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Today, Rebecca McGrath, center, joined (from left) Ronna Hauser, SVP of policy and pharmacy affairs at NCPA, and Doug Hoey, CEO of NCPA, as well as Cardinal Health colleagues Jerrica Mathis, director of government relations, and Scott Streator, VP of business development and managed care, at our annual Retail Business Conference. They shared legislative updates and encouraged independent pharmacists to advocate for the Equitable Community Access to Pharmacist Services Act.

By Rebecca McGrath, senior vice president, government relations and public policy

As part of its response to the COVID-19 pandemic, the federal government used the Public Health Service Act to declare a public health emergency (PHE) on January 27, 2020. The PHE gives the federal government flexibility in issuing a variety of waivers that modify certain requirements for Medicare, Medicaid, and other areas, and to authorize certain medical countermeasures – intended to solve complicated public health challenges for providers, patients and the entire health care industry.

All of these waivers and countermeasures are set to expire when the PHE ends, or at a specific time after the PHE ends. We don’t yet know when that will be; this afternoon, the PHE was renewed through October 13, 2022. (Earlier this year, the Biden administration and the Secretary of Health and Human Services (HHS) indicated their intention to give states 60 days’ notice prior to the PHE termination to plan for Medicare and Medicaid waivers that will be rolled back.) 

What we do know is that now is the time to start planning for the inevitable transition, and to identify those waivers that have increased access to health care and therefore should be made permanent. It is important for us to be thoughtfully and closely engaged with our federal and private sector partners to ensure we exit the public health emergency with a coordinated transition, and to prevent sudden disruptions in patient care. Highlighted here are several of the specific issues we are working on.

1: As a member of the Future of Pharmacy Care Coalition, we are supporting passage of the Equitable Community Access to Pharmacist Services Act (HR 7213). HR 7213 is federal legislation that would increase Americans’ access to pharmacist services by allowing pharmacists to practice at the top of their license.

For more than two years, pharmacists have been on the frontlines of the pandemic. Pharmacists have provided critical health care services to their communities, particularly in medically underserved and rural areas where health care systems are stressed or nonexistent.

Last year, the HHS amended the Public Readiness and Emergency Preparedness (PREP) Act to allow licensed pharmacists, pharmacy technicians and pharmacy interns to administer COVID-19 tests, vaccines, and treatment.

The Equitable Community Access to Pharmacist Services Act would make these amendments permanent and make pharmacists eligible providers for Medicare beneficiaries for services related to the COVID-19 pandemic and specific infectious diseases. These amendments include testing for COVID-19, influenza (flu), respiratory syncytial virus (RSV) and strep throat, administering vaccines for COVID-19 and flu, and treating patients with COVID-19, flu, or strep throat. The act would also help our country prepare for future emergencies by creating a mechanism to establish Medicare coverage and payment for pharmacist-provided services that the HHS deems necessary in addressing public health needs in the potential event of another public health emergency or communicable disease threat.

The Equitable Community Access to Pharmacist Services Act is supported by more than 100 national and state-based associations representing patients, pharmacists, community pharmacies, and rural and underserved communities. It is also supported by major patient advocacy groups, including the American Diabetes Association and the Arthritis Foundation; national medical provider groups, including the National Hispanic Medical Association and the National Association of Black Nurses; major consumer health advocacy groups, including the National Rural Health Association; and all leading pharmacy and pharmacist associations.

2: In partnership with Medically Home and the Advanced Care at Home Coalition, we’re supporting the pandemic-inspired Hospital Inpatient Services Modernization Act (H.R. 7053/ S.3792), which would extend Acute Hospital Care at Home waiver flexibilities.

In 2020, the Centers for Medicare & Medicaid Services (CMS) implemented the Acute Hospital Care at Home (AHCAH) waiver program, which has allowed Medicare beneficiaries to receive acute-level health care services in their homes throughout the pandemic.

