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Health Policy Update for Wednesday, April 14

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, April 14.

Temporary Halt to Use of the Johnson & Johnson Janssen Vaccine

  • The White House held a press briefing on Tuesday, April 13 during which the White House press secretary, its COVID-19 response coordinator, and Dr. Anthony Fauci discussed the decision to halt administration of the Johnson & Johnson (Janssen) vaccine until its safety can be further examined.  Learn more from a transcript of that briefing.
  • Representatives of the FDA and CDC briefed the news media on the situation involving the Johnson & Johnson vaccine.  Listen to that briefing here.
  • The FDA and CDC issued a joint statement noting some adverse effects from the Johnson & Johnson COVID-19 vaccine and explaining that

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution.

Congress – Medicare Sequestration Legislation

COVID-19

  • The House has passed a bill to extend the moratorium on the two percent Medicare sequestration cut that has been delayed throughout the pandemic; this latest delay would extend to December 31, 2021.   President Biden is expected to sign the bill and then CMS will begin processing the claims it has been holding since April 1 in anticipation of the bill’s passage.  Those claims will be paid without the two percent sequestration deduction.

The White House

COVID-19

Centers for Medicare & Medicaid Services

COVID-19

  • CMS is terminating some of its COVID-19 waivers for health care providers that apply to long-term-care settings.  Find the terminated waivers, marked in red with “terminated effective,” followed by a May 9 or May 10, 2021 date, on pages 18 and 19 of its compendium of COVID-19 emergency blanket waivers.

Health Policy News

  • CMS has extended the deadline for interested parties to apply to participate in its Primary Care First Cohort 2 to May 21, 2021 and the deadline for payer applications has been extended to June 18, 2021.  Learn more from the following resources:

Department of Health and Human Services

COVID-19

  • HHS’s Office for Civil Rights, Administration for Community Living, and Office of the Assistant Secretary for Planning and Evaluation have published several new resources to help states, vaccination providers, and others’ COVID-19 response activities improve access to vaccines for people with disabilities and older adults.  These resources clarify legal requirements, illustrate some of the barriers to vaccine access faced by people with disabilities and older people, and offer strategies for ensuring accessibility.  These resources include:
  • New guidance from the Office for Civil Rights outlining legal standards under federal civil rights laws prohibiting disability discrimination and providing examples of the application of legal standards in the context of COVID-19 vaccine programs and how to implement them.
  • An Office of Civil Rights fact sheet presenting specific steps that those involved in the planning and distribution of vaccines to combat the COVID-19 pandemic may wish to consider to promote compliance with disability rights laws and provide access to vaccination programs for people with disabilities.
  • The Administration for Community Living has compiled strategies and best practices for helping older adults and people with disabilities gain access to COVID-19 vaccines.
  • Learn more about these activities and other relevant resources from these agencies in the HHS news release announcing this initiative.

Health Policy News

  • HHS marked Black Maternal Health Week by announcing actions to expand access to continuous health care coverage and access to preventive care in rural areas to improve maternal health outcomes.  HHS also announced that Illinois will be the first state to provide continuity of full Medicaid benefit coverage for mothers by offering extended eligibility for a woman during the entire first year after delivery.  In addition, HHS announced a Notice of Funding Opportunity that will make $12 million available over four years for a Rural Maternity and Obstetrics Management Strategies program that will enable awardees to test models to address unmet needs for their target population, with applicants required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.  Three award recipients will each receive up to $1 million annually for up to four years to test models to address unmet needs for their target population.  Learn more from the following resources:
  • HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Training in Primary Care Medicine and Dentistry.  Nominations are due September 30.  See the HRSA notice here.

Food and Drug Administration

COVID-19

Government Accountability Office

COVID-19

  • The GAO has published a new report titled “Efforts to Increase Vaccine Availability and Perspectives on Initial Implementation.”  Find a brief summary of the report here and the entire report here.

Health Policy Update for Monday, April 12

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, April 12.

The White House

COVID-19

Health Policy and Budget News

  • The Biden administration has released its proposed FY 2022 discretionary budget, which addresses, among other things, many aspects of health care policy.  Find the news release announcing the proposed budget here and the budget document itself here.

Centers for Medicare & Medicaid Services

COVID-19

Proposed Rules

  • CMS has published a special edition of its online publication MLN Connects devoted entirely to its recently published regulations proposing FY 2022 Medicare payments for skilled nursing facilities, hospice providers, inpatient rehabilitation facilities, and inpatient psychiatric facilities.

