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Federal Health Policy Update for Wednesday, July 14

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, July 14.  Some of the language used below is taken directly from government documents.

CMS – Proposed 2022 Medicare Physician Fee Schedule Rule

CMS has released its proposed Medicare physician fee schedule rule for 2022.  Highlights of the proposed rule, which is more than 1700 pages, include:

  • loosening current restrictions on the use of telehealth and expanding its use for behavioral health services;
  • expanding the reach of the Medicare Diabetes Prevention Program;
  • requiring clinicians to meet a higher performance threshold to receive incentives under the Quality Payment Program;
  • authorizing physician assistants to bill Medicare directly for the Part B services they provide; and
  • phasing out coinsurance for colorectal screening additional services.

In addition, CMS is soliciting stakeholder feedback on health equity data collection and on current Medicare payments for administering vaccines.

For further information about the proposed physician fee schedule rule, see the following resources:

CMS’s news release announcing the newly proposed rule

a CMS fact sheet

quality program update fact sheet

Medicare Diabetes Prevention Program update fact sheet

the proposed rule itself

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published the latest edition of MLN Connects, its online weekly bulletin.  This week’s edition includes an article about cognitive assessment resources for providers, updated FY 2022 ICD-10-CMS codes, and opportunities for web-based training on aspects of Medicare billing.  For this and more, go here.
  • CMS has announced that it will open a National Coverage Determination (NCD) analysis through which it will review and determine whether Medicare will establish a national Medicare coverage policy for monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease.  NCDs are program instructions developed by CMS to describe the nation-wide conditions for Medicare coverage for a specific item or service.  This NCD analysis will be applicable to national coverage considerations for aducanumab, which was recently approved by the FDA, as well as any future monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease.  As part of the NCD process, a 30-day public comment period began on July 12.  CMS will host two public listening sessions in July to provide an opportunity for public input.  Learn more from this CMS announcement.
  • CMS has announced that it will distribute $15 million in American Rescue Plan funding to provide community-based mobile crisis intervention services for those with Medicaid.  The $15 million funding opportunity is available to state Medicaid agencies, not providers, for planning grants to support developing these programs.
  • CMS’s Accountable Health Communities (AHC) Model assesses whether bridging the gap between clinical care and social services can reduce health care utilization and costs for Medicare and Medicaid beneficiaries.  In February 2021, CMS hosted its third annual AHC meeting virtually to convene 28 bridge organizations participating in the AHC model and key partners, including community service providers, state Medicaid agencies, and advisory board members.  Meeting participants collaborated and shared insights to sustain their screening, referral, and navigation strategies to address the health-related social needs of Medicare and Medicaid beneficiaries.  Learn more about their insights in the brief “Planning for Sustainability and Advancing Health Equity during the Public Health Emergency.

Provider Relief Fund

Department of Health and Human Services

Health Policy News

  • HHS has provided $398 million in American Rescue Plan money through the Small Rural Hospital Improvement Program to 1540 small rural hospitals for COVID-19 testing and mitigation.  See the HHS announcement here, including a list of how much was distributed to hospitals in each state.
  • HHS’s Health Resources and Services Administration (HRSA) has published a notice in the Federal Register announcing the availability of complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSAs) as of April 30, 2021.  See the HRSA notice here and find the updated lists of HPSAs here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Please note that the vaccine’s FAQ and separate fact sheets translated into other languages have not yet been updated.

Medicaid and CHIP Payment and Access Commission (MACPAC)

Occupational Safety and Health Administration (OSHA)

Office of Management and Budget (OMB)

  • OMB has published its semi-annual work plan presenting its regulatory priorities in the coming months.  Among the HHS matters listed, in addition to those that occur regularly, are:
    • Streamlining the Medicaid and CHIP Application, Eligibility Determination, Enrollment, and Renewal Processes
    • Medicaid Drug Misclassification, Beneficiary Access Protection, and Drug Program Administration
    • Mandatory Medicaid and CHIP Core Set Reporting
    • Medicaid Managed Care Risk-Sharing Mechanisms
    • Temporary Federal Medical Assistance Percentage (FMAP) increase under the Families First Coronavirus Response Act

See the complete HHS list here.

Stakeholder Events

Thursday, July 15 – Centers for Disease Control

CDC National Call Series on COVID-19-Related Response Strategies

Thursday, July 15 at 2:00 – 3:00 pm ET Click here to join
CDC’s COVID-19 response team conducts a national call weekly to provide state, tribal, local, and territorial (STLT) partners with timely updates and opportunities for peer-to-peer learning and sharing of successful response strategies. Over the summer, these weekly COVID-19 community of practice webinars will focus on topics related to school readiness.

Monday, July 19 – National Emergency Management Association (NEMA)

Mission-Ready Packages Workshop for Resource Providers

Monday, July 19 at 1:00 pm ET  Click here for registration

NEMA is hosting a workshop on developing mission ready packages (MRPs). MRPs are specific response or recovery capabilities that have been created to ensure the skills, capabilities, and associated costs are bundled prior to an emergency or disaster for more efficient deployment. These workshop sessions are designed for resource providers. A resource provider is any organization that is able to deploy under the Emergency Management Assistance Compact (EMAC) and that has capabilities that might be needed during an emergency response. Previous knowledge of EMAC or MRPs is not required.

