PCORI Biweekly COVID-19 Scan: Telehealth Utilization and Reimbursements, Sanofi-GSK Booster Vaccine (June 23-July 6, 2022)
The Briefing provides an at-a-glance view of some important developments in the information universe surrounding COVID-19. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.
The National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) Tech program has initiated a faster genotyping method for SARS-CoV-2 variant detection that might supplement next generation sequencing of virus samples. The data are available on a free dashboard and the materials needed to reproduce the method are detailed in a free, peer-reviewed paper so that other public and private labs can make use of the technique.
Tracking variants is crucial to decisions regarding future vaccine formulations, and the recent FDA Vaccines and Related Biological Products Advisory Committee meeting recommended the use of bivalent vaccines that also target the BA.4 and BA.5 subvariants of Omicron (see Topics to Watch for a booster that addresses the Beta and Omicron variant). Looking ahead, Pfizer and BioNTech announced that they, too, are investigating a next generation, pan-coronavirus shot, and will join Moderna and others to develop a pipeline of potentially variant-proof vaccines.
ECRI Horizon Scanning has selected the topics below as those with potential for impact relative to COVID-19 in the United States within the next 12 months. All views presented are preliminary and based on readily available information at the time of writing.
Because these topics are rapidly developing, we cannot guarantee the accuracy of this information after the date listed on this publication. In addition, all views expressed in the commentary section are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders. Topics are listed in alphabetical order.
Extension of Regulatory Flexibilities for Telehealth Utilization and Reimbursement Beyond the COVID-19 Pandemic
At a Glance
- Before the COVID-19 pandemic, telehealth utilization and reimbursement were limited to specific zip codes, health care settings, and technologic modalities (e.g., audio-only services were generally not covered).
- As a result of loosened restrictions on telehealth, the provision and utilization of health care services for Medicare and Medicaid beneficiaries using telehealth increased during the pandemic. Federal and state regulations are now covering some costs of telehealth services beyond the duration of the COVID-19 pandemic.
- Federal extensions include an additional year of Medicaid funding through the American Rescue Plan Act, through March 31, 2025, and an additional 5 months of Medicare reimbursement after the end of the public health emergency, through the Consolidated Appropriations Act, 2022.
- States’ legislations include the H 654 VT 2021-2022, extending regulatory flexibilities in the state of Vermont through June 2023, and others.
Before the COVID-19 pandemic, telehealth utilization and reimbursement were limited to specific zip codes, health care settings, and technologic modalities (e.g., audio-only services were generally not covered). Federal and state laws expanding telehealth utilization and reimbursement, initially intended for the duration of the COVID-19 public health emergency, are now being extended to promote telehealth utilization beyond the COVID-19 pandemic.
In December 2020, the Centers for Medicare & Medicaid Services (CMS) added 144 telehealth services through the end of the COVID-19 public health emergency. With this expansion, a US Department of Health and Human Services (HHS) study found that Medicare beneficiaries increasingly used telehealth services during the COVID-19 pandemic; the number of telehealth visits (including in-home and audio-only visits) increased from 840,000 in 2019 to 52.7 million in 2020, and behavioral health providers saw the largest increase in telehealth utilization compared with other providers.
Originally slated to end in March 2024, the HHS announced in June 2022 that extended funding would be available through the American Rescue Plan Act for another year, making it accessible until March 31, 2025. This allows states to continue expanding and strengthening home and community-based services for people with Medicaid. Another regulation, the Consolidated Appropriations Act, 2022, expanded telehealth flexibilities for people on Medicare for an additional 5 months after the end of the COVID-19 public health emergency. These flexibilities include cross-state licensing, which would enable more providers to be reimbursed for telehealth services, and they would allow the location of the initial visit to be a home setting. Additionally, the 2022 CMS Physician Fee Schedule stated that certain telehealth services (e.g., physical and occupational therapy, emergency department visits, among others) will remain on the list until December 2023.
