements; 10 (H) demonstrate the insurer-designated pharmacy is accredited by a 11 national accreditation organization; 12 (I) demonstrate ability to deliver medications to a physician's 13 office, hospital or clinic in a clinically appropriate dosage and in a 14 ready-to-administer dosage form; and 15 (J) offer site neutral payment for such medications to the physician's 16 office, hospital or clinic administering the medication, which payment 17 shall include the costs for the providers to intake, store and dispose 18 of such medications. 19 (4) No corporation organized under this article shall by contract, 20 written policy or written procedure require (A) a medication requiring 21 sterile compounding by the provider, or (B) a medication with a 22 patient-specific dosage requirement to be based upon lab or test results 23 on the day of the patient visit, to be distributed from an insurer-de- 24 signated pharmacy to a physician's office, hospital or clinic for admin- 25 istration. 26 § 3. Section 4406-c of the public health law is amended by adding a 27 new subdivision 11 to read as follows: 28 11. (a) No health care plan shall by contract or written policy or 29 written procedure allow or require a plan-designated pharmacy to 30 dispense a medication directly to a patient with the intention that the 31 patient will transport the medication to a physician's office, hospital 32 or clinic for administration. 33 (b) A health care plan may offer coverage for, but shall not require 34 the use of a home infusion pharmacy to dispense sterile intravenous 35 drugs ordered by physicians to patients in their homes or the use of an 36 infusion site external to a patient's provider office or clinic. 37 (c) A health care plan, in order to require the distribution of 38 patient-specific medication from an insurer-designated pharmacy to a 39 physician's office, hospital or clinic for administration, shall estab- 40 lish an agreement with the physician, hospital or clinic responsible for 41 receiving and administering such medications to ensure proper receipt, 42 transfer, handling, and storage of the medication prior to adminis- 43 tration that includes, but is not limited to, the following provisions: 44 (i) provide at least ninety days' notice to providers and enrollees 45 prior to the implementation of such a requirement; 46 (ii) have a patient-specific expedited exception process for cases in 47 which a provider certifies that it is unsafe for a patient to receive 48 medication from a plan-designated pharmacy; 49 (iii) provide same day delivery of medications; 50 (iv) make available on-call access to a pharmacist or nurse twenty- 51 four hours per day, seven days per week; 52 (v) utilize cold chain logistics or other means to ensure a drug 53 remains at the appropriate temperature through all stages of supply and 54 storage;A. 9516 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.