Federal Health Policy Update for Monday, June 28

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

Supreme Court Decision in Affordable Care Act Case

  • The Supreme Court has declined to hear an appeal of a case in which insurers unsuccessfully sued to recover reductions in their Affordable Care Act federal cost-sharing reduction payments.

White House

Department of Health and Human Services

COVID-19

  • HHS and the FDA have paused all distribution of bamlanivimab and etesevimab together and etesevimab alone, to pair with existing supply of bamlanivimab, on a national basis until further notice.  In addition, the FDA has recommended that health care providers nation-wide use alternative authorized monoclonal antibody therapies and not use bamlanivimab and etesevimab administered together at this time.  Learn more about why the agencies have taken this action and what they propose as alternatives from this message distributed by HHS’s Office of the Assistant Secretary for Preparedness and Response,
  • HHS’s Office of the Inspector General has published a report on the impact of COVID-19 on Medicare beneficiaries residing in nursing homes during 2020.  Learn more from the OIG’s announcement and summary of the report and from the OIG report “COVID-19 Had a Devastating Impact on Medicare Beneficiaries in Nursing Homes During 2020.”

Health Policy News

  • HHS and the CDC have awarded 59 jurisdictions with $200 million to bolster support for and enhance the disease intervention specialists workforce.  These awards represent the initial funding of a $1.13 billion investment being made over the next five years under the American Rescue Plan and will provide these jurisdictions, public health programs, and the CDC with support to expand and leverage the work of disease intervention specialists.  Learn more from the CDC’s announcement and find a list of the funding recipients here.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has provided guidance to state Medicaid programs about the circumstances under which health care facilities still operating under their emergency preparedness plans because of COVID-19 will temporarily remain exempt from participating in required full-scale emergency preparedness exercises and testing.  See the CMS guidance letter here.

Health Policy News

  • CMS has announced the appointment of Daniel Tsai as deputy administrator and director of its Center for Medicaid and CHIP Services.  Tsai comes from Massachusetts, where he served as the assistant secretary for MassHealth and state Medicaid director.  Learn more about Tsai and the agency he will help lead in this CMS news release.
  • CMS has released a Center for Medicaid and CHIP Services bulletin to introduce a series of tools and toolkits for states and CMS to use to improve the monitoring and oversight of managed care in Medicaid and the Children’s Health Insurance Program (CHIP) that will help improve beneficiaries’ access to care.  This bulletin also provides guidance setting the content and format of the Annual Managed Care Program Report required by CMS regulations and introduces additional resources and technical assistance toolkits that states can use to improve compliance with managed care standards and requirements.  Learn more from the new CMS bulletin.
  • CMS has published the latest edition of MLN Connects, its online publication.  For articles about updates of the hospital outpatient prospective payment system and the clinical laboratory fee schedule and more, go here.
  • CMS has updated its FAQ on its final rule on interoperability and patient access.  Find the information here.
  • CMS announced that it will provide $20 million in American Rescue Plan money to support state-based marketplaces to improve access to affordable, comprehensive health insurance coverage for consumers in their states.  States can apply for funding to help modernize or update their systems, programs, or technology to comply with federal marketplace requirements.  Learn more about the new funding from this CMS announcement.
  • CMS’s Center for Medicare and Medicaid Innovation has announced an anti-kickback safe harbor for CMS-sponsored model patient incentives under the agency’s Maternal Opioid Misuse Model.  Learn more here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Health Policy News

  • The FDA has approved the drug Pradaxa (dabigatran etexilate), the first oral blood thinning medication for children.  Learn more from this FDA news release.
  • The FDA has issued draft guidance encouraging industry to include patients with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in cancer clinical trials regardless of whether they have received existing alternative treatment options.  See the FDA announcement of this new policy and the draft guidance itself, which was published in the Federal Register.

