ASHP Submits Comments to Senate HELP Committee on the PREVENT Pandemic Act

Dear Chairwoman Murray and Ranking Member Burr,

Thank you for the opportunity to comment on the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act). As the healthcare community and policy makers continue to develop strategies to combat the ongoing pandemic and respond to future health threats, ASHP recognizes the many challenges associated with public health preparedness and response capabilities. As an organization, we greatly appreciate your leadership and the efforts of the Senate HELP Committee to address these issues and are grateful to be able to offer our suggestions on these policies.

ASHP is the collective voice of pharmacists who serve as patient care providers in hospitals, health systems, ambulatory clinics, and other healthcare settings spanning the full spectrum of medication use. The organization’s more than 60,000 members include pharmacists, student pharmacists, and pharmacy technicians. For 80 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety. For more information about the wide array of ASHP activities and the many ways in which pharmacists advance healthcare, visit ASHP’s website, ashp.org, or its consumer website, SafeMedication.com.

ASHP offers the following comments to this legislation:

Sections 101, 103

Throughout the pandemic, the U.S. Department of Health and Human Services (HHS) has utilized PREP Act authority to broaden patients’ access to an array of critical medical countermeasures from their pharmacist. However, in many instances the Centers for Medicare and Medicaid Services (CMS) did not establish a mechanism to enable reimbursement for pharmacist-led services delivered to Medicare enrollees, thereby limiting Medicare beneficiaries’ access to pharmacy-based clinical services. With that in mind, we request the following considerations:

• Section 101 – require the Task Force’s final report to include an evaluation of whether payment mechanisms are in place to support Medicare and Medicaid beneficiary access to services authorized by HHS under the PREP Act authority.
• Section 103 – require ASPR to coordinate with other HHS agencies to ensure payment mechanisms are in place to maximize patient access to services authorized under the PREP Act.

Section 112

ASHP asks that the report to congress include an assessment of whether the limitation on providers eligible to provide access to medications for opioid use disorder, imposed by the Federal X waiver program, limited access to MOUDs during the public health emergency, and provide a recommendation regarding whether MOUD access would improve if the X waiver requirement were eliminated. ASHP has long been a proponent of eliminating the X waiver, given its onerous requirements, and supports the Mainstreaming Addiction Treatment Act (H.R. 1384, S. 445)

Sections 201, 202

ASHP asks that the grantees and the National Academies evaluate which authorizations utilized under the recent PREP Act declaration were most effective at expanding access to care and reducing disparities in care, and to determine whether these authorizations should be made permanent and how they could have been more effective.

Through the PREP Act declaration, HHS authorized pharmacists to provide access to vaccinations, testing for COVID, flu, and RSV, and to order and administer COVID-19 therapeutics, including subcutaneous monoclonal antibodies. The PREP Act declaration allowing pharmacists to order and administer COVID-19 therapeutics significantly expands patient access to much needed treatments. Despite these benefits, however, CMS did not provide a payment mechanism for Medicare and Medicare beneficiaries to access those services. We ask that you address this issue.

Section 221

Pharmacists were and continue to be key frontline public health workers during the pandemic. ASHP asks the Committee to ensure that pharmacists are eligible for the loan repayment program for frontline workers.

Section 224

ASHP asks that pharmacy technicians are eligible to participate in the Volunteer Health Professionals Program.

Section 401 – 408

Warm Base Manufacturing Capacity - ASHP applauds the language encouraging warm base manufacturing capacity for medical countermeasures and encourage BARDA to incentivize advanced manufacturing technology and develop new continuous manufacturing technology for critical drugs and active pharmaceutical ingredients. We recommend BARDA and FDA strengthen our nation’s supply chain by incentivizing the development and use of advanced and continuous manufacturing technology for critical drugs and active pharmaceutical ingredients (APIs), including support for advanced manufacturing grant appropriations. Further, we recommend these technologies be adopted and implemented in both domestic and foreign manufacturing facilities. (This is a key element of the recommendations by ASHP, AMA, ASCO, ASA and USP to strengthen the US drug and medical device supply chain. The full set of coalition recommendations can be found here.

Improvements to the Strategic National Stockpile -The COVID-19 pandemic highlighted weaknesses in our supply chain, including difficulty accessing the Strategic National Stockpile (SNS), as well as deficiencies in the medications and devices included in the SNS. We recommend the following additional steps to improve the function, composition, and accessibility of the SNS during public health emergencies. (These recommendations reflect the consensus of a coalition of healthcare provider organizations, including ASHP, AMA, ASCO, ASA, and USP, that partnered to identify opportunities to improve the functioning of the SNS.)

