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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.

Federal Health Policy Update for Wednesday, October 6

The following is the latest health policy news from the federal government as of 2:15 p.m. on Wednesday, October 6.  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

Surprise Billing Regulation

  • The Departments of Health and Human Services, Labor, and Treasury and the Office of Personnel Management have issued an interim final rule with comment period to further implement the No Surprises Act, the law that seeks to protect consumers from surprise medical bills that was passed last December.  This rule is the third in a series implementing the No Surprises Act:  the first two were a rule to help collect data on the air ambulance provider industry and a rule in July on consumer protections against surprise billing.  Collectively, these rules take effect January 1, 2022 and ban surprise billing for emergency services as well as certain non-emergency care provided by out-of-network providers at in-network facilities and limit high out-of-network cost-sharing for emergency and non-emergency services for patients.  This latest rule details a process that will take patients out of the middle of payment disputes, provides a process to settle out-of-network rates between providers and payers, and outlines requirements for health care cost estimates for uninsured or self-pay individuals.  Other consumer protections in the rule include a payment dispute resolution process for uninsured or self-pay individuals.  It also adds protections in an external review process so that individuals with job-based or individual health plans can dispute denied payment for certain claims.  To learn more about the latest rule implementing the No Surprises Act, see the following resources:

Department of Health and Human Services

COVID-19

  • A new HHS report found that COVID-19 vaccinations may have helped prevent approximately 265,000 COVID-19 infections, 107,000 hospitalizations, and 39,000 deaths among Medicare beneficiaries alone between January and May of 2021.  The study was conducted by researchers with HHS’s Office of the Assistant Secretary for Planning and Evaluation.  Learn more from this HHS news release and the HHS report.
  • HHS’s Office for Civil Rights has issued guidance to help the public understand when the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule applies to disclosures and requests for information about whether a person has received a COVID-19 vaccine.  The guidance reminds the public that the HIPAA Privacy Rule does not apply to employers or employment records.  Learn more from the HHS news release announcing the guidance and from the guidance itself.

Health Policy News

  • HHS has rescinded a regulation that required health centers to create and maintain new practices necessary to determine patients’ eligibility to receive certain drugs at or below the discounted price paid by the health center or subgrantees plus an administration fee under the section 340B prescription drug discount program.  In particular, the rule affected patient eligibility for insulin products at reduced prices.  Although HHS is withdrawing the rule itself, the executive order the rule was intended to implement remains in effect and, according to language in the recission, “HHS is exploring non-regulatory options to implement the Executive Order.”  Learn more from the Federal Register notice rescinding the 2020 rule.
  • HHS has issued a final rule to revise the Title X family planning program.  The rule restores eligibility for federal family planning funds for organizations that also perform abortions or provide referrals for them, requires family planning facilities to broaden their array of services, and adds health equity considerations to the review of grant requests.  Learn more from HHS’s announcement about the new rule and from the rule itself.
  • HHS has awarded $2.21 billion in Ryan White HIV/AIDS Program funding for cities, counties, states, and local community-based organizations in FY 2021.  The Ryan White HIV/AIDS Program provides care and treatment services to low-income people with HIV and serves approximately 50 percent of all people diagnosed with HIV in the U.S.  Learn more from the HHS announcement, which includes links to several categories of grant recipients.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has updated its information about Medicare and Medicaid opioid prescribing rates based on geography.  Find the updated Medicare data here and the updated Medicaid data here.
  • CMS is offering web-based training to assist skilled nursing facility providers with coding for data element O0100, part of the Minimum Data Set.  Go here for a description of the training and the on-demand training itself.

Centers for Disease Control and Prevention

COVID-19

Health Policy News

  • The CDC announced that it has awarded 20 grants under its “Closing the Gap with Social Determinants of Health Accelerator Plans” initiative.  The funding, which was awarded on a competitive basis, is intended to help accelerate actions in state, local, tribal, and territorial jurisdictions that lead to improved chronic disease outcomes among persons experiencing health disparities and inequities.  Learn more about the program and the grant recipients in this CDC announcement.

Food and Drug Administration

  • The FDA has issued emergency use authorization for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter COVID-19 antigen test.  The agency expects this authorization to double rapid at-home testing capacity in the U.S. over the next several weeks.  By the end of the year the manufacturer plans to produce more than 100 million tests a month, and this number will rise to 200 million a month by February of 2022.  Learn more from this FDA announcement.
  • The FDA has revised its guidance on the compounding of drugs by hospitals and health systems.  Learn more from the FDA announcement of the revision and from the newly revised guidance.

National Institutes of Health

  • The NIH has released a study of the impact of the COVID-19 pandemic on Black, American Indian/Alaska Native, and Latino individuals in the United States.  Learn more from this NIH news release, which summarizes the study’s findings, and from the Annals of Internal Medicine article “Racial and Ethnic Disparities in Excess Deaths During the COVID-19 Pandemic, March to December 2020.”
  • An NIH analysis has found the risk of COVID-19 breakthrough infections among vaccinated patients with substance use disorders to be low overall but higher than the risk among vaccinated people without substance use disorders.  The study also found that co-occurring health conditions and adverse socioeconomic determinants of health, which are more common in people with substance use disorders, appear to be largely responsible for the increased risk of COVID-19 breakthrough infections.  People with substance use disorders – such as alcohol, cannabis, cocaine, opioid, and tobacco use disorders – also had elevated rates of severe outcomes, including hospitalization and death, following breakthrough infections.  Learn more from this NIH news release and from the article “Increased risk for COVID-19 breakthrough infection in fully vaccinated patients with substance use disorders in the United States between December 2020 and August 2021,” published in the journal World Psychiatry.
  • Through its High-Risk, High-Reward Research program, the NIH has awarded 106 grants “…to support highly innovative and broadly impactful biomedical or behavioral research by exceptionally creative scientists…”  Learn more about the categories in which the grants were awarded and find links to more information about those categories and this year’s grant winners in this NIH news release.

