H.R. 3635 Promises to Strengthen PPE Stockpile for Future Emergencies

  

This Capitol Beat article was guest-written by Debbi Waters, MSN, RN, MJ, CHC, a student in the McKendree University Doctor of Nursing Practice (DNP) in Ethical Leadership Program, who is completing her leadership practicum in partnership with ANA Senior Policy Advisor Lisa Stand.

This month, Congress took a positive step in preventing a repeat of the catastrophic shortages of personal protective equipment (PPE) experienced by nurses at the outset of the COVID-19 pandemic. With bipartisan support, the House of Representatives passed H.R. 3635, the Strengthening America’s Strategic National Stockpile Act of 2021.

It has been nearly two years since the COVID-19 pandemic began to rapidly spread across the United States (U.S.), triggering the worst public health emergency the nation has witnessed in more than a century. From the beginning of the pandemic in 2020, nurses quickly found themselves fearing for their personal safety, as well as the safety of their patients and families, as PPE supplies were being depleted at an extraordinarily fast pace. Nurses on the frontlines were directed to abandon evidence-based infection prevention standards, for instance, by being required to wear the same PPE for extended periods of time, and to reuse PPE across multiple shifts. In an American Nurses Association (ANA) survey in May of 2020, 45 percent of nurses reported experiencing PPE shortages, with 79 percent of nurses reporting being encouraged or required to reuse PPE, of those 59 percent felt unsafe in doing so. The ANA completed a second survey, ending on August 14, 2020, with 47 percent of nurses reporting intermittent to occasional PPE shortages. Forty-two percent of participating nurses reported an increase in PPE availability, as compared to 36 percent reporting no change; however, 68 percent continued to report being required by their facility to reuse single-use PPE, with 62 percent reporting feeling somewhat to very unsafe. The enormity of the impact of COVID-19 on healthcare workers is yet to be determined; however, the failure to provide basic PPE to frontline nurses and healthcare workers was profound and consequential to physical and mental well-being of our nation’s nursing workforce.

Why is H.R. 3635 Important?
H.R. 3635 would address key vulnerabilities within the federal government’s ability to adequately respond to such large-scale public health emergency, particularly with the medical supply chain.

The U.S., as with most other countries around the globe, utilized unprecedented amounts of PPE during the COVID-19 pandemic. At times, the PPE burn rate was nearly a 100 percent increase over historical levels. Very early in the pandemic as hospitals exhausted PPE supplies and began experiencing challenges in purchasing supplies through the usual “just in time” supply chain channels, and as local and state supplies became depleted, states called up the federal government for assistance through the Strategic National Stockpile (SNS)

The SNS, long considered to be the contingency plan for public health emergencies, was ill-prepared to respond to a threat the size and scope of this pandemic, certainly not for a threat simultaneously affecting all 56 states, territories, and the District of Columbia. The SNS endured years of underfunding and budget cuts by Congress that, compounded by a failure to replenish and rotate stock, led not only to inadequate amounts of PPE, but also to the delivery of PPE that was expired, rotting, and inappropriate for safe use in protecting nurses from the dangers of COVID-19.

Maintaining the Stockpile
H.R. 3635 would address the issue of expired and unsafe supplies by allowing the U.S. Department of Health and Human Services (HHS) to distribute supplies from the SNS to any federal department or agency, on a reimbursable basis, if the supplies are within one year of expiration and can be replenished within the SNS. In addition, HHS would be required to ensure that supplies and equipment within the SNS are in working order.

Domestic Production
The COVID-19 pandemic also exposed the risks associated with U.S. dependence on foreign sources for nearly 60 percent of the nation’s medical supplies. This dependence created cataclysmic sourcing and price challenges for American hospitals and healthcare providers, caused by stockpiling of supplies and price gouging, at one point upwards of 1,000 percent the customary cost, for supplies that were of poor quality and at times counterfeit. The inability of domestic manufacturing proved to be detrimental to nurses who were providing care to COVID-19 patients. H.R. 3635 calls for the creation of a pilot program designed to strengthen the U.S. supply chain by increasing domestic manufacturing. Specifically, the pilot requires HHS to establish and maintain geographically dispersed domestic reserves of critical medical supplies, including PPE, and increased emergency stock of those critical supplies through cooperative agreements or partnerships with manufacturers to produce and maintain supplies. Additionally, the bill provides temporary authorization for HHS to disperse grants to states for use in maintaining or expanding state strategic stockpiles of critical supplies that are deemed essential by the State in preparation for future public health emergencies.

