A05449 Summary:

BILL NO    A05449 

SAME AS    No same as 

SPONSOR    Englebright (MS)

COSPNSR    Lupardo

MLTSPNSR   

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.
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A05449 Actions:

BILL NO    A05449 

02/23/2015 referred to health
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A05449 Votes:

There are no votes for this bill in this legislative session.
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A05449 Memo:

BILL NUMBER:A5449

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 redistribution 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 Medicaid 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 legislation directs DOH to establish procedures to
assure an efficient process, 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 processing 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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A05449 Text:

                           S T A T E   O F   N E W   Y O R K
       ________________________________________________________________________

                                         5449

                              2015-2016 Regular Sessions

                                 I N  A S S E M B L Y

                                   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    S 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  public
   19  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.
                                                                  LBD08994-01-5
       A. 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    S 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.
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