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Federal Health Policy Update for Thursday, December 16

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

Provider Relief Fund

  • HHS’s Health Resources and Services Administration (HRSA) is releasing $9 billion in phase 4 Provider Relief Fund grants.  Payments will average $58,000 for what HHS is calling “small” providers, $289,000 for medium providers, and $1.7 million for large providers.  Learn more about the release of these funds from this HHS news release and go here for an explanation of how the agency calculated the payments.  The remainder of Phase 4 funding is expected to be distributed in January.
  • HRSA has updated its FAQ for its provider relief programs:  the Provider Relief Fund and American Rescue Plan rural payments.  The updated FAQ includes new information about reporting on mergers and acquisitions, reporting patient metrics, reporting on state and federal tax credits, and more.  The 12 new and modified questions, all dated 12/9/2021, can be found on pages 3, 10, 14, 15, 18, 34, and 36 of the updated Provider Relief Fund FAQ.

The White House

  • The Biden administration has issued an executive order on “Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government.”  The portion of the executive order that addresses health care directs the Secretary of Health and Human Services to:
    • continue to design and deliver new, personalized online tools and expanded customer support options for Medicare enrollees;
    • strengthen requirements for maternal health quality measurement, including measuring perinatal quality and patient care experiences, and evaluating the measurements by race and ethnicity to aim to better identify inequities in maternal health care delivery and outcomes;
      to the maximum extent permitted by law, support coordination between benefit programs to ensure applicants and beneficiaries in one program are automatically enrolled in other programs for which they are eligible;
    • to the maximum extent permitted by law, support streamlining State enrollment and renewal processes and removing barriers, including by eliminating face-to-face interview requirements and requiring prepopulated electronic renewal forms, to ensure eligible individuals are automatically enrolled in and retain access to critical benefit programs;
    • develop guidance for entities regulated pursuant to the Health Insurance Portability and Accountability Act (HIPAA) on providing telehealth in compliance with HIPAA rules, to improve patient experience and convenience following the end of the COVID-19 public health emergency;
    • test methods to automate patient access to electronic prenatal, birth, and postpartum health records (including lab results, genetic tests, ultrasound images, and clinical notes) to improve patient experiences in maternity care, health outcomes, and equity.
  • The White House has posted transcripts of December 10 and December 15 briefings given by its COVID-19 response team and public officials.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has updated its COVID-19 Medicare provider enrollment relief FAQ.  Find the updated FAQ here.  These updates are intended in part to assist both new providers and those that have temporarily expanded their facilities.

Health Policy Update

  • CMS has published a new edition of MLN Connects, its online newsletter of information about Medicare payments.  The latest edition includes articles about the two percent Medicare sequester that Congress recently delayed, changes in Medicare Advantage monoclonal antibody claims that take effect on January 1, changes in telehealth fees for originating sites, payments for opioid treatments, and more.  Go here to see the latest edition of MLN Connects.
  • CMS has sent a letter to state Medicaid directors to help them understand new requirements related to the Consolidated Appropriations Act of 2021, which established new requirements for state Medicaid programs, including new reporting requirements for non-disproportionate share hospitals (Medicaid DSH) supplemental payments and a change in the methodology for calculating the hospital-specific DSH limit.   Find that letter here.
  • CMS has sent a letter to state Medicaid directors urging them to encourage hospitals to consider implementation of evidence-based best practices for the management of obstetric emergencies, along with interventions to address other key contributors to maternal health disparities, to support the delivery of equitable, high-quality care for all pregnant and postpartum individuals.  The letter reminds Medicaid directors that beginning with October 1, 2021 discharges, CMS adopted a new structural quality measure for the Hospital Inpatient Quality Reporting (IQR) Program that asks hospitals to attest to whether they participate in a state-wide and/or national maternal safety quality collaborative and whether they have implemented patient safety practices or bundles to improve maternal outcomes.  Find the CMS letter here.  CMS has reinforced this message with this news release.

Department of Health and Human Services

Health Policy Update

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has published a discussion paper about 3D printing medical devices at the point of care, such as hospitals and doctors’ offices.  The purpose of the paper is to gather feedback from the public to inform future policy development.  Find the FDA announcement here and the discussion paper here.  The deadline for submitting comments is February 8.

National Institutes of Health

  • The percentage of adolescents reporting substance use decreased significantly in 2021, according to the latest results from the NIH’s “Monitoring the Future” survey of substance use behaviors and related attitudes among eighth, 10th, and 12th graders in the United States.  In line with continued long-term declines in the use of many illicit substances among adolescents previously reported by the Monitoring the Future survey, these findings represent the largest one-year decrease in overall illicit drug use reported since the survey began in 1975.   Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • Members of the Medicare Payment Advisory Commission met virtually last week.  Among the subjects MedPAC commissioners and staff discussed were hospital inpatient services, hospital outpatient services, physician services, ambulatory surgical center services, outpatient dialysis, hospice care, skilled nursing facilities, home health, inpatient rehabilitation facilities, and long-term-care hospitals.  Go here to find the meeting presentations on these subjects and go here to see a transcript of the meetings.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • Members of the Medicaid and CHIP Payment and Access Commission met virtually last week.  Among the subjects MACPAC commissioners and staff discussed were directed payments in Medicaid managed care, “money follows the person” program residency criteria, monitoring access to care for Medicaid beneficiaries, behavioral health services, health equity, and nursing facility staffing issues.  For a summary of the meeting and links to the presentations made during the two days of meetings, go here.
  • MACPAC has released the 2021 edition of the MACStats:  Medicaid and CHIP Data Book, with updated data on national and state Medicaid CHIP enrollment, spending, benefits, and beneficiaries’ health, service use, and access to care.  Find this year’s data book here.

Government Accountability Office (GAO)

  • The CARES Act, the Consolidated Appropriations Act of 2021, and the American Rescue Plan all appropriate funds to address behavioral health challenges created by the COVID-19 pandemic and the CARES Act requires the GAO to report on the challenges these funds are addressing and the effect they are having.  The GAO’s findings can be found in its new report “Behavioral Health and COVID-19:  Higher Risk Populations and Related Federal Relief Fund.  Find a summary of the report here and the full report here.

Federal Health Policy Update for Tuesday, November 23

The following is the latest health policy news from the federal government as of 2:30 p.m. on Tuesday, November 23.  Some of the language used below is taken directly from government documents.

