Advocacy

Wisconsin’s independent voice- advocating to strengthen Wisconsin’s biohealth industry.

Public Policy Plays a Critical Role in Biohealth Industry Success 

BioForward Wisconsin’s mission is a leading force in our advocacy efforts. As an organization, we believe that improving and saving lives is neither a partisan nor a local issue. We work within the entire political spectrum to serve the industry, champion parties and policies that support patients and technologies that save lives, and advocate for the best outcomes for patients. As an action-oriented association in the heart of the biohealth innovation territory, BioForward is uniquely positioned within an interconnected ecosystem of biohealth organizations at the frontier of life sciences and medical breakthroughs to advocate regionally and nationally to impact health on a global scale. ”

-Lisa Johnson, CEO 

BioForward works actively to:

  • Shape state and federal policy through education and engaging with policymakers 
  • Collaborate with legislators, industry, and research institutions on critical biohealth issues and initiatives 
  • Monitor and inform members of legislation that will impact our industry 
  • Educate members on how they can be engaged in public policy 
  • Provide essential data to decision-makers on the economic benefit of Wisconsin’s biohealth industry 

State & Local Legislative Activities

We have now begun the 2023—2024 legislative session. BioForward is committed to supporting our education systems from K-12 to technical colleges to our university system. We will be utilizing our 2022 WI Biohealth Economic Impact Report to demonstrate the importance of our biohealth industry as we advocate for various legislative and budget programs. Follow 2023 State Legislative and Administrative Actions & Updates for more information. 

2023 STATE LEGISLATIVE AND ADMINISTRATION ACTIONS & UPDATES

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:

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

STATE GOVERNMENT UPDATES:

2023 LEGISLATIVE RESOURCE

BIO Vaccine Education Materials

Value of Vaccines- Fact Sheet

2022 WISCONSIN ELECTION RECAP

November 11, 2022

Wisconsin Reelects Governor Tony Evers to a Second Term.

Democratic incumbent Governor Tony Evers captured 51.2% of the vote, while Republican challenger, Tim Michels, had 47.79%. According to reporting by WisPolitics, Evers has broken several historical trends with this victory. He is the first gubernatorial candidate to win a race while his party was in the White House since Republican Tommy Thompson in 1990. He is also the first Democrat to pull it off in 60 years.

Attorney General Dem Josh Kaul is Reelected.

Democratic incumbent Attorney General, Josh Kaul won reelection by narrowly beating Republican challenger, Fond du Lac County District Attorney, Eric Toney. With 99 percent of votes counted, Kaul had 50.1% to Toney’s 49.9%. This is an even slimmer margin than the 0.25% margin that Kaul beat Republican Attorney General Brad Schimel by in 2018.

Ron Johnson wins US Senate Reelection.

In the battle for Wisconsin’s U.S. Senate seat on the ballot, incumbent Republican Senator Ron Johnson beat Democratic challenger, Lt. Gov. Mandela Barnes. Johnson secured 50.50%, while Barnes captured 49.50% of the vote.

Republican Majority in the State Senate will be 22-10 Next Session.

The Senate Republicans have picked up their 2/3 veto-proof majority with a 22-11 majority heading into the 2023-24 legislative session. However, because the Assembly came up short, the legislature will not have a veto-proof Republican majority.

State Assembly Republican Majority will be 64-35.

The Wisconsin State Assembly will reconvene with a 64-35 majority in January 2023. Although they picked up three seats, they are still two seats short of the veto-proof majority that they were seeking.

Republican Van Orden Wins Open 3rd Congressional District.

The race for the open 3rd Congressional District vacated by Dem Congressman Ron Kind’s retirement was won by Republican former Navy SEAL Derrick Van Orden who beat Democratic candidate State Senator Brad Pfaff. Senator Pfaff will return to his State Senate seat, as his seat was not up for reelection in this year.

Key Wisconsin State Senate Races:

  • Republican Rob Hutton won the 5th State Senate District left open when current State Senator Dale Kooyenga decided not to run for reelection.
  • Republican State Rep. Rachel Cabral-Guevara will move to the Wisconsin State Senate, winning her race for the 19th State Senate District, which was vacated by Republican Lt. Gov candidate Roger Roth.
  • Former Republican State Rep. Romaine Quinn wins the 25th State Senate District seat, which was vacated by retiring Democratic State Senator Janet Bewley.
  • Republican candidate Cory Tomczyk wins the 29th Senate District vacated by retiring Republican State Senator Jerry Petrowski.

