SB17: Bill Text

SB17,29,7 2. Prior to applying for an exemption, preliminary animal studies or preliminary clinical investigation establishes that the innovative medical technology or major enhancement to existing medical technology has a reasonable probability of advancing clinical diagnosis or therapy.

SB17,29,10 3. In the development and evaluation of the clinical applications, the applicant undertakes scientifically sound studies to determine clinical efficacy, safety, cost-effectiveness and appropriate utilization levels in a clinical setting.

SB17,29,14 4. The clinical trials, evaluation or research are conducted according to scientifically sound protocols subject to peer review and approval in accord with the requirements applicable to investigations and clinical evaluation involving human subjects.

SB17,29,16 5. The innovative medical technology is being installed to conduct necessary research, development and evaluation.

SB17,29,22 6. The applicant does not include any recovery of capital expenses incurred as part of an exemption under this subsection in its expense and revenue budget for purposes of rate setting until the applicant receives the approval of the federal food and drug administration and of the commission under this section for general medical use. The applicant may recover operating expenses only after all of the following occur:

SB17,29,23 a. Approval by the federal food and drug administration for safety and efficacy.

SB17,29,24 b. A 3rd party agrees to pay for these expenses.

SB17,30,3 (c) The commission may not grant more than 2 exemptions for any particular type of innovative medical technology or for any particular major enhancement to existing medical technology.

SB17,30,9 (4) Public hearing requirement. (a) Any person intending to undertake a project or activity subject to this section shall cause to be published a class 1 notice under ch. 985 in the official newspaper designated under s. 985.04 or 985.05 or, if none exists, in a newspaper likely to give notice in the area of the proposed project or activity. The notice shall describe the proposed project or activity and describe the time and place for the public hearing required under par. (b).

SB17,30,22 (b) No sooner than 30 days after the date of publication of the notice under par. (a), the person shall conduct a public hearing on the proposed project or activity. The hearing shall be on the expected impact of the proposed project or activity on health care costs, the expected improvement, if any, in the local health care delivery system, and any other issue related to the proposed project or activity. Management staff, if any, of the person seeking to undertake the project or activity and, if possible, at least 3 members of the governing board of a not-for-profit health care provider, if any, seeking to undertake the project or activity shall attend the public hearing to review public testimony. The person seeking to undertake the project or activity shall record accurate minutes of the meeting, shall include copies of the minutes and any written testimony presented at the hearing in an application concerning the project or activity that is submitted under sub. (7) and shall submit the application within 10 days after the date of the public hearing.

SB17,31,2 (5) Notification requirement. Any person intending to undertake a project subject to this section shall notify the commission in writing of this intent at least 30 days prior to submitting an application for review. Any application expires unless the commission declares it complete within one year after the date the applicant notifies the commission of its intent to undertake the project.

SB17,31,7 (6) Application fee. Each application for review of a project or activity subject to this section shall be accompanied by a fee that is established in rules promulgated by the commission. The commission shall promulgate rules that establish application fees that are sufficient to fund all of the commission's expenses under this section.

SB17,31,14 (7) Review requirements. (a) The commission's review of an application begins on the date that it receives a completed application, including the fee under sub. (6). On or before the 20th day of the month following receipt of a completed application, the commission shall send a notice of receipt of a completed application to the applicant and shall publish a class 2 notice under ch. 985 containing this information in a daily newspaper with general circulation in the area where the proposed project would be located.

SB17,31,22 (b) The commission may group applications for the same or similar types of facilities, services or applications that are proposed, for concurrent review. The commission shall base its review under this paragraph on a comparative analysis of these applications, using the criteria specified in sub. (8) and a ranking of its priorities. The applicant has the burden of proving, by a preponderance of the evidence, that each of the criteria specified in sub. (8) has been met or does not apply to the project. The commission shall, by rule, establish its review requirements under this paragraph.

SB17,32,3 (8) Review criteria. The commission shall use the following criteria in reviewing each application under this section, plus any additional criteria that it develops by rule. The commission shall consider cost containment as its first priority in applying these criteria, and shall consider the recommendations and comments of affected parties. The commission may not approve any project under this section unless the applicant demonstrates all of the following:

SB17,32,4 (a) The project is consistent with the state health services plan under sub. (16).

SB17,32,5 (b) A need for the project, as determined by current and projected utilization.

SB17,32,8 (c) The project would efficiently and economically use resources, including financing for capital investment and operating expenses, when measured against alternative uses of resources.

SB17,32,9 (d) Sufficient cash reserves and cash flow to pay operating and capital costs.

SB17,32,13 (e) Increases in operating and capital costs resulting from the project are reasonable, including the direct charge to the consumer and the charges to be paid by medical assistance and by disability insurers. The commission shall determine the effect on these rates of the applicant's project for review under this paragraph.

SB17,32,14 (f) Financing is available at market rates.

SB17,32,15 (g) Health care personnel are available and would be effectively used.

SB17,32,16 (h) Proposed construction costs are consistent with industry averages.

SB17,32,18 (j) Any proposed addition of area and construction or renovation alternatives are cost-effective.