The White House

Provider Relief Fund

  • HHS announced that it has begun distributing $7.5 billion in American Rescue Plan rural payments to providers and suppliers that serve rural Medicaid, Children’s Health Insurance Program (CHIP), and Medicare beneficiaries.  The average payment is $170,700, with payments ranging from $500 to $43 million for an entire health system.  More than 40,000 providers in all 50 states, Washington, D.C., and six territories will receive these rural provider payments.  Learn more from this HHS news release.  In addition, go here for a state-by-state breakdown of the payments and here for a data set with all of the recipients of this $7.5 billion in rural provider payments.
  • HHS’s Health Resources and Services Administration, which administers the Provider Relief Fund, has established a 60-day grace period for complying with the fund’s Reporting Period 1.  The grace period began on October 1, 2021, and will end on November 30, 2021 at 11:59 p.m. (eastern).  Learn more here, under “60-Day Grace Period – Reporting Period 1.”

Department of Health and Human Services

COVID-19

  • HHS’s Office of the Assistant Secretary for Preparedness and Response has posted a presentation titled “Monoclonals and More:  Issues and Opportunities with Early COVID-19 Treatment Options.”  The presentation includes information about therapeutics and their use and distribution, guidelines for determining appropriate treatments, and links to presentations and other resources.  Find the presentation here.

Health Policy Update

  • HHS has announced that it will be awarding an additional $1.5 billion to help grow and diversify the nation’s health care workforce and bolster equitable health care in the communities that need it most.  These awards are supporting the National Health Service Corps, Nurse Corps, and Substance Use Disorder Treatment and Recovery programs, which address workforce shortages and health disparities by providing scholarship and loan repayment funding for health care students and professionals in exchange for a service commitment in hard-hit and high-risk communities.  Learn more about these new resources for health care workforce development in this White House news release and another news release from HHS.
  • HHS has announced the availability of $35 million in American Rescue Plan funding to enhance and expand the telehealth infrastructure and capacity of Title X family planning providers.  HHS plans to use funds to award an estimated 60 one-time grants to active Title X grantees.  Applicants can begin the application process on Grants.gov and must apply by February 3.  Learn more from this HHS news release.
  • A new HHS report concludes that millions of Americans with private health insurance experience some kind of surprise medical billing.  The report found that surprise medical bills are relatively common among privately insured patients and can average more than $1,200 for services provided by anesthesiologists, $2,600 for surgical assistants, and $750 for childbirth-related care.  HHS has issued the report as it continues to develop regulations implementing the No Surprises Act, which was enacted earlier this year.  Learn more about the report from this HHS news release and see the full issue brief “Evidence on Surprise Billing: Protecting Consumers with the No Surprises Act.”
  • HHS has announced the creation of a new federal advisory committee, the Ground Ambulance and Patient Billing Advisory Committee.  As mandated by the No Surprises Act, the new advisory committee will be charged with providing recommendations to the secretaries of HHS, Labor, and Treasury on ways “to protect consumers from exorbitant charges and balance billing when using ground ambulance services.”  Learn more about the new Ground Ambulance and Patient Advisory Committee, its composition, and its scope of endeavor from this HHS news release and this Federal Register notice.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

  • CMS’s Center for Medicare and Medicaid Innovation has published an evaluation of year six of its Independence at Home Demonstration, in which selected primary care practices provide home-based primary care to targeted chronically ill beneficiaries for a three-year period, with CMS tracking beneficiaries’ care experience through quality measures and paying incentives to practices that meet quality measures while generating savings for Medicare.  Go here to learn more about the program and find a link to the program’s year-six evaluation.

Centers for Disease Control and Prevention

Medicaid and CHIP Payment and Access Commission (MACPAC)

Stakeholder Events

CMMI – The Value-Based Insurance Design Health Equity Business Case for Medicare Advantage Organizations – December 2

The Center for Medicare and Medicaid Innovation (CMMI) is sponsoring a series of webinars for current and potential Medicare Advantage Organization participants in its Value-Based Insurance Design Model.  The first webinar in the series will provide an overview of the model’s health equity incubation sessions effort, articulate a business case for Medicare Advantage organizations to leverage Value-Based Insurance Design Model components to address health inequities in their member populations, and provide specific guidance and clarification on the full extent of health equity-focused flexibilities that fall under the model’s waiver authority.  The first webinar will be held on Thursday, December 2 at 2:30 p.m. (eastern).  Go here for more information about the webinar and to register to participate.

CDC – Molecular Approaches for Clinical and Public Health Applications to Detect Influenza and COVID-19 Viruses – December 9

The CDC will hold a webinar on Thursday, December 9 to share with clinicians information about molecular approaches for clinical and public health applications to detect the influenza virus and COVID-19.  Go here to learn more about the webinar and how to participate.

Federal Health Policy Update for Wednesday, November 10

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, November 10.  Some of the language used below is taken directly from government documents.

The White House

  • The White House announced that it will spend $785 million in American Rescue Plan funding to support community-based organizations building vaccine confidence across communities of color, rural areas, and low-income populations; bolster the efforts of Tribal communities leading the way in mitigating the spread of the virus; expand public health systems’ ability to respond to the needs of people with disabilities and older adults who have been among the highest risk for infection or death from COVID-19; and continue its mission to build a more diverse and sustainable public health workforce, including a new apprenticeship program that will train thousands of our COVID-19 community health workers and prepare them for long-term careers in public health.  Learn more from a White House fact sheet about the initiative.
  • The president has issued a memo to the secretary of the Department of Homeland Security and the administrator of the Federal Emergency Management Agency (FEMA) directing them to continue reimbursing states for 100 percent of the cost of using their national guard units in their response to the COVID-19 pandemic through April 1, 2022.  See that memo here.
  • The White House has posted a transcript of the November 10 press briefing given by its COVID-19 response team and public officials.  Go here for the slides presented during that briefing.

Provider Relief Fund:  Phase 3 Payment Reconsideration

  • The Health Resources and Services Administration (HRSA) is accepting requests for reconsideration from providers that believe their Provider Relief Fund Phase 3 payments were incorrectly calculated.  Providers may not revise or correct their submitted application and the reconsideration will address only the calculation itself and not objections to the calculation methodology.  Go here for further information.  The deadline for submitting requests for reconsideration of Phase 3 payments is this Friday, November 12.

Department of Health and Human Services

COVID-19

  • HHS will invest $650 million from the American Rescue Plan to strengthen manufacturing capacity for quick, high-quality diagnostic testing through rapid point-of-care molecular tests and improve Americans’ access to them.  HHS will use these funds to ramp up U.S. domestic manufacturing capacity.  Learn more from this HHS announcement.
  • HHS will spend $143.5 million in American Rescue Plan money to expand community-based efforts to conduct tailored local outreach about vaccines, build vaccine confidence, and address barriers to vaccination in their communities.  The funding will support two programs in which award recipients will develop regional and local partnerships to reach unvaccinated individuals, including pregnant women and people from underserved and high-risk communities, to help bolster COVID-19 vaccination efforts.  Learn more from this HHS news release.  Much of the funding has already been awarded but $10 million is still available, to be awarded on a competitive basis.  Learn more from this HHS funding notice.  Applications are due December 10.

