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Federal Health Policy Update for Thursday, July 22

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, July 22.  Some of the language used below is taken directly from government documents.

White House

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published its proposed calendar year 2022 Medicare outpatient prospective payment system regulation.  Among other subjects, the proposed regulation addresses hospital outpatient and ambulatory surgery center payment rates, hospital price transparency, the section 340B prescription drug discount program, changes in the inpatient-only list and ambulatory surgery center covered procedures list, changes in the hospital outpatient and surgery center quality reporting programs, the newly created rural emergency hospital provider type, the Radiation Oncology Model, temporary flexibilities implemented to facilitate the response to COVID-19, and more.  Stakeholder comments are due by September 17.  Learn more from the following resources.
  • CMS’s Center for Medicare and Medicaid Innovation has updated the web page of its Radiation Oncology Model to reflect changes in the program addressed in the newly published proposed Medicare outpatient prospective payment system regulation.  The updated web page includes links to additional resources about the Radiation Oncology Model.
  • CMS has published the latest edition of MLN Connects, its online weekly bulletin.  This week’s edition includes a description, billing information, a fact sheet, and more for the monoclonal antibody tocilizumab, which recently received FDA emergency authorization for use in treating COVID-19 patients; information on ICD-10-CM codes for FY 2022; a change in the national coverage for a (CAR) T-cell therapy; and more.  For this and more, go here.
  • CMS has published an advisory to alert certain clinicians who are qualifying alternative payment model (APM) participants and eligible to receive APM incentive payments that CMS does not have the current billing information it needs to send them their payments.  The advisory tells these clinicians how to update their billing information to receive their payments.  Affected physicians must submit updated billing information by November 1.  Read the notice here.
  • CMS has released an informational bulletin informing states that the Department of Homeland Security’s  2019 public charge rule has been vacated and is no longer in effect.  The notice explains that effective March 9, 2021, the Department of Homeland Security started applying the 1999 interim field guidance for public charge inadmissibility determinations, which is the policy that was in place before the 2019 public charge final rule.  Under that 1999 guidance, that agency will not consider an individual’s receipt of Medicaid benefits as part of the public charge determination except for individuals who are institutionalized on a long-term basis (such as nursing facility residents) and are receiving Medicaid coverage for their institutional services.  HHS has published a news release with the same information.

Department of Health and Human Services

COVID-19

  • HHS has renewed for 90 days its declaration of the public health emergency caused by COVID-19.
  • HHS will spend more than $1.6 billion from the American Rescue Plan to support testing and mitigation measures in high-risk congregate settings to prevent the spread of COVID-19 and detect and stem potential outbreaks.  $100 million will be spent to expand dedicated testing and mitigation resources for people with mental health and substance use disorders; $80 million will go to support state and local COVID-19 testing and mitigation measures among people experiencing homelessness, residents of congregate settings including group homes and encampments; and $169 million will be spent for testing and mitigation in federal prisons.  Learn more from the HHS news release.
  • HHS has distributed nearly $100 million in American Rescue Plan money to rural health clinics to support outreach efforts to increase vaccinations in their communities.  The funds will go to nearly 2000 Rural Health Clinics, which will use these resources to develop and implement additional vaccine confidence and outreach efforts in medically underserved rural communities.  See HHS’s news release for more information and for a link to a list of how much money was distributed on a state-by-state basis.

Health Policy News

  • HHS’s Health Resources and Services Administration (HRSA) has announced a change in user fees charged to individuals and entities authorized to request information from the National Practitioner Data Bank.  The new fee will be $2.50 for both continuous and one-time queries and $3.00 for self-queries.  Learn more about this increase and other changes in use of the National Practitioner Data Bank in this Federal Register notice.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has formally accepted Pfizer’s application for full approval of its Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 in individuals 16 years of age and older and has granted the application priority review.  Currently, the vaccine is authorized for emergency use in individuals ages 12 and older.  Learn more here.

Government Accountability Office

Medicaid and CHIP Payment and Access Commission (MACPAC)

State Medicaid programs are required to cover certain mental health services for adults while other mental health services are optional.  In a new compendium, MACPAC documents coverage of selected mental health services available to Medicaid beneficiaries in each state and the District of Columbia.  Find a link to the report here.

