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Federal Health Policy Update for Monday, May 10

The following is the latest health policy news from the federal government as of 2:15 p.m. on Monday, May 10.  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 and the Department of Housing and Urban Development (HUD) have announced a joint-agency effort to increase access to COVID-19 prevention and treatment services, including testing and vaccinations, among disproportionately affected communities, including among HUD-assisted households and people experiencing homelessness.  This program will seek to leverage the Health Center COVID-19 Health Vaccine Program, which currently provides a direct supply of vaccines to nearly 800 health centers across the country.  HHS and HUD expects this effort to reach more than 6,000 multi-family housing properties, 6,700 homeless shelters, and approximately 7,500 public housing properties.  Learn more from the departments’ announcement of their joint initiative.
  • HHS’s Health Resources and Services Administration (HRSA) will hold an informational webinar on the agency’s new COVID-19 Coverage Assistance Fund program under which participating providers are reimbursed at Medicare rates for administering COVID-19 vaccines to underinsured individuals.  Presenters will provide an overview and orient health care providers to the program by covering information such as enrolling as a provider participant, submitting patient information, submitting claims, and receiving payments via direct deposit.  The webinar will be held on Wednesday, May 12 at 2:00 p.m. (eastern).  Go here to register.

Health Policy News

  • HHS announced that its Office for Civil Rights will interpret and enforce Section 1557 and Title IX’s prohibitions on discrimination based on sex to include: (1) discrimination on the basis of sexual orientation; and (2) discrimination on the basis of gender identity.  Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in covered health programs or activities.  Go here to see HHS’s announcement of this policy and its rationale for it and go here to see the notice HHS intends to publish in the Federal Register.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

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

  • New Program:  HRSA COVID-19 Coverage Assistance Fund
  • COVID-19: Work of Hospital Allied & Supportive Care Providers
  • IRF, LTCH, & SNF: Report Quality Data by May 17
  • Building COVID-19 Vaccine Confidence Webinar — May 13
  • New Waived Tests

Go here for links to these and other items.

Treasury Department

COVID-19

  • The Treasury Department has posted an interim final rule, not yet published in the Federal Register, implementing the Coronavirus State Fiscal Recovery Fund and the Coronavirus Local Fiscal Recovery Fund established under the American Rescue Plan Act.  The interim final rule addresses uses of the $350 billion from the American Rescue Plan, including for public health expenditures, addressing the negative effects of the public health emergency, replacing lost public-sector revenue, providing premium pay for essential workers, and more.  Learn more from the following resources:

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

  • The FDA will convene a virtual meeting of its Vaccines and Related Biological Products Advisory Committee on June 10 to provide a status update on its approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age.  The committee also will discuss the data needed to support an EUA and a biologics license application for a COVID-19 vaccine intended for use in children less than 12 years of age.  The committee will not discuss any specific products.  See the FDA announcement of this meeting here.

Stakeholder Events

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.

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.

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 Monday, May 3

The following is the latest health policy news from the federal government as of 3:15 p.m. on Monday, May 3.  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 and its Health Resources & Services Administration (HRSA) have announced a new program to cover the costs of administering COVID-19 vaccines for patients enrolled in health plans that either do not cover vaccination fees or that cover them with patient cost-sharing.  Since providers cannot bill patients for COVID-19 vaccination fees, this new program, the COVID-19 Coverage Assistance Fund (CAF), addresses an outstanding compensation need for providers.  Learn more about the program from HHS’s announcement about the new program and a new web page for the program.
  • To support the launch of this new COVID-19 Coverage Assistance Fund, HRSA 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 and HRSA have awarded more than $32 million in American Rescue Plan funds to 122 organizations that provide training and technical assistance support to HRSA Health Center Program-supported health centers nation-wide.  These organizations – Primary Care Associations (PCAs), National Training and Technical Assistance Partners (NTTAPs), and Health Center Controlled Networks (HCCNs) – will use the funds to provide health centers with COVID-19-related training, technical assistance, and health information technology support.  Learn more about the funding recipients and how and where the money will be used in this HHS news release.
  • HHS has updated the list of providers that have received grants from the CARES Act’s Provider Relief Fund.  Go here to explore the recipient database.

Health Policy News

  • CMS has extended and made some changes in its Comprehensive Care for Joint Replacement model.  The program has been extended for three years for some current participants; the basis for target price calculations has been changed; the definition of an episode of care has changed; and there are other changes.  See the final rule, which was published in the Federal Register, for further information about these and other changes.
  • CMS has announced changes in aspects of how the federal health insurance marketplace will operate in plan year 2022.  Among those changes is a provision that will lower maximum out-of-pocket costs to consumers by $400 while increasing competition among insurers.  CMS’s second 2022 Notice of Benefit and Payment Parameters final rule, also known as the “2022 payment notice,” includes several provisions to help consumers distinguish between plan options and increase opportunities to qualify for future special enrollment periods when consumers are eligible to enroll in marketplace plans outside annual open enrollment.  This includes laid-off workers, who will be eligible for a special enrollment period when their employer or federal subsidies end.  CMS expects these special enrollment period policies to offer greater flexibility for people who need health insurance.  Learn more about the changes these new policies will bring from the following sources:

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

  • The FDA has approved an abbreviated new drug application for 23.4% Sodium Chloride Injection USP, 120 mEq/30 mL (4 mEq/mL) single-dose vial, indicated as an additive in parenteral (injection) fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion.
  • The FDA also has approved an abbreviated new drug application for Morphine Sulfate Injection USP, 30 mg/30 mL (1 mg/1 mL) single-dose (preservative-free Patient Controlled Analgesia [PCA] vial), indicated for the management of pain severe enough to require use of an opioid analgesic by PCA and for which alternative treatments are inadequate.
  • The FDA has revoked its emergency use authorization of the Battelle CCDS Critical Care Decontamination System, which was authorized for use in decontaminating compatible N95 respirators for multiple-user reuse by health care personnel.  With supplies now improved, the FDA now discourages the reuse of N95 respirators.

National Institutes of Health

  • The NIH is awarding $29 million in grants funded by the American Rescue Plan for Community Engagement Alliance Against COVID-19 Disparities “To bolster research to help communities disproportionately affected by COVID-19…”  The awards will provide $15 million to 11 teams already conducting research and outreach to help strengthen COVID-19 vaccine confidence and access, testing, and treatment in communities of color.  An additional $14 million will fund 10 new research teams to extend the reach of COVID-19 community-engaged research and outreach.  Learn more from the NIH’s announcement about this initiative.

Stakeholder Events

Wednesday, May 5
FDA Product-Specific Guidances:  Lighting the Development Pathway for Generic Drugs
Wednesday, May 5 at 9:00 am – 12:30 pm ET.  Click here for connection information.
The FDA will provide an overview of product-specific guidances, including how they are developed and revised and their role in facilitating generic drug development and generic drug application review.  The FDA will also discuss ways prospective and current generic drug applicants can use PSGs, including those for complex products, to improve the efficiency of generic drug development.

Wednesday, May 5
CDC Zoonoses and One Health Update (ZOHU) Call
Wednesday, May 5, at 2:00 pm – 3:00 pm ET.  Click here to learn more.
ZOHU calls are one-hour monthly webinars that provide education on zoonotic and infectious diseases, One Health, antimicrobial resistance, food safety, vector-borne diseases, recent outbreaks, and related health threats at the animal-human-environment interface.

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.