In The News

Free Covid Tests Will Be Offered Again to All U.S. Households

StatNews | By Helen Branswell and Rachel Cohrs

The federal government is again offering free Covid-19 tests to Americans, providing a fifth round of free tests in part to meet current needs, in part to stimulate a domestic testing industry that has struggled with cratering demand for the rapid diagnostics.

The measure, announced Wednesday, will see rapid tests released from the Strategic National Stockpile. In addition, 12 domestic test manufacturers will receive investments totaling $600 million to help “warm-base” the U.S. capacity for rapid test production, both for Covid and future disease threats.

“We will make available some of those tests that we have in our stockpile,” Xavier Becerra, health and human services secretary, said in Washington, “so that Americans can … use those tests during this viral season.”

Earlier in the pandemic, demand for rapid tests was huge. But it has been up and down, based on levels of transmission — and on the intensity of public concern. For instance, some manufacturers scaled back production in 2021, as the national vaccination effort gained ground.

When the massive Omicron wave hit in late 2021 and early 2022, it took weeks to get significant supplies of tests available again, Dawn O’Connell, HHS assistant secretary for preparedness and response, told STAT in an interview. Since the end of the public health emergency in May, some health insurers have declined to pay for rapid tests, further depressing sales.

The country needs to have ongoing production capacity, based in the U.S., O’Connell said.

“What it does is keep the lines running, so we no longer have that boom and bust [cycle],” she said. “This capability is important now for Covid and we’re using it and exercising it now as we’re heading into the fall and winter season. But it’s going to be critically important for other outbreaks that we’re responding to in the future.”

Households will be entitled to receive four free rapid tests apiece, with ordering at COVIDtests.gov opening on Sept. 25. O’Connell said test shipments are expected to start on Oct. 2.

The money flowing to the 12 domestic producers will require them to keep their production bases warm. O’Connell said that after the winter, when public demand for tests may again shrink, the federal government will receive, as part of the deal, 200 million new Covid tests to replenish the national stockpile.

She encouraged people to order the tests and use them, especially when planning to spend time around people for whom Covid remains a significant health threat.

“We’ve seen each fall and winter season an increase in cases as people move indoors and are seeing their families again and interacting in smaller groups and closer quarters. We wanted to make sure as we head into that season … that we provide an avenue for people to be able to receive these tests for free,” O’Connell said.

“It’s just one of the arrows in our quiver for the fall and winter season and we’re pleased to provide these tools to protect Americans from Covid and keep their family members safe.”

 

Potential Government Shutdown: Threat Assessment Report

Healthcare Ready

Situation Overview

  • There [is less than one week] until the September 30 deadline for Congress to pass 12 spending bills to avert a government shutdown.  
  • There are currently two options for Congress if new appropriations bills are not enacted by October 1:
  • Pass 12 appropriation bills by September 30 or the government will shut down until they are passed into law.
  • Pass a short-term continuing resolution that will keep agencies operational through a specified date. 
  • Every government shutdown has different impacts to federal agencies and departments however essential services remain running – such as processing Medicare claims.   

Potential Impacts to Healthcare

Potential Impacts to Centers for Medicare and Medicaid Services (CMS)

  • The Medicare Program will continue to operate in the event of a government shutdown because it is paid for with mandatory funds outside of the discretionary appropriations process.*
  • While Medicare will continue to process claims, most of the CMS workforce will be furloughed.
  • CMS would suspend funding for healthcare fraud and abuse teams as well as conducting fewer certifications for providers. *

Potential Impacts to Health Centers and Health Centers Workforce

  • Lawmakers in both the House and Senate are currently reviewing distinct bills aimed at bolstering funding for health centers and critical workforce programs.
  • Anticipated disruptions in funding have the potential to affect the day-to-day operations of health centers, leading to possible immediate or long-term consequences for patient access to services. As funding sources vary by individual health center, depending on the specific health center, interruptions or reductions in funding could result in adverse effects on site operations, as well as initiatives designed to attract and retain staff. The National Association of Community Health Centers (NACHC) hosted a press briefing on potential impacts on September 18.

