BioOhio Update on Federal Issues & Policy

Bioscience Advocacy in Our Nation’s Capital

BioOhio works in a non-partisan manner with state and federal agencies, officials, and representatives to promote Ohio’s bioscience industry, BioOhio members, and Ohio’s health and prosperity.

BioOhio has a regular presence on Capitol Hill, meeting with members of congress and their healthcare staff, providing data, information, and guidance on bioscience-related issues. BioOhio representatives also participate in annual fly-ins organized by BIO and AdvaMed.

BioOhio’s government relations partner at the federal level is G2G Consulting.

If you would like to get involved or have questions about these issues, please contact a member of the BioOhio team.

On this page, you will find summaries and links relevant to BioOhio’s work in federal government relations.

Repeal of Medicare Coverage of Innovative Technology (MCIT) (10/13/21). BioOhio wrote to the Centers for Medicare & Medicaid Services and the Ohio delegation in the wake of MCIT’s repeal. We strongly encourage the establishment of rules to establish an expedited coverage pathway as soon as possible to ensure doctors and patients can access the care they need for the best chance of a full recovery and life.  Read the full letter here (pdf)

• H.R. 3 Will Stifle Innovation, Upend the Investment Cycle and Devastate Ohio’s Bioscience Industry (9/15/21). BioOhio wrote the Ohio Delegation to share concerns with H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, which will harm Ohio’s bioscience industry and ultimately patients in Ohio and across the country. Read the full letter here (pdf)

Medicaid Coverage of Innovation Technology (MCIT) Letter to CMS (6/25/2021). In response to the open comment period earlier this year, BioOhio sent a letter to CMS to ask they establish the MCIT program as soon as possible to ensure patients receive the care they need. Read the full letter here (pdf)

Support of Telehealth to House Ways and Means Committee (6/25/2021). In response to a hearing on telehealth, BioOhio sent a letter to the House Ways and Means Committee to highlight their support of telehealth and urge Congress to consider permanently extending the policies that have enabled us to provide remote, high-quality care for our patients during the COVID-19 pandemic. Read the full letter here (pdf)

• BioOhio statement to the U.S. Senate Committee on Homeland Security and Governmental Affairs (5/19/21) regarding the hearing entitled “COVID-19 Part II: Evaluating the Medical Supply Chain and Pandemic Response Gaps.” As we have learned through the COVID-19 pandemic, a supply chain mainly operated outside of the United States can be detrimental in a public health emergency. With more investments and a more competitive environment, the bioscience industry can be better prepared for future pandemics. We can ensure that, should this happen again, our supply chain is robust and more rooted here in the U.S. Read the full letter here (pdf).

COVID-19 & Personal Protective Equipment (PPE):  BioOhio has been actively engaged in conversations pertaining to the bioscience industry’s response to COVID-19, including ventilator and PPE production and testing and diagnostic development and expansion. Additionally, BioOhio is advocating for businesses, including venture and private entity backed companies, to make for the best use of federal relief funding to support the industry in the short and long term.

Virtual Town HallsBioOhio’s virtual town halls and Friday Forums are constructive, neutral ground for discussion with federal and state legislators, policymakers, and advocates from all political parties and points of view. Past events have featured Sens. Brown and Portman and Reps. Stivers, Joyce, Gonzalez, and Lt. Governor Husted, among others. These roundtables give the community the opportunity to ask questions directly to their representatives and keep policymakers engaged with the industry and what it needs to grow and thrive. Visit the Past Events page for links to previous forums.

Medical Device Tax Repeal:  In December 2019, Congress permanently removed the 2.3% Medical Device Tax. BioOhio has strongly opposed this tax since it was first proposed and has worked with its national partners, such as MDMA and AdvaMed, to urge Congress and the Administration to eliminate this tax before a temporary suspension was set to expire on December 31, 2019. The permanent removal of this tax is a victory for the industry as a whole.

Surprise Medical Billing:  A series of bills addressing surprise medical billing have been introduced in the House and Senate. BioOhio and industry partners monitor these bills closely and will continue to advocate to protect the environment that sustains biomedical innovation and ensure patients have access to the medicines they need with out-of-pocket costs they can afford.

The Safe Step Act (H.R. 2279 & S. 2546):  This legislation has appeared in both the House and Senate. BioOhio is an advocate of Step Therapy legislation that requires insurance companies to put the health of their patients first.

The Lower Drug Costs Now Act (H.R. 3):  BioOhio and its industry partners strongly oppose this legislation, instead advocating to keep existing programs intact, protecting patients from unaffordable out-of-pocket costs, and inappropriate restrictions on access to prescribed medicines.

Ensuring Patient Access to Critical Breakthrough Products Act of 2019 (H.R. 5333):  BioOhio supports the reintroduction of this legislation, which would guarantee an immediate transitional reimbursement code issued by the Centers for Medicare and Medicaid Services (CMS) to devices and diagnostics that receive FDA Breakthrough designation, eliminating up to three year waits for patient access to lifesaving, technologies.

The Support Technology and Research for Our Nation’s Growth and Economic Resilience (STRONGER) Patents Act (H.R. 3666):  Introduced in 2019 by Ohio Congressman Steve Stivers (R), this act would strengthen the U.S. patent system and protect the property rights of inventors and businesses. BioOhio is a strong advocate of this important legislation.

Value-Based Health Care:  BioOhio supports the transition from a fee-for-service/product, volume-based, payment framework in the U.S. healthcare system to a value-based paradigm to achieve better clinical outcomes, lower costs, and improve the patient experience.

The Fostering Innovation Act (H.R. 3388):  This was introduced in February 2019 to build on the success of the JOBS Act by extending certain exemptions for an additional five years for pre-revenue biotech companies. It would allow biotech companies without an FDA approved product to avoid the costly compliance-related disclosures required of in-market organizations.