Other WI Congressional Race Results:

  • S. Rep. Bryan Steil, R-Janesville, won reelection against Dem Ann Roe.
  • S. Rep. Mike Gallagher, R-Allouez, won reelection against independent Paul Boucher and Libertarian Jacob VandenPlas.
  • S. Rep. Tom Tiffany, R-Minocqua, won reelection against Dem Richard Ausman.
  • S. Rep. Glenn Grothman, R-Glenbeulah, was unopposed.
  • S. Rep. Scott Fitzgerald, R-Juneau, won reelection against Dem Mike Van Someren.
  • S. Rep. Mark Pocan, D-Town of Vermont, won reelection against Republican Erik Olsen and Independent Douglas Alexander.
  • S. Rep. Gwen Moore, D-Milwaukee, won reelection against Republican Tim Rogers.

Senate and Assembly Republicans Elect Leadership for 2023-24. The day after the election, the Wisconsin State Senate and Assembly Republican caucuses met separately to elect the following leaders for the 2023-24 legislative session:

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
2022 STATE LEGISLATIVE AND ADMINISTRATION ACTIONS & UPDATES

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. 

Madison Local Issue

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.

2022 State Issues

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.
2021 STATE LEGISLATIVE AND ADMINISTRATION ACTIONS & UPDATES

Current Legislative Actions BioForward is Tracking 

Support Co-pay Accumulator Legislation (2021 SB 215 / AB 184) 

Senator Andre Jacque (R-DePere) and Representative Paul Tittl (R-Manitowoc) have introduced 2021 Senate Bill 215 and Assembly Bill 184, known as “co-pay accumulator legislation.” This legislation would require health insurance policies that offer prescription drug benefits, self-insured health plans, and pharmacy benefit managers, to apply amounts paid for prescription drugs by or on behalf of a person covered under the policy/plan to any calculation of an out-of-pocket maximum or any cost-sharing requirement of the policy or plan. 

These bills have been introduced and are waiting for legislative review and action. 

BioForward Supports NORD Ambassadors in the Creation of Rare Disease Advisory Council (RDAC)

NORD and the Wisconsin Rare Disease Advisory Council Coalition are working on creating a Rare Disease Advisory Council (RDAC) in Wisconsin. BioForward supports the creation of RDAC in Wisconsin.

BioForward monitoring:

  • Prohibiting Step Therapy for Certain Cancer Drugs (AB745/SB 716)
  • Right to Try Off Label Therapies
  • Banning “White Bagging” in Wisconsin

2021-23 Wisconsin biennial budget signed by Governor Evers (view our whitepaper) (view the press release)

The 2021-23 Wisconsin biennial budget bill was $685 million in net general and categorical school aids, which will provide two-thirds of school funding for the next two years. In addition, the Governor committed to designating an additional $100 million for education from the most recent federal pandemic relief funding designated for Wisconsin. This investment is very significant compared to other recent budgets.

However, we do not believe that funding for education is a one-time commitment.

Watch for BioForward’s ongoing efforts to advocate for additional educational funding for K-12 and our higher education systems.

Issues that BioForward is advocating for/tracking:

  1. Talent Attraction and Retention Initiatives Funded. Requires the Wisconsin Economic Development Corporation to expend at least $3 million during the 2021-23 biennium for talent attraction and retention initiatives.
  2. Refundable Research Credit Increased. Increases the refundable portion of the research credit from 10% to 15% for taxable years beginning after Dec. 31, 2021. BioForward advocated an increase of 20% to this credit in our budget communications. For more information on who may qualify for the credits and on what form are they claimed, please see page 31 of Dept of Revenue Business Tax Incentives publication: https://www.revenue.wi.gov/DOR%20Publications/pb123-2020.pdf
  3. All Drug Transparency and Drug Pricing Provisions REMOVED.
  4. Funding for UW Engineering School – Not Included. BioForward will continue to advocate for these types of vital UW System funding projects that have an impact on our industry’s long term talent needs

Wisconsin PBM Legislation (Senate Bill 3, now Wisconsin Act 9) 

A reintroduction of the PBM bill from the last session moved along quickly. This bill, authored by a large group of bipartisan legislators, generally requires pharmacy benefit managers to be licensed with the commissioner of insurance or to have an employee benefit plan administrator license under current law.  The bill also established certain requirements on pharmacy benefit managers and certain health plans regarding their interactions with pharmacies and pharmacists. 

Governor Evers signed the bill on March 26, 2021. 

Legislation to Allow Pharmacy Students to Administer Vaccines Proceeds (2021 AB 4 / 2021 SB 60) 

Assembly Health Committee Chairman, Rep. Joe Sanfelippo and Sen. Dale Kooyenga, introduced AB 4 / SB 60, legislation that would allow pharmacy students and pharmacy technicians to administer vaccines. The companion bills both had hearings and were recommended for passage. A number of organizations — including Walgreens, the Pharmacy Society of Wisconsin and the Medical College of Wisconsin — backed it, saying it would dramatically expand the number of vaccinators in the state. BioForward registered in support of this legislation. 

Governor Evers signed the bill on February 19, 2021. 