Government Accountability Office (GAO)

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.

CDC – Recommendations for Influenza Prevention and Treatment in Children – October 7

The CDC and experts from the American Academy of Pediatrics will hold a webinar on Thursday, October 7 at 2:00 p.m. (eastern) to discuss strategies that primary care providers and medical subspecialists can use to improve, prevent, and control influenza among children during the upcoming flu season.  Go here to learn more about the webinar and how to participate.

MedPAC – Public Meeting – October 7 and October 8

The Medicare Payment Advisory Commission (MedPAC) will hold its October public meetings on  Thursday, October 7 and Friday, October 8.  The meetings will be held virtually.  Go here to find the agenda for the two days of meetings and information about how to join those meetings.

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.

Federal Health Policy Update for Thursday, September 30

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

Provider Relief Fund:  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 will run for four weeks.  Providers must submit their completed application by October 26.  Go here for further information.

Provider Relief Fund:  More Information

  • As the period begins for applying for Provider Relief Fund Phase 4 grants and funding for rural hospitals provided through the American Rescue Plan (ARP), HRSA has updated some of its resources providing information about who is eligible to apply for these funds and how to submit applications.
  • HRSA’s Provider Relief Fund web site has a new section titled “Requesting a Phase 3 Payment Reconsideration.”  This is for providers that did not receive the grants they expected from the Phase 3 distribution.  The new section notes that HRSA will only consider reconsideration requests from providers that believe their Phase 3 payment calculation was incorrect and that the agency will not consider reconsideration requests that would require a change in payment methodology or policy.
  • Another section on the Provider Relief Fund web site has been renamed “Phase 4 and ARP Rural Payments.”  This section reminds interested parties that the portal is now open for applications and will remain open until the application deadline of October 26.  It also offers links to extensive resources to assist providers applying for funds, including application instructions, sample application forms, a “how to apply” flow chart, an annual revenues from patient care worksheet, an annual revenues adjustment worksheet, general program information, a general fact sheet, a fact sheet for complex organizational structures, two FAQs, and terms and conditions for both the Phase 4 grants and the rural hospital distribution.
  • HHS also has relocated and updated its separate Provider Relief Fund FAQ web site, which it has renamed “Provider Relief Programs:  Provider Relief Fund and ARP Rural Payments Frequently Asked Questions.”  The updated FAQ has 30 additions that address a wide variety of matters involving applying for new grants, reporting on the use of previously awarded grants, eligibility for future funding, and more.  These additions can be found on pages 3 5, 9, 13, 17, 27, 32, 33, and 57-61; are all marked either 9/13 or 9/29.
  • In addition, the FAQ web site has five entirely new sections from page 61 through 67:
    • ARP Rural Payments Overview and Eligibility” (p.61)
    • “Phase 4/ARP Rural Payment Tax Identification Number (TIN) Validation Process” (p. 62)
    • “Phase 4 Application Process” (p. 63)
    • “Phase 4 Complex Financial Situations” (p. 65)“
    • ARP Rural Payments Application Process” (p. 67).
  • HRSA had previously scheduled a web event on Tuesday, October 5 for providers interested in pursuing Provider Relief Fund grants and funding for rural hospitals.  The purpose of this webcast is to provide guidance on how to navigate the application portal for seeking grants.  Learn more here and find a link to register to participate.
  • HRSA has now announced two additional web events for the same purpose:  on Wednesday, October 13 (go here to register) and Thursday, October 21 (go here to register).
  • HHS recently hosted a briefing session to provide information about these upcoming funding opportunities.  View a video of that session here.

Congress

  • Congress has passed a continuing resolution to fund the federal government at current levels until December 3.  This continuing resolution does not include any remedy for the federal government’s debt limit, which the Treasury Secretary has predicted will be reached by mid-October.  Congressional Democrats continue internal negotiations on the infrastructure bill and a reconciliation package containing President Biden’s domestic “social infrastructure” priorities.

The White House

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has posted the latest edition of MLN Connects, its online newsletter.  The latest issue reports on clinical laboratory fee schedule updates, correct billing for post-acute care transfers, an update of the outpatient prospective payment system, and more.  Go here for the latest edition of MLN Connects.
  • CMS has released the 2022 premiums, deductibles, and other key information for Medicare Advantage and Part D prescription drug plans in advance of the annual Medicare Open Enrollment to help Medicare enrollees decide on coverage.  The average premium for Medicare Advantage plans will be lower in 2022 at $19 a month, compared to $21.22 in 2021, while projected enrollment continues to increase.  As previously announced, the average 2022 premium for Part D coverage will be $33 a month, compared to $31.47 in 2021.  Learn more from this CMS news release.
  • CMS has announced the CY 2022 participants in its Medicare Advantage Value-Based Insurance Design Model.  For CY 2022, the model will have 34 participating Medicare Advantage organizations, up from 14 in 2020 and 19 in 2021.  Learn more about the model and how it works and find a list of participating plans for 2022 in this CMS fact sheet.
  • CMS has announced CY 2022 Part D plan sponsor participants in its Part D Senior Savings Model.  Learn more about the program, how it works, and the 2022 participants from the Part D Senior Savings Model web page.

