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2005 - 2006 LEGISLATURE
March 10, 2005 - Introduced by Senators Roessler, Stepp, Brown, Cowles,
Kanavas, A. Lasee, Lazich, Kedzie
and Wirch, cosponsored by Representatives
Vukmir, Underheim, Albers, Bies, Gard, Benedict, Gronemus, Gunderson,
Hahn, Hines, Hundertmark, Jeskewitz, Kerkman, Lehman, Montgomery,
Mursau, Nass, Seidel, Ott, Petrowski, Pettis, Vrakas, Vruwink
and M.
Williams
. Referred to Committee on Health, Children, Families, Aging and
Long Term Care.
SB109,1,6 1An Act to amend 255.056 (title), 255.056 (1) (a), 255.056 (2), 255.056 (3), 255.056
2(4), 255.056 (6) and 255.056 (7) (a) (intro.) and 2. to 4., (b), (c), (d), (e), (f) and (g);
3and to create 255.056 (1) (am) and 255.056 (1) (h) of the statutes; relating to:
4expanding the cancer drug repository program to include prescription drugs
5and supplies for chronic disease and requiring the exercise of rule-making
6authority.
Analysis by the Legislative Reference Bureau
Under current law, under the cancer drug repository program, any person may
donate an unused prescription drug for use to treat cancer, the side effects of cancer,
or the side effects of any prescription drug that has been used to treat cancer or the
side effects of cancer. The cancer drug or supplies needed to administer it may be
donated on the premises of a medical facility or pharmacy that meets requirements
in the Department of Health and Family Services (DHFS) rules. Persons receiving
the donated drugs for use must meet eligibility criteria in rules promulgated by
DHFS. No donated cancer drugs or supplies may be resold. Manufacturers that do
not exercise bad faith have immunity from civil and criminal liability for matters
related to the donation, acceptance, and dispensing of donated cancer drugs and
supplies. Other persons who do not act recklessly, wantonly or with intentional
misconduct with respect to donating, accepting, distributing, or dispensing cancer
drugs or supplies are immune from civil liability and findings of unprofessional
conduct.

The bill, effective January 1, 2006, expands the cancer drug repository program
to include prescription drugs and supplies for chronic diseases, as defined in the bill.
The bill modifies one of the rules that DHFS must promulgate, to specify that the
maximum handling fee that a medical facility or pharmacy may charge for accepting,
distributing, or dispensing donated cancer or chronic disease drugs may not be less
than 350 percent of the dispensing fee permitted to be charged for prescription drugs
under Medical Assistance. The bill requires DHFS to submit proposed rules
concerning these changes to the Legislative Council staff by the date that is four
months after publication of the bill as an act.
For further information see the state and local fiscal estimate, which will be
printed as an appendix to this bill.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
SB109, s. 1 1Section 1. 255.056 (title) of the statutes, as affected by 2003 Wisconsin Acts
2175
and 327, is amended to read:
SB109,2,3 3255.056 (title) Cancer and chronic diseases drug repository.
SB109, s. 2 4Section 2. 255.056 (1) (a) of the statutes, as affected by 2003 Wisconsin Acts
5175
and 327, is amended to read:
SB109,2,76 255.056 (1) (a) "Cancer or chronic disease drug" means a prescription drug that
7is used to treat any of the following:
SB109,2,88 1. Cancer or chronic disease or side effects of cancer or chronic disease.
SB109,2,109 2. The side effects of any prescription drug that is used to treat cancer or side
10effects of cancer
under subd. 1.
SB109, s. 3 11Section 3. 255.056 (1) (am) of the statutes is created to read:
SB109,2,1512 255.056 (1) (am) "Chronic disease" means any disease, illness, impairment, or
13other physical condition, other than cancer, that requires health care and treatment
14over a prolonged period and, although amenable to treatment, frequently progresses
15to increasing disability or death.
