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bulletin informing states that the Department of Homeland Security’s  2019 public charge rule has been vacated and is no longer in effect.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 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 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.

 

Vaccination Rates Low Among Medicaid Recipients

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

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

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

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

 

Federal Health Policy Update for Friday, July 2

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

Supreme Court

  • The Supreme Court has announced that it will hear a case in its next term challenging cuts in 340B payments and another involving Medicare disproportionate share.

White House

Provider Relief Fund

  • HHS has published new information about use of Provider Relief Fund grants, accounting for the use of those grants, expense and lost revenue calculations, changes in ownership, reporting on the use of Provider Relief Fund resources, and more.  The changes, including links to new documents, worksheets, instructions, an FAQ, a link to a webinar to learn about these changes, and more can be found on the Provider Relief Fund’s “reporting requirements and auditing” web page.  Recipients of Provider Relief Fund grants should review this new information carefully.
  • HHS also has updated its Provider Relief Fund FAQ site to reflect the changes introduced on the primary Provider Relief Fund web site (described above).  The update includes 24 new or updated items addressing the expenditure of Provider Relief Fund grants, accounting for and reporting on the use of those grants, recoupments, FEMA funds, and more.  The changes, marked “7/1/2021,” can be found on pages 8, 9, 11, 12, 16, and 22-27.

Department of Health and Human Services

COVID-19

  • HHS’s Office of the Assistant Secretary for Preparedness and Response has introduced a COVID-19 monoclonal antibody therapeutics calculator for infusion sites (mAbs Calculator) to inform staffing decisions and resource investments needed for COVID-19 monoclonal antibody therapeutic infusion sites.  Go here to learn more about the calculator and to find a link to it.
  • HHS’s COVID-19 health equity task force met this week to consider interim recommendations addressing the inequities and the impact of long-COVID or Post-Acute Sequelae COVID-19 infection and access to personal protective equipment, testing, and therapeutics.  Go here for a summary of the meeting and links to a recording of the event.

Health Policy News

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has released the final notice for the Basic Health Program federal funding methodology for program year 2022.  This document provides the methodology and data sources necessary to determine federal payment amounts for program year 2022 to states that elect to establish a Basic Health Program to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through qualified health plans in the exchange.  Learn more in the proposed rule.
  • CMS has proposed updating its End-Stage Renal Disease (ESRD) prospective payment system rates, changing the ESRD Quality Incentive Program, and modifying the ESRD Treatment Choices (ETC) Model.  The proposed changes to the ETC Model policies seek to encourage dialysis providers to decrease disparities in rates of home dialysis and kidney transplants among ESRD patients with lower socioeconomic status.  Other changes in the proposed ESRD regulation address rates, wage index, an update of the outlier policy, a transitional add-on payment adjustment for new and innovative equipment and supplies applications, and more.  Learn more from the following resources:

Centers for Disease Control and Prevention

COVID-19

  • The CDC has published a report in which it evaluates the effectiveness of COVID-19 vaccines among health care workers during the early phase of vaccinations.  Find the report here.
  • The CDC has updated its guidance for laboratories on the use of pooling for COVID-19 testing.  The new guidance notes that while pooling specimens for public health surveillance purposes is still acceptable, the focus now is on its use for diagnostic and screening testing.
  • The CDC has issued a guide for jurisdictions on expanding COVID-19 vaccine distribution to primary care providers to address disparities in immunizations.  Find it here.
  • The CDC has published research on the efficacy of portable air cleaners and masking for reducing indoor exposure to simulated exhaled COVID-19 aerosols.  Read the report here.

Health Policy News

  • The CDC reports that the number of cancer screenings received by women through the CDC’s National Breast and Cervical Cancer Early Detection Program declined 87 percent for breast cancer and 84 percent for cervical cancer during April 2020 compared numbers for that month over the past five years.  The CDC attributes this to delayed in seeking care because of COVID-19.  Learn more here.

Food and Drug Administration

COVID-19

  • With improved access nation-wide to N95 masks, the FDA has revoked emergency use authorizations for certain respirators and decontamination systems.  See the FDA announcement.  The FDA also will hold a webinar to share information and answer questions about its revocation of EUAs for non-NIOSH-approved respirators and decontamination systems.  Go here to learn more about the webinar.

Health Policy News

  • The FDA has alerted users of Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices due to potential health risks.  Go here to see the FDA announcement.
  • The FDA has approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment.  Learn more here.
  • The FDA has released a Cyclospora prevention, response, and research action plan.  The plan focuses on improving prevention, enhancing response activities, and filling knowledge gaps to help prevent Cyclospora contamination of foods and to help prepare for responding to future outbreaks.  See the FDA announcement for more.

National Institutes of Health

  • The NIH announced that it is funding five additional projects to identify ways of safely returning students and staff to in-person school in areas with vulnerable and underserved populations. Learn more about the new projects and other NIH-funded projects with similar objectives in this NIH announcement.

FEMA

  • FEMA has revised its COVID-19 funeral assistance policy to assist with COVID-19-related fatalities that occurred in the early months of the pandemic.  The change is intended to help families paying for funeral costs for people who died of COVID-19 but for which that cause of death was not noted on their death certificate.  Learn more from FEMA’s announcement of the change, which also has links to additional resources.

Stakeholder Events

Thursday, July 8 – HHS

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.  A webinar will be held on Thursday, July 8 at 1:00 p.m. (eastern)  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.

Wednesday, July 8 – HHS – Provider Relief Fund

HHS will host a webcast on Wednesday, July 8 at 3:00 p.m. (eastern) to present updated information on the use of Provider Relief Fund grants and reporting and auditing requirements associated with the receipt and use of those grants.  Go here to register.

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=UTJMTlZmYzVScmNZamd2d2J4SU92Zz09External Link Disclaimer

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.

 

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 Tuesday, June 15

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

NASH Advocacy

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

Provider Relief Fund

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

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

Department of Health and Human Services

COVID-19

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

Health Policy News

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

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

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

National Institutes of Health

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

Medicare Payment Advisory Commission (MedPAC)

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

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

Medicaid and CHIP Payment and Access Commission (MACPAC)

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

National Association of Medicaid Directors

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

Government Accountability Office

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

Stakeholder Events

Wednesday, June 16 – FDA

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

Wednesday and Thursday, June 16 and June 17 – FEMA

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

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

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

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

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

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

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

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

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

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

CMS – Coronavirus (COVID-19) Stakeholder Calls 

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

Webinar dates and registration links are below:

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

Go here for registration information for the remaining dates.

NASH Seeks Congress’s Help With 340B

Changing hospital admissions experiences in the past year resulting from the COVID-19 pandemic could jeopardize some safety-net hospitals’ continued eligibility for the section 340B prescription drug discount program and NASH is asking for Congress’s help to prevent this.

COVID-19 led to a reduction of hospitals admissions as people deferred addressing their medical problems out of fear of contracting the virus.  These reduced admissions, a one-year anomaly, could affect safety-net hospitals’ ability to continue participating in the 340B program, which is an essential tool for  helping hospitals provide low-cost prescription drugs to low-income patients in the communities they serve.

For this reason, NASH has asked members of Congress to co-sponsor and support H.R. 3203 and S. 773, which would protect hospitals from losing eligibility for the 340B program based on one year of once-in-a-lifetime admissions pattern changes.  See NASH’s message to members of Congress.