Department of Health and Human Services

COVID-19

Centers for Disease Control and Prevention

National Institutes of Health

  • The NIH has issued a request for information seeking feedback from stakeholders in the scientific research community, clinical practice communities, patient and family advocates, scientific and professional organizations, federal partners, internal NIH stakeholders, and other interested constituents on research opportunities and operational activities related to the NIH Strategic Plan to Advance Research on the Health and Well-Being of Sexual and Gender Minorities for fiscal years 2021–2025.  The goal of this request for information is to provide organizations, researchers, non-profits, and community members an opportunity to identify potential research opportunities and operational activities related to the NIH mission.  Comments must be received by December 3, 2021.  Learn more from this Federal Register notice.

Stakeholder Events

HRSA – New Provider Relief Fund and Rural Hospital Grants – October 5, 13, and 21

The Health Resources and Services Administration will hold web events on Tuesday, October 5, 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 the event is to provide guidance on how to navigate the application portal for seeking these grants.

  • To register for the October 5 webcast, go here.
  • To register for the October 13 webcast, go here.
  • To register for the October 21 webcast, go here.

CDC – Recommendations for Influenza Prevention and Treatment in Children – October 7

The CDC and experts from the American Academy of Pediatrics will hold a webinar on Thursday, October 7 at 2:00 p.m. (eastern) to discuss strategies that primary care providers and medical subspecialists can use to improve, prevent, and control influenza among children during the upcoming flu season.  Go here to learn more about the webinar and how to participate.

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.

 

Federal Health Policy Update for Tuesday, September 28

The following is the latest health policy news from the federal government as of 2:30 p.m. on Tuesday, September 28.  Some of the language used below is taken directly from government documents.

Provider Relief Fund:  Application Reminder

  • Beginning on September 29, health care providers may 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 will run for four weeks.  Providers must submit their completed application by October 26.  Go here for further information.

Provider Relief Fund:  More Information

  • HHS has updated its information on Phase 4 Provider Relief Fund grants and American Rescue Plan grants for rural providers.  The new information includes:
    • Types of eligible providers.
    • An explanation that although general distribution payments will be allocated based on “changes to operating revenue and expenses” from July 1, 2020 to March 31, 2021, the payments can be used to cover eligible lost revenue and expenses incurred from January 1, 2020 through December 31, 2022.
    • The addition of the time period for identifying care provided to individuals living in rural areas:  January 1, 2019 through September 30, 2020.
  • The Health Resources and Services Administration will hold web events on Thursday, September 30 and Tuesday, October 5 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 grants.  Learn more here and find a link to register to participate.  HRSA has announced that it will hold additional sessions during the weeks of October 11 and October 18; dates and times for those events have not yet been announced.
  • HHS recently hosted a briefing session to provide information about these upcoming funding opportunities.  View a video of that session here.

Department of Health and Human Services

COVID-19

Health Policy News

  • HHS has awarded nearly $1 billion in American Rescue Plan funding to nearly 1300 Health Resources and Services Administration (HRSA) Health Center Program-funded health centers in all 50 states, the District of Columbia, and the U.S. territories to support major health care construction and renovation projects.  According to HHS, health centers will use this funding for COVID-19-related capital needs, constructing new facilities, renovating and expanding existing facilities to enhance response to pandemics, and purchasing new state-of-the-art equipment, including telehealth technology, mobile medical vans, and freezers to store vaccines.  Learn more about the funding, its intended use, and how much money was granted to facilities in each state in this HHS news release.
  • Following up on a previously announced commitment, HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) has announced the distribution of $825 million in federal funds to 231 community mental health centers across the country.  This grant program is intended to enable community mental health centers to more effectively address the needs of individuals who have a serious emotional disturbance or mental illness, often accompanied by substance use disorders.  For a more detailed description of the work the community mental health centers are expected to do with this money and a link to a list of the 231 facilities awarded grants, see this HHS news release.

Centers for Medicare & Medicaid Services

COVID-19

  • Following the FDA’s recent authorization of a booster dose of the Pfizer COVID-19 vaccine for certain high-risk populations and a recommendation from the CDC, CMS will continue to provide coverage for booster doses without cost-sharing.  Beneficiaries with Medicare will pay nothing for COVID-19 vaccines or their administration and there is no copayment, coinsurance, or deductible.  In addition, nearly all Medicaid and CHIP beneficiaries must receive coverage of COVID-19 vaccines and their administration without cost-sharing.  COVID-19 vaccines and their administration, including boosters, will also be covered without cost-sharing for eligible consumers of most issuers of health insurance in the commercial market.  Learn more from this CMS news release.

Health Policy News

  • CMS has posted a special edition of its online newsletter MLN Connects explaining that effective September 20 it is exercising enforcement discretion for skilled nursing facility consolidated billing provisions related to flu and pneumococcal vaccines that enables Medicare-enrolled immunizers, including pharmacies, to bill directly and get direct reimbursement from Medicare, including for vaccine administration and product, whether these vaccines are administered at the same time (co-administered) as a COVID-19 vaccine or at different times.  Find the notice here.

Centers for Disease Control and Prevention

National Institutes of Health

  • The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, has awarded approximately $36.3 million to three academic institutions to conduct research to develop vaccines to protect against multiple types of coronaviruses and viral variants.  The awards are intended to fuel vaccine research for a diverse family of coronaviruses, with a primary focus on potential pandemic-causing coronaviruses such as COVID-19.  Learn more about the anticipated research and the grant recipients in this NIH news release.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC commissioners met last week to discuss a variety of Medicaid and CHIP payment and access issues, including communicating with beneficiaries, workforce issues, monitoring access to care, health IT adoption among behavioral health providers, and vaccines for adults.  Go here for a summary of the meeting and links to issue briefs prepared to support the commissioners’ discussions.