Centers for Disease Control and Prevention

COVID-19

National Institutes of Health

COVID-19

  • The NIH has issued new guidance on the use of monoclonal antibodies to treat patients with COVID-19.  This varies from past guidance because of differences in the effectiveness of some monoclonal antibodies, used on their own or in combination with others, on COVID-19 and COVID-19 variants.  Go here to see the NIH’s notice, explanation, and rationale for the changing recommendations.

Food and Drug Administration

COVID-19

  • The FDA has issued a letter to health care personnel and facilities recommending transition from use of decontaminated disposable respirators.  The FDA recommends that health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontamination or bioburden reduction, currently used on disposable respirators for reuse.  Based on the increased domestic supply of new respirators approved by the CDC’s National Institute for Occupational Safety and Health (NIOSH) currently available to facilitate this transition, the FDA and CDC believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems.

Federal Emergency Management Agency

COVID-19

  • FEMA has published audit-related guidance to assist recipients and sub-recipients of COVID-19-related public assistance to document and account for disaster costs, minimize the loss of FEMA funding, maximize financial recovery, provide information about procurement and contracting requirements during emergency and exigent circumstances, and prevent fraud, waste, and abuse of disaster funds.  Find the FEMA fact sheet here.  Find information about emergency medical care activities eligible for FEMA support here.

Department of Labor

Health Policy News

The Department of Labor has posted resources to inform stakeholders about new COBRA premium assistance authorized by the American Rescue Plan.  Find those resources here.

Medicaid and CHIP Payment and Access Commission

Health Policy News

MACPAC has published an annotated bibliography of racial and ethnic disparities in Medicaid.

 

Health Policy Update for Thursday, April 8

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, April 8.

Provider Relief Fund

  • The Provider Relief Fund web page has been updated to announce a webinar next Tuesday, April 13 about the HRSA COVID-19 uninsured program under which participating providers are reimbursed at Medicare rates for testing, treating, and administering COVID-19 vaccines to uninsured individuals.  Go here for further information (in the shaded box labeled “update”).

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has added 24 new audiology and speech language pathology services to its list of telehealth services covered during the COVID-19 emergency.  Go here to find the updated list of telehealth services authorized during the pandemic.

Proposed Rules

  • CMS has published its proposed FY 2022 skilled nursing facility prospective payment system rule.  Learn more about the proposed rule from this CMS fact sheet and from the proposed rule itself.
  • CMS has published its proposed FY 2022 hospice wage index and payment update, hospice conditions of participation updates, and hospice and home health quality reporting program requirements.  Learn more the CMS fact sheet from this Federal Register notice.

Health Policy News

  • CMS will hold a webinar titled “Building Capacity in the Direct Service Workforce:  Moving Forward from the Summit” on Wednesday, April 28, 2021.  The purpose of the webinar is to advance learning and recommendations from the “Quality Jobs Equal Quality Care: Building Capacity in the Direct Care Workforce” event that was held at Advancing States’ HCBS Conference on December 3, 2020.  The webinar will highlight capacity-building strategies shared by states during the HCBS conference, is open to the public, and will focus on strategies for state Medicaid agencies, state agency partners, managed care plans, and home and community based services providers.  Go here for more information and here to register.

Department of Health and Human Services

Federal Funding Opportunity

  • HHS’s Administration for Community Living has published a notice about a funding opportunity.  The notice is titled “Aging and Disability Resource Center/No Wrong Door System COVID–19 Vaccine Access Supplemental Funding” and it states that “This funding opportunity is to support a new effort to get the nation’s most vulnerable and at-risk seniors and people with disabilities vaccinated.”  The notice was published today (April 8) and applications are due at 11:59 p.m. on Friday, April 9.  The notice also states that “Eligible Applicants for this award are existing ADRC/NWD COVID–19 CARES Act grantees that received funding on April 1, 2020.”  Learn more from the Federal Register notice.

Centers for Disease Control and Prevention

COVID-19

Health Policy News

  • The CDC and the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that federal funding may now be used to purchase rapid fentanyl test strips in an effort to help curb the dramatic spike in drug overdose deaths largely driven by the use of strong synthetic opioids, including illicitly manufactured fentanyl.  Learn more about the new policy and the federal grantees to which it applies in this CDC news release.

Congressional Research Service

  • The Congressional Research Service has published a new report titled “State and Federal Authority to Mandate COVID-19 Vaccination.”  Find it here.

Health Policy Update for Wednesday, April 7

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, April 7.