Potential Impacts to the Department of Health and Human Services (HHS)

  • In the event of a government shutdown, FDA will continue its core functions such as responding to public health emergencies, monitoring drug shortages and emerging outbreaks, supporting medical product recalls, and other critical public health issues. 
  • Additionally, the regulation of medical devices by CDRH will continue in the event of a government shutdown because it is funded through user fees.*
  • HHS will continue COVID-19 activities by utilizing funding provided in the FY20 and FY21 emergency supplemental appropriations bills.
  • The Administration for Strategic Preparedness and Response (ASPR) will maintain minimal readiness for all hazards which will be critical ahead of a potential tripledemic (flu, COVID-19, and RSV) this fall and winter. With drug shortages continuing to affect the nation, it is critical that all other readiness functions are in place to mitigate any surges in respiratory illnesses. 
  • The National Institutes of Health (NIH) will continue COVID-19 research and clinical activities.
  • While roughly 40% of HHS’ workforce would be furloughed if the government shut down, HHS will use exceptions in the Antideficiency Act (ADA) to retain staff in support of funded activities for Medicare, Medicaid, and other mandatory health program payments.

Potential Impacts to Veterans Affairs

  • Most veterans and active-duty service members’ health benefits will not be affected by a government shutdown.*

Potential Impacts to Pandemic Preparedness

  • The Pandemic and All-Hazards Preparedness Act (PAHPA) was first enacted in 2006. Last reauthorized in 2019, the legislation provides funding for a vast number of preparedness programs and initiatives related to medical counter measures; the Strategic National Stockpile (SNS); and other preparedness programs carried out at local, state, and federal levels.
  • Although PAHPA and its subsequent reauthorizations received unanimous bipartisan support when passed, there are notable differences among the Senate and two House versions. The potential effects on preparedness programs and initiatives due to a delay in reauthorization remain uncertain. Nevertheless, a potential decrease in funding or a prolonged delay in reauthorization could substantially impact preparedness and response programs of national significance.
 

FY2024 Hospice Medicare and Medicaid Base Rates – At a Glance

NAHC

Beginning October 1, 2023, hospice base payment rates will increase by 3.1 percent, as published in the final FY 2024 Hospice Payment Rule.  As is customary, the Medicaid program waits until Medicare rates are finalized to issue guidance on the applicable corresponding hospice payment rates. The Centers for Medicare & Medicaid Services (CMS) Medicaid Financial Management Group recently issued a memorandum  containing the minimum Medicaid hospice rates that will be applicable for FY2024.

Hospices should note that the hourly rate for Continuous Home Care ($65.23 under Medicare and $65.25 for Medicaid) will be the rate applicable to the Service-Intensity Add-on (SIA) applied to certain in-person visit hours delivered by RNs and Social Workers in the last week of life while a patient is on Routine Home Care (RHC). 

Medicare and Medicaid rates vary slightly due to consideration of potential copayments that are included when calculating the Medicare rates but not those for Medicaid.

Recently CMS also issued Transmittal 12193/Change Request 13289, which communicates the Update to Payment Rates, Hospice Cap, Hospice Wage Index and Hospice Pricer for FY2024 to the Medicare Administrative Contractors (MACs).

Both of these communications – the Medicaid Financial Management Group Memorandum and Transmittal 12193 – provide a breakdown of the labor and non-labor portion of the rates for use when applying the wage index  and include information on rates that will be applicable for those hospices that failed to meet the quality reporting requirements applicable to FY2024.  

Effective beginning with FY2024, section 1814(i)(5)(A)(i) of the Social Security Act was amended by the Consolidated Appropriations Act of 2021 (CAA) to increase the payment reduction for Medicare hospices who fail to meet hospice quality measure reporting requirements from 2 percentage points to 4 percentage points. Medicaid minimum rates would be reduced by the amount of any penalty due to non-reporting provided a state has chosen to implement this optional Medicaid hospice rate reduction for lack of quality reporting and imposition of the penalty as well as the penalty percentage has been specified in the Medicaid state plan.

The TABLE below contains a comparison drawn from these two documents of the FY2023 Medicare and Medicaid rates. The labor portion of these rates must be further adjusted by the wage index. It should be noted that CMS will continue to follow a policy put into effect beginning with FY2023 under which reductions in wage index values from one year to the next will be limited to a drop of 5 percent. The table below contains the new labor shares for the daily payment rates.