Health Policy News

  • HHS’s Office on Women’s Health has announced that more than 200 hospitals are participating in the HHS Perinatal Improvement Collaborative, which will focus on improving maternal and infant health outcomes by reducing disparities.  Including hospitals from all 50 states, the collaborative will be the first to evaluate how pregnancy affects overall population health by linking inpatient data of newborns to their mothers.  Learn more about the program and find a list of the participating hospitals in this HHS announcement.

HHS/Center for Medicare and Medicaid Innovation

Next Thursday, November 18, the CMS Innovation Center (CMMI) will host a webinar listening session at 1 p.m. (eastern).  Register for that webinar and find more information here.

CMMI has requested stakeholder input on three specific questions and NASH intends to submit responses on behalf of its members.  To do so, we need to hear from you.  Please review the CMMI questions below and send us your written responses no later than the close of business this Friday, November 12.  If you prefer to share your responses to these questions via phone, we will be happy to schedule a call with you.

Questions from CMMI

  1. What is the greatest obstacle to participating in a CMS Innovation Center or other value-based, accountable care model, and how do you recommend the CMS Innovation Center alleviate this obstacle?
  2. CMS is currently exploring quicker, more actionable data, learning collaboratives, and payment and regulatory flexibilities. What else could the CMS Innovation Center do to support clinicians and help them be successful in models?
  3. How can CMMI better incorporate patient needs and goals into models? How should the impacts of value-based care on patients be measured?

NASH staff will compile member responses and submit them to CMMI prior to next week’s listening session.

Centers for Medicare & Medicaid Services

COVID-19

  • Last week CMS held a webinar to explain the new federal regulation that mandates COVID-19 vaccines for all health care workers and others employed by provider organizations regulated under Medicare’s conditions of participation.  Learn more about the regulation from this video of the webinar and the slides presented during the event.  CMS also has posted an infographic about the requirement.
  • The Surgeon General has released a new community toolkit to help individuals, health care professionals and administrators, teachers, school administrators, librarians, and faith leaders to understand, identify, and stop the spread health misinformation in their communities.  Learn more from this HHS announcement and go here to see the toolkit.

Centers for Disease Control and Prevention

Medicaid and CHIP Payment and Access Commission (MACPAC)

Stakeholder Events

HHS – Monoclonals and More:  Issues and Opportunities with Early COVID-19 Treatment Options – November 12

HHS’s Office of the Assistant Secretary for Preparedness and Response will hold a webinar on COVID-19 treatment with monoclonal antibodies on Friday, November 12 at 12:30 p.m. during which it will address some of the most current recommendations for use of monoclonal antibodies, upcoming therapies, and the challenges and opportunities that new therapies may pose in conjunction with monoclonal antibodies and other treatments (e.g., prioritization and distribution).  Speakers also will highlight operational principles for a scaled strategy for use of these therapeutics in a scarce resource situation.  For more information about the webinar and to register, go here.

CMS – COVID-19 Vaccines and Rural Communities – November 15

CMS will hold a webinar on COVID-19 vaccines and rural communities for its community providers and partners working in rural areas.  Go here for further information about the webinar and to register to participate.

CDC – Antibiotic Prescribing and COVID-19 – November 18

The CDC will hold a webinar titled “What Clinicians, Pharmacists, and Public Health Partners Need to Know About Antibiotic Prescribing and COVID-19” on Wednesday, November 18 at 2:00 p.m. (eastern).  Go here for information about the webinar, the presenters, and how to participate.

Federal Health Policy Update for Monday, October 25

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, October 25.  Some of the language used below is taken directly from government documents.

NASH Advocacy:  MedPAC and Safety-Net Hospitals

On the heels of a recent meeting of the Medicare Payment Advisory Commission (MedPAC) during which commission members discussed the challenges inherent in attempting to identify safety-net hospitals, NASH has written to the agency to suggest that it consider a different approach to addressing that matter.  In the letter, NASH suggests that MedPAC urge Medicare to look not at individual hospitals and what kinds of patients they serve but to focus instead on vulnerable communities and then to identify the hospitals that are caring for meaningful proportions of the residents of those communities.  Go here to see NASH’s letter to MedPAC.  In response to this letter, MedPAC scheduled a meeting with NASH to discuss this concept.

NASH Advocacy:  Surprise Billing Regulation

Representatives Suozzi (D-NY), Wenstrup (R-OH), Ruiz (D-CA), and Bucshon (R-IL) are leading a bi-partisan congressional sign-on letter to HHS Secretary Becerra and others, urging the administration to revise the Surprise Billing, Part II interim final rule’s (IFR) implementation of the independent dispute resolution (IDR) process.

The letter states that

…we urge you to revise the IFR to align with the law as written by specifying that the certified IDR entity should not default to the median in-network rate and should instead consider all of the factors outlined in the statute without disproportionately weighting one factor.

NASH is listed among the supporters of this letter.

Action required:  NASH members should contact their House members today to ask them to sign on to the Suozzi-Wenstrup-Ruiz-Bucshon letter to support the successful implementation of Congress’s surprise billing ban.  The deadline for representatives to sign onto the letter is this Friday, October 29.

If you would like more information about the letter or if you need contact information for your representatives, contact Kate Finkelstein.

Provider Relief Fund:  Deadline for Submission is Tuesday, October 26

  • The Health Resources and Services Administration (HRSA) will accept applications for $25.5 billion in health care relief funds until October 26.  Go here for further information.
  • HRSA has modified some of the terms for applying for assistanceAll applicants must complete the first step of the application process (i.e., submitting their Tax Identification Number (TIN) and associated information for Internal Revenue Service (IRS) validation no later than October 26, 2021 at 11:59 PM EST.  The required IRS validation that occurs after completion of the first step may take a few days.  If an applicant submits their TIN for validation by the October 26, 2021 deadline and that TIN is subsequently validated by the IRS, the applicant will have until November 3, 2021 at 11:59 PM EST to complete and submit their application.
  • The Provider Relief Fund FAQ has been updated with seven modified or new questions on pages 4, 9, 10 (two questions), 37, and 58 (two questions); all are dated 10/20/2021.  Entities that have received Provider Relief Funds in the past and/or intend to apply for Phase 4 funds should review these changes carefully.