Government Accountability Office (GAO)

  • The GAO has published a short report that draws from a number of past GAO reports to describe examples of racial and ethnic health disparities, barriers that may contribute to disparities, and federal efforts to help address them.  In this report the GAO cites policy considerations and reiterates recommendations to improve gaps in race and ethnicity data.  Learn more in “GAO Health Care Capsule:  Racial and Ethnic Health Disparities.”
  • In 2016, HHS selected eight states to participate in a time-limited demonstration to establish certified community behavioral health clinics to help improve their response to depression and opioid use challenges within their Medicaid populations.  The GAO has now reviewed the efforts of those states, including the degree to which spending on these services changed during the demonstration period, and has offered recommendations on provider payments and overlap with other Medicaid payments.  Learn more from the GAO report “Medicaid Behavioral Health:  CMS Guidance Needed to Better Align Demonstration Payment Rates with Costs and Prevent Duplication.”

Stakeholder Events

HRSA – New Provider Relief Fund and Rural Hospital Grants – September 30 and October 5

The Health Resources and Services Administration will hold web events on Thursday, September 30 and Tuesday, October 5 for providers interested in pursuing Provider Relief Fund grants and funding for rural hospitals provided through the American Rescue Plan.  The purpose of the event is to provide guidance on how to navigate the application portal for seeking these grants.  Learn more here and find a link to register to participate.

CDC – Evaluating and Supporting Patients Presenting With Fatigue Following COVID-19 – September 30

The CDC will hold a webinar on evaluating and supporting patients who present with fatigue following treatment for COVID-19.  The webinar will be held on Thursday, September 30.  For further information on the subjects the webinar will cover, those who will be participating in the event, and how to join the webinar, go here.

HHS/Office of the Assistant Secretary for Preparedness and Response – Grand Rounds for EMS, Critical Care, and Emergency Department ICU Care of Pediatric COVID Patients – September 30

The agency’s “clinical rounds” sessions return on Thursday, September 30 at noon (eastern) with presenters who will discuss emergency management resources and information that can be used to improve operations during the COVID-19 pandemic.  Go here to register to participate in the remote event.

CDC – Recommendations for Influenza Prevention and Treatment in Children – October 7

The CDC and experts from the American Academy of Pediatrics will hold a webinar on Thursday, October 7 at 2:00 p.m. (eastern) to discuss strategies that primary care providers and medical subspecialists can use to improve, prevent, and control influenza among children during the upcoming flu season.  Go here to learn more about the webinar and how to participate.

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.

Federal Health Policy Update for Thursday, September 23

The following is the latest health policy news from the federal government as of 3:30 p.m. on Thursday, September 23.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

  • HHS’s Health Resources and Services Administration has posted new information about planned distributions of additional COVID-19 supplemental funding for health care providers through the Provider Relief Fund and for qualified rural hospitals through funding made available through the American Rescue Plan.  Included in the new posting is information about:
    • Web events to explain what the agency is doing and what providers must do to pursue funding, to be held on Thursday, September 30 and Tuesday, October 5.
    • An application deadline of October 26.
    • What providers are eligible for funding.
    • Documentation grant applicants will need to submit.

Learn more from the updated Provider Relief Fund web page.

Department of Health and Human Services

COVID-19

Health Policy News

  • HHS’s Office of the National Coordinator for Health Information Technology has awarded $73 million in cooperative agreement grants as part of its Public Health Informatics & Technology Workforce Development Program to strengthen U.S. public health information technology (IT) efforts, improve COVID-19 data collection, and increase representation of underrepresented communities within the public health IT workforce.  Learn more about how the money will be used and find a list of the grant recipients in this HHS news release.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has granted exceptions for certain Medicare quality reporting and value-based purchasing programs located in areas affected by Hurricane Ida.  These exceptions apply to acute-care hospitals, ambulatory surgical centers, prospective payment system-exempt cancer hospitals, inpatient psychiatric facilities, inpatient rehabilitation facilities, long-term-care hospitals, and skilled nursing facilities in parts of Louisiana, Mississippi, New York, and New Jersey.  Learn more about the exceptions and the specific geographic areas to which they apply in this CMS notice.
  • CMS has published the latest edition of MLN Matters, its online newsletter.  The new edition includes articles about various Medicare billing issues, an update of the ambulatory surgical center payment system, and more.  Find it all here.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has amended its emergency use authorization for the Pfizer COVID-19 vaccine to allow for use of a single booster dose to be administered at least six months after completion of the primary series in individuals 65 years of age and older; individuals 18 through 64 at high risk of severe COVID-19; and individuals 18 through 64 years whose frequent institutional or occupational exposure to COVID-19 puts them at high risk of serious complications from COVID-19.  See the FDA announcement and an explanation of the decision here.

Stakeholder Events

MACPAC – September meetings – September 24

The Medicaid and CHIP Payment and Access Commission (MACPAC) is holdings its scheduled September meeting of commissioners on Thursday, September 23 and Friday, 24 to discuss federal Medicaid and CHIP policies.  The meetings are being be held virtually.  Find the meeting agenda here and go here to register to view the sessions.

CDC – Latest CDC Recommendations for Pfizer COVID-19 Booster Vaccination – September 28

The CDC will hold a webinar on Tuesday, September 28 to give clinicians an overview of the Pfizer COVID-19 booster vaccination.  Clinicians will learn about the vaccine booster recommendations, the safety of booster dose, and clinical guidance for using the Pfizer booster vaccine.  Go here for more information about the event and to register to participate.

HRSA – New Provider Relief Fund and Rural Hospital Grants – September 30 and October 5

The Health Resources and Services Administration will hold web events on Thursday, September 30 and Tuesday, October 5 for providers interested in pursuing Provider Relief Fund grants and funding for rural hospitals provided through the American Rescue Plan.  The purpose of the event is to provide guidance on how to navigate the application portal for seeking these grants.  Learn more here and find a link to register to participate.

