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Federal Health Policy Update for Monday, January 3

The following is the latest health policy news from the federal government as of 2:45 p.m. on Monday, January 3.  Some of the language used below is taken directly from government documents.

The White House

  • President Biden has issued a memorandum to the Secretary of Health and Human Services, the Secretary of Homeland Security, and the Administrator of the Federal Emergency Management Agency on maximizing assistance to respond to COVID-⁠19.  Among other things, the memorandum calls for FEMA to provide emergency and disaster assistance, to establish or expand COVID-19 testing sites at the request of state governments, and to underwrite the full costs it incurs in such efforts.  Learn more from the memorandum.
  • The White House has posted a transcript of the December 29 press briefing given by its COVID-19 response team and public officials.

Provider Relief Fund

  • The Provider Relief Fund reporting portal is now open for reporting period 2 and will remain open through March 31, 2022.  Go here for more information about what organizations do and do not need to report and how to do so.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

  • CMS’s Center for Medicare and Medicaid Innovation has a “Most Favored Nation Model” that seeks to test a way to lower prescription drug costs by paying no more for high-cost Medicare Part B drugs and biologicals than the lowest price that drug manufacturers receive in other, similar countries. The program was schedule to begin in 2021 but was delayed when a federal court issued a preliminary injunction against that implementation.  Between the court’s ruling and stakeholder feedback, CMMI has decided to withdraw its Most Favored Nation Model and did so in this Federal Register notice.  Additional information can be found on CMMI’s Most Favored Nation Model web page.

Department of Health and Human Services

Health Policy Update

  • HHS is working with states to promote access to Medicaid services for people with mental health and substance use disorder crises by giving states a new option for supporting community-based mobile crisis intervention services for individuals with Medicaid through newly available federal funds.  The American Rescue Plan grants CMS new authority to provide states with additional resources and tools to enhance these programs, including additional federal funding to states for qualifying mobile crisis intervention services for three years.  This new Medicaid option also offers flexibility for states to design programs that work for their communities, allowing states to apply for this new option under several Medicaid authorities.  Learn more from this HHS news release and this guidance letter CMS has sent to state Medicaid directors.
  • HHS has published a Notice of Benefit and Payment Parameters 2023 Proposed Rule that seeks to make it easier for consumers to find affordable, comprehensive health coverage.  Among other steps, the proposed rule seeks to advance standardized plan options, implement network adequacy reviews, strengthen access to essential community providers, and prohibit discriminatory practices.  Learn more from this HHS news release, this HHS fact sheet, and the proposed rule itself.  Interested parties have until January 27 to submit formal written comments.

Occupational Safety and Health Administration (OSHA)

  • In June, OSHA adopted a “Healthcare Emergency Temporary Standard” to protect workers from COVID-19 in settings where they provide health care or health care services, doing so with the expectation that this standard would be formalized in regulation within six months.  Now, OSHA has announced that while the regulation still has not been finalized it “…will vigorously enforce the general duty clause and its general standards, including the Personal Protective Equipment (PPE) and Respiratory Protection Standards, to help protect healthcare employees from the hazard of COVID-19” while modifying certain other aspects of the standard.  Learn more about the standard and the ways in which the agency intends to enforce and modify it in this OSHA statement.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has amended its emergency use authorization (EUA) for the Pfizer COVID-19 vaccine to expand the use of a single booster dose to include use in individuals 12 through 15 years of age; to shorten the time between the completion of the original Pfizer vaccine regimen and a booster dose to at least five months; and to allow for a third primary series dose for certain immunocompromised children five through 11 years of age.  Learn more from this FDA news release.
  • The FDA has updated its EUA for COVID-19 convalescent plasma by placing new limits on its use.  See the announcement here and the revised EUA here.
  • The FDA is inviting industry organizations to participate in the selection of non-voting industry representatives to serve on certain panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health by nominating such individuals in writing.  The agency also seeks nominations for non-voting industry representatives to serve on certain device panels.  Learn more from this Federal Register notice.  The deadline for nominations is February 2.

Stakeholder Events

HHS Office of the Assistant Secretary for Preparedness – January 6

HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) and Project ECHO will hold a “COVID-19 Clinical Rounds: A Peer-to-Peer Virtual Community of Practice” event on Thursday, January 6 at 12:00 (eastern).  COVID-19 Clinical Rounds are resource webinars intended for consultant physicians involved in critical care practice, fellows, residents, pharmacists, nursing staff, nurse practitioners, physician assistants, respiratory therapists, and allied health staff.  Go here to register for the January 6 event and find recordings of previous events here.

