A potentially “game-changing” piece of legislation recently introduced on Capitol Hill includes a provision to cover payment for qualified clinical pharmacists delivering “pharmacogenetic consultations.”

H.R. 6000, known as “CURES 2.0” – introduced on November 16, 2021, by Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) – is aimed at speeding up the delivery of groundbreaking, lifesaving cures; treatments; and innovations to those who need them the most.

To advance this goal, the legislation would create an entirely new agency aimed at ending some of the world’s most difficult-to-treat diseases such as cancer, diabetes, ALS, and Alzheimer disease. The Advanced Research Projects Agency for Health would be housed within the NIH and tasked with finding new cures and treatments for a slate of illnesses that affect tens of millions of Americans across the country.

Opportunities for Clinical Pharmacists

By specifying that “qualified clinical pharmacists” should be responsible for delivering pharmacogenetic consultations, Congress is deliberately recognizing clinical pharmacists’ unique contributions to the growing area of precision medicine. ACCP applauds Congress’s growing understanding of clinical pharmacists’ unique value in providing advanced approaches for the treatment of complex conditions.

For this legislative proposal, pharmacogenetic consultation refers specifically to a consultation furnished to an individual with respect to a physician-requested genetic or genomic test that provides advice and recommendations regarding the dosage, safety, and efficacy of particular drugs, biologics, and other treatments according to the individual’s pharmacogenetic result.

ACCP has already held meetings with staff members from lead congressional offices to help these policy-makers better understand the potential for pharmacogenetic testing to allow for precisely specified and delivered medical care on the basis of the unique characteristics of an individual patient’s genetic profile, as well as the patient’s lifestyle and environment.

However, precision medicine is not limited to genetic testing. ACCP also recommends that Congress explore opportunities to expand the definition to ensure precision medicine and pharmacotherapy treatments are available to a broader range of patient populations. Oncology pharmacists, for example, examine protein expression in cancer cells to provide better information about a specific type of cancer, the best treatment to use, and how well a treatment works.

Telehealth and Clinical Pharmacists

Of great significance to many ACCP members and the patients they serve, the CURES 2.0 legislation would also make permanent certain telehealth flexibilities under the Medicare program related to the COVID-19 public health emergency.

More About CURES 2.0

Specifically, this exciting legislation would:

• Transform how Medicare covers innovative new treatments and technologies to make these new discoveries available to patients sooner
• Increase access to telehealth services for Medicare and Medicaid patients, including making permanent the telehealth flexibilities under the Medicare program related to the COVID-19 public health emergency
• Provide training and educational programs for at-home caregivers – including family members with no prior health care experience – to help them better care for loved ones when they are home
• Require more diversity in clinical trials to ensure any new drugs and treatments approved for use in the United States are both safe and effective for a greater – and more representative – portion of the population
• Provide patients with more information about the illnesses they face and the treatments available to make them a more integral part of the decision-making process

The legislation would also take steps to address the ongoing COVID-19 pandemic, including requiring the Department of Health & Human Services to:

• Conduct a nationwide study on the implications of long COVID
• Develop a nationwide testing and vaccine distribution strategy to be used in future pandemics

Next Steps

ACCP works with a wide range of coalitions focused on legislative and regulatory reform initiatives that integrate team-based, value-driven, evidence-based approaches to achieving patient care outcomes. The pharmacogenomic consultation provision that could cover clinical pharmacists in certain Medicare payment structures, together with growing interest in comprehensive medication management (CMM) at the Center for Medicare and Medicaid Innovation, further demonstrates the growing success of ACCP’s strategy to align the profession with high-profile, broadly endorsed, multistakeholder legislative efforts on Capitol Hill.

Working with colleagues at the Colorado Pharmacists Society, ACCP has already formally endorsed CURES 2.0 and is committed to working with College members and congressional leaders to advance its passage. To get more involved in this effort, contact ACCP’s Director of Government Affairs at [email protected]; or visit the Pharmacogenomics Payment and Policy Taskforce housed within GTMRx.