CDC – Evaluating and Supporting Patients Presenting With Fatigue Following COVID-19 – September 30

The CDC will hold a webinar on evaluating and supporting patients who present with fatigue following treatment for COVID-19.  The webinar will be held on Thursday, September 30.  For further information on the subjects the webinar will cover, those who will be participating in the event, and how to join the webinar, go here.

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

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.

Federal Health Policy Update for Tuesday, September 21

The following is the latest health policy news from the federal government as of 2:45 p.m. on Tuesday, September 21.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • NASH has submitted formal comments to CMS on the agency’s proposed outpatient prospective payment system regulation for calendar year 2022.  Writing from the perspective of private community safety-net hospitals, NASH addresses proposals and request for information about health equity, the section 340B prescription drug discount program, hospital price transparency requirements, proposed changes in Medicare’s inpatient-only procedures list, and the extension of provider flexibilities introduced in response to the COVID-19 public health emergency.  See NASH’s comment letter here.
  • In July the newly formed Congressional Social Determinants of Health Caucus invited stakeholders to respond to a series of questions designed to help the caucus learn more about social determinants of health and what Congress might do to address them more effectively.  Go here to read NASH’s response to the caucus’s questionnaire.

Provider Relief Fund

  • HHS has updated its Provider Relief Fund reporting portal’s frequently asked questions.  Find the updated FAQ here.
  • HHS has published a Provider Relief Fund reporting portal user guide.  Find the guide here.

The White House

Department of Health and Human Services

COVID-19

  • The federal government has responded to recent increases in COVID-19 cases by assuming control of the distribution of monoclonal antibodies used to treat the virus.  Learn more from the announcement of this new approach.  Federal officials also explain the new policy, why they are pursuing it, and how it will work in this video of a web event.

Health Policy News

  • HHS has extended the open enrollment period for people seeking health insurance on the federally facilitated marketplace and has extended the scope of services provided by navigators for that marketplace.  The department also has authorized state marketplaces to set their own open enrollment dates.  Learn more from this HHS news release.
  • HHS and its Health Resources and Services Administration (HRSA) have awarded $48 million to 271 HRSA-supported health centers in 26 states, Puerto Rico, and the District of Columbia to expand HIV prevention and treatment, outreach, and care coordination services.  To learn more about the awards, how the money will be used, and the award recipients, see this HHS announcement.
  • HHS and HRSA have awarded $350 million in grants to every state to support safe pregnancies and healthy babies.  Funding will be used expand home visiting services to families most in need, increase access to doulas, address health disparities in infant deaths, and improve data reporting on maternal mortality.  The money is being awarded through the Maternal, Infant, Early Childhood Home Visiting Program, the Healthy Start Initiative, and the State Systems Developmental Initiative.  To learn more about how HHS intends for the money to be spent, how much money is being allocated through these programs, and how much money individual recipients will receive, see this HHS announcement.
  • HRSA has announced the availability of funding to support continued access to comprehensive, culturally competent, high-quality primary health care services for communities and populations currently served by its Health Center Program.  Eligible organizations include domestic public or non-profit private entities that propose to serve an announced service area and its associated population(s) to ensure continued access to affordable, quality primary health care services.  Learn more from this HRSA announcement.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • The latest edition of the CMS online publication MLN Connects includes Medicare’s quarterly provider quality compliance newsletter and information about annual HPSA updates, flu vaccine payment allowances, updated clinical lab fees, and more.  Find the September 16 edition of MLN Connects here.
  • CMS has posted a pre-publication version of a final rule that sets forth revised 2022 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges and State-based Exchanges on the federal platform; repeals separate billing requirements related to the collection of separate payments for the portion of QHP premiums attributable to coverage for certain abortion services; expands the annual open enrollment period and Navigator duties; implements a new monthly special enrollment period for qualified individuals or enrollees, or the dependents of a qualified individual or enrollee, who are eligible for advance payments of the premium tax credit (APTC) and whose household income does not exceed 150 percent of the federal poverty level, available during periods of time during which APTC benefits are available such that certain applicable taxpayers’ applicable percentage is set at zero, such as during tax years 2021 and 2022 under the section 9661 of the American Rescue Plan Act of 2021; repeals the recent establishment of a Direct Enrollment option for Exchanges; and modifies regulations and policies related to section 1332 waivers.  Find the document here.
  • CMS has published three FAQs that explain that the agency will not take enforcement action against certain payers for the payer-to-payer data exchange provision of the May 2020 Interoperability and Patient Access final rule until future rulemaking is finalized.  CMS’s decision to exercise enforcement discretion for the payer-to-payer policy until future rulemaking occurs does not affect any other existing regulatory requirements and implementation timelines outlined in the final rule.  Go here to see the announcement and find links to the FAQs.
  • CMS has proposed repealing the Medicare Coverage of Innovative Technology and Definition of ‘”Reasonable and Necessary” final rule, which was published on January 14, 2021 and is scheduled to take effect on December 15.  The repealed rule was a response to concerns that breakthrough technologies were not being made available to the Medicare population in a timely manner but CMS now believes more care must be taken before authorizing the use of such technologies for Medicare patients.  Find the proposed rule here.
  • CMS has published its Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) Quarterly Q&As December 2020 document so inpatient rehabilitation facility (IRF) providers have the benefit of clarifications to existing guidance.
  • CMS has published the Long-Term-Care Hospital (LTCH) CARE Data Set Quarterly Q&As, September 2021, Consolidated September 2020 to September 2021 document so LTCH providers have the benefit of the clarifications to existing guidance.
  • CMS has awarded $15 million in planning grants to 20 states to support expanding community-based mobile crisis intervention services for Medicaid beneficiaries.  Learn more about the services the grants will underwrite and find a list of grant recipients in this CMS announcement.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has revised its emergency use authorization (EUA) for the monoclonal antibodies bamlanivimab and etesevimab, administered together, to include emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.  In this revision of the EUA, bamlanivimab and etesevimab, administered together, are authorized for use after exposure to the virus and are not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the COVID-10 virus.  Learn more from the FDA announcement, the revised EUA, and this fact sheet for providers.
  • The FDA has updated its enforcement policy for masks, barrier face coverings, face shields, surgical masks, and respirators during the COVID-19 public health emergency.  Find the updated policy here.

