Federal Advocacy

Current Federal Policy, Issues, and Opportunities

The following are selected key areas of focus for OLS, our partners, and members. Use the links below for direct access to press releases, bill text, status, and testimony from proponents, opponents, and other interested parties. Activity prior to November 2022 was conducted under the name BioOhio.

• Ohio Supports the SBIR & STTR Programs, a Letter to the Ohio Delegation (9/12/2022). BioOhio submitted a letter this week to congressional representatives and senators in support of the SBIR/STTR programs’ reauthorization. Nearly 70 Ohio life science stakeholders — business leaders and others who are invested in Ohio’s growing life sciences ecosystem — joined as co-signers to BioOhio’s advocacy efforts. Read the full letter here (pdf)

• National Coverage Analysis (NCA) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (2/10/22). BioOhio and fellow members of the Council of State Bioscience Associations, a coalition of forty-six state bioscience associations across the United States, submitted comments to the Centers for Medicare & Medicaid Services regarding the recent National Coverage Analysis (NCA) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG-00460N). Read the full letter here (pdf).

• Letter of support for the Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act of 2021 (S. 2740) (2/7/22). BioOhio supports the PREPARE Act because it will create a stronger domestic supply chain, building the much-needed capacity we need to serve our patient population but also creating jobs for Ohioans and Americans alike. We would like to thank Senators Brown and Cassidy for introducing this important legislation. Read the full letter here (pdf).

• 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)

• New Legislation Aims to Increase Early Cancer Detection in Medicare (5/27/21).  A bill reintroduced in the U.S. Senate aims to improve access to new and innovative cancer screenings among Medicare beneficiaries in order to increase early detection of more cancers for more Americans. The Medicare Multi-Cancer Early Detection Screening Coverage Act would establish a Medicare benefit category for multi-cancer screening tests and would allow the Centers for Medicare and Medicaid Services (CMS) to use an evidence-based process to determine coverage for blood-based tests and future multi-cancer testing innovations. Read the full release from the American Cancer Society here.

• 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 Relief Legislation:  Congressional lawmakers have been debating the substance of a 5th legislative package to help the country weather the health and economic effects of the COVID-19 pandemic. Negotiations have spanned several months, stalling at times over disagreements surrounding unemployment insurance benefits and aid to state and local governments. This, combined with a rapidly approaching Presidential election and a potential Supreme Court confirmation process, has reduced the chances of a 5th COVID stimulus deal being reached until at least after the Nov. 3rd election. Media Coverage on CBPP.org

• Medical Device User Fee Amendments:  Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA). Under the user fee system, medical device companies pay fees to the FDA when they register their establishments, list their devices with the agency, submit an application or notification to market a new medical device in the U.S., and for certain other types of submissions. The U.S. Food and Drug Administration is required to incorporate public input on this fee amendment decision-making process and does so through regular public hearings. Current fee amendments will be in place from Oct. 1, 2017, until Sept. 30, 2022. New legislation is required for the FDA to continue to collect user fees for the medical device program in future fiscal years. Link to FDA website with additional information

• Buy American & Reshoring:  A presidential election issue, following shortages of personal protective equipment (PPE) and critical medical supplies due to COVID-19, policy proposals have been brought forth to “reshore” U.S. medical and PPE supply chains. Depending on the specific language of the policy proposal, of which various versions have been recently introduced by congressional lawmakers, this policy could create unintended consequences, ultimately burdening Ohio’s bioscience and pharmaceutical industries if improperly enacted. 8/6 Executive Order on Pharmaceuticals  •  Response from PhRMA

• International Pricing Index:  President Trump has issued executive orders addressing the price of prescription drugs. While these orders take aim at significant issues faced by consumers of prescription drugs, certain provisions of these and other related policies may inhibit future biomedical and pharmaceutical innovation throughout the commercialization process. National-level organizations as well as state bioscience chapters are carefully monitoring the execution and implementation of these orders. 7/24 Executive Orders on WhiteHouse.gov  •  9/13 Executive Order on WhiteHouse.gov  •  Response from PhRMA  •  Response from BIO

• CMS Breakthrough Pathways:  The Centers for Medicare & Medicaid Services (CMS) recently released its long-awaited proposed rule on “Medicare Coverage of Innovative Technologies.” The proposed rule would make significant changes to streamline Medicare coverage for FDA-designated breakthrough technologies that have market authorization. The rule would create a new, voluntary Medicare Coverage of Innovative Technologies (MCIT) pathway that would provide immediate, national Medicare coverage of any FDA-market authorized breakthrough device if the device meets certain criteria. This automatic coverage would begin on the date of FDA-market authorization and would last for four years, after which time coverage would be determined through existing processes. This proposed rule is the result of years of advocacy on the part of national-level organizations such as AdvaMed and its member companies, who are generally supportive of the policies included in the measure. Supportive legislation has been introduced in the House and Senate that would be complementary to this CMS decision. Sen. McSally has introduced S.3914, the Ensuring Patient Access to Critical Breakthrough Products Act of 2020. Rep. Suzan DelBene is thought soon to carry this, as she has introduced this legislation before. Full text of the proposed rule on the Federal Register (pdf)

• Verifying Accurate, Leading-edge IVCT Development (VALID):  This legislation would modernize the critical framework that the U.S. FDA uses for regulatory oversight over certain diagnostics, including laboratory-developed tests (LDTs) and in-vitro diagnostics (IVDs), in a risk-based manner that provides vital assurances to the public for accurate and high-quality testing. This bill would help ensure the healthcare industry keep pace with scientific progress in the field and would foster overall innovation. This risk-based framework brings together essential reforms for all diagnostics and is vitally important to ensure a consistent and predictable pathway for developers as well as timely patient access to cutting-edge diagnostic technologies. National-level industry organizations such as AdvaMed have testified in support of this policy proposal. This legislation has been introduced in the House and Senate by Rep. Diana DeGette (D-CO-1) and Sen. Richard Burr (R-NC) respectively. Link to bill text on Congress.gov  •  Press Release from the Office of Rep. DeGette  •  Section-by-section overview from the Office of Sen. Burr (pdf)

• Medical Supply Transparency and Delivery Act:  This legislation would require the president to utilize all available authorities under the Defense Production Act to mobilize a federal response to the pandemic through an equitable and transparent process. Companions bills were introduced in the House and Senate by Rep. Jason Crow (D-CO-06) and Sen. Tammy Baldwin (D-WI). While this legislation is not anticipated to gain momentum in the 116th Congress, national-level organizations such as AdvaMed and state bioscience chapters are closely following this legislation. Link to bill on Congress.gov  •  Press release from the Office of Sen. Baldwin

• 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 Halls:  BioOhio’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.