Extending telehealth utilization and reimbursement flexibilities beyond the COVID-19 pandemic might allow health care providers to continue to deliver timely care postpandemic, especially for people at an increased risk of severe illness, such as the elderly or those who need long-term care, and might have longer-term structural impacts on the health and well-being of the population.
Early feedback from ECRI internal stakeholders suggested that initial expansion of telehealth services during the COVID-19 pandemic had beneficial effects such as: improved access to health care (including mental health counseling); the ability for patients to remotely participate in clinical trials; and evidence for the continued use of telehealth by patients experiencing debilitating conditions. Remote evaluations might improve health outcomes particularly for patients with compromised immune systems whose in-person appointments could be delayed. These telehealth appointments might allow patients access to specialists outside of their geographic area, and better facilitate timely medication adjustments. Obtaining care using telemedicine might be easier than finding transportation to a health care facility for similar clinical interactions. Additionally, it might be less resource- and time-intensive for clinicians.
However, stakeholders expressed concerns that the 5-month extension for the use of telehealth services for patients with Medicare might be insufficient to produce lasting improvements to health outcomes or health care delivery. It might also limit responses to new COVID variants and other public health threats.
- Categories: Systems and Management
- Areas of potential impact: Patient outcomes, population health, clinician and/or caregiver safety, health care delivery and process, health care disparities, health care costs, protected health information security
Sanofi-GSK Next-generation Booster Vaccine to Prevent COVID-19
At a Glance
- Waning efficacy is seen in the months after vaccination with available COVID-19 vaccines despite booster doses. The FDA recently announced it advises manufacturers to add an Omicron-variant-specific component to their booster vaccines, with the aim of having updated vaccines ready for fall 2022.
- Sanofi and GSK have collaborated to develop a “next generation” COVID-19 vaccine that generates antibodies to target the spike proteins of the original virus, plus the Beta and Omicron variants to prevent COVID-19.
- Preliminary data from phase 2/3 and phase 3 trials suggest the vaccine, given as a booster, significantly increased the number of neutralizing antibodies against multiple SARS-CoV-2 variants, including Omicron, compared with available vaccine boosters.
- The companies are planning to submit the clinical trial data to regulatory authorities, with the aim of making the booster vaccine available later this year.
COVID-19 vaccine efficacy significantly decreases in the months following vaccination, even after a booster dose. On June 30, 2022, the FDA advised manufacturers to add an Omicron variant spike protein component to their current booster vaccine composition, with the aim of having modified bivalent booster vaccines ready for use by early to mid-fall 2022.
Sanofi (Bridgewater, NJ) and GSK plc (Brentford, United Kingdom) are developing one such next-generation booster – an adjuvanted vaccine containing recombinant spike protein modeled on the Beta SARS-CoV-2 variant and the original, parental D614 form. Thus, it might target both the Beta variant and the original strain, while potentially increasing protection against other variants, including Omicron. The vaccine is being investigated for use as a single booster dose in a developer-sponsored phase 2/3 trial and an independent phase 3 trial.
Preliminary data from the trials reported in June 2022 suggest the vaccine is effective in increasing antibody titers against multiple SARS-CoV-2 variants. In the phase 2/3 trial, the Sanofi-GSK vaccine doubled the number of neutralizing antibodies against Omicron BA.1 and BA.2 compared with the parent D614-based booster. In the phase 3 trial enrolling 247 participants previously vaccinated with an mRNA COVID-19 vaccine, the next-generation booster produced a 10-fold increase in neutralizing antibody titers against the original D614 strain in 76.1% of patients who received the Sanofi-GSK vaccine and in 63.2% of patients who received the Pfizer BioNTech parent D614 booster. The developers intend to submit this data to regulatory authorities in the upcoming weeks, aiming to make it available later this year. The Sanofi-GSK vaccine is also being developed as a primary vaccination against COVID-19, although the FDA has advised manufacturers not to change the formulation for primary vaccination at this time. The next-generation booster vaccine was found to have a favorable safety and tolerability profile, with few (less than 4%) grade 3 reactions being reported.
