Chapter 255

255.04(3)(c)1.c. c. Documentation of approval of the research protocol by an institutional review board of a domestic institution that has a federalwide assurance approved by the office for human research protections of the federal department of health and human services.

255.04(3)(c)1.d. d. Any other information requested by the department.

255.04(3)(c)2. 2. The proposed research is for the purpose of studying cancer, cancer prevention, or cancer control.

255.04(4) (4) The report of information under sub. (1) or (5) may not be construed as a violation of any person’s responsibility for maintaining the confidentiality of patient health care records, as defined under s. 146.81 (4).

255.04(5) (5) The department may, to the extent feasible, collect information related to the occupation of cancer patients in order to fulfill the purpose of s. 250.04 (3) (b) 4.

255.04(6) (6) The department may charge a reasonable fee for disclosing information to a researcher under sub. (3) (c).

255.04(7) (7) Information obtained by the department under sub. (1) or (5) or obtained by a person under sub. (3) (c) is not subject to inspection, copying, or receipt under s. 19.35 (1).

255.04(8) (8) No person to whom information is disclosed under sub. (3) (c) may do any of the following:

255.04(8)(a) (a) Use the information for a purpose other than for the performance of research as specified in the application under sub. (3) (c) 1., as approved by the department.

255.04(8)(b) (b) Disclose the information to a person who is not connected with performance of the research.

255.04(8)(c) (c) Reveal in the final research product information that may identify an individual whose information is disclosed under sub. (3) (c).

255.04(9) (9) Whoever violates sub. (8) (a), (b), or (c) is liable to the subject of the information for actual damages and costs, plus exemplary damages of up to $1,000 for a negligent violation and up to $5,000 for an intentional violation.

255.04(10) (10) 

255.04(10)(a) (a) Whoever intentionally violates sub. (8) (a), (b), or (c) may be fined not more than $15,000 or imprisoned for not more than one year in the county jail or both.

255.04(10)(b) (b) Any person who violates sub. (8) (a), (b), or (c) may be required to forfeit not more than $100 for each violation. Each day of continued violation constitutes a separate offense, except that no day in the period between the date on which a request for a hearing is filed under s. 227.44 and the date of the conclusion of all administrative and judicial proceedings arising out of a decision under this paragraph constitutes a violation.

255.04(10)(c) (c) The department may directly assess forfeitures under par. (b). If the department determines that a forfeiture should be assessed for a particular violation or for failure to correct the violation, the department shall send a notice of assessment to the alleged violator. The notice shall specify the alleged violation of the statute and the amount of the forfeiture assessed and shall inform the alleged violator of the right to contest the assessment under s. 227.44.

255.04 History History: 1985 a. 29; 1989 a. 173 ss. 2, 13; 1993 a. 16; 1993 a. 27 s. 48; Stats. 1993 s. 255.04; 1993 a. 183; 1997 a. 114; 2009 a. 28.

255.05 255.05 Cancer control and prevention grants.

255.05(1) (1) Definitions. In this section:

255.05(1)(a) (a) “Institution” means any hospital, nursing home, county home, county mental hospital, community-based residential facility or other place licensed or approved by the department under s. 49.70, 49.71, 49.72, 50.02, 50.03, 50.35, 51.08 or 51.09.

255.05(1)(b) (b) “Nonprofit corporation” means a nonstock corporation organized under ch. 181 that is a nonprofit corporation, as defined in s. 181.0103 (17).

255.05(1)(c) (c) “Organization” means a nonprofit corporation or a public agency which proposes to provide services to individuals.

255.05(1)(d) (d) “Public agency” means a county, city, village, town or school district or an agency of this state or of a county, city, village, town or school district.

255.05(2) (2) From the appropriation account under s. 20.435 (1) (cc), the department shall award up to $400,000 in each fiscal year as grants to applying individuals, institutions or organizations for the conduct of projects on cancer control and prevention. Funds shall be awarded on a matching basis, under which, for each grant awarded, the department shall provide 50 percent, and the grantee 50 percent, of the total grant funding.

255.05(3) (3) The department shall promulgate rules establishing the criteria and procedures for the awarding of grants for projects under sub. (2).

255.05 History History: 1987 a. 399; 1989 a. 31; 1991 a. 39; 1993 a. 27 s. 344; Stats. 1993 s. 255.05; 1995 a. 27; 1997 a. 27, 79; 1999 a. 9; 2007 a. 96; 2009 a. 28.

255.05 Cross-reference Cross-reference: See also ch. DHS 147, Wis. adm. code.

255.054 255.054 Prostate cancer research program.

255.054(1) (1) The Medical College of Wisconsin, Inc. shall use the moneys appropriated under s. 20.250 (2) (h) and the University of Wisconsin Carbone Cancer Center shall use the moneys paid under s. 71.10 (5h) (i) for prostate cancer research projects. These moneys may not be used to supplant funds available for prostate cancer research from other sources.