The White House

  • In anticipation of the FDA’s independent advisory committee meeting on October 26 and the CDC’s independent advisory committee meeting on November 2-3, the administration has unveiled a plan to ensure that if a vaccine is authorized for children ages 5-11 it is quickly distributed and made conveniently and equitably available to families across the country.  Learn more from this White House fact sheet.
  • The White House has posted transcripts of the October 20 and October 22 press briefings given by its COVID-19 response team and public officials.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has issued guidance to states about the statutory requirement for them to cover COVID-19-related treatment without cost-sharing in Medicaid and CHIP for many seniors, low-income adults, pregnant women, children, and people with disabilities who receive health coverage through these programs.  This coverage includes care for conditions that could complicate the treatment of COVID-19 in patients who are presumed positive for the virus or have been diagnosed with COVID-19.  Find a news release about the guidance here and find the guidance itself here.
  • CMS has posted a new edition of MLN Connects, its online newsletter.  This latest edition includes features on new/modifications of the place of service codes for telehealth, a prescriber’s guide to Medicare prescription drug opioid policies, and more.  Go here to find these and other items.
  • In a separate, special edition of MLN Connects, CMS presents new Medicare rates and billing information for Moderna and Johnson & Johnson booster vaccines.
  • The CMS Innovation Center has published a document that shares its strategic direction for the coming years.  Driving Health System Transformation – A Strategy for the CMS Innovation Center’s Second Decade reviews the lessons the agency has learned over the past ten years and lays out its objectives for the next ten.  Find it here.
  • CMS’s Center for Medicare and Medicaid Innovation has posted the fourth evaluation report and performance year 5 (2020) financial and quality results for its Next Generation ACO Model.  Find the report by going here and scrolling down to “Performance Year 5 (2020 (XLS).”
  • CMS’s “Medicare & You” handbook is now available in Chinese, Korean, and Vietnamese.  Go here for the agency’s announcement and links to the new handbooks.

Department of Health and Human Services

Health Policy News

  • HHS is awarding $797.5 million in American Rescue Plan funding to support survivors of domestic violence and sexual assault and their children.  The funds will cover COVID-19 testing, vaccines, mobile health units, and other support for domestic violence services programs and increase support for sexual assault service providers and culturally specific services.  Learn more about the new spending and how it will be distributed in this HHS news release and additional program resources.
  • HHS proposes repealing two final rules:  “Department of Health and Human Services Good Guidance Practices,” published in the Federal Register on December 7, 2020; and “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions,” published in the Federal Register of January 14, 2021, maintaining that “…they create unnecessary hurdles that hinder the Department’s ability to issue guidance, bring enforcement actions, and take other appropriate actions that advance the Department’s mission.”  Learn more about the rules that would be repealed and HHS’s rationale for doing so in this Federal Register notice.

Centers for Disease Control and Prevention

  • The CDC has taken a series of actions to address COVID-19 booster vaccines, deciding that:
    • The use of a single booster dose of the Moderna COVID-19 vaccine that may be administered at least six months after completion of the primary series to individuals 65 years of age and older; 18 through 64 years of age at high risk of severe COVID-19; and 18 through 64 years of age with frequent institutional or occupational exposure to COVID-19.
    • The use of a single booster dose of the Johnson & Johnson vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older.
    • Each of the available COVID-19 vaccines may be use as a booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.  This is now being referred to by many as “mixing and matching.”
    • A single booster dose of the Pfizer vaccine may be administered at least six months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to COVID-19.

Stakeholder Events

CDC – Information about Recent Updates to CDC’s Recommendations for COVID-19 Boosters – October 26

On Tuesday, October 26 the CDC will provide an overview for clinicians of the most recent recommendations for administering COVID-19 booster vaccines and updates about the latest recommendations and clinical considerations for administering those boosters.  Go here for further information about the webinar and how to participate.

CDC – Pediatric COVID-19 Vaccines – November 4

The CDC will hold a webinar on Thursday, November 4 to provide an overview of its recommendations and clinical considerations for administering COVID-19 vaccines to children between the ages of five and eleven years old.  Go here for further information about the webinar and how to participate.

HHS – Monoclonals and More:  Issues and Opportunities with Early COVID-19 Treatment Options – November 12

HHS’s Office of the Assistant Secretary for Preparedness and Response will hold a webinar on COVID-19 treatment with monoclonal antibodies on Friday, November 12 at 12:30 p.m. during which it will address some of the most current recommendations for use of monoclonal antibodies, upcoming therapies, and the challenges and opportunities that new therapies may pose in conjunction with monoclonal antibodies and other treatments (e.g., prioritization and distribution).  Speakers also will highlight operational principles for a scaled strategy for use of these therapeutics in a scarce resource situation.  For more information about the webinar and to register, go here.

Federal Health Policy Update for Tuesday, October 19

The following is the latest health policy news from the federal government as of 2:30 p.m. on Tuesday, October 19.  Some of the language used below is taken directly from government documents.

Provider Relief Fund:  Reminder That Applications Are Now Being Accepted

  • The Health Resources and Services Administration (HRSA) has opened its portal for providers to apply for $25.5 billion in health care relief funds, including $8.5 billion in American Rescue Plan resources for providers that serve rural patients covered by Medicare, Medicaid, or the Children’s Health Insurance Program and $17 billion for Provider Relief Fund Phase 4 grants, for a broad range of providers that have experienced changes in operating revenues and expenses as a result of the COVID-19 emergency.  The application deadline is October 26.  Go here for further information.

The White House

Department of Health and Human Services

COVID-19

  • HHS has renewed its declaration of a public health emergency because of the COVID-19 pandemic.  It now extends until January 16, 2022.
  • HHS’s Office of the Inspector General (OIG) performed an audit to identify actions that selected states took or planned to take to ensure that Medicaid beneficiaries continued to receive prescription drugs during the COVID-19 pandemic.  Find its audit report here.
  • HHS’s OIG has updated its work plan to add a review of nursing home reporting of COVID-19 data to the National Healthcare Safety Network.  Go here to see the updated OIG work plan and here for additional information about the new review.
  • HHS’s Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public to inform its review of telehealth during COVID–19.  For more information about the kind of input the agency seeks, see its request for information notice in the Federal Register.  The deadline for submissions is November 12.
  • On Thursday, September 30, the COVID-19 Health Equity Task Force held its seventh public meeting to vote on a final slate of recommendations for mitigating health inequities caused or exacerbated by the COVID-19 pandemic and for preventing such inequities in the future.  For a summary and links to video of the meeting, go here.

