Tech Hub Matching Funds Legislation (Assembly Bill 916/Senate Bill 894):
On February 21st, Act 96 was enacted (000001.ildoc) (wisconsin.gov), providing $7.5m in matching funds to the WI Biohealth Tech Hub to support its Phase 2 Regional & Innovation Tech Hub application which was submitted to the EDA on February 28, 2024.
This legislation had overwhelming bi-partisan support passing 96-0 in the Assembly and 31-1 in the Senate. It was then enacted by Governor Evers. More information on the Wi Biohealth Tech Hub: https://www.bioforward.org/wisconsin-biohealth-tech-hub/
SUPPORT: All Co-pays Count Legislation
This legislation requires health insurance policies that offer prescription drug benefits, self-insured health plans, and pharmacy benefit managers acting on behalf of policies or plans to apply amounts paid by or on behalf of a person covered under the policy or plan for prescription drugs to any calculation of an out-of-pocket maximum amount or to any cost-sharing requirement of the policy or plan in Wisconsin. For additional information, check out their website at this link WI All Copays Count Coalition (wi4patients.com) and read the recent press release.
Watch this powerful video about why all co-pays count: https://vimeo.com/user13782109/review/818097108/a71ed27fed
SUPPORT: Clinical Trials Legislation (AB 398 / SB 387).
This bill provides that for the purposes of the minimum wage law and worker’s compensation law an individual who is a participant in a clinical research trial and receives remuneration, a stipend, or compensation for participating in the trial is not an employee of the entity that conducts the trial. The bill also provides that such participation is generally not considered covered employment under the unemployment insurance (UI) law. As a consequence, amounts paid by employers for such participation are not subject to UI contribution requirements and are not counted as base period wages for purposes of determining eligibility for UI benefits. This legislation has passed both the Assembly and Senate and BioForward is advocating for the Governor to sign this legislation.
https://docs.legis.wisconsin.gov/2023/related/proposals/ab398.pdf
OPPOSE: Gain of Function Legislation (AB 413 / SB 401)
On January 10, the Assembly Committee on Colleges and Universities heard testimony on legislation that would ban the Universities of Wisconsin and the Technical College System from conducting research that could enhance the transmission of pandemic pathogens. Lawmakers authoring the bill said that it would protect Wisconsinites from potentially catastrophic consequences. UW-Madison and the Medical College of Wisconsin provided written testimony in opposition to the bill, arguing it would “significantly hinder the ability of researchers in Wisconsin to conduct research of extreme importance to the state.” They noted a variety of concerns about the legislation, including that the language in the bill is too broad. The definition in the bill applies to “potentially pandemic” pathogens, including viruses, fungi and bacteria the groups argued don’t have pandemic potential. The Senate Committee on Health held a similar hearing on the Senate version of the legislation on January 18, 2024.
SUPPORT: Protect Our Farms. (AB 957/ SB 892)
This legislation would prevent local governments from enacting animal welfare ordinances in areas zoned for agricultural use – including prohibiting them from restricting what the animals can be used for after they leave the farm or facility. This bill has passed the Assembly and the Senate and is under review by the Governor.
BIO Vaccine Education Materials
BioForward Initiatives
BioForward is actively working with Governor Evers and Wisconsin legislators to pass all copays count legislation, an R&D tax credit refundability increase, full repeal of the personal property taxes, and to support the University of Wisconsin System & Technical Colleges.
On Wednesday, July 5th, Governor Evers signed the 2023-2025 State Budget into law as Act 19 (with 51 partial vetoes). We are pleased to have two key issues that BioForward strongly supported included in the State Budget, namely:
Tech Hub Matching Funds Legislation
Representatives from the Wisconsin State Senate and State Assembly have drafted legislation that would secure $7.5 million in state matching funds for the Wisconsin Biohealth Tech Hub’s federal implementation grant. The funding would be designated to support projects aligned with the overarching Tech Hub designation, which would strengthen our EDA Tech Hub Phase II application.
Increased R&D Tax Credit Refundability
The signed budget included a 10% increase in the credit refundability to 25% beginning in 2024, the biggest increase in refundability since the credit was initially made refundable at 10%. The specific language is included in sections 338-340, 342-345 (page 152, here).
Elimination of Personal Property Taxes
The State Budget included a complete elimination of personal property taxes contained in Assembly Bill 245, now 2023 Wisconsin Act 12 related to shared revenue. The 2023 Wisconsin Act 12 was signed into law on June 21, 2023, to take effect on January 1, 2024. The specific language included is on page 2 and page 5, SECTION 24. 60.85 (1) (f), SECTION 25. 60.85 (1) (h), and SECTION 26. 60.85 (1) (o), (here).