MedPAC – January 13-14

The Medicare Payment Advisory Commission (MedPAC) will hold its next public meeting on January 13 and 14.  Watch this space for a meeting agenda and information about virtual participation.

MACPAC – January 20-21

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next public meeting on January 20 and 21.  Watch this space for a meeting agenda and information about virtual participation.

Federal Health Policy Update for Tuesday, October 19

The following is the latest health policy news from the federal government as of 2:30 p.m. on Tuesday, October 19.  Some of the language used below is taken directly from government documents.

Provider Relief Fund:  Reminder That Applications Are Now Being Accepted

  • The Health Resources and Services Administration (HRSA) has opened its portal for providers to apply for $25.5 billion in health care relief funds, including $8.5 billion in American Rescue Plan resources for providers that serve rural patients covered by Medicare, Medicaid, or the Children’s Health Insurance Program and $17 billion for Provider Relief Fund Phase 4 grants, for a broad range of providers that have experienced changes in operating revenues and expenses as a result of the COVID-19 emergency.  The application deadline is October 26.  Go here for further information.

The White House

Department of Health and Human Services

COVID-19

  • HHS has renewed its declaration of a public health emergency because of the COVID-19 pandemic.  It now extends until January 16, 2022.
  • HHS’s Office of the Inspector General (OIG) performed an audit to identify actions that selected states took or planned to take to ensure that Medicaid beneficiaries continued to receive prescription drugs during the COVID-19 pandemic.  Find its audit report here.
  • HHS’s OIG has updated its work plan to add a review of nursing home reporting of COVID-19 data to the National Healthcare Safety Network.  Go here to see the updated OIG work plan and here for additional information about the new review.
  • HHS’s Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public to inform its review of telehealth during COVID–19.  For more information about the kind of input the agency seeks, see its request for information notice in the Federal Register.  The deadline for submissions is November 12.
  • On Thursday, September 30, the COVID-19 Health Equity Task Force held its seventh public meeting to vote on a final slate of recommendations for mitigating health inequities caused or exacerbated by the COVID-19 pandemic and for preventing such inequities in the future.  For a summary and links to video of the meeting, go here.

Health Policy News

  • HHS has announced the availability of $100 million in American Rescue Plan funding for state-run programs that support, recruit, and retain primary care clinicians who live and work in underserved communities.  This funding seeks to help improve health equity by ensuring that clinicians working in high-need communities remain in them.  HHS’s Health Resources and Services Administration’s Bureau of Health Workforce is accepting applications for these grants from all 50 states, Washington D.C., and U.S. territories.  HRSA estimates it will make up to 50 awards of up to $1 million a year over the program’s four-year project period.  Learn more about the funding from this HHS announcement and go here to learn about HRSA’s State Loan Repayment Program.  Applications are due April 8, 2022.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published the latest installment of MLN Connects, its online newsletter.  The new edition includes articles about submitting claims for pneumonia vaccines, correct billing practices for non-physician outpatient services provided during or shortly after inpatient stays, changes in the Laboratory National Determination Edit Software for January of 2022, and more.  Find it all here.
  • CMS’s Center for Medicare and Medicaid Innovation has published evaluations of three model programs:  the Maryland Total Cost of Care Model, the Vermont All-Payer Accountable Care Organization Model, and the Pennsylvania Rural Health Model.  Find the new evaluations here.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has awarded 11 new clinical trial research grants worth more than $25 million over the next four years through its Orphan Products Grants Program to clinical investigators to support the development of medical products for patients with rare diseases.  Learn more about the grant recipients and the research they are pursuing in this FDA news release.
  • The FDA has approved an abbreviated new drug application for propofol injectable emulsion single patient-use vials.  This drug is an intravenous general anesthetic and sedation drug listed in the FDA Drug Shortage Database that is used in the treatment of COVID-19 patients.  Learn more from the FDA announcement.

