Federal Health Policy Update for the Week of September 5-12

The following is the latest health policy news from the federal government for the week of September 5-12.  Some of the language used below is taken directly from government documents.

The White House

• The White House has published a fact sheet on the administration’s plan to get Americans an updated COVID-19 shot and to manage COVID-19 this fall.  The major components of the plan are providing access to free, updated vaccines; ensuring easy access to testing and treatment; encouraging safe practices; and preparing for potential surges and new variants.  Find that fact sheet here.
• The White House’s COVID-19 response team and other public officials have briefed the press on the federal government’s latest efforts in its response to the COVID-19 public health emergency.  Find a transcript of that briefing here.

Centers for Medicare & Medicaid Services

• CMS has issued a request for information “…seeking public input on accessing healthcare and related challenges, understanding provider experiences, advancing health equity, and assessing the impact of waivers and flexibilities provided in response to the COVID-19 Public Health Emergency.”  The request for information also seeks feedback to inform CMS’s assessment of the impact of waivers and flexibilities provided in response to the COVID-19 public health emergency.  Learn more about the CMS request for information, what the agency seeks, and how it anticipates using the feedback it receives from this CMS news release.  Public comments are due by November 4.
• CMS and HHS have announced that people with Medicare, Medicaid, Children’s Health Insurance Program (CHIP) coverage, private insurance coverage, or no health coverage can get COVID-19 vaccines, including the updated Moderna and Pfizer-BioNTech COVID-19 vaccines, at no cost for as long as the federal government continues purchasing and distributing these COVID-19 vaccines.  Learn more from this CMS news release.  Find codes for billing for these free vaccines here.
• CMS and HHS have announced approval of Oregon’s proposal to cover community-based mobile crisis intervention services through Medicaid.  Such a service, authorized by the American Rescue Plan, will be the first of its kind in the country and will enable Oregon to provide community-based stabilization services to Medicaid-covered individuals experiencing mental health and/or substance use crises throughout the state by connecting them to a behavioral health specialist 24 hours a day, every day of the year.  Learn more from this HHS news release.
• CMS has approved the extension of Medicaid and CHIP coverage for 12 months after pregnancy in Indiana and West Virginia, bringing to 24 the number of states that have now taken advantage of the provision in the American Rescue Plan that makes this benefit possible.  Learn more from this CMS announcement.
• CMS has posted information about a recent update of the FY 2022 Medicare outpatient prospective payment system.  The update includes information about new COVID-19 vaccine and administration CPT codes; a redosing update for EVUSHELD; and a new procedure to assess coronary disease severity using computed tomography Find the updated information here.
• CMS, in partnership with the Consumer Financial Protection Bureau, has sent a joint letter to nursing homes and their debt collectors urging them to examine their debt collection practices and ensure that they comply with federal law that prohibits nursing homes from requiring family members or caregivers to guarantee payment for a resident’s nursing home stay.  The letter was precipitated by concerns that some nursing facilities have attempted to evade this prohibition by creating admission contracts that attempt to hold third parties liable for a resident’s debt.  Learn more from this CMS news release and see the letter here.
• The latest edition of MLN Connects, CMS’s online newsletter addressing Medicare reimbursement matters, includes features on claims processing manual changes for exceptions to the average sales price payment methodology, a program for acute-care hospitals to evaluate payment patters electronic reports, and more.  Find it here.

Department of Health and Human Services

• Providers that received one or more Provider Relief Fund payment exceeding $10,000 between January 1, 2021 and June 30, 2021 are required to report on their use of those funds in Reporting Period 3.  Learn more about the requirements and how to comply with them from this Provider Relief Fund web site notice.  The reporting deadline is September 30.
• HHS’s Office of the Inspector General has released the report “Medicare Telehealth Services During the First Year of the Pandemic: Program Integrity Risks.”  The report notes that the use of telehealth increased dramatically during the first year of the pandemic and concludes that the proportion of claims submitted to Medicare that could be viewed as “high risk” of being fraudulent was very low.  Learn more from the HHS OIG report “Medicare Telehealth Services During the First Year of the Pandemic: Program Integrity Risks” and find a summary of that report here.
• In another report, HHS’s OIG concludes that even though telehealth had been viewed recently as primarily a means of helping residents of rural and geographically isolated areas obtain difficult-to-find medical services, Medicare beneficiaries in urban areas were more likely than those in rural areas to use telehealth during the first year of the COVID-19 pandemic under eased requirements for access to such services.  Learn more from the data brief “Certain Medicare Beneficiaries, Such as Urban and Hispanic Beneficiaries, Were More Likely Than Others To Use Telehealth During the First Year of the COVID-19 Pandemic.”
• HHS has posted a guide to best practices in the use of telehealth in the delivery of cancer care.
• HHS has updated its web page with funding opportunities for telehealth and broadband-related programs.
• HHS’s Health Resources and Services Administration (HRSA) is seeking nominations of qualified candidates for consideration for appointment to the Advisory Commission on Childhood Vaccines, which advises HHS on issues related to implementation of the National Vaccine Injury Compensation Program.  Learn more about the commission and the background HRSA seeks in potential members from this Federal Register notice.  There is no deadline for nominations.