Stakeholder Events

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.

Monday, August 23 – CMS

Advisory Panel on Hospital Outpatient Payment

Monday, August 23 from 9:30 a.m. to 5:00 p.m. (eastern)

CMS’s Advisory Panel on Hospital Outpatient Payment will meet virtually to advise the agency about the clinical integrity of the Ambulatory Payment Classification groups and their associated weights and about supervision of hospital outpatient therapeutic services.  The advice provided by the panel will be considered as CMS prepares its annual updates for the hospital outpatient prospective payment system.

The public may participate in this meeting by webinar or teleconference.  Teleconference dial-in and webinar information will appear on the final meeting agenda, which will be posted here when available.

 

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 Friday, July 9

The following is the latest health policy news from the federal government as of 2:45 p.m. on Friday, July 9.  Some of the language used below is taken directly from government documents.

White House

President Biden has issued an executive order “…to promote competition in the American economy, which will lower prices for families, increase wages for workers, and promote innovation and even faster economic growth.”  Among other things, the executive order calls for closer scrutiny of corporate consolidation, maintaining that such consolidation results in a “…lack of competition [that] drives up prices for consumers.  As fewer large players have controlled more of the market, mark-ups (charges over cost) have tripled.  Families are paying higher prices for necessities – things like prescription drugs, hearing aids, and internet service.”  The order also includes a provision that “… enforcement should focus in particular on labor markets, agricultural markets, healthcare markets (which includes prescription drugs, hospital consolidation, and insurance), and the tech sector.”

In a section on hospitals, the order notes that

Hospital consolidation has left many areas, especially rural communities, without good options for convenient and affordable healthcare service.  Thanks to unchecked mergers, the ten largest healthcare systems now control a quarter of the market.  Since 2010, 139 rural hospitals have shuttered, including a high of 19 last year, in the middle of a healthcare crisis.  Research shows that hospitals in consolidated markets charge far higher prices than hospitals in markets with several competitors.

It also

  • Underscores that hospital mergers can be harmful to patients and encourages the Justice Department and FTC to review and revise their merger guidelines to ensure patients are not harmed by such mergers.
  • Directs HHS to support existing hospital price transparency rules and to finish implementing bipartisan federal legislation to address surprise hospital billing.

Learn more from the White House fact sheet on the executive order, which addresses other aspects of health care as well.

Provider Relief Fund

  • The Provider Relief Fund’s “Reporting Requirements and Auditing” page has been updated with new information about Provider Relief Fund recipient reporting deadlines, requirements, and worksheets.  Find it here.
  • The Health Resources and Services Administration (HRSA) will host recorded Reporting Technical Assistance Sessions to provide technical assistance on reporting requirements for Provider Relief Fund recipients and stakeholders.  For the July 14 session at 3:00 p.m., go here to register and for the July 20 session at 3:00 go here to register.

Department of Health and Human Services

COVID-19

  • HHS has published notice of the extension of the designation issued on February 1, 2021 identifying health and medical resources necessary to respond to the spread of COVID-19 that are scarce or the supply of which would be threatened by excessive accumulation by people or entities not needing the excess supplies.  These designated materials are subject to the hoarding prevention measures authorized under Executive Order 13910 and section 102 of the Defense Production Act of 1950.  Learn more from the Federal Register notice.  The notice lists specific items that have had their “scarce” designation removed and others that have not.  The action took effect on July 1 and interested parties have until August 7 to submit comments.

