Posts

NASH Seeks Changes in Provider Relief Fund Distributions

Concerned that some private safety-net hospitals have not received Provider Relief Fund Phase 3 distributions and that others have not received adequate grants, the National Alliance of Safety-Net Hospitals has written to Health and Human Services Secretary Xavier Becerra to ask for changes in HHS’s approach to the CARES Act grants intended to help hospitals absorb the additional expenses they have incurred and the revenue they have lost as a result of the COVID-19 emergency.

Specifically, NASH urged HHS to:

  • Review the eligibility criteria and methodology for determining Provider Relief Fund grants to ensure that they reach true safety-net hospitals, and in particular those that serve especially large numbers of Medicaid patients.
  • Recalculate Phase 3 grants in a way that better reflects the true financial obstacles safety-net hospitals have faced throughout the COVID-19 emergency.
  • Apply more appropriate criteria and a better methodology for calculating payments in future Provider Relief Fund distributions.

Learn more from NASH’s letter to HHS Secretary Becerra.

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 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.

Federal Health Policy Update for Thursday, April 29

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, April 29.  Some of the language used below is taken directly from government documents.

The White House

COVID-19

Health Policy News

  • Speaking before a joint session of Congress, President Biden on Wednesday night formally presented his proposed American Families Plan.  In general, the plan defers action on most health care matters to other, separate legislation, but it does call for $200 billion to permanently expand Affordable Care Act health insurance subsidies and another $225 billion for paid medical leave.  The president also called on Congress to authorize the federal government to engage in some price negotiation for prescription drugs for Medicare beneficiaries and urged the National Institutes of Health to establish a new agency devoted to developing breakthrough cancer cures.  Go here to see a summary of the American Families Plan.

Department of Health and Human Services

Health Policy News

  • Earlier this week HHS announced the availability of $1 billion for Health Resources and Services Administration (HRSA)-Health Center Program funded health centers to support major construction and renovation projects across the country.  Learn more about this program, and about pursuing funding through it, from the following resources:

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published its proposed Medicare hospital inpatient prospective payment system and long-term-care hospital rate system rule for FY 2022.  Highlights of the proposed rule include:
  • A 2.8 percent increase in inpatient rates for acute-care hospitals.
  • Use of FY 2019 utilization data to filter out the impact of COVID-19 on utilization.
  • A $600 million reduction in the Medicare DSH uncompensated care pool.
  • Beginning in 2023, 1000 new medical residency slots over the next four years and changes in other graduate medical education policies.
  • A reduction from 68.3 percent to 67.6 percent in the labor-related share of inpatient payments and other wage index changes.
  • Consideration of changes in the Hospital Readmissions Reduction Program to reflect health equity factors.
  • Repeal of the requirement that hospitals report median payer-specific negotiated charges with Medicare Advantage plans on cost reports.
  • Introduction of a “measure suppression policy” to adjust quality program measures to reflect impact of COVID-19.

Learn more about the proposed regulation from the following resources:

News

Compliance

Claims, Prices, & Codes

MLN Matters Articles

Publications

Food and Drug Administration

COVID-19

Centers for Disease Control and Prevention

COVID-19

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.

Federal Health Policy Update for Tuesday, April 27

The following is the latest health policy news from the federal government as of 3:00 p.m. on Tuesday, April 27.

The White House

COVID-19

Health Policy News

Congress

  • The New Democrat Coalition is a group of 94 mostly centrist Democrats working to bridge the gap between left and right on health care by offering proposals that seek to build on the policy infrastructure that currently exists rather than replacing it.  The coalition has written to President Biden with its list of policy recommendations that it asks him to incorporate into the American Families Plan.  Learn more about the New Democrat Coalition here and learn more about the health care policies it espouses in its recent letter to President Biden.
  • A group of 17 Democratic senators has written to President Biden asking him to pursue expansion of Medicare in his soon-to-be-unveiled American Families Plan.  Read that letter here.

Department of Health and Human Services

COVID-19

Health Policy News

  • HHS has announced the availability of $1 billion in American Rescue Plan money for Health Resources and Services Administration (HRSA)-Health Center Program-funded health centers to support major construction and renovation projects across the country.  Health centers that receive this funding will be able to use it for COVID-19-related capital needs and to construct new facilities, renovate and expand existing facilities, and purchase new equipment.  All of the nation’s nearly 1,400 HRSA-funded health centers will be eligible for these funds.  See the HHS announcement here and find information about submitting applications, which are due June 24, here.
  • HHS has released new buprenorphine practice guidelines that, among other things, remove a long-time requirement tied to training, which some practitioners have cited as a barrier to treating more people.  The order exempts eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives from federal certification requirements related to training, counseling, and other ancillary services that are part of the process for obtaining a waiver to treat up to 30 patients with buprenorphine.  For additional resources, consult:
  • HHS has published a request for information in the Federal Register about the development of a national public health strategy for the prevention and control of vector-borne diseases in humans.  The RFP solicits “…specific input regarding strategic goals, benchmarks, gaps, duplicative federally funded programs, and opportunities to enhance coordination data collection, research, and the development of diagnostics, treatments, vaccines and other related activities…” Submissions are due by June 11.  Go here to see the notice.
  • The administration has announced a new round of appointments to staff positions at HHS.  They are:

Office of the Secretary
Cynthia Palafox (she/her), Director of Scheduling and Advance
Karuna Seshasai (she/her), Executive Secretary
Alia Schechter (she/her), Special Assistant to the Secretary

Office of Intergovernmental and External Affairs
Carrie Pugh (she/her), Director of External Affairs

