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Latest Top (4) News

Statement from HHS Chief of Staff Brian Harrison on Efforts to Increase Transparency at HHS

Today, the Department of Health and Human Services (HHS) through a Notice published in the Federal Register announced a policy to enhance transparency at HHS by requiring that all assumptions, working papers, models, and other information used as part of any impact analysis associated with a rule or demonstration project are shared at the time the results of that analysis are publicly disclosed. HHS Chief of Staff Brian Harrison issued the following statement:

“We are providing needed transparency by requiring the Department to show its math so the American people can know and challenge the methods government uses to calculate effects of regulations it imposes on them.”

Frequently Asked Questions on Public Access to Materials Underlying Impact Analyses

*This content is in the process of Section 508 review. If you need immediate assistance accessing this content, please submit a request to digital@hhs.gov.

Tue, 24 Nov 2020 09:00:00 -0500

HHS and DOD Award $11.6 Million Contract to Puritan Medical Products to Boost U.S. Production of Swabs for Cue Health COVID-19 Tests

The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DOD) have jointly awarded an $11.6 million contract to Puritan Medical Products Company, LLC, to expand domestic production capacity of Cue Sample Wands, the nasal swabs used exclusively with the COVID-19 cartridge-based molecular testing system developed and manufactured by Cue Health, Inc. The test generates results in about 20 minutes at the point-of-care (POC).

Awarded November 19, the new contract will allow Puritan Medical to expedite upgrades at its Maine facility and increase production capability of Cue’s nasal swabs to 3 million per month by March 2021. These efforts support the federal government’s procurement of 6 million Cue test kits – which include the Cue Sample Wand as well as Cue COVID-19 Test Cartridges – as part of a $481 million contract awarded to Cue October 13 to increase production to 100,000 test kits per day by March 2021. During the week of November 9, HHS began a pilot distribution of the test kits, shipping 27,000 test kits to five states.

These expansion contracts are just some of the ways that the federal government is addressing the growing demand for testing supplies while also supporting industrial capacity in the U.S. In April 2020, under the Defense Production Act, the federal government awarded a $75.5 million contract to Puritan to increase the company’s capacity to manufacture non-proprietary foam specimen collection swabs – the preferred COVID-19 testing swab – to 20 million swabs per month by July 2020.

To further address capacity restraints, HHS and DOD awarded in July a second expansion contract for $51.51 million for Puritan Medical to establish a new production facility in Maine, increasing production capacity of flock-tip swabs to an additional 45 million swabs per month or more by March 2021. The expansion was funded by the CARES Act to meet demand for the swabs for testing both COVID-19 and the seasonal flu. Puritan Medical is the only U.S.-based manufacturer of flock tip swabs.

Funded by the Health Care Enhancement Act, the new contract was led by the Department of Defense Assisted Acquisition Cell in coordination with the HHS Office of the Assistant Secretary for Health to support domestic industrial base expansion for critical medical resources.

The Cue COVID-19 Test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on June 10, 2020. The test is performed by a health professional under the supervision of an authorized laboratory operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens, and only for the duration of emergency use declaration.

The Cue Health platform was developed and validated with funding from BARDA, starting in 2018 for the development of a molecular influenza test, with the option to expand the effort to include coronaviruses. On March 31, 2020, BARDA announced its $13.6 million collaboration with Cue to accelerate the development, validation and manufacturing of Cue’s COVID-19 test.

To learn more about federal support for the all-of-America COVID-19 response, visit coronavirus.gov.

Mon, 23 Nov 2020 17:15:00 -0500

HHS Allocates Regeneron Therapeutic to Treat Patients With Mild to Moderate COVID-19

The U.S. Department of Health and Human Services today announced plans to allocate initial doses of Regeneron’s investigational monoclonal antibody therapeutic, casirivimab and imdevimab, which received emergency use authorization from the U.S. Food and Drug Administration on November 21, 2020, for treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19 at high risk of hospitalization.

In July, the federal government announced federal funding to support large-scale manufacturing of casirivimab and imdevimab with approximately 300,000 doses of the medicine expected to result from the project. HHS will allocate these government-owned doses to state and territorial health departments which, in turn, will determine which healthcare facilities receive the infusion drug.

“Authorization and distribution of this new Regeneron antibody treatment is another significant step forward in treating patients and bridging us to the rollout of safe and effective vaccines, with all of these efforts made possible by Operation Warp Speed,” said HHS Secretary Alex Azar. “Federal allocation of therapeutics like Regeneron’s, in cooperation with our state and local government partners, will help ensure that they go to the patients who need them the most, just days after the product is authorized.”

“We are committed to the equitable and efficient distribution of resources like casirivimab and imdevimab to help prevent hospitalization from COVID-19 as much as possible,” said HHS Assistant Secretary for Preparedness and Response Robert Kadlec, M.D. “To that end, we are coordinating with Regeneron, its distributor, and state and territorial health departments to get therapeutics into the hands of healthcare providers quickly, with a focus on areas of the country currently hardest hit by the pandemic.”

