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

Provider Relief Fund

  • The Provider Relief Fund last week distributed more than $413 million to more than 3600 providers across the country, the fourth round of Phase 4 payments since those payments began last November.  This is in addition to nearly $7.5 billion in American Rescue Plan (ARP) Rural payments over the past four months.  HHS’s Health Resources and Services Administration (HRSA), which administers the Provider Relief Fund, has now processed 89 percent of the applications it received for Phase 4 grants and HHS reports that “Remaining applications require additional manual review and HRSA is working to process them as quickly as possible.”  Learn more about this latest round of Phase 4 Provider Relief Fund grants and find links to a state-by-state breakdown of payments and a list of all recipients in this HHS news release.
  • The Provider Relief Fund Uninsured Program, which has reimbursed providers at Medicare rates for testing uninsured individuals for COVID-19 and treating those diagnosed with the virus, has stopped accepting such claims due to lack of sufficient funds.  Confirmation of receipt of claim submission no longer means the claim will be paid.  No claims submitted after March 22, 2022 at 11:59 pm (eastern) for testing or treatment will be processed for adjudication/payment.
  • After April 5, this program also will stop accepting claims for administering vaccines to uninsured individuals.  See this notice for further information about both deadlines for submitting claims.
  • Providers that received Provider Relief Fund payments of more than $10,000 in the aggregate between July 1 and December 31, 2020 must report on their use of those funds to HHS by March 31.  For information about reporting requirements, forms, reporting instructions, and more on what the agency refers to as “Reporting Period 2,” go here.

White House

  • The White House has launched, a new, one-stop shop website to help people gain access to tools like vaccines, tests, treatments, and masks and get the latest updates on COVID-19 in their area.  The site includes a test-to-treat locator to help people find pharmacies and community health centers where they can get tested for COVID-19 and receive appropriate treatments if needed.  Test-to-treat locations also are available in more than 240 FQHCs and Indian Health Service facilities.  Learn more from the White House fact sheet on the new COVID-19 site.
  • The White House has released the administration’s proposed budget for FY 2023.  Among the areas targeted for additional health care spending are:
    • accelerated innovation through the Advanced Research Projects Agency for Health
    • the “Cancer Moonshot” initiative
    • mental health
    • HIV/AIDS
    • adequate and stable funding for the Indian Health Service
    • preparation for future pandemics and health security against other biological threats
    • building advanced public health systems and capacity
    • expanded access to vaccines
    • maternal health and equity
    • expanded access to health care services for low-income women
    • expanded access to affordable, high-quality early child care and learning
    • child and family well-being in the child welfare system
    • support for survivors of domestic violence and other forms of gender-based violence
    • services for refugees
    • assistance with home energy and water bills

Learn more from the primary budget document, the proposed HHS budget,  and other White House budget materials.

Senate Finance Committee

The Senate Finance Committee has released the bipartisan report “Mental Health Care in the United States:  the Case for Federal Action,” explaining that “The purpose of the report is to support the current bipartisan initiative being undertaken by the Committee to improve behavioral health for Americans
covered under federal health programs.  The Committee takes a broad view of behavioral health to include both mental health conditions and SUD [substance use disorders], reflecting the reality that mental health and SUD are often, though not always, co-occurring.”

Department of Health and Human Services

Health Policy Update

  • HHS and its Substance Abuse and Mental Health Services Administration (SAMHSA) have announced two funding opportunities that will provide more than $300 million to help Certified Community Behavioral Health Clinics (CCBHCs) expand and increase access to evidence-based mental health and substance use services.  This includes providing essential mental health services, such as 24-hour mobile crisis teams, screening, and case management, to vulnerable communities that would otherwise lack access to services.  The first of the two programs, Certified Community Behavioral Health Clinic – Planning, Development, and Implementation grants, will help clinics establish and implement new CCBHC programs.  Under the second program, Certified Community Behavioral Health Clinic – Improvement and Advancement grants will help existing CCBHCs enhance and improve their programs.
    • For general information about the new programs, see this HHS news release.
    • For information about the planning, development, and implementation grants (156 grants for up to $1 million each for up to four years), go here.
    • For information about the improvement and advancement grants (also 156 grants for up to $1 million each for up to four years), go here.
  • HHS has awarded $256.6 million in grants to help 76 organizations deliver equitable, affordable, client-centered, and high-quality family planning services.  These grants will restore access to Title X services nation-wide and fill service gaps caused by more than a quarter of Title X providers withdrawing from the program over the past two-and-a-half years in response to a recently repealed Title X rule.  Learn more about the grant funding and find a list of recipients in this HHS news release.
  • HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children, which provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS.  HRSA is seeking nominations of qualified candidates for appointment to two positions on the committee beginning in 2023.  Nominations are due by April 11.  Learn more about the positions and what HRSA seeks in this Federal Register notice.
  • HRSA also seeks nominations from organizations to send representatives to serve as a liaison to the Advisory Committee on Heritable Disorders in Newborns and Children.  Selections will be based on a review of the organization’s subject area of expertise, mission, relevance, and benefit provided relative to the committee’s purpose.  Organizational representatives are non-voting liaisons.  The committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS.  Nominations are due by May 1.  Learn more about what HHS seeks in this Federal Register notice.

