Federal Health Policy Update for Thursday, July 22

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

White House

Centers for Medicare & Medicaid Services

Health Policy News

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bulletin informing states that the Department of Homeland Security’s  2019 public charge rule has been vacated and is no longer in effect.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

Department of Health and Human Services

COVID-19

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

Health Policy News

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

Centers for Disease Control and Prevention

Food and Drug Administration

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

Government Accountability Office

Medicaid and CHIP Payment and Access Commission (MACPAC)

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

Stakeholder Events

Wednesday, August 4 – Centers for Disease Control

Zoonoses and One Health Update (ZOHU) Call

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

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

Monday, August 23 – CMS

Advisory Panel on Hospital Outpatient Payment

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

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

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

 

Federal Health Policy Update for Wednesday, July 14

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

CMS – Proposed 2022 Medicare Physician Fee Schedule Rule

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

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

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

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

CMS’s news release announcing the newly proposed rule

a CMS fact sheet

quality program update fact sheet

Medicare Diabetes Prevention Program update fact sheet

the proposed rule itself

Centers for Medicare & Medicaid Services

Health Policy News

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

Provider Relief Fund

Department of Health and Human Services

Health Policy News

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

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

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

Medicaid and CHIP Payment and Access Commission (MACPAC)

Occupational Safety and Health Administration (OSHA)

Office of Management and Budget (OMB)

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

See the complete HHS list here.

Stakeholder Events

Thursday, July 15 – Centers for Disease Control

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

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

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

Mission-Ready Packages Workshop for Resource Providers

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

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

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

Provider Relief Fund Reporting Requirements

Tuesday, July 20 at 3:00 pm ET

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

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

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

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

Wednesday, August 4 – Centers for Disease Control

Zoonoses and One Health Update (ZOHU) Call

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

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

 

Federal Health Policy Update for Friday, July 9

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

White House

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

In a section on hospitals, the order notes that

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

It also

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

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

Provider Relief Fund

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

Department of Health and Human Services

COVID-19

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

Health Policy News

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

Centers for Medicare & Medicaid Services

Health Policy News

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

COVID-19

Centers for Disease Control and Prevention

COVID-19

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

Food and Drug Administration

COVID-19

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

Medicaid and CHIP Payment and Access Commission (MACPAC)

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

National Institutes of Health

Stakeholder Events

Tuesday, July 13 – Food and Drug Administration

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

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

Webinar Passcode: $vrC6z

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

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

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

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

Federal Health Policy Update for Monday, June 28

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

Supreme Court Decision in Affordable Care Act Case

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

White House

Department of Health and Human Services

COVID-19

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

Health Policy News

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

Centers for Medicare & Medicaid Services

COVID-19

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

Health Policy News

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

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Health Policy News

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

Occupational Safety and Health Administration

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

National Institutes of Health

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

Medicare Payment Advisory Commission (MedPAC)

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

Medicaid and CHIP Payment and Access Commission (MACPAC)

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

Government Accountability Office

Stakeholder Events

CMS – Coronavirus (COVID-19) Stakeholder Calls 

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

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

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

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

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

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

Federal Health Policy Update for Tuesday, June 15

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

NASH Advocacy

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

Provider Relief Fund

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

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

Department of Health and Human Services

COVID-19

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

Health Policy News

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

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

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

National Institutes of Health

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

Medicare Payment Advisory Commission (MedPAC)

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

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

Medicaid and CHIP Payment and Access Commission (MACPAC)

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

National Association of Medicaid Directors

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

Government Accountability Office

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

Stakeholder Events

Wednesday, June 16 – FDA

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

Wednesday and Thursday, June 16 and June 17 – FEMA

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

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

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

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

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

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

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

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

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

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

CMS – Coronavirus (COVID-19) Stakeholder Calls 

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

Webinar dates and registration links are below:

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

Go here for registration information for the remaining dates.

Federal Health Policy Update for Thursday, June 3

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

White House

Health Policy News

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

COVID-19

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

Congress

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

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

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

Go here for links to these and other items.

