Posts

Federal Health Policy Update for Friday, July 2

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

Supreme Court

  • The Supreme Court has announced that it will hear a case in its next term challenging cuts in 340B payments and another involving Medicare disproportionate share.

White House

Provider Relief Fund

  • HHS has published new information about use of Provider Relief Fund grants, accounting for the use of those grants, expense and lost revenue calculations, changes in ownership, reporting on the use of Provider Relief Fund resources, and more.  The changes, including links to new documents, worksheets, instructions, an FAQ, a link to a webinar to learn about these changes, and more can be found on the Provider Relief Fund’s “reporting requirements and auditing” web page.  Recipients of Provider Relief Fund grants should review this new information carefully.
  • HHS also has updated its Provider Relief Fund FAQ site to reflect the changes introduced on the primary Provider Relief Fund web site (described above).  The update includes 24 new or updated items addressing the expenditure of Provider Relief Fund grants, accounting for and reporting on the use of those grants, recoupments, FEMA funds, and more.  The changes, marked “7/1/2021,” can be found on pages 8, 9, 11, 12, 16, and 22-27.

Department of Health and Human Services

COVID-19

  • HHS’s Office of the Assistant Secretary for Preparedness and Response has introduced a COVID-19 monoclonal antibody therapeutics calculator for infusion sites (mAbs Calculator) to inform staffing decisions and resource investments needed for COVID-19 monoclonal antibody therapeutic infusion sites.  Go here to learn more about the calculator and to find a link to it.
  • HHS’s COVID-19 health equity task force met this week to consider interim recommendations addressing the inequities and the impact of long-COVID or Post-Acute Sequelae COVID-19 infection and access to personal protective equipment, testing, and therapeutics.  Go here for a summary of the meeting and links to a recording of the event.

Health Policy News

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has released the final notice for the Basic Health Program federal funding methodology for program year 2022.  This document provides the methodology and data sources necessary to determine federal payment amounts for program year 2022 to states that elect to establish a Basic Health Program to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through qualified health plans in the exchange.  Learn more in the proposed rule.
  • CMS has proposed updating its End-Stage Renal Disease (ESRD) prospective payment system rates, changing the ESRD Quality Incentive Program, and modifying the ESRD Treatment Choices (ETC) Model.  The proposed changes to the ETC Model policies seek to encourage dialysis providers to decrease disparities in rates of home dialysis and kidney transplants among ESRD patients with lower socioeconomic status.  Other changes in the proposed ESRD regulation address rates, wage index, an update of the outlier policy, a transitional add-on payment adjustment for new and innovative equipment and supplies applications, and more.  Learn more from the following resources:

Centers for Disease Control and Prevention

COVID-19

  • The CDC has published a report in which it evaluates the effectiveness of COVID-19 vaccines among health care workers during the early phase of vaccinations.  Find the report here.
  • The CDC has updated its guidance for laboratories on the use of pooling for COVID-19 testing.  The new guidance notes that while pooling specimens for public health surveillance purposes is still acceptable, the focus now is on its use for diagnostic and screening testing.
  • The CDC has issued a guide for jurisdictions on expanding COVID-19 vaccine distribution to primary care providers to address disparities in immunizations.  Find it here.
  • The CDC has published research on the efficacy of portable air cleaners and masking for reducing indoor exposure to simulated exhaled COVID-19 aerosols.  Read the report here.

Health Policy News

  • The CDC reports that the number of cancer screenings received by women through the CDC’s National Breast and Cervical Cancer Early Detection Program declined 87 percent for breast cancer and 84 percent for cervical cancer during April 2020 compared numbers for that month over the past five years.  The CDC attributes this to delayed in seeking care because of COVID-19.  Learn more here.

Food and Drug Administration

COVID-19

  • With improved access nation-wide to N95 masks, the FDA has revoked emergency use authorizations for certain respirators and decontamination systems.  See the FDA announcement.  The FDA also will hold a webinar to share information and answer questions about its revocation of EUAs for non-NIOSH-approved respirators and decontamination systems.  Go here to learn more about the webinar.

