FDA will review fewer COVID-19 test EUA submissions

The FDA has granted emergency use authorization for more than 430 COVID-19 tests. [Photo courtesy of Mayo Clinic]

The FDA is pushing COVID-19 test developers away from emergency use authorization (EUA) submissions in favor of more traditional pathways, the agency said today.

The FDA said it intends to review “only a small subset” of new EUA submissions, encouraging test makers to seek regulatory approval through de novo classification or 510(k) clearance pre-market review pathways.

The policy update comes a week after the U.S. Department of Health and Human Services Office of Inspector General released a study that found the FDA’s EUA process authorized problematic tests and frustrated diagnostics developers.

The FDA’s “calculated decisions to increase availability of COVID-19 testing … often came at a potential cost to test quality,” the report said. R…

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U.S. government earmarks $1.6 billion to battle opioid crisis and overdose epidemic

[Photo by Karolina Grabowska from Pexels]

The U.S. Department of Health and Human Services (HHS) has awarded more than $1.6 billion as a part of an initiative to battle the drug overdose epidemic.

SAMHSA’s State Opioid Response (SOR), Tribal Opioid Response (TOR) grant programs and Health Resources and Services Administration (HRSA)’s rural communities opioid response programs will lead the new initiative.

The government plan will expand access to the opioid mu receptor antagonist naloxone, and improve access to opioid treatment programs. It also includes provisions to reduce abuse of stimulants such as cocaine and methamphetamine that contribute to the overdose epidemic.

The government initiative will also provide funding for law enforcement in high-intensity drug trafficking areas.

Drug-involved overdose deaths have surged in recent years, according to federal statistics.

In 2020…

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How safe is health information after the overturning of Roe?

[Image from Unsplash]

The U.S. Department of Health and Human Services today issued guidance meant to better protect women’s health information as state abortion bans kick in after the U.S. Supreme Court’s overturning of Roe v. Wade.

Despite the HHS actions, women may still wonder whether their health information is entirely safe going forward — a potential challenge for the creators of digital health software.

The new HHS Office for Civil Rights (OCR) guidance addresses when the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule permits disclosure of PHI without an individual’s authorization. Its release comes amid calls on social media for women to delete period tracking apps. (The New York Times, however, reports that the opposite is happening, with a Berlin-based period-tracking app company called Clue saying it would not comply with U.S. law enforcement seeking info…

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HHS reports 63-fold increase in telehealth use during pandemic

Photo by National Cancer Institute on Unsplash

A new study from the U.S. Department of Health and Human Services found a 63-fold increase in Medicare telehealth use during the COVID-19 pandemic.

The report analyzed Medicare fee-for-service data from 2019 and 2020 and highlighted that people in urban areas were more likely to seek and use telehealth services than rural residents. In addition, the report found that Medicare beneficiaries who were Black were less likely than white beneficiaries to use telehealth.

Get the full story on our sister site, Medical Design & Outsourcing.

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HHS reports 63-fold increase in telehealth use during pandemic

Photo by National Cancer Institute on Unsplash

A new study from the U.S. Department of Health and Human Services found that there was a 63-fold increase in Medicare telehealth use during the COVID-19 pandemic.

The report analyzed Medicare fee-for-service data frmo 2019 and 2020 and highlighted that telehealth services were more sought after and accessed more in urban areas and rural communities. The report also showed that Black Medicare beneficiaries were less likely than white beneficiaries to use telehealth.

“This report provides valuable insights into telehealth usage during the pandemic,” Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure said in a news release. “CMS will use these insights – along with input from people with Medicare and providers across the country – to inform further Medicare telehealth policies.”

Specialists like behavioral health provider…

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House committee investigates $70M federal contract for AutoMedx ventilators

The AutoMedx SAVe II+ ventilator (Image from AutoMedx)

A Congressional committee has launched an investigation into a $70 million White House contract for ventilators that reportedly are inadequate to treat people with COVID-19.

The Department of Defense signed a $16.2 million contract in spring 2020 to buy SAVe II ventilators, manufactured by AutoMedx (Addison, Tex.), from the supplier Combat Medical Systems, according to the House Committee on Oversight and Reform. Soon after this contract was signed, officials at the Department of Health and Human Services (HHS) reportedly concluded that the SAVe II ventilator model was inadequate to treat coronavirus patients, a news release from the committee says.

Get the full story on our sister site, Medical Design & Outsourcing.

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7 core strategies in Biden’s battle against COVID-19

[Photo by Fusion Medical Animation on Unsplash]

Included in President Joe Biden’s sprawling strategy document for dealing with the COVID-19 pandemic are an array of plans intended to ramp up vaccination efforts.

