Has the White House Lost Faith in the Johnson & Johnson Vaccine?

Between the issues that resulted in a brief federal pause in the administration of Johnson & Johnson’s Janssen COVID-19 vaccine and production problems plaguing the company’s production contractor, the Biden administration is not necessarily counting on the vaccine in the future.

According to Politico, “…privately, frustrated senior health officials have largely written off the shot, according to seven people with knowledge of the matter.”

In addition, “… the chaos has disappointed the Biden team, which once argued that the company’s one-dose vaccine would be central to turning the tide of the pandemic.  Instead, the administration has concluded that the company can’t be counted on for any significant production until it gets the green light from regulators to resume vaccination, according to two sources.

Learn more about the vaccine’s problems and the administration’s perspective on it in the Politico article “White House writes off Johnson & Johnson vaccine after string of production failures.”

 

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  • HHS has rescinded in its entirety the rule entitled “National Vaccine Injury Compensation Program:  Revisions to the Vaccine Injury Table,” which was finalized during the final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.

Health Policy Update for Friday, April 16

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

The White House

COVID-19

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

Health Policy News

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

Federal Communications Commission

COVID-19

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

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

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

News

Compliance

Events

Multimedia

Department of Health and Human Services

COVID-19

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

Centers for Disease Control and Prevention

COVID-19

 

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