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Federal Health Policy Update for Friday, May 14

The following is the latest health policy news from the federal government as of 2:30 p.m. on Friday, May 14.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • NASH has written to Health and Human Services Secretary Xavier Becerra to urge his department to apply more appropriate criteria and a better methodology for calculating payments in all future Provider Relief Fund distributions.  Learn more from NASH’s letter to HHS Secretary Becerra.

The CDC and Mask Guidance

The White House

COVID-19

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has released data highlighting the continued impact of the COVID-19 emergency on Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries and their utilization of health care services.  The data show that from March through October 2020, beneficiaries skipped millions of primary, preventive, and mental health care visits due to COVID-19 in comparison to the same time period in 2019.  Although utilization rates for some treatments have rebounded to pre-pandemic levels, mental health services show the slowest rebound.  Learn more from the following resources:

Health Policy News

  • CMS has issued guidance to states on how they can receive enhanced American Rescue Plan funding to increase access to home and community-based services (HCBS) for Medicaid beneficiaries.  This guidance seeks to assist states with leveraging federal resources to increase health equity in Medicaid beneficiaries’ access to HCBS, positive health outcomes, and community integration.  Those resources include a one-year increase of 10 percent in federal Medicaid matching money for such expenditures.  The guidance was issued to states through a CMS letter to state Medicaid directors.  Go here to see CMS’s announcement about the enhanced HCBS funding and go here to see the CMS letter to state Medicaid directors.

Centers for Disease Control and Prevention

COVID-19

FEMA

Federal Health Policy Update for Wednesday, May 12

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, May 12.  Some of the language used below is taken directly from government documents.

The White House

COVID-19

  • The White House has announced additional efforts to encourage people to get vaccinated against COVID-19, including free rides to vaccination sites from Lyft and Uber, vaccination clinics at community colleges, and additional resources for states’ community outreach efforts.  This will include funding for FEMA for phone banks, door-to-door canvassing, and pop-up vaccination clinics in workplaces and churches.  See the White House fact sheet for additional information.

Department of Health and Human Services

COVID-19

  • HHS has awarded $40 million in American Rescue Plan funds to support emergency home visiting assistance for families affected by the COVID-19 pandemic.  These funds will be used to provide services and emergency supplies, such as diapers, food, water, and hand sanitizer.  Families that cannot gain access to home visiting services due to the pandemic will be provided technology to participate in virtual home visits.  Funds, which will be administered through HHS’s Maternal, Infant, and Early Childhood Home Visiting Program, also will be used to train home visitors on emergency preparedness and response planning for families and on how to safely conduct virtual intimate partner violence screenings.  Learn more about the new funding and how it will be used in this HHS announcement.

Health Policy News

  • The Senate has confirmed the nomination of Andrea Palm to serve as Deputy Secretary of HHS by a vote of 61 to 37 and she has already been sworn into office.  It is the number two position in the department.  Most recently, Palm led Wisconsin’s Department of Health Services.  Previously, she served in the Obama administration as HHS’s chief of staff and as a policy advisor to the White House Domestic Policy Council.
  • The Senate held a procedural vote on Wednesday that advanced the nomination of Chiquita Brooks-LaSure to become CMS administrator.  Another procedural vote will be needed before a final confirmation vote, but confirmation is expected this month.
  • HHS’s Agency for Healthcare Research and Quality (AHRQ) has issued a request for nominees to serve on its Initial Review Group, which is responsible for the scientific peer review of AHRQ grant applications.  The group conducts scientific and technical review for health services research grant applications.  Nominations are due by June 1.  Learn more from the Federal Register notice.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has published an interim final rule with comment period establishing long-term-care facility vaccine immunization requirements for residents and staff.  This includes new requirements for educating residents or resident representatives and staff about the benefits and potential side effects of COVID-19 and offering the vaccine.  It also requires long-term-care facilities to report COVID-19 vaccine and treatment data to the CDC’s National Health Safety Network.  Learn more from the following resources:

Health Policy News

CMS has posted the latest edition of its online publication MLN Connects.  Among items of interest in this edition are:

  • Medicare Shared Savings Program Application:  NOIA Opens June 1
  • IRF Quality Reporting Program:  Achieving a Full AIF Webinar — May 19
  • Medicare Shared Savings Program:  Establishing a Repayment Mechanism Webcast — May 27
  • The Fiscal Year (FY) 2021 Skilled Nursing Facility (SNF) PC Pricer is now available.