Health Policy News

  • HHS has updated interoperability standards to support the collection and electronic exchange of data on sexual orientation, gender identity, and social determinants of health.  Learn more from HHS’s announcement about this development and from the United States Core Data for Interoperability version 2 (USCDI v2), a standardized set of health data classes and constituent data elements for nation-wide, interoperable health information exchange.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has shared a notice from the federal Cybersecurity and Infrastructure Security Agency and the FBI about how multiple managed service providers and their customers can protect themselves from recent supply-chain ransomware attacks leveraging a vulnerability in Kaseya VSA software.  Learn more here.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has developed an infectious disease surge annex tabletop exercise toolkit that can be used by health care coalitions to enhance operational area awareness and capability to effectively address the needs of patients seeking care following exposure to an infectious agent.  Health care coalitions are not required to use this template but it can be used to satisfy funding opportunity announcement requirements for the hospital preparedness program cooperative agreement.  Find the toolkit and links to other resources here.
  • The same HHS office has prepared a home care and hospice emergency operations plan that includes emergency operations plans specific to home care and hospice agencies.

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 updated FAQ about repayment of COVID-19 accelerated and advance payments, including information about how recoupment works and how it affects providers’ Medicare claims payment amounts.  For this and more, including articles on updated HCPCS codes for skilled nursing facilities and updated durable medical equipment, prosthetics, orthotics, and supplies, go here.
  • CMS has announced the appointment of Dr. Meena Seshamani, M.D., Ph.D. as Deputy Administrator and Director of Center for Medicare.  Dr. Seshamani most recently served as vice president of clinical care transformation at MedStar Health, where she conceptualized, designed, and implemented population health and value-based care initiatives and served on the senior leadership of a health system with 10 hospitals and more than 300 outpatient sites.  Prior to MedStar Health, she was director of the Office of Health Reform at HHS.  Dr. Seshamani received her B.A. with honors in business economics from Brown University, her M.D. from the University of Pennsylvania School of Medicine, and her Ph.D. in health economics from the University of Oxford.  Learn more from the CMS announcement of the appointment.
  • The CMS Center for Medicare and Medicaid Innovation’s Financial Alignment Initiative is designed to provide individuals dually enrolled in Medicare and Medicaid with a better care experience and to better align the financial incentives of the Medicare and Medicaid programs.  Through this initiative, CMS partners with states to test new models for their effectiveness in accomplishing these goals.  Now, the innovation center has posted evaluation and savings reports from participating states Washington, Colorado, Minnesota, New York, and Virginia.  Find those reports and other information about the program here.

COVID-19

Centers for Disease Control and Prevention

COVID-19

Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively. We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.

Food and Drug Administration

COVID-19

  • The FDA has authorized the use, under the emergency use authorization for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility.  Questions had been raised about the safety of the batch but the FDA has investigated and concluded it is safe.  See the FDA announcement of this decision here and the letter the FDA sent to JanssenBiotech explaining its decision.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has responded to the Office of Management and Budget request for information “Methods and Leading Practices for Advancing Equity and Support for Underserved Communities Through Government” with a letter that highlights opportunities for CMS and state agencies that jointly operate Medicaid and the State Children’s Health Insurance Program (CHIP) to document specific disparities in health care and develop new opportunities to improve access to and the quality of care beneficiaries receive.  The letter also outlines areas that could be addressed through subregulatory guidance, waiver opportunities, and technical assistance.  Learn more from the MACPAC letter to OMB.

National Institutes of Health

Stakeholder Events

Tuesday, July 13 – Food and Drug Administration

The FDA will host a webinar to share information and answer questions about its revocation of EUAs for non-NIOSH-approved respirators and decontamination systems.  It will present information about its June 30, 2021 “Update:  FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities.”  To join the webinar:

Zoom Webinar Link: https://fda.zoomgov.com/j/1600971341?pwd=UTJMTlZmYzVScmNZamd2d2J4SU92Zz09

Webinar Passcode: $vrC6z

Dial: 833-568-8864
Webinar ID: 160 097 1341
Passcode: 292602

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.

Wednesday, July 14 and Tuesday, July 20 – Health Resources and Services Administration (HRSA)

HRSA will host recorded Reporting Technical Assistance Sessions to provide technical assistance on reporting requirements for Provider Relief Fund recipients and stakeholders.  For the July 14 session at 3:00 p.m. go here to register and for the July 20 session at 3:00 p.m. go here to register.

Federal Health Policy Update for Wednesday, June 30

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, June 30.  Some of the language used below is taken directly from government documents.