National Institutes of Health

  • The NIH has awarded $470 million to build a national study population of diverse research volunteers and support large-scale studies on the long-term effects of COVID-19.  Learn more from this NIH news release.

Stakeholder Events

MACPAC – September meetings – September 23 and 24

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its scheduled September meeting of commissioners on Thursday, September 23 and Friday, 24 to discuss federal Medicaid and CHIP policies.  The meetings will be held virtually.  Find the meeting agenda here and go here to register to view the sessions.

CDC – Evaluating and Supporting Patients Presenting With Fatigue Following COVID-19 – September 30

The CDC will hold a webinar on evaluating and supporting patients who present with fatigue following treatment for COVID-19.  The webinar will be held on Thursday, September 30 at 2:00 p.m. (eastern).  For further information on the subjects the webinar will cover, those who will be participating in the event, and how to join the webinar, go here.

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

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 from 1 p.m. to 5 p.m. (eastern) and October 14 from 1 p.m. to 4:00 p.m.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.

 

Federal Health Policy Update for Monday, September 13

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, September 13.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

  • HHS and its Health Resources and Services Administration (HRSA) are making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic.  This funding includes $8.5 billion in American Rescue Plan money for providers that serve rural Medicaid, Children’s Health Insurance Program (CHIP), or Medicare patients and an additional $17 billion for Provider Relief Fund Phase 4 grants for a broad range of providers that can document revenue loss and expenses associated with the pandemic.  To learn more about the funding to be distributed and how it will be distributed, see the following resources:

NASH members received a more detailed explanation about the availability of these funds last Friday, September 10.

The White House

Department of Health and Human Services

COVID-19

  • HHS has amended the Public Readiness and Emergency Preparedness (PREP) Act declaration to provide liability protection to licensed pharmacists, pharmacy technicians, and pharmacy interns to provide a pathway for increased access to COVID-19 therapeutics – specifically, monoclonal antibodies – especially in surge states with rising numbers of COVID-19 cases and in rural areas where access to inpatient and outpatient services may be more limited.  For more information about the health care professionals to which these protections have been extended and about the protections themselves, see this HHS announcement.  This amendment of the PREP Act also will be published in the Federal Register; go here to see a pre-publication version of the Federal Register notice.

Health Policy News

  • HHS, the departments of Labor and the Treasury, and the Office of Personnel Management have proposed rules that would require health plans, issuers, and providers of air ambulance services to submit detailed data regarding air ambulance services specified in the reporting requirements of the No Surprises Act.  The rules also outline CMS’s authority to fully enforce Title I (the No Surprises Act) and Title II (Transparency) of Division BB of the Consolidated Appropriations Act of 2021 in states that do not have the authority to enforce or fail to substantially enforce one or more of the provisions and seek to help consumers understand the compensation being paid to agents and brokers who help them select health insurance.  This is the latest regulatory action in a series of rulemaking implementing the No Surprises Act.  Learn more from the following resources:
  • HHS is awarding $20 million in American Rescue Plan grant funding to state-based marketplaces to increase consumer access to affordable, comprehensive health insurance coverage.  The grants will be used by 21 state-based marketplaces to modernize IT systems and/or conduct targeted consumer outreach activities to help make health care coverage enrollment simpler.  Learn more about how the money will be used and which state-based marketplaces will receive it in this HHS announcement.
  • HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) is awarding more than $123 million in funding through six grant programs to provide support to communities and health care providers to help combat the overdose epidemic.  Grants are being awarded through six existing programs:  Medication Assisted Treatment for Prescription Drug and Opioid Addiction; Tribal Opioid Response Grants; Screening, Brief, Intervention, and Referral to Treatment; Strategic Prevention Framework for Prescription Drugs; First Responder-Comprehensive Addiction and Recovery Act Grants; and Providers Clinical Support System – Universities.  Learn more about where the money will go and how it will be spent in this HHS news release.

Centers for Medicare & Medicaid Services

COVID-19

  • The administration announced that it will require COVID-19 vaccination of staff in all Medicare- and Medicaid-certified facilities.  CMS, in collaboration with the CDC, announced that emergency regulations requiring vaccinations for nursing home workers will be expanded to include hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in the Medicare and Medicaid programs.  Go here to find an explanation of the new policy.

Health Policy News

  • CMS announced that it is rescinding audit determinations for providers notified in January of 2021 that they had failed to qualify for what is known as the “mid-build exception.”  The Bipartisan Budget Act of 2015 changed how off-campus provider-based departments are paid for items and services furnished to Medicare beneficiaries.  CMS will review each previously failing provider’s audit findings for compliance with statutory requirements and for accuracy and completeness and providers that received failing audit determinations are no longer required to report or return overpayments based on those determinations.  Each provider will receive a letter rescinding the previous determination.   An updated audit determination letter will be issued following the review of each provider’s audit.  A new overpayment return deadline for self-identified overpayments will be included in that letter should the provider receive a failing audit determination.  Learn more from this CMS announcement.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has approved an abbreviated new drug application for dexmedetomidine injection USP, 200 mcg/2 mL, indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures.  The drug is often used on COVID-19 patients who need ventilators.  See the FDA’s announcement.