Office of the Assistant Secretary for Public Affairs
Tericka Lambert (she/her), Director of Digital Engagement

Office of the Assistant Secretary for Legislation
Rose Sullivan (she/her), Principal Deputy Assistant Secretary for Legislation

Office of the Assistant Secretary for Health
Arsenio Mataka (he/him), Senior Advisor for Health Equity and Climate

Administration for Children and Families
Kathryn “Kate” Wolff (she/her), Senior Advisor

Centers for Medicare and Medicaid Services
Hannah Katch (she/her), Senior Advisor

Food and Drug Administration
Erica Jefferson (she/her), Associate Commissioner for External Affairs

Food and Drug Administration

COVID-19

  • The FDA and CDC have lifted the pause on use of the Johnson & Johnson Janssen vaccine.  See the agencies’ joint news release announcing and explaining their decision.
  • The FDA has published a notice in the Federal Register about the authorization of emergency use of certain medical devices during the COVID-19 emergency.  The notice, found here, includes COVID-19 diagnostic tests.

Centers for Disease Control and Prevention

COVID-19

Medicaid and CHIP Payment and Access Commission

COVID-19

  • MACPAC has published a report on provider use of Medicaid retainer payments during the COVID-19 pandemic.  Retainer payments are temporary payments intended to preserve the financial viability of providers during disruptions in care, and unlike most other types of Medicaid payments, they are not tied to specific services used by a Medicaid enrollee.  During the COVID-19 pandemic, many states have used retainer payment authority as a source of relief for home and community-based providers experiencing decreases in utilization, temporary practice closures, or other circumstances that limit their ability to provide covered services to Medicaid beneficiaries.  See the MACPAC report here.

Stakeholder Events

Tuesday, April 27

FDA Webinar Series – Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
Tuesday, April 27 at 12:00 pm ET.  Click here for connection information.
The FDA hosts a webinar series to keep stakeholders informed about the latest resources and news related to PPE use during the COVID-19 pandemic.

Wednesday, April 28
FDA Virtual Town Hall SeriesCoronavirus (COVID-19) Test Development and Validation
Wednesday, April 28 at 12:15 pm ET.  Click here for connection information.
The FDA will host a virtual town hall for COVID-19 test developers.  The purpose of this event is to help answer technical questions about the development and validation of tests for COVID-19.

Thursday, April 29
FEMA National Business Emergency Operations Center Business & Infrastructure Conference Call
Thursday, April 29 at 3:00 pm ET.  Conference Dial-in:  800-619-3427, Participant PIN: 2725748.
This is a business and infrastructure partners call in alignment with President Biden’s plan to respond to COVID-19.  FEMA will work with other federal agencies to coordinate with state, tribal, and territorial authorities and private sector partners and others to assist, augment, and expedite vaccinations in the United States.

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.

Friday, 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.

Federal Health Policy Update for Thursday, April 22

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, April 22.

Department of Health and Human Services

COVID-19

  • HHS’s Office of the Assistant Secretary for Preparedness and Response has published a new edition of its online publication The Exchange.  The issue focuses on the work of hospital allied and supportive care providers during COVID-19 and is divided into three subjects:  COVID-19 and acute hospital care, home care, and hospice; the role of allied health care professionals; and engineering and environmental support during COVID-19.  For each subject the issue directs readers to links detailing experiences from the field and to additional resources.  Learn more from the latest edition of The Exchange.
  • HHS has rescinded in its entirety the rule entitled “National Vaccine Injury Compensation Program:  Revisions to the Vaccine Injury Table,” which was finalized during the final days of the previous administration.  The rule made it more difficult for people to seek compensation from shoulder and fainting injuries associated with receiving vaccines.  The published notice repealing it noted that such a change could detract from the COVID-19 vaccination effort.  Learn more from the official Federal Register notice of the rescission.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published the latest edition of MLN Connects, its weekly online publication about Medicare and Medicare reimbursement matters.  The following is the table of contents of this week’s edition, with links to each item.

News

Compliance

Events

Publications

Multimedia

  • CMS’s Office of Minority Health will hold a two-day virtual forum titled “The Road to Equity:  Examining Structural Racism in Health Care” on April 27 and April 28 to highlight its renewed focus on health equity, addressing structural racism in health care, and establishing federal agencies’ roles as equity partners.  Speakers from various federal and partner agencies will focus on the impact of COVID-19 on health disparities and initiatives to promote equity. Go here for information about the programs’ times, agendas, and registration.
  • CMS has issued a new release of its “Market Saturation and Utilization Data Tool.”  CMS describes the tool as something it uses

…to monitor market saturation as a means to help prevent potential fraud, waste, and abuse (FWA).  Market saturation, in the present context, refers to the density of providers of a particular service within a defined geographic area relative to the number of beneficiaries receiving that service in the area.  The data can be used to reveal the degree to which use of a service is related to the number of providers servicing a geographic region.  There are also a number of secondary research uses for these data, but one objective of making these data public is to assist health care providers in making informed decisions about their service locations and the beneficiary population they serve.

Learn about what is new in this latest release and find links to the data tool in this CMS fact sheet.

The White House

COVID-19

Centers for Disease Control and Prevention

COVID-19

National Institutes of Health

  • The NIH announced that a Phase 2/3 trial to evaluate a new fully-human polyclonal antibody therapeutic targeted to COVID-19 has begun enrolling non-hospitalized people with mild or moderate cases of COVID-19.  Learn more from the NIH news release.

Medicare Payment Advisory Commission

  • MedPAC has posted its formal comment letter on CMS’s final rule on Medicare coverage of innovative technology and its definition of “reasonable and necessary.”  Find the MedPAC letter here.

 

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.