Federal Health Policy Update for Friday, July 16

The following is the latest health policy news from the federal government as of 2:45 p.m. on Friday, July 16.  Some of the language used below is taken directly from government documents.

White House

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS is providing notifications to facilities that were determined to be out of compliance with Quality Reporting Program (QRP) requirements for CY 2020, which will affect their FY 2022 Annual Payment Update (APU).  Non-compliance notifications are being distributed by the Medicare Administrative Contractors (MACs) and were placed into facilities’ CASPER folders in QIES, for Hospice and SNFs, and into facilities’ My Reports folders in iQIES for IRFs and LTCHs onJuly 14, 2021.  Facilities that receive a letter of non-compliance may submit a request for reconsideration to CMS via email no later than11:59 pm on August 13, 2021. Facilities that receive a notice of non-compliance and would like to request a reconsideration should see the instructions in their notice of non-compliance and on the appropriate QRP webpage:
  • The Medicare Geographic Classification Review Board application is available for the FY 2023-2025 reclassification cycle.  The current application and reinstatement period is open through September 1, 2021.  MGCRB rules have been updated, effective immediately, to update several administrative items, specifically:
    • MGCRB mailing address (for use with statewide applications)
    • S. Census Bureau links in Appendix C (for most recent reference maps (March 2020))
    • clarification of Rule 3.1 to address acceptance of correspondence subsequent to submitting the initial application

Go here for MGCRB rules, frequently asked questions, and electronic filing support.

Provider Relief Fund

  • The “reporting requirements and auditing” section of the Provider Relief Fund web page has been updated.  The Provider Relief Fund FAQ page also has been updated with new questions on pages 2, 14, 23, and 31.  Fund recipients should review these changes carefully.
    • One particular new question is noteworthy:  on page 31, the question asks “How do I appeal or dispute a decision made?”  The response is:  “HHS recognizes that providers may have questions regarding the accuracy of their PRF payments. HHS is developing a structured reconsiderations process to review and reconsider payment accuracy based on submitted supporting documentation.  Details regarding this process will be provided in coming weeks.”

Department of Health and Human Services

COVID-19

  • HHS has announced the availability of an estimated $103 million in American Rescue Plan funding over a three-year period to reduce burnout and promote mental health among the health workforce.  Awards will take into particular consideration the needs of rural and medically underserved communities, will seek to help health care organizations establish a culture of wellness  among the health and public safety workforce, and will seek support training that builds resiliency for those at the beginning of their health careers.  There are three funding opportunities for which HHS will accept applications:
  • Promoting Resilience and Mental Health Among Health Professional Workforce – approximately 10 awards will be made totaling approximately $29 million over three years to health care organizations to support members of their workforce.  This includes establishing, enhancing, or expanding evidence-informed programs or protocols to adopt, promote, and implement an organizational culture of wellness that includes resilience and mental health among their employees.
  • Health and Public Safety Workforce Resiliency Training Program – approximately 30 awards will be made totaling approximately $68 million over three years for educational institutions and other appropriate state, local, Tribal, public, or private non-profit entities training those early in their health careers.  This includes providing evidence-informed planning, development, and training in health profession activities to reduce burnout and suicide and promote resiliency among the workforce.
  • Health and Public Safety Workforce Resiliency Technical Assistance Center – one award will be made for approximately $6 million over three years to provide tailored training and technical assistance to HRSA’s workforce resiliency programs.

See the HHS announcement here.  To apply for the Provider Resiliency Workforce Training Notice of Funding Opportunities, visit Grants.gov.  Applications are due August 30, 2021.

  • HHS has awarded nearly $144 million in American Rescue Plan funding to 102 HRSA Health Center Program look-alikes (LALs) to respond to and mitigate the spread of COVID-19 and enhance health care services and infrastructure in communities across the country.  LALs are community-based health care providers that provide essential primary health care services to underserved communities and vulnerable populations but do not otherwise receive HRSA Health Center Program funding.  Learn more in the HHS announcement about the funding, which also has a link to a list of grant recipients.

