[Submitted electronically to OASHcomments@hhs.gov]
Office of the Assistant Secretary of Health
200 Independence Ave. S.W.
Washington, D.C. 20201
Re: RFI Response — Long-Term Monitoring of Health Care System Resilience
ASHP is pleased to submit comments to Office of the Assistant Secretary of Health (OASH) regarding the request for information related to the long-term monitoring of healthcare system resilience (the “RFI”). ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s nearly 55,000 members include pharmacists, student pharmacists, and pharmacy technicians. For more than 75 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety.1
ASHP appreciates the opportunity to provide OASH feedback regarding health system resilience. We thank OASH for taking a broad approach. Our responses are derived from member feedback, so we have focused them on those areas that are most relevant to member experience. We have organized our feedback below to follow the headings and question numbers on the RFI.
Barrier and Opportunities for Health System Resilience
- What have been the most significant barriers to assessing, monitoring, and strengthening health system resilience in the U.S.?
Resilience capacity is critical for health systems to respond, adapt, and transform to threats to patient health and the healthcare environment. There are a number of areas crucial to health system resiliency including, but not limited to: secure supply chains, health and well-being of the workforce, high functioning teams, adequate infrastructure, collaborative partnerships with external stakeholders, and continuous quality improvement within a learning healthcare system. Broad barriers include limited resources, inability to address health disparities and social determinants of health, and lack of standardized metrics and reporting parameters. While each category deserves equal consideration and commitment to assess, monitor, and strengthen health system resilience, ASHP’s comments focus on the medication supply chain and the well-being and resilience of the healthcare workforce. We welcome further discussion on the remaining categories as OASH deems necessary.
As OASH is aware, the COVID-19 response has been plagued by medication shortages, including many of the sedatives and paralytics essential to safely and effectively intubate patients requiring mechanical ventilation. Health systems have also grappled with shortages of basic supplies, including personal protective equipment (PPE). As far as we aware, the supply chain has not been a major focus of resilience assessment, monitoring, and strengthening to date.
Additionally, a commitment to the health and well-being of the workforce requires a multifaceted approach that includes ensuring their health (e.g. infection prevention), safety (e.g. workplace violence prevention), and well-being (burnout prevention). ASHP has policy and advocates on each of those areas of emphasis. As it relates to our comments in this RFI, ASHP has a longstanding commitment to fostering and sustaining the well-being and resilience of the healthcare workforce, including pharmacists and pharmacy technicians.2 We believe a healthy, thriving clinician workforce is essential to ensuring optimal patient health outcomes and safety.
We are concerned that there has not been adequate and uniform commitment to assessing, monitoring, and strengthening clinician well-being and resilience. Health systems are fundamentally dependent on people – pharmacists, doctors, nurses, and others on the frontlines of patient care, practicing at their highest capability. COVID-19 has exacted a heavy toll on the clinician workforce, further exacerbating the existing fault lines causing clinician burnout in hospitals and health systems. Clinicians are overwhelmed, particularly those in hot spots and those experiencing redeployment to a less familiar patient care area. They are facing the loss of colleagues and patients, all while trying to protect themselves and their own families. This stress is likely compounded for clinicians whose health systems have implemented clinician layoffs, furloughs, or salary reductions to defray the pandemic’s financial impact. We encourage the development of metrics for clinician resilience as well as methods to integrate these metrics into broader assessments of health system resilience. Equally important to assessing and monitoring clinician resilience is an emphasis on external, system-based factors known to impact healthcare workforce resiliency.
2. What policies and programs can be improved to mitigate the risk of COVID-19 and avoid negative impacts on patient outcomes?
- Addressing Drug Shortages: ASHP was pleased that the Coronavirus Aid, Relief, and Economic Security (CARES) Act included a number of provisions addressing drug shortages, many of which mirrored ASHP shortages recommendations.3 Unfortunately, drug shortages continue to be a feature of the U.S. healthcare system and pose a particular threat during pandemics and other public health emergencies. Thus, we urge policymakers to build up supply chains resilience across the globe, with a particular emphasis on improving domestic advanced manufacturing capabilities.
The Food & Drug Administration (FDA) has identified advanced manufacturing as a potential alternative to traditional batch manufacturing, which could improve the quality and resilience of drug production. Investment in domestic, advanced manufacturing, in the form of tax incentives or grants, would reduce our dependence on highly concentrated foreign sources of drug production, and would allow manufacturers to more rapidly reallocate manufacturing to products in shortage than is possible through traditional production. Making use of advanced manufacturing technology saves time, reduces the potential for error, and enables a nimbler approach to changing market demands.
- Maintaining flexibilities through 2020: Although the hope is that there will be no second COVID-19 wave in the fall, the current steep increase in case count begs the question of whether the first wave will have ended by fall. Add seasonal influenza to COVID-19 cases, and there is a high likelihood that healthcare systems across the country will be under tremendous strain. Rather than rolling back flexibility piecemeal and then losing valuable time having to re-promulgate the same flexibilities, ASHP urges federal agencies, particularly the Centers for Medicare & Medicaid Services (CMS) and the Food & Drug Administration (FDA), to extend all current COVID-19 related regulatory flexibilities through at least January 2021.
- Enhance Agency Information-Sharing: ASHP urges federal agencies, particularly the Health & Human Services (HHS) subagencies, to maintain strong information-sharing practices with other agencies. Although the risk of major shortages of sedatives and paralytics necessary for mechanical ventilation abated somewhat with the reduction in cases, as the case count climbs, so do the shortage risks. CMS coordination with FDA and DEA was highly beneficial in addressing shortages early on – continued coordination may help mitigate the impact of future shortages by ensuring concerted action.