Tuesday, July 20 – Health Resources and Services Administration (HRSA)

Provider Relief Fund Reporting Requirements

Tuesday, July 20 at 3:00 pm ET

HRSA will host a recorded Reporting Technical Assistance session to provide technical assistance on reporting requirements for Provider Relief Fund recipients and stakeholders.  To register for the July 20 session go here.

Thursday, July 22 – HHS’s Health Sector Cybersecurity Coordination Center (HC3)
HC3
Cybersecurity Threat Briefing – Qbot/QakBot

Thursday, July 22 at 1:00 pm ET – Click here for registration

HC3 is holding its second July threat briefing, the topic will be “Qbot/QakBot.”  This webinar will provide actionable information on health sector cybersecurity threats and mitigations.  HC3 analysts will engage in discussions with participants on current threats and highlight best practices and mitigation tactics.

Wednesday, August 4 – Centers for Disease Control

Zoonoses and One Health Update (ZOHU) Call

Wednesday, August 4 at 2:00 – 3:00 pm ETClick here for more information

ZOHU Calls are one-hour monthly webinars that provide timely education on zoonotic and infectious diseases, One Health, antimicrobial resistance, food safety, vector-borne diseases, recent outbreaks, and related health threats at the animal-human-environment interface.

 

Federal Health Policy Update for Monday, June 28

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

Supreme Court Decision in Affordable Care Act Case

  • The Supreme Court has declined to hear an appeal of a case in which insurers unsuccessfully sued to recover reductions in their Affordable Care Act federal cost-sharing reduction payments.

White House

Department of Health and Human Services

COVID-19

  • HHS and the FDA have paused all distribution of bamlanivimab and etesevimab together and etesevimab alone, to pair with existing supply of bamlanivimab, on a national basis until further notice.  In addition, the FDA has recommended that health care providers nation-wide use alternative authorized monoclonal antibody therapies and not use bamlanivimab and etesevimab administered together at this time.  Learn more about why the agencies have taken this action and what they propose as alternatives from this message distributed by HHS’s Office of the Assistant Secretary for Preparedness and Response,
  • HHS’s Office of the Inspector General has published a report on the impact of COVID-19 on Medicare beneficiaries residing in nursing homes during 2020.  Learn more from the OIG’s announcement and summary of the report and from the OIG report “COVID-19 Had a Devastating Impact on Medicare Beneficiaries in Nursing Homes During 2020.”

Health Policy News

  • HHS and the CDC have awarded 59 jurisdictions with $200 million to bolster support for and enhance the disease intervention specialists workforce.  These awards represent the initial funding of a $1.13 billion investment being made over the next five years under the American Rescue Plan and will provide these jurisdictions, public health programs, and the CDC with support to expand and leverage the work of disease intervention specialists.  Learn more from the CDC’s announcement and find a list of the funding recipients here.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has provided guidance to state Medicaid programs about the circumstances under which health care facilities still operating under their emergency preparedness plans because of COVID-19 will temporarily remain exempt from participating in required full-scale emergency preparedness exercises and testing.  See the CMS guidance letter here.

Health Policy News

  • CMS has announced the appointment of Daniel Tsai as deputy administrator and director of its Center for Medicaid and CHIP Services.  Tsai comes from Massachusetts, where he served as the assistant secretary for MassHealth and state Medicaid director.  Learn more about Tsai and the agency he will help lead in this CMS news release.
  • CMS has released a Center for Medicaid and CHIP Services bulletin to introduce a series of tools and toolkits for states and CMS to use to improve the monitoring and oversight of managed care in Medicaid and the Children’s Health Insurance Program (CHIP) that will help improve beneficiaries’ access to care.  This bulletin also provides guidance setting the content and format of the Annual Managed Care Program Report required by CMS regulations and introduces additional resources and technical assistance toolkits that states can use to improve compliance with managed care standards and requirements.  Learn more from the new CMS bulletin.
  • CMS has published the latest edition of MLN Connects, its online publication.  For articles about updates of the hospital outpatient prospective payment system and the clinical laboratory fee schedule and more, go here.
  • CMS has updated its FAQ on its final rule on interoperability and patient access.  Find the information here.
  • CMS announced that it will provide $20 million in American Rescue Plan money to support state-based marketplaces to improve access to affordable, comprehensive health insurance coverage for consumers in their states.  States can apply for funding to help modernize or update their systems, programs, or technology to comply with federal marketplace requirements.  Learn more about the new funding from this CMS announcement.
  • CMS’s Center for Medicare and Medicaid Innovation has announced an anti-kickback safe harbor for CMS-sponsored model patient incentives under the agency’s Maternal Opioid Misuse Model.  Learn more here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Health Policy News

  • The FDA has approved the drug Pradaxa (dabigatran etexilate), the first oral blood thinning medication for children.  Learn more from this FDA news release.
  • The FDA has issued draft guidance encouraging industry to include patients with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in cancer clinical trials regardless of whether they have received existing alternative treatment options.  See the FDA announcement of this new policy and the draft guidance itself, which was published in the Federal Register.

Occupational Safety and Health Administration

  • OSHA has issued an emergency temporary standard to protect health care and health care support service workers from occupational exposure to COVID-19 in settings where people with COVID-19 are reasonably expected to be present.  Compliance with some of the new requirements is mandatory as of July 6 and compliance with the rest of the requirements is mandatory as of July 21.  Learn more from OSHA’s notice in the Federal Register.