National Institutes of Health

  • High-dose buprenorphine therapy, provided under emergency department care, is safe and well tolerated in people with opioid use disorder experiencing opioid withdrawal symptoms, according to a study supported by the National Institutes of Health’s National Institute on Drug Abuse through the Helping to End Addiction Long-term Initiative, or the NIH HEAL Initiative.  Go here to learn more.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has published its annual data book, which provides information on national health care and Medicare spending as well as Medicare beneficiary demographics, dual-eligible beneficiaries, quality of care in the Medicare program, and Medicare beneficiary and other payer liability.  It also examines provider settings and presents data on Medicare spending, beneficiaries’ access to care in the setting, and the sector’s Medicare profit margins, if applicable.  Find the data book here.

Congressional Research Service

  • In June the Occupational Safety and Health Administration (OSHA) promulgated an emergency temporary standard (ETS) for the prevention of the transmission of COVID-19 in health care employment settings.  OSHA has not used this authority since 1983, and the Congressional Research Service has prepared a report on what the ETS means and how it works.  Find that report here.

Stakeholder Events

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.

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 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 Thursday, June 10

The following is the latest health policy news from the federal government as of 3:00 p.m. on Thursday, June 10.  Some of the language used below is taken directly from government documents.

White House

Health Policy News

  • The White House has released a memo titled “What We Urge You To Do To Protect Against The Threat of Ransomware.”  This memo addresses the growing number and size of ransomware incidents and calls upon government and the private sector to take steps to protect their organizations from this growing threat.  The memo also outlines the federal government’s recommended best practices.  Find the memo here.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • CMS has published the latest edition of MLN Connects, its online publication.  For articles about prior authorization for hospital outpatient departments, ICD-10 PCS procedure codes for FY 2022, HCPCS codes subject to and excluded from CLIA amendments, Medicare’s quarterly compliance newsletter, and more, go here.

Department of Health and Human Services

COVID-19

  • HHS Secretary Xavier Becerra has written to providers to remind them that COVID-19 tests and vaccines are to be “…free for any individual living in the United States, regardless of their insurance or immigration status.”  The letter reminds providers of how they may seek reimbursement for their testing and vaccine administration costs from entities other than their patients.  See the HHS announcement of this reminder from Secretary Becerra and the letter to providers.
  • HHS announced that the federal government will purchase approximately 1.7 million courses of the investigational antiviral treatment molnupiravir (MK-4482), which is used to treat COVID-19, pending emergency use authorization or approval by the FDA.  The drug is currently in phase 3 trials.  The value of the purchase is $1.2 billion.  See the HHS announcement here.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has updated its COVID-19 Behavioral Health Resources page to help address health care professional stress and resilience, including self-care resources and combating compassion fatigue.

Occupational Safety and Health Administration

  • OSHA posted a new emergency rule, soon to be published in final form, describing new steps that health care entities must take to protect their workers from COVID-19.  The steps address the use of personal protective equipment, ventilation, social distancing, time off for vaccines, and more.  Learn more from information posted on the OSHA web site and from the new emergency rule itself.  The rule takes effect upon official publication.

Centers for Disease Control and Prevention

COVID-19

National Institutes of Health

  • The NIH announced that a clinical trial is under way in five U.S. cities to determine whether delivering integrated health services through mobile clinics can improve HIV and substance use outcomes among people with opioid use disorder who inject drugs.  Learn more here.

Stakeholder Events

Friday, June 11 – FDA
Identification of Medicinal Products: Path to Global Implementation
Friday, June 11 at 1:00 – 2:30 pm ET  Click here to learn more
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.

Friday, June 11 – FDA
Identification of Medicinal Products:  Path to Global Implementation
Friday, 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.

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 the 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 the benefits of the medication outweigh its risks.

Health Policy Update for Tuesday, June 8

The following is the latest health policy news from the federal government as of 2:45 p.m. on Tuesday, June 8.  Some of the language used below is taken directly from government documents.

White House

Health Policy News

COVID-19

  • The White House has posted transcripts of the June 3 and June 8 press briefings given by its COVID-19 response team and public health officials.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • According to reports, Jon Blum will join CMS as principal deputy administrator, the same position he held during the Obama administration.  Also, Erin Richardson, currently a lobbyist for the Federation of American Hospitals, will join CMS as administrator Chiquita Brooks-LaSure’s chief of staff.  Ms. Richardson served on the White House Domestic Policy Council during the Obama administration.
  • CMS has published a guide to using the health-related social needs screening tool from the Accountable Health Communities Model.  Health-related social needs are individual-level, adverse social conditions that negatively affect individuals’ health care and are distinguished from social determinants of health.  Find the guide here.
  • CMS has issued a 2021 navigator notice of funding opportunity that will make $80 million in grant funding available to navigators in states with a federally-facilitated marketplace for the 2022 plan year.  Go here to see CMS’s announcement about the funding and go here to see formal notice of the funding opportunity.  Applications are due July 6.

