The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, September 9. Some of the language used below is taken directly from government documents.
The White House
- The White House has issued a fact sheet outlining how the administration plans to improve the country’s readiness for future pandemics. The major elements of the plan are transforming medical defenses, ensuring situational awareness, strengthening public health systems, building core capabilities, and managing the mission.
- The White House has posted a transcript of the September 2 press briefing given by its COVID-19 response team and public health officials. Find the slides presented during the briefing here.
- Democrats on the House Energy and Commerce Committee today introduced their contribution to their party’s anticipated $3.5 trillion dollar spending bill. Their portion of the reconciliation bill addresses expanding Medicaid in non-expansion states, reducing prescription drug prices, increasing federal spending on home-based care, and more. Find their summary of their proposals here.
Provider Relief Fund
- HHS’s Human Resources and Services Administration (HRSA) has published a notice explaining how Provider Relief Fund payments can be used for a wide variety of direct and indirect costs of recruiting and retaining personnel during the COVID-19 emergency. Find the notice here.
- With the next deadline for health care providers to report on their use of Provider Relief Fund grants coming up on September 30, HRSA will hold an “office hours” web event on Friday, September 10 at 1:00 (eastern) to address issues involving Provider Relief Fund reporting and auditing requirements. For information about how to join the event and more about reporting and auditing requirements, go here.
Department of Health and Human Services
- HHS Secretary Xavier Becerra has released a new plan to reduce prescription drug prices. One of the key policies in this effort is legislation that would enable the Secretary of HHS to negotiate Medicare Part B and Part D drug prices directly with pharmaceutical companies and make those prices available to other purchasers. Learn more about this plan from the HHS announcement, an HHS fact sheet, and the full plan.
- The Office of the Assistant Secretary for Preparedness and Response has announced a new Notice of Funding Opportunity to establish Partnership(s) for Enhanced Efforts To Strengthen The Nation’s Healthcare And Public Health Preparedness, Response, And Recovery To Disasters And Other Emergencies. This program seeks to fund up to seven new cooperative agreements to enable the agency’s broad collaboration with public health and health care sectors and emergency management services to ensure that local governments, communities, private sector entities, non-governmental organizations, academia, and individuals can optimally coordinate their respective national health security roles and responsibilities to achieve community health resilience and strengthen health care, public health, and emergency management systems in preparation of, response to, and recovery from disasters and other emergencies. $20 million in grants will be awarded, with a maximum grant of $4 million. The deadline for applications is September 22.
- HHS’s Office of the Assistant Secretary for Planning and Readiness has updated its information on planning considerations for the administration of monoclonal antibodies. Find the updated information here.
- The Office of the Assistant Secretary for Planning and Readiness has published guidance to hospitals on how to address a surge of patients with behavioral health challenges during the COVID-19 pandemic.
- HHS’s Office of the Inspector General has published a report that describes the complex care needs of beneficiaries hospitalized with COVID-19. The report focuses on surges in COVID-19 hospitalizations in six localities and builds upon prior OIG work that describes the extent to which hospitals have been strained by COVID-19. Find the report here.
- Another report by HHS’s OIG found that the COVID-19 case and death data submitted by nursing homes to the federal government is incomplete and inaccurate despite CMS’s efforts to require such data reporting weekly. Find the report here.
Centers for Medicare & Medicaid Services
Health Policy News
- CMS has posted two new editions of MLN Connects, its online newsletter. Subjects addressed in the September 2 edition include changes in Medicare provider enrollment processes, information about CMS’s planned implementation of its ambulance prior authorization model, the hospice quality reporting program, and more. Go here to see the September 2 edition of MLN Connects.
- The September 9 edition of MLN Connects includes information about a payment update on outpatient clinic visit services at excepted off-campus provider-based departments, the Medicare fee-for-service response to the COVID-19 emergency, skilled nursing facility consolidated billing web-based training, and more. Find the September 9 edition of MLN Connects here.
- CMS is distributing $452 million in federal funding to support 13 states’ efforts to improve access to affordable, comprehensive health insurance coverage through section 1332 state-based reinsurance waivers. As a result of changes made in the American Rescue Plan Act of 2021, residents in states implementing reinsurance waivers may have access to more affordable health insurance coverage. States also will have more pass-through funding to implement their waiver. Learn more about the funding, how it will be used, and which states will receive it in this HHS news release.
- CMS’s Center for Medicare and Medicaid Innovation has posted the annual report for its Comprehensive Care for Joint Replacement Model. Go here to see the annual report and here for more information about and resources for the program.