Health Policy News

  • HHS has announced the availability of $100 million in American Rescue Plan funding for state-run programs that support, recruit, and retain primary care clinicians who live and work in underserved communities.  This funding seeks to help improve health equity by ensuring that clinicians working in high-need communities remain in them.  HHS’s Health Resources and Services Administration’s Bureau of Health Workforce is accepting applications for these grants from all 50 states, Washington D.C., and U.S. territories.  HRSA estimates it will make up to 50 awards of up to $1 million a year over the program’s four-year project period.  Learn more about the funding from this HHS announcement and go here to learn about HRSA’s State Loan Repayment Program.  Applications are due April 8, 2022.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published the latest installment of MLN Connects, its online newsletter.  The new edition includes articles about submitting claims for pneumonia vaccines, correct billing practices for non-physician outpatient services provided during or shortly after inpatient stays, changes in the Laboratory National Determination Edit Software for January of 2022, and more.  Find it all here.
  • CMS’s Center for Medicare and Medicaid Innovation has published evaluations of three model programs:  the Maryland Total Cost of Care Model, the Vermont All-Payer Accountable Care Organization Model, and the Pennsylvania Rural Health Model.  Find the new evaluations here.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has awarded 11 new clinical trial research grants worth more than $25 million over the next four years through its Orphan Products Grants Program to clinical investigators to support the development of medical products for patients with rare diseases.  Learn more about the grant recipients and the research they are pursuing in this FDA news release.
  • The FDA has approved an abbreviated new drug application for propofol injectable emulsion single patient-use vials.  This drug is an intravenous general anesthetic and sedation drug listed in the FDA Drug Shortage Database that is used in the treatment of COVID-19 patients.  Learn more from the FDA announcement.

National Institutes of Health

  • The NIH has published preliminary technical research on the effectiveness of mixing different sources of COVID-19 vaccines when receiving booster shots.
  • The NIH reports that a clinical trial has found that treatment with the immunomodulator interferon beta-1a plus the antiviral remdesivir was not superior to treatment with remdesivir alone in hospitalized adults with COVID-19 pneumonia.  In addition, in a subgroup of patients who required high-flow oxygen, investigators found that interferon beta-1a was associated with more adverse events and worse outcomes.  Learn more in this NIH news release.
  • New NIH-funded research suggests how certain treatments are effective for patients with COVID-19 who develop multisystem inflammatory syndrome in children (MIS-C).  Learn more in this NIH news release.
  • The NIH announced that it has issued contract awards totaling $77.7 million to develop and manufacture new rapid diagnostic tests for COVID-19.  The home and point-of-care testing platforms target the need for high-performance, low-cost home tests and point-of-care tests that can potentially detect multiple respiratory infections.  Learn more from this NIH news release.
  • The NIH has awarded 11 grants worth $58 million over five years to focus on interventions to address health disparities and advance health equity.  The grants were awarded based on the significance of the research problem, the novelty of the idea or approach, and the magnitude of the potential impact rather than on preliminary data or experimental details.  Learn more from this NIH news release.

Department of Education

  • The Department of Education has introduced a new resource, which it calls “Supporting Child and Student Social, Emotional, Behavioral and Mental Health,” that outlines key challenges in providing and accessing mental health supports in schools and provides evidence-based recommendations for educators, staff, and providers to create a system of supports for students with behavioral health needs and their families.  Learn more from this White House fact sheet and from the publication Supporting Child and Student Social, Emotional, Behavioral and Mental Health.

National Academies of Sciences, Engineering, and Medicine

  • The National Academies of Sciences, Engineering, and Medicine has published advice for talking to parents about getting their children vaccinated against COVID-19.  Learn more from this news release.

Stakeholder Events

HRSA – New Provider Relief Fund and Rural Hospital Grants – October 21

The Health Resources and Services Administration will hold web events on Thursday, October 21 for providers interested in pursuing Provider Relief Fund grants and funding for rural hospitals provided through the American Rescue Plan.  The purpose of these events is to provide guidance on how to navigate the application portal for seeking such grants.  To register for the October 21 webcast, go here.

CDC – Information about Recent Updates to CDC’s Recommendations for COVID-19 Boosters

On Tuesday, October 26 the CDC will provide an overview for clinicians of the most recent recommendations for administering COVID-19 booster vaccines and updates about the latest recommendations and clinical considerations for administering those boosters.  Go here for further information about the webinar and how to participate.

CDC – Pediatric COVID-19 Vaccines – November 4

The CDC will hold a webinar on Thursday, November 4 to provide an overview of its recommendations and clinical considerations for administering COVID-19 vaccines to children between the ages of five and eleven years old.  Go here for further information about the webinar and how to participate.

Federal Health Policy Update for Tuesday, September 28

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

Provider Relief Fund:  Application Reminder

  • Beginning on September 29, health care providers may apply for $25.5 billion in health care relief funds, including $8.5 billion in American Rescue Plan resources for providers that serve rural patients covered by Medicare, Medicaid, or the Children’s Health Insurance Program and $17 billion for Provider Relief Fund Phase 4 grants for a broad range of providers that have experienced changes in operating revenues and expenses as a result of the COVID-19 emergency.  The application period will run for four weeks.  Providers must submit their completed application by October 26.  Go here for further information.

Provider Relief Fund:  More Information

  • HHS has updated its information on Phase 4 Provider Relief Fund grants and American Rescue Plan grants for rural providers.  The new information includes:
    • Types of eligible providers.
    • An explanation that although general distribution payments will be allocated based on “changes to operating revenue and expenses” from July 1, 2020 to March 31, 2021, the payments can be used to cover eligible lost revenue and expenses incurred from January 1, 2020 through December 31, 2022.
    • The addition of the time period for identifying care provided to individuals living in rural areas:  January 1, 2019 through September 30, 2020.
  • The Health Resources and Services Administration will hold web events on Thursday, September 30 and Tuesday, October 5 for providers interested in pursuing Provider Relief Fund grants and funding for rural hospitals provided through the American Rescue Plan.  The purpose of these events is to provide guidance on how to navigate the application portal for seeking grants.  Learn more here and find a link to register to participate.  HRSA has announced that it will hold additional sessions during the weeks of October 11 and October 18; dates and times for those events have not yet been announced.
  • HHS recently hosted a briefing session to provide information about these upcoming funding opportunities.  View a video of that session here.