Supreme Court Decision in Site-Neutral Payment Case

  • The Supreme Court has declined to hear an appeal of a case rejecting the bid of hospital interests to prevent Medicare’s implementation of site-neutral payment rates for outpatient clinic visits.

Provider Relief Fund

CMS has updated the following pages on its Provider Relief Fund web site:  For Providers, General Information, Data, Reporting Requirements and Auditing, and FAQs.  The updates incorporate changes originally communicated in the June 11, 2021 update of the Post-Payment Notice of Reporting requirements.  CMS has summarized those changes in a revised answer to the question “What’s the latest regarding the CARES Act Provider Relief Fund” on the FAQ page?”, which reads as follows:

HHS revised the Post-Payment Notice of Reporting Requirements – PDF* as of June 11, 2021. This new version supersedes all previous versions of the Post-Payment Notice of Reporting Requirements documents. Key updates include:

  • The period of availability of funds is based on the date the payment is received (rather than requiring all payments be used by June 30, 2021, regardless of when they were received).
  • Recipients are required to report for each Payment Received Period in which they received one or more payments exceeding, in the aggregate, $10,000 (rather than $10,000 cumulatively across all PRF payments).
  • Recipients will have a 90-day period to complete reporting (rather than a 30-day reporting period).
  • The reporting requirements are now applicable to recipients of the Nursing Home Infection Control Distribution (formally known as the Skilled Nursing Facility and Nursing Home Infection Control Distribution) in addition to General and other Targeted Distributions.
  • The PRF Reporting Portal will open for providers to start submitting information on July 1, 2021.

Providers should review these changes carefully.

(Please note that the changes on several of the site’s pages refer visitors to the Provider Relief Fund Reporting Portal but that portal will be unavailable until Thursday morning, July 1 at 8:00 a.m. (eastern.)

Department of Health and Human Services

COVID-19

  • HHS’s Office of Minority Health (OMH) has awarded $250 million in grants to 73 local governments as part of a new, two-year initiative to identify and implement best practices for improving health literacy to enhance COVID-19 vaccination and other mitigation practices among underserved populations.  Learn more about the program and find a list of those awarded grants here.
  • HHS and its Office of Head Start at the Administration for Children and Families is awarding $1 billion in American Rescue Plan Act funds to Head Start programs nation-wide.  These funds will help more than 1500 Head Start programs build back to fully operational, in-person comprehensive services this fall and some of the money is expected to be used to support COVID-19 vaccinations for staff and participating families.  Learn more from this HHS announcement.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has proposed a new rule that sets forth proposed revised 2022 user fee rates for insurers offering qualified health plans through federally-facilitated exchanges and state-based exchanges on the federal platform and proposes repealing billing requirements related to the collection of separate payments for the portion of qualified health plan premiums attributable to coverage for certain abortion services.  Under the proposed rule, exchange customers would have an extra 30 days to enroll, the enrollment period would be extended from November 1 to January 15 (it currently ends on December 15), and a new monthly special enrollment period would give low-income individuals and families additional opportunities to enroll in a no-premium plan.  Learn more from this CMS news release; a CMS fact sheet; and the proposed regulation itself.  Stakeholder comments are due by July 28.
  • CMS has published its proposed calendar year 2022 home health prospective payment system rate update.  Among other things, the proposed rule would increase rates 1.7 percent; expand the home health value-based purchasing model nation-wide, making participation mandatory; recalibrate case-mix weights; introduce an occupational therapy low-utilization payment adjustment add-on factor for assessments; introduce changes in the home health quality reporting program and solicit stakeholder input on possible future changes that address health equity; and make permanent certain regulatory waivers introduced in response to the COVID-19 emergency, including the use of telehealth.  Learn more from the CMS announcement about the proposed rule; a separate news release addressing how the rule seeks to improve home health services for older adults and people with disabilities; and the proposed rule itself.  The deadline for stakeholder comment is August 27.
  • CMS has published the latest edition of MLN Connects, its online publication.  For articles about the July 2021 update of the ambulatory surgical center payment system, 2021 alternative payment model (APM) incentive payments, and more, go here.
  • In a study to determine whether CMS has designed and implemented effective internal controls related to hospital preparedness for emerging infectious diseases such as COVID-19, CMS’s Office of the Inspector General has concluded that those controls were well-designed and implemented during the COVID-19 emergency but that CMS’s authority is insufficient for it to ensure preparedness at accredited hospitals.  Find a summary of the study here and the full report here.