Occupational Safety and Health Administration

  • OSHA has issued an emergency temporary standard to protect health care and health care support service workers from occupational exposure to COVID-19 in settings where people with COVID-19 are reasonably expected to be present.  Compliance with some of the new requirements is mandatory as of July 6 and compliance with the rest of the requirements is mandatory as of July 21.  Learn more from OSHA’s notice in the Federal Register.

National Institutes of Health

  • NIH director Francis S. Collins and other leaders have outlined their vision for a new science entity, the Advanced Research Projects Agency for Health, that was included in the president’s fiscal year 2022 budget with requested funding of $6.5 billion.  The purpose of the agency is to accelerate biomedical innovation and adoption of technologies and approaches to revolutionize health care and medicine.  Find the NIH announcement and a link to additional information about the agency here.
  • An NIH study published in the journal Science Translational Medicine concludes that “…there were 4.8 undiagnosed SARS-CoV-2 infections for every diagnosed case of COVID-19, and an estimated 16.8 million infections were undiagnosed by mid-July 2020 in the United States.”  Find the study here.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has submitted formal comments to CMS about that agency’s proposed regulation describing how it plans to pay for acute-care hospital and long-term-care hospital inpatient care in FY 2022.  The MedPAC letter addresses limited parts of the proposed regulation.  Go here to see MedPAC’s letter to CMS.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has published a fact sheet with an updated analysis of physician acceptance of new Medicaid patients, including at the state level.  The analysis found that physicians were significantly less likely to accept new patients covered by Medicaid than patients with Medicare or private insurance, although acceptance varied by specialty and by state.  Learn more from the new MACPAC fact sheet “Physician Acceptance of New Medicaid Patients:  Findings from the National Electronic Health Records Survey.”
  • MACPAC has published an issue brief that describes how Medicaid programs can pay for certain housing-related services.  Learn more from the MACPAC issue brief “Medicaid’s Role in Housing.”

Government Accountability Office

Stakeholder Events

CMS – Coronavirus (COVID-19) Stakeholder Calls 

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.  Webinar dates and registration links are below:

  • Tuesday, June 29, 1:00-1:30 pm ET:  Faith-Based Toolkit – Register here
  • Thursday,  July 1, 1:00-2:00 pm ET:  Toolkits for Racial and Ethnic Minority Communities – Register here
  • Thursday, July 8, 1:00-1:30 pm ET:  Older Adults Toolkit – 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.

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.

Health Care Reportedly Out of Biden American Families Plan

President Biden’s soon-to-be-introduced “American Families Plan” proposal apparently will not include a major health care component.

The New York Times reports that

The plan will not include an up to $700 billion effort to expand health coverage or reduce government spending on prescription drugs. Officials have decided to instead pursue health care as a separate initiative…

Learn more about what is expected from the American Families Plan – and what is not expected – in the New York Times article “Biden Will Seek Tax Increase on Rich to Fund Child Care and Education.”

 

The New Administration’s Health Care Team

Becker’s Hospital Review has published a list of 35 officials who are currently part of the Biden administration’s health care team.

Some are staff, some are appointments awaiting Senate confirmation, and some are serving on an interim basis until permanent replacements can be chosen and/or confirmed.

The list includes links to information about each individual.

See the list here.

Coronavirus Update for Wednesday, December 23

The following is the latest COVID-19 information from the federal government as 2:30 p.m. on Wednesday, December 23.

Provider Relief Fund

Centers for Medicare & Medicaid Services

Food and Drug Administration

Centers for Disease Control and Prevention

National Institutes of Health

American Medical Association

Coronavirus Update for Tuesday, December 9

The following is the latest COVID-19 information from the federal government as 2:30 p.m. on Tuesday, December 8.