Centers for Disease Control and Prevention
- The CDC and AmeriCorps have launched Public Health AmeriCorps, a new partnership to support the recruitment, training, and development of a new generation of public health leaders who will be ready to respond to the nation’s public health needs. The program, which is supported by $400 million from the American Rescue Plan Act, is anticipated to fund up to 5,000 AmeriCorps positions over the next five years. Learn more about the program from this CDC news release and this notice about the funding opportunities it offers. The deadline for funding applications is November 8.
- The CDC has awarded more than $116 million in year one of a three-year, $348 million program to organizations for community health worker services to support COVID-19 prevention and control. Learn more about the purpose of the funding and find a link to a list of recipients in this CDC announcement.
- CDC Director Rochelle P. Walensky, M.D., M.P.H. has endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for use of the Pfizer-BioNTech’s licensed vaccine for people 16 and older. Read her statement.
- The CDC has published research on the association between COVID-19 and cases of myocarditis from March 2020 to January 2021. Go here to see the CDC report.
- The CDC has updated its tips for caregivers for talking to patients with intellectual and developmental disabilities about COVID-19 vaccines. It also announced that it will launch special COVID-19 resources for people with intellectual and developmental disabilities.
- The CDC has updated its information about allergic reactions to COVID-19 vaccines.
- The CDC has updated its information about COVID-19 booster shots.
- The CDC has updated its information for people who received one dose of the Pfizer or Moderna vaccine about getting a second dose of those vaccines.
- The CDC has updated its guidance for people who are fully vaccinated against COVID-19.
- The CDC has updated its information on caring for patients experiencing post-COVID-19 medical problems.
- The CDC has published research on long-term symptoms among adults tested for COVID-19.
- The CDC has posted resources on three aspects of COVID-19 among children and adolescents: data on hospitalizations associated with COVID-19, emergency department visits and admissions for COVID-19, and a collection of pediatric data.
- The CDC has updated its information about COVID-19 variants.
- The CDC has updated its FAQs on COVID-19 vaccines.
Food and Drug Administration
- The FDA has revised its guidance on the authorized use of the monoclonal antibodies bamlanivimab and etesevimab when administered together. The Emergency Use Authorization now authorizes the use of bamlanivimab and etesevimab, administered together, only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to five percent. The FDA has posted a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together are currently authorized and a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together, are not currently authorized and will periodically update both lists as new data becomes available.
- The FDA has posted a letter to veterinarians and retailers informing them of the danger of treating people for COVID-19 with animal ivermectin.
- The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on September 17 to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (booster) dose of the Pfizer vaccine to individuals 16 years of age and older. Learn more here.
National Institutes of Health
- An investigational HIV vaccine tested in a clinical trial co-sponsored by the NIH posed no safety concerns but did not provide sufficient protection against HIV infection among women, according to a preliminary analysis of the study data. Learn more from this NIH news release.
Medicare Payment Advisory Commission (MedPAC)
- MedPAC has written to CMS to convey its views on CMS’s proposed physician fee schedule and changes to Medicare Part B regulation. Find its letter here.
- MedPAC’s commissioners met last week for two days to discuss Medicare payment issues. During the meetings MedPAC addressed the following issues:
- The effects of the COVID-19 emergency and considerations on MedPAC’s 2022 assessment of Medicare payment adequacy.
- Potential reforms of the Part D low-income premium subsidy.
- A report on designing a value incentive program for post-acute care.
- A report on the impact of Bipartisan Budget Act of 2018 changes to the home health prospective payment system.
Medicaid and CHIP Payment and Access Commission (MACPAC)
- MACPAC has published two new reports: Access in Brief: Health Care Needs of Adults
Involved with the Criminal Justice System and Value-Based Payment for Maternity Care in Medicaid: Findings from Five States.
American Medical Association
- The AMA has announced eight new CPT codes for COVID-19 vaccine administration. Learn more from this AMA notice.
- The AMA has issued its annual update of CPT codes. The update includes 405 editorial changes, including 249 new codes, 63 deletions, and 93 revisions. Learn more from this AMA news release.
FDA – Workshop Addressing Response to the Opioid Crisis – October 13
The FDA will hold a workshop entitled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS)” to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS effort. The public workshop will be held on October 13 from 1 p.m. to 5 p.m. (eastern) and October 14 from 1 p.m. to 4:05 p.m. For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.