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Updated CMS Guidelines for COVID-19 Tests and Booster Shot

Medisys Compliance

On 4 th April 2022, CMS announced that more than 59 million Americans with Medicare Part B, including those enrolled in a Medicare Advantage plan, now have access to Food and Drug Administration (FDA) approved, authorized, or cleared over-the-counter COVID-19 tests at no cost.

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Coding COVID for Uninsured Patients

AIHC

A separate program, the HRSA COVID-19 Coverage Assistance Fund, is available to reimburse providers for COVID-19 vaccine administration to underinsured individuals whose health plan either does not include COVID-19 vaccination as a covered benefit or covers COVID-19 vaccine administration but with cost-sharing.

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Weekly Roundup – September 21, 2024

Healthcare IT Today

Read more… FDA FHIR Pilot Automates Adverse Events Reporting and Validation. Jay Nakashima at eHealth Exchange detailed how California’s Cedars-Sinai used FHIR to send adverse events related to COVID-19 vaccines to the FDA – a process that replaced manual data entry and faxing.

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SQA Regulatory Surveillance Summary 4 | Monthly Update 2021

SQA

Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021. That’s why the government is implementing a multi-faceted procurement strategy to provide a COVID-19 vaccine to every Canadian who wants one by September.

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Future Trends and Regulatory Challenges in Pharma

Dot Compliance

The race to develop a COVID-19 vaccine highlighted the power of artificial intelligence (AI) and machine learning (ML) as Johnson & Johnson, Moderna and Pfizer employed these technologies to swiftly get their vaccines to market. The next evolution is for companies to implement Industry 4.0 References. References.

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3 Lessons Learned from Pandemic-Era Clinical Development Regulatory Practices

HIT Consultant

Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA. The world has been in urgent need of COVID-19 vaccines, treatments, and diagnostic tools. Food and Drug Administration (FDA), along with greater flexibility around mandates on alternatives to traditional clinical information. About Ronan Brown.

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COVID-19 Vaccines for Children Under 5

American Medical Compliance

Soon, children aged 6 months and older will be eligible to receive one of two FDA approved vaccines: Moderna and Pfizer BioNTech. Starting Friday June 24th, doses will begin shipping and millions of kids will have access to COVID-19 vaccines. Vaccine Availability. Response from Families and Health Officials.