NACDS Urges Biden Administration to Address “Important Missed Step” to Maintain Preparedness Against “Tripledemic”

Sustaining PREP Act pharmacy flexibilities through October 2024 will help keep patients and pharmacies from having to “guess” about issues related to pharmacy access

Emphasizing that “the nation cannot afford to have an economic slowdown caused by COVID-19 and flu hospitalizations,” the National Association of Chain Drug Stores (NACDS) today reiterated long-standing calls for the Biden Administration to provide much-needed consistency and predictability for policies key to patients’ access to vaccinations and other pandemic services.

Specifically, NACDS is calling for the Biden Administration and the U.S. Department of Health and Human Services (HHS) to issue a new Public Readiness and Emergency Preparedness Act (PREP Act) amendment that keeps vital pharmacy policies in place through October 2024. NACDS also is calling for the Administration to release a transparent plan for the commercialization of COVID-19 countermeasures, and for the U.S. Congress to pass the Equitable Community Access to Pharmacist Services Act (H.R. 7213).

In just one example presented by NACDS, failure to keep the PREP Act pharmacy flexibilities in place would reduce vaccination capacity by almost 40% – if the capacity of pharmacy technicians were rolled back.

NACDS conveyed its urgent call in an open letter to President Biden, HHS Secretary Xavier Becerra, the White House COVID-19 Task Force, and Members of Congress. The full text of the letter appears here:

We are writing to support recent efforts to raise awareness regarding the impending “tripledemic” that the nation faces entering the winter months. Our pharmacies and pharmacy teams are honored to have provided 276 million vaccinations for COVID-19 and stand ready as the primary point of access for Americans who seek vaccinations for both COVID-19 and influenza. However, to continue to meet the volume of care services and equitable reach in communities across the country, the National Association of Chain Drug Stores (NACDS):

• Seeks your partnership in making sure that a disruption of vaccination access and uptake does not adversely – and unnecessarily – affect the economy and workforce

• Asks for immediate issuance of a new Public Readiness and Emergency Preparedness Act (PREP Act) amendment that sustains the policies essential for pharmacies to plan staff structures and to meet public demand

• Calls on the Administration to release a transparent plan for commercialization of COVID-19 countermeasures to help sustain access to care – especially for the uninsured and underinsured

• Urges Congress to pass bipartisan legislation to create a reliable pharmacy reimbursement pathway through Medicare for equitable access to COVID-19 treatments, including Paxlovid (H.R. 7213, the Equitable Community Access to Pharmacist Services Act).

Pharmacies and pharmacy teams have helped America get on top of the COVID-19 pandemic. The fact that 90% of Americans live within five miles of a pharmacy has proven decisive and irreplaceable. Pharmacies have provided more than 276 million COVID-19 shots. At times in the pandemic they’ve given more than 50% of the COVID-19 shots in this country, and now they are giving two of every three shots. More than 40% of individuals vaccinated at pharmacies are from racial and ethnic minority groups and half of pharmacy COVID-19 vaccination sites are in areas of high social vulnerability. Pandemic interventions by pharmacy personnel have averted more than 1 million deaths, more than 8 million hospitalizations, and $450 billion in healthcare costs. The impact defined by sheer volume of care services and equitable reach provided by pharmacies seemed unimaginable to many prior to the pandemic. The data tell the real story.

Currently, two trends are re-emerging: lingering pandemic challenges are apparent, and the government is again turning to pharmacies and pharmacy teams for help. Unpredictable COVID-19 variants now loom amid an increasingly active flu season. Unfortunately, pandemic fatigue may cause some Americans to delay vaccinations. We anticipate potentially the worst “twindemic” to date – and even a “tripledemic” with the rise of “RSV” cases affecting respiratory systems. We commend your leadership in urging Americans to get their flu shots and COVID-19 boosters. Further, we anticipate that – as seen before – Americans ultimately will surge to pharmacies for vaccinations given growing health threats, a desire to travel for the holidays, and urgency to stay at work and to keep children in schools. They also will look to pharmacies for testing and for treatments like Paxlovid. The nation cannot afford to have an economic slowdown caused by COVID-19 and flu hospitalizations. 

For preparedness, we must reiterate the call for action that we have urged throughout 2022 – a crucial remedy for an important missed step. It is imperative that the U.S. Department of Health and Human Services (HHS) and the Biden Administration issue a new Public Readiness and Emergency Preparedness Act (PREP Act) amendment to extend the expiration date of pandemic pharmacy flexibilities until October 1, 2024. Together, the PREP Act flexibilities are a catalyst for preparedness. They make it possible for pharmacy team members – for example, pharmacists and pharmacy technicians – to perform vital roles in vaccination, testing, and treatment for COVID-19, for flu, and for other illnesses. The purpose of the PREP Act during the pandemic is to harmonize policies across the country, rather than relying on a patchwork of state policies. States are modernizing their laws to ensure pharmacy teams can perform needed services, though that has not yet occurred to a degree that is sufficient to maintain preparedness amid ongoing public health risks. 