Department of Health and Human Services

COVID-19

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

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

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

National Institutes of Health

COVID-19

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

Health Policy News

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

Congressional Research Service

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

Medicaid and CHIP Payment and Access Commission

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

Medicare Payment Advisory Commission

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

U.S. Equal Employment Opportunity Commission

Stakeholder Events

FEMA

Monday, June 7

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

FDA

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

Federal Health Policy Update for Thursday, May 27

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

The White House

COVID-19

Medicaid and CHIP Payment and Access Commission

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

Centers for Medicare & Medicaid Services

Health Policy News

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

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

Go here for links to these and other items.

Department of Health and Human Services

COVID-19

Health Policy News

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

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

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

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

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

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

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

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

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

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Stakeholder Events

FEMA

Friday, May 28

Monday, June 7

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

CDC

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

CDC

Thursday, June 3

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

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

FDA

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

Internal Revenue Service

Federal Health Policy Update for Wednesday, May 5

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

The White House

COVID-19

Department of Health and Human Services

COVID-19

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

Health Policy News

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

Centers for Medicare & Medicaid Services

COVID-19

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

Centers for Disease Control and Prevention

COVID-19

Medicaid and CHIP Payment and Access Commission

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

American Medical Association

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

Stakeholder Events

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

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

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

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

Wednesday, May 12

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

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

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

Federal Health Policy Update for Tuesday, April 20

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

Congress

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

The White House

COVID-19

Centers for Medicare & Medicaid Services

COVID-19

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

Department of Health and Human Services

COVID-19

Food and Drug Administration

COVID-19

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

Centers for Disease Control and Prevention

COVID-19

National Institutes of Health

COVID-19

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

Medicaid and CHIP Payment and Access Commission

Health Policy News

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

MACPAC Meets

The Medicaid and CHIP Payment and Access Commission met for two days last week in Washington, D.C.

The following is MACPAC’s own summary of the sessions.

MACPAC kicked off its April meeting with a review of a draft chapter for the June 2021 report to Congress and recommendations on addressing high-cost specialty drugs. Since 2017, the Commission has been working to identify potential models that could help states address the challenges of high prices. The presentation focused on drugs that have been approved by the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway. Such approvals are based on whether the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit; however, unlike under the traditional pathway, the clinical benefit has yet to be verified.

On Friday, the Commission voted to approve two recommendations* that address Medicaid payment for such drugs. The recommendations would increase the rebates under the Medicaid Drug Rebate Program on accelerated approval drugs until these drugs have verified the clinical benefit. Once the FDA converts the drugs to traditional approval, the rebates would revert back to the standard amounts.

Commissioners then turned their attention to ways states can integrate care through Medicare Advantage dual eligible special needs plans (D-SNPs) using contract authority under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA, P.L. 110-275). The draft chapter for the June report describes why MACPAC is focused on D-SNPs, MIPPA strategies available to states, state ability to use these strategies, and MACPAC’s plans for future work on specific strategies that if made mandatory could give further momentum to state efforts.

The Commission then discussed two additional draft chapters for the June 2021 report related to behavioral health services. Staff presented a draft chapter and recommendations on improving access to mental health services for adult Medicaid beneficiaries, followed by a draft chapter and recommendations on improving access to behavioral health services for children and youth.

Commissioners on Friday approved recommendations* that call on the Secretary of the U.S. Department of Health and Human Services to:

  • direct relevant agencies to issue joint subregulatory guidance that addresses how Medicaid and the State Children’s Health Insurance Program (CHIP) can be used to fund a crisis continuum for beneficiaries experiencing behavioral health crises;
  • direct a coordinated effort to provide education, technical assistance, and planning support to expand access to such services;
  • direct relevant agencies to issue joint subregulatory guidance that addresses the design and implementation of benefits for children and adolescents with significant mental health conditions covered by Medicaid and CHIP; and
  • direct a coordinated effort to provide education, technical assistance, and planning support to expand access to such services.