255.054(2) (2) Annually by January 1, the Medical College of Wisconsin, Inc., and the Board of Regents of the University of Wisconsin System shall each report to the appropriate standing committees of the legislature under s. 13.172 (3) and to the governor on the prostate cancer research projects each has conducted under sub. (1) in the previous fiscal year.

255.054 History History: 2005 a. 460; 2011 a. 32.

255.055 255.055 Cancer research program.

255.055(1) (1) The Medical College of Wisconsin, Inc. shall use the moneys appropriated under s. 20.250 (2) (g) and the University of Wisconsin Carbone Cancer Center shall use the moneys paid under s. 71.10 (5f) (i) for cancer research projects. These moneys may not be used to supplant funds available for cancer research from other sources.

255.055(2) (2) Annually by January 1, the Medical College of Wisconsin, Inc., and the Board of Regents of the University of Wisconsin System shall each report to the appropriate standing committees of the legislature under s. 13.172 (3) and to the governor on the cancer research projects each has conducted under sub. (1) in the previous fiscal year.

255.055 History History: 2003 a. 176; 2011 a. 32, 222.

255.056 255.056 Drug repository.

255.056(1) (1) Definitions. In this section:

255.056(1)(b) (b) “Dispense” has the meaning given in s. 450.01 (7).

255.056(1)(bg) (bg) “Drug” has the meaning given in s. 450.01 (10).

255.056(1)(c) (c) “Medical facility” has the meaning given in s. 943.145 (1).

255.056(1)(d) (d) “Pharmacist” has the meaning given in s. 450.01 (15).

255.056(1)(e) (e) “Pharmacy” means a pharmacy that is licensed under s. 450.06.

255.056(1)(f) (f) “Practitioner” has the meaning given in s. 450.01 (17).

255.056(1)(g) (g) “Prescription drug” has the meaning given in s. 450.01 (20).

255.056(1)(h) (h) “Supplies” means items that are necessary to administer a drug.

255.056(2) (2) The department shall establish and maintain a drug repository program, under which any person may donate a drug or supplies, other than a drug specified under sub. (2m), for use by an individual who meets eligibility criteria specified by rule by the department. Donation may be made on the premises of a medical facility or pharmacy that elects to participate in the program and meets requirements specified by rule by the department. The medical facility or pharmacy may charge an individual who receives a drug or supplies under this subsection a handling fee that may not exceed the amount specified by rule by the department. A medical facility or pharmacy that receives a donated drug or supplies under this subsection may distribute the drug or supplies to another eligible medical facility or pharmacy for use under the program under this section.

255.056(2m) (2m) None of the following drugs may be donated, accepted, distributed, or dispensed under this section:

255.056(2m)(a) (a) A controlled substance, as defined in s. 961.01 (4).

255.056(2m)(b) (b) A drug for which the U.S. food and drug administration requires that a patient using the drug be enrolled in a registry as provided under 21 USC 355-1 (f) (3) (F).

255.056(3) (3) A drug or supplies may be accepted and dispensed under the program specified in sub. (2) only if all of the following requirements are met:

255.056(3)(a) (a) The drug or supplies are in their original, unopened, sealed, and tamper-evident packaging or, if packaged in single-unit doses, the single-unit-dose packaging is unopened.

255.056(3)(b) (b) In the case of a drug, the drug bears an expiration date that is later than 90 days after the date that the drug was donated.

255.056(3)(c) (c) The drug or supplies are not adulterated or misbranded, as determined by a pharmacist employed by, or under contract with, the medical facility or pharmacy, who shall inspect the drug or supplies before the drug or supplies are dispensed.

255.056(3)(d) (d) For a prescription drug or supplies used to administer a prescription drug, the drug or supplies are prescribed by a practitioner for use by an eligible individual and are dispensed by a pharmacist or practitioner.

255.056(4) (4) No drug or supplies that are donated for use under this section may be resold.

255.056(5) (5) Nothing in this section requires that a medical facility, pharmacy, pharmacist, or practitioner participate in the program under this section.

255.056(6) (6) 

255.056(6)(a) (a) Unless the manufacturer of a drug or supply exercises bad faith, the manufacturer is not subject to criminal or civil liability for injury, death, or loss to a person or property for matters related to the donation, acceptance, or dispensing of a drug or supply manufactured by the manufacturer that is donated by any person under this section, including liability for failure to transfer or communicate product or consumer information or the expiration date of the donated drug or supply.

255.056(6)(b) (b) Except as provided in par. (c), any person, except the manufacturer of a drug or supply, is immune from civil liability for injury to or the death of the individual to whom the drug or supply is dispensed and may not be found guilty of unprofessional conduct for his or her acts or omissions related to donating, accepting, distributing, or dispensing a drug or supply under this section.

255.056(6)(c) (c) The immunity or the prohibition on a finding of guilty of unprofessional conduct under par. (b) does not extend to donation, acceptance, distribution, or dispensation of a drug or supply by a person whose act or omission involves reckless, wanton, or intentional misconduct.

255.056(7) (7) The department shall promulgate all of the following as rules:

255.056(7)(a) (a) Requirements for medical facilities and pharmacies to accept and dispense donated drugs or supplies under this section, including all of the following:

255.056(7)(a)1. 1. Eligibility criteria.