National Institutes of Health

  • NIH director Francis S. Collins and other leaders have outlined their vision for a new science entity, the Advanced Research Projects Agency for Health, that was included in the president’s fiscal year 2022 budget with requested funding of $6.5 billion.  The purpose of the agency is to accelerate biomedical innovation and adoption of technologies and approaches to revolutionize health care and medicine.  Find the NIH announcement and a link to additional information about the agency here.
  • An NIH study published in the journal Science Translational Medicine concludes that “…there were 4.8 undiagnosed SARS-CoV-2 infections for every diagnosed case of COVID-19, and an estimated 16.8 million infections were undiagnosed by mid-July 2020 in the United States.”  Find the study here.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has submitted formal comments to CMS about that agency’s proposed regulation describing how it plans to pay for acute-care hospital and long-term-care hospital inpatient care in FY 2022.  The MedPAC letter addresses limited parts of the proposed regulation.  Go here to see MedPAC’s letter to CMS.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has published a fact sheet with an updated analysis of physician acceptance of new Medicaid patients, including at the state level.  The analysis found that physicians were significantly less likely to accept new patients covered by Medicaid than patients with Medicare or private insurance, although acceptance varied by specialty and by state.  Learn more from the new MACPAC fact sheet “Physician Acceptance of New Medicaid Patients:  Findings from the National Electronic Health Records Survey.”
  • MACPAC has published an issue brief that describes how Medicaid programs can pay for certain housing-related services.  Learn more from the MACPAC issue brief “Medicaid’s Role in Housing.”

Government Accountability Office

Stakeholder Events

CMS – Coronavirus (COVID-19) Stakeholder Calls 

HHS’s “We Can Do This” campaign is a national initiative to build confidence in COVID-19 vaccines and get more people vaccinated.  This campaign offers tailored resources and toolkits for stakeholders to use to provide COVID-19 vaccine information to at-risk populations.  CMS is partnering with the campaign to offer several webinars to walk through each toolkit and its resources and train community organizations, local voices, and trusted leaders to use the campaign tools for vaccine outreach efforts to diverse communities.  Webinar dates and registration links are below:

  • Tuesday, June 29, 1:00-1:30 pm ET:  Faith-Based Toolkit – Register here
  • Thursday,  July 1, 1:00-2:00 pm ET:  Toolkits for Racial and Ethnic Minority Communities – Register here
  • Thursday, July 8, 1:00-1:30 pm ET:  Older Adults Toolkit – Register here

Wednesday, Thursday, and Friday, July 7, July 8, and July 9 CMS

CMS – Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set

CMS will hold virtual meetings on July 7, 8, and 9, to discuss its preliminary coding recommendations for revisions of the HCPCS Level II code set.  For information about times, registration, submission of materials, signing up to speak, and submitting comments, click here.

Tuesday, July 13 Office of the National Coordinator for Health Information Technology (ONC)
ONC Workshop: Advancing SDOH Data Use and Interoperability for Achieving Health Equity
Tuesday, July 13 at 10:00 am – 4:00 pm ET  Click here for connection information
This workshop will explore existing and emerging data standards, tools, approaches, policies, models, and interventions for advancing the use and interoperability of non-clinical health data for individual and community health improvement.  It will share varying perspectives of health policy-makers and health improvement implementers to highlight inventive solutions, share challenges, and offer ideas on data modernization to advance health equity.  The workshop offers introductory content as well as deep exploration of key topics as part of social determinants of health IT data use and interoperability including facilitated, expert stakeholder engagement.

Federal Health Policy Update for Tuesday, June 15

The following is the latest health policy news from the federal government as of 3:30 p.m. on Tuesday, June 15.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • Reduced hospital admissions as a result of people deferring needed medical care during the pandemic could jeopardize safety-net hospitals’ continued eligibility for the section 340B prescription drug program.  Two bills currently in Congress, H.R. 3203 and S. 773, would protect safety-net hospitals and others from this one-year anomaly and NASH has written to members of Congress asking them to co-sponsor and support those bills.  See NASH’s letter to members of Congress.

Provider Relief Fund

  • Late last week HHS announced that it has increased the amount of time providers will have to report information and extended key deadlines for expending Provider Relief Fund payments for recipients that received payments after June 30, 2020.  The revised reporting requirements will be applicable to providers that received one or more payments exceeding, in the aggregate, $10,000 during a single payment-received period from the Provider Relief Fund General Distributions, Targeted Distributions, and/or Skilled Nursing Facility and Nursing Home Infection Control Distributions.  For additional information, see the following resources:

HHS also has updated its Provider Relief Fund FAQ to reflect those changes.  The changes in the FAQ, which address how much time fund recipients have to spend their grants, how they must report on their spending, how audits will be conducted, and how certain data elements in the reporting requirements are defined, can be found within the document on pages 8, 14, 16, 22-25, and 40.  HHS also has updated the FAQ section of the Provider Relief Fund web site and the reporting requirements and auditing section of that site to reflect these changes.

Department of Health and Human Services

COVID-19

  • HHS announced that it has provided $424.7 million in funding from the American Rescue Plan to more than 4200 Rural Health Clinics (RHCs) for COVID-19 testing and mitigation.  Later this summer HHS will issue up to $35.3 million in additional funding to RHCs that meet eligibility requirements.  Funding is based on how many certified clinic sites RHCs operate and is $100,000 for each clinic site.  RHCs will use the money to maintain and increase COVID-19 testing, expand access to testing for rural residents, and broaden efforts to mitigate the spread of the virus in ways tailored to local communities.  See HHS’s announcement about the funding.
  • HHS’s Office of the Secretary for Preparedness and Response has published a document titled “Innovations in COVID-19 Patient Surge Management” that offers brief case studies on how four different jurisdictions handled major increases in COVID-19 cases.