Provider Relief Fund

  • HHS announced that the Provider Relief Fund will distribute $523 million in second-round performance payments to 9248 nursing homes as rewards for successfully reducing COVID-19-related infections and deaths between September and October.  HHS concluded that between September and October, 69 percent of 13,251 eligible nursing homes met the incentive program’s infection control criteria.  See HHS’s announcement of the nursing home distribution and a list of how much of this money HHS distributed to nursing homes in individual states.
  • HHS has updated its CARES Act Provider Relief Fund FAQ with nine new or modified questions and answers.  Find the new items, all labeled “12/4/2020,” on pages 2, 6, 14, 15, 16-17, 25, 34, 47, and 55.  Fund recipients should review this new information carefully, and in particular, the question on page 6 about erroneous payments, which reverses previous policy, and questions on audit terms and extensions on pages 14 and 15.

Centers for Medicare & Medicaid Services

CMS COVID-19 Stakeholder Calls 

CMS hosts recurring stakeholder engagement sessions to share information about the agency’s response to COVID-19.  These sessions are open to members of the health care community and are intended to provide updates, share best practices among peers, and offer participants an opportunity to ask questions of CMS and other subject matter experts.

COVID-19 Office Hours Call

Tuesday, December 22 at 5:00 (eastern)

Toll Free Dial In:  833-614-0820; Access Passcode:  3968359

Audio Webcast link:  go here.

Hospitals Without Walls Call

On November 25, CMS announced the expansion of its Hospitals Without Walls program by introducing its Acute Hospital Care At Home program, giving eligible hospitals unprecedented regulatory flexibilities to treat eligible patients in their homes.  This program was developed to support models of at-home hospital care that have succeeded in several hospitals and networks.  A CMS Hospitals Without Walls stakeholder call will feature two organizations walking through their programs and a question and answer session.  Slides/resources will be posted on CMS.gov prior to the call.

Wednesday, December 9 at 4:00-5:00 PM (eastern)

Toll Free Attendee Dial-In:  833-614-0820; Access Passcode:  1235939

Audio Webcast Link:  go here.

Conference lines are limited so CMS encourages interested parties to join via audio webcast.

To listen to the audio files and read the transcripts for past stakeholder calls, go here.

Department of Health and Human Services

  • HHS has released new hospital COVID-19 capacity data at the facility level.  Previously released data about hospital capacity that had been released was aggregated at the state level but this new, more granular data release aggregates daily hospital reports into a “week at a time” picture while providing a view of how COVID-19 is affecting hospitals and communities.  See HHS’s announcement about the new data and an FAQ about the data and go here for access to the data itself.

Food and Drug Administration

Centers for Disease Control and Prevention

States Expect Medicaid Enrollment, Spending to Rise in FY 2021

States expect to see their Medicaid enrollment and spending rise in FY 2021, driven by increases in unemployment resulting from the COVID-19 pandemic and maintenance-of-effort requirements in legislation enacted earlier this year.

A Kaiser Family Foundation survey of state Medicaid directors found that those officials expect their Medicaid enrollment to rise 8.2 percent in FY 2021 and their Medicaid spending to increase 8.4 percent that same year.  Most states expect the 6.2 percentage point increase in federal Medicaid matching funds that was included in the Families First Coronavirus Response Act, passed this March, to expire at the end of 2020.

Learn more about how states see their Medicaid responsibilities changing in the coming year and the underlying causes of those changes in the Kaiser Family Foundation report “Medicaid Enrollment & Spending Growth: FY 2020 & 2021.”

Coronavirus Update for Tuesday, June 30

Coronavirus update for Tuesday, June 30 as of 2:30 p.m.

Department of Health and Human Services

  • An HHS spokesperson tweeted yesterday that “@HHSGov expects to renew the Public Health Emergency due to COVID-19 before it expires.”
  • HHS announced that it has entered into an agreement to secure a supply of remdesivir, a drug used to treat COVID-19. Hospitals will have to purchase the drug from the pharmaceutical company and its distributor at the negotiated price of about $3200 a treatment, with the amount each hospital can purchase to be determined by the federal government and state health departments based on recent COVID-19 caseloads.  Those allocation decisions will be made every two weeks, and beginning on July 6 hospitals will be asked to submit their data through the TeleTracking web portal by Monday at 8 p.m. ET every two weeks.

