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)(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)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 Cross-reference
Cross-reference: See also ch.
DHS 148, Wis. adm. code.
255.06
255.06
Well-woman program. 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)(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.
255.06(2)(g)
(g)
Osteoporosis prevention and education. Conduct an osteoporosis prevention and education program to raise public awareness concerning the causes and nature of osteoporosis, the risk factors for developing osteoporosis, the value of prevention and early detection of osteoporosis, and options for diagnosing and treating osteoporosis.
255.06(2)(h)
(h)
Multiple sclerosis education. Conduct a multiple sclerosis education program to raise public awareness concerning the causes and nature of multiple sclerosis and options for diagnosing and treating multiple sclerosis.
255.06(2)(i)
(i)
Multiple sclerosis services. Allocate and expend up to $60,000 as reimbursement for the provision of multiple sclerosis services to women.
255.06(3)
(3)
Service coordination. The department shall coordinate the services provided under this section with the services provided under the minority health program under s.
250.20 (2) to
(4), to ensure that disparities in the health of women who are minority group members are adequately addressed.
255.06(4)
(4)
Information about women who receive services. The department shall obtain and share information about women who receive services that are reimbursed under this section as provided in s.
49.475.
255.065
255.065
Breast density notification. 255.065(1)(a)
(a) “Dense breast tissue” means heterogeneously dense breasts or extremely dense breasts based on the Breast Imaging Reporting and Data System established by the American College of Radiology.
255.065(2)
(2) A facility that performs mammography examinations shall, in delivering, as required under
42 USC 263b (f) (1) (G) (ii) (IV), a summary of the results of any mammography examination, provide to patients with dense breast tissue a notice regarding breast density in substantially the following form:
BREAST DENSITY NOTIFICATION
Your mammogram shows that your breast tissue is dense. Dense breast tissue is found in almost 40 percent of women and is a normal finding. However, studies show that dense breast tissue can make it harder to find cancer on a mammogram and is associated with a slightly increased risk of breast cancer. Regular screening mammograms are still recommended for you. This information is provided to raise your awareness about the result of your mammogram. You can use this information to talk with your health care professional about your own risks for breast cancer. Together, you can decide which screening options are right for you. The results of your mammogram were sent to your doctor. Please note that breast density is affected by several factors and may change over time.
255.065(3)
(3) Nothing in this section may be construed to create a duty of care or other legal obligation beyond the duty to provide notice as set forth in this section.
255.065 History
History: 2017 a. 201.
255.07
255.07
Life-saving allergy medication; use of epinephrine. 255.07(1)(a)
(a) “Administer" means the direct application of an epinephrine auto-injector or prefilled syringe to the body of an individual.
255.07(1)(b)
(b) “Authorized entity" means any entity or organization, other than a school described in s.
118.2925, operating or participating in a business, activity, or event at which allergens capable of causing anaphylaxis may be present, including a recreational and educational camp, college, university, day care facility, youth sports league, amusement park, restaurant, place of employment, and sports arena.
255.07(1)(bg)
(bg) “Authorized individual” means an individual who has successfully completed the training program under sub.
(5).
255.07(1)(c)
(c) “Epinephrine auto-injector" means a device for the automatic injection of epinephrine into the human body to prevent or treat a life-threatening allergic reaction.
255.07(1)(d)
(d) “Health care practitioner" means a physician, a physician assistant, or an advanced practice nurse who is certified to issue prescription orders under s.
441.16.
255.07(1)(e)
(e) “Prefilled syringe” means a device that is approved by the federal food and drug administration, that contains a dose of epinephrine, and that is used for the manual injection of epinephrine into the human body to prevent or treat a life-threatening allergic reaction.
255.07(2)
(2)
Prescribing to an authorized entity or individual permitted. 255.07(2)(a)(a) A health care practitioner may prescribe an epinephrine auto-injector or prefilled syringe in the name of an authorized entity or an authorized individual for use in accordance with this section. A health care practitioner may issue to one or more persons a standing order authorizing the dispensing of epinephrine auto-injectors or prefilled syringes for use under sub.
(4) by an authorized individual or by an employee or agent of an authorized entity who has completed the training required by sub.
(5).
255.07(2)(b)
(b) A health care provider with prescribing authority who is employed by or under contract with the department may issue a statewide standing order for the dispensing of epinephrine auto-injectors or prefilled syringes for use under sub.
(4) by authorized individuals or by employees or agents of authorized entities who have completed the training required by sub.