Health Policy News

  • HHS’s Office of the Secretary for Preparedness and Response has published a new table-top exercise toolkit to help emergency planners create an interactive, discussion-based exercise focusing on the effects on health care coalitions and health care facilities of large numbers of patients seeking care following exposure to an infectious agent.  Find the toolkit here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

  • The FDA announced that it has authorized the use of a limited supply of Johnson & Johnson COVID-19 vaccine manufactured at a plant that is not yet an authorized manufacturing facility.  At the same time, it concluded that some vaccine materials manufactured in that same plant may not be used for COVID-19 vaccines.  In addition, the FDA has extended the expiration date for the refrigerated Johnson & Johnson vaccine after reviewing information submitted by the company.  Learn more from this FDA news release.
  • In a new episode of the FDA Office of Minority Health and Health Equity Forum Podcast, Rear Admiral Richardae Araojo discusses FDA’s emergency use authorization process with Rear Admiral Denise Hinton, the FDA’s chief scientist.  Go here for a transcript of the discussion and to find a link to the podcast itself.

National Institutes of Health

  • The NIH reports that results from a Phase 3 clinical trial show that the Novavax investigational vaccine demonstrated 90.4 percent efficacy in preventing symptomatic COVID-19 disease.  The vaccine showed 100 percent protection against moderate and severe disease.  In people at high risk of developing complications from COVID-19 the vaccine showed 91 percent efficacy in preventing symptomatic COVID-19 disease.  Learn more from the NIH news release.
  • The NIH announced that a new antibody testing study examining samples originally collected through its “All of Us” research program found evidence of COVID-19 infections in five states earlier than had initially been reported.  The results expand on findings from a CDC study that suggested that SARS-CoV-2, the virus that causes COVID-19, was present in the U.S. as far back as December of 2019.  See the NIH news release here.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has released its annual report to Congress.  The report includes:
  • Mandatory reports that evaluate the skilled nursing facility value-based purchasing program; assess the impact of recent changes in Medicare’s clinical laboratory fee schedule payment rates; and examine the relationship between clinician services and other Medicare services.
  • Reports requested by Congress on private equity and Medicare and Medicare beneficiaries’ access to care in rural areas (an interim report).
  • Additional reports on rebalancing Medicare Advantage benchmark policy; streamlining CMS’s portfolio of alternative payment models; revising Medicare’s indirect medical education payments to better reflect teaching hospitals’ costs; Medicare vaccine coverage and payment; and improving Medicare’s policies for separately payable drugs in the hospital outpatient prospective payment system.

Learn more from MedPAC’s announcement about its June report and find the report itself here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has sent its annual report to Congress.  The report addresses high-cost specialty drugs in the Medicaid program; access to mental health services for those enrolled in Medicaid and the State Children’s Health Insurance Program (CHIP); integration of physical and behavioral health care through electronic health records; Medicaid’s non-emergency transportation benefit; and state strategies for integrating care for people who are dually eligible for Medicaid and Medicare.  See MACPAC’s announcement about its report here and find the report itself here.

National Association of Medicaid Directors

  • The National Association of Medicaid Directors has published “Medicaid Forward,” which it describes as identifying “…opportunities for action to address immediate and long-term challenges for children’s health emerging from the COVID crisis across communities.  The report is amplified by real-world examples of states that have implemented the strategies outlined in the framework.”

Government Accountability Office

  • The Medicare Access and CHIP Reauthorization Act of 2015 established the Physician-Focused Payment Model Technical Advisory Committee to provide comments and recommendations to HHSSHH on physician payment models and gave the Comptroller General responsibility for appointing its members.  GAO is now accepting nominations of individuals to serve on this committee.  Letters of nomination and resumes should be submitted no later than July 16.  Learn more from this notice published in the Federal Register.

Stakeholder Events

Wednesday, June 16 – FDA

Virtual Town Hall Series – Coronavirus (COVID-19) Test Development and Validation
Wednesday, June 16 at 12:15 pm ET  Click here for connection information
The FDA will host a virtual town hall for COVID-19 test developers.  The purpose of this town hall is to help answer technical questions about the development and validation of tests for COVID-19.

Wednesday and Thursday, June 16 and June 17 – FEMA

COVID-19 Pandemic Operational Guidance Webinars
Wednesday, June 16 at 7:00 at 8:00 pm ET  Click here for connection information

FEMA is offering a series of webinars throughout the month of June to further educate people on its pandemic operational guidance.  The webinar will cover information included in COVID-19 Pandemic Operational Guidance: All Hazards Incident Response and Recovery, a document aimed at helping emergency managers plan for disaster response and recovery while adhering to public health guidelines to prevent the spread of COVID-19.  This is webinar is also being offered on Thursday, June 17 at 1:00 – 2:00 PM.

Thursday, June 17 – U.S. Health Sector Cybersecurity Coordination Center (HC3)
HC3 Cybersecurity Threat Briefing on Threat Hunting
Thursday, June 17 at 1:00 pm ET  Click here to learn more
HHS’s HC3 program invites stakeholders to join its second cybersecurity threat briefings in June; the topic will be “Threat Hunting.”  This initiative will provide actionable information on health sector cybersecurity threats and mitigations.  HC3 analysts will present relevant cybersecurity topics, engage in discussions with participants on current threats, and highlight best practices and mitigation tactics.