Go here for links to these and other items.

Food and Drug Administration

COVID-19

  • The FDA has authorized the use of the Pfizer COVID-19 vaccine for emergency use in adolescents between the ages of 12 and 15; it was already authorized for use among older teenagers.  See the FDA’s announcement of this authorization and its letter of authorization here.
  • In light of this new authorization, the FDA has updated its fact sheet for health care providers for administering the COVID-19 vaccine; its fact sheet for recipients and caregivers; and its FAQ on the Pfizer vaccine.

Centers for Disease Control and Prevention

COVID-19

Stakeholder Events

Thursday, May 13

CMS and the CDC – Nursing Homes

Thursday, May 13 at 4:00 p.m. (eastern)

CMS and the CDC will host a national nursing home stakeholder call.  Register here.

Federal Health Policy Update for Wednesday, May 5

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, May 5.  Some of the language used below is taken directly from government documents.

The White House

COVID-19

Department of Health and Human Services

COVID-19

  • HHS has created a web page for its new COVID-19 Coverage Assistance Fund through which providers can be reimbursed for the cost of administering COVID-19 vaccines to the uninsured and to those whose health insurance requires a co-pay for vaccinations.  This web page offers information about how the program works and how providers can submit claims for reimbursement.
  • To support the launch of this new COVID-19 Coverage Assistance Fund, HHS will hold a webinar on Thursday, May 6 at 2:00 p.m. (eastern) to introduce stakeholders to what the program will do and how it will work.  Go here for further information and to register to participate.
  • HHS has announced the availability of $250 million in American Rescue Plan funds to develop and support a community-based workforce that will share information about vaccines, increase COVID-19 vaccine confidence, and address barriers to vaccination for individuals living in vulnerable and medically underserved communities.  For the first funding opportunity, released today, approximately 10 award recipients will be funded to engage with multiple organizations regionally and locally, including with community-based organizations, health centers, minority-serving institutions, and other health and social service entities.  The second funding opportunity will be released in the near future and will focus on smaller community-based organizations.  To learn more about program eligibility and to apply for funding, visit Grants.gov.  Applications are due May 18, 2021.  See HHS’s announcement about the new program.
  • HHS and its Health Resources and Services Administration (HRSA) have announced the availability of $1 billion in American Rescue Plan funds to strengthen COVID-19 response efforts and increase vaccinations in rural communities.  HRSA’s Rural Health Clinic COVID-19 Testing and Mitigation Program will provide $460 million to more than 4,600 rural health clinics (RHCs) to maintain and increase COVID-19 testing, expand access to testing for rural residents, and broaden efforts to mitigate the spread of the virus in ways tailored to their local communities.  HRSA will provide up to $100,000 per RHC-certified clinic site.  In addition, HRSA will provide $398 million to existing grantees of the Small Rural Hospital Improvement Program to work with approximately 1,730 small rural hospitals and critical access hospitals on COVID-19 testing and mitigation, with funding to be used to support all eligible rural hospitals, up to $230,000 per hospital.  Finally, through its Rural Health Clinic Vaccine Confidence Program, HRSA will make nearly $100 million available in grants to eligible RHCs nation-wide to address health equity gaps by offering support and resources to medically underserved rural communities where COVID-19 vaccine uptake lags.  HRSA will fund all eligible RHCs that apply.  Learn more from this announcement about the new funding.
  • HHS’s Office of the Inspector General has updated its FAQ outlining situations in which it is willing to exercise its discretion in the enforcement of existing guidelines in support of the flexibility needed to respond effectively to the COVID-19 emergency.  See the updated FAQs here.