These budget outcomes mean that our member companies will be able to reinvest the tax savings back into their businesses. BioForward is proud to have helped deliver these wins to our industry and will stay committed to actively advocating for changes that help our industry grow.
SUPPORT: Coverage of Breast Cancer Screenings by Health Insurance Policies (SB 121)
This bill requires health insurance policies to provide coverage with no patient cost-sharing for supplemental breast screening examinations or diagnostic breast examinations for an individual who is at increased risk of breast cancer, as determined in accordance with the most recent applicable guidelines of the National Comprehensive Cancer Network. SB 121 ensures that men and women, regardless of socio-economic background, have access to life-saving breast imaging.
SUPPORT: All Co-pays Count Legislation
This legislation requires health insurance policies that offer prescription drug benefits, self-insured health plans, and pharmacy benefit managers acting on behalf of policies or plans to apply amounts paid by or on behalf of a person covered under the policy or plan for prescription drugs to any calculation of an out-of-pocket maximum amount or to any cost-sharing requirement of the policy or plan in Wisconsin. For additional information, check out their website at this link WI All Copays Count Coalition (wi4patients.com) and read the recent press release.
Watch this powerful video about why all co-pays count: https://vimeo.com/user13782109/review/818097108/a71ed27fed
SUPPORT: Increase in Refundable Research Tax Credit
BioForward is a coalition member working to increase the Wisconsin Refundable Research Credit from 15% to a higher limit. More details to be provided as updates occurred through the state budget process. For current information on the Wisconsin Research credits, click on the link: https://www.revenue.wi.gov/Pages/Businesses/incentives-research.aspx.
SUPPORTED: Complete Repeal of the Personal Property Tax (AB 245) now 2023 Wisconsin Act 12
Gov. Tony Evers has signed Assembly Bill 245, now 2023 Wisconsin Act 12 into law, completely repealing Wisconsin`s Personal Property Tax. BioForward strongly supported and advocated for the passage of this bill because it saves our biohealth companies and Wisconsin businesses over $200 million annually in tax relief allowing them to reinvest the tax savings back into their companies. Here is a link to the 2023 Wisconsin Act 12: https://content.govdelivery.com/attachments/WIGOV/2023/06/20/file_attachments/2531011/ab245.pdf. The repeal of the Personal Property Tax is mentioned on page 2 and on page 5 SECTION 24. 60.85 (1) (f), SECTION 25. 60.85 (1) (h), and SECTION 26. 60.85 (1) (o).
SUPPORT: Increase Funding to the UW System including:
Funding for the UW-Madison College of Engineering Building Project. Click here to support!
Funding for Phase II of the University of Wisconsin-Eau Claire Science and Health Sciences Building to ensure that UW-EC continues its traditions as a national leader in undergraduate research. It will be a catalyst for talent and workforce development for northwest Wisconsin.
Senate and Assembly Republicans Elect Leadership for 2023-24:
Senate Republican Leadership
- Senate President – Chris Kapenga
- Senate President Pro Tempore – Patrick Testin
- Majority Leader – Devin LeMahieu
- Assistant Majority Leader – Dan Feyen
- Caucus Chair – Van Wanggaard
- Caucus Vice-Chair – Joan Ballweg
Assembly Republican Leadership
- Assembly Speaker – Robin Vos
- Assembly Speaker Pro Tempore – Kevin Petersen
- Majority Leader – Tyler August
- Assistant Majority Leader – Jon Plumer
- Caucus Chair – Rob Summerfield
- Caucus Vice-Chair – Cindi Duchow
- Caucus Sergeant at Arms – Treig Pronschinske
2023 State Government Updates:
- Gov. Ever Appoints Kirsten Johnson to DHS Secretary: Press Release: Gov. Evers Appoints Kirsten Johnson to DHS Secretary (govdelivery.com)
- 2023 -24 School Year Immunization Requirement: Immunization: 2023 Child Care and 2023-2024 School Year Immunization Requirements | Wisconsin Department of Health Services
BioForward State Advocacy Update – Preview of 2023
Wisconsin has reelected Democratic Governor Tony Evers for his second term. At the same time, the State Assembly and the State Senate will have very strong Republican majorities in 2023. With a Democratic governor and a Republican legislature, Wisconsin will have a “divided government” in the state legislature again for the upcoming 2023-24 legislative session.
In January 2023, the Governor will immediately begin work on the next biennial budget bill and the legislature will be in session and will work on numerous legislative issues. Although no specific legislation can be introduced until January, below is a preview of the issues that are on the state advocacy priority list for BioForward for the 2023-24 Wisconsin legislative session.