Thursday, June 17 – CDC
Evaluating and Caring for Patients with Post-COVID Conditions
Thursday, June 17 at 2:00 – 3:00 pm ET  Click here to learn more

During this CDC Clinician Outreach and Communication Activity (COCA) Call, clinicians will learn about the CDC’s new interim guidance that provides a framework for health care providers in their initial assessment, evaluation, management, and follow-up of persons with possible post-COVID conditions. Post-COVID conditions refer to the wide range of physical and mental health consequences experienced by some patients that are present four or more weeks after COVID-19 infection, including by patients who had initial mild or asymptomatic acute infection.

Friday, June 18 – Office of the National Coordinator for Health Information Technology (ONC)
ONC Workshop: Advancing Social Determinants of Health Data Use and Interoperability for Achieving Health Equity
Friday, June 18 at 10:00 am – 4:30 pm ET  Click here to learn more
This workshop will explore existing and emerging data standards, tools, approaches, policies, models, and interventions for advancing the use and interoperability of non-clinical health data for individual and community health improvement.  It will enable varying perspectives of health policy-makers and health improvement implementers to highlight inventive solutions, share challenges, and review ideas on data modernization to advance health equity.  The workshop offers introductory content as well as deep exploration of key topics as part of social determinants of health IT data use and interoperability, including facilitated, expert stakeholder engagement.

Tuesday, June 22 – FDA
FDA Drug Topics: Overview of Risk Evaluation and Mitigation Strategies (REMS) for Health Care Providers
Tuesday, June 22 at 1:00 – 2:15 pm ET  Click here to learn more
This webinar will provide an overview of REMS and discuss how REMS safety requirements affect prescribers, dispensers, and patients.  Participants should gain an understanding of the REMS authorities, how REMS are implemented, and the entities that provide oversite and support.  REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure that the benefits of the medication outweigh its risks.

Wednesday, Thursday, and Friday, July 7, July 8, and July 9 – CMS

CMS – Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set

CMS will hold virtual meetings on July 7, 8, and 9, to discuss its preliminary coding recommendations for revisions of the HCPCS Level II code set.  For information about times, registration, submission of materials, signing up to speak, and submitting comments, click here.

CMS – Coronavirus (COVID-19) Stakeholder Calls 

HHS’s “We Can Do This” campaign is a national initiative to build confidence in COVID-19 vaccines and get more people vaccinated.  This campaign offers tailored resources and toolkits for stakeholders to use to provide COVID-19 vaccine information to at-risk populations.  CMS is partnering with the campaign to offer several webinars to walk through each toolkit and its resources and train community organizations, local voices, and trusted leaders to use the campaign tools for vaccine outreach efforts to diverse communities.

Webinar dates and registration links are below:

  • Thursday, June 17 1:00-1:30 pm ET: Rural Toolkit – Register here
  • Tuesday, June 22, 1:00-1:30 pm ET: Spanish Language Toolkits – Registration TBD*
  • Thursday June 24, 1:00-1:30 pm ET: Healthcare workers Toolkit – Registration TBD
  • Tuesday, June 29, 1:00-1:30 pm ET: Faith-Based Toolkits – Registration TBD
  • Thursday, July 1, 1:00-2:00 pm ET: Toolkits for Racial and Ethnic Minority Communities – Registration TBD
  • Thursday, July 8, 1:00-1:30 pm ET: Older Adults Toolkit – Registration TBD

Go here for registration information for the remaining dates.

Federal Health Policy Update for Thursday, May 27

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, May 27.  Some of the language used below is taken directly from government documents.

The White House

COVID-19

Medicaid and CHIP Payment and Access Commission

  • In a new issue brief, MACPAC describes the current use of health care provider taxes in Medicaid, the history and current state of the rules governing their use, and the potential effects of changes to these policies.

Centers for Medicare & Medicaid Services

Health Policy News

CMS has posted the latest edition of its online publication MLN Connects.  Among items of interest in this edition are:

  • Critical Care Evaluation & Management Services:  Comparative Billing Report in May
  • Medicare Shared Savings Program:  Submit Notice of Intent to Apply Beginning June 1
  • Submit Medicare GME Affiliation Agreements during COVID-19 PHE by January 1
  • Addition of the Shared System CWF to the Business Requirements for the Healthcare Common Procedure Coding System (HCPCS) codes U0002QW and 87635QW Mentioned in Change Request 11765
  • International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) – July 2021
  • Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – July 2021 Update
  • Complying with Medicare Signature Requirements – Revised
  • Medicare Diabetes Prevention & Diabetes Self-Management Training – Revised
  • Medicare Mental Health– Revised

Go here for links to these and other items.