National Institutes of Health

  • The NIH has published preliminary technical research on the effectiveness of mixing different sources of COVID-19 vaccines when receiving booster shots.
  • The NIH reports that a clinical trial has found that treatment with the immunomodulator interferon beta-1a plus the antiviral remdesivir was not superior to treatment with remdesivir alone in hospitalized adults with COVID-19 pneumonia.  In addition, in a subgroup of patients who required high-flow oxygen, investigators found that interferon beta-1a was associated with more adverse events and worse outcomes.  Learn more in this NIH news release.
  • New NIH-funded research suggests how certain treatments are effective for patients with COVID-19 who develop multisystem inflammatory syndrome in children (MIS-C).  Learn more in this NIH news release.
  • The NIH announced that it has issued contract awards totaling $77.7 million to develop and manufacture new rapid diagnostic tests for COVID-19.  The home and point-of-care testing platforms target the need for high-performance, low-cost home tests and point-of-care tests that can potentially detect multiple respiratory infections.  Learn more from this NIH news release.
  • The NIH has awarded 11 grants worth $58 million over five years to focus on interventions to address health disparities and advance health equity.  The grants were awarded based on the significance of the research problem, the novelty of the idea or approach, and the magnitude of the potential impact rather than on preliminary data or experimental details.  Learn more from this NIH news release.

Department of Education

  • The Department of Education has introduced a new resource, which it calls “Supporting Child and Student Social, Emotional, Behavioral and Mental Health,” that outlines key challenges in providing and accessing mental health supports in schools and provides evidence-based recommendations for educators, staff, and providers to create a system of supports for students with behavioral health needs and their families.  Learn more from this White House fact sheet and from the publication Supporting Child and Student Social, Emotional, Behavioral and Mental Health.

National Academies of Sciences, Engineering, and Medicine

  • The National Academies of Sciences, Engineering, and Medicine has published advice for talking to parents about getting their children vaccinated against COVID-19.  Learn more from this news release.

Stakeholder Events

HRSA – New Provider Relief Fund and Rural Hospital Grants – October 21

The Health Resources and Services Administration will hold web events on Thursday, October 21 for providers interested in pursuing Provider Relief Fund grants and funding for rural hospitals provided through the American Rescue Plan.  The purpose of these events is to provide guidance on how to navigate the application portal for seeking such grants.  To register for the October 21 webcast, go here.

CDC – Information about Recent Updates to CDC’s Recommendations for COVID-19 Boosters

On Tuesday, October 26 the CDC will provide an overview for clinicians of the most recent recommendations for administering COVID-19 booster vaccines and updates about the latest recommendations and clinical considerations for administering those boosters.  Go here for further information about the webinar and how to participate.

CDC – Pediatric COVID-19 Vaccines – November 4

The CDC will hold a webinar on Thursday, November 4 to provide an overview of its recommendations and clinical considerations for administering COVID-19 vaccines to children between the ages of five and eleven years old.  Go here for further information about the webinar and how to participate.

Federal Health Policy Update for Tuesday, October 12

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

Provider Relief Fund:  Reminder That Applications Are Now Being Accepted

  • The Health Resources and Services Administration (HRSA) has opened its portal for providers to apply for $25.5 billion in health care relief funds, including $8.5 billion in American Rescue Plan resources for providers that serve rural patients covered by Medicare, Medicaid, or the Children’s Health Insurance Program and $17 billion for Provider Relief Fund Phase 4 grants for a broad range of providers that have experienced changes in operating revenues and expenses as a result of the COVID-19 emergency.  The application period runs for four weeks.  Providers must submit their completed application by October 26.  Go here for further information.

The White House

Department of Health and Human Services

COVID-19

Health Policy News

  • HHS has launched a Spanish version of its QuestionBuilder app, which can help Latino patients prepare for their in-person or telehealth appointments.  Go here to learn more about the app and its features.
  • HHS’s Office of the National Coordinator for Health Information Technology has launched a new initiative called USCDI+ to support the identification and establishment of domain- or program-specific datasets that will operate as extensions of the existing USCDI.  In particular, USCDI+ is a service that ONC will provide to federal partners that seek to establish, harmonize, and advance the use of interoperable datasets that extend beyond the core data in the USCDI to meet agency-specific programmatic requirements.  Learn more from ONC’s USCDI+ web page.
  • HHS has released its Climate Adaptation and Resilience Plan to bolster the resilience of its operations and assets from the accelerating impacts of climate change.  The plan provides a road map for assuring that all parts of the department address the threats to health and well-being related to climate change for all people in the United States, especially those most vulnerable. The plan also ensures continuity of operations of HHS facilities in the face of extreme weather events and fosters healthy greenhouse gas reduction and resilience efforts in the public health sector and community.  Learn more about the plan from this HHS news release, the plan itself, and an HHS policy statement about the plan.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has updated its COVID-19 frequently asked questions on Medicare fee-for-service billing with new information about the application of the revised definition of “direct supervision” to the work of physical therapists and occupational therapists.  Find the new information here, on page 172.
  • CMS has updated its COVID-19 emergency declarations blank waivers for health care providers to waive certain requirements for Medicare-dependent hospitals for the rest of the official public health emergency period.  See the new information on page 12 of the blanket waivers document.