Stakeholder Events

 CDC – Evaluating and Supporting Patients Presenting With Fatigue Following COVID-19 – September 30

The CDC will hold a webinar on evaluating and supporting patients who present with fatigue following treatment for COVID-19.  The webinar will be held on Thursday, September 30 at 2:00 p.m. (eastern).  For further information on the subjects the webinar will cover, those who will be participating in the event, and how to join the webinar, go here.

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

The FDA will hold a workshop entitled “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 from 1 p.m. to 5 p.m. (eastern) and October 14 from 1 p.m. to 4:00 p.m.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.

 

Federal Health Policy Update for Thursday, September 9

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, September 9.  Some of the language used below is taken directly from government documents.

The White House

Congress

  • Democrats on the House Energy and Commerce Committee today introduced their contribution to their party’s anticipated $3.5 trillion dollar spending bill.  Their portion of the reconciliation bill addresses expanding Medicaid in non-expansion states, reducing prescription drug prices, increasing federal spending on home-based care, and more.  Find their summary of their proposals here.

Provider Relief Fund

  • HHS’s Human Resources and Services Administration (HRSA) has published a notice explaining how Provider Relief Fund payments can be used for a wide variety of direct and indirect costs of recruiting and retaining personnel during the COVID-19 emergency.  Find the notice here.
  • With the next deadline for health care providers to report on their use of Provider Relief Fund grants coming up on September 30, HRSA will hold an “office hours” web event on Friday, September 10 at 1:00 (eastern) to address issues involving Provider Relief Fund reporting and auditing requirements.  For information about how to join the event and more about reporting and auditing requirements, go here.

Department of Health and Human Services

COVID-19

  • HHS Secretary Xavier Becerra has released a new plan to reduce prescription drug prices.  One of the key policies in this effort is legislation that would enable the Secretary of HHS to negotiate Medicare Part B and Part D drug prices directly with pharmaceutical companies and make those prices available to other purchasers.  Learn more about this plan from the HHS announcement, an HHS fact sheet, and the full plan.
  • The Office of the Assistant Secretary for Preparedness and Response has announced a new Notice of Funding Opportunity to establish Partnership(s) for Enhanced Efforts To Strengthen The Nation’s Healthcare And Public Health Preparedness, Response, And Recovery To Disasters And Other Emergencies.  This program seeks to fund up to seven new cooperative agreements to enable the agency’s broad collaboration with public health and health care sectors and emergency management services to ensure that local governments, communities, private sector entities, non-governmental organizations, academia, and individuals can optimally coordinate their respective national health security roles and responsibilities to achieve community health resilience and strengthen health care, public health, and emergency management systems in preparation of, response to, and recovery from disasters and other emergencies.  $20 million in grants will be awarded, with a maximum grant of $4 million.  The deadline for applications is September 22.
  • HHS’s Office of the Assistant Secretary for Planning and Readiness has updated its information on planning considerations for the administration of monoclonal antibodies.  Find the updated information here.
  • The Office of the Assistant Secretary for Planning and Readiness has published guidance to hospitals on how to address a surge of patients with behavioral health challenges during the COVID-19 pandemic.
  • HHS’s Office of the Inspector General has published a report that describes the complex care needs of beneficiaries hospitalized with COVID-19.  The report focuses on surges in COVID-19 hospitalizations in six localities and builds upon prior OIG work that describes the extent to which hospitals have been strained by COVID-19.  Find the report here.
  • Another report by HHS’s OIG found that the COVID-19 case and death data submitted by nursing homes to the federal government is incomplete and inaccurate despite CMS’s efforts to require such data reporting weekly.  Find the report here.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has posted two new editions of MLN Connects, its online newsletter.  Subjects addressed in the September 2 edition include changes in Medicare provider enrollment processes, information about CMS’s planned implementation of its ambulance prior authorization model, the hospice quality reporting program, and more.  Go here to see the September 2 edition of MLN Connects.
  • The September 9 edition of MLN Connects includes information about a payment update on outpatient clinic visit services at excepted off-campus provider-based departments, the Medicare fee-for-service response to the COVID-19 emergency, skilled nursing facility consolidated billing web-based training, and more.  Find the September 9 edition of MLN Connects here.
  • CMS is distributing $452 million in federal funding to support 13 states’ efforts to improve access to affordable, comprehensive health insurance coverage through section 1332 state-based reinsurance waivers.  As a result of changes made in the American Rescue Plan Act of 2021, residents in states implementing reinsurance waivers may have access to more affordable health insurance coverage.  States also will have more pass-through funding to implement their waiver.  Learn more about the funding, how it will be used, and which states will receive it in this HHS news release.
  • CMS’s Center for Medicare and Medicaid Innovation has posted the annual report for its Comprehensive Care for Joint Replacement Model.  Go here to see the annual report and here for more information about and resources for the program.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has revised its guidance on the authorized use of the monoclonal antibodies bamlanivimab and etesevimab when administered together.  The Emergency Use Authorization now authorizes the use of bamlanivimab and etesevimab, administered together, only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to five percent.  The FDA has posted a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together are currently authorized and a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together, are not currently authorized and will periodically update both lists as new data becomes available.
  • The FDA has posted a letter to veterinarians and retailers informing them of the danger of treating people for COVID-19 with animal ivermectin.
  • The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on September 17 to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (booster) dose of the Pfizer vaccine to individuals 16 years of age and older.  Learn more here.