Department of Health and Human Services

COVID-19

Health Policy News

Office of the Secretary
Dr. Stephen “Steve” Cha (he/him), Counselor to the Secretary, AHRQ/FDA/NIH
Melanie Fontes Rainer (she/her), Counselor to the Secretary, ACA/Marketplaces/OCR/CMMI
Steven Lopez (he/him), Counselor to the Secretary, Equity/OASH/HRSA/IHS
Ben Scott (he/him), Advance Representative
Josie Villanueva Prescott (she/her), Counselor to the Secretary, ACF/ACL
Dr. Mary Wakefield (she/her), Counselor to the Secretary
Laurence Wilson (he/him), Advance Representative

Office of the Deputy Secretary
Angela Botticella (she/her), Chief of Staff

Office of Intergovernmental and External Affairs
Molly Doris-Pierce (she/her), Special Assistant

Office of the Assistant Secretary for Legislation
Leslie Zelenko (she/her), Senior Advisor and Congressional Liaison

Office of the Assistant Secretary for Public Affairs
Kamara Jones (she/her), Deputy Assistant Secretary for Strategic Planning

Administration for Community Living
Dr. Anjali Forber-Pratt (she/her), Director, National Institute on Disability, Independent Living and Rehabilitation Research

Health Resources and Services Administration
Elaina Boutte (she/her), Special Assistant

Office of the Assistant Secretary for Health
Jessica “Jess” Swafford Marcella (she/her), Deputy Assistant Secretary for Population Affairs

Office of the Assistant Secretary for Planning and Evaluation
Dr. Tisamarie “Tisa” Sherry (she/her), Deputy Assistant Secretary for Planning and Evaluation (Office of Behavioral Health, Disability, and Aging Policy)

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Stakeholder Events

FEMA

Friday, May 28

Monday, June 7

FEMA’s National Exercise Division has developed exercise starter kits with sample documents to assist organizations with planning and conducting tabletop exercises aligning with the updated National Exercise Program 2021-2022 Principal’s Strategic Priorities.  FEMA will host webinars for whole community exercise practitioners.  The webinars will introduce the new exercise starter kits, providing stakeholders with an overview of the kits along with how to use them.  Visit the Homeland Security Exercise and Evaluation Program Webinar webpage to register.

CDC

Wednesday, June 2
Zoonoses and One Health Update (ZOHU) Call
Wednesday, June 2 at 2:00 – 3:00 pm ET   Click here to learn more
ZOHU Calls are one-hour monthly webinars that provide education on zoonotic and infectious diseases, One Health, antimicrobial resistance, food safety, vector-borne diseases, recent outbreaks, and related health threats at the animal-human-environment interface.

CDC

Thursday, June 3

CDC/Clinical Outreach and Communication Activity – “Long COVID”

The CDC will hold a one-hour call about its new interim guidance that provides a framework for health care providers in their initial assessment, evaluation, management, and follow-up of persons suspected of long COVID.  Go here for further information on the subject of the call and how to join it.

FDA

Friday, June 11
Identification of Medicinal Products:  Path to Global Implementation
Monday, June 11 at 1:00 – 2:30 pm ET  Click here to learn more
The FDA will present updates on the identification of medicinal products standards development and implementation with an emphasis on international collaboration, pilot projects on substance, dosage form, and pharmaceutical identification.

Internal Revenue Service

Federal Health Policy Update for Friday, May 14

The following is the latest health policy news from the federal government as of 2:30 p.m. on Friday, May 14.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • NASH has written to Health and Human Services Secretary Xavier Becerra to urge his department to apply more appropriate criteria and a better methodology for calculating payments in all future Provider Relief Fund distributions.  Learn more from NASH’s letter to HHS Secretary Becerra.

The CDC and Mask Guidance

The White House

COVID-19

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has released data highlighting the continued impact of the COVID-19 emergency on Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries and their utilization of health care services.  The data show that from March through October 2020, beneficiaries skipped millions of primary, preventive, and mental health care visits due to COVID-19 in comparison to the same time period in 2019.  Although utilization rates for some treatments have rebounded to pre-pandemic levels, mental health services show the slowest rebound.  Learn more from the following resources:

Health Policy News

  • CMS has issued guidance to states on how they can receive enhanced American Rescue Plan funding to increase access to home and community-based services (HCBS) for Medicaid beneficiaries.  This guidance seeks to assist states with leveraging federal resources to increase health equity in Medicaid beneficiaries’ access to HCBS, positive health outcomes, and community integration.  Those resources include a one-year increase of 10 percent in federal Medicaid matching money for such expenditures.  The guidance was issued to states through a CMS letter to state Medicaid directors.  Go here to see CMS’s announcement about the enhanced HCBS funding and go here to see the CMS letter to state Medicaid directors.

Centers for Disease Control and Prevention

COVID-19

FEMA

Federal Health Policy Update for Wednesday, May 12

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

The White House

COVID-19

  • The White House has announced additional efforts to encourage people to get vaccinated against COVID-19, including free rides to vaccination sites from Lyft and Uber, vaccination clinics at community colleges, and additional resources for states’ community outreach efforts.  This will include funding for FEMA for phone banks, door-to-door canvassing, and pop-up vaccination clinics in workplaces and churches.  See the White House fact sheet for additional information.

Department of Health and Human Services

COVID-19

  • HHS has awarded $40 million in American Rescue Plan funds to support emergency home visiting assistance for families affected by the COVID-19 pandemic.  These funds will be used to provide services and emergency supplies, such as diapers, food, water, and hand sanitizer.  Families that cannot gain access to home visiting services due to the pandemic will be provided technology to participate in virtual home visits.  Funds, which will be administered through HHS’s Maternal, Infant, and Early Childhood Home Visiting Program, also will be used to train home visitors on emergency preparedness and response planning for families and on how to safely conduct virtual intimate partner violence screenings.  Learn more about the new funding and how it will be used in this HHS announcement.