SB109, s. 4 16Section 4. 255.056 (1) (h) of the statutes is created to read:
SB109,3,2
1255.056 (1) (h) "Supplies" means items that are necessary to administer a
2cancer or chronic disease drug.
SB109, s. 5 3Section 5. 255.056 (2) of the statutes, as affected by 2003 Wisconsin Acts 175
4and 327, is amended to read:
SB109,3,185 255.056 (2) The department shall establish and maintain a cancer and chronic
6diseases
drug repository program, under which any person may donate a cancer or
7chronic disease
drug or supplies needed to administer a cancer drug for use by an
8individual who meets eligibility criteria specified by rule by the department.
9Donation may be made on the premises of a medical facility or pharmacy that elects
10to participate in the program and meets requirements specified by rule by the
11department. The medical facility or pharmacy may charge an individual who
12receives a cancer or chronic disease drug or supplies needed to administer a cancer
13drug
under this subsection a handling fee that may not exceed the amount specified
14by rule by the department. A medical facility or pharmacy that receives a donated
15cancer or chronic disease drug or supplies needed to administer a cancer drug under
16this subsection may distribute the cancer or chronic disease drug or supplies to
17another eligible medical facility or pharmacy for use under the program under this
18section.
SB109, s. 6 19Section 6. 255.056 (3) of the statutes, as affected by 2003 Wisconsin Acts 175
20and 327, is amended to read:
SB109,3,2321 255.056 (3) A cancer or chronic disease drug or supplies needed to administer
22a cancer drug
may be accepted and dispensed under the program specified in sub. (2)
23only if all of the following requirements are met:
SB109,4,224 (a) The cancer or chronic disease drug or supplies needed to administer a cancer
25drug is
are in its their original, unopened, sealed, and tamper-evident unit dose

1packaging or, if packaged in single-unit doses, the single-unit-dose packaging is
2unopened.
SB109,4,43 (b) The cancer or chronic disease drug bears an expiration date that is later
4than 6 months after the date that the drug was donated.
SB109,4,95 (c) The cancer or chronic disease drug or supplies needed to administer a cancer
6drug is
are not adulterated or misbranded, as determined by a pharmacist employed
7by, or under contract with, the medical facility or pharmacy, who shall inspect the
8drug or supplies needed to administer a cancer drug before the drug or supplies are
9dispensed.
SB109,4,1210 (d) The cancer or chronic disease drug or supplies needed to administer a cancer
11drug
are prescribed by a practitioner for use by an eligible individual and are
12dispensed by a pharmacist.
SB109, s. 7 13Section 7. 255.056 (4) of the statutes, as affected by 2003 Wisconsin Acts 175
14and 327, is amended to read:
SB109,4,1615 255.056 (4) No cancer or chronic disease drug or supplies needed to administer
16a cancer drug
that are donated for use under this section may be resold.
SB109, s. 8 17Section 8. 255.056 (6) of the statutes, as affected by 2003 Wisconsin Acts 175
18and 327, is amended to read:
SB109,4,2519 255.056 (6) (a) Unless the manufacturer of a drug or supply exercises bad faith,
20the manufacturer is not subject to criminal or civil liability for injury, death, or loss
21to a person or property for matters related to the donation, acceptance, or dispensing
22of a cancer or chronic disease drug or supply manufactured by the manufacturer that
23is donated by any person under this section, including liability for failure to transfer
24or communicate product or consumer information or the expiration date of the
25donated cancer or chronic disease drug or supply.
SB109,5,6
1(b) Except as provided in par. (c), any person, except the manufacturer of a drug
2or supply, is immune from civil liability for injury to or the death of the individual
3to whom the cancer or chronic disease drug or supply is dispensed and may not be
4found guilty of unprofessional conduct for his or her acts or omissions related to
5donating, accepting, distributing, or dispensing a cancer or chronic disease drug or
6supply under this section.