We must ask: why keep pharmacies guessing about whether team members will remain empowered to perform vital pandemic services? Why keep Americans guessing about whether they will have access to vaccinations from their trusted pharmacy? To simplify a complex situation, two events would curb the PREP Act authorities by which pharmacies have been able to meet Americans’ needs during the pandemic. These two events are 1) the expiration of the public health emergency (PHE) and 2) the move from federally purchased to commercially available (i.e., an end to the government programs) COVID-19 vaccines and treatments including Paxlovid. PHE extensions by law can only be made three months at a time. While these extensions have been somewhat predictable throughout the pandemic, signals from the federal government suggest there is nothing certain about further 90-day extensions. Regarding commercialization, HHS continues to shift timelines – recently indicating February 2023 as a start date and now moving to a murky early-to-mid 2023 timeframe. Because of the lack of clarity, pharmacies are hanging on every word from the government to anticipate whether an end to the PHE or the move to commercialization will halt the ability of pharmacy team members to perform critical services.

In one example, PREP Act expiration would reduce vaccination capacity by almost 40%. The ability of pharmacy technicians to vaccinate for COVID-19 and flu is largely tied to the PREP Act. Pharmacy technicians have provided up to 38% of vaccination doses provided by pharmacies. The current cloud of uncertainty is starkly inconsistent with calls for Americans to protect themselves with vaccinations, and with calls for pharmacies to do even more. It is reasonable to expect that pharmacies should have confidence that pharmacy technicians will be empowered to vaccinate until October 2024. Planning is essential, and pharmacies – like other healthcare destinations – cannot just flip a switch when it comes to managing their workforce. The current environment presents enough challenges, without exacerbating them by forcing pharmacies to gauge policies on a month-to-month basis. There literally is no good reason not to take the simple action of confirming that all PREP Act pharmacy flexibilities will remain in place until October 1, 2024. Clarity on this issue would help to minimize frustrations for Americans and for pharmacy teams alike – and such clarity should be viewed as essential for the credibility of public health preparedness and for good government. 

In addition to issuing a new PREP Act amendment confirming that pharmacy flexibilities will remain in place until October 1, 2024, two other steps are needed: a transparent plan for the commercialization of COVID-19 countermeasures and the enactment of the Equitable Community Access to Pharmacist Services Act (H.R. 7213). Also consistent with NACDS’ long-standing urging, two important steps would help to prevent a roll-back of public health preparedness. For one, HHS and the Biden Administration need to release a transparent plan with specific timelines for the commercialization of COVID-19 countermeasures to help sustain access to care – especially for the uninsured and underinsured. Second, equitable access to COVID-19 treatments including Paxlovid – and other key aspects of preparedness – hinge on passage of the Equitable Community Access to Pharmacist Services Act (H.R. 7213).

It may not be widely known that COVID-19 funding for the uninsured ended in March 2022 for testing and treatments, and in April 2022 for vaccinations. Given their participation in federal programs, pharmacies have sustained these services since those times without compensation. The method for continuing to meet the needs of the most vulnerable – at the point of commercialization – is one aspect of government planning that remains incomplete. The bipartisan H.R. 7213 would create a reliable pharmacy reimbursement pathway through Medicare for pandemic-related services. It is the lack of such a pathway that serves as a major barrier to empowering pharmacists to help improve equity and access to COVID-19 treatments including Paxlovid. This is a reason why these medications cannot reliably make their way to those who need them most. Resolving this issue is just one of the benefits of this extremely reasonable legislation.

America’s pharmacies and pharmacy teams continue to serve valiantly as the face of neighborhood healthcare. Throughout the pandemic, NACDS has advised federal and state governments of actions essential to safeguard individuals, communities, and the nation. The response has worked best when NACDS’ recommendations have been acted upon – thus empowering the pharmacies and pharmacy teams on the front lines of care. Now, uncertainties in the current COVID-19, flu, and RSV environment – and uncertainties in policies designed to serve Americans at this critical time – can be mitigated by taking long-awaited action to ensure pharmacy PREP Act flexibilities remain in place until October 2024. Releasing a transparent plan for the commercialization of COVID-19 countermeasures and enacting H.R. 7213 also will go a long way toward meeting the needs of Americans at this time and into the future.

By taking the key actions outlined in this letter, pharmacies and pharmacy teams in communities across the country can continue to meet the needs of every American, and particularly the most vulnerable.