146.348146.348 Reimbursement in cancer clinical trial programs. 146.348(1)(a)(a) “Cancer clinical trial” means a research study that tests a new cancer treatment regimen on patients, including chemotherapy and other new treatments. 146.348(1)(b)(b) “Inducement” means paying a person money, including a lump sum or salary payment, to participate in a cancer clinical trial. 146.348(1)(c)(c) “Patient-subject” means a person participating in a cancer clinical trial. 146.348(2)(2) All sponsors of cancer clinical trials shall provide potential patient-subjects at the time of the informed consent process the following information: 146.348(2)(a)(a) Whether reimbursement for travel and ancillary costs may be available to patient-subjects. 146.348(2)(b)(b) That coverage of the travel and ancillary costs is done to eliminate financial barriers to enrollment in order to retain patient-subjects in the cancer clinical trial. 146.348(2)(c)(c) Whether family members, friends, or chaperones who attend the cancer clinical trial treatments to support the patient-subject may be eligible for reimbursement of their travel and ancillary costs. 146.348(3)(a)(a) Reimbursement of travel, ancillary costs, and other direct patient-incurred expenses related to cancer clinical trial participation will not be considered an undue inducement to participate in a cancer clinical trial. 146.348(3)(b)(b) Reimbursement for travel and ancillary costs may not be considered coercive or as exerting undue influence to participate in a cancer clinical trial, but rather shall be considered a means to create parity in cancer clinical trial access and remove a barrier to participation for financially burdened patient-subjects. 146.348(3)(c)(c) Government, industry, public charities, private foundations and other nonprofit organizations, associations, corporations and other business entities, individuals, and any other legal or commercial entities may offer financial support to patient-subjects, or the family, friends, or chaperones of patient-subjects, to cover ancillary costs through their support of a reimbursement entity or program. 146.348(4)(a)(a) Language informing patient-subjects that reimbursement entities or programs that cover travel, ancillary costs, and other direct patient-incurred expenses may be available must be submitted for review to the relevant federally designated institutional review board in conjunction with the review of a proposed cancer clinical trial and included in the informed consent form approved by the institutional review board. 146.348(4)(b)(b) A reimbursement entity or program must disclose the nature of the ancillary support and general guidelines on financial eligibility to interested patient-subjects and employ a reimbursement process that conforms to federal law and guidance. 146.348 HistoryHistory: 2019 a. 150. 146.35146.35 Female genital mutilation prohibited. 146.35(1)(1) In this section, “infibulate” means to clasp together with buckles or stitches. 146.35(2)(2) Except as provided in sub. (3), no person may circumcise, excise or infibulate the labia majora, labia minora or clitoris of a female minor. 146.35(3)(3) Subsection (2) does not apply if the circumcision, excision or infibulation is performed by a physician, as defined in s. 448.01 (5), and is necessary for the health of the female minor or is necessary to correct an anatomical abnormality. 146.35(4)(4) None of the following may be asserted as a defense to prosecution for a violation of sub. (2): 146.35(4)(a)(a) Consent by the female minor or by a parent of the female minor to the circumcision, excision or infibulation. 146.35(4)(b)(b) The circumcision, excision or infibulation is required as a matter of custom or ritual. 146.35(5)(5) Whoever violates sub. (2) is guilty of a Class H felony. 146.37146.37 Health care services review; civil immunity. 146.37(1)(a)(a) “Health care provider” includes an ambulance service provider, as defined in s. 256.01 (3), and an emergency medical services practitioner, as defined in s. 256.01 (5), and an emergency medical responder, as defined in s. 256.01 (4p). 146.37(1g)(1g) Except as provided in s. 153.76, no person acting in good faith who participates in the review or evaluation of the services of health care providers or facilities or the charges for such services conducted in connection with any program organized and operated to help improve the quality of health care, to avoid improper utilization of the services of health care providers or facilities or to determine the reasonable charges for such services, or who participates in the obtaining of health care information under subch. I of ch. 153, is liable for any civil damages as a result of any act or omission by such person in the course of such review or evaluation. Acts and omissions to which this subsection applies include, but are not limited to, acts or omissions by peer review committees or hospital governing bodies in censuring, reprimanding, limiting or revoking hospital staff privileges or notifying the medical examining board or podiatry affiliated credentialing board under s. 50.36 or taking any other disciplinary action against a health care provider or facility and acts or omissions by a medical director in reviewing the performance of emergency medical services practitioners, as defined in s. 256.01 (5), or ambulance service providers. 146.37(1m)(1m) The good faith of any person specified in subs. (1g) and (3) shall be presumed in any civil action. Any person who asserts that such a person has not acted in good faith has the burden of proving that assertion by clear and convincing evidence. 146.37(2)(2) In determining whether a member of the reviewing or evaluating organization or the medical director has acted in good faith under sub. (1g), the court shall consider whether the member or medical director has sought to prevent the health care provider or facility and its counsel from examining the documents and records used in the review or evaluation, from presenting witnesses, establishing pertinent facts and circumstances, questioning or refuting testimony and evidence, confronting and cross-examining adverse witnesses or from receiving a copy of the final report or recommendation of the reviewing organization or medical director. 