Transparency and Tracking
Strengthening America’s Strategic National Stockpile Act of 2021 would require HHS to develop a transparent process for distribution and use of supplies from the SNS by January 1, 2022. This would include a process for states, localities, tribes, and territories (SLTT) to request supplies; the decision-making process HHS will follow when determining if the request will be fulfilled or denied; and the process for the prioritization of distribution to the SLTT. In addition, the bill would require a monthly report to be provided detailing the requests submitted by SLTT, including the amount of materials and supplies requested, along with the outcomes of those requests. In the event a supply request is only partially filled or denied, the rationale for those outcomes must be included.

Our nation must begin building upon the lessons learned during the COVID-19 pandemic by planning and preparing a response to future public health emergencies. We must remain vigilant, as COVID-19 will not be an isolated incident, if we are going to prevent a repeat of the catastrophic failures experienced during the COVID-19 response. H.R. 3635 is a positive step towards ensuring the U.S. response to upcoming public health emergencies will be more efficient and effective, while protecting the health and safety of our frontline healthcare workers and we thank Representative Elissa Slotkin for her leadership in addressing this critical issue.

Next Steps
There is still work to be done to ensure the Strengthening America’s Strategic National Stockpile Act of 2021 is signed into law. This legislation now moves to the Senate where a companion bill S.1974 was introduced in June 2021. As you know, things tend to move slowly in the Senate and they need a groundswell of support from their constituents to pass legislation. Without action, nurses will be no more protected in future pandemics, than we were in March of 2020. Please visit our Latest News page for updates on the legislation and a chance for every nurse and health care advocate to take action and message their members of Congress soon.

Large health care investments cap off eventful 2020 as we look ahead into 2021

  

What a historic year it has been on so many levels. Leaving behind the first year of a new decade that saw struggles which we could not have foreseen in January 2020, and going into a holiday season that looks vastly different from years passed and a future that is still unclear – it’s easy to focus on the negative. However, despite the trials and tribulations of this year, it is important and inspiring to recognize all of the ground-breaking work that ANA and nurses have done in the policy, government affairs and advocacy spaces, as we look towards what is on the horizon in 2021.

At the time of publication, Congress is in the process of passing a year-end package that will avert a government shutdown, include money for vaccines and COVID-19 aid to frontline workers, boost the economy, and include language to protect patients from surprise billing for health care. ANA has been working with our allies in Congress, and advocating to get these items addressed. Please be on the lookout for further details on the year-end package by visiting ANA’s new advocacy page. In the meantime, let’s acknowledge the progress made throughout 2020, which was necessitated by the COVID-19 public health emergency (PHE).

Earlier this year, the U.S. Congress and the President signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Included in the law is language that reauthorizes Title VIII Nursing Workforce Development Programs and authorizes Nurse Practitioners (NPs) and Clinical Nurse Specialists (CNSs) to order home health care for their patients. These are longtime ANA federal legislative priorities, and we applaud Congress and the administration on their passage in the early stages of the pandemic. Advanced Practice Registered Nurses (APRNs) like NPs and CNSs are key to COVID-19 care and maintaining access to non-COVID-19 care throughout the crisis.

By summer, ANA was becoming a regular voice for nurses as Congress sought additional solutions to PHE challenges in the healthcare system. ANA President Ernest Grant testified at a hearing before the Senate Finance Committee, “Part 2: Protecting the Reliability of the U.S. Medical Supply Chain During the COVID-19 Pandemic.” Dr. Grant was there to answer the many questions Senators had about the impact of COVID-19. Questions ranged from what more the federal government could do to strengthen the supply chain, to the needs of nurses on the ground.

ANA also responded on behalf of nurses to proposals outlined in a white paper released by the Senate Health, Education, Labor, and Pension (HELP) Committee. The Committee requested input on what the U.S. had learned from the past 20 years of public health preparedness and response, and how we can better prepare for future pandemics. ANA’s response focused on how to rebuild and maintain state and federal stockpiles, improving public health capabilities, and increasing medical supply surge capacity and distribution. 