Department of Health and Human Services

COVID-19

Health Policy News

  • HHS has awarded nearly $1 billion in American Rescue Plan funding to nearly 1300 Health Resources and Services Administration (HRSA) Health Center Program-funded health centers in all 50 states, the District of Columbia, and the U.S. territories to support major health care construction and renovation projects.  According to HHS, health centers will use this funding for COVID-19-related capital needs, constructing new facilities, renovating and expanding existing facilities to enhance response to pandemics, and purchasing new state-of-the-art equipment, including telehealth technology, mobile medical vans, and freezers to store vaccines.  Learn more about the funding, its intended use, and how much money was granted to facilities in each state in this HHS news release.
  • Following up on a previously announced commitment, HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) has announced the distribution of $825 million in federal funds to 231 community mental health centers across the country.  This grant program is intended to enable community mental health centers to more effectively address the needs of individuals who have a serious emotional disturbance or mental illness, often accompanied by substance use disorders.  For a more detailed description of the work the community mental health centers are expected to do with this money and a link to a list of the 231 facilities awarded grants, see this HHS news release.

Centers for Medicare & Medicaid Services

COVID-19

  • Following the FDA’s recent authorization of a booster dose of the Pfizer COVID-19 vaccine for certain high-risk populations and a recommendation from the CDC, CMS will continue to provide coverage for booster doses without cost-sharing.  Beneficiaries with Medicare will pay nothing for COVID-19 vaccines or their administration and there is no copayment, coinsurance, or deductible.  In addition, nearly all Medicaid and CHIP beneficiaries must receive coverage of COVID-19 vaccines and their administration without cost-sharing.  COVID-19 vaccines and their administration, including boosters, will also be covered without cost-sharing for eligible consumers of most issuers of health insurance in the commercial market.  Learn more from this CMS news release.

Health Policy News

  • CMS has posted a special edition of its online newsletter MLN Connects explaining that effective September 20 it is exercising enforcement discretion for skilled nursing facility consolidated billing provisions related to flu and pneumococcal vaccines that enables Medicare-enrolled immunizers, including pharmacies, to bill directly and get direct reimbursement from Medicare, including for vaccine administration and product, whether these vaccines are administered at the same time (co-administered) as a COVID-19 vaccine or at different times.  Find the notice here.

Centers for Disease Control and Prevention

National Institutes of Health

  • The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, has awarded approximately $36.3 million to three academic institutions to conduct research to develop vaccines to protect against multiple types of coronaviruses and viral variants.  The awards are intended to fuel vaccine research for a diverse family of coronaviruses, with a primary focus on potential pandemic-causing coronaviruses such as COVID-19.  Learn more about the anticipated research and the grant recipients in this NIH news release.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC commissioners met last week to discuss a variety of Medicaid and CHIP payment and access issues, including communicating with beneficiaries, workforce issues, monitoring access to care, health IT adoption among behavioral health providers, and vaccines for adults.  Go here for a summary of the meeting and links to issue briefs prepared to support the commissioners’ discussions.

Government Accountability Office (GAO)

  • The GAO has published a short report that draws from a number of past GAO reports to describe examples of racial and ethnic health disparities, barriers that may contribute to disparities, and federal efforts to help address them.  In this report the GAO cites policy considerations and reiterates recommendations to improve gaps in race and ethnicity data.  Learn more in “GAO Health Care Capsule:  Racial and Ethnic Health Disparities.”
  • In 2016, HHS selected eight states to participate in a time-limited demonstration to establish certified community behavioral health clinics to help improve their response to depression and opioid use challenges within their Medicaid populations.  The GAO has now reviewed the efforts of those states, including the degree to which spending on these services changed during the demonstration period, and has offered recommendations on provider payments and overlap with other Medicaid payments.  Learn more from the GAO report “Medicaid Behavioral Health:  CMS Guidance Needed to Better Align Demonstration Payment Rates with Costs and Prevent Duplication.”

Stakeholder Events

HRSA – New Provider Relief Fund and Rural Hospital Grants – September 30 and October 5

The Health Resources and Services Administration will hold web events on Thursday, September 30 and Tuesday, October 5 for providers interested in pursuing Provider Relief Fund grants and funding for rural hospitals provided through the American Rescue Plan.  The purpose of the event is to provide guidance on how to navigate the application portal for seeking these grants.  Learn more here and find a link to register to participate.

CDC – Evaluating and Supporting Patients Presenting With Fatigue Following COVID-19 – September 30

The CDC will hold a webinar on evaluating and supporting patients who present with fatigue following treatment for COVID-19.  The webinar will be held on Thursday, September 30.  For further information on the subjects the webinar will cover, those who will be participating in the event, and how to join the webinar, go here.

HHS/Office of the Assistant Secretary for Preparedness and Response – Grand Rounds for EMS, Critical Care, and Emergency Department ICU Care of Pediatric COVID Patients – September 30

The agency’s “clinical rounds” sessions return on Thursday, September 30 at noon (eastern) with presenters who will discuss emergency management resources and information that can be used to improve operations during the COVID-19 pandemic.  Go here to register to participate in the remote event.

CDC – Recommendations for Influenza Prevention and Treatment in Children – October 7

The CDC and experts from the American Academy of Pediatrics will hold a webinar on Thursday, October 7 at 2:00 p.m. (eastern) to discuss strategies that primary care providers and medical subspecialists can use to improve, prevent, and control influenza among children during the upcoming flu season.  Go here to learn more about the webinar and how to participate.

FDA – Workshop Addressing Response to the Opioid Crisis – October 13 and October 14

The FDA will hold a workshop titled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS)” to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS effort.  The public workshop will be held on October 13 and October 14.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.

Federal Health Policy Update for Monday, September 13

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, September 13.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

  • HHS and its Health Resources and Services Administration (HRSA) are making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic.  This funding includes $8.5 billion in American Rescue Plan money for providers that serve rural Medicaid, Children’s Health Insurance Program (CHIP), or Medicare patients and an additional $17 billion for Provider Relief Fund Phase 4 grants for a broad range of providers that can document revenue loss and expenses associated with the pandemic.  To learn more about the funding to be distributed and how it will be distributed, see the following resources:

NASH members received a more detailed explanation about the availability of these funds last Friday, September 10.

The White House

Department of Health and Human Services

COVID-19

  • HHS has amended the Public Readiness and Emergency Preparedness (PREP) Act declaration to provide liability protection to licensed pharmacists, pharmacy technicians, and pharmacy interns to provide a pathway for increased access to COVID-19 therapeutics – specifically, monoclonal antibodies – especially in surge states with rising numbers of COVID-19 cases and in rural areas where access to inpatient and outpatient services may be more limited.  For more information about the health care professionals to which these protections have been extended and about the protections themselves, see this HHS announcement.  This amendment of the PREP Act also will be published in the Federal Register; go here to see a pre-publication version of the Federal Register notice.

