Weekly Policy Blog: CBSA Releases 2022 Policy + Advocacy Report
By: Colorado BioScience Association Date: 01/09/2023
CBSA leads Policy + Advocacy to support a collaborative, pro-innovation environment for life sciences in Colorado. We work to advance state and federal policies that support the companies in our ecosystem and the patients they serve.
In 2022, CBSA collaborated with partners and policymakers to promote and champion state and federal legislation that would advance Colorado’s health innovation ecosystem. Throughout the year, the Policy + Advocacy team built coalitions to support policies that would make a meaningful impact on patients and also counter legislation that would make it harder for life sciences companies to advance new technologies and treatments for patients.
The full 2022 CBSA Policy + Advocacy Report can be found here. A high-level summary is included below.
2022 Colorado Legislative Session
During the 2022 Colorado legislative session, CBSA weighed and supported three bills; opposed two bills; and reviewed, discussed, and worked on countless more. As always, CBSA’s efforts were focused around CBSA’s state Policy Priorities. Highlights include:
- Renewing and Expanding the Advanced Industries Investment Tax Credit (HB22-1149): CBSA proudly led advocacy efforts to reauthorize and expand the Advanced Industries Investment Tax Credit, which supports access to capital for companies in Colorado’s designated Advanced Industries, including life sciences. CBSA is proud to have achieved a key win for the Colorado life sciences ecosystem with the passage of HB22-1149. The bill reauthorized the Advanced Industries Investment Tax Credit for four years, increased the funds available from $750,000 to $4 million, and raised the investment cap from $50,000 per investor to $100,000 per investor.
- Expansion of Experiential Learning (SB22-140): CBSA supported SB22-140 and workforce development initiatives to create a talent pipeline for the growing life sciences ecosystem. CBSA was pleased by the passage of this bill.
- Colorado Rare Disease Advisory Council (SB22-186): CBSA supported SB22-186, whose passage created the Colorado Rare Disease Advisory Council, which includes a representative from the biotechnology or pharmaceutical industry. CBSA’s advocacy ultimately led to one of CBSA’s recommended candidates being selected for that position.
- Consumer Right to Repair Powered Wheelchairs (HB22-1031): CBSA opposed HB22-1031’s right to repair powered wheelchairs, but was pleased that the bill was passed with an amendment stating that manufacturers are not liable for faulty or improper repairs.
- Public Protections from Toxic Air Contaminants (HB22-1244): CBSA opposed HB22-1244 due to concerns around CDPHE regulating air toxins more stringently than the EPA and potential unintended consequences of CDPHE establishing a toxic air contaminant monitoring program that could impact the utilization and availability of Ethylene Oxide for the sterilization of medical devices and other medical products. A version of this bill with a narrowed scope was signed into law.
- Perfluoroalkyl And Polyfluoroalkyl Chemicals (HB22-1345): CBSA took an “amend” position on HB22-1345, which prohibits the sale or distribution of certain consumer product categories that contain intentionally added PFAS chemicals, and was very pleased that we were able to successfully get an exemption for drugs, medical devices, biologics, or diagnostics approved or authorized by the FDA or the USDA.
- Pharmacy Benefit Manager Prohibited Practices (HB22-1122): HB22-1122 created the Colorado 340B Prescription Drug Program Anti-Discrimination Act. CBSA took an “amend” position on the bill because it prohibits PBMs from requiring pharmacies to use a modifier that identifies whether their reimbursement claim is for a 340B drug.
- Coverage Requirements for Healthcare Products (HB22-1370): CBSA took an “amend” position on HB22-1370, which ultimately passed, because the bill includes several reforms that would improve affordability of and access to prescription medicines, but it falls short of addressing the misaligned incentives in the current rebate system and perpetuates fundamental mis-incentives with respect to plan design.
2022 Federal Policy Engagement
In 2022, CBSA worked tirelessly to promote and champion federal legislation that would advance Colorado’s health innovation ecosystem. This federal policy engagement was focused around CBSA’s federal Policy Priorities. Highlights include:
- Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs: CBSA worked with a national effort to mobilize Colorado’s life sciences community to ensure the SBIR and STTR programs were reauthorized. CBSA celebrated a policy victory when Congress reauthorized these critical sources of non-dilutive financing for early-stage life sciences companies in Colorado.
- User Fee Program Reauthorization: CBSA and our national partners strongly advocated for the reauthorization of the critically important FDA prescription drug, generic drug, biosimilar, and medical device User Fee Programs. We were pleased to see these programs reauthorized for another five years, even though many riders supported by CBSA were left out, including the Verifying Accurate Leading-Edge In Vitro Clinical Tests (IVCTs) Development (VALID) Act. CBSA will continue to advocate for important riders as Congress evaluates avenues to move them forward in 2023.
- Engagement on the WTO TRIPS Waiver: CBSA opposes the Trade-Relations Aspects of Intellectual Property Rights (TRIPS) Agreement waiver and any expansion of it to COVID-19 therapeutics or diagnostics. CBSA is continuing to monitor the Biden administration’s interagency review of the proposed expanded waiver.
- Multi-Cancer Early Detection Screening Coverage Act (MCED): CBSA is supportive of the pathway MCED would provide for Medicare coverage of screening tests that can detect multiple types of cancer before symptoms develop. This bill did not make it into the 2023 Omnibus Appropriations Bill signed into law on December 29, 2022, but this legislation continues to be a priority and CBSA and national partners will continue to advocate for it in 2023.
- Inflation Reduction Act: As part of a nationwide effort led by our partners at BIO, CBSA worked to mobilize Colorado’s life sciences community to combat provisions in the Inflation Reduction Act that allow the federal government to negotiate prescription drug prices. The legislation passed and while CBSA is disappointed with the outcome, CBSA thanks our community for speaking out against government price setting on prescription drugs. We will continue to advocate for policies that protect patient access and medical innovation.
- Transitional Coverage for Emerging Technologies (TCET): CBSA is supportive of the new TCET rule CMS is working to develop that would create an alternative, expedited pathway for Medicare to provide coverage and payment for emerging devices and diagnostics. While there is no final outcome to report yet, CBSA is working with national partners to express our support for CMS to issue a proposed rule.
- The PASTEUR Act: The Pioneering Antimicrobial Subscriptions to End Up-Surging Resistance Act (PASTEUR Act) would establish an outcomes and value-based alternative payment model where the federal government pays companies set amounts for critical-need antimicrobials based on the treatment’s value to public health. The PASTEUR Act did not make it into the 2023 Omnibus Appropriations Bill, but the omnibus bill did include several other provisions related to antimicrobial resistance (AMR). CBSA will continue to work with national partners to express our support for passage of the PASTEUR Act.
Looking Ahead to 2023
As CBSA’s Policy + Advocacy team prepares for the 2023 Colorado legislative session, we plan to continue our collaborations with partners and policymakers focused around CBSA’s Policy Priorities. Following CBSA’s successful efforts to reauthorize and expand the Advanced Industries Investment Tax Credit Program, CBSA will turn its attention to extending the Advanced Industries Accelerator Grant Program, which is a critical source of non-dilutive funding for Colorado life sciences companies. CBSA will continue to advance its federal Policy Priorities by working with national partners to build on the momentum generated by this year’s progress going into the 118th Congress.