Feds Update Provider Relief Fund Spending, Reporting Requirements

The Department of Health and Human Services  has revised its requirements for reporting on and expending CARES Act Provider Relief Fund payments.

Today HHS and its Health Resources and Services Administration  announced that they have 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.

Highlights of the revisions are:

  • 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 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.

For additional information, see the following resources:

 

Federal Health Policy Update for Thursday, June 10

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

White House

Health Policy News

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

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

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

Department of Health and Human Services

COVID-19

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

Occupational Safety and Health Administration

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

Centers for Disease Control and Prevention

COVID-19

National Institutes of Health

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

Stakeholder Events

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

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

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

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

Health Policy Update for Tuesday, June 8

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

White House

Health Policy News

COVID-19

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

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

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

Department of Health and Human Services

Health Policy News

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

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Health Policy News

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

Medicare Payment Advisory Commission

Patient-Centered Outcomes Research Institute

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

Stakeholder Events

Wednesday, June 9 – FDA

Virtual Town Hall Series- Coronavirus (COVID-19) Test Development and Validation
Wednesday, June 9 at 12:15 pm ET  Click here for connection information
FDA will host a virtual town hall for COVID-19 test developers. The purpose of this town hall is to help answer technical questions about the development and validation of tests for COVID-19.

Thursday, June 10 – FEMA
COVID-19 Pandemic Operational Guidance Webinars
Thursday, June 10 at 11:00 am at 12:00 pm  ET Click here for connection information
FEMA is offering a series of webinars throughout the month of June to further educate people on the pandemic operational guidance.  The webinar will cover information included in the COVID-19 Pandemic Operational Guidance: All Hazards Incident Response and Recovery, a document aimed at helping emergency managers plan for disaster response and recovery while adhering to public health guidelines to prevent the spread of COVID-19.

Thursday, June 10 – CMS

Rural Health Open Door Forum

Thursday, June 10 at 2:00 ET

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

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

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

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

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

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

Medicaid Enrollment Continues to Rise

Medicaid enrollment in 36 states rose 17.7 percent from February 2020 to March 2021.

Leading the way were two Medicaid expansion states, Utah and Nebraska, which saw their Medicaid enrollment increase 37.6 percent and 30.9 percent, respectively.

Other states with major increases in Medicaid enrollment were Missouri (26.5 percent), Illinois (26.3 percent), and Indiana (25.7 percent).  The increases appear to have been driven by pandemic-related job losses and the accompanying economic downturn.

Learn more about where and why Medicaid enrollment is rising from the article “What is Happening With Medicaid Enrollment in Q1 of 2021?” on the web site of the Georgetown University Health Policy Institute.

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 Tuesday, May 25

The following is the latest health policy news from the federal government as of 2:45 p.m. on Tuesday, May 25.  Some of the language used below is taken directly from government documents.

The White House

COVID-19

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • The Senate has confirmed the nomination of Chiquita Brooks-LaSure to be CMS administrator.

Department of Health and Human Services

COVID-19

  • HHS and its Health Resources and Services Administration (HRSA) have announced that they will spend $4.8 billion in American Rescue Plan money to support HRSA’s COVID-19 Uninsured Program.  This funding will enable the program to continue reimbursing health care providers for testing uninsured individuals for COVID-19.  See the announcement here.
  • HHS and HRSA announced the availability of $14.2 million from the American Rescue Plan to expand pediatric mental health care access by integrating telehealth services into pediatric primary care.  The funding will expand Pediatric Mental Health Care Access (PMHCA) projects into new states and geographic areas nationwide, including tribal areas. These new state and regional networks of pediatric mental health care teams will provide teleconsultations, training, technical assistance, and care coordination for pediatric primary care providers to diagnose, treat, and refer children and youth with mental health conditions and substance use disorders.  Learn more from the following resources:
  • HHS’s Office of the Inspector General has updated its FAQ in which it outlines when it will exercise its discretionary authority to pursue matters directly related to the COVID-19 public health emergency to address the question of whether providers may offer financial incentives for people to receive COVID-19 vaccines.