- Remove Barriers to Full Clinician Engagement: To promote health system resilience, CMS and other policymakers should remove barriers that prevent clinicians from practicing at the top of their training. Pharmacists, for instance, should be able to fully engage in the provision of Medicare services that increase access to care (e.g., opioid treatment programs, telehealth services, chronic care management, etc.). CMS recently granted increased flexibility to physician supervision for other non-physician practitioners—physician assistants (PAs) and PA services in the PFS final rule.4 In hospitals and health systems, pharmacists in health care teams function very similarly to nurse practitioners and PAs. Thus, it makes sense for CMS to extend these flexibilities to pharmacists as well.
When pharmacists partner with physicians and other health care professionals they streamline and improve outcomes, but regulations and policies that do not fully recognize pharmacists’ services limit patient access to care. Lack of CMS coverage of pharmacist-provided care services, rigid supervision requirements and unclear coverage policies for incident-to services create unnecessary layers of complexity for health care providers and patients. In turn, this can seriously limit how hospitals can engage their pharmacists, reducing health system flexibility and the corresponding resilience that stems from the ability to quickly modify care models to meet pressing needs (e.g., the swift transition to telehealth during the pandemic).
Key Indicators & Data Sources of Health System Resilience
- What is your definition of health system resilience within the context of your organization? Does the definition of resilience need to be defined differently based on geographic region and/or the domain of healthcare being assessed?
While ASHP lacks formal policy on the definition of health system resilience at this time, our body of policies, positions, guidelines, and resources are aimed at bolstering it in some capacity. We recognize that, as a nation, we should embody a standardized definition, approach and commitment to assess, monitor, and strengthen health system resiliency and we stand ready to collaborate with OASH in this effort. In fact, we believe it is imperative that health-system pharmacy has a voice in any planning moving forward on this topic. We anticipate that there may need to be different definitions based on populations of patients, geographic regions, or healthcare settings, for example. Other countries considering health system resiliency have been mindful of areas that may be generalizable and those areas that require more context.
2. What key indicators or data sets are being used within your organization to assess health system resilience?
At present, there is not a single metric for determining resilience. We would like to partner with OASH and other policymakers to develop metrics that assess and monitor the areas we have highlighted above, including supply chain and clinician resilience. While capacity and outcomes might be partial metrics, there are other areas of hospital and health system practice that are not as readily quantifiable. It is difficult to determine, for instance, the general resilience of the drug supply chain. We offer as a potential solution to these barriers, several ASHP resources to use as a framework in which to approach metric development, including the ASHP Guidelines on Managing Shortages.5 Developing metrics based on recommendations from these resources enable a mechanism for assessment and monitoring, which will then inform efforts to improve the resiliency of the supply chain.
As a sponsoring member of the National Academy of Medicine Action Collaborative on Clinician Well-being and Resilience, we recommend consideration of the outputs from that effort. In particular, we recommend careful study of recommendations from the NAM Consensus Report, Taking Action against Clinician Burnout: A Systems Approach to Professional Well-Being for approaches to assess and monitor interventions aimed at improving well-being and resilience.6
- What private and public sectors should HHS engage as part of such a collaborative effort?
ASHP’s members have been on the frontlines of COVID-19 response, playing an essential role in maintaining patients’ access to high quality care. Our members are already planning for the next outbreak — whether it is a new wave of COVID-19 or a novel disease. ASHP applauds the Administration for taking steps to plan for future health emergencies and we encourage the creation of targeted public-private partnerships.
Specifically, in order to streamline critical public health information-sharing, ASHP and other similarly situated provider organizations should be included in the public-private partnership. Throughout COVID-19 response, ASHP, along with our partner provider associations, have been a critical source of information-sharing for federal health agencies. At the outset of the crisis, we flagged a number of high-risk areas, including medications at risk of shortage and lack of personal protective equipment (PPE) availability that proved prescient. We have continued to provide real-time updates to federal agencies and assisted in coordinating strategic national stockpile requests and identifying the regulatory flexibility necessary to ensuring adequate medication supply for COVID-19 treatment. Formal inclusion in a public-private partnership will streamline information-sharing, saving valuable time that was lost during COVID-19 because of difficulty identifying the correct points-of-contact for each agency.
We look forward to continuing to work with OASH and other policymakers to fight COVID-19. If you have questions or if ASHP can assist OASH in any way, please contact me at 301-664-8698 or email@example.com.
Jillanne Schulte Wall, J.D.
Senior Director, Health & Regulatory Policy
1 For more information about the wide array of ASHP activities and the many ways in which pharmacists advance healthcare, visit ASHP’s website, www.ashp.org , or its consumer website, www.SafeMedication.com.
2 ASHP Commitment Statement on Clinician Well-Being and Resilience, available at https://nam.edu/wp-content/uploads/2017/11/American-Society-of-Health-System-Pharmacists_Commitment-Statement.pdf . Accessed July 7, 2020.
3 See, e.g., ASHP, “Drug Shortages Roundtable Report” (2017), available at https://www.ashp.org/Drug-Shortages/Shortage-Resources/Roundtable-Report.
4 CMS. Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies. Final Rule. 84 FR 62568. November 15, 2019, available at: https://www.federalregister.gov/documents/2019/11/15/2019-24086/medicare-program-cy-2020-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other
5 Erin Fox and Milena McLaughlin, ASHP Guidelines for Managing Drug Product Shortages, Am. J. Health-Sys. Pharm. (Nov. 2018), available at https://academic.oup.com/ajhp/article/75/21/1742/5160014?searchresult=1.
6 National Academies of Science, Engineering, and Medicine, “Taking Action Against Clinician Burnout: A Systems Approach to Professional Well-Being” (2019), available at https://doi.org/10.17226/25521.