| |
| |
|
|
A BILL TO BE ENTITLED
|
|
|
AN ACT
|
|
|
relating to a pilot program for donation and redistribution of |
|
|
certain unused prescription medications; authorizing a fee. |
|
|
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
|
|
SECTION 1. Chapter 431, Health and Safety Code, is amended |
|
|
by adding Subchapter O to read as follows: |
|
|
SUBCHAPTER O. PRESCRIPTION DRUG DONATION PILOT PROGRAM |
|
|
Sec. 431.451. DEFINITIONS. In this subchapter: |
|
|
(1) "Charitable drug donor" means: |
|
|
(A) a licensed convalescent or nursing facility |
|
|
or related institution, licensed hospice, hospital, physician, or |
|
|
pharmacy; |
|
|
(B) a pharmaceutical seller or manufacturer that |
|
|
donates drugs under a qualified patient assistance program; or |
|
|
(C) the licensed health care professional |
|
|
responsible for administration of drugs in a penal institution, as |
|
|
defined by Section 1.07, Penal Code, in this state. |
|
|
(2) "Charitable medical clinic" has the meaning |
|
|
assigned by Section 431.321. |
|
|
(3) "Manufacturer" means a person, other than a |
|
|
charitable drug donor, as defined in Chapter 82, Civil Practice and |
|
|
Remedies Code. |
|
|
(4) "Patient assistance program" means a qualified |
|
|
program offered by a pharmaceutical manufacturer under which the |
|
|
manufacturer provides drugs to financially disadvantaged persons |
|
|
at no charge or at a substantially reduced cost. The term does not |
|
|
include the provision of a drug as part of a clinical trial. |
|
|
(5) "Pilot program" means the prescription drug |
|
|
donation pilot program under this subchapter. |
|
|
(6) "Prescription drug" has the meaning assigned by |
|
|
Section 551.003, Occupations Code. |
|
|
(7) "Seller" means a person, other than a charitable |
|
|
drug donor, as defined in Chapter 82, Civil Practice and Remedies |
|
|
Code. |
|
|
Sec. 431.452. ESTABLISHMENT OF PILOT PROGRAM. (a) The |
|
|
department shall establish a pilot program for donation and |
|
|
redistribution of prescription drugs under this subchapter. |
|
|
(b) The department shall conduct the pilot program in one or |
|
|
more municipalities with a population of more than 500,000 but less |
|
|
than one million. |
|
|
Sec. 431.453. DONATION OF UNUSED DRUGS. (a) A charitable |
|
|
drug donor may donate certain unused prescription drugs to the |
|
|
department for the pilot program under this subchapter. |
|
|
(b) A seller or manufacturer of a drug that donates drugs |
|
|
through a qualified patient assistance program is considered a |
|
|
charitable drug donor. |
|
|
(c) A charitable drug donor shall use appropriate |
|
|
safeguards established by department rule to ensure that the drugs |
|
|
are not compromised or illegally diverted while being stored or |
|
|
transported. |
|
|
(d) The department may not accept the donated drugs unless: |
|
|
(1) the charitable drug donor certifies that the drugs |
|
|
have been properly stored while in the possession of the donor or of |
|
|
the person for whom the drugs were originally dispensed; |
|
|
(2) the charitable drug donor provides the department |
|
|
with a verifiable address and telephone number; and |
|
|
(3) the person transferring possession of the drugs |
|
|
presents photographic identification. |
|
|
Sec. 431.454. CIRCUMSTANCES UNDER WHICH DONATED DRUGS MAY |
|
|
BE ACCEPTED. (a) The department may accept donated drugs only in |
|
|
accordance with this subchapter. |
|
|
(b) The donated drugs must be: |
|
|
(1) prescription drugs; and |
|
|
(2) approved by the federal Food and Drug |
|
|
Administration and: |
|
|
(A) sealed in unopened tamper-evident unit dose |
|
|
packaging; |
|
|
(B) be oral medication in sealed single-dose |
|
|
containers approved by the federal Food and Drug Administration; or |
|
|
(C) be topical or inhalant drugs in sealed |
|
|
units-of-use containers approved by the federal Food and Drug |
|
|
Administration. |
|
|
(c) A drug packaged in single unit doses may be accepted and |
|
|
distributed if the outside packaging is opened but the single unit |
|
|
dose packaging is unopened. |
|
|
(d) Donated drugs may not: |
|
|
(1) be the subject of a mandatory recall by a state or |
|
|
federal agency or a voluntary recall by a drug seller or |
|
|
manufacturer; |
|
|
(2) be adulterated or misbranded; |
|
|
(3) be a controlled substance under Chapter 481; |
|
|
(4) be a parenteral or injectable medication; |
|
|
(5) require refrigeration; or |
|
|
(6) expire less than 60 days after the date of the |
|
|
donation. |
|
|
(e) The department may distribute the donated drugs only |
|
|
after a licensed pharmacist has determined that the drugs are of an |
|
|
acceptable integrity. |
|
|
(f) The department may not charge a fee for the drugs |
|
|
donated under the pilot program other than a nominal handling fee to |
|
|
defray the costs incurred in implementing the pilot program under |
|
|
this subchapter. |
|
|
(g) The department may not resell the drugs donated under |
|
|
the pilot program. |
|
|
Sec. 431.455. PRESCRIPTION, PROVISION, AND ADMINISTRATION |
|
|
OF DONATED DRUGS. (a) The donated drugs may be accepted and |
|
|
provided or administered to patients only by: |
|
|
(1) a charitable medical clinic; |
|
|
(2) a physician's office using the drugs for patients |
|
|
who receive assistance from the medical assistance program under |
|
|
Chapter 32, Human Resources Code, or for other indigent health |
|
|
care; or |
|
|
(3) a licensed health care professional responsible |
|
|
for administration of drugs in a penal institution, as defined by |
|
|
Section 1.07, Penal Code, in this state. |
|
|
(b) A prescription drug provided or administered to a |
|
|