The White House

Health Policy News

  • President Biden’s first budget proposal is expected to be released this Friday, April 9.  It could have important policy implications for health care providers of all types.

COVID-19

Federal Emergency Management Agency

  • FEMA has published a notice titled “Coronavirus (COVID-19) Pandemic:  Safe Opening and Operation Work Eligible for Public Assistance;” the announcement “…defines the framework, policy details, and requirements for determining the eligibility of safe opening and operation work and costs under the PA [Public Assistance] Program.”  Authorized by the declaration of a national emergency, FEMA will reimburse selected entities for “…the safe opening and operation of eligible facilities” under its public assistance program.  Generally, such facilities are owned and operated by state and local governments, but in some cases those entities may contract for such operations with private, non-profit organizations, which would be eligible for such assistance.  FEMA payments under this program are made only to state and local governments, which then reimburse any private, non-profit organizations with which they have contracted for eligible work performed between January 21, 2021 and September 30, 2021.  For further information see this FEMA notice, which addresses in greater detail how the program works, including eligibility, eligible expenses, and more.

Centers for Medicare & Medicaid Services

Proposed Rules

Health Policy News

CMS has posted the latest edition of its weekly online publication MLN Connects.  The following is its table of contents (with links to the individual items).

News

Compliance

Claims, Pricers, & Codes

Events

MLN Matters® Articles

Publications

Multimedia

Department of Health and Human Services

COVID-19

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

  • The FDA has issued emergency use authorization for the first antibody test authorized for use with home-collected dried blood spot samples.  Samples collected at home are then sent to the laboratory of the product’s creator for analysis.  The test is available only by prescription.  See the FDA announcement and its emergency use authorization letter.

National Institutes of Health

COVID-19

The NIH has launched a clinical trial to determine whether people who are highly allergic or have a mast cell disorder are at increased risk for an immediate, systemic allergic reaction to the Moderna or Pfizer COVID-19 vaccines.  Learn more about the trial and its objectives here.

 

Health Policy Update for Monday, April 5

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, April 5.

The White House

COVID-19

Provider Relief Fund

Are there any restrictions on how hospitals that receive Medicaid disproportionate share hospital (DSH) payments can use Provider Relief Fund General and Targeted Distribution payments? (Added 2/24/2021)

Yes. Providers may not use PRF payments to reimburse expenses or losses that have been reimbursed from other sources or that other sources are obligated to reimburse. Therefore, if a hospital has received Medicaid DSH payments for the uncompensated costs of furnishing inpatient and/or outpatient hospital services to Medicaid beneficiaries and to individuals with no source of third party coverage for the services, these expenses would be considered reimbursed by the Medicaid program and would not be eligible to be covered by money received from a General or Targeted Distribution payment.

Centers for Medicare & Medicaid Services

COVID-19

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

National Institutes of Health

Health Policy Update for Thursday, April 1

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, April 1.

Medicare Accelerated and Advance Payments Program

The White House

COVID-19

Health Policy News

  • The Biden administration has unveiled its proposed “American Jobs Plan.”  A portion of that plan addresses health care provided in the home.  Learn more from the administration’s fact sheet on the plan and the section in it titled “Solidify the Infrastructure of our Care Economy by Creating Jobs and Raising Wages and Benefits for Essential Home Care Workers.”

Provider Relief Fund

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • CMS has posted the latest edition of its online publication MLN Connects, which features information about Medicare policy and reimbursement matters.  The following is its table of contents (with links):

News

Compliance

Claims, Pricers, & Codes

Events

MLN Matters® Articles

Multimedia

Department of Health and Human Services

COVID-19

Health Policy News

  • HHS has posted a presentation from a webinar on lessons learned from recent cybersecurity incidents involving health care providers.  Go here to find the presentation and go here to view the webinar.
  • HHS announced that additional savings and lower health care costs are available for consumers on HealthCare.gov through increased tax credits for health insurance made available through the American Rescue Plan.  See the announcement here and find a link to additional information about newly reduced health insurance premiums here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

  • The FDA has approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation, such as for COVID-19.  See the FDA’s notice of this approval here.

Federal Communications Commission – Grants

  • The FCC has launched round two of its COVID-19 telehealth program, which was established by the CARES Act “to support efforts of health care providers to address coronavirus by providing telecommunications services, information services, and devices necessary to enable the provision of telehealth services” during the COVID-19 pandemic.  Round two is funded with $250 million from the American Rescue Plan.  Some aspects of the program have changed.  The application window, which should be announced soon, will be brief.  Learn more from this FCC notice.