Department of Health and Human Services

Health Policy News

  • HHS’s Office of the Assistant Secretary for Preparedness and Response has issued a warning describing current vulnerabilities, including to ransomware threats, for selected health care information systems.  Find that notice here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Health Policy News

  • The FDA has approved Aduhelm (aducanumab) for the treatment of Alzheimer’s.  Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.  Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit.  Go here to see the FDA announcement and go here for further information about Aduhelm.

Medicare Payment Advisory Commission

Patient-Centered Outcomes Research Institute

  • PCORI, a non-profit organization created through the Affordable Care Act, is launching a Health Systems Implementation Initiative that it says it hopes will “…provide a channel to facilitate real-world uptake and use of evidence in healthcare delivery systems.”  To this end, PCORI has published a request for information through which it seeks “…to learn about health systems’ interest in undertaking implementation projects to improve care delivery based on findings from PCORI-funded research and related evidence.  Further, PCORI seeks feedback regarding the incentives and support that would enable health systems to undertake these activities.”  See an introduction to the project here and find the RFI here.  Questions are due by June 24 and responses are due by July 15.

Stakeholder Events

Wednesday, June 9 – FDA

Virtual Town Hall Series- Coronavirus (COVID-19) Test Development and Validation
Wednesday, June 9 at 12:15 pm ET  Click here for connection information
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.

Thursday, June 10 – FEMA
COVID-19 Pandemic Operational Guidance Webinars
Thursday, June 10 at 11:00 am at 12:00 pm  ET Click here for connection information
FEMA is offering a series of webinars throughout the month of June to further educate people on the pandemic operational guidance.  The webinar will cover information included in the 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.

Thursday, June 10 – CMS

Rural Health Open Door Forum

Thursday, June 10 at 2:00 ET

Items on the agenda include the FY 2022 inpatient prospective payment system rule, including graduate medical education policies, and a COVID-19 vaccination payment update.

This call will be by conference call only.  To participate by phone dial 1-888-455-1397 and reference conference passcode 8604468.  Persons participating by phone are not required to RSVP.  TTY Communications Relay Services are available for the hearing impaired.  For TTY services dial 7-1-1 or 1-800-855-2880 and a relay communications assistant will help.  Instant Replay is available by dialing 1-866-346-7095; no passcode needed.

Friday, June 11 – FDA
Identification of Medicinal Products: Path to Global Implementation
Monday, June 11 at 1:00 – 2:30 pm ET  Click here to learn more
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.

Friday, June 11 – FDA
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.

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 the 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 the benefits of the medication outweigh its risks.

Medicare Beneficiaries Happier With Their Health Insurance Than Privately Insured

People who are enrolled in Medicare are happier with their health insurance than those with private health insurance, according to a recent JAMA report.

Researchers found that the privately insured had a more difficult time finding doctors, were less likely to have a personal physician, had to deal with higher medical costs, were more likely to have medical debt, were more likely not to fill prescriptions because of their cost, and were less satisfied with their care than people insured by Medicare.

The findings were true whether people purchased their own health insurance or had employer-sponsored insurance.

Learn more about how the privately insured, Medicare beneficiaries, and Medicaid beneficiaries view their health insurance and health care experiences in the Healthcare Dive article “Privately insured face worse access, higher costs than those in public plans: JAMA report.”

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

CMS to Hospitals: We’re Watching You

The federal government is watching to see whether hospitals are following its new rules on price transparency.

And apparently, not all hospitals are.

Since the first of the year the Centers for Medicare & Medicaid Services has been monitoring hospitals’ compliance with a new rule that requires public disclosure of their prices, and in April it began writing to hospitals that were not meeting the regulatory standard, telling them they have 90 days to address their shortcomings.

Hospitals that fail to meet the CMS standard are subject to fines and public disclosure of their non-compliant status.Learn more from the Becker’s Hospital Review article “Hospitals get 1st CMS warning on price transparency failure.”

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.