(5).
255.07(3)
(3)
Authorized entities or individuals permitted to maintain supply. An authorized entity or an authorized individual may acquire and maintain a supply of epinephrine auto-injectors and prefilled syringes pursuant to a prescription issued in accordance with this section. The authorized entity or authorized individual shall store an epinephrine auto-injector or prefilled syringe in a location readily accessible in an emergency and in accordance with the epinephrine auto-injector's or prefilled syringe's instructions for use. An authorized entity shall designate an employee or agent who has completed the training required in sub.
(5) to be responsible for the storage, maintenance, control, and general oversight of epinephrine auto-injectors or prefilled syringes acquired by the authorized entity.
255.07(4)
(4)
Use of epinephrine. An employee or agent of an authorized entity who has completed the training required by sub.
(5) or an authorized individual may use an epinephrine auto-injector or prefilled syringe prescribed under sub.
(2) to do any of the following:
255.07(4)(a)
(a) Provide one or more epinephrine auto-injectors or prefilled syringes to any individual who the employee, agent, or authorized individual believes in good faith is experiencing anaphylaxis, or to the parent, guardian, or caregiver of that individual for immediate administration, regardless of whether the individual has a prescription for an epinephrine auto-injector or prefilled syringe or has previously been diagnosed with an allergy.
255.07(4)(b)
(b) Administer an epinephrine auto-injector or prefilled syringe to any individual who the employee, agent, or authorized individual believes in good faith is experiencing anaphylaxis, regardless of whether the individual has a prescription for an epinephrine auto-injector or prefilled syringe or has previously been diagnosed with an allergy.
255.07(5)(a)(a) An employee or agent described in sub.
(3) or
(4) or an individual seeking to be an authorized individual shall complete an anaphylaxis training program and at least every 4 years thereafter. The employee, agent, or individual shall complete a training program conducted by a nationally recognized organization experienced in training laypersons in emergency health treatment or an organization approved by the department. The department may approve an organization to conduct training, either online or in person, that covers, at a minimum, all of the following:
255.07(5)(a)1.
1. How to recognize signs and symptoms of severe allergic reactions, including anaphylaxis.
255.07(5)(a)2.
2. Standards and procedures for the storage and administration of an epinephrine auto-injector and, if applicable, a prefilled syringe.
255.07(5)(a)3.
3. Emergency follow-up procedures after an epinephrine auto-injector or prefilled syringe is administered, including the necessity of calling the telephone number “911" or another telephone number for an emergency medical service provider.
255.07(5)(b)
(b) The organization that conducts the training under par.
(a) shall issue a certificate, on a form approved by the department, to each person who successfully completes the anaphylaxis training program.
255.07(6)
(6)
Good Samaritan protections; liability. 255.07(6)(a)
(a) All of the following are not liable for any injury that results from the administration or failure to administer an epinephrine auto-injector or prefilled syringe under this section, unless the injury is the result of an act or omission that constitutes gross negligence or willful or wanton misconduct:
255.07(6)(a)1.
1. An authorized entity or authorized individual that possesses and makes available an epinephrine auto-injector or prefilled syringe and employees, agents, and authorized individuals that store, maintain, control, oversee, provide, or use an epinephrine auto-injector or prefilled syringe.
255.07(6)(a)2.
2. A health care practitioner who prescribes or dispenses an epinephrine auto-injector or prefilled syringe to an authorized entity or authorized individual.
255.07(6)(a)3.
3. A pharmacist or other person who dispenses an epinephrine auto-injector or prefilled syringe to an authorized entity or authorized individual.
255.07(6)(b)
(b) The use of an epinephrine auto-injector or prefilled syringe under this section does not constitute the practice of medicine or of any other health care profession that requires a credential to practice.
255.07(6)(c)
(c) This immunity from liability or defense provided under this subsection is in addition to and not in lieu of that provided under s.
895.48 or any other defense or immunity provided under state law.
255.07(6)(d)
(d) A person is not liable for any injuries or related damages that result from providing or administering an epinephrine auto-injector or prefilled syringe outside of this state if the person satisfies any of the following criteria:
255.07(6)(d)1.
1. The person would not have been liable for injuries or damages if the epinephrine auto-injector or prefilled syringe was provided or administered in this state.
255.07(6)(d)2.
2. The person is not liable for injuries or damages under the law of the state in which the epinephrine auto-injector or prefilled syringe was provided or administered.