Health Policy News

  • The FDA has alerted users of Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices due to potential health risks.  Go here to see the FDA announcement.
  • The FDA has approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment.  Learn more here.
  • The FDA has released a Cyclospora prevention, response, and research action plan.  The plan focuses on improving prevention, enhancing response activities, and filling knowledge gaps to help prevent Cyclospora contamination of foods and to help prepare for responding to future outbreaks.  See the FDA announcement for more.

National Institutes of Health

  • The NIH announced that it is funding five additional projects to identify ways of safely returning students and staff to in-person school in areas with vulnerable and underserved populations. Learn more about the new projects and other NIH-funded projects with similar objectives in this NIH announcement.

FEMA

  • FEMA has revised its COVID-19 funeral assistance policy to assist with COVID-19-related fatalities that occurred in the early months of the pandemic.  The change is intended to help families paying for funeral costs for people who died of COVID-19 but for which that cause of death was not noted on their death certificate.  Learn more from FEMA’s announcement of the change, which also has links to additional resources.

Stakeholder Events

Thursday, July 8 – HHS

HHS’s “We Can Do This” campaign is a national initiative to build confidence in COVID-19 vaccines and get more people vaccinated.  This campaign offers tailored resources and toolkits for stakeholders to use to provide COVID-19 vaccine information to at-risk populations.  CMS is partnering with the campaign to offer several webinars to walk through each toolkit and its resources and train community organizations, local voices, and trusted leaders to use the campaign tools for vaccine outreach efforts to diverse communities.  A webinar will be held on Thursday, July 8 at 1:00 p.m. (eastern)  Register here.

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

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

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

Wednesday, July 8 – HHS – Provider Relief Fund

HHS will host a webcast on Wednesday, July 8 at 3:00 p.m. (eastern) to present updated information on the use of Provider Relief Fund grants and reporting and auditing requirements associated with the receipt and use of those grants.  Go here to register.

Tuesday, July 13 – Food and Drug Administration

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

Zoom Webinar Link: https://fda.zoomgov.com/j/1600971341?pwd=UTJMTlZmYzVScmNZamd2d2J4SU92Zz09External Link Disclaimer

Webinar Passcode: $vrC6z

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

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

 

Federal Health Policy Update for Thursday, April 29

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, April 29.  Some of the language used below is taken directly from government documents.

The White House

COVID-19

Health Policy News

  • Speaking before a joint session of Congress, President Biden on Wednesday night formally presented his proposed American Families Plan.  In general, the plan defers action on most health care matters to other, separate legislation, but it does call for $200 billion to permanently expand Affordable Care Act health insurance subsidies and another $225 billion for paid medical leave.  The president also called on Congress to authorize the federal government to engage in some price negotiation for prescription drugs for Medicare beneficiaries and urged the National Institutes of Health to establish a new agency devoted to developing breakthrough cancer cures.  Go here to see a summary of the American Families Plan.

Department of Health and Human Services

Health Policy News

  • Earlier this week HHS announced the availability of $1 billion for Health Resources and Services Administration (HRSA)-Health Center Program funded health centers to support major construction and renovation projects across the country.  Learn more about this program, and about pursuing funding through it, from the following resources:

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published its proposed Medicare hospital inpatient prospective payment system and long-term-care hospital rate system rule for FY 2022.  Highlights of the proposed rule include:
  • A 2.8 percent increase in inpatient rates for acute-care hospitals.
  • Use of FY 2019 utilization data to filter out the impact of COVID-19 on utilization.
  • A $600 million reduction in the Medicare DSH uncompensated care pool.
  • Beginning in 2023, 1000 new medical residency slots over the next four years and changes in other graduate medical education policies.
  • A reduction from 68.3 percent to 67.6 percent in the labor-related share of inpatient payments and other wage index changes.
  • Consideration of changes in the Hospital Readmissions Reduction Program to reflect health equity factors.
  • Repeal of the requirement that hospitals report median payer-specific negotiated charges with Medicare Advantage plans on cost reports.
  • Introduction of a “measure suppression policy” to adjust quality program measures to reflect impact of COVID-19.