Centers for Disease Control and Prevention

COVID-19

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:

  • 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 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 Monday, June 21

The following is the latest health policy news from the federal government as of 2:15 p.m. on Monday, June 21.  Some of the language used below is taken directly from government documents.

Supreme Court Decision in Affordable Care Act Challenge

  • The Supreme Court upheld the constitutionality of the Affordable Care Act in the California v. Texas case by a 7-2 vote in which the court concluded that the plaintiffs did not have standing to pursue the matter because they were not directly harmed.  See the court’s opinion here.

White House

Department of Health and Human Services

COVID-19

  • HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) has suspended distribution of the monoclonal antibodies bamlanivimab/etesevimab in Rhode Island because of the rising prevalence in that state of the COVID-19 P.1 (Gamma) variant (first identified in Brazil) and the B.1.351 (Beta) variant (first identified in South Africa) and the relative ineffectiveness of these therapies in fighting these variants.  ASPR has already suspended distribution of these monoclonal antibodies in Arizona, California, Florida, Indiana, Oregon, Washington, Illinois, and Massachusetts for the same reason and recommends the use of alternative therapies.  Go here for further information.
  • HHS announced that the administration will invest more than $3 billion in American Rescue Plan money to accelerate the discovery, development, and manufacture of antiviral medicines as treatments for COVID-19 and other viruses.  For more information on the plan and how the $3 billion will be allocated, see the HHS announcement.
  • HHS and its Office of the National Coordinator for Health Information Technology (ONC) announced the establishment of an $80 million Public Health Informatics & Technology Workforce Development Program (PHIT Workforce Program) to strengthen U.S. public health informatics and data science.  As part of this launch, ONC is inviting colleges and universities – particularly Historically Black Colleges and Universities (HBCUs), Tribal Colleges and Universities (TCUs), Hispanic Serving Institutions (HSIs), Asian American and Native American Pacific Islander-Serving Institutions (AANAPISIs), and other minority-serving institutions (MSIs) to apply for funding through a consortium that will develop the curriculum, recruit and train participants, secure paid internship opportunities, and assist in career placement at public health agencies, public health-focused non-profits, or public health-focused private sector or clinical settings.  Learn more about the program from this HHS announcement and this notice of the funding opportunity.  Applications are due August 11.

Health Policy News

  • HHS’s Office of the National Coordinator for Health Information Technology (ONC), in collaboration with standards development organizations and others, has released the Project US@ (‘USA’) Draft Technical Specification Version 1.0 for public comment.  Project US@ was created to develop a unified, cross-standards, health care industry-wide specification for representing patient addresses to improve patient matching.  See the HHS/ONC announcement about the release here and find the draft specifications here.  Comments are due July 31.
  • The White House has nominated Christi Grimm to be HHS’s inspector general.  The position is subject to Senate confirmation.  Learn more about her here.
  • Medicaid enrollment rose by nearly 9.9 million individuals, a 13.9 percent increase, between February 2020, the month before the COVID-19 emergency was declared, and the end of January 2021.  Among the 50 states and the District of Columbia more than 80.5 million people were enrolled and receiving full benefits from the Medicaid and CHIP programs by the end of January 2021.  Learn more from this HHS news release.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has written a letter about hospital recertification survey suspensions that may become necessary due to new COVID-19 case surges. The last national hospital survey suspension expired on March 23, 2021, and while CMS has concluded that extending the suspension is not merited, it outlines in the letter the conditions under which it will consider suspending individual surveys.  See the CMS letter here.
  • On May 11 CMS published an interim final rule with comment period that added new COVID-19 vaccination reporting requirements for nursing home staff and residents and provided a four-week grace period for facilities to educate themselves on the new requirements and to operationalize reporting.  On June 10 CMS posted the first set of weekly nursing home COVID-19 vaccination data, which includes vaccination status of both residents and staff, as reported by facilities.  Current data shows that at nursing homes that have reported, approximately 75 percent of residents and 50 percent of staff have received a COVID-19 vaccine.  Learn more from the Nursing Home Data web site.