Centers for Medicare & Medicaid Services

Health Policy Update

  • CMS has issued a memorandum to Clinical Laboratory Improvement Amendments (CLIA) state survey agencies with updated guidance on actions to fully resume CLIA survey activities.  This includes guidance for on-site surveys and guidance for enforcement actions and proficiency testing review.
  • CMS has released a Medicaid Drug Rebate Program notice for participating drug manufacturers and a notice for states that provides technical guidance for value-based purchasing (VBP) arrangements for drug therapies using multiple best prices.  Beginning on July 1, states will be able to take advantage of certain VBP arrangements for selected drugs under new authority finalized by CMS in a final rule published December 31, 2020.  Learn more from this CMS announcement; this notice that CMS sent to participating drug companies; and this notice that CMS sent to participating states.
  • CMS has published the March 24 and March 31 editions of MLN Connects, its online newsletter on Medicare payment-related matters.
    • The March 24 edition includes features on the March 31 deadline for providers to apply for new residency positions; a reminder of an upcoming deadline for interested parties to comment on proposed ICD-10 procedure codes and updates; information for providers about registering for CMS’s Open Payments System program; a reminder for LTCHs, inpatient rehabilitation facilities, and home health providers about upcoming deadlines to review data they have submitted to CMS; and more.
    • The March 31 edition includes information on cognitive impairment assessments for Medicare beneficiaries; strategies for ensuring that diabetes patients have adequate supplies for their continuous glucose monitors; information on changes in the ambulatory surgical center payment system that take effect on April 1; required information for clinical laboratories on collecting and reporting data for the private payer rate-based payment system; and more.
  • CMS has published guidance to clarify requirements for covered entities when conducting electronic transactions using virtual credit cards and adopted HIPAA standards for health care electronic funds transfers and remittance advice transactions.

Centers for Disease Control and Prevention

  • A new CDC study reports that receiving two or three doses of an mRNA COVID-19 vaccine was associated with a 90 percent reduction in risk for COVID-19–associated ventilation or death.  Protection from three mRNA vaccine doses during the period of omicron predominance was 94 percent.  Find the study here.
  • A new CDC study found that in January of 2022, unvaccinated adults and those vaccinated with a primary series, but no booster or additional dose, were 12 and three times as likely to be hospitalized, respectively, as adults who received booster or additional doses.  Hospitalization rates among non-Hispanic Black adults increased more than rates in other racial/ethnic groups.  Find that study here.
  • The CDC has updated its resources for providers to use in their pursuit of health equity in access to COVID-19 vaccines.
  • The CDC has updated its information on reported adverse effects from COVID-19 vaccines.

Food and Drug Administration

  • The FDA has authorized a second booster dose of either the Pfizer or Moderna COVID-19 vaccines for older people and certain immunocompromised individuals.  The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series.  This action will make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization, and death.  Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns.  Learn more from the FDA’s announcement, including who should seek the second booster shot and why the FDA made this decision at this time.
  • The FDA has announced that the COVID-19 treatment sotrovimab is no longer authorized for use at this time in HHS regions 1 and 2 because of the high frequency of the omicron BA.2 sub-variant in those areas and data showing that the authorized dose of sotrovimab is unlikely to be effective against that sub-variant.  As a result, sotrovimab may not be administered for treatment of COVID-19 in these regions under the emergency use authorization until further notice by the agency:  HHS region 1 – Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont; and HHS region 2 – New Jersey, New York, Puerto Rico, and the Virgin Islands.  Learn more from this FDA notice.  The FDA also has updated its fact sheet on sotrovimab.
  • In light of interruptions in the supply of prefilled 0.9% sodium chloride (saline) intravenous lock/ flush syringes because of increased demand as a result of the COVID-19 emergency and supply chain challenges, the FDA has issued a letter to health care personnel offering recommendations and conservation strategies.

National Institutes of Health

  • A study supported by the NIH found that Black children with asthma sought assistance from community health centers less frequently than white children while Latino children were more likely to visit community health centers for acute, chronic, and preventive care overall.  The pattern of low clinic utilization by Black children was accompanied by more frequent emergency department visits compared to the other groups.  The difference in utilization at the community health center level suggests there are other factors beyond affordability influencing disparities in health care utilization, the study concluded.  Learn more from this NIH news release.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has posted a new issue brief in which it describes federal data standards for capturing information on race and ethnicity and federal requirements for monitoring disparities in Medicaid and describes the availability of such information in Medicaid administrative data and federal household surveys that capture health care use and experiences of Medicaid beneficiaries, among other sources.  MACPAC found significant limitations in using both administrative data and federal survey data for analyses related to race ethnicity. Some states have high rates of missing data, and there are also concerns about validity when compared to external benchmarks.  Learn more in the new MACPAC issue brief “Availability of Race and Ethnicity Data for Medicaid Beneficiaries.”

