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Moderna’s U.K. Vaccine Patent Pledge Cut Short by Boilerplate