Health Policy News

  • CMS has published the latest edition of MLN Connects, its online publication.  For articles about monoclonal antibodies, HCPCS coding additions, and more, go here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

  • The FDA has translated its Pfizer vaccine fact sheet for recipients and caregivers into additional languages.  Find the complete collection here.
  • The FDA has approved a nasal antihistamine for non-prescription use through a process called a partial prescription to non-prescription switch.  The FDA approved Astepro (azelastine hydrochloride nasal spray, 0.15 percent) for seasonal and perennial allergic rhinitis for adults and children six years of age and older.  See the FDA announcement here.

Stakeholder Events

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:

  • Tuesday, June 22, 1:00-1:30 pm ET:  Spanish Language Toolkits – Register here
  • Thursday June 24, 1:00-1:30 pm ET:  Healthcare workers Toolkit – Register here
  • 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

Federal Health Policy Update for Thursday, June 3

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, June 3.  Some of the language used below is taken directly from government documents.

White House

Health Policy News

  • Late last week the Biden administration released its proposed FY 2022 budget.  Most of the health care provisions had already been disclosed and discussed prior to the formal budget release.  For additional information about the proposed budget, see the following resources:

COVID-19

  • President Biden announced a “National Month of Action” to mobilize a drive to get 70 percent of U.S. adults at least one COVID-19 shot by July 4.  Throughout the month, national organizations, local government leaders, community-based and faith-based partners, businesses, employers, social media influencers, celebrities, athletes, colleges, young people, and thousands of volunteers across the nation will be asked to work together to get their communities vaccinated.  Learn more about the various facets of this campaign in this administration fact sheet.

Congress

  • Representative Frank Pallone, chair of the House Energy and Commerce Committee, and Senator Patty Murray, chair of the Senate Health, Education, Labor and Pensions Committee, have released a letter “…requesting information on design considerations for legislation to develop a public health insurance option” with a stated goal of “…establishing a federally administered public option… to work towards achieving universal coverage, while making health care simpler and more affordable for patients and families.”  The letter invites interested parties to respond to eight specific questions about such a public health insurance option, with written comments due by July 31.  Find the Pallone/Murray letter here.

Centers for Medicare & Medicaid Services

COVID-19

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:  Submit Notice of Intent to Apply by June 7
    • Clinical Diagnostic Laboratories:  Key Dates for New & Reconsidered Test Codes
    • Clinical Diagnostic Laboratories:  Private Payor Rate-Based CLFS Resources
    • MACs Resume Medical Review on a Post-payment Basis
    • Improper Payment for Intensity-Modulated Radiation Therapy Planning Services
    • International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) – October 2021
    • National Coverage Determination (NCD) 110.24:  Chimeric Antigen Receptor (CAR) T-cell Therapy
    • National Coverage Determination (NCD) 210.3:  Screening for Colorectal Cancer (CRC) – Blood-Based Biomarker Tests
    • National Coverage Determination (NCD) Removal
    • Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Charge Payment

Go here for links to these and other items.

Department of Health and Human Services

COVID-19

  • HHS and its Health Resources and Services Administration (HRSA) have announced that $100 million in new funding is available through HRSA’s Rural Health Clinic Vaccine Confidence Program to support efforts to encourage residents of rural areas to receive COVID-19 vaccines.  Medicare-certified rural health clinics and organizations that own and operate such clinics are eligible for funding.  Learn more about the grant opportunity here.  Grant applications are due June 23.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

  • The FDA has recommended that health care workers and facilities transition away from crisis capacity personal protective equipment conservation strategies, such as using non-NIOSH-approved disposable respirators, including non-NIOSH-approved imported respirators such as KN95s.  This recommendation is in follow-up to an April 9, 2021 letter in which the FDA recommended a transition away from decontamination or bioburden-reduction systems for cleaning and disinfecting disposable respirators, which were being reused by health care personnel.  See the FDA’s new recommendation here and its April 9 letter here.