SB17,32,19 (k) The project is consistent with efficiency standards and criteria.

SB17,32,25 (L) The applicant is participating in a utilization review program that is applicable to a statistical sampling of all hospital patients regardless of payment source, that requires public disclosure of all review data in a form useful to the commission but protects the identities of individual patients and health care professionals and that is conducted by persons who are free from any substantial conflict of interest.

SB17,33,2 (m) The applicant has prepared a plan acceptable to the commission for the provision of health care to indigents.

SB17,33,7 (9) Review process. (a) The commission shall hold a public meeting upon the request of an affected party to review projects seeking approval, at which all affected parties may present testimony. The commission may consider projects seeking approval that are within a related area at joint public meetings. The commission shall keep minutes or other record of testimony presented at the public meeting.

SB17,33,18 (b) The commission shall issue an initial finding to approve or reject the project within 75 days after the date that it publishes its notice under sub. (7) (a), unless all applicants consent to an extension of this period. The commission may not require substantial modification of any project as a condition of approval without the applicant's consent. The commission may extend by 60 days the review cycle of all projects being reviewed concurrently under sub. (7) (b), if it finds that completing the reviews within 75 days after the date it publishes its notice under sub. (7) (a) is not practicable due to the volume of applications received. The commission shall submit its decision to the applicant. Unless the applicant makes a timely request for a hearing under par. (c), the commission's initial finding under this paragraph is its final action.

SB17,33,24 (c) 1. Any applicant whose project is rejected may request a public hearing to review the commission's initial finding under par. (b), if the request is submitted in writing within 10 days after the commission's decision, or may initiate a hearing under s. 227.42. The commission shall commence the hearing under par. (b) within 30 days after receiving a timely request, unless all parties consent to an extension of this period.

SB17,34,3 2. Except as provided in s. 227.42, ss. 227.43 to 227.50 do not apply to hearings under this paragraph. The commission shall promulgate rules to establish all of the following:

SB17,34,4 a. Procedures for scheduling hearings under this paragraph.

SB17,34,7 b. Procedures for conducting hearings under this paragraph, including methods of presenting arguments, cross-examination of witnesses and submission of exhibits.

SB17,34,9 c. Procedures following the completion of a hearing under this paragraph, including the establishment of time limits for issuance of a decision.

SB17,34,11 d. Standards relating to ex parte communication in hearings under this paragraph.

SB17,34,12 e. Procedures for reconsideration and rehearing.

SB17,34,13 3. The commission shall issue all decisions in writing.

SB17,34,17 4. Each applicant at any hearing under this paragraph has the burden of proving, by clear and convincing evidence, that the commission's initial finding was contrary to the weight of the evidence on the record when considered as a whole, arbitrary and capricious or contrary to law.

SB17,34,21 (10) Judicial review. Any applicant adversely affected by a decision of the commission under sub. (9) (c) may petition for judicial review of the decision under s. 227.52. The scope of judicial review shall be as provided in s. 227.57 and the record before the reviewing court shall consist of all of the following:

SB17,34,23 (a) The application and all supporting material received prior to the commission's initial finding under sub. (9) (b).

SB17,34,24 (b) The record of the public meeting under sub. (9) (a).

SB17,35,2 (c) The commission's analysis of the project and its compliance with the criteria specified in sub. (8).

SB17,35,3 (d) The record of the hearing held under sub. (9) (c).

SB17,35,4 (e) The commission's decision and analysis issued under sub. (9) (b) or (c) 3.

SB17,35,7 (11) Validity and contents of an approval. (a) An approval is valid for one year from the date of issuance. The commission may grant a single extension of up to 6 months.

SB17,35,9 (b) The commission shall specify the maximum expenditure that may be obligated for a project.

SB17,35,14 (c) Each approval shall include the proposed timetable for implementing and completing the project and, for the 3-year period following completion of the project, the project's depreciation and interest schedule, staff required for the project, the proposed per diem rate needed to pay capital costs and the proposed per diem rate needed to pay operating costs.

SB17,35,20 (12) Rate approval. Rate reimbursement to cover the cost of the project established for medical assistance under s. 49.45 (3) (e) may not exceed the rates proposed in the approval under sub. (11) (c) by more than 5% during the 3-year period following completion of the project. This subsection does not apply if the hospital demonstrates to the satisfaction of the commission that the excess was due to conditions beyond its control.

SB17,36,2 (13) Capital budget reporting. Each hospital shall annually, by January 1, beginning January 1, 1998, report to the commission a proposed capital budget for the 5-year period that begins with July 1, 1998. This budget shall specify all anticipated capital expenditures subject to this section and anticipated application dates, if any. This requirement does not apply to the purchase or other acquisitions of a hospital under sub. (1) (d). An application under sub. (5) from a hospital to approve a project is not complete until the commission receives this information.

SB17,36,3 (14) Rule making. The commission shall promulgate all of the following rules:

SB17,36,4 (a) Establishing review requirements under sub. (7) (b).

SB17,36,5 (b) Establishing procedures and standards under sub. (9) (c) 2.