patient under the pilot program must be prescribed by a |
|
|
practitioner for use by that patient. |
|
|
(c) The clinic or physician providing or administering the |
|
|
drug may charge a nominal handling fee in an amount prescribed by |
|
|
department rule. |
|
|
(d) A clinic, physician, or other licensed health care |
|
|
professional receiving donated drugs may not resell the drugs. |
|
|
Sec. 431.456. CENTRAL DRUG REPOSITORY. The department |
|
|
shall establish a location to centrally store drugs donated under |
|
|
this subchapter for distribution to qualifying recipients. |
|
|
Sec. 431.457. DATABASE OF DONATED DRUGS. The department |
|
|
shall establish and maintain an electronic database in which: |
|
|
(1) the department shall list the name and quantity of |
|
|
each drug donated to the department under the pilot program; and |
|
|
(2) a charitable medical clinic, physician, or other |
|
|
licensed health care professional may search for and request |
|
|
donated drugs. |
|
|
Sec. 431.458. RULES. This subchapter shall be governed by |
|
|
department rules that are designed to protect the public health and |
|
|
safety, including: |
|
|
(1) the maximum handling fee that may be imposed by a |
|
|
clinic or physician providing or administering a donated drug to a |
|
|
patient; |
|
|
(2) provisions for maintenance of the database of |
|
|
donated drugs; and |
|
|
(3) any necessary forms for the administration of the |
|
|
pilot program. |
|
|
Sec. 431.459. LIMITATION ON CIVIL AND CRIMINAL LIABILITY. |
|
|
(a) Charitable drug donors, manufacturers and sellers of donated |
|
|
drugs, charitable medical clinics, physicians, penal institutions, |
|
|
and their employees acting in good faith in providing or |
|
|
administering prescription drugs under the pilot program are not |
|
|
civilly or criminally liable or subject to professional |
|
|
disciplinary action for harm caused by providing or administering |
|
|
drugs donated under this subchapter unless the harm is caused by: |
|
|
(1) wilful or wanton acts of negligence; |
|
|
(2) conscious indifference or reckless disregard for |
|
|
the safety of others; or |
|
|
(3) intentional conduct. |
|
|
(b) This section does not apply if the harm results from the |
|
|
failure to comply with the requirements of this subchapter. |
|
|
(c) This section does not apply to a charitable medical |
|
|
clinic that fails to comply with the insurance provisions of |
|
|
Chapter 84, Civil Practice and Remedies Code. |
|
|
Sec. 431.460. REPORTS TO LEGISLATURE. Not later than |
|
|
January 1 of each odd-numbered year, the department shall report to |
|
|
the legislature on the results of the pilot program. The report |
|
|
must include: |
|
|
(1) the pilot program's efficacy in expanding access |
|
|
to prescription medications; |
|
|
(2) any cost savings to the state or local governments |
|
|
resulting from or projected to result from the pilot program; |
|
|
(3) an evaluation of the pilot program's database and |
|
|
system of distribution; |
|
|
(4) any health and safety issues posed by providing or |
|
|
administering donated drugs; |
|
|
(5) recommendations on improvements to the pilot |
|
|
program; and |
|
|
(6) an evaluation of potential expansion of the pilot |
|
|
program. |
|
|
SECTION 2. (a) As soon as practicable after the effective |
|
|
date of this Act, the Department of State Health Services shall |
|
|
conduct a study to determine the feasibility of establishing a |
|
|
program under which: |
|
|
(1) a hospital, a nursing facility, or another health |
|
|
facility may transfer to the department, or an entity designated by |
|
|
the department, for no payment, unused drugs that the hospital, |
|
|
nursing facility, or health facility received reimbursement for the |
|
|
cost of under Medicaid; and |
|
|
(2) the department, or the entity designated by the |
|
|
department, distributes to public hospitals the unused drugs |
|
|
transferred to the department or entity under Subdivision (1) of |
|
|
this subsection. |
|
|
(b) In conducting the study under Subsection (a) of this |
|
|
section, the Department of State Health Services shall consider the |
|
|
rules the executive commissioner of the Health and Human Services |
|
|
Commission may need to adopt to implement the program described in |
|
|
Subsection (a) of this section, including rules that provide for: |
|
|
(1) the types of unused drugs that may be transferred |
|
|
to the department or an entity designated by the department; |
|
|
(2) the procedures for transferring unused drugs to |
|
|
the department or the entity designated by the department; |
|
|
(3) the procedures for allocating and distributing the |
|
|
unused drugs to public hospitals; and |
|
|
(4) the qualifications for an entity to be designated |
|
|
by the department to receive and distribute unused drugs under the |
|
|
program, including demonstrated expertise in handling, storing, |
|
|
and assessing prescription and nonprescription drugs and |
|
|
coordinating with the state's public hospital system. |
|
|
(c) Not later than September 1, 2016, the Department of |
|
|
State Health Services shall submit to the legislature a report |
|
|
containing the findings of the study conducted under Subsection (a) |
|
|
of this section. |
|
|
SECTION 3. Not later than December 1, 2015, the Department |
|
|
of State Health Services shall establish the central repository and |
|
|
database required by Subchapter O, Chapter 431, Health and Safety |
|
|
Code, as added by this Act. |
|
|
SECTION 4. The change in law made by this Act applies only |
|
|
to a drug that is donated, accepted, provided, or administered on or |
|
|
after January 1, 2016. |
|
|
SECTION 5. This Act takes effect September 1, 2015. |