80R756 JTS-D

By: Nelson S.B. No. 39

A BILL TO BE ENTITLED

AN ACT

relating to a cancer drug donation program.

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. CANCER DRUG DONATION PROGRAM

Sec. 431.451. DEFINITIONS. In this subchapter:

(1) "Cancer drug" means a prescription drug used to treat:

(A) cancer or its side effects; or

(B) the side effects of a prescription drug used to treat cancer or its side effects.

(2) "Department" means the Department of State Health Services.

(3) "Health care facility" means:

(A) a general or special hospital as defined by Chapter 241;

(B) an ambulatory surgical center licensed under Chapter 243;

(C) an institution licensed under Chapter 242; or

(D) any other facility, including an outpatient clinic, that provides diagnosis or treatment services to patients with cancer.

(4) "Participant" means a physician's office, pharmacy, or health care facility that has elected to participate in the program and that accepts donated cancer drugs and supplies under the rules adopted by the department for the program.

(5) "Pharmacy" means an entity licensed under Chapter 560, Occupations Code.

(6) "Physician's office" means the office of a person licensed to practice medicine in this state or another state of the United States.

(7) "Practitioner" has the meaning assigned by Section 551.003, Occupations Code.

(8) "Prescription drug" has the meaning assigned by Section 551.003, Occupations Code.

(9) "Program" means the cancer drug donation program created under this subchapter.

(10) "Supplies" means any supplies used in the administration of a cancer drug.

Sec. 431.452. DONATION TO PROGRAM. (a) A person may donate a cancer drug or supplies to the program at a physician's office, pharmacy, or health care facility that elects to participate in the program and meets criteria established by the department for participation.

(b) A person may not donate, through the program, a cancer drug or supplies for a specific individual.

(c) A participant may not resell a cancer drug or supplies donated to the program.

Sec. 431.453. DISTRIBUTION. A cancer drug or supplies distributed to an eligible individual under the program must:

(1) be prescribed by a practitioner for use by an eligible individual; and

(2) be dispensed by a pharmacist.

Sec. 431.454. REQUIREMENTS FOR DONATED DRUGS AND SUPPLIES. (a) Except as provided by this subsection, a cancer drug or supplies may only be accepted or dispensed under the program if the drug is in its original, unopened, sealed, and tamper-evident unit-dose packaging. A cancer drug packaged in single unit doses may be accepted and dispensed if the outside packaging is opened but the single-unit-dose packaging is unopened.

(b) A cancer drug may not be accepted or dispensed under the program if the drug:

(1) bears an expiration date that is earlier than six months after the date the drug was donated; or

(2) is adulterated or misbranded as determined under Subsection (c).

(c) Before being dispensed to an eligible individual, a cancer drug or supplies donated under the program must be inspected by a pharmacist to determine that the drug or supplies are not adulterated or misbranded.

(d) A dispenser of donated products may not submit a claim or otherwise seek reimbursement from any public or private third party payer for donated drugs dispensed to an eligible individual under the program, and a public or private third party payer is not required to provide reimbursement for donated drugs dispensed to an individual through the program.

Sec. 431.455. STORAGE, DISTRIBUTION, AND DISPENSING; FEE. (a) A participant shall comply with all applicable provisions of state and federal law relating to the storage, distribution, and dispensing of donated cancer drugs.

(b) A participant may charge a nominal handling fee for distributing or dispen sing cancer drugs or supplies under the program.

Sec. 431.456. ELIGIBILITY REQUIREMENTS AND RESTRICTIONS. (a) To be eligible to receive cancer drugs or supplies under the program, an individual must be uninsured or underinsured, as determined by department rule.

(b) An individual who is eligible to receive drugs or supplies under the medical assistance program under Chapter 32, Human Resources Code, or under any other prescription drug program funded wholly or partly by the state is not eligible to receive cancer drugs or supplies under the program.

Sec. 431.457. RULES. The department, on the recommendation of the Texas State Board of Pharmacy, shall adopt rules to carry out this subchapter. Rules adopted under this section must address:

(1) eligibility criteria, including a method to determine priority of recipients under the program;

(2) standards and procedures for participants that accept, store, distribute, or dispense donated cancer drugs or supplies;

(3) necessary forms for administration of the program, including forms for use by persons who donate, accept, distribute, or dispense cancer drugs or supplies under the program;

(4) the maximum handling fee that may be charged by a participant under Section 431.455(b);

(5) categories of cancer drugs and supplies that the program will accept for dispensing;

(6) categories of cancer drugs and supplies that the program will not accept for dispensing and the reason that such drugs and supplies will not be accepted; and

(7) maintenance and distribution of the participant registry established under Section 431.458.

Sec. 431.458. PARTICIPANT REGISTRY. The department shall establish and maintain a participant registry for the program. The department shall make the participant registry available to any person wishing to donate cancer drugs or supplies to the program. The participant registry shall:

(1) include the participant's name, address, and telephone number; and

(2) identify whether the participant is a physician's office, a pharmacy, or a health care facility.

Sec. 431.459. LIABILITY. (a) A donor of a cancer drug or supplies, or a participant in the program who exercises reasonable care in donating, accepting, distributing, or dispensing cancer drugs or supplies under the program, is not criminally liable, is not civilly liable for damages other than economic damages, and is not subject to professional disciplinary action for bodily injury, death, or property damage that arises from those activities.

(b) A pharmaceutical manufacturer is not liable for damages, other than economic damages, for bodily injury, death, or property damage that arise from the transfer of a prescription drug under this subchapter, including liability for failure to transfer or communicate product or consumer information regarding the transferred drug, including the expiration date of the transferred drug.

SECTION 2. The Department of State Health Services shall adopt initial rules for Subchapter O, Chapter 431, Health and Safety Code, as added by this Act, not later than December 1, 2007.

SECTION 3. (a) Section 431.459, Health and Safety Code, as added by this Act, applies only to a cause of action that accrues on or after the effective date of this Act. An action that accrued before the effective date of this Act is governed by the law applicable to the action immediately before the effective date of this Act, and that law is continued in effect for that purpose.

(b) Section 431.459, Health and Safety Code, as added by this Act, is an exercise of authority under Section 66(c), Article III, Texas Constitution, and takes effect only if this Act receives a vote of three-fifths of all the members elected to each house, as provided by Section 66(e) of that article.

SECTION 4. This Act takes effect September 1, 2007.