Government Accountability Office

COVID-19

Health Policy Update for Tuesday, March 30

The following is the latest health policy news from the federal government as of 3:30 p.m. on Tuesday, March 30.

Medicare Sequestration

  • In anticipation of possible congressional action to extend the two percent sequester reduction suspension, CMS has instructed the Medicare Administrative Contractors (MACs) to hold all claims with dates of service on or after April 1, 2021 for a short period without affecting providers’ cash flow.  This will minimize the volume of claims the MACs must reprocess if Congress extends the suspension.  The MACs will automatically reprocess any claims paid with the reduction applied if necessary.  NASH has been a strong proponent of extending the suspension of the Medicare sequester.

The White House

COVID-19

  • The White House has posted a fact sheet explaining that President Biden will announce that 90 percent of the adult U.S. population will be eligible for vaccination and 90 percent will have a vaccination site within five miles of their home by April 19.  The key elements of the plan are:
  • Expanding vaccines to 20,000 more local pharmacies, bringing the total to nearly 40,000 pharmacies across the country by April 19.
  • Launching a new effort to get the most vulnerable and at-risk seniors and people with disabilities vaccinated.
  • Expanding the number of mass vaccination centers across the country.
  • The White House has posted a transcript of the March 29 press briefing provided by its COVID-19 response team and public health officials.

Department of Health and Human Services

COVID-19

  • HHS, the CDC, and the Administration for Community Living (ACL) will spend nearly $100 million to help increase vaccinations among older adults and people with disabilities.  With funding from the CDC, the ACL will award nearly $93 million in grants to aging and disability networks in every state and territory.  This effort will include an additional $5 million in funding for national hotlines to help older adults and people with disabilities register for vaccinations and to connect them with local disability and aging agencies that can provide services and supports necessary to obtain them.  Learn more from HHS’s announcement of this initiative.

Health Policy News

  • HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) is accepting applications for FY 2021 screening, brief intervention, and referral-to-treatment grants.  The purpose of this program is to implement screening, brief intervention, and referral-to-treatment services for children, adolescents, and/or adults in primary care and community health settings with a focus on screening for underage drinking, opioid use, and other substance use.  Eligible applicants include public and private non-profit health care or behavioral health care systems such as hospital systems, pediatric health care providers, children’s hospitals, and community health or behavioral health centers, HMOs, PPOs, and FQHC systems.  Applications are due April 19.  Learn more from the SAMHSA announcement.
  • HHS’s Center for Medicare and Medicaid Innovation has announced that its request for applications to participate in an aspect of its Community Health Access and Rural Transformation (CHART) Model designed to involve 20 rural-focused accountable care organizations will be delayed from April of 2021 to the spring of 2022.  Learn more here.

Centers for Medicare & Medicaid Services

COVID-19

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

Health Policy News

  • In a message to state survey agencies, CMS announced that it has lifted the previously extended 30-day survey suspension for hospitals.  Survey activity will resume in accordance with previous non-long-term-care guidance.  Under the suspension, surveys had been limited to immediate jeopardy complaint allegations posing imminent danger to patients at the hospital, non-compliance with Medicare hospital conditions of participation, and matters requiring immediate action to be taken to protect the health and safety of patients.  Hospital recertification surveys were suspended except for a subset of hospital re-accreditation surveys under guidance provided to the accrediting organizations.  Hospital enforcement actions for deficiencies that did not represent immediate jeopardy had their termination date extended for at least 30 days.  CMS is now lifting the 30-day limitations imposed for hospital surveys as of March 23, 2021.  Among the resumed activities are reviews of non-immediate jeopardy hospital complaints, hospital plans of correction, desk reviews, on-site reviews, and work on open enforcement cases.  Learn more in this CMS memo to state survey agencies.

Centers for Disease Control and Prevention

COVID-19

National Institutes of Health

COVID-19

  • In a preliminary NIH study of recovered COVID-19 patients, researchers found that T-cells in those patients recognize most COVID-19 variants and offer some protection against those variants.  This suggests that vaccines may offer similar protection.  The NIH notes that additional research is needed.  Learn more here.

Federal Emergency Management Agency

COVID-19

  • FEMA announced that it has amended 58 COVID-19-related disaster declarations to increase FEMA’s share of the eligible costs associated addressing the disaster activities covered by the declarations from 75 percent to 100 percent.  See FEMA’s announcement here.
  • FEMA announced that it will provide financial assistance for COVID-19-related funeral expenses incurred after January 20, 2020.  Go here for information about eligibility and applications.