Support for Liability Protection from COVID-19 Lawsuits for Wisconsin Businesses and Universities 

In the fall of 2020, Wisconsin legislators introduced legislation that would provide safe harbor protection for businesses, homeowners, and government entities such as schools or universities from COVID-19 litigation. 

Supported and signed by Governor Evers. 

  1. 2021 WI Act 3, Wis. Stat. § 895.476. 

PPP Loan Deductibility 

Support state law change to allow businesses that received PPP loans to deduct expenses paid with the loan proceeds (i.e., change to state law to match federal law). 2021 Wisconsin Act 1.  Act Memo. 

BioForward Promotes Investments Into Biohealth Economic Infrastructure as a Part of the 2021-23 Biennial Budget Bill 

BioForward urged the State Legislature and Governor Evers to support Wisconsin’s biohealth economic infrastructure in the 2021-23 biennial budget bill through additional support for UW-Madison, expansion of UW-System funding and borrowing authority, and expansion of R&D tax credits and workforce development issues.  Further, BioForward has requested that the initiatives related to pharmaceutical pricing and transparency be removed from the biennial budget debate. 

Legislature and Administration Updates 

Andrea Palm Joins Biden Administration – Karen Timberlake is New DHS Secretary-Designee 

On January 18, 2021, it was announced that Department of Health Services (DHS) Secretary-designee Andrea Palm has been nominated to be Deputy Secretary of the U.S. Department of Health and Human Services in the Biden Administration. She will depart DHS to undertake this opportunity on January 20, 2021. 

Gov. Evers also announced that Karen Timberlake, DHS secretary under former Gov. Jim Doyle during the 2009 H1N1 pandemic virus response, will serve as DHS interim secretary. Timberlake will officially start at the DHS on January 25, 2021.  Timberlake has most recently been working for Michael Best Strategies, a contract lobby firm, in Madison. 

Legislative Leadership in 2021-22 

All of the legislative caucuses have met and elected the following leadership for 
next session. 

Assembly Republican Leadership 2021-22 

  • Speaker – Robin Vos 
  • Speaker Pro Tempore – Tyler August 
  • Majority Leader – Jim Steineke 
  • Assistant Majority Leader – Kevin Petersen 
  • Caucus Chair – Tyler Vorpagel 
  • Assistant Caucus Chair – Cindi Duchow 
  • Caucus Secretary – Jessie Rodriguez 
  • Caucus Sergeant at Arms – Sam Kerkman 

Assembly Democratic Leadership 2021-22 

  • Minority Leader – Gordon Hintz 
  • Assistant Minority Leader – Dianne Hesselbein 
  • Caucus Chair – Mark Spreitzer 
  • Assistant Caucus Chair – Lisa Subeck 
  • Caucus Secretary – Beth Meyers 
  • Caucus Sergeant at Arms – Kaylan Haywood 

Senate Republican Leadership 2021-22 

  • Senate Majority Leader – Devin LeMahieu 
  • Senate President – Chris Kapenga 
  • Senate President Pro Tempore – Patrick Testin 
  • Senate Assistant Majority Leader – Dan Feyen 
  • Senate Caucus Chair – Van Wanggaard 
  • Senate Caucus Vice-Chair – Kathy Bernier 

Senate Democratic Leadership 2021-22 

  • Minority Leader – Janet Bewley 
  • Assistant Minority Leader – Janis Ringhand 
  • Caucus Chair – Jeff Smith 
  • Assistant Caucus Chair – Melissa Sargent 

2021 COVID-19 Vaccine Activities & Updates 

We are fortunate to be living in a time when most major diseases can be prevented by effective and safe vaccines. According to CDC and every medical professional organization, the United States has the safest vaccine supply in history. The stage is set for success, but it is our responsibility to take advantage of the scientific advances that have already been made by getting vaccinated now for those diseases that can be controlled. It is important to get as many people vaccinated for COVID-19 as possible so that we can get past this pandemic.  We do this for ourselves and each other. 

  • Vaccination of biohealth companies’ employees: the following is a sequence of events related to the COVID-19 vaccine distribution- 
    • December 8, 2020: BioForward proactively requested that Wisconsin’s biohealth industry be eligible for Phase 1b vaccinations since many of our companies should be designated as frontline workers in the fight against this pandemic due to our critical products and services related to the treatment, prevention and testing of COVID-19.
    • January 14, 2021: BioForward responded to the State Disaster Medical Advisory Committee’s (SDMAC) recommendations for Phase 1b COVID Vaccination, which the recommendations excluded manufacturing that encompasses the biohealth industry. BioForward sent the SDMAC a comment letter and also made our companies aware they too could comment if they felt strongly about having our industry in Phase 1b. 
    • January 27, 2021. BioForward reached out to member companies after Wisconsin’s Department of Health Services finalized Phase 1b COVID vaccinations. The following category would apply to many Wisconsin biohealth companies: 
    • Vaccine Facts and Vaccines 101: 
    • Educating our members and state 

    Federal Legislative Activities

    A key value we bring our members is to advocate not only on a state level but on federal issues that affect Wisconsin’s biohealth industry and research institutions. We have strategic collaborations with partners such as the Biotechnology Innovation Organization (BIO)Pharmaceutical Research and Manufacturers of American (PhRMA), and the Advanced Medical Technology Association (AdvaMed) who serve to advance legislative policies having the greatest impact on Wisconsin’s biohealth ecosystem.