National Institutes of Health

COVID-19

  • The NIH announced that a new study has found that COVID-19 does not appear to pose a threat to the safety of the nation’s blood supply.  The analysis supports current donor screening guidelines, that do not require testing blood samples for COVID-19 but do require that donors be screened for physical symptoms of COVID-19 and for infections that occurred within 14 days of the blood donation.  The blood of donors with recent COVID-19 infections, or who develop infections after recent donations, cannot be used.  Learn more from this NIH news release.
  • The NIH has started a clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of different COVID-19 vaccines to determine the safety and effectiveness of individuals receiving vaccines and boosters made by different pharmaceutical companies.  Learn more here.
  • The NIH announced that the experimental drug TEMPOL may be a promising oral antiviral treatment for COVID-19, as indicated by a study of cell cultures by NIH researchers.  Learn more from this NIH news release.

Health Policy News

  • The NIH has launched a clinical trial to assess the safety and effectiveness of an investigational influenza vaccine designed to provide long-lasting protection against multiple flu virus strains.  Healthy participants 18 to 50 years old will receive either a licensed seasonal influenza vaccine or the experimental vaccine that has been formulated to protect against multiple strains of influenza for much longer than one flu season.  Learn more here.

Congressional Research Service

  • The CRS has published a brief report on Medicaid’s money follows the person rebalancing demonstration program.  Find it here.

Medicaid and CHIP Payment and Access Commission

  • MACPAC has published an issue brief on Medicaid base and supplemental payments to hospitals that reviews each type of Medicaid hospital payment, with information on payment goals, payment amounts, and the relationship to other types of Medicaid payments.  It also provides examples showing how the use of supplemental payments varies by state and additional information about how state methods for financing Medicaid payments affect net hospital payments.  Find the report here.

Medicare Payment Advisory Commission

  • The GAO has appointed two new members to the MedPAC board:  Stacie B. Dusetzina, PhD, associate professor of health policy and an Ingram associate professor of cancer research at Vanderbilt University Medical Center in Nashville, Tennessee, andThe following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, June 3.  Some of the language used below is taken directly from government documents.

U.S. Equal Employment Opportunity Commission

Stakeholder Events

FEMA

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.

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.

Federal Health Policy Update for Wednesday, May 19

The following is the latest health policy news from the federal government as of 2:15 p.m. on Wednesday, May 19.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • NASH has written to all members of Congress urging them to contact Health and Human Services Secretary Xavier Becerra about directing more of its remaining CARES Act Provider Relief Fund money to private safety-net hospitals to help them serve their diverse, predominantly low-income communities during the COVID-19 emergency.  Go here to see NASH’s message to Congress.

The White House

COVID-19

Centers for Medicare & Medicaid Services

Health Policy News

Go here for links to these and other items.

Department of Health and Human Services

COVID-19

  • HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) is distributing $3 billion in American Rescue Plan funding for its mental health and substance use block grant programs.  The Community Mental Health Services Block Grant Program and Substance Abuse Prevention and Treatment Block Grant Program are distributing $1.5 billion each to states and territories to help communities addressing mental health and substance use needs during the COVID-19 pandemic.  Learn more from HHS’s news release announcing the funding.
  • HHS’s Office of the Inspector General has updated its work plan for COVID-19-related audits, evaluations, and inspections scheduled for May.
  • In conjunction with the California Justice Department and the U.S. Attorney’s Office for the Eastern District of California, HHS’s Office of the Inspector General has issued a news release advising the public that they should not be asked by providers to pay for COVID-19 vaccines and reminding providers that they may not attempt to charge or bill consumers for administering those vaccines.  See the news release here.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has published information about the challenges of providing hospice care amid the COVID-19 pandemic and about providing home care during the public health emergency.

Health Policy News

Senate Finance Committee Hearing

The Senate Finance Committee held a hearing today on COVID-19 flexibilities.