Health Policy News

  • The administration announced that HHS and its Administration for Community Living will spend $1.4 billion in American Rescue Plan money to address a variety of needs of older Americans.  Among its uses will be $460 million for home and community-based services; $44 million for evidence-based health promotion and disease prevention; $145 million to help family caregivers support their loved ones; and $10 million to safeguard the health and welfare of residents of long-term-care facilities.  Learn more from this fact sheet.
  • HHS has issued a request for nominations to the Advisory Council on Alzheimer’s Research, Care, and Services.  Nominations are due May 31.  See the Federal Register announcement for additional information.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has issued a new waiver for treatment in place for ground ambulance services during the COVID-19 public health emergency and has posted a fact sheet on this waiver.
  • In support of this new waiver CMS has updated its document “COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing” with revised questions on pages 50 and 51 and new questions on pages 55-60 for ground ambulance providers.  All result from a provision in the American Rescue Plan that established circumstances under which Medicare may reimburse providers for a service that did not arise during a community-wide emergency medical service but that instead is a result of the COVID-19 emergency.  Go here to see the new and revised questions.

Centers for Disease Control and Prevention

COVID-19

Medicaid and CHIP Payment and Access Commission

  • MACPAC has published a new report titled Examining the Potential for Additional Re-balancing of Long-Term Services and Supports.  Find it here.

American Medical Association

  • The AMA has updated its Current Procedural Code (CPT) code sets to include new vaccine and administration codes for the COVID-19 vaccine currently being developed by the company Novavax.  This vaccine has not yet been approved for use.  Learn more from an AMA news release.

Stakeholder Events

Friday, May 7
FDA
Common Labeling Deficiencies and Tips for Generic Drug Applications
Friday, May 7 at 1:00pm – 2:00pm ET.  Click here for connection information.
The FDA will discuss the most common labeling mistakes found in abbreviated new drug applications (ANDAs) and how to avoid them and offer other labeling tips.  The FDA also will provide answers to common labeling questions asked by generic drug applicants.

Wednesday, May 12
Cybersecurity and Infrastructure Security Agency (CISA)

CISA 2021 Hurricane Webinar
Wednesday, May 12 at 10:30 am – 12:00pm ET.  Click here for registration.

This webinar will focus on providing awareness of CISA’s role and resources in hurricane preparedness and response activities associated with systems that make landfall on the continental U.S. or U.S. territories while in a COVID-19 environment.  It will also feature presentations from the NOAA Liaison to the National Operations Center and FEMA’s National Business Emergency Operations Center.

Wednesday, May 12

HHS Office of the Assistant Secretary for Preparedness and Response – Vaccine Promotion

Wednesday, May 12 at 1:30 pm ET.  Click here for further information and registration.

Speakers will discuss a New York City initiative dedicated to building confidence in COVID-19 vaccines; provide information about the current FDA-authorized COVID-19 vaccines and their safety and effectiveness; and share effective communication strategies to encourage friends, family, colleagues, and the community to get vaccinated.  The webinar will share additional educational resources and tools developed by local health care partners and there will be time for participant Q&A.

Federal Health Policy Update for Tuesday, April 20

The following is the latest health policy news from the federal government as of 3:00 p.m. on Tuesday, April 20.

Congress

  • This afternoon Senator John Cornyn (R-TX) put a hold on the president’s nomination of Chiquita Brooks-LaSure to be CMS administrator in response to the administration’s decision to revoke a Medicaid waiver the previous administration granted to his state.

The White House

COVID-19

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has issued section 1135 waivers to Colorado, Maine, and Tennessee.  1135 waivers give states greater flexibility to serve their Medicaid beneficiaries during the COVID-19 public health emergency.

Department of Health and Human Services

COVID-19

Food and Drug Administration

COVID-19

  • The FDA has revoked its emergency use authorization that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used to treat mild to moderate COVID-19 in adults and certain pediatric patients.  Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of COVID-19 variants that are resistant to bamlanivimab alone resulting in an increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use.  For additional information, see the following resources:
  • The FDA has authorized an amendment for many authorized COVID-19 tests that permits emergency use of such tests on pooled specimens for testing individuals without symptoms or other reasons when tested at least once a week as part of a serial testing program without prospective FDA review.  Learn more from this FDA announcement.