    2023 FEDERAL LEGISLATIVE ACTIONS

    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.

    Our national partners, AdvaMed and BIO, are conducting meetings to update federal legislators on our industry and federal agenda for the 118th United States Congress. More details to come as additional information are provided. 

    3/23. 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.

    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

    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.

    2022 FEDERAL LEGISLATIVE ACTIONS

    2022 Federal Issues

    November 2022

    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.

    September 2022

    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.

    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

    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/

    7/22 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:

    6/22. 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

    4/22. 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). 

    3/22 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.

     

    2021 FEDERAL LEGISLATIVE ACTIONS
    • Oppose: World Health Organization’s proposal and the Biden Administration support of Trade-Related Aspects of Intellectual Property Rights (TRIPS).
      • Wisconsin biohealth businesses employ more than 119,000 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, President Biden is proposing giving away similar rights globally pertaining to COVID-19 vaccines.
      • Please see BioForward’s Op-Ed in opposition to TRIPS
    • Oppose: H.R 3.
      • This legislation introduces international reference pricing and foreign price controls as a strategy to reduce prescription drug costs. Proposals like H.R. 3, and similar bills that introduce price controls, particularly foreign reference pricing, into government and private healthcare programs will consequentially threaten patient access and choice, cede America’s global leadership in biomedical innovation, and will have a disproportionately disastrous impact on small, emerging biotech companies.
      • By imposing artificial price controls tried to what other countries pay for their medicines, H.R. 3 would significantly erode the U.S.-based biopharmaceutical economy. In countries where reference pricing and price controls are already used, patients face limited access and significant wait times for those medicines that are approved. 
      • Please read more information at: https://www.bio.org/savecures

    Innovation Investments 

    Investing in the expansion of COVID testing, therapeutics, and vaccines 

    Protecting and Expanding Patient Access to Treatments 

    Education on precision medicine allows doctors to find a person’s unique disease risks and treatments that will work best for each individual. Includes expanding biomarker and genetic testing, gene editing, and gene and cell therapies 

    • Oppose: CY22 Part D Payment Modernization Model RFA. Concerned that these policies can have significant impacts on patient access to new and novel treatments. 

    Protecting Intellectual Property Rights 

    Support: Defending the University & Small Business Patent Proclamations Act, better known as Bayh-Dole Act: https://bayhdole40.org/about/#members 

    BioForward Advocacy News

    Public Policy Team

    Government Affairs Committee

    Sandra Benen

    Sandra Benen

    Director State Government Affairs, GSK

    Hollis Cloninger

    Hollis Cloninger

    Director Quality and Compliance, Eurofins

    Helen Fitzpatrick

    Helen Fitzpatrick

    Senior Director, Regional Lead, State Govt. Affairs, Bristol Myers Squibb

    Peter Fotos

    Peter Fotos

    Deputy Vice President, State Advocacy, PhRMA

    Dee (Dodge) George

    Dee (Dodge) George

    Assistant Director, State Govt. Affairs, Novartis

    Sarah Waun

    Sarah Waun

    Senior Manager, State Govt. Affairs, Genentech

    Kevin Johnson

    Kevin Johnson

    Senior Manager, State Govt. Affairs, Amgen

    Lisa Johnson

    Lisa Johnson

    CEO, BioForward

    Jordan Lamb

    Jordan Lamb

    Legislative Counsel, The Welch Group

    Amber Pearce Shaw

    Amber Pearce Shaw

    Government Affairs, Exact Sciences

    Charles Neider

    Charles Neider

    President, Neider & Boucher, S.C.

    Nicolas Paris

    Nicolas Paris

    CEO, Gilson

    Kathy Voskuil

    Kathy Voskuil

    Global Policy & Public Affairs-Alliance Development, Pfizer

    Kevin Walters

    Kevin Walters

    Public Affairs Analyst, WARF

    Find Your Legislators & Legislative Committees

    BioForward periodically sends out legislative alerts asking members to contact their senators or representatives on issues of importance to the biohealth industry. You can find them on the map. 

    2023-24 Wisconsin Assembly Standing Committees

    2023-24 Wisconsin Senate Standing and Joint Committees Members