After a break on Thursday, Commissioners discussed a draft chapter for the June 2021 report to Congress on how electronic health records (EHRs) can be used to strengthen clinical integration and improve patient care.  Adoption of EHRs remains low among behavioral health providers. The chapter provides an overview of MACPAC’s work to date on clinical integration for behavioral and  physical health services, and discusses how data-sharing can improve the quality of care for beneficiaries with behavioral health conditions. It concludes by identifying ways to strengthen EHR uptake among Medicaid’s behavioral health providers.

Next, Commissioners reviewed a draft chapter on non-emergency medical transportation (NEMT). In recent years, policymakers at the state and federal levels have begun to re-examine this benefit. As part of a congressionally mandated request, MACPAC conducted a multi-pronged study of NEMT that will be published as a chapter in the June 2021 report to Congress. This presentation included the key findings of MACPAC’s study and an overview of the topics covered in the draft chapter.

On Friday, the day kicked off with a discussion of the challenges that states face in providing more care through home- and community-based services (HCBS). As of fiscal year (FY) 2018, HCBS spending as a percentage of long-term services and supports spending remained under 50 percent in 18 states and the District of Columbia. To understand why some states have made less progress in rebalancing, MACPAC contracted with RTI International and the Center for Healthcare Strategies. This presentation summarized the results of the work, as well as proposed policy considerations.

The Commission then heard a staff presentation on key Medicaid and CHIP managed care quality requirements, as well as quality improvement and measurement activities conducted by states, plans, and the Centers for Medicare & Medicaid Services. Staff also provided a summary of preliminary findings on state performance over time on selected core set measures and managed care plan performance on performance improvement projects, which suggest the effectiveness of these efforts is unclear. Staff and Commissioners identified potential areas for future MACPAC work related to quality of care in Medicaid and CHIP.

After the Commission voted on several recommendations, staff provided an update on the current state of Transformed Medicaid Statistical Information System (T-MSIS) data submissions and MACPAC’s work to validate and analyze the data. MACPAC found that data submissions have improved since 2016, but some challenges remain.

The meeting concluded with a panel discussion about Medicaid’s use of telehealth services, which expanded during the COVID-19 pandemic. Commissioners heard from Chethan Bachireddy, chief medical officer for the Virginia Department of Medical Assistance Services; Tracy Johnson, Medicaid director for the Colorado Department of Health Care Policy and Financing; and Sara Salek, chief medical officer for the Arizona Health Care Cost Containment System. Panelists described the use of telehealth during the pandemic, considerations for post-pandemic telehealth policies, and challenges to the use and adoption of telehealth in Medicaid and how these states are addressing them.

*All recommendations were approved as presented in draft.

Supporting the discussion were the following briefing papers:

  1. High-Cost Specialty Drugs Review of Draft Chapter and Recommendations
  2. Strategies for State Contracts with Dual Eligible Special Needs Plans
  3. Access to Mental Health Services for Adults: Draft Chapter and Recommendations
  4. Access to Behavioral Health Services for Children and Adolescents: Draft Chapter and Recommendations
  5. Electronic Health Records as a Tool for Integration of Behavioral Health Services
  6. Mandated Report: Non-Emergency Medical Transportation Benefit
  7. Progress on Rebalancing: Lessons from States
  8. Ensuring Medicaid and CHIP Quality
  9. Update on Transformed Medicaid Statistical Information System (T-MSIS)
  10. Panel Discussion: What States are Learning from Expanded Use of Telehealth

Because they serve so many Medicaid and CHIP patients – more than the typical hospital – MACPAC’s deliberations are especially important to private safety-net hospitals.

MACPAC is a non-partisan legislative branch agency that provides policy and data analysis and makes recommendations to Congress, the Secretary of the U.S. Department  of Health and Human Services, and the states on a wide variety of issues affecting Medicaid and the State Children’s Health Insurance Program.  Find its web site here.