Advocating for Pro Innovation

HLC Position:

HLC is focusing on the continuing implementation of the Inflation Reduction Act (IRA). HLC has already publicly expressed its concern with the new law’s direction related to the damaging effects of bringing government price controls into the Medicare drug program and, specifically, criticizing the disparity in treatment between small and large molecule drugs which could drive investment dollars away from critical medications for cancer, diabetes, Alzheimer’s disease, and other serious conditions. HLC will continue closely to monitor IRA drug pricing implementation to ensure that it is fully transparent and that there is a clear understanding of its ramifications for population health, patient access to care, and the future of medical innovation. While the Medicare-for-All movement has stalled on Capitol Hill because Republicans hold a House majority and moderate Democrats are not fully behind the concept, there is still no shortage of activity in the states to create a larger role for government in health coverage and reimbursement, beginning with public option programs. While HLC does not have the resources to intervene directly in state legislative matters, it remains involved in the Partnership for America’s Health Care Future. This coalition promotes the value of competition and consumer choice in the healthcare marketplace and underscores the negative ramifications of efforts engineered by some political leaders and well-financed foundations to diminish the role of the private sector in healthcare and expand government command-and-control policies under the guise of “transparency” or “affordability.”

HLC 2023 Activities:

• HLC continues to provide guidance to the Centers for Medicare and Medicaid Services (CMS) on IRA prescription drug provisions’ implementation. This work includes:
  • Publishing three op-eds, one highlighting the IRA’s adverse impact on innovation, and two sharing findings from the Medicare Today 2023 Senior Satisfaction Survey on the Part D prescription drug program, in which 91 percent of seniors reported being pleased with their plan and 67 percent wanting private plans to continue negotiating prices with pharmaceutical companies directly and not with the federal government.
  • Hosting an HLC policy committee meeting on the implementation of the prescription drug provisions in the IRA.
  • Mary R. Grealy appearing as a featured guest on an episode of the “Making Medicine” podcast, a production of Incubate, an organization of venture capital firms focused on life sciences and intellectual property.
  • Moderating a panel, “More Than a List: The Ripple Effect of the Inflation Reduction Act for Patient Access and Part D,” hosted by the Partnership to Fight Chronic Disease.
  • Joining a group letter urging Congress to enact legislation to bring parity to small molecule drugs (which the IRA will subject to price controls only nine years after Food and Drug Administration (FDA) approval) by giving them the same 13 years as biologics.
  • HLC regional directors continue to educate congressional offices on the disconnect in the policy between large and small molecules in the IRA.
  • Responding to CMS’s initial guidance for the Medicare Part B and Part D Prescription Drug Inflation Rebate Program, emphasizing that Health and Human Services’ (HHS) implementation of the IRA must happen in a way that includes sufficient safeguards and provides clarity in the implementation process for all stakeholders, especially the patient.
• HLC leads advocacy to educate lawmakers on the adverse business implications of the stacking provision included in CMS’s proposed Medicaid Drug Rebate Program (MDRP) proposed rule. This work has included:
  • Commissioning an issue brief produced by Avalere on the business implications of CMS’ proposal to stack price concessions across the supply chain.
  • Directly engaging with CMS and members of Congress on the issue.
  • Publishing the blog post, “Proposed Rule Change Would Make U.S. Healthcare System Even More Complicated and Potentially More Costly.”
  • Submitting comments to CMS on its MDRP proposed rule and joining a group letter urging CMS not to finalize the stacking provision.
• HLC continues to advocate the need to invest in preventive healthcare innovation in order to improve patient outcomes and also save healthcare dollars in the long run. This work has included:
  • Leading advocacy to encourage passage of 114/H.R.766, the “Preventive Health Savings Act,” to allow Congress more easily to request Congressional Budget Office (CBO) estimates of preventive health initiatives. HLC coordinated and submitted a stakeholder support letter with over 50 signatories to bill sponsors and the House Budget Committee (HBC).
  • Joining group letters to the House Energy and Commerce (E&C) and Ways and Means (W&M) Committees and the Senate Finance Committee (SFC) in support of  2407/H.R. 4818, the “Treat and Reduce Obesity Act” (TROA).
  • Joining group letters to Senate and House appropriators opposing cuts to the U.S. Preventive Services Task Force (USPSTF) and engaged with HHS staff in support of cancer innovation and the USPSTF.

• In collaboration with the S. House Health Care Innovation Caucus, HLC hosted the Healthcare Innovation Expo on Capitol Hill, an event at which members of Congress and congressional staff experience the new tools, technologies, and practices being developed by HLC member companies and organizations. Some 54 members of Congress attended this year’s event.
• HLC submitted two letters to the U.S. International Trade Commission (USITC) regarding its investigation analyzing the universe of existing COVID-19 diagnostics and therapeutics in relation to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. In its letter, HLC urged the USITC to oppose expanding the TRIPS waiver of intellectual property (IP) rights of the COVID-19 vaccine to diagnostics and therapeutic treatments for COVID-19 out of concern that doing so would have serious consequences for U.S. innovation leadership, economic and national security, and could threaten U.S. jobs.
• HLC submitted a letter to the E&C Subcommittee on Health in advance of its hearing, “Examining Proposals that Provide Access to Care for Patients and Support Research for Rare Diseases.” HLC pointed out that price setting provisions in the IRA will be detrimental to innovation in the rare disease space.
• HLC proposed solutions to ensure a resilient supply chain in response to a congressional request for information (RFI) from the SFC and E&C Committees and subsequent SFC hearing on ways to address drug shortages.
• HLC submitted a letter to the Senate Committee on Health, Education, Labor and Pensions (HELP) Subcommittee on Primary Health and Retirement Security in advance of its hearing, “Superbugs: The Impact of Antimicrobial Resistance on Modern Medicine.” The letter emphasized the urgency of the current lack of innovation in addressing antimicrobial resistance (AMR) and supported the innovative subscription model proposed in 1355/H.R.2940, the “Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act.”
• HLC hosted a webinar, “What’s New in Cancer Innovation?,” highlighting how changes in the legislative and regulatory environment can turbocharge continued lifesaving innovations.
• HLC submitted letters in advance of three U.S. House committee hearings on healthcare price transparency and competition held by the E&C, W&M, and Education and the Workforce