  • Go here to read the opening statement of the committee chair, Senator Ron Wyden (D-OR) and go here to read the opening statement of the committee’s ranking minority member, Senator Mike Crapo (R-ID).
  • Go here to see the testimony of individuals who appeared at the hearing.
  • The Medicare Payment Advisory Commission has submitted a written statement to the committee.  The MedPAC statement notes that “While many of these actions have been helpful in addressing the short-term issues presented by the pandemic, continuing those changes indefinitely would have drawbacks.  Therefore, policymakers should be cautious about extending them beyond the duration of the public health emergency (PHE) or other scheduled expiration date.”  The statement pays particular attention to telehealth and post-acute care.  Go here to see the MedPAC submission “Temporary modifications of Medicare policies in response to the coronavirus public health emergency.”
  • The Government Accountability Office has submitted a report to the Senate Finance Committee on the same subject.  The GAO notes that it undertook this work, titled “Medicare and Medicaid:  COVID-19 Program Flexibilities and Considerations for Their Continuation,” because of a CARES Act provision that calls for the agency to “… conduct monitoring and oversight of the federal government’s response to the COVID-19 pandemic.”  Find the GAO submission here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

National Institutes of Health

COVID-19

National Academy of Medicine

FEMA

Government Accountability Office

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 Monday, May 10

The following is the latest health policy news from the federal government as of 2:15 p.m. on Monday, May 10.  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 and the Department of Housing and Urban Development (HUD) have announced a joint-agency effort to increase access to COVID-19 prevention and treatment services, including testing and vaccinations, among disproportionately affected communities, including among HUD-assisted households and people experiencing homelessness.  This program will seek to leverage the Health Center COVID-19 Health Vaccine Program, which currently provides a direct supply of vaccines to nearly 800 health centers across the country.  HHS and HUD expects this effort to reach more than 6,000 multi-family housing properties, 6,700 homeless shelters, and approximately 7,500 public housing properties.  Learn more from the departments’ announcement of their joint initiative.
  • HHS’s Health Resources and Services Administration (HRSA) will hold an informational webinar on the agency’s new COVID-19 Coverage Assistance Fund program under which participating providers are reimbursed at Medicare rates for administering COVID-19 vaccines to underinsured individuals.  Presenters will provide an overview and orient health care providers to the program by covering information such as enrolling as a provider participant, submitting patient information, submitting claims, and receiving payments via direct deposit.  The webinar will be held on Wednesday, May 12 at 2:00 p.m. (eastern).  Go here to register.

Health Policy News

  • HHS announced that its Office for Civil Rights will interpret and enforce Section 1557 and Title IX’s prohibitions on discrimination based on sex to include: (1) discrimination on the basis of sexual orientation; and (2) discrimination on the basis of gender identity.  Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in covered health programs or activities.  Go here to see HHS’s announcement of this policy and its rationale for it and go here to see the notice HHS intends to publish in the Federal Register.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

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

  • New Program:  HRSA COVID-19 Coverage Assistance Fund
  • COVID-19: Work of Hospital Allied & Supportive Care Providers
  • IRF, LTCH, & SNF: Report Quality Data by May 17
  • Building COVID-19 Vaccine Confidence Webinar — May 13
  • New Waived Tests

Go here for links to these and other items.

Treasury Department

COVID-19

  • The Treasury Department has posted an interim final rule, not yet published in the Federal Register, implementing the Coronavirus State Fiscal Recovery Fund and the Coronavirus Local Fiscal Recovery Fund established under the American Rescue Plan Act.  The interim final rule addresses uses of the $350 billion from the American Rescue Plan, including for public health expenditures, addressing the negative effects of the public health emergency, replacing lost public-sector revenue, providing premium pay for essential workers, and more.  Learn more from the following resources:

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

  • The FDA will convene a virtual meeting of its Vaccines and Related Biological Products Advisory Committee on June 10 to provide a status update on its approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age.  The committee also will discuss the data needed to support an EUA and a biologics license application for a COVID-19 vaccine intended for use in children less than 12 years of age.  The committee will not discuss any specific products.  See the FDA announcement of this meeting here.

Stakeholder Events

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.

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.

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.