February 14, 2006, Introduced by Reps. Vander Veen, Garfield, Shaffer, Gosselin, Kooiman, Polidori, Spade, Huizenga, Ball, Gleason, Taub, Marleau, Green, Vagnozzi, Van Regenmorter, Amos, Pastor, Pearce, Newell, Miller and Ward and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending section 17766 (MCL 333.17766), as amended by 2004 PA
329, and by adding part 52A.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
PART 52A CANCER DRUG DONATION PROGRAM
Sec. 5251. This part shall be known and may be cited as the
"cancer drug donation program".
Sec. 5253. (1) As used in this part:
(a) "Cancer drug" means a prescription drug used to treat
cancer or its side effects or used to treat the side effects of a
prescription drug used to treat cancer or its side effects.
(b) "County medical care facility" means that term as defined
in section 20104.
(c) "Department" means the department of community health.
(d) "Donor" means a person, health care facility, pharmacy,
drug or device manufacturer, drug or device wholesale distributor,
or any other entity that donates cancer drugs, or supplies needed
to administer cancer drugs, in accordance with this part.
(e) "Freestanding surgical outpatient facility" means that
term as defined in section 20104.
(f) "Health care facility" means a facility licensed in
accordance with article 17 as a county medical care facility,
freestanding surgical outpatient facility, home for the aged,
hospital, hospital long-term care unit, nursing home, or hospice.
(g) "Home for the aged" means that term as defined in section
20106.
(h) "Hospice" means that term as defined in section 20106.
(i) "Hospital" means that term as defined in section 20106.
(j) "Hospital long-term care unit" means that term as defined
in section 20106.
(k) "Manufacturer" means that term as defined in section
17706.
(l) "Nursing home" means that term as defined in section 20109.
(m) "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
and regulations adopted and promulgated by the department under
this part.
(n) "Pharmacist" means that term as defined in section 17707.
(o) "Pharmacy" means a facility as defined in section 17707
and licensed in accordance with part 177.
(p) "Physician's office" means the office of a person licensed
to practice medicine or osteopathic medicine and surgery under
article 15.
(q) "Prescriber" means that term as defined under section
17708.
(r) "Prescription drug" means that term as defined in section
17708.
(s) "Program" means the cancer drug donation program created
under section 5255.
(t) "Supplies" means any supplies used in the administration
of a cancer drug.
(u) "Wholesale distributor" means that term as defined in
section 17709.
(2) In addition, article 1 contains general definitions and
principles of construction applicable to all articles in this code.
Sec. 5255. (1) There is created within the department a cancer
drug donation program to allow for the voluntary donation of cancer
drugs and supplies and the dispensing of those drugs to certain
residents of this state in accordance with this part. The program
shall be administered by the department. Within 90 days after the
effective date of this part, the department, in consultation with
the state board of pharmacy, shall promulgate rules and regulations
to carry out the provisions of this part. The rules and regulations
shall include, at a minimum, each of the following:
(a) Eligibility criteria for recipients of the cancer drugs
and supplies donated under this program, including, but not limited
to, a method to determine priority of those recipients.
(b) Standards and procedures for participants that accept,
store, distribute, or dispense donated cancer drugs and supplies.
(c) Necessary forms for administration of the program,
including, but not limited to, forms for use by persons or entities
that donate, accept, distribute, or dispense cancer drugs or
supplies under the program.
(d) The maximum handling fee that may be charged by a
participant that accepts, distributes, or dispenses donated cancer
drugs or supplies.
(e) Categories of cancer drugs and supplies that the program
will accept for dispensing.
(f) Categories of cancer drugs and supplies that the program
will not accept for dispensing and the reason that those drugs or
supplies will not be accepted.
(g) Maintenance and distribution of the participant registry
established under subsection (2).
(2) As part of the program, the department shall establish and
maintain a participant registry. The participant registry shall
include the participant's name, address, and telephone number and
shall identify whether the participant is a physician's office, a
pharmacy, a county medical care facility, a freestanding surgical
outpatient facility, a home for the aged, a hospital, a hospital
long-term care unit, a nursing home, or a hospice. The registry
shall be maintained on the department's website and made available
to the public for any person or entity wishing to donate cancer
drugs or supplies to the program.
Sec. 5257. (1) Any person or entity may donate cancer drugs or
supplies to the program. Donations shall be made at a physician's
office, pharmacy, or health care facility that elects to
participate in the program and that meets the criteria established
by the department.