Department of Homeland Security/Public Charge Rule

• The U.S. Department of Homeland Security has amended its regulations governing how it determines whether non-citizens are admissible to the U.S.  The new regulation overturns a controversial regulation, often referred to as a “public charge regulation,” that the previous administration issued in August of 2019.  Under the new rule, the federal government will not penalize individuals who choose to seek most health-related benefits and other supplemental government services available to them, including most Medicaid benefits and CHIP, by deeming them inadmissible to the U.S. on this basis; pursuing such benefits will no longer jeopardize the immigration status of such individuals, as it did under the superseded regulation.  Learn more about the new regulation from this HHS news release and from the regulation itself.

Monkeypox

• The CDC has published information about the clinical use of tecovirimat (Tpoxx) for treatment of monkeypox under an investigation research protocol.  Find the study’s findings here.  Separately, the NIH has announced the launch of a Phase 3 clinical trial evaluating the Tpoxx treatment that is now enrolling adults and children with monkeypox infections.  Learn about the study here.
• The FDA has taken two actions to expand access to monkeypox testing.  First, it has issued guidance that outlines its current thinking regarding enforcement policies, recommendations for emergency use authorization (EUA) requests for monkeypox diagnostic tests, and its plans to prioritize review of EUA requests while also providing voluntary templates that test developers may use when validating a test or submitting an EUA request; find that guidance here.  Second, the FDA has issued its first EUA for a monkeypox in vitro diagnostic test.  Learn about these developments and more from this FDA news release.
• In support of these actions, HHS Secretary Xavier Becerra has signed a declaration permitting the FDA Commissioner to issue emergency use authorizations for in vitro diagnostics to expand the availability of tests for monkeypox.  Learn more from an HHS news release and from the declaration itself.
• The CDC has posted a series of updates about monkeypox-related issues.
• The CDC has posted an updated map showing the distribution of 21,985 confirmed cases of monkeypox in the U.S. as of September 12.
• The White House monkeypox response team has briefed the press on the most recent steps in the federal response to the monkeypox outbreak.  Find a transcript of that briefing here.

Centers for Disease Control and Prevention

• The CDC has issued a health alert to notify health care providers, laboratories, infection control specialists, and public health departments about recent increases in severe respiratory illness requiring hospitalization in children and to urge providers to consider EV-D68 as a possible cause of acute, severe respiratory illness (with or without fever) in children.  The alert also warns of the potential for an increase in these cases in the upcoming weeks and offers recommendations to providers, laboratories, infection preventionists, public health departments, and the public.  Find the alert here.
• The CDC has announced that as a result of a court order, effective immediately and as of April 18, 2022, its January 29, 2021 order requiring masks on public transportation conveyances and at transportation hubs is no longer in effect.  The agency will not enforce the order but continues to recommend that people wear masks in indoor public transportation settings at this time.  Learn more from this updated CDC guidance on wearing masks in travel and public transportation settings.  The CDC also has updated its FAQ on COVID-19 and travel.
• The CDC has updated its FAQ on COVID-19 vaccines for children and teenagers.

Medicare Payment Advisory Commission (MedPAC)

• MedPAC has submitted formal comments to CMS in response to the latter’s proposed 2023 outpatient prospective payment system rule.  MedPAC’s letter addresses payments for 340B-covered drugs, additional payments for new rural emergency hospitals, the extension of selected telehealth flexibilities, health equity, and more.  Find MedPAC’s letter here.

Stakeholder Events

CDC – Flu Prevention and Treatment Recommendations for Pediatric Providers – September 15

The CDC will hold a webinar during which it will present to pediatric providers its recommendations for preventing and treating flu among children on Thursday, September 15 at 2:00 (eastern).  This webinar also offers continuing education credits.  Learn more about the webinar and how to participate from this CDC announcement.

MACPAC – September 15-16

MACPAC, the Medicaid and CHIP Payment and Access Commission, will meet virtually on Thursday, September 15 and Friday, September 16.  Go here for the meeting agenda, session times, and information on how to participate.

CDC – Long COVID and Cardiovascular Symptoms – September 20

The CDC will hold a webinar on Long COVID during which it will outline the recommended clinical approach to identifying and managing cardiovascular complications in Long COVID patients.  The webinar will be held on Tuesday, September 20 at 2:00 (eastern); continuing education credits will be available.  Learn more about the webinar and how to join it from this CDC notice.

CMMI – Person-Centered Care – September 20

The CMS Innovation Center (CMMI) will host a webinar on Tuesday, September 20 at 3:30 p.m. (eastern) to share information about its approach to testing models and innovations that support person-centered care.  Go here to learn more about the webinar and find a link to register to participate.

NIH – Cancer Care and Telehealth – September 23

The NIH’s National Cancer Institute will hold a webinar to continue its exploration of emergent research gaps and opportunities for the use of telehealth in cancer prevention and control.  The webinar will be held on Friday, September 23 at noon (eastern).  To learn more about the webinar and how to join it, go here.

FDA – Oncologic Drugs Advisory Committee – October 28

The FDA’s Oncologic Drugs Advisory Committee will meet virtually on Friday, October 28 at 10:00 (eastern).  The general function of this committee is to provide advice and recommendations to the FDA on regulatory issues.  Learn more about the meeting, including about the docket, how to submit comments, and how to participate, from this Federal Register notice.