146.37(3)(3) This section applies to any person acting in good faith who participates in the review or evaluation of the services of a psychiatrist, or facilities or charges for services of a psychiatrist, conducted in connection with any organization, association or program organized or operated to help improve the quality of psychiatric services, avoid improper utilization of psychiatric services or determine reasonable charges for psychiatric services. This immunity includes, but is not limited to, acts such as censuring, reprimanding or taking other disciplinary action against a psychiatrist for unethical or improper conduct. 146.37 AnnotationAnyone who has the good faith belief that they are participating in a valid peer review procedure of a health care provider is entitled to the presumption of good faith under sub. (1g) and is immune from liability unless the presumption is overcome. Limjoco v. Schenck, 169 Wis. 2d 703, 486 N.W.2d 567 (Ct. App. 1992). 146.37 AnnotationWhen a third party becomes an integral part of the ongoing medical services review, its actions are eligible for immunity from civil liability under this section. It would defeat the purpose of this section if the participation of an outside entity enlisted by a reviewing committee to perform an assessment of the abilities of a physician to perform effectively while on call is not eligible for immunity simply because the outside entity is not part of a formal “peer review program.” Rechsteiner v. Hazelden, 2008 WI 97, 313 Wis. 2d 542, 753 N.W.2d 496, 06-1521. 146.37 AnnotationWhen a third party’s diagnosis of the condition of the doctor subject to review was indistinguishable from the employing hospital’s review, evaluation, and analysis of the doctor’s ability to perform as an on-call surgeon, the diagnosis was the essence of the peer review process initiated by the hospital. Even if the diagnosis was negligent, it was immune because it was central to the peer review process. However, this case does not mean that the peer review statute will immunize medical negligence in all situations, irrespective of the circumstances. Rechsteiner v. Hazelden, 2008 WI 97, 313 Wis. 2d 542, 753 N.W.2d 496, 06-1521. 146.37 AnnotationA person reviewing a peer can be found to have acted in bad faith even if procedural rights under sub. (2) were not denied, but whether procedural rights were denied is a factor that must be considered in a determination of “good faith.” Qasem v. Kozarek, 716 F.2d 1172 (1983). 146.38146.38 Health care services review; confidentiality of information. 146.38(1)(a)(a) “Evaluator” means a medical director or a registered nurse who coordinates review of an emergency medical services program of a health care provider. 146.38(1)(b)(b) “Health care provider” means any of the following: 146.38(1)(b)3.3. A person working under the supervision of or in collaboration with a person specified in subd. 1. 146.38(1)(b)4.4. A parent, subsidiary, or affiliate organization of a facility, association, or business entity, as specified in subd. 2. 146.38(1)(bm)(bm) “Incident or occurrence report” means a written or oral statement that is made to notify a person, organization, or an evaluator who reviews or evaluates the services of health care providers or charges for such services of an incident, practice, or other situation that becomes the subject of such a review or evaluation. 146.38(1m)(1m) No person who participates in the review or evaluation of the services of health care providers or charges for such services may disclose an incident or occurrence report or any information acquired in connection with such review or evaluation except as provided in sub. (3) or (3m). 146.38(2)(2) All persons, organizations, or evaluators, whether from one or more entities, who review or evaluate the services of health care providers in order to help improve the quality of health care, to avoid improper utilization of the services of health care providers, or to determine the reasonable charges for such services shall keep a record of their investigations, inquiries, proceedings and conclusions. No such record may be released to any person under s. 804.10 (4) or otherwise except as provided in sub. (3) or (3m). No such record may be used in any civil or criminal action against the health care provider or any other health care provider; however, except for incident or occurrence reports or records from other persons, organizations, or evaluators reviewing or evaluating health care providers, information, documents or records presented during the review or evaluation may not be construed as immune from discovery under s. 804.10 (4) or use in any civil or criminal action merely because they were so presented. Any person who testifies during or participates in the review or evaluation may testify in any civil or criminal action as to matters within his or her knowledge, but may not testify as to information obtained through his or her participation in the review or evaluation, nor as to any conclusion of such review or evaluation. 146.38(2m)(2m) An incident or occurrence report may not be used in any civil or criminal action against a health care provider. 146.38(3)(3) Information acquired in connection with the review and evaluation of health care services shall be disclosed and records of such review and evaluation shall be released, with the identity of any patient whose treatment is reviewed being withheld except as permitted under s. 146.82, in the following circumstances: 146.38(3)(a)(a) To the health care provider whose services are being reviewed or evaluated, upon the request of such provider; 146.38(3)(b)(b) To any person with the consent of the health care provider whose services are being reviewed or evaluated; 146.38(3)(c)(c) To the person requesting the review or evaluation, for use solely for the purpose of improving the quality of health care, avoiding the improper utilization of the services of health care providers, and determining the reasonable charges for such services; 146.38(3)(dm)(dm) With regard to an action under s. 895.441, to a court of record after issuance of a subpoena; and 146.38(3)(f)(f) To the appropriate examining or licensing board or agency, when the organization or evaluator conducting the review or evaluation determines that such action is advisable. 