Health Policy News

  • The Senate has confirmed the nomination of Andrea Palm to serve as Deputy Secretary of HHS by a vote of 61 to 37 and she has already been sworn into office.  It is the number two position in the department.  Most recently, Palm led Wisconsin’s Department of Health Services.  Previously, she served in the Obama administration as HHS’s chief of staff and as a policy advisor to the White House Domestic Policy Council.
  • The Senate held a procedural vote on Wednesday that advanced the nomination of Chiquita Brooks-LaSure to become CMS administrator.  Another procedural vote will be needed before a final confirmation vote, but confirmation is expected this month.
  • HHS’s Agency for Healthcare Research and Quality (AHRQ) has issued a request for nominees to serve on its Initial Review Group, which is responsible for the scientific peer review of AHRQ grant applications.  The group conducts scientific and technical review for health services research grant applications.  Nominations are due by June 1.  Learn more from the Federal Register notice.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has published an interim final rule with comment period establishing long-term-care facility vaccine immunization requirements for residents and staff.  This includes new requirements for educating residents or resident representatives and staff about the benefits and potential side effects of COVID-19 and offering the vaccine.  It also requires long-term-care facilities to report COVID-19 vaccine and treatment data to the CDC’s National Health Safety Network.  Learn more from the following resources:

Health Policy News

CMS has posted the latest edition of its online publication MLN Connects.  Among items of interest in this edition are:

  • Medicare Shared Savings Program Application:  NOIA Opens June 1
  • IRF Quality Reporting Program:  Achieving a Full AIF Webinar — May 19
  • Medicare Shared Savings Program:  Establishing a Repayment Mechanism Webcast — May 27
  • The Fiscal Year (FY) 2021 Skilled Nursing Facility (SNF) PC Pricer is now available.

Go here for links to these and other items.

Food and Drug Administration

COVID-19

  • The FDA has authorized the use of the Pfizer COVID-19 vaccine for emergency use in adolescents between the ages of 12 and 15; it was already authorized for use among older teenagers.  See the FDA’s announcement of this authorization and its letter of authorization here.
  • In light of this new authorization, the FDA has updated its fact sheet for health care providers for administering the COVID-19 vaccine; its fact sheet for recipients and caregivers; and its FAQ on the Pfizer vaccine.

Centers for Disease Control and Prevention

COVID-19

Stakeholder Events

Thursday, May 13

CMS and the CDC – Nursing Homes

Thursday, May 13 at 4:00 p.m. (eastern)

CMS and the CDC will host a national nursing home stakeholder call.  Register here.

Federal Health Policy Update for Wednesday, May 5

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, May 5.  Some of the language used below is taken directly from government documents.

The White House

COVID-19

Department of Health and Human Services

COVID-19

  • HHS has created a web page for its new COVID-19 Coverage Assistance Fund through which providers can be reimbursed for the cost of administering COVID-19 vaccines to the uninsured and to those whose health insurance requires a co-pay for vaccinations.  This web page offers information about how the program works and how providers can submit claims for reimbursement.
  • To support the launch of this new COVID-19 Coverage Assistance Fund, HHS will hold a webinar on Thursday, May 6 at 2:00 p.m. (eastern) to introduce stakeholders to what the program will do and how it will work.  Go here for further information and to register to participate.
  • HHS has announced the availability of $250 million in American Rescue Plan funds to develop and support a community-based workforce that will share information about vaccines, increase COVID-19 vaccine confidence, and address barriers to vaccination for individuals living in vulnerable and medically underserved communities.  For the first funding opportunity, released today, approximately 10 award recipients will be funded to engage with multiple organizations regionally and locally, including with community-based organizations, health centers, minority-serving institutions, and other health and social service entities.  The second funding opportunity will be released in the near future and will focus on smaller community-based organizations.  To learn more about program eligibility and to apply for funding, visit Grants.gov.  Applications are due May 18, 2021.  See HHS’s announcement about the new program.
  • HHS and its Health Resources and Services Administration (HRSA) have announced the availability of $1 billion in American Rescue Plan funds to strengthen COVID-19 response efforts and increase vaccinations in rural communities.  HRSA’s Rural Health Clinic COVID-19 Testing and Mitigation Program will provide $460 million to more than 4,600 rural health clinics (RHCs) to maintain and increase COVID-19 testing, expand access to testing for rural residents, and broaden efforts to mitigate the spread of the virus in ways tailored to their local communities.  HRSA will provide up to $100,000 per RHC-certified clinic site.  In addition, HRSA will provide $398 million to existing grantees of the Small Rural Hospital Improvement Program to work with approximately 1,730 small rural hospitals and critical access hospitals on COVID-19 testing and mitigation, with funding to be used to support all eligible rural hospitals, up to $230,000 per hospital.  Finally, through its Rural Health Clinic Vaccine Confidence Program, HRSA will make nearly $100 million available in grants to eligible RHCs nation-wide to address health equity gaps by offering support and resources to medically underserved rural communities where COVID-19 vaccine uptake lags.  HRSA will fund all eligible RHCs that apply.  Learn more from this announcement about the new funding.
  • HHS’s Office of the Inspector General has updated its FAQ outlining situations in which it is willing to exercise its discretion in the enforcement of existing guidelines in support of the flexibility needed to respond effectively to the COVID-19 emergency.  See the updated FAQs here.

