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Hospitals Failing To Meet New COVID-19 Data Reporting Mandate To Get Warning Letters : Shots

The federal government is starting to enforce new COVID-19 data reporting requirements for hospitals.

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Studio 642/Getty Images/Tetra images RF

The federal government is starting to enforce new COVID-19 data reporting requirements for hospitals.

Studio 642/Getty Images/Tetra images RF

The federal government is starting to crack down on the nation’s hospitals for not reporting complete COVID-19 data into a federal data collection system.

The enforcement timeline starts Wednesday, said Seema Verma, administrator for the Centers for Medicare and Medicaid Services, in a call with reporters Tuesday. CMS issued a rule in early September requiring hospitals to report full, daily COVID-19 data to the federal government, including such information as the number of patients and ventilators they have. On Wednesday, CMS is sending letters to hospitals across America alerting many that they have not been in compliance.

Later this month, the department of Health and Human Services will also start posting a list of hospitals noting whether they are out of compliance.

The consequences are potentially severe. After multiple notifications, hospitals are subject to “termination from both Medicare and Medicaid, meaning the hospital would not receive reimbursement from these programs,” Verma says. This would be a major loss of funding and could go into effect as early as mid-December.

The warning letters are the latest in a string of actions, over several months, designed to get hospitals to provide more daily COVID-19 data to the federal government. Getting more complete COVID-19 data has been a mission of Dr. Deborah Birx, a lead on the White House Coronavirus Task Force.

Daily hospital admission data is being used “to understand where this epidemic is, how it’s moving through different populations and ensuring that we’re meeting the needs of specific hospitals and communities,” Dr. Birx said on the call. “In order to make that data useful, it also has to be timely, complete and valid.”

Hospitals have struggled with the reporting requests, which increased in July and became mandatory in September, and have added to their administrative burdens in the midst of a pandemic. Hospitals have been asked, cajoled and are now being forced to provide that data on a daily basis. The industry is very concerned.

“Tying data reporting to participation in the Medicare program remains an overly heavy-handed approach that could jeopardize access to hospital care for all Americans,” said Rick Pollack, head of the American Hospital Association, in a statement.

The hospital data reporting system drew controversy in mid-July, when the Department of Health and Human Services instructed hospitals to stop reporting data to the CDC, which had been collecting the data — reported voluntarily by hospitals — through a system many had used for decades. Instead, hospitals were told to report to a newer system directly managed by HHS, which oversees the CDC, raising concerns among politicians and public health experts of political interference in public health surveillance.

Hospitals were initially incentivized to report into the newer system by a threat that

Enhancing Patient Care: European Experts Meet on the Margins of GC64 to Strengthen Safety and Quality in Radiation Medicine

The virtual side-event benefitted from the attendance of more than 140 counterparts, experts and stakeholders in the region. (Photo: O. Yusuf/IAEA)

Identifying and Addressing Gaps

“General Safety Requirement Part 3 provides a solid basis for the Member States to develop their national legislation for radiation protection in medicine. However, its successful implementation related to medical exposure—including the exposure of patients, carers, comforters and volunteers in biomedical research — is a significant challenge,” said Dean Zontar, an Inspector-Councillor at the Slovenian Radiation Protection administration.

Zontar also delivered a presentation on behalf of a group of experts who evaluated current adherence to the IAEA’s Safety Standards for radiation protection in medical exposure. Using the IAEA Radiation Safety Information Management System (RASIMS) and other relevant information, he demonstrated how and where progress had been achieved by Member States in Europe and Central Asia receiving TC support, and underscored the challenges which persist.

“Although the Europe region is seen as having good radiation protection and safety regulatory systems, there are still many gaps in both regulatory requirements and in their implementation in practice,” Zontar said. “In many countries there is an apparent lack of understanding of the specifics of regulating medical exposure, and further support to improve understanding is needed,” he added.

To provide this kind of support, the IAEA routinely develops, disseminates and delivers training and expert guidance to countries around the world to support the work of the regulatory bodies, medical radiation facilities  and healthcare staff involved in the diagnostic and therapeutic use of ionizing radiation.

“Cooperation between stakeholders such as regulatory authorities, health authorities and medical professional bodies is essential and should be improved,” said Jenia Vassileva, an IAEA Radiation Protection Specialist who addressed the side-event participants, explaining the Agency’s role in strengthening patient protection regimes. “The TC Europe region will be the first to benefit from comprehensive advisory missions to Member States to support their full adherence to the IAEA safety standards for medical exposure.”

Quality assurance is an important component of IAEA support in the field of medical imaging. Virginia Tsapaki, an IAEA Medical Physicist specializing in diagnostic radiology, underscored this association between quality and imaging in her subsequent presentation.

 “Quality assurance and dosimetry is critical in medical imaging. A mistake, misuse or malfunction of an X-ray machine can affect the diagnosis of the patient,” explained Tsapaki. “X-ray systems must be closely monitored using established quality assurance programmes and the use of machines should be tailored to each individual patient’s needs.”

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