SB17,36,7 (c) Establishing a method for defining an acute care service area under sub. (16) (b).

SB17,36,8 (d) Establishing appropriate fees for applications, as specified in sub. (6).

SB17,36,11 (15) Enforcement. (a) No person may recover through charges or rates any depreciation, interest or principal payments or any operating expenses associated with a project subject to this section that does not have the commission's approval.

SB17,36,14 (b) 1. If a project whose cost falls below the minimum threshold specified in sub. (1) (a), (b) or (c) incurs costs exceeding the threshold, the person who operates the project shall submit an application for the commission's approval under sub. (1).

SB17,36,17 2. If a project that has received the commission's approval incurs a cost overrun, the person who operates the project shall submit another application for the commission's approval under sub. (1).

SB17,36,18 (c) No person may subdivide a project to avoid the requirements of this section.

SB17,36,25 (d) The commission's approval of any project is revoked if the capital expenditures specified in the approval have not been obligated, if financing in an amount sufficient to complete the project has not been obtained or if substantial and continuing progress has not been undertaken within the period specified in the approval. In addition, the commission's approval of any project is revoked if the person who operates a project misses any other deadlines specified in the approval and fails to make a good faith effort to meet these deadlines.

SB17,37,4 (e) The commission may reject the application for approval of a project operated by any person who has repeatedly been subject to the penalties specified in this subsection or may impose restrictions as part of its approval to ensure compliance with this section.

SB17,37,10 (16) State health services plan. (a) The commission shall adopt a state health services plan using information provided by the office of health care information in the office of the commissioner of insurance, at least once every 3 years that includes a description of the hospital system in the state and identifies health care needs and surpluses with respect to existing health care services, facilities and equipment and other components the commission finds useful.

SB17,37,15 (b) The commission may not accept any application for a project under this section for the addition of hospital beds that would exceed the number of beds described by the state health services plan for the acute care service area where the project would be located. The commission shall establish its method for defining an acute care service area by rule.

SB17, s. 14 Section 14. 632.75 (5) of the statutes is amended to read:

SB17,37,20 632.75 (5) Payments for hospital services. No insurer may reimburse a hospital for patient health care costs at a rate exceeding the rate established under ch. 54, 1985 stats., or s. 146.60, 1983 stats., for care provided prior to July 1, 1987 subch. II of ch. 196.

SB17, s. 15 Section 15 . Nonstatutory provisions.

SB17,37,22 (1)  Public service commission; hospital rate setting.

SB17,38,2 (a) By October 1, 1997, the public service commission shall submit, under section 16.515 of the statutes, a request to supplement the appropriation under section 20.155 (3) (gm) of the statutes, as created by this act, that details a proposed budget for activities of the public service commission under subchapter II of chapter 196 of the statutes, as created by this act.

SB17,38,6 (b)  1. The public service commission shall submit proposed rules required under section 196.993 of the statutes, as created by this act, to the legislative council staff for review under section 227.15 (1) of the statutes no later than January 1, 1998. These rules may not take effect before July 1, 1998.

SB17,38,14 2. Using the procedure under section 227.24 of the statutes, the public service commission shall promulgate rules required under section 196.993 (2) of the statutes, as created by this act, for the period prior to the effective date of the rules submitted under subdivision 1., but not to exceed the period authorized under section 227.24 (1) (c) and (2) of the statutes. Notwithstanding section 227.24 (1) (a) and (2) (b) of the statutes, the public service commission need not provide evidence of the necessity of preservation of the public peace, health, safety or welfare in promulgating the rules under this paragraph.

SB17,38,16 (c) By January 1, 1998, the public service commission shall do all of the following:

SB17,38,19 1. Estimate the total amount of revenue required for fiscal year 1997-98 for administration by the commission of subchapter II of chapter 196 of the statutes, as created by this act.

SB17,39,2 2. Assess the estimated total amount under subdivision 1 . to hospitals, as defined in section 150.01 (12) of the statutes, under the rates established by rule under paragraph (b) 2. and in proportion to each hospital's respective net income, as defined in section 196.9996 (1) (e) of the statutes, as created by this act, during the hospital's most recently concluded entire fiscal year, except that the public service commission may not assess a hospital that has a net income of 3% or less over the net income for the hospital's next most recently concluded entire fiscal year.

SB17,39,4 3. Credit all payments of assessments to the appropriation under section 20.155 (3) (gm) of the statutes, as created by this act.

SB17,39,6 (d) Every hospital that is assessed under paragraph (c ) 2. shall, by April 1, 1998, pay the entire amount assessed the hospital.

SB17, s. 16 Section 16. Initial applicability.

SB17,39,10 (1) Public service commission; hospital rate setting. This act first applies to requests for rate changes submitted under subchapter II of chapter 196 of the statutes, as created by this act, on July 1, 1998.

SB17, s. 17 Section 17. Effective dates. This act takes effect on September 1, 1997, or on the day after publication, whichever is later, except as follows:

SB17,39,14 (1) Hospital rate setting. The repeal of section 20.155 (3) (a) of the statutes takes effect on January 1, 1999.

SB17,39,15 (End)