• Finalize and regularly update a list of medicines and devices necessary to respond to potential national-scale public health emergencies, which should be included in the SNS. These drugs may differ from those on the essential medicines list.
• Increase transparency regarding the specific products and quantities of such products included in the SNS.
• Add monoclonal antibodies for known pathogens to SNS and expand SNS scope for biological attacks to include pandemic preparedness and response.
• Incentivize the creation of private-sector reserves of essential medicines, medical devices, and supplies not adequately provided by the SNS:
  • Implement systems to help facilitate the communication of inventory and availability in geographic regions so that facilities can share inventory when necessary and able.
  • Consider expansion of the Hospital Preparedness Program;
  • Ensure physician offices, nursing homes, ambulatory surgical centers, dialysis providers, and other non-hospital settings are included in communication and distribution programs;
  • Use data from wholesalers and distributors to forecast supply, rather than requiring regular hospital inventorying of drugs, devices, and personal protective equipment (PPE).
• Implement enhancements to the Office of the Assistant Secretary for Preparedness and Response (ASPR) SNS Control Tower – a program ASPR defines as providing data from commercial partners across PPE categories and pharmaceuticals to help federal response officials with understanding supply and demand in emergencies and with decision-making on when and where to deploy SNS supplies:
  • Improve control tower visibility in the supply chain, including the upstream supply chain:
    • Upstream refers to processes that occur prior to the finished product, such as securing APIs, excipients, raw material, components, parts or accessories, and other starting materials.
    • Expand control tower scope beyond the current 38 pharmaceutical products to additional critical medicines, including all medicines, medical devices, and PPE. The control tower would be responsible for monitoring the supply chain, proactively identifying medical products at risk of shortage, and identifying solutions, and tracking the return on U.S. government investments in improving the resiliency of the supply chain.
• Create a workable process for SNS requests:
  • Establish a process for planned non-emergency distributions from SNS to medical facilities of medications and devices prior to their expiration dates at discounted prices to promote practiced workflows and decrease wastage of expired and obsolete products.
  • Publish a clear, nationally consistent process for making requests from the SNS, including publication of contact information for key personnel in each agency that has responsibility for managing requests and distributions from the SNS.
  • Engage pharmacists, physicians, other clinicians, and supply chain experts to develop processes for maintaining and refreshing products in the SNS.
  • Create a standard distribution logistics process for medications, devices, and related supplies from the SNS, which incorporates feedback from clinicians and supply chain experts, including clear expectations for how updates to these processes will be publicized, if needed, in the event of a national emergency.
  • Publish criteria, including an overarching organizational strategy, which will be used to prioritize distribution of products from the SNS, including clear expectations for how updates to these criteria will be publicized, if needed, under both normal operations and in the event of a national emergency.

Section 410

ASHP applauds the creation of a pilot to support state-based stockpiles of medical supplies needed to respond to a public health emergency. ASHP asks the Committee to consider:

• Establishing a mechanism to support private sector stockpiling of needed medical supplies as described above.
• Incentivizing medical supply and pharmaceutical distributors to manage both “private sector-owned” medical materiel (just-in-time for normal operations) and government-owned/distributor-managed emergency stockpiles (just-in-case for emergencies) that can flow into the private sector supply chain when release of government-owned materiel during public health emergencies, disasters, or contingencies is authorized.
• Requiring the development of critical pharmaceutical and medical supply requirement listings based on a national hazard vulnerability assessment to guide the composition of government and distributor-managed emergency stockpiles.

Sections 511, 513

ASHP strongly supports the sections regarding registration and inspection of foreign drug and device establishments.

Section 512

ASHP strongly supports Section 512 regarding extension of expiration dates for certain drugs.

Sections 515-517

ASHP strongly supports Sections 515-517 extending supply chain requirements to medical devices. These provisions are consistent with the recommendations of ASHP and other healthcare providers including AMA, ASCO, ASA, and USP. We also encourage the Committee include two additional provisions to improve drug supply chain resilience, consistent with recommendations of ASHP, AMA, ASCO, ASA and USP:

• Improve multinational cooperation on supply chain resilience: We recommend regulatory and legislative actions that increase the overall resilience of the United States supply chain by enhancing international cooperation and collaboration with foreign supply chain partners, including but not limited to foreign governments and manufacturers.
  • Enhance support for innovation and public-private partnerships for research, development, and deployment of effective and affordable disease tracking tools, diagnostics, therapeutics, and vaccines;
  • Advance and support intergovernmental, regulatory and private sector partnerships:
    • Such partnerships would advance research, development, and deployment of effective infectious disease tracking tools, diagnostics, therapeutics, and vaccines, including by establishing and leveraging public-private partnerships and supporting advance purchase agreements, as necessary and appropriate; improve infection control within healthcare settings; combat the threat of antimicrobial resistance; expand lab capacity through the provision of material and technical assistance.
• Incentivize quality and resilience: We recommend regulatory and legislative action that creates incentives for manufacturers to improve drug and device manufacturing quality. Further, we recommend that policy solutions are focused on outcomes that improve the overall resilience of our nation’s medication and device supply chains.
  • Require the Food and Drug Administration (FDA) to provide ratings of the quality management processes of medication and device manufacturers that are predictive of supply chain and manufacturing vulnerabilities and to make the ratings publicly available.
  • Identify key starting materials, active pharmaceutical ingredients, and finished dosage forms of essential medicines, including vaccines, that should have domestic manufacturing capacity to improve the resilience of the U.S. drug supply, and incentivize their production without limiting access to foreign sources of the product. A fact-based approach should be used to decide what drug products and ingredients need to be on-shored.
  • Reduce instances of contamination in finished drug products.

ASHP appreciates the opportunity to provide feedback on the discussion draft addressing pandemic and public health preparedness and response. We look forward to continuing to work with the Committee on this issue. Please contact myself, Tom Kraus at [email protected], or Doug Huynh at [email protected], if you have any questions or if we can provide any additional information.

Sincerely,

Tom Kraus
VP, Government Relations
ASHP (American Society of Health-System Pharmacists)