Also included are proposals for accelerating the development of therapies such as antiviral compounds effective against SARS-CoV-2 and other coronaviruses with pandemic potential.

The “full-scale, wartime” plans have considerable relevance for the pharmaceutical and medical device industries. (More information is available on the medical-device ramifications of the plan from our sister site, Medical Design & Outsourcing.)

While the plan stands out from the prior administration’s COVID-19 response in its detail and earnestness, several portions effectively represent a continuation of existing policy. The policy, for instance, says it will end the U.S. government’s practice of stockpil…

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U.S. government stockpile of COVID-19 vaccines already drained

Pfizer-BioNTech vaccine image courtesy of Wikipedia

Last week, President-elect Joe Biden vowed to release COVID-19 vaccine doses from a government stockpile. 

On Jan. 13, the U.S. Department of Health and Human Services (HHS) echoed that sentiment, stating it would “no longer stockpile millions of COVID-19 vaccine doses held to ensure Americans receive their second shot,” according to a brief notice. 

But federal officials had already drained vaccine reserves before the HHS vowed to open up a vaccine stockpile, according to state officials who had been expecting more doses.

Local government officials expecting vaccine supplies to roughly double starting next week are now forced to contend with the status quo. 

Critics of Operation Warp Speed, a public-private partnership established by the Trump administration to support COVID-19 vaccine distribution, have been frustrated with the speed …

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CMS agrees to cover ‘breakthrough’ medical devices

Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning.

Once the Medicare Coverage of Innovative Technology (MCIT) final rule goes into effect, national Medicare coverage will begin on the date of a breakthrough device’s FDA market authorization would begin and continue for 4 years.

The proposed rule, scheduled to be published September 1 in the Federal Register, has been under discussion for years and would remedy a nationwide patchwork of Medicare coverage for such devices. Currently, a breakthrough device may be covered in one state or area of a state and not another, depending upon a local coverage determination made by a Medicare administrative contractor.

The MCIT pathway would be voluntary and device manufacturers would notify the Centers for Medicare and Medicaid Services if they want to use this coverage option.

“This coverage pathway d…

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BREAKING: U.S. to reportedly pay Abbott $750M for new COVID-19 tests

Multiple reports have said President Trump will announce a $750 million deal with Abbott (NYSE:ABT) for 150 million of its rapid COVID-19 antigen tests.

As first reported by Politico before being confirmed by other outlets, a White House official said that Trump will announce the deal tonight, using his speech at the Republican National Convention to confirm the news.

The U.S. Department of Health and Human Services confirmed the reports in a news release late Thursday. Trump spoke for more than an hour at the RNC but did not make an announcement related to the deal with Abbott.

“This is a major development that will help our country to remain open, get Americans back to work, and kids back to school,” White House communications director Alyssa Farah said in a statement to CNBC. “The Trump Administration is proud to partner with Abbott Labs to make this purchase possible to help the American people.”

“The introduction of Abbott’s antigen test is a…

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Labor unions, environmental groups demand federal action on PPE

(Photo by SJ Objio on Unsplash)

A group of labor unions and environmental organizations is petitioning the Trump Administration to mandate production of personal protective equipment (PPE) using the Defense Production Act.

The petition, submitted Aug. 11 to the U.S. departments of Health and Human Services and Homeland Security, dovetails with the FDA’s issuance on Monday of its first list of PPE shortages, which includes surgical gowns, gloves, testing supplies and ventilation-related products for the sickest patients. PPE shortages have plagued the U.S. since the COVID-19 pandemic spread to this country.

Get the full story on our sister site, Medical Design & Outsourcing.

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HHS puts $6.5M more toward COVID-19 testing

The U.S. Department of Health and Human Services (HHS) said today it will provide a total of $6.5 million to help two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional diagnostic tests for COVID-19 per month.

The investments in Aegis Sciences (Nashville, Tenn.) and in Sonic Healthcare USA (Austin, Texas) will provide laboratory equipment supplied by Beckman Coulter and Thermo Fisher Scientific (NYSE:TMO) and increase staffing and infrastructure to boost testing nationwide by an  additional 1 million tests each week by early October, according to the agency.

Aegis will add laboratory staff and begin construction on new lab space at its Nashville testing facilities to meet its goal of processing more than 60,000 test samples per day beginning in September. Aegis has agreed to partner with the Office of the Assistant Secretary for Health to perform testing of samples from select locations with vulnerable populations, accor…

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