Centers for Medicare & Medicaid Services

CMS has updated its toolkit on state actions to mitigate the prevalence of COVID-19 in nursing homes.

CMS COVID-19 Stakeholder Calls

CMS hosts recurring stakeholder engagement sessions to share information related to the agency’s response to COVID-19.  These sessions are open to members of the health care community and are intended to provide updates, share best practices among peers, and offer attendees an opportunity to ask questions of CMS and other subject matter experts.

CMS COVID-19 Office Hours Calls

Tuesday, June 30th at 5:00 – 6:00 PM Eastern

Toll Free Attendee Dial In: 833-614-0820; Access Passcode: 5125839

Audio Webcast link:  go here.

Tuesday, July 7th at 5:00 – 6:00 PM Eastern

Toll Free Attendee Dial In: 833-614-0820; Access Passcode: 3048844

Audio Webcast link:  go here.

Tuesday, July 14th at 5:00 – 6:00 PM Eastern

Toll Free Attendee Dial In: 833-614-0820; Access Passcode: 2550919

Audio Webcast link:  go here.

Tuesday, July 21st at 5:00 – 6:00 PM Eastern

Toll Free Attendee Dial In: 833-614-0820; Access Passcode: 7477995

Audio Webcast link:  go here.

Tuesday, July 28th at 5:00 – 6:00 PM Eastern

Toll Free Attendee Dial In: 833-614-0820; Access Passcode: 1492795

Audio Webcast link:  go here.

Nursing Homes Call

Wednesday, July 8th at 4:30 – 5:00 PM Eastern

Toll Free Attendee Dial-In: 833-614-0820; Access Passcode: 2997138

Audio Webcast Link: go here.

Wednesday, July 22nd at 4:30 – 5:00 PM Eastern

Toll Free Attendee Dial-In: 833-614-0820; Access Passcode: 1143564

Audio Webcast Link:  go here.

Home Health and Hospice Calls

Tuesday, July 7th at 3:00 – 3:30 PM Eastern

Toll Free Attendee Dial-In: 833-614-0820; Access Passcode: 9480618

Audio Webcast Link: go here.

Tuesday, July 21st at 3:00 – 3:30 PM Eastern

Toll Free Attendee Dial-In: 833-614-0820; Access Passcode: 6080197

Audio Webcast Link:  go here.

Dialysis Organizations Call

Wednesday, July 8th at 5:30 – 6:00 PM Eastern

Toll Free Attendee Dial-In: 833-614-0820; Access Passcode: 8481378

Audio Webcast Link:  go here.

Wednesday, July 22nd at 5:30 – 6:00 PM Eastern

Toll Free Attendee Dial-In: 833-614-0820; Access Passcode: 7692208

Audio Webcast Link: go here.

Nurses Call

Thursday, July 9th at 3:00 – 3:30 PM Eastern

Toll Free Attendee Dial-In: 833-614-0820; Access Passcode: 9386539

Audio Webcast Link:  go here.

Thursday, July 23rd at 3:00 – 3:30 PM Eastern

Toll Free Attendee Dial-In: 833-614-0820; Access Passcode: 7971869

Audio Webcast Link: go here.

Lessons from the Front Lines

Friday, July 17th at 12:30 – 2:00 PM Eastern

Toll Free Attendee Dial-In: 833-614-0820; Access Code: 3096434

Web Link:  go here.

Conference lines are limited so CMS encourages interested parties to join via audio.  To listen to the audio files and read the transcripts for the COVID-19 Stakeholder calls, visit CMS’s Podcast and Transcripts page.

Food and Drug Administration

Centers for Disease Control & Prevention

Department of Labor

  • The Department of Labor has issued guidance on child labor, paid sick leave, and expanded family and medical leave amid school and camp closures necessitated by COVID-19. See the announcement, which includes links to department policy bulletins.

American Medical Association

Federal Funding Opportunities for Hospitals

  • NASH has prepared a document that collects and presents in one place the various new federal funding opportunities for hospitals resulting from legislation addressing the COVID-19 public health emergency.  Find that document here.