Federal Health Policy Update for Friday, March 26

Beginning this week, NASH is expanding its regular updates to encompass a broader scope of federal health policy endeavors to include other matters of importance to providers.  Feel free to share this newsletter with others in your organization or to send us the email addresses of those you think might be interested and we will send it directly to them.

The following is the latest such information from the federal government as of 2:30 p.m. on Friday, March 26.

NASH Advocacy

The Senate voted 90-2 to extend the moratorium on the two percent sequester of Medicare payments through the end of 2021.  The House will take up the bill when it returns to Washington, DC in mid-April.  The current moratorium will expire on March 31, but CMS is expected to use its authority to hold Medicare payments for up to 14 days to give the House time to pass the legislation.  NASH sent a thank you note to all 90 senators who voted for the bill.

The White House

COVID-19

Department of Health and Human Services

COVID-19

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • CMS has posted the latest edition of MLN Connects, its online publication with the latest information about Medicare reimbursement policy.  The following is the table of contents of the March 25 edition, with links to the individual articles:

News

Compliance

Claims, Pricers, & Codes

MLN Matters® Articles

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

  • The FDA announced that “Given the sustained increase in [COVID-19] viral variants in the United States that are resistant to bamlanivimab administered alone, and the availability of other authorized monoclonal antibody therapies that are expected to retain activity to these variants, the U.S. Government, in coordination with Eli Lilly and Company, will stop the distribution of bamlanivimab alone starting today, March 24, 2021.”  Using the other monoclonal antibody therapies, the FDA reasons, will increase the likelihood of successful treatment against COVID-19 variants.  Go here to see the FDA’s announcement and explanation and for links to resources that describe the available monoclonal antibodies and their differences in greater detail.

Federal Health Policy Update for Wednesday, March 24

Beginning today, NASH is expanding its regular updates to encompass a broader scope of federal health policy endeavors to include other matters of importance to providers.  Feel free to share this newsletter with others in your organization or to send us the email addresses of those you think might be interested and we will send it directly to them.

The following is the latest such information from the federal government as of 2:45 p.m. on Wednesday, March 24.

Congress

The temporary delay of implementation of the Medicare two percent sequester expires at the end of the month and amid considerable advocacy by the health care community, Congress is considering extending this delay.  Last week the House passed a bill that would extend the current moratorium through December 31, 2021 and would waive “PAYGO” rules that apply to the American Rescue Plan Act that would necessitate an additional two percent sequester on Medicare payments starting in January, which would be added to the existing sequester to result in a four percent sequester. The Senate will not take up the House bill but could take up S. 748, which would extend the current moratorium for the duration of the COVID-19 public health emergency.  Even if it does take up S. 748 this week the House is unlikely to address it immediately because both chambers will recess after Friday until April 9.  It is possible CMS may hold claims for a short period after March 31 if it appears Congress will act on this matter without much delay.

Provider Relief Fund

New Provider Relief Fund reporting requirements – PDF* were issued on January 15, 2021 in accordance with the Coronavirus Response and Relief Supplemental Appropriations Act of 2021.  In response to stakeholder feedback, HHS is currently reviewing this guidance and Provider Relief Fund reporting timelines.  We will post any updates on this website as soon as they are available.  We continue to encourage recipients of $10,000 or more in aggregate Provider Relief Fund payments to register in the Provider Relief Fund Reporting Portal.

White House

COVID-19

  • The White House has posted transcripts of the March 19, March 22, and March 24 press briefings provided by its COVID-19 response team and public health officials.

Department of Health and Human Services

Health Policy News

  • The Biden administration has nominated the following individuals to positions in the Department of Health and Human Services.

Office of the Secretary
Kristina Schake, Counselor to the Secretary for Strategic Communications

Office of the Assistant Secretary for Public Affairs
Israel Igualate, Deputy Speechwriter

Office of the General Counsel
Barbara McGarey, Deputy General Counsel

Office of the Assistant Secretary for Planning and Evaluation
Rebecca Haffajee, Principal Deputy Assistant Secretary for Planning and Evaluation
Miranda Lynch, Deputy Assistant Secretary for Planning and Evaluation (Human Services Policy)

Office of the Assistant Secretary for Preparedness and Response
Jonathan Warsh, Senior Policy Advisor COVID Response
Leni Hirsch, Special Assistant COVID Response

Office of the Assistant Secretary for Administration
Cheryl Campbell, Principal Deputy Assistant Secretary for Administration

Office of Global Affairs
Stephanie Psaki, Senior Advisor on Human Rights and Gender Equity

Substance Abuse and Mental Health Services Administration
Trina Dutta, Senior Advisor

See this HHS news release for further information.