The hospice Aggregate Cap for the year ending September 30, 2024, is $34,494.01.

FY 2024 Medicare Hospice Payment Rates under MEDICARE and MEDICAID*

 

Description

 

Revised Labor Share

FY2024 MEDICARE Rate

FY2024 MEDICAID Payment Rate

Routine Home Care (Days 1-60)

  66%

  $218.33

  $218.61

Routine Home Care (Days 61+)

  66%

  $172.35

  $172.57

Continuous Home Care Full Rate = 24 hours

  75.2%

  $1565.46 ($65.23/hr)

  $1,566.07 ($65.25 hourly rate)

Inpatient Respite Care

  61%

  $507.71

  $534.43

General Inpatient Care

  63.5%

  $1,145.31

  $1,145.31  

 

Invitation to Participate in ‘Patients’ Right to Know” Act Stakeholder Process (re: HB23-1218)

Colorado Department of Public Health and Environment (CDPHE)

You are invited to participate in the stakeholder process regarding the “Patients’ Right to Know” Act, or HB23-1218, a law passed by the Colorado Legislature in the 2023 session. This new law requires hospitals, rehabilitation hospitals, freestanding emergency departments, and licensed community clinics to make publicly available a list of the health care services which are generally available or subject to significant restriction specifically relating to health care in three areas:

  • Reproductive health-care services;
  • LGBTQ health-care services; and
  • End-of-life health-care services.

In response to the new law the Division will develop, in collaboration with stakeholders, a “Service Availability Form.” Once the form itself is developed, the Division will work to establish rules which bring the law into the pertinent health facility licensing chapters. Once the form is finalized and published, the affected health facilities will be required to provide this form to patients, members of the public, and the Department for public display. For more information, please see the whitepaper here

Our first monthly meeting will be Tuesday, September 26th, 2023, from 12:30 pm to 3:30 pm, and on the fourth Tuesday of the month thereafter until the process concludes in spring 2024.

Notice will be emailed directly to all individuals who sign up to receive such messages. Please sign up here. Please feel free to share this link with other interested parties.

All who are interested are welcome to attend and participate. Meeting documents, including agendas, proposed rule language, presentations, etc., will be posted to the public meeting drive no later than a week before each meeting. 

You are receiving this email because you signed up to the interested parties list for this project. If you wish to no longer receive these emails, please reply to this email with that request.

If you have any questions or comments prior to the meeting, feel free to contact myself, Ash Jackson at [email protected], or Alexandra Haas, at [email protected].

Best Regards,

Ash Jackson, Policy Advisor
Policy & Regulation Services
CDPHE

 

Who Should Get a COVID Vaccine This Year?

Reuters | By Michael Erman

(Reuters) - The U.S. drug regulator authorized updated COVID-19 vaccines from Pfizer and its partner BioNTech as well as from Moderna on Monday as the country prepares to start an autumn vaccination campaign as soon as this week. A third vaccine from Novavax remains under review.

The U.S. Food and Drug Administration approved the shots for those aged 12 and above, and authorized them for emergency use in children aged 6 months through 11 years. Advisers to the U.S. Centers for Disease Control and Prevention are set to meet on Tuesday to discuss recommendations on who should get the vaccines this year. CDC Director Mandy Cohen said last month she expects the shots to be given annually, but not all doctors agree everyone needs them each year.

How is this year's vaccine different from last year?

Pfizer with BioNTech, Moderna and Novavax all have created new versions of their COVID-19 vaccines. Unlike last year's booster shot that included the original strain of the virus and the then-dominant Omicron variant, this year's shot targets only XBB.1.5, the predominant variant through most of 2023.

The companies have said their retooled vaccines have been shown in early testing to work against newer Omicron subvariants now circulating, including the highly mutated BA.2.86.

Should seniors, the immunocompromised and pregnant people get the shot this year?

There is broad consensus among doctors that these groups should receive at least an annual COVID-19 vaccine to protect against the virus because of their elevated risk of severe disease, hospitalization and death. For instance, the British government's vaccine committee said only adults 65 and older and some of these other categories will be offered the shot as they are the most likely to benefit…

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