2023-25 Biennial Budget Bill – Support for UW and Support for Wisconsin Businesses
The biennial budget bill controls the spending for the State of Wisconsin for the next two fiscal years. This bill will cover all state expenditures from July 1, 2023, through June 30, 2024. BioForward is particularly interested in any tax issues that could affect our Wisconsin companies and also the funding and support provided to public education, support to STEM education, the University of Wisconsin system and UW-Madison by the state in this legislation.
Support the Repeal of Personal Property Tax
BioForward has supported efforts to repeal Wisconsin’s personal property tax for the past two sessions. The PPT imposes an unequal local tax burden on small business across Wisconsin. The “personal property tax” is a business tax that is assessed and collected by some local municipalities on certain property located within a business. It has become an administrative and financial burden that does not generate a very large or considerable revenue amount. As such, a very large coalition of businesses from across industry sectors has come together to work toward repealing this tax. It has strong bipartisan support and hopefully will be approved in 2023.
Support Legislation to Prohibit Co-Pay Accumulators – Help Patients Afford Medication at the Pharmacy Counter
Copay accumulator provisions in health insurance policies exclude copay assistance from counting toward a patient’s deductible or out of pocket costs. If a patient has an insurance plan with a “copay accumulator” program, the part of their copay that is paid by a prescription drug manufacturer’s copay assistance program will be accepted at the pharmacy and used toward the cost of the medication but that money will not count toward their deductible or their annual maximum out-of-pocket costs. BioForward is a part of a coalition of patient advocacy groups and manufacturers who are working to pass legislation to prohibit this practice in Wisconsin. To date, fourteen states have already banned accumulator provisions.
Carefully Monitor and Engage on any Prescription Drug Pricing Transparency Initiatives.
We have seen various legislative proposals introduced over the past several sessions aimed at increasing prescription drug pricing transparency. Because of the complexity of these proposals and their consequences, we carefully monitor these issues and will engage with the input and guidance of our members, as needed.
Attorney Jordan Lamb serves as BioForward’s lead legal and legislative counsel. Successful management of governmental issues for BioForward depends on our comprehensive approach to the unique challenges ranging from health policy to business issues that are faced by Wisconsin biohealth businesses. Our approach to each issue depends on a combination of legal analysis, statute and rule design, constituency involvement, political action and media management.
OPPOSE: City of Madison Proposes Ban on Breeding and Selling Animals for Research.
The proposed ordinance item #68608, related to a ban on breeding and selling animals for research, was not included in the agenda for the Board of Health (BOH) meeting on 9/7. Currently, this matter has been placed on file and no timetable for further BOH review. BioForward and the Biohealth community, including UW-Madison, aggressively advocated against this ban.
The proposed City of Madison ordinance that had been pending before the Dane County Board of Health since January 2022, could have negatively affected our local (Madison/Dane County) research and biohealth community. Two alders from the Madison City Council: Proposed Ordinance No. 68608 which would have banned the breeding or selling of vertebrate animals for the purpose of medical, surgical or chemical experimentation in the City of Madison.
SUPPORT: Co-pay Accumulator Legislation (2021 SB 215/AB 184)
FAILED TO PASS (2021 SB 215 and AB 184). This legislation requires health insurance policies that offer prescription drug benefits, self-insured health plans, and pharmacy benefit managers acting on behalf of policies or plans to apply amounts paid by or on behalf of a person covered under the policy or plan for prescription drugs to any calculation of an out-of-pocket maximum amount or to any cost-sharing requirement of the policy or plan in Wisconsin.
- The Assembly Health Committee held a public hearing on AB 184 on February 16, 2022. There was no hearing in the Senate Committee and no vote on this legislation in the Assembly Committee. BioForward will work to support this legislation again during the 2023-24 legislative session.
SUPPORTED-Engineering School Planning Bill PASSES (AB 775 / SB 728)
Legislation to require the Building Commission to allocate $1,000,000 from the state building trust fund to conduct planning and design services and prepare a design report for the construction of a new engineering building at the University of Wisconsin-Madison passed both houses and was signed by Governor Evers on March 18, 2022.
https://content.govdelivery.com/attachments/WIGOV/2022/03/18/file_attachments/2107255/ab775.pdf
SUPPORTED-Qualified New Business Venture Eligibility Changes PASSES (AB 759 / SB 729)
Legislation that would help Wisconsin-based start-ups who acquire another business from outside of Wisconsin not lose their Early-Stage Investment Tax Credits due to their expansion has passed both houses and will be sent to the Governor. Current law requires companies to have at least 51% of their employees in Wisconsin in order to qualify for the credit. Under this bill, the company would be allowed one calendar year from acquisition in which they could drop below the 51% threshold and still qualify for the tax credit. Business’ headquarters must remain in Wisconsin and all current Wisconsin employees remain in Wisconsin as well.