To receive this daily update directly, sign up for our mailing list at info@safetynetalliance.org.)

Coronavirus Update for Thursday, June 4, 2020

Coronavirus update for Thursday, June 4 as of 2:30 p.m.

NASH Advocacy

Today NASH sent a letter to HHS Secretary Alex Azar and CMS Administrator Seema Verma expressing safety-net hospitals’ disappointment that HHS still has not made a targeted distribution of CARES Act Provider Relief Funds to providers of especially high volumes of care to Medicaid and government-insured patients and urging them to do so as soon as possible.  See NASH’s letter here.

 

Centers for Medicare & Medicaid Services

Department of Health and Human Services

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has introduced a new web-based resource, Testing Supply Substitution Strategies, that includes detailed information to help support labs performing authorized COVID-19 tests.
  • The FDA has updated the question-and-answer appendix in its guidance Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency with new information about compliance for electronic systems used to generate electronic signatures on clinical trial records.
  • The FDA has issued an alert to providers about the temporary absence of the “paralyzing agent” warning statement on the vial caps of the neuromuscular blocking agents vecuronium bromide and rocuronium bromide, both of which are often used for patients requiring medical ventilation.
  • The FDA has issued emergency use authorizations (EUAs) for five new commercial diagnostic tests for COVID-19. Find them here, here, here, here, and here.
  • Federal Funding Opportunities for Hospitals

    • NASH has prepared a document that collects and presents in one place the various new federal funding opportunities for hospital resulting from legislation addressing the COVID-19 public health emergency.  Find that document here.

    (To receive this daily update directly, sign up for our mailing list at info@safetynetalliance.org.)

Coronavirus Update for April 10, 2020

The following is the latest information from federal regulators as of 3:30 p.m. on Friday, April 10.

Centers for Medicare & Medicaid Services

Federal Communications Commission (COVID-19 Telehealth Program)

Last week the FCC announced a $200 million grant program to help health care providers develop connected care services to patients at their homes or mobile locations in response to the COVID-19 pandemic.  Today the FCC announced that it will begin accepting applications for this money on Monday, April 13.  See this FCC news release for further details on the program and the application process.

Food and Drug Administration

Centers for Disease Control and Prevention

Federal Emergency Management Agency

FEMA has issued a news release announcing that it will seek to give states the option of assuming control of federal community-based COVID-19 testing sites.

White House

President Trump has issued a memorandum on providing federal support for governors’ use of the National Guard to respond to COVID-19.  A similar order was issued earlier this week and this new order adds 13 states to the list of those previously authorized to use the National Guard in this manner, with the Federal Emergency Management Agency directed to assume 100 percent of the associated costs.  The new states are Arizona, Colorado, Kentucky, Mississippi, Montana, Nevada, North Carolina, Oregon, Pennsylvania, South Carolina, Virginia, Wisconsin, and West Virginia.

Federal Funding Opportunities for Hospitals

NASH has prepared a document that collects and presents in one place the various new federal funding opportunities for hospitals resulting from legislation addressing the COVID-19 public health emergency.  Find that document here.

(To receive this daily update directly, sign up for our mailing list at info@safetynetalliance.org.)

NASH Endorses Surprise Medical Bills Legislation

The National Alliance of Safety-Net Hospitals has endorsed the Consumer Protections Against Surprise Medical Bills Act of 2020, surprise medical bills legislation developed by the House Ways and Means Committee.

In a letter to the committee’s chairman and ranking member, NASH wrote that

NASH supports the bill’s protection of patients from surprise medical bills for care they receive from out-of-network providers; we support the concept of patients receiving an “Advance Explanation of Benefits”; and most of all, we support a mediation process to be used when insurers and providers do not agree on appropriate payments that requires those parties to engage in good-faith negotiations; that employs mediated dispute resolution when those negotiations do not lead to agreement on payments; and that excludes from that mediation the use of specific, standard benchmark rates.

See the entire NASH letter here.