(2) A cancer drug or supply shall only be accepted or
dispensed under this 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.
(3) Each drug donated under this program shall be inspected by
a pharmacist. If the pharmacist determines that a drug has been
adulterated or misbranded, then the drug shall be properly disposed
of and not dispensed under this program. A cancer drug shall not be
accepted or dispensed under this program if the drug bears an
expiration date that is earlier than 6 months after the date the
drug was donated or if the drug is adulterated or misbranded as
determined under this subsection.
Sec. 5259. (1) Only a prescriber can prescribe the cancer
drugs and supplies donated to the program, and those drugs and
supplies shall only be prescribed to an individual who is
determined to be eligible under the rules and regulations
promulgated by the department. A prescriber shall not dispense the
cancer drugs or supplies donated under this program. Only a
pharmacist, notwithstanding section 17766(f), may dispense those
drugs and supplies donated under this program.
(2) Cancer drugs or supplies donated to this program shall not
be sold. A pharmacist who dispenses those drugs and supplies
donated under this program shall not submit a claim or otherwise
seek reimbursement from any public or private third party payer for
drugs or supplies dispensed to any eligible individual in
accordance with this program, nor shall a public or private third
party payer be required to provide reimbursement for donated drugs
or supplies dispensed by a pharmacist to an eligible individual in
accordance with this program.
Sec. 5261. A participant who accepts drugs and supplies
donated in accordance with this program shall comply with all
applicable provisions of state and federal law relating to the
storage, distribution, and dispensing of those donated drugs and
supplies. A participant may charge a nominal handling fee, as
determined under rules promulgated by the department, for
distributing or dispensing those drugs or supplies in accordance
with this program.
Sec. 5263. An individual who is a recipient of pharmaceutical
benefits under the state medicaid program or who has prescription
drug coverage under any other public health care payment or
benefits plan funded in whole or in part by this state is not
eligible to receive drugs or supplies donated under this program.
Sec. 5265. (1) A donor or participant who exercises reasonable
care in donating, accepting, distributing, or dispensing cancer
drugs or supplies under this program and does those activities in
accordance with the rules and regulations adopted and promulgated
under this part is immune from civil or criminal liability and from
professional disciplinary action of any kind for any injury, death,
or loss to person or property relating to those activities.
(2) A drug or device manufacturer is not liable for any claim
or injury arising from the transfer of any cancer drugs or supplies
under this program, including, but not limited to, liability for
failure to transfer or communicate product or consumer information
regarding the transferred drug or supply, as well as the expiration
date of the transferred drug or supply.
Sec. 5267. If any provision of this part or its application to
any person or circumstance is held invalid, the invalidity does not
affect other provisions or applications of this part that can be
given effect without the invalid provision or application, and to
this end, the provisions of this part are severable.
Sec. 17766. Except as provided in part 52A or section 17766d,
a person who does any of the following is guilty of a misdemeanor:
(a) Obtains or attempts to obtain a prescription drug by
giving a false name to a pharmacist or other authorized seller,
prescriber, or dispenser.
(b) Obtains or attempts to obtain a prescription drug by
falsely representing that he or she is a lawful prescriber,
dispenser, or licensee, or acting on behalf of a lawful prescriber,
dispenser, or licensee.
(c) Falsely makes, utters, publishes, passes, alters, or
forges a prescription.
(d) Knowingly possesses a false, forged, or altered
prescription.
(e) Knowingly attempts to obtain, obtains, or possesses a drug
by means of a prescription for other than a legitimate therapeutic
purpose, or as a result of a false, forged, or altered
prescription.
(f) Possesses or controls for the purpose of resale, or sells,
offers to sell, dispenses, or gives away, a drug, pharmaceutical
preparation, or chemical that has been dispensed on prescription
and has left the control of a pharmacist.
(g) Possesses or controls for the purpose of resale, or sells,
offers to sell, dispenses, or gives away, a drug, pharmaceutical
preparation, or chemical that has been damaged by heat, smoke,
fire, water, or other cause and is unfit for human or animal use.
(h) Prepares or permits the preparation of a prescription
drug, except as delegated by a pharmacist.
(i) Sells a drug in bulk or in an open package at auction,
unless the sale has been approved in accordance with rules of the
board.