An early draft of the “Cures 2.0” legislation that would create a new agency to develop new treatments for cancer, Alzheimer disease, and other high-profile diseases also includes Medicare coverage for “genomic precision medicine consultations” delivered by qualified clinical pharmacists.

ACCP has held meetings with legislative staff from the lead congressional offices to learn more about this important development and how we can work with Congress and other key stakeholders to help advance it through the legislative and regulatory process.

Lead sponsors Diana DeGette (D-CO) and Fred Upton (R-MI) named the “discussion draft” legislation currently in circulation on Capitol Hill “Cures 2.0” – a reference to the landmark 21st Century Cures Act of 2016, which set out to modernize the FDA’s decision-making process in the development of drugs, biological products, and devices.

The centerpiece of Cures 2.0 is the creation of a $6.5 billion Advanced Research Projects Agency-Health (ARPA-H) to specifically focus on innovative treatments in cancer, diabetes, and Alzheimer disease. This concept has been championed by President Joe Biden to build on the success of Operation Warp Speed in combining private sector innovation with public sector funding and coordination.

Why Process Matters

This “discussion draft” – which is still early in development – is designed to facilitate discussion and feedback from stakeholders. On the basis of this process, leaders from the House Committee on Energy and Commerce will coordinate with their colleagues in the Senate to develop a formal piece of legislation to be introduced in Congress.

Key to understanding ACCP’s advocacy strategy is recognizing the realities of the current political climate. This “qualified clinical pharmacist” provision in Cures 2.0 illustrates that Congress increasingly recognizes the unique value that qualified clinical pharmacists provide in advanced approaches to the treatment of complex conditions. But year after year, legislation is introduced in Congress that fails to generate the interprofessional, multi-stakeholder support and political momentum necessary to overcome political opposition to the price tag that inevitably accompanies any major legislative initiative.

Because of a Congressional Budget Office accounting process that only includes upfront costs and not downstream savings, it is inevitable that undefined, fee-for-service Medicare expansion will bring a hefty price tag that has in the past proven an insurmountable political obstacle, especially given the opposition of organized medicine and other established professions already competing for scarce fee-for-service dollars.

Collaborative Advocacy

ACCP has developed a collaborative advocacy mission that aligns its Washington agenda with physician-led efforts to reform Medicare structures to pay for primary care teams to care for people, not doctors to deliver services. We recognize the importance of fundamentally addressing the shortcomings in the Social Security Act to remove barriers that exclude pharmacists’ services from payment mechanisms. But we also recognize that, without the support of organized medicine, Congress will not enact a sweeping expansion of the existing fee-for-service mechanism to allow all pharmacists to directly bill for services.

ACCP works with a wide range of coalitions focused on team-based, value-driven, legislative and regulatory reform initiatives that could integrate its evidence-based approach to achieving patient care outcomes. The proposed “genomic precision medicine” provision that could cover clinical pharmacists in certain Medicare payment structures is only a small section of a much broader initiative to create a federal agency aimed at advancing innovative treatments for certain diseases in the wake of the COVID pandemic.

But this provision, together with growing interest in comprehensive medication management (CMM) at the Medicare Innovation Center, provides further evidence of the growing success of ACCP’s strategy to align the profession with high-profile, broadly endorsed, multi-stakeholder legislative efforts on Capitol Hill.

Next Steps

Congressional staff have agreed to accept feedback from stakeholders with a comment deadline of July 16. ACCP will use this opportunity to solicit feedback from members to address key definitions that might be included in the final legislative language. Our goal is to help leading clinical pharmacists in the areas of genomics and precision medicine share best practices with lawmakers, congressional staff, and other key stakeholders as the College works collaboratively to advance this sweeping reform package. Click here to read a summary of the Cures 2.0 proposal.