Health Policy News

  • A federal court has found that HHS must recalculate years worth of Medicare direct graduate medical education payments to teaching hospitals because of the manner in which it weighted the number of full-time medical graduates those hospitals could claim for reimbursement when they exceeded their resident caps.  In addition to directing HHS to recalculate the payments to the hospitals that sued, the ruling should enable other hospitals that exceeded their resident cap limit to pursue payment recalculation as well.  Learn more from the federal court decision.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has released its Healthcare System Cybersecurity: Readiness & Response Considerations.  Information in this document is related to the effects of a cyber incident on the health care operational environment – specifically, the ability to care for patients and maintain business practices and readiness during such an event.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Health Policy News

  • The FDA has published a discussion paper, “Conveying Materials Information about Medical Devices to Patients and Healthcare Providers:  Considerations for a Framework,” intended to stimulate discussion and to solicit feedback from a variety of stakeholders on how materials information should be communicated in medical device labeling.  The FDA seeks input on the paper by July 19.  Go here to find the FDA’s announcement, additional information about the FDA’s actions, and a link to the paper itself.

Stakeholder Events

CDC

Thursday, May 27

CDC/Clinical Outreach and Communication Activity – Severe COVID-19

The CDC will update clinicians on the underlying medical conditions associated with severe COVID-19, describe the methods used to rate the evidence linking conditions to severe COVID-19, review the evidence on risk for conditions included, and provide resources for providers treating patients with underlying medical conditions.  Go here for further information on the call and how to join it.

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.

5 p.m. (eastern), May 20

1 p.m. (eastern), May 28

9 a.m. (eastern), June 7

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.

 

Federal Health Policy Update for Wednesday, May 19

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

NASH Advocacy

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

The White House

COVID-19

Centers for Medicare & Medicaid Services

Health Policy News

Go here for links to these and other items.

Department of Health and Human Services

COVID-19

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

Health Policy News

Senate Finance Committee Hearing

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

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

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

National Institutes of Health

COVID-19

National Academy of Medicine

FEMA

Government Accountability Office

Safety-Net Hospitals Need More COVID Aid, NASH Tells Congress

The federal government should direct more of its remaining CARES Act Provider Relief Fund money to private safety-net hospitals, the National Association of Safety-Net Hospitals told members of Congress in a message delivered yesterday.

While the Provider Relief Fund has been a lifesaver for safety-net hospitals, NASH noted, the formula for distributing money put high-volume Medicaid hospitals at a disadvantage compared to the typical community hospital while separate distributions of the CARES Act money specifically for safety-net providers missed many such hospitals entirely

Last week NASH wrote to Health and Human Services Secretary Xavier Becerra to bring this situation to his attention and seek his assistance, and in its Monday message to members of Congress, NASH asked those members to convey to Secretary Becerra their support for greater aid to private safety-net hospitals in future Provider Relief Fund distributions.

See NASH’s message to members of Congress.

NASH Seeks Changes in Provider Relief Fund Distributions

Concerned that some private safety-net hospitals have not received Provider Relief Fund Phase 3 distributions and that others have not received adequate grants, the National Alliance of Safety-Net Hospitals has written to Health and Human Services Secretary Xavier Becerra to ask for changes in HHS’s approach to the CARES Act grants intended to help hospitals absorb the additional expenses they have incurred and the revenue they have lost as a result of the COVID-19 emergency.

Specifically, NASH urged HHS to:

  • Review the eligibility criteria and methodology for determining Provider Relief Fund grants to ensure that they reach true safety-net hospitals, and in particular those that serve especially large numbers of Medicaid patients.
  • Recalculate Phase 3 grants in a way that better reflects the true financial obstacles safety-net hospitals have faced throughout the COVID-19 emergency.
  • Apply more appropriate criteria and a better methodology for calculating payments in future Provider Relief Fund distributions.

Learn more from NASH’s letter to HHS Secretary Becerra.