SB109,5,107 (c) The immunity or the prohibition on a finding of guilty of unprofessional
8conduct under par. (b) does not extend to donation, acceptance, distribution, or
9dispensation of a cancer or chronic disease drug or supply by a person whose act or
10omission involves reckless, wanton, or intentional misconduct.
SB109, s. 9 11Section 9. 255.056 (7) (a) (intro.) and 2. to 4., (b), (c), (d), (e), (f) and (g) of the
12statutes, as affected by 2003 Wisconsin Acts 175 and 327, are amended to read:
SB109,5,1513 255.056 (7) (a) (intro.) Requirements for medical facilities and pharmacies to
14accept and dispense donated cancer or chronic disease drugs or supplies needed to
15administer cancer drugs
under this section, including all of the following:
SB109,5,1816 2. Standards and procedures for accepting, safely storing, and dispensing
17donated cancer or chronic disease drugs or supplies needed to administer cancer
18drugs
.
SB109,5,2319 3. Standards and procedures for inspecting donated cancer or chronic disease
20drugs or supplies needed to administer cancer drugs to determine if the cancer drug
21or supplies needed to administer a cancer drug are in its their original, unopened,
22sealed, and tamper-evident unit dose packaging or, if packaged in single-unit doses,
23the single-unit-dose packaging is unopened.
SB109,6,224 4. Standards and procedures for inspecting donated cancer or chronic disease
25drugs or supplies needed to administer cancer drugs to determine that the cancer

1drug or supplies needed to administer a cancer drug are not adulterated or
2misbranded.
SB109,6,73 (b) Eligibility criteria for individuals to receive donated cancer or chronic
4disease
drugs or supplies needed to administer cancer drugs dispensed under the
5program. The standards shall prioritize dispensation to individuals who are
6uninsured or indigent, but will permit dispensation to others if an uninsured or
7indigent individual is unavailable.
SB109,6,108 (c) A means, such as an identification card, by which an individual who is
9eligible to receive a donated cancer or chronic disease drug or supplies needed to
10administer a cancer drug
may indicate that eligibility.
SB109,6,1411 (d) Necessary forms for administration of the cancer and chronic diseases drug
12repository program, including forms for use by persons that donate, accept,
13distribute, or dispense cancer or chronic disease drugs or supplies needed to
14administer cancer drugs
under the program.
SB109,6,1915 (e) The maximum handling fee that a medical facility or pharmacy may charge
16for accepting, distributing, or dispensing donated cancer or chronic disease drugs or
17supplies needed to administer cancer drugs. The fee under this paragraph may not
18be less than 350 percent of the dispensing fee permitted to be charged for prescription
19drugs for which coverage is provided under s. 49.46 (2) (b) 6. h.
SB109,6,2220 (f) A list of cancer or chronic disease drugs and supplies needed to administer
21cancer drugs
, arranged by category or by individual cancer drug or supply, that the
22cancer and chronic diseases drug repository program will accept for dispensing.
SB109,7,223 (g) A list of cancer or chronic disease drugs and supplies needed to administer
24cancer drugs
, arranged by category or by individual cancer drug or supply, that the
25cancer and chronic diseases drug repository program will not accept for dispensing.

1The list shall include a statement that specifies the reason that the cancer drug or
2supplies needed to administer a cancer drug are ineligible for donation.
SB109, s. 10 3Section 10. Nonstatutory provisions.
SB109,7,94 (1) Cancer and chronic diseases drug repository program; rules. The
5department of health and family services shall submit in proposed form the rules
6required under section 255.056 (7) (a) (intro.) and 2. to 4., (b), (c), (d), (e), (f), and (g)
7of the statutes, as affected by this act, to the legislative council staff under section
8227.15 (1) of the statutes no later than the first day of the 5th month beginning after
9the effective date of this subsection.
SB109, s. 11 10Section 11. Effective date.
SB109,7,1211 (1) This act takes effect on January 1, 2006, or on the day after publication,
12whichever is later.
SB109,7,1313 (End)
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