Congressional Research Service

  • The Congressional Research Service has updated its report “Occupational Safety and Health Administration (OSHA):  COVID-19 Emergency Temporary Standards (ETS) on Health Care Employment and Vaccinations and Testing for Large Employers” to reflect the outcome of recent court rulings.  Find the updated report here.

Stakeholder Events

CMS – Improving Maternal Health by Reducing Low-Risk Cesarean Delivery Learning Collaborative – March 31

CMS’s Improving Maternal Health by Reducing Low-Risk Cesarean Delivery Learning Collaborative will hold a webinar titled “The Role of Medicaid in Reducing Low-Risk Cesarean Delivery: Improving Outcomes and Reducing Disparities” on Thursday, March 31 at 2:00 p.m. (eastern).  During the webinar, experts will describe the initiatives they took to reduce the number of low-risk cesarean deliveries.  To learn more about the webinar and register to participate, go here.

CMS – Emerging Technologies – March 31

CMS will hold public listening sessions on transitional coverage for emerging technologies on Thursday, March 31 at 3:00 (eastern).  The purpose of these sessions is to obtain feedback to help inform CMS’s development of an alternative coverage pathway to provide transitional coverage for emerging technologies following the repeal of the January 2021 Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule.  For additional information about the listening sessions and to register to participate, go here.  Learn more about the feedback CMS is seeking from participants here.  This is the second CMS listening session on this subject; for a transcript and recording of the first session, go here.

CMS/CMMI – VBID Model – Health Equity Incubation Program – Addressing Food and Nutritional Insecurity – March 31

CMMI’s Medicare Advantage Value-Based Insurance Design Model team and national leaders will discuss pathways for addressing food and nutrition insecurity during a webinar on the agency’s Health Equity Incubation Program on Thursday, March 31 at 3:00 (eastern). This event will begin with an overview of the importance of advancing food and nutrition security as a means of addressing poor health outcomes and social needs among the Medicare population and delve into identification and stratification of food insecurity and/or malnourishment, including recommendations for screening tools and publicly available data and the business case for Medicare Advantage plans to address these health inequities in their member populations.  To learn more about the webinar go here and to register to participate go here.

FDA – Identifying Key Competencies for Opioid Prescriber Education – April 4-5

The FDA and the Duke-Margolis Center for Public Policy are collaborating to host a two-day virtual public workshop focused on identifying gaps in the content of existing opioid prescriber education offerings and core competencies that should be included in educational content for opioid prescribers and other health care providers, including prescriber education under a Risk Evaluation and Mitigation Strategy.  The sessions will be held on Monday, April 4 and Tuesday, April 5 from 1:00 to 5:00 p.m. (eastern).  Go here for more information and to register to participate.

CMS/CMMI – ACO REACH Health Equity Webinar – April 5

CMMI will host a webinar on Tuesday, April 5 at 4:00 p.m. (eastern) to highlight health equity provisions added to the ACO REACH model.  Go here to register to participate.

CMS/CMMI – Medicare Advantage Value-Based Insurance Design Model – 2023 Hospice Benefit Component Overview – April 5

CMMI will host an office hours session on Tuesday, April 5, 2022 at 3:00 p.m. (eastern) to discuss the Medicare Advantage Value-Based Insurance Design Model and its Hospice Benefit Component. Participants will receive an overview of the model and the CY 2023 application process and have an opportunity for questions and answers with the model team.  For more information about the program and how to register for the event, go here.

CMS – Listening Session to Inform Provider Education Materials Regarding Site Selection for the Inpatient Only List – April 6

CMS will soon be developing provider education materials regarding site selection for procedures recently removed from the CMS Inpatient Only (IPO) list.  The focus of these materials will be necessary documentation supporting inpatient admission decisions for these procedures.  On Wednesday, April 6 at 3:00 (eastern) the agency will hold a listening session to give leaders, staff, and practitioners in hospital inpatient and outpatient departments an opportunity to provide input on important concepts and useful formats for future educational materials.  Go here to register to participate.

CMS/CMMI – ACO REACH General Office Hours – April 12

CMMI’s ACO REACH model team will host a general office hours session on Tuesday, April 12 at 3:00 p.m. (eastern) to answer questions as a follow-up to the financial and health equity webinars.  Go here to register to participate.

CMS – Medicare Cost Report E-Filing System: Interim Rate & Settlement Documentation Webinar – April 26

CMS will hold a webinar to provide information about new functionality in the Medicare Cost Report E-Filing system to Medicare Part A providers and organization that files cost reports on Tuesday, April 26 at 1:00 (eastern).  Go here to learn more about the webinar, including what it will cover and how to submit questions in advance, and go here to register to participate.