Centers for Disease Control and Prevention

COVID-19

National Institutes of Health

COVID-19

  • The NIH announced that it will fund a large, randomized, placebo‑controlled Phase 3 clinical trial to test several existing prescription and over-the-counter medications for people to self-administer to treat symptoms of COVID-19.  Part of the Accelerating COVID‑19 Therapeutic Interventions and Vaccines (ACTIV) public–private partnership, the ACTIV-6 trial aims to provide evidence-based treatment options for the majority of adult patients with COVID-19 who have mild to moderate symptoms and are not sick enough to be hospitalized.  NIH will spend $155 million for the trial.  See the NIH announcement here.  Learn more about the ACTIV program here.

Medicaid and CHIP Payment and Access Commission

Health Policy News

  • MACPAC has published an overview of the role Medicaid plays in rural health.  The brief describes the characteristics of rural residents generally, including socioeconomic factors, insurance status, and health status and then addresses provider availability, particularly for primary care services and rural hospitals. The brief concludes with a discussion of Medicaid policies and services that are particularly important for providing health care in rural areas.

Health Policy Update for Friday, April 16

The following is the latest health policy news from the federal government as of 2:45 p.m. on Friday, April 16.

The White House

COVID-19

  • The White House announced $1.7 billion in new federal spending from the American Rescue Plan to help states and other jurisdictions improve their detection, monitoring, and mitigation of COVID-19 variants.  This $1.7 billion includes $1 billion to expand genomic sequencing; $400 million to support innovation initiatives, including the launch of new innovative Centers of Excellence in Genomic Epidemiology; and $300 million to build and support a National Bioinformatics Infrastructure.The first pool of funding will be distributed in early May and second pool will be invested over the next several years.  For further information, including the allocation of the first pool of funding by state, see the White House announcement.
  • The White House announced another $4 billion in spending from the American Rescue Plan “…to combat COVID-19 in Indian Country.”  The funding consists of $600 million to increase COVID-19 vaccinations in Indian country; $1 billion to detect, diagnose, trace, monitor, and mitigate COVID-19 infections; and $2 billion for tribal health systems due to lost reimbursements for care during the pandemic.  Learn more from the White House announcement.
  • The White House has posted a transcript of the April 16 press briefing provided by its COVID-19 response team and public health officials.

Health Policy News

  • Last week the White House’s COVID-19 Health Equity Task Force held its second meeting to discuss the administration’s whole-of-society approach to mitigating the health inequities caused or exacerbated by the COVID-19 pandemic and for preventing such inequities in the future.  Learn more from this news release describing the meeting and view the meeting in two parts, here and here.

Federal Communications Commission

COVID-19

  • The FCC will begin accepting applications for Round 2 of its COVID-19 Telehealth Program on Thursday, April 29.  The program, which will provide another $250 million in grants, supports the efforts of health care providers to continue serving their patients by providing reimbursement for telecommunications services, information services, and connected devices necessary to enable telehealth during the COVID-19 pandemic.  Go here for links to the FCC’s news release and public notice, and for additional information on eligibility and the application process, review the application process guidance available here, on the Universal Service Administrative Company’s COVID-19 Telehealth Program webpage.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • CMS has published the latest edition of its online Medicare publication MLN Connects.  The following is a table of the contents of this week’s issue with links to the individual articles:

News

Compliance

Events

Multimedia

Department of Health and Human Services

COVID-19

  • HHS’s Office of the Inspector General has posted a notice reminding vaccine providers and the public that COVID-19 vaccines are being provided by the federal government and must be administered at no cost to recipients.  Providers participating in the CDC’s COVID-19 vaccination program are obligated to comply with the terms of that program.  See the OIG’s message here.
  • HHS has posted a guide to implementing programs offering acute hospital care at home that presents tips on operating such programs and links to resources for assisting with such undertakings.
  • HHS has posted “COVID-19 Healthcare Delivery Impacts,” a document that outlines the major challenges that face the health care system during a pandemic like COVID-19 and offers mitigation strategies for addressing those challenges.

Centers for Disease Control and Prevention

COVID-19