Federal Health Policy Update for Friday, July 16

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

White House

Centers for Medicare & Medicaid Services

Health Policy News

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

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

Provider Relief Fund

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

Department of Health and Human Services

COVID-19

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

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

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

National Institutes of Health

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

Medicare Payment Advisory Commission (MedPAC)

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

Congressional Research Service

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

Stakeholder Events

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

Mission-Ready Packages Workshop for Resource Providers

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

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

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

Provider Relief Fund Reporting Requirements

Tuesday, July 20 at 3:00 pm ET

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

Wednesday, August 4 – Centers for Disease Control

Zoonoses and One Health Update (ZOHU) Call

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

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

 

Federal Health Policy Update for Wednesday, July 14

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

CMS – Proposed 2022 Medicare Physician Fee Schedule Rule

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

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

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

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

CMS’s news release announcing the newly proposed rule

a CMS fact sheet

quality program update fact sheet

Medicare Diabetes Prevention Program update fact sheet

the proposed rule itself

Centers for Medicare & Medicaid Services

Health Policy News

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

Provider Relief Fund

Department of Health and Human Services

Health Policy News

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

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

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

Medicaid and CHIP Payment and Access Commission (MACPAC)

Occupational Safety and Health Administration (OSHA)

Office of Management and Budget (OMB)

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

See the complete HHS list here.

Stakeholder Events

Thursday, July 15 – Centers for Disease Control

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

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

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

Mission-Ready Packages Workshop for Resource Providers

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

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

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

Provider Relief Fund Reporting Requirements

Tuesday, July 20 at 3:00 pm ET

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

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

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

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

Wednesday, August 4 – Centers for Disease Control

Zoonoses and One Health Update (ZOHU) Call

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

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

 

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.

Federal Health Policy Update for Monday, May 10

The following is the latest health policy news from the federal government as of 2:15 p.m. on Monday, May 10.  Some of the language used below is taken directly from government documents.

The White House

COVID-19

Department of Health and Human Services

COVID-19

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

Health Policy News

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

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

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

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

Go here for links to these and other items.

Treasury Department

COVID-19

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

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

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

Stakeholder Events

Cybersecurity and Infrastructure Security Agency (CISA)
CISA 2021 Hurricane Webinar
Wednesday, May 12 at 10:30 am – 12:00pm ET.  Click here for registration.

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

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

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

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

CMS and the CDC – Nursing Homes

Thursday, May 13 at 4:00 p.m. (eastern)

CMS and the CDC will host a national nursing home stakeholder call.  Register here.

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.

CMS Reconsidering Medicare Payment Models

Five Medicare alternative payment models previously slated for implementation are being delayed, cancelled, or reconsidered.

The five APMs whose futures are not clear are:

  • The Community Health Access and Rural Transformation Model ACO Track
  • Primary Care First
  • Kidney Care Choices
  • Geographic Direct Contracting
  • Part D Payment Modernization Model

Learn more about the Centers for Medicare & Medicaid Services’ latest actions on these models in the Becker’s Hospital Review article “5 CMS payment models that are under review, delayed.”

Health Policy Update for Thursday, April 8

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, April 8.

Provider Relief Fund

  • The Provider Relief Fund web page has been updated to announce a webinar next Tuesday, April 13 about the HRSA COVID-19 uninsured program under which participating providers are reimbursed at Medicare rates for testing, treating, and administering COVID-19 vaccines to uninsured individuals.  Go here for further information (in the shaded box labeled “update”).

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has added 24 new audiology and speech language pathology services to its list of telehealth services covered during the COVID-19 emergency.  Go here to find the updated list of telehealth services authorized during the pandemic.

Proposed Rules

  • CMS has published its proposed FY 2022 skilled nursing facility prospective payment system rule.  Learn more about the proposed rule from this CMS fact sheet and from the proposed rule itself.
  • CMS has published its proposed FY 2022 hospice wage index and payment update, hospice conditions of participation updates, and hospice and home health quality reporting program requirements.  Learn more the CMS fact sheet from this Federal Register notice.

Health Policy News

  • CMS will hold a webinar titled “Building Capacity in the Direct Service Workforce:  Moving Forward from the Summit” on Wednesday, April 28, 2021.  The purpose of the webinar is to advance learning and recommendations from the “Quality Jobs Equal Quality Care: Building Capacity in the Direct Care Workforce” event that was held at Advancing States’ HCBS Conference on December 3, 2020.  The webinar will highlight capacity-building strategies shared by states during the HCBS conference, is open to the public, and will focus on strategies for state Medicaid agencies, state agency partners, managed care plans, and home and community based services providers.  Go here for more information and here to register.