255.056(7)(a)2. 2. Standards and procedures for accepting, safely storing, and dispensing donated drugs or supplies.

255.056(7)(a)3. 3. Standards and procedures for inspecting donated drugs or supplies to determine if the drug or supplies are in their original, unopened, sealed, and tamper-evident packaging or, if packaged in single-unit doses, the single-unit-dose packaging is unopened.

255.056(7)(a)4. 4. Standards and procedures for inspecting donated drugs or supplies to determine that the drug or supplies are not adulterated or misbranded.

255.056(7)(b) (b) Eligibility criteria for individuals to receive donated drugs or supplies dispensed under the program. The standards shall prioritize dispensation to individuals who are uninsured or indigent, but will permit dispensation to others if an uninsured or indigent individual is unavailable.

255.056(7)(c) (c) A means, such as an identification card, by which an individual who is eligible to receive a donated drug or supplies may indicate that eligibility.

255.056(7)(d) (d) Necessary forms for administration of the drug repository program, including forms for use by persons that donate, accept, distribute, or dispense drugs or supplies under the program.

255.056(7)(e) (e) The maximum handling fee that a medical facility or pharmacy may charge for accepting, distributing, or dispensing donated drugs or supplies. The fee under this paragraph may not be less than 300 percent of the dispensing fee permitted to be charged for prescription drugs for which coverage is provided under s. 49.46 (2) (b) 6. h.

255.056(7)(g) (g) A list of drugs and supplies, arranged by category or by individual drug or supply, that the drug repository program will not accept for dispensing. The list shall include a statement that specifies the reason that the drug or supplies are ineligible for donation.

255.056 History History: 2003 a. 175, 327; 2005 a. 16; 2009 a. 142.

255.056 Cross-reference Cross-reference: See also ch. DHS 148, Wis. adm. code.

255.06 255.06 Well-woman program.

255.06(1) (1) Definitions. In this section:

255.06(1)(a) (a) “Hospital” has the meaning given in s. 50.33 (2).

255.06(1)(b) (b) “Mammography” means the making of a record of a breast by passing X rays through a body to act on specially sensitized film.

255.06(1)(c) (c) “Medicare” has the meaning given in s. 49.498 (1) (f).

255.06(1)(d) (d) “Nurse practitioner” means a registered nurse who is licensed under ch. 441 or who holds a multistate license, as defined in s. 441.51 (2) (h), issued in a party state, as defined in s. 441.51 (2) (k), and whose practice of professional nursing under s. 441.001 (4) includes performance of delegated medical services under the supervision of a physician, naturopathic doctor, dentist, or podiatrist.

255.06(1)(e) (e) “Poverty line” means the nonfarm federal poverty line for the continental United States, as defined in 42 USC 9902 (2).

255.06(2) (2) Well-woman program. From the appropriation account under s. 20.435 (1) (cb), the department shall administer a well-woman program to provide reimbursement for health care screenings, referrals, follow-ups, case management, and patient education provided to low-income, underinsured, and uninsured women. Reimbursement to service providers under this section shall be at the rate of reimbursement for identical services provided under medicare, except that, if projected costs under this section exceed the amounts appropriated under s. 20.435 (1) (cb), the department shall modify services or reimbursement accordingly. Within this limitation, the department shall implement the well-woman program to do all of the following:

255.06(2)(a) (a) Breast cancer screening services. Provide not more than $422,600 in each fiscal year as reimbursement for the provision of breast cancer screening services to women who are aged 40 years or older and whose income does not exceed 250 percent of the poverty line, by a hospital or organization that has a mammography unit available for use and that is selected by the department under procedures established by the department. The department shall reduce reimbursement for a service provided under this paragraph by the amount of any applicable 3rd-party coverage.

255.06(2)(b) (b) Media announcements and educational materials. Allocate and expend at least $20,000 in each fiscal year to develop and provide media announcements and educational materials to promote breast cancer screening services that are available under pars. (a) and (c) and to promote health care screening services for women that are available under par. (e).

255.06(2)(c) (c) Breast cancer screenings using mobile mammography van. Reimburse the city of Milwaukee public health department for up to $115,200 in each fiscal year for the performance of breast cancer screening activities with the use of a mobile mammography van.

255.06(2)(d) (d) Specialized training for rural colposcopic examinations and activities. Provide not more than $25,000 in each fiscal year as reimbursement for the provision of specialized training of nurse practitioners to perform, in rural areas, colposcopic examinations and follow-up activities for the treatment of cervical cancer.

255.06(2)(e) (e) Health care screening, referral, follow-up, case management, and patient education. Reimburse service providers for the provision of health care screening, referral, follow-up, case management, and patient education to low-income, underinsured, and uninsured women.

255.06(2)(f) (f) Women’s health campaign. Conduct a women’s health campaign to do all of the following:

255.06(2)(f)1. 1. Increase women’s awareness of issues that affect their health.

255.06(2)(f)2. 2. Reduce the prevalence of chronic and debilitating health conditions that affect women.