  • HHS announced that it is extending access to the special enrollment period of the Affordable Care Act’s health insurance marketplace until August 15.  The purpose of this extension is to give consumers additional time to take advantage of new savings made available through the American Rescue Plan and give new and current enrollees an additional three months to enroll or re-evaluate their coverage needs with increased tax credits available to reduce premiums.  Learn more from this HHS announcement.HH  Find additional information in this accompanying HHS fact sheet.
  • HHS’s Office of the Inspector General has published the report “Hospitals Reported that the COVID-19 Pandemic Has Significantly Strained Health Care Delivery.”  HHS describes the report as “…a national snapshot, from the perspective of front-line hospital administrators, on how responding to the COVID-19 pandemic has affected their capacity to care for patients, staff, and communities.  This is not a review of the HHS response to the COVID-19 pandemic.”

Centers for Medicare & Medicaid Services

COVID-19

National Nursing Home Stakeholder Call

On Thursday, March 25, 2021 at 4:00pm (eastern), CMS will address questions about its updated nursing home visitation guidance.  In addition, participants will hear from a nursing home administrator currently implementing the new guidance.   Register for this Zoom call here.  Resources for the call are:

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration – COVID-19

COVID-19

  • The FDA has issued emergency use authorization for the first machine learning-based COVID-19 non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation.  The device is worn as an arm band and uses artificial intelligence.  See the FDA’s announcement and its emergency use authorization letter.

National Institutes of Health

COVID-19

  • In a news release, the NIH announced that “Results from a large clinical trial in the United States and South America indicate that AstraZeneca’s COVID-19 vaccine, AZD1222, is well-tolerated and protects against symptomatic COVID-19 disease, including severe disease or hospitalization. The independent Data and Safety Monitoring Board (DSMB) overseeing the trial identified no safety concerns related to the vaccine.”
  • Later the same day, the NIH’s Data and Safety Monitoring Board (DSMB) announced that it has notified NIAID (the National Institute of Allergy and Infectious Diseases), BARDA (the Biomedical Advanced Research and Development Authority), and AstraZeneca that “it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial.  The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”

 

Coronavirus Update for Friday, March 19

The following is the latest COVID-19 information from the federal government as of 3:00 p.m. on Friday, March 19.

White House

Provider Relief Fund

Department of Health and Human Services

  • HHS announced that it will spend $10 billion from the American Rescue Plan to increase COVID-19 screening and testing to help schools reopen, increase testing in underserved populations, and provide new guidance on asymptomatic screening testing in schools, workplaces, and congregate settings.  Learn more from this HHS news release.  The CDC will administer $2.25 billion of this sum to increase testing in underserved populations; learn more about its plans in this CDC news release.
  • HHS announced that it will spend $150 million to increase access to COVID-19 monoclonal antibody therapeutic treatments for patients in vulnerable communities across the country.  Assistance may include additional staffing, improved infusion center capacity in traditional and non-traditional health care settings, and equipment to administer intravenous infusion treatments. The effort also will seek to improve awareness among health care providers and patients about the treatment options available, including where and how to obtain them.  Learn more from this HHS announcement.

HHS COVID-19 Stakeholder Calls

HHS’s Office of the Assistant Secretary for Preparedness and Response sponsors COVID-19 Clinical Rounds Peer-to-Peer Virtual Communities of Practice that are interactive virtual learning sessions that seek to create a peer-to-peer learning network in which clinicians from the U.S. and abroad who have experience treating patients with COVID-19 share their challenges and successes.  These webinar topics are covered every week:

  • EMS:  Patient Care and Operations (Mondays, 12:00-1:00 PM eastern)
  • Critical Care:  Lifesaving Treatment and Clinical Operations (Tuesdays, 12:00-1:00 PM eastern)
  • Emergency Department:  Patient Care and Clinical Operations (Thursdays, 12:00-1:00 PM eastern)

Go here for information about signing up to participate in the sessions and go here for access to materials and video recordings of past sessions.

Centers for Disease Control and Prevention

Food and Drug Administration

Government Accountability Office

  • The GAO has published a new report, “COVID-19 in Nursing Homes,” in which it notes that HHS has taken steps in response to the pandemic but that several GAO recommendations have not been implemented.  See the report’s highlight and the entire report itself.