Health Policy News

  • HHS, the departments of Labor and the Treasury, and the Office of Personnel Management have proposed rules that would require health plans, issuers, and providers of air ambulance services to submit detailed data regarding air ambulance services specified in the reporting requirements of the No Surprises Act.  The rules also outline CMS’s authority to fully enforce Title I (the No Surprises Act) and Title II (Transparency) of Division BB of the Consolidated Appropriations Act of 2021 in states that do not have the authority to enforce or fail to substantially enforce one or more of the provisions and seek to help consumers understand the compensation being paid to agents and brokers who help them select health insurance.  This is the latest regulatory action in a series of rulemaking implementing the No Surprises Act.  Learn more from the following resources:
  • HHS is awarding $20 million in American Rescue Plan grant funding to state-based marketplaces to increase consumer access to affordable, comprehensive health insurance coverage.  The grants will be used by 21 state-based marketplaces to modernize IT systems and/or conduct targeted consumer outreach activities to help make health care coverage enrollment simpler.  Learn more about how the money will be used and which state-based marketplaces will receive it in this HHS announcement.
  • HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) is awarding more than $123 million in funding through six grant programs to provide support to communities and health care providers to help combat the overdose epidemic.  Grants are being awarded through six existing programs:  Medication Assisted Treatment for Prescription Drug and Opioid Addiction; Tribal Opioid Response Grants; Screening, Brief, Intervention, and Referral to Treatment; Strategic Prevention Framework for Prescription Drugs; First Responder-Comprehensive Addiction and Recovery Act Grants; and Providers Clinical Support System – Universities.  Learn more about where the money will go and how it will be spent in this HHS news release.

Centers for Medicare & Medicaid Services

COVID-19

  • The administration announced that it will require COVID-19 vaccination of staff in all Medicare- and Medicaid-certified facilities.  CMS, in collaboration with the CDC, announced that emergency regulations requiring vaccinations for nursing home workers will be expanded to include hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in the Medicare and Medicaid programs.  Go here to find an explanation of the new policy.

Health Policy News

  • CMS announced that it is rescinding audit determinations for providers notified in January of 2021 that they had failed to qualify for what is known as the “mid-build exception.”  The Bipartisan Budget Act of 2015 changed how off-campus provider-based departments are paid for items and services furnished to Medicare beneficiaries.  CMS will review each previously failing provider’s audit findings for compliance with statutory requirements and for accuracy and completeness and providers that received failing audit determinations are no longer required to report or return overpayments based on those determinations.  Each provider will receive a letter rescinding the previous determination.   An updated audit determination letter will be issued following the review of each provider’s audit.  A new overpayment return deadline for self-identified overpayments will be included in that letter should the provider receive a failing audit determination.  Learn more from this CMS announcement.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has approved an abbreviated new drug application for dexmedetomidine injection USP, 200 mcg/2 mL, indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures.  The drug is often used on COVID-19 patients who need ventilators.  See the FDA’s announcement.

Stakeholder Events

 CDC – Evaluating and Supporting Patients Presenting With Fatigue Following COVID-19 – September 30

The CDC will hold a webinar on evaluating and supporting patients who present with fatigue following treatment for COVID-19.  The webinar will be held on Thursday, September 30 at 2:00 p.m. (eastern).  For further information on the subjects the webinar will cover, those who will be participating in the event, and how to join the webinar, go here.

 FDA – Workshop Addressing Response to the Opioid Crisis – October 13

The FDA will hold a workshop entitled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS)” to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS effort.  The public workshop will be held on October 13 from 1 p.m. to 5 p.m. (eastern) and October 14 from 1 p.m. to 4:00 p.m.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.

 

Federal Health Policy Update for Thursday, September 9

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, September 9.  Some of the language used below is taken directly from government documents.

The White House

Congress

  • Democrats on the House Energy and Commerce Committee today introduced their contribution to their party’s anticipated $3.5 trillion dollar spending bill.  Their portion of the reconciliation bill addresses expanding Medicaid in non-expansion states, reducing prescription drug prices, increasing federal spending on home-based care, and more.  Find their summary of their proposals here.

Provider Relief Fund

  • HHS’s Human Resources and Services Administration (HRSA) has published a notice explaining how Provider Relief Fund payments can be used for a wide variety of direct and indirect costs of recruiting and retaining personnel during the COVID-19 emergency.  Find the notice here.
  • With the next deadline for health care providers to report on their use of Provider Relief Fund grants coming up on September 30, HRSA will hold an “office hours” web event on Friday, September 10 at 1:00 (eastern) to address issues involving Provider Relief Fund reporting and auditing requirements.  For information about how to join the event and more about reporting and auditing requirements, go here.