Learn more about the proposed regulation from the following resources:

News

Compliance

Claims, Prices, & Codes

MLN Matters Articles

Publications

Food and Drug Administration

COVID-19

Centers for Disease Control and Prevention

COVID-19

Stakeholder Events

Wednesday, May 5
FDA Product-Specific Guidances:  Lighting the Development Pathway for Generic Drugs
Wednesday, May 5 at 9:00 am – 12:30 pm ET.  Click here for connection information.
The FDA will provide an overview of product-specific guidances, including how they are developed and revised and their role in facilitating generic drug development and generic drug application review.  The FDA will also discuss ways prospective and current generic drug applicants can use PSGs, including those for complex products, to improve the efficiency of generic drug development.

Wednesday, May 5
CDC Zoonoses and One Health Update (ZOHU) Call
Wednesday, May 5, at 2:00 pm – 3:00 pm ET.  Click here to learn more.
ZOHU calls are one-hour monthly webinars that provide education on zoonotic and infectious diseases, One Health, antimicrobial resistance, food safety, vector-borne diseases, recent outbreaks, and related health threats at the animal-human-environment interface.

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

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

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

Wednesday, May 12

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

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

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

Health Policy Update for Thursday, April 8

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

Provider Relief Fund

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

Centers for Medicare & Medicaid Services

COVID-19

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

Proposed Rules

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

Health Policy News

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

Department of Health and Human Services

Federal Funding Opportunity

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

Centers for Disease Control and Prevention

COVID-19

Health Policy News

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

Congressional Research Service

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

Health Policy Update for Wednesday, April 7

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, April 7.

The White House

Health Policy News

  • President Biden’s first budget proposal is expected to be released this Friday, April 9.  It could have important policy implications for health care providers of all types.

COVID-19

Federal Emergency Management Agency

  • FEMA has published a notice titled “Coronavirus (COVID-19) Pandemic:  Safe Opening and Operation Work Eligible for Public Assistance;” the announcement “…defines the framework, policy details, and requirements for determining the eligibility of safe opening and operation work and costs under the PA [Public Assistance] Program.”  Authorized by the declaration of a national emergency, FEMA will reimburse selected entities for “…the safe opening and operation of eligible facilities” under its public assistance program.  Generally, such facilities are owned and operated by state and local governments, but in some cases those entities may contract for such operations with private, non-profit organizations, which would be eligible for such assistance.  FEMA payments under this program are made only to state and local governments, which then reimburse any private, non-profit organizations with which they have contracted for eligible work performed between January 21, 2021 and September 30, 2021.  For further information see this FEMA notice, which addresses in greater detail how the program works, including eligibility, eligible expenses, and more.

Centers for Medicare & Medicaid Services

Proposed Rules

Health Policy News

CMS has posted the latest edition of its weekly online publication MLN Connects.  The following is its table of contents (with links to the individual items).

News

Compliance

Claims, Pricers, & Codes

Events

MLN Matters® Articles

Publications

Multimedia

Department of Health and Human Services

COVID-19

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

  • The FDA has issued emergency use authorization for the first antibody test authorized for use with home-collected dried blood spot samples.  Samples collected at home are then sent to the laboratory of the product’s creator for analysis.  The test is available only by prescription.  See the FDA announcement and its emergency use authorization letter.

National Institutes of Health

COVID-19

The NIH has launched a clinical trial to determine whether people who are highly allergic or have a mast cell disorder are at increased risk for an immediate, systemic allergic reaction to the Moderna or Pfizer COVID-19 vaccines.  Learn more about the trial and its objectives here.

 

Health Policy Update for Monday, April 5

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, April 5.

The White House

COVID-19

Provider Relief Fund

Are there any restrictions on how hospitals that receive Medicaid disproportionate share hospital (DSH) payments can use Provider Relief Fund General and Targeted Distribution payments? (Added 2/24/2021)

Yes. Providers may not use PRF payments to reimburse expenses or losses that have been reimbursed from other sources or that other sources are obligated to reimburse. Therefore, if a hospital has received Medicaid DSH payments for the uncompensated costs of furnishing inpatient and/or outpatient hospital services to Medicaid beneficiaries and to individuals with no source of third party coverage for the services, these expenses would be considered reimbursed by the Medicaid program and would not be eligible to be covered by money received from a General or Targeted Distribution payment.

Centers for Medicare & Medicaid Services

COVID-19

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

National Institutes of Health