National Institutes of Health

  • An investigational HIV vaccine tested in a clinical trial co-sponsored by the NIH posed no safety concerns but did not provide sufficient protection against HIV infection among women, according to a preliminary analysis of the study data.  Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has written to CMS to convey its views on CMS’s proposed physician fee schedule and changes to Medicare Part B regulation.  Find its letter here.
  • MedPAC’s commissioners met last week for two days to discuss Medicare payment issues.  During the meetings MedPAC addressed the following issues:
    • The effects of the COVID-19 emergency and considerations on MedPAC’s 2022 assessment of Medicare payment adequacy.
    • Potential reforms of the Part D low-income premium subsidy.
    • A report on designing a value incentive program for post-acute care.
    • A report on the impact of Bipartisan Budget Act of 2018 changes to the home health prospective payment system.

For briefs and presentations on these subjects go here; for a transcript of the MedPAC meetings go here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

American Medical Association

  • The AMA has announced eight new CPT codes for COVID-19 vaccine administration.  Learn more from this AMA notice.
  • The AMA has issued its annual update of CPT codes.  The update includes 405 editorial changes, including 249 new codes, 63 deletions, and 93 revisions.  Learn more from this AMA news release.

Stakeholder Event

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

The FDA will hold a workshop entitled “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 from 1 p.m. to 5 p.m. (eastern) and October 14 from 1 p.m. to 4:05 p.m.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.

 

 

Federal Health Policy Update for Thursday, August 26

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, August 26.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • NASH has written to the chairs and ranking members of the congressional committees of jurisdiction over health care to ask them to prevent the anticipated January 1, 2022 tripling of the current Medicare sequester from two percent to six percent of all provider Medicare payments and to consider the challenges that community safety-net hospitals have long faced, and that they now continue to face to an unprecedented degree, when looking for budget savings to offset new federal spending during upcoming federal budget deliberations.  See NASH’s letter here.

Provider Relief Fund

The White House

Centers for Medicare & Medicaid Services

COVID-19

  • Health care providers can now receive additional payments from Medicare for administering vaccines to multiple residents in one home setting or a communal home setting.  Previously, CMS increased Medicare payments for vaccines administered in the home, and now, under this new policy, vaccine providers can receive the increased payment up to five times when fewer than ten Medicare beneficiaries receive the vaccine on the same day in the same home or communal setting.  Learn more from this CMS announcement.
  • CMS has written to Medicare Advantage organizations and Medicare-Medicaid health plans to inform them that in light of the recent surge of the COVID-19 delta variant and increased hospitalizations across the country, it strongly encourages those organizations to waive or relax plan prior authorization requirements and utilization management processes to facilitate the movement of patients from general acute-care hospitals to post-acute care and other clinically-appropriate settings, including skilled nursing facilities, long-term-care hospitals, inpatient rehabilitation facilities, and home health agencies.  The ability of hospitals to transfer patients to appropriate levels of care without unnecessary delays or administrative burdens, CMS writes, is critical to ensuring that hospitals have open acute-care beds to treat patients requiring emergency care.  See the CMS message here.
  • CMS has updated its Medicare provider enrollment relief FAQ.  Find it here.

Department of Health and Human Services

Health Policy News

  • Along with the Department of the Treasury and Department of Labor, HHS is vested with responsibility for implementing the 2020 law that requires health care payers to make available to the public machine-readable files for in-network rates and out-of-network allowed amounts and billed charges for plan years.  That information was to be available publicly by January 1, 2022, but now, the departments have delayed implementation of this requirement for six months.  Learn more from this HHS FAQ.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response will award a single grant of $3 million to establish a new Regional Disaster Health Response System site.  It would be part of a tiered system that builds upon and unifies existing assets within states and across regions to support a more coherent, comprehensive, and capable health care disaster response system able to respond health security threats.  Entities eligible for grants include hospitals, local health care facilities, political subdivisions, states, emergency medical services organizations, and emergency management organizations.  Learn more about the funding opportunity here and here and about the Regional Disaster Health Response System here.  Applications are due September 20.
  • HHS’s Agency for Healthcare Research and Quality has published a statistical brief on diabetes-related inpatient stays in 2018.

Food and Drug Administration

COVID-19

  • The FDA has granted its first full (non-emergency use authorization only) approval of a COVID-19 vaccine.  The vaccine that has been known as the Pfizer-BioNTech COVID-19 Vaccine and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.  The vaccine also continues to be available under emergency use authorization for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.  Learn more from this FDA news release.
  • The FDA has posted updated information about COVID-19 booster shots, including when they will be available, who should get them, and when people should get them.  Find that information here.

Centers for Disease Control and Prevention

COVID-19

U.S. Citizenship and Immigration Services

  • Under provisions of the Immigration and Nationality Act, the Department of Homeland Security’s U.S. Citizenship and Immigration Services administers the public charge ground of inadmissibility as it pertains to applicants for admission to the U.S. and adjustment of status.  The agency has published an advance notice of proposed rulemaking to seek broad public feedback on the public charge ground of inadmissibility to the U.S. that will inform its development of a future regulatory proposal.  Find the Federal Register notice here.  Comments are due by October 22.

National Institutes of Health

  • A study funded by the NIH has found that drinking alcohol and smoking tobacco cigarettes throughout the first trimester of pregnancy is associated with nearly three times the risk of late stillbirth compared to women who neither drink nor smoke during pregnancy or quit both before the end of the first trimester.  Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has submitted formal comments to CMS in response to CMS’s proposed home health prospective payment system regulation for 2022.  See MedPAC’s comment letter here.

Congressional Research Service

  • The Congressional Research Service has updated its report Finding Medicare Fee-For-Service (FFS) Payment System Rules:  Schedules and Resources.  Find it here.