146.38(3m)(a)(a) Information acquired in connection with the review and evaluation of health care services may be disclosed, and records of such review and evaluation may be released, in statistical form with the consent of the person authorizing or with the authority to authorize the review or evaluation. Information disclosed or records released under this subsection shall not reveal the identity of any patient except as permitted under s. 146.82. 146.38(3m)(b)(b) Information acquired in connection with the review or evaluation of health care services may be disclosed, and the records of such a review or evaluation released, to any of the following persons, with the consent of the person authorizing or with the authority to authorize the review or evaluation: 146.38(3m)(b)3.3. The parent, subsidiary, or affiliate organization of the employer of a health care provider, as defined in sub. (1) (b) 1. and 3. 146.38(3t)(3t) A record described under sub. (2) or an incident or occurrence report disclosed either under sub. (3) or (3m) or in violation of this section remains confidential and may not be used in any civil or criminal action against the health care provider or any other health care provider. 146.38(4)(4) Any person who discloses information or releases a record in violation of this section, other than through a good faith mistake, is civilly liable therefor to any person harmed by the disclosure or release. 146.38(6)(6) Health care provider specific information acquired by an administrative agency in order to help improve the quality of health care, to avoid the improper utilization of services of health care providers, or to determine the reasonable charges for health care services is exempt from inspection, copying, or receipt under s. 19.35 (1). 146.38 AnnotationThe conclusions of a hospital governing body, based on records and conclusions of peer review committees, were not privileged under this section. State ex rel. Good Samaritan Medical Center-Deaconess Hospital Campus v. Maroney, 123 Wis. 2d 89, 365 N.W.2d 887 (Ct. App. 1985). 146.38 AnnotationOutlining the methodology for determining privileged records under sub. (2). Franzen v. Children’s Hospital of Wisconsin, Inc., 169 Wis. 2d 366, 485 N.W.2d 603 (Ct. App. 1992). 146.38 AnnotationDiscussing the methodology for determining privileged communications under sub. (1m). Mallon v. Campbell, 178 Wis. 2d 278, 504 N.W.2d 357 (Ct. App. 1993). 146.38 AnnotationBecause this section does not provide for the loss of confidentiality due to disclosure to third parties, no waiver exists under this section. Ollman v. Wisconsin Health Care Liability Insurance Plan, 178 Wis. 2d 648, 505 N.W.2d 399 (Ct. App. 1993). 146.38 AnnotationStatistical data regarding a hospital’s rates of infection for postoperative patients qualifies as a report in statistical form under former sub. (3) (d), 1999 stats., and is subject to discovery. A court need not conduct an in camera inspection to determine if material sought may be released when there is a request for information that on its face is clearly protected by this section. Braverman v. Columbia Hospital, Inc., 2001 WI App 106, 244 Wis. 2d 98, 629 N.W.2d 66, 00-0901. 146.38 AnnotationThe Department of Health and Family Services is a person subject to restrictions under sub. (1m) regarding the release of information. Braverman v. Columbia Hospital, Inc., 2001 WI App 106, 244 Wis. 2d 98, 629 N.W.2d 66, 00-0901. 146.38 AnnotationSite reviews by associations to which local hospitals voluntarily submit for review in order to improve the quality of health care services constitutes peer review, the discovery of which is barred by this section. Hofflander v. St. Catherine’s Hospital, Inc., 2003 WI 77, 262 Wis. 2d 539, 664 N.W.2d 545, 00-2467. 146.38 AnnotationThe party asserting the health care services review privilege under sub. (1m) bears the burden of establishing two conditions: 1) the investigation must be part of a program organized and operated to improve the quality of health care at the hospital; and 2) the person conducting the investigation must be acting on behalf of, or as part of a group with relatively constant membership, officers, a purpose, and a set of regulations. The privilege did not apply to an investigation conducted by an individual doctor, and not the hospital’s peer review committee, that was initiated by the hospital to report a problem to the supervisor of the residency program in which the defendant resident was enrolled, and not to improve the quality of health care at the hospital. Phelps v. Physicians Insurance Co. of Wisconsin, 2005 WI 85, 282 Wis. 2d 69, 698 N.W.2d 643, 03-0580. 146.38 AnnotationA health care provider cannot rely on this section, conferring a “peer review privilege,” to withhold documents that are relevant to a federal investigation. Because participants in peer review already expect that peer-review materials may be disclosed in certain circumstances, there appears to be nothing to be gained by recognizing the privilege in the limited circumstances presented by this case. United States v. Aurora Health Care, Inc., 91 F. Supp. 3d 1066 (2015). 146.40146.40 Instructional programs for nurse aides; reporting client abuse. 146.40(1)(ad)(ad) “Client” means a person who receives services from an entity. 146.40(1)(aw)(aw) “Feeding assistant” means an individual who has completed a state-approved training and testing program, as specified by the department by rule, or training, as described in sub. (2m), that satisfies the state-approved training requirement, to perform one nursing-related duty, as defined by the department by rule. 146.40(1)(bt)(bt) “Intermediate care facility for persons with an intellectual disability” has the meaning given for “intermediate care facility for the mentally retarded” under 42 USC 1396d (d).
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