Health Policy News

  • CMS has posted the latest edition of MLN Connects, its online newsletter covering Medicare policy.  The new edition includes articles about a modification of the Medicare-dependent hospital waiver, a quarterly update of the end-stage renal disease prospective payment system, FY 2022 updates of the inpatient psychiatric facilities prospective payment system, new claims-based measures added to the hospice quality reporting program, and more.  Find the new edition of MLN Connects here.
  • CMS has released its 2022 star ratings for Medicare Advantage (Medicare Part C) and Medicare Part D prescription drug plans to help people with Medicare compare plans ahead of Medicare open enrollment, which begins on October 15.  Learn more about the star ratings and find additional resources in this CMS news release.
  • CMS has issued a new report describing what Z codes for social determinants of health revealed about Medicare fee-for-services beneficiaries in 2019.  Find the report here.

Centers for Disease Control and Prevention

National Institutes of Health

  • More than 140,000 children in the U.S. have lost a primary or secondary caregiver because of COVID-19, the NIH reports.  Learn more in this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC met last week.  Issues on its agenda included addressing the high prices of pharmaceutical products and other technologies covered by Medicare; data on Medicare’s net prices for prescription drugs and other drug pricing metrics; a report for Congress on vulnerable Medicare beneficiaries’ access to care; features of Medicare’s alternative payment models; improving Medicare Advantage risk adjustment by limiting the influence of outlier predictions; and the Medicare hospital wage index.  Go here to find the briefs and presentations used to guide the commissioners’ discussions; a transcript should appear at this site as well later this week.

Medicaid and CHIP Payment and Access Commission (MACPAC)

American Medical Association

Stakeholder Events

HRSA – New Provider Relief Fund and Rural Hospital Grants – October 13 and 21

The Health Resources and Services Administration will hold web events on Wednesday, October 13 and Thursday, October 21 for providers interested in pursuing Provider Relief Fund grants and funding for rural hospitals provided through the American Rescue Plan.  The purpose of these events is to provide guidance on how to navigate the application portal for seeking such grants.

  • To register for the October 13 webcast, go here.
  • To register for the October 21 webcast, go here.

FDA – Workshop Addressing Response to the Opioid Crisis – October 13 and October 14

The FDA will hold a workshop titled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS)” to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS effort.  The public workshop will be held on October 13 and October 14.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.

Vaccination Rates Low Among Medicaid Recipients

Individuals enrolled in Medicaid are less likely to have received COVID-19 vaccines than the population as a whole, according to a recently published report.

Among the possible reasons for this low rate, observers speculate, is greater vaccine hesitancy among low-income individuals (as identified in a nation-wide survey), less flexible work schedules, and economic barriers such as lack of transportation or child care.

This can pose a special challenge for safety-net hospitals because the communities they serve have more Medicaid beneficiaries than the typical community.

Learn more about the extent of the problem around the country and what state Medicaid programs are doing to encourage more Medicaid beneficiaries to roll up their sleeves and get vaccinated in the Roll Call article “Medicaid beneficiaries less likely to get COVID-19 shots.”

 

Coronavirus Update for Monday, January 4, 2021

The following is the latest COVID-19 information from the federal government as of 2:30 p.m. on Monday, January 4.

Provider Relief Fund

  • HHS has updated its CARES Act Provider Relief Fund FAQ with six changes, all dated 12/28/2020.  They can be found on pages 6 (accounting for Provider Relief Fund distributions), 16 (use of Provider Relief Fund grant money), 40 (HHS’s methodology for calculating Phase 3 distributions), 41 (two changes:  one about how much providers should expect to receive from the Phase 3 distribution and the other about when providers can expect to receive their Phase 3 distributions), and 56 (addressing nursing home infection control incentive payments).

Centers for Medicare & Medicaid Services

Food and Drug Administration

Centers for Disease Control and Prevention

Vaccines

Clinical Matters

Other CDC Activities

Department of Labor

  • The Department of Labor has issued new guidance to states on unemployment insurance programs based on the unemployment insurance provisions contained in the Continued Assistance for Unemployed Workers Act of 2020, which is part of the Consolidated Appropriations Act of 2021.  Go here to see the department’s announcement about this guidance and go here to see the guidance itself and related documents.
  • The Department of Labor has issued guidance on the expiration of paid sick leave and expanded family medical leave for COVID-19.  Go here to see the department’s announcement about the new guidance and go here for an FAQ on family and medical leave related to COVID-19.