Against: Biosimilar Red Tape Elimination Act (S. 2305) and the Medication Affordability and Patent Integrity Act (S. 2780).
These bills, if enacted, would strike at the heart of America’s medical innovation sector by undermining the IP infrastructure that drives it. The Biosimilar Red Tape Elimination Act would irresponsibly deem all biosimilars as interchangeable with their reference products without the necessary evaluation by the Food and Drug Administration (FDA). Medication Affordability & Patent Integrity Act imposes burdensome new reporting requirements on biopharmaceutical companies, ostensibly to prevent the U.S. Patent and Trademark Office (USPTO) from issuing patents for "inherent" aspects of drugs.
Support: Ensuring Patient Access to Critical Breakthrough Products Act
This bipartisan legislation has now been introduced in both houses of Congress and provides for Medicare coverage of breakthrough technologies to which so many patients are in need of access. The FDA’s Breakthrough Devices Program is intended to provide patients and health care providers with timely access to emerging medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The FDA invites med tech innovators to seek the designation if their device meets the criteria. The accepted devices will receive prioritized FDA review. As of Sept.30, 2024, 1,029 devices have received the designation, and 124 devices have received marketing authorization.
Support: Longstanding Deduction for R&D Expenditures
BioForward once again supports restoring the longstanding deduction for R&D expenditures which was changed in 2022 to a mandatory five-year amortization for domestic R&D. This greatly impacts emerging growth companies that depend on expensing the R&D expenditure in the year incurred. (H.R.2673 S.866)
Update: The House Ways & Means Committee approved the Small Business Jobs Act (H.R. 3937), which includes language to delay retroactively through 2025 the mandatory capitalization of R&D expenses.
BioForward appreciates Senator Tammy Baldwin for co-sponsoring S.866. BioForward appreciates Representative Glenn Grothman (WI-06) for co-sponsoring H.R. 2673.
6/13. Support: Efforts by the Partnership to Fight Chronic Disease (PFCD)
BioForward supports efforts by the Partnership to Fight Chronic Disease (PFCD) and other partnered organizations to urge the Centers for Medicare and Medicaid Services (CMS) to reconsider its National Coverage Decision requiring Coverage with Evidence Development for an entire class of Alzheimer’s disease therapies. This decision has ripple effects beyond just the Alzheimer’s community and sets a dangerous precedent for other people living with chronic conditions.
4/23. Support: Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 2407)
Cancer is surpassing heart disease as the leading cause of death in America because we find most cancers too late. Since Medicare covers those at greatest risk for cancer – America’s seniors – the program should allow access to life-saving cancer screenings once approved by the FDA and evaluated by CMS.
This legislation would give CMS a direct path to cover multi-cancer screenings following FDA approval without compromising their administrative discretion. By passing this bill, Congress would build on a legacy of bipartisan action, having previously enacted coverage pathways for mammography, pap smears, and prostate and colorectal cancer screenings. Absent Congressional approval, Medicare coverage of MCED technologies could be unnecessarily delayed for many years following FDA approval, and the vast majority of seniors would struggle to access these screenings during that time. In addition, increasing early detection will reduce late-stage treatment costs and realize savings for Medicare and seniors, ultimately changing the long-term trajectory of cancer spending.
BioForward appreciates Representative Mark Pocan (WI-02) for co-sponsoring H.R.2407
3/23 - BioForward supports restoring the longstanding deduction for R&D expenditures
BioForward once again supports restoring the longstanding deduction for R&D expenditures which was changed in 2022 to a mandatory five-year amortization for domestic R&D. This greatly impacts emerging growth companies that depend on expensing the R&D expenditure in the year incurred. (H.R.2673 S.866)
Update: The House Ways & Means Committee approved the Small Business Jobs Act (H.R. 3937), which includes language to delay retroactively through 2025 the mandatory capitalization of R&D expenses.
BioForward appreciates Senator Tammy Baldwin for co-sponsoring S.866. BioForward appreciates Representative Glenn Grothman (WI-06) for co-sponsoring H.R. 2673.
Support: The Pandemic All Hazards Preparedness Act (PAHPA) Reauthorization Bills
PAHPA establishes measures to prepare for the next pandemic, biothreats, and public health emergencies. Existing authorities expire on Sept. 30, 2023.