More and more, patients want to get their care at home. In fact, according to McKinsey & Company, “up to $265 billion worth of care services for Medicare fee-for-service and Medicare Advantage beneficiaries could shift to the home by 2025 without a reduction in quality or access.” Rob Schlissberg, President of Cardinal Health at-Home Solutions, has noted, “Ultimately, we believe that enabling hospital-level care at home can significantly advance health equity, lower costs, and, most importantly, improve patient outcomes.”

More than 200 hospitals and health systems in 34 states have received the AHCAH waiver, which has demonstrated positive outcomes and potential cost savings, by reducing hospital readmissions, emergency department visits, and the use of skilled nursing facilities. The AHCAH waiver allows hospitals and health systems to meet increased capacity demands during the pandemic and highlights the need for broader adoption of hospital-level care at home in federal health care programs.

Because the AHCAH waiver program is tied to the public health emergency, which must be renewed every 90 days, patients who are currently receiving care at home – and their care providers – face uncertainty about the future of their care.

The Hospital Inpatient Services Modernization Act would extend the hospital care at home waiver flexibilities for two years from the end of the public health emergency, and create a pathway for providers to be reimbursed for such in-home care. The bill would require (within one year of its enactment) that CMS issue regulations that establish health and safety requirements for acute-level care at home.

The pandemic has inspired both greater desire for and greater acceptance of hospital-level care at home. We believe that the AHCAH waiver will help sustain this momentum, as well as provide time for health care providers to gain additional experience and collect more data that can help shape a long-term payment model for these services within the Medicare and Medicaid program. 

3: To help reduce further medical supply chain disruptions and medical product shortages, Cardinal Health issued comments to the Food and Drug Administration (FDA) urging the agency to extend its proposed transition plan for medical devices that have been issued Emergency Use Authorization (EUA).

EUA is a tool the FDA uses to make unapproved medical products or unapproved uses of approved medical products more readily available to health care providers to diagnose, treat, or prevent serious diseases or conditions caused by public health emergencies. During the pandemic, EUAs were given to Personal Protective Equipment (PPE), like face shields and other barriers and respirators; ventilators and ventilator accessories; infusion pumps; remote or wearable patient monitoring devices; continuous renal replacement therapy devices, and other medical products.

Recently the FDA issued a proposal, called the Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, to remove the EUAs from these products once the public health emergency ends. The plan is designed to prevent commercial market disruptions.

However, the FDA plan allows a six-month timeframe for the transition, which we believe is inadequate and could lead to disruptions and product waste. Cardinal Health responded to the plan with a letter to the FDA, and also joined more than 100 members of the Health Industry Distributors Association (HIDA) in recommending that the transition be stretched over as many as 19 months, to ensure that EUA medical products can work their way through the supply chain and be used by providers rather than discarded.

The pandemic’s disruption of the global supply chain has resulted in higher costs of care, longer wait times, and inconsistent deliveries of medical supplies; experts expect these disruptions will persist into 2023. These disruptions impact the work care providers can perform, and can put the most vulnerable patients at greater risk.

Throughout the pandemic, Cardinal Health has been transforming its supply chain, working to minimize or avoid disruption whenever possible. Along with other distributors, we have been working to diversify sourcing, expand U.S. manufacturing, and add to inventory stores in our distribution centers. Ultimately, all of this work is leading to a more resilient supply chain.

In the meantime, however, we cannot let the transition for medical devices with EUAs increase product shortages or cause supply chain disruptions. We must do all that we can to ensure that patients are able to receive the care they need, when they need it.

We believe health care stakeholders – including pharmacies, distributors like Cardinal Health, and the government – will need to work closely to ensure a smooth transition.

Rebecca McGrath, senior vice president, government relations and public policy, is an experienced government relations professional with a proven ability to achieve federal legislative, programmatic, regulatory, and advocacy-related goals on behalf of Cardinal Health and patient advocacy organizations. She has an extensive track record of success in securing passage of legislation and inclusion of direct appropriations, building consensus regarding policy change among industry and stakeholder partners, and maintaining long-standing bipartisan relationships. McGrath holds a Bachelor of Arts from Skidmore College and a Juris Doctor from American University, Washington College of Law.