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Federal Health Policy Update for Wednesday, December 1

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The following is the latest health policy news from the federal government as of 3:00 p.m. on Wednesday, December 1.  Some of the language used below is taken directly from government documents.

Omicron Variant

  • The CDC has confirmed the first case of the COVID-19 omicron variant on U.S. soil.  Learn more from this CDC news release.

Health Care Employee Vaccine Mandate

COVID-19

  • A federal court has issued a preliminary injunction blocking enforcement of the federal government’s requirement that health care workers receive COVID-19 vaccines by December 6.  Find the court’s ruling here.  The ultimate ruling will be made by a higher court.

No Surprises Act

  • CMS has released a series of documents addressing implementation of the No Surprises Act, the surprise medical billing law that takes effect on January 1.  Go here for a link to a zip file of those documents.
  • A reminder:  stakeholder comments on the most recent regulation implementing the No Surprises Act are due this coming Monday, December 6,

The White House

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has issued guidance to inform Medicare Part D sponsors of permissible flexibilities during the COVID-19 public health emergency related to oral antiviral drug(s) for COVID-19 if such drug(s) become available under FDA emergency use authorization and are procured by the federal government.  Find that guidance here.
  • CMS has updated its compendium of Medicare emergency declaration blanket waivers for health care providers with two changes:  one, on page 21, addresses requirements for individuals employed as directors of food and nutrition services in long-term-care facilities and another, on page 33, alters Medicare ground ambulance data collection reporting requirements.  Find the revised blanket waivers document here.

Health Policy Update

  • CMS has published a request for public comments on potential changes in the requirements that transplant programs, organ procurement organizations, and end-stage renal disease facilities must meet to participate in the Medicare and Medicaid programs.  Learn more about what CMS seeks in this Federal Register notice.  Stakeholder comments are due in 60 days.
  • CMS has announced that it will not move forward with the Seriously Ill Population component of its Primary Care First Model.  That component was designed to have advanced primary care practices coordinate care for high-need, seriously ill beneficiaries.  After review, CMS concluded that the program’s outreach methodology was unlikely to result in sufficient beneficiary participation to allow for model evaluation.  Learn more from this CMS announcement.
  • CMS has published two documents addressing Medicaid and CHIP in the post-COVID-19 world:  “Strategies States and the U.S. Territories Can Adopt to Maintain Coverage of Eligible Individuals as They Return to Normal Operations” and “Connecting Kids to Coverage: State Outreach, Enrollment and Retention Strategies.”
  • CMS has posted the latest edition of MLN Connects, its online publication addressing Medicare payment matters.  This edition includes items on new 2022 web pricers for inpatient prospective payment system hospitals, inpatient rehabilitation facilities, and long-term-care hospitals; information about the 2022 physician fee schedule rule; news about telehealth originating site facility payments; information about disproportionate share hospital (DSH) payments; and more.  Go here for the new MLN Connects.

Department of Health and Human Services

Health Policy Update

  • HHS has launched a website for the HHS 405(d) Aligning Health Care Industry Security Approaches Program.  The purpose of the site is to provide the health care and public health sectors “…with useful, impactful, and vetted resources, products, videos, and tools that help raise awareness and provide cybersecurity practices, which drive behavioral change and move toward consistency in mitigating the most relevant cybersecurity threats to the sector.”  The website features health care-focused resources such as cybersecurity posters and infographics, installments of a bi-monthly newsletter, webinar recordings, and threat-specific products to support cybersecurity awareness and training.  Learn more from this HHS news release and go here to find the new site.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has updated its guidance on the use of the monoclonal antibodies amlanivimab and etesevimab when administered together, expanding their authorized use to all U.S. states and territories.  Find that guidance here.
  • The FDA has issued emergency use authorization for the emergency use of the unapproved monoclonal antibody product sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct COVID-19 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death.  Go here for an FDA fact sheet on the drug’s use.
  • The FDA has issued a statement outlining its efforts to investigate and address the potential impact of the COVID-19 omicron variant.  Find that statement here.

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.

Center for Medicare and Medicaid Innovation – Roundtable on Health Equity Strategy – December 8

CMMI will hold a roundtable event on Wednesday, December 8 at 1:30 p.m. (eastern) to discuss how it can carry out its strategic objective of advancing health equity.  The agency also invites written comments on the subject.  For further information about the roundtable and to register to participate, go here.

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.

MEDPAC – commission meeting – December 9-10

Members of the Medicare Payment Advisory Committee will meet virtually on December 9 and 10.  Information about how to join the meeting will be forthcoming; when it is, that information will be posted here.

Federal Health Policy Update for Tuesday, November 23

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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.