Update: The Pandemic All Hazards Preparedness Act (PAHPA) reauthorization bills has moved forward with committees in the House and Senate approving their respective proposals. Incentives included in the bills will promote research into medical countermeasures (MCMs), including an extension of the MCM priority review voucher, technologies to support vaccine development and manufacturing, as well as amendments to reduce unnecessary reporting requirements for the Strategic National Stockpile and to establish a program for reviewing MCMs for emerging pathogens at the FDA.
Oppose: World Health Organization’s proposal and the Biden Administration support of Trade-Related Aspects of Intellectual Property Rights (TRIPS). MC12 TRIP Waiver on COVID-19 Therapeutics & Diagnostics
Wisconsin biohealth businesses employ more than 129,000 people statewide and are extremely dependent on research and development with intellectual property rights in place to appropriately protect the successes of this industry. Unfortunately, WHO is proposing to expand TRIPS covering not only vaccines but also COVID therapeutics. BioForward is opposed to this expansion.
This waiver expansion under consideration is inconsistent with the Biden Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy, issued on September 12, 2022. The TRIPS waiver expansion would fundamentally undermine a key objective of the Executive Order itself, which is to ensure United States global leadership in the field of biotechnology. See related op-ed for more information.
Support: Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 1946/S. 1873)
Cancer is surpassing heart disease as the leading cause of death in America because we find most cancers too late. Since Medicare covers those at greatest risk for cancer – America’s seniors – the program should allow access to life-saving cancer screenings once approved by the FDA and evaluated by CMS.
This legislation would give CMS a direct path to cover multi-cancer screenings following FDA approval without compromising their administrative discretion. By passing this bill, Congress would build on a legacy of bipartisan action, having previously enacted coverage pathways for mammography, pap smears, prostate, and colorectal cancer screenings. Absent Congressional approval, Medicare coverage of MCED technologies could be unnecessarily delayed for many years following FDA approval, and the vast majority of seniors would struggle to access these screenings during that time. In addition, increasing early detection will reduce late-stage treatment costs and realize savings for Medicare and seniors, ultimately changing the long-term trajectory of cancer spending.
Ongoing-Support SBIR/STTR Reauthorization
Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs were set to expire on September 30, 2022. SBIR and STTR are an essential part of America’s Innovative high-tech ecosystem. Any disruption to this system could have had a severe effect on R&D-focused small businesses. BioForward supported both AdvaMed and BIO’s legislative advocacy to achieve the reauthorization of these vital programs. Wisconsin’s stats: Over $114,000,000 in SBIR/STTR grants from 2017—2021.
- On September 30, 2022, President Biden signed the SBIR and STTR Extension Act of 2022, reauthorizing the SBIR/STTR programs to continue through fiscal year 2025.
- September 20th, Senate Reauthorized funding and moved to House for final funding authorization: https://www.bioforward.org/2022/09/21/good-day-bio-sbir-sttr-passes-senate-moves-to-house/
Supported Medical Device User Fee Amendment (MDUFA) V Reauthorization
On September 30, 2022, the President signed into law the five-year reauthorization of the Medical Device User Fee Amendment (MDUFA) agreement, the fifth iteration of this user-fee agreement since the system’s implementation in 2002. It provides FDA with the resources it needs to review device submissions in a timely, efficient, and cost-effective way.
https://www.advamed.org/industry-updates/news/congress-passes-historic-mdufa-v-reauthorization/
Supported Prescription Drug User Fee Act (PDUFA) VII Reauthorization
On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. This new law includes the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products.
https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027
Oppose Drug Price Control Legislation that would alter the Medicare program
Supporting BIO’s coalition in opposition. https://www.bio.org/press-release/new-drug-pricing-deal-could-propel-us-light-years-back-dark-ages-biomedical-research. Helpful information pertaining to this subject can be found at:
Supported The Bayh-Dole Coalition, arguing against government-imposed arbitrary price controls
Joined the coalition in urging the Department of Health and Human Services to reject once again the petition asking the federal government to grant march-in rights for the patents on Xtandi, a prostate cancer drug, because of its price.
Supported The Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 1946) a S. 1873
Aimed to overcome access hurdles by allowing a pathway for timely coverage of multi-cancer early detection tests once they are approved by the Food and Drug Administration (FDA).
Supported BIO’s legislative advocacy to restore the longstanding deduction for R&D expenditures which was recently changed to a mandatory five-year amortization for domestic R&D
Legislative Activities
We actively engage in legislative advocacy to support Wisconsin's biohealth industry at both the state and federal levels. Our efforts focus on policy initiatives that foster innovation, drive economic growth, and ensure a competitive business environment. Stay informed about our current legislative activities and how we are working to influence positive change for the biohealth sector.