Health Policy News

  • The administration announced that HHS and its Administration for Community Living will spend $1.4 billion in American Rescue Plan money to address a variety of needs of older Americans.  Among its uses will be $460 million for home and community-based services; $44 million for evidence-based health promotion and disease prevention; $145 million to help family caregivers support their loved ones; and $10 million to safeguard the health and welfare of residents of long-term-care facilities.  Learn more from this fact sheet.
  • HHS has issued a request for nominations to the Advisory Council on Alzheimer’s Research, Care, and Services.  Nominations are due May 31.  See the Federal Register announcement for additional information.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has issued a new waiver for treatment in place for ground ambulance services during the COVID-19 public health emergency and has posted a fact sheet on this waiver.
  • In support of this new waiver CMS has updated its document “COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing” with revised questions on pages 50 and 51 and new questions on pages 55-60 for ground ambulance providers.  All result from a provision in the American Rescue Plan that established circumstances under which Medicare may reimburse providers for a service that did not arise during a community-wide emergency medical service but that instead is a result of the COVID-19 emergency.  Go here to see the new and revised questions.

Centers for Disease Control and Prevention

COVID-19

Medicaid and CHIP Payment and Access Commission

  • MACPAC has published a new report titled Examining the Potential for Additional Re-balancing of Long-Term Services and Supports.  Find it here.

American Medical Association

  • The AMA has updated its Current Procedural Code (CPT) code sets to include new vaccine and administration codes for the COVID-19 vaccine currently being developed by the company Novavax.  This vaccine has not yet been approved for use.  Learn more from an AMA news release.

Stakeholder Events

Friday, May 7
FDA
Common Labeling Deficiencies and Tips for Generic Drug Applications
Friday, May 7 at 1:00pm – 2:00pm ET.  Click here for connection information.
The FDA will discuss the most common labeling mistakes found in abbreviated new drug applications (ANDAs) and how to avoid them and offer other labeling tips.  The FDA also will provide answers to common labeling questions asked by generic drug applicants.

Wednesday, May 12
Cybersecurity and Infrastructure Security Agency (CISA)

CISA 2021 Hurricane Webinar
Wednesday, May 12 at 10:30 am – 12:00pm ET.  Click here for registration.

This webinar will focus on providing awareness of CISA’s role and resources in hurricane preparedness and response activities associated with systems that make landfall on the continental U.S. or U.S. territories while in a COVID-19 environment.  It will also feature presentations from the NOAA Liaison to the National Operations Center and FEMA’s National Business Emergency Operations Center.

Wednesday, May 12

HHS Office of the Assistant Secretary for Preparedness and Response – Vaccine Promotion

Wednesday, May 12 at 1:30 pm ET.  Click here for further information and registration.

Speakers will discuss a New York City initiative dedicated to building confidence in COVID-19 vaccines; provide information about the current FDA-authorized COVID-19 vaccines and their safety and effectiveness; and share effective communication strategies to encourage friends, family, colleagues, and the community to get vaccinated.  The webinar will share additional educational resources and tools developed by local health care partners and there will be time for participant Q&A.

Federal Health Policy Update for Tuesday, April 20

The following is the latest health policy news from the federal government as of 3:00 p.m. on Tuesday, April 20.

Congress

  • This afternoon Senator John Cornyn (R-TX) put a hold on the president’s nomination of Chiquita Brooks-LaSure to be CMS administrator in response to the administration’s decision to revoke a Medicaid waiver the previous administration granted to his state.

The White House

COVID-19

Centers for Medicare & Medicaid Services

COVID-19

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

Department of Health and Human Services

COVID-19

Food and Drug Administration

COVID-19

  • The FDA has revoked its emergency use authorization that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used to treat mild to moderate COVID-19 in adults and certain pediatric patients.  Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of COVID-19 variants that are resistant to bamlanivimab alone resulting in an increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use.  For additional information, see the following resources:
  • The FDA has authorized an amendment for many authorized COVID-19 tests that permits emergency use of such tests on pooled specimens for testing individuals without symptoms or other reasons when tested at least once a week as part of a serial testing program without prospective FDA review.  Learn more from this FDA announcement.

Centers for Disease Control and Prevention

COVID-19

National Institutes of Health

COVID-19

  • The NIH announced that it will fund a large, randomized, placebo‑controlled Phase 3 clinical trial to test several existing prescription and over-the-counter medications for people to self-administer to treat symptoms of COVID-19.  Part of the Accelerating COVID‑19 Therapeutic Interventions and Vaccines (ACTIV) public–private partnership, the ACTIV-6 trial aims to provide evidence-based treatment options for the majority of adult patients with COVID-19 who have mild to moderate symptoms and are not sick enough to be hospitalized.  NIH will spend $155 million for the trial.  See the NIH announcement here.  Learn more about the ACTIV program here.

Medicaid and CHIP Payment and Access Commission

Health Policy News

  • MACPAC has published an overview of the role Medicaid plays in rural health.  The brief describes the characteristics of rural residents generally, including socioeconomic factors, insurance status, and health status and then addresses provider availability, particularly for primary care services and rural hospitals. The brief concludes with a discussion of Medicaid policies and services that are particularly important for providing health care in rural areas.

Health Policy Update for Friday, April 16

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

The White House

COVID-19

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

Health Policy News

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

Federal Communications Commission

COVID-19

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

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

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

News

Compliance

Events

Multimedia

Department of Health and Human Services

COVID-19

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

Centers for Disease Control and Prevention

COVID-19