A data-driven system will ensure continued fair and equitable distribution of these new products. Beginning immediately, weekly allocations to state and territorial health departments will be proportionally based on confirmed COVID-19 cases in each state and territory over the previous seven days, based on data hospitals and state health departments enter into the HHS Protect data collection platform.

“We have worked with state and territory partners to refine the process based on experience with previous therapeutics and diagnostics and now expect that after pulling this weekly data, shipments can be on their way within hours,” Dr. Kadlec added.

The intravenous administration of therapeutics to non-hospitalized patients with confirmed mild to moderate COVID-19 presents unique challenges. To accommodate IV infusions, outpatient facilities must have appropriate healthcare staffing, training and equipment. As such, additional preparation time may be required for some treatment facilities before they can administer the drug to patients.

The infusion process takes approximately one hour and may followed by an observation period. Under the EUA, casirivimab and imdevimab must be administered together and in settings where health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. Facilities also must have space available to administer the medication in a manner that minimizes infection transmission.

Possible locations include hospital outpatient facilities, hospital emergency departments, and alternate care sites set up by hospitals and health departments under the ‘hospital without walls’, flexibility provided by the Centers for Medicare and Medicaid Services to support a surge of hospitalized patients. The government-owned doses will be available at no cost to patients, although healthcare facilities could charge for administering the medicine – as is customary with such government-purchased products. CMS created a billing code for reimbursement of these costs for Medicare patients.

Regeneron developed casirivimab and imdevimab with preclinical and clinical development support through a long-standing flexible agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response. Regeneron used the same proprietary technology platforms and cocktail approach to develop a novel triple antibody treatment for Ebola that is now under regulatory review by the FDA.

Currently, casirivimab and imdevimab is being evaluated in an ongoing clinical trial as part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership led by the National Institutes of Health with funding and other support from the BARDA. ACTIV is part of a coordinated research strategy to prioritize and speed development of the most promising treatments and vaccines.

The medicine is a combination of two virus-neutralizing monoclonal antibodies. Monoclonal antibodies, which mimic the human immune system, are produced outside of the body by a single clone of cells or a cell line with identical antibody molecules and then delivered to patients by injection or infusion. The antibodies bind to certain proteins of a virus, reducing the ability of the virus to infect human cells.

Allocation of casirivimab and imdevimab will be allocated to specific states, territories, and jurisdictions this week and in subsequent weeks. The allocation dashboard will be updated each distribution week. 

The drug is the third COVID-19 therapeutic for which HHS has provided allocation oversight. The first, Veklury (remdesivir), gained FDA approval and is now widely available, and earlier this month HHS began allocation oversight of the second, bamlanivimab from Eli Lilly and Company. Working with the Department of Defense, HHS is partnering with multiple other companies to develop, manufacture and make available therapeutics to treat COVID-19.

About HHS, ASPR, and BARDA:

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 56 BARDA-supported products have achieved FDA approval, licensure or clearance. For more on BARDA’s portfolio for COVID-19 diagnostics, vaccines and treatments and about partnering with BARDA, visit medicalcountermeasures.gov. To learn more about federal support for the all-of-America COVID-19 response, visit coronavirus.gov.

Mon, 23 Nov 2020 14:30:00 -0500

Secretary Azar Statement on Final Rule to Increase Access to Lifesaving Organs

Today, the Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (CMS), is finalizing a rule that is designed to increase the supply of lifesaving organs available for transplant in the United States by requiring that the organizations responsible for organ procurement be transparent in their performance, highlighting the best and worst performers, and requiring them to compete on their ability to successfully facilitate transplants.

HHS Secretary Alex Azar issued the following statement:

“There are few more transformative interventions for someone’s health than an organ transplant, but thousands of Americans are deprived of this lifesaving opportunity every year by a broken system. By making overdue reforms to hold organ procurement organizations accountable, we’re giving thousands of Americans waiting for organ transplants a chance at better, longer, and healthier lives.”

To read Secretary Azar’s remarks on Trump Administration actions in September to support living donations and promote transplants, please visit: https://www.hhs.gov/about/leadership/secretary/speeches/2020-speeches/remarks-press-steps-advance-american-kidney-health.html

For more on the progress on President Trump’s Advancing American Kidney Health initiative, please visit: https://www.hhs.gov/about/news/2020/08/17/hhs-reports-progress-on-president-trumps-advancing-american-kidney-health-initiative.html

For the full press release on the final organ procurement rule, please visit: https://www.cms.gov/newsroom/press-releases/cms-finalizes-policy-will-increase-number-available-lifesavings-organs-holding-organ-procurement

For a fact sheet on the final rule, please visit: https://www.cms.gov/newsroom/fact-sheets/organ-procurement-organization-opo-conditions-coverage-final-rule-revisions-outcome-measures-opos

To view the final rule, please visit: https://www.cms.gov/files/document/112020-opo-final-rule-cms-3380-f.pdf

Fri, 20 Nov 2020 19:30:00 -0500