ANA has been consistently present with effective advocacy on personal protective equipment (PPE), which has been in short supply all year. As a result, the enterprise was tapped as leadership of a broad-based the coalition that will be a united voice to Congress and the administration on PPE and supply chain issues, to improve public health.

As we pivot to start working with the incoming administration, ANA has hit the ground running, providing substantive recommendations to transition leaders, and applauding the appointment of a registered nurse to President-elect Biden’s COVID-19 Task Force. We have communicated the many ways in which ANA and nurses can be a resource to the transition and the upcoming administration. We continue to solidify relationships to ensure that ANA will maintain a strong voice in the White House and key agencies in the months ahead.

Like the rest of the Policy and Government Affairs team, the ANA Political Action Committee (ANA-PAC) experienced a very successful year in 2020 despite the multitude of challenges it faced at the start of the pandemic. For starters, the PAC continued its winning streak with a 95 percent win rate in the 2020 general election for the nearly 100 candidates the PAC supported based on their pro-nursing agendas. Members of ANA drove their support unlike in years passed to the tune of over 5,600 contributors to the PAC which was an increase of 34 percent over 2019 and counting! And it doesn’t stop there: the financial strength of the PAC continues to improve as receipts are up 3 percent over last year and this number only continues to grow as we head toward the year end. Policy and GOVA will be spending the early part of 2021 strategizing our support for our existing nursing champions and starting new outreach efforts to those new freshman members of Congress. Stay tuned for updates in the next ANA-PAC quarterly newsletter.

ANA advocacy on federal regulatory policy has also strengthened nurses and demonstrated the power of nurses’ voices. With the COVID-19 PHE extended until March 2021, Medicare payment flexibilities gained in 2020 will continue. A number of these provisions expand access to APRNs for non-COVID-19 care as well as COVID-19 care, which has been a boon to patients and their providers throughout the pandemic, especially in rural areas.

The readiness of the Centers for Medicare and Medicaid Services (CMS) to remove regulatory barriers to practice has come as a result of direct advocacy over the years by ANA and partner organizations. The voices of frontline nurse providers were also heard, as CMS gathered first-hand accounts and created space to share this information on regular conference calls with nurses about the impacts of COVID-19 on their practice.

The pandemic has demonstrated the value of APRNs across the health care system, and CMS’ actions tell us that Medicare leaders are hearing us. The future is indeed bright, as CMS continues to review unnecessary barriers and craft regulatory relief. ANA policy leaders are right there, urging specific changes, and making a powerful case for making permanent changes to expand access to APRNs. We saw some success in the physician payment rule for 2021, which removed federal restrictions on APRN supervision of diagnostic tests.

CMS was not the only agency hearing nurses’ voices as important decisions were made. Early and often, ANA repeatedly called for steps to improve protections for frontline providers, including a return as soon as possible to pre-pandemic standards for PPE.

We made our case to the Occupational Safety and Health Administration, the Office of Minority Health at HHS, the Department of Veterans Affairs, Federal Emergency Management Agency, Government Accountability Office, and the White House Economic Advisors. ANA has become the “go to” organization for agency staff when they hear about events happening on the ground to work together to improve conditions for nurses. 

The pandemic made ANA’s presence even more valuable with the American Medical Association’s (AMA) RUC and CPT committees, which are the driving force for health care reimbursement. ANA CPT advisors were at the table when the CPT codes for both the Pfizer and Moderna vaccines were developed. In a separate process, ANA advisors were consulted to account for increased practice expenses incurred during the pandemic. Throughout, ANA engaged feedback and comment from the nursing community. All of these accomplishments could not be done without the loud impassioned voice of our ANA members and RNAction advocates. This united voice sent nearly 460,000 letters to Congress, responded to public comments and engaged in several surveys where the results were presented to Congressional offices across Capitol Hill. All of the input from nurses, our nation’s most trusted profession for 18 straight years, directly impacted legislation and policy throughout the year. We have you to thank for that – your efforts on the frontlines, your expertise and your advocacy do not go unnoticed. With over 200,000 RNAction advocates, we are poised to improve the profession of nursing and conditions for your patients again in 2021.