Department of Health and Human Services

Federal Funding Opportunity

  • HHS’s Administration for Community Living has published a notice about a funding opportunity.  The notice is titled “Aging and Disability Resource Center/No Wrong Door System COVID–19 Vaccine Access Supplemental Funding” and it states that “This funding opportunity is to support a new effort to get the nation’s most vulnerable and at-risk seniors and people with disabilities vaccinated.”  The notice was published today (April 8) and applications are due at 11:59 p.m. on Friday, April 9.  The notice also states that “Eligible Applicants for this award are existing ADRC/NWD COVID–19 CARES Act grantees that received funding on April 1, 2020.”  Learn more from the Federal Register notice.

Centers for Disease Control and Prevention

COVID-19

Health Policy News

  • The CDC and the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that federal funding may now be used to purchase rapid fentanyl test strips in an effort to help curb the dramatic spike in drug overdose deaths largely driven by the use of strong synthetic opioids, including illicitly manufactured fentanyl.  Learn more about the new policy and the federal grantees to which it applies in this CDC news release.

Congressional Research Service

  • The Congressional Research Service has published a new report titled “State and Federal Authority to Mandate COVID-19 Vaccination.”  Find it here.

MedPAC Meets

The Medicare Payment Advisory Commission met in Washington, D.C. last week to discuss various Medicare payment issues.

Among the issues discussed at MedPAC’s April meeting were:

  • Medicare skilled nursing facility value-based purchased program.
  • Medicare alternative payment models (APMs).
  • Medicare Advantage benchmark policy.
  • Medicare indirect medical education (Medicare IME) payments.
  • Medicare vaccine coverage and payments.
  • Medicare payment for prescription drugs prescribed on an outpatient basis.
  • Private equity and Medicare.
  • Medicare clinical laboratory fee schedule.

MedPAC is an independent congressional agency that advises Congress on issues involving Medicare.  While its recommendations are not binding on either Congress or the administration, MedPAC is highly influential in governing circles and its recommendations often find their way into legislation, regulations, and new public policy.  Because so many patients of private safety-net hospitals are insured by Medicare, MedPAC’s deliberations are especially important to those hospitals.

Go here for links to the policy briefs and presentations that supported MedPAC’s discussion of these issues.

New Medicare Policy May Save Money for Government But Cost Patients More

A new Medicare policy expected to save money for the federal government may end up doing so at the expense of Medicare beneficiaries who may find themselves faced with costs that Medicare previously paid.

Under the new policy, selected procedures that Medicare once authorized only when performed on an inpatient basis can now be performed on an outpatient basis.  The underlying rationale for the policy, which took effect on January 1 and will be phased in over the next three years, is that such an approach should foster competition and possibly lower Medicare costs.

But some of those procedures still require meaningful after-care that can range from prescription drugs to post-surgical monitoring to facility fees to home care and more – costs included in Medicare reimbursement for inpatient surgery but not included in the price of outpatient surgery.  Thus, while patients generally face the same maximum deductible for inpatient and outpatient procedures, they may be more likely to be forced to spend that full deductible if they choose to have the surgery performed on an outpatient basis.

This also could pose a challenge for private safety-net hospitals, which serve especially large numbers of low-income patients.  Many of those patients already have difficulty paying their Medicare co-payments, and this could leave safety-net hospitals with additional uncompensated care costs.

Learn more about how this situation came about, its implications for Medicare beneficiaries, and the possibility of this unusual situation being corrected in the Washington Post article “New cost-cutting Medicare rule may add costs to patients.”

Administration to Review Public Charge Rule

President Biden has ordered a review of the federal public charge rule.

The controversial rule, which would limit immigration to the U.S. for people who might at some point become dependent on public aid programs, has been the subject of litigation since it was proposed in 2019.

The White House executive order directs

…the Secretary of State, the Attorney General, the Secretary of Homeland Security, and the heads of other relevant agencies, as appropriate…[to] review all agency actions related to implementation of the public charge ground of inadmissibility…

The officials were ordered to report their findings to the president within 60 days.

The public charge rule authorizes the U.S. Citizenship and Immigration Services to deny a green card to any immigrant who receives certain public benefits – such as food stamps, public housing vouchers, welfare, or Medicaid – for more than 12 months within any three-year period.  The expressed purpose of the rule is to deny green cards to individuals who may become dependent on publicly funded services – a so-called “public charge.”

Health care advocates feared the rule would discourage some immigrants to whom the rule does not even apply from seeking to participate in certain public aid programs and even encourage some to whom the rule does not apply to disenroll from the public aid programs, such as Medicaid, in which they are already legally enrolled.

NASH has expressed its opposition to the public charge rule on a number of occasions, including in this position statement.

Implementation of the rule, which was proposed in 2019 and took effect in September of last year, was delayed in November by a federal court.

Learn more about the administration’s latest action in this presidential executive order.