We were unable to find information regarding the potential cost of the Sanofi-GSK vaccine. COVID-19 vaccines are currently free to all eligible individuals, paid for by the federal government.
Waning efficacy of available COVID-19 vaccines against SARS-CoV-2 variants with mutated spike proteins highlights a need for updated “next-generation” COVID-19 vaccines.
Early feedback from ECRI internal stakeholders suggested that, if effective, the next-generation booster vaccine might impact population health outcomes, especially for individuals at increased risk of severe COVID-19 and those with complications (e.g., elderly persons, patients undergoing treatment for cancer or autoimmune disease), although this impact might be marginal compared with additional conventional boosters. Newer, emerging variants might also challenge the next-generation booster vaccine’s efficacy.
Given that COVID-19 vaccine administration and distribution infrastructure and guidelines are already in place, the Sanofi-GSK next-generation booster vaccine might cause only minor disruption to the US health care delivery system. Many people who previously chose to be vaccinated against COVID-19 are likely to want this booster, which might significantly increase health care costs for the payer (currently, the federal government).
Disparities in access to the new vaccine might occur for certain individuals due to geographical constraints.
- Categories: Vaccines and Prophylaxis
- Areas of potential impact: Patient health outcomes, population health outcomes, health disparities
Horizon scanning is a systematic process that serves as an early warning system to inform decision makers about possible future opportunities and threats. Health care horizon scanning identifies technologies, innovations, and trends with potential to cause future shifts or disruptions—positive or negative—in areas such as access to care, care delivery processes, care setting, costs of care, current treatment models or paradigms, health disparities, health care infrastructure, public health, and patient health outcomes.
The PCORI Health Care Horizon Scanning System (HCHSS) conducts horizon scanning to better inform its patient-centered outcomes research investments. Initially, PCORI defined the HCHSS project scope to focus on interventions with high potential for disruption in the United States in 5 priority areas: Alzheimer’s disease and other dementias, cancer, cardiovascular diseases, mental and behavioral health conditions, and rare diseases. In addition, the system captures high-level disruptive trends across all clinical areas, which may lead PCORI to expand the project scope to include other priority areas in the future.
In early 2020, the COVID-19 pandemic created a fast-moving, widespread public health crisis. In May 2020, PCORI expanded its HCHSS to elucidate the landscape of potentially impactful applications for COVID-19. The HCHSS COVID-19 supplement scans for, identifies, monitors, and reports on emerging and available COVID-19-related treatments, diagnostics, preventive measures, management strategies, and systems changes with potential for high impact to patient outcomes—for individuals and populations—in the United States in the next 12 months.
The HCHSS COVID-19 supplement produces 3 main outputs:
- Biweekly COVID-19 Scans (eg, this document) provide ECRI Horizon Scanning with a vehicle to inform PCORI and the public in a timely manner of important topics of interest identified during ongoing scanning and topic identification or through the ECRI stakeholder survey process.
- Status Reports (quarterly) briefly list and describe all COVID-19-related topics identified, monitored, and recently archived.
- High Impact Reports (every 4 months) highlight those topics that ECRI internal stakeholders (eg, physicians, nurses, allied health professionals, public health professionals, first responders, health systems experts, clinical engineers, researchers, business and finance professionals, and information technology professionals) have identified as having potential for high impact relative to COVID-19 in the United States.
In May 2021, the COVID-19 supplement was modified and merged with the HCHSS. The Biweekly COVID-19 Scans continue, while the Status Reports and High Impact Reports were folded into the PCORI Horizon Scanning Database and High Potential Disruption Reports.
Commentary in this COVID-19 Scan reflects preliminary views of ECRI Horizon Scanning and internal ECRI stakeholders.
The information contained in this document has not been vetted by other stakeholders.
We welcome your comments on this Scan. Send them by email to [email protected].
Posted: July 13, 2022
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