|SAME AS||No Same As|
|Amd S2803-e, Pub Health L|
|Provides that residential health care facilities may return and redistribute unused medication provided that such medication is in the manufacturer's original, tamper evident packaging; directs the commissioner of health to establish a reasonable fee of reimbursement of costs related to the receipt, restocking and redistribution of such medication payable to the pharmacy to which such medication is returned.|
|02/23/2015||referred to health|
|01/06/2016||referred to health|
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NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A5449 SPONSOR: Englebright (MS)
TITLE OF BILL: An act to amend the public health law, in relation to return and redistribution of unused medication   PURPOSE OR GENERAL IDEA OF BILL: To clarify provisions governing the return and redistribution of unused medication provided in certain residential health care facilities, provide for a reasonable fee for the costs of such return and redistrib- ution and to direct the establishment of an electronic method by which a pharmacy can effectuate such returns for Medicaid purposes.   SUMMARY OF PROVISIONS: Section 1. Amends Section 2803-e (1) of the public health law to further clarify how unused medications must be packaged to be received, restocked and redistributed by a pharmacy; amends subdivision 2 of such section to direct the commissioner of health, in consultation with an advisory committee, to establish a reasonable fee of reimbursement of costs related to the receipt, restocking and redistribution of such medications to the pharmacy; adds a new subdivision 5 to such section to direct the commissioner to establish procedures to assure that any such return of medications, receipt, restocking or redistribution, comply with HIPAA and related electronic submission requirements; adds a new subdivision 6 to such section to establish the advisory committee referred to in subdivision 2. Subdivision 7 restricts civil liability of prescription drug manufacturers under certain circumstances.   JUSTIFICATION: In a recent Medicaid update, the Department of Health (DOH) provided guidelines for unused medication in a nursing home setting suggesting that nursing home pharmacy services providers reimburse or credit the nursing home or purchaser of such drug product for the unused medication that is restocked and redispensed, noting that drugs listed on the Medi- caid Nursing Home Carve-Out List must be credited back to the Medicaid program. Unfortunately, electronic coding standards required by HIPAA currently contain no codes for issuing a credit to a payor, thus making implementation of such a return credit policy unworkable. This legis- lation directs DOH to establish procedures to assure an efficient proc- ess, including access to the original claim, reversal, adjustment and rebilling activities reflecting the credit. The bill further directs the commissioner of health to establish a fee to cover the costs of process- ing such returns and credits. "Return" is not simply "dispensing in reverse", requiring several safeguards, manual processes and tracking activities which are costly. An advisory committee is established in the bill to assist the commissioner in determining such fee.   PRIOR LEGISLATIVE HISTORY: 2007-08: S.652 Referred to Health 2009-10: S.3500 Referred to Health 2011-12 A.4150A referred to Health 2013-14 A.4643 referred to Health   FISCAL IMPLICATIONS: None to the state.   EFFECTIVE DATE: This act shall take effect on the 120th day after enactment.
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STATE OF NEW YORK ________________________________________________________________________ 5449 2015-2016 Regular Sessions IN ASSEMBLY February 23, 2015 ___________ Introduced by M. of A. ENGLEBRIGHT, LUPARDO -- read once and referred to the Committee on Health AN ACT to amend the public health law, in relation to return and redis- tribution of unused medication The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Section 2803-e of the public health law, as added by chap- 2 ter 902 of the laws of 1977 and renumbered by chapter 340 of the laws of 3 1980, is amended to read as follows: 4 § 2803-e. Residential health care facilities; return and redistrib- 5 ution of unused medication. 1. Notwithstanding any inconsistent 6 provision of law, rule or regulation to the contrary, the commissioner 7 is hereby authorized and directed to permit either a resident or 8 consultant pharmacist or his or her designee in a residential health 9 care facility to return to the pharmacy from which it was purchased any 10 unused medication provided that such medication is sealed in the 11 manufacturer's original unopened[ ,] tamper evident packaging and either 12 individually packaged [ units] or packaged in unit-dose packaging and 13 within the recommended period of shelf life, and, if oral or parenteral 14 medications, sealed in single-dose containers approved by the federal 15 Food and Drug Administration, and, if a topical or inhalant drug, is 16 sealed in units-of-use containers approved by the federal Food and Drug 17 Administration and provided that such medication is not a controlled 18 substance as defined in section thirty-three hundred six of [ the public19 health law] this chapter. 20 2. The pharmacy to which such medication as described in subdivision 21 one of this section is returned shall be permitted to receive, restock 22 and redistribute that medication. The commissioner, in consultation 23 with the advisory committee established by subdivision six of this 24 section, shall establish a reasonable fee of reimbursement of costs EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD08994-01-5A. 5449 2 1 related to the receipt, restocking and redistribution of such medication 2 payable to the pharmacy to which such medication is returned. 3 3. The pharmacy to which such medication as described in subdivision 4 one of this section is returned shall be required to reimburse or credit 5 the purchaser of that medication for the unused medication that is 6 restocked and redistributed. No pharmacy shall be required to accept any 7 medication returned under subdivision one of this section. 8 4. Neither an individual patient or the state, if a patient is a 9 recipient of a state funded program, shall be charged for unused medica- 10 tion which according to the provisions of this law is returned for 11 reimbursement or credit. 12 5. The commissioner shall establish procedures to assure that any 13 return of medications authorized by this section, and any receipt, 14 restocking or redistribution of medication so returned shall comply with 15 the federal Health Insurance Portability and Accountability Act (HIPAA) 16 of 1996, as amended. 17 6. The department shall convene an advisory committee to assist the 18 commissioner in developing a reasonable fee of reimbursement pursuant to 19 the provisions of subdivision two of this section. The advisory commit- 20 tee shall be comprised of licensed pharmacists currently engaged in the 21 provision of long term care pharmacy services. Members of the committee 22 shall be appointed by the governor: two members of the committee shall 23 be appointed on the recommendation of the temporary president of the 24 senate and the speaker of the assembly; and two members shall be 25 appointed on the recommendation of the minority leader of the assembly 26 and the minority leader of the senate. 27 7. A prescription drug manufacturer shall not, in the absence of bad 28 faith, be subject to criminal or civil liability for injury, death, or 29 loss to person or property for matters related to the return, donation, 30 acceptance, redistribution or dispensing of a prescription drug manufac- 31 tured by the prescription drug manufacturer that is donated by any 32 person under the program, including but not limited to liability for 33 failure to transfer or communicate product or consumer information or 34 the expiration date of the donated prescription drug. 35 § 2. This act shall take effect on the one hundred twentieth day after 36 it shall have become a law; provided, however, that the commissioner of 37 health shall promulgate rules and regulations prior to such effective 38 date.