Department of Health and Human Services

COVID-19

  • HHS Secretary Xavier Becerra has released a new plan to reduce prescription drug prices.  One of the key policies in this effort is legislation that would enable the Secretary of HHS to negotiate Medicare Part B and Part D drug prices directly with pharmaceutical companies and make those prices available to other purchasers.  Learn more about this plan from the HHS announcement, an HHS fact sheet, and the full plan.
  • The Office of the Assistant Secretary for Preparedness and Response has announced a new Notice of Funding Opportunity to establish Partnership(s) for Enhanced Efforts To Strengthen The Nation’s Healthcare And Public Health Preparedness, Response, And Recovery To Disasters And Other Emergencies.  This program seeks to fund up to seven new cooperative agreements to enable the agency’s broad collaboration with public health and health care sectors and emergency management services to ensure that local governments, communities, private sector entities, non-governmental organizations, academia, and individuals can optimally coordinate their respective national health security roles and responsibilities to achieve community health resilience and strengthen health care, public health, and emergency management systems in preparation of, response to, and recovery from disasters and other emergencies.  $20 million in grants will be awarded, with a maximum grant of $4 million.  The deadline for applications is September 22.
  • HHS’s Office of the Assistant Secretary for Planning and Readiness has updated its information on planning considerations for the administration of monoclonal antibodies.  Find the updated information here.
  • The Office of the Assistant Secretary for Planning and Readiness has published guidance to hospitals on how to address a surge of patients with behavioral health challenges during the COVID-19 pandemic.
  • HHS’s Office of the Inspector General has published a report that describes the complex care needs of beneficiaries hospitalized with COVID-19.  The report focuses on surges in COVID-19 hospitalizations in six localities and builds upon prior OIG work that describes the extent to which hospitals have been strained by COVID-19.  Find the report here.
  • Another report by HHS’s OIG found that the COVID-19 case and death data submitted by nursing homes to the federal government is incomplete and inaccurate despite CMS’s efforts to require such data reporting weekly.  Find the report here.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has posted two new editions of MLN Connects, its online newsletter.  Subjects addressed in the September 2 edition include changes in Medicare provider enrollment processes, information about CMS’s planned implementation of its ambulance prior authorization model, the hospice quality reporting program, and more.  Go here to see the September 2 edition of MLN Connects.
  • The September 9 edition of MLN Connects includes information about a payment update on outpatient clinic visit services at excepted off-campus provider-based departments, the Medicare fee-for-service response to the COVID-19 emergency, skilled nursing facility consolidated billing web-based training, and more.  Find the September 9 edition of MLN Connects here.
  • CMS is distributing $452 million in federal funding to support 13 states’ efforts to improve access to affordable, comprehensive health insurance coverage through section 1332 state-based reinsurance waivers.  As a result of changes made in the American Rescue Plan Act of 2021, residents in states implementing reinsurance waivers may have access to more affordable health insurance coverage.  States also will have more pass-through funding to implement their waiver.  Learn more about the funding, how it will be used, and which states will receive it in this HHS news release.
  • CMS’s Center for Medicare and Medicaid Innovation has posted the annual report for its Comprehensive Care for Joint Replacement Model.  Go here to see the annual report and here for more information about and resources for the program.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has revised its guidance on the authorized use of the monoclonal antibodies bamlanivimab and etesevimab when administered together.  The Emergency Use Authorization now authorizes the use of bamlanivimab and etesevimab, administered together, only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to five percent.  The FDA has posted a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together are currently authorized and a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together, are not currently authorized and will periodically update both lists as new data becomes available.
  • The FDA has posted a letter to veterinarians and retailers informing them of the danger of treating people for COVID-19 with animal ivermectin.
  • The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on September 17 to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (booster) dose of the Pfizer vaccine to individuals 16 years of age and older.  Learn more here.

National Institutes of Health

  • An investigational HIV vaccine tested in a clinical trial co-sponsored by the NIH posed no safety concerns but did not provide sufficient protection against HIV infection among women, according to a preliminary analysis of the study data.  Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has written to CMS to convey its views on CMS’s proposed physician fee schedule and changes to Medicare Part B regulation.  Find its letter here.
  • MedPAC’s commissioners met last week for two days to discuss Medicare payment issues.  During the meetings MedPAC addressed the following issues:
    • The effects of the COVID-19 emergency and considerations on MedPAC’s 2022 assessment of Medicare payment adequacy.
    • Potential reforms of the Part D low-income premium subsidy.
    • A report on designing a value incentive program for post-acute care.
    • A report on the impact of Bipartisan Budget Act of 2018 changes to the home health prospective payment system.

For briefs and presentations on these subjects go here; for a transcript of the MedPAC meetings go here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

American Medical Association

  • The AMA has announced eight new CPT codes for COVID-19 vaccine administration.  Learn more from this AMA notice.
  • The AMA has issued its annual update of CPT codes.  The update includes 405 editorial changes, including 249 new codes, 63 deletions, and 93 revisions.  Learn more from this AMA news release.

Stakeholder Event

FDA – Workshop Addressing Response to the Opioid Crisis – October 13

The FDA will hold a workshop entitled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS)” to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS effort.  The public workshop will be held on October 13 from 1 p.m. to 5 p.m. (eastern) and October 14 from 1 p.m. to 4:05 p.m.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.

 

 

Federal Health Policy Update for Friday, August 13

The following is the latest health policy news from the federal government as of 1:30 p.m. on Friday, August 13.  Some of the language used below is taken directly from government documents.

Food and Drug Administration

COVID-19

  • The FDA has amended the emergency use authorizations for both the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine to authorize administering an additional dose of those vaccines to certain immunocompromised individuals, including solid organ transplant recipients and those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
  • The FDA has revised its emergency use authorization for the monoclonal antibody REGEN-COV (casirivimab and imdevimab, administered together) to add an authorization of REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms) who are at high risk for progression to severe COVID-19, including hospitalization or death.  Learn more here.

The White House

  • The White House has posted a transcript of the August 12 press briefing given by its COVID-19 response team and public health officials. View press briefing slides here.
  • The White House announced a series of COVID-19-related initiatives, including:
  • $8.5 billion in American Rescue Plan funding in the coming weeks to help compensate health care providers that serve rural Medicare, Medicaid, and CHIP patients for lost revenue and increased expenses associated with COVID-19.
  • $500 million in American Rescue Plan funding to create the Emergency Rural Health Care Grant Program, which will provide at least $350 million to help rural hospitals and local communities improve access to COVID-19 vaccines and testing, medical supplies, telehealth, and food assistance, and support construction or renovation of rural health care facilities and up to $125 million in grants to plan and implement models that help improve the long-term viability of rural health care providers.
  • $52 million from the American Rescue Plan to train a range of health care workers to fill in-demand professions in rural areas affected by the pandemic. Applications for this funding will be available in the coming weeks.
  • A demonstration project to enhance access to pulmonary rehabilitation services in critical access hospitals that serve rural communities with high rates of chronic obstructive pulmonary disease.
  • Expanded Veterans Affairs training programs for rural providers.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS announced that people with Medicare who qualify for an additional dose of COVID-19 can receive it at no cost.  This is in response to the FDA’s recent action to authorize an additional dose of COVID-19 vaccine for immunocompromised individuals.  CMS will share more information and guidance in the coming days about billing and coding for the additional dose of the COVID-19 vaccine for immunocompromised patients.
  • CMS has written to state officials to outline how it will assist states with their planning to resume routine Medicaid, CHIP, and Basic Health Program operations for the eventual end of the COVID-19 public health emergency.  Specifically, this letter provides updated guidance that extends the timeframe for states to complete pending eligibility and enrollment work to up to 12 months after the public health emergency ends and requires states to complete a redetermination of eligibility after the public health emergency for all beneficiaries prior to taking any adverse action.
  • CMS has published the latest edition of MLN Connects, its online weekly bulletin.  This week’s edition includes articles about CMS resuming the Targeted Probe & Education program and new waived laboratory tests, effective October 1. For this and more, go here.

Health Policy News

Department of Health and Human Services

COVID-19

  • HHS announced that it will require more than 25,000 members of its health care workforce to be vaccinated against COVID-19.  This includes staff at the Indian Health Service, the NIH, and members of the U.S. Public Health Service Commissioned Corps.  Read the press release here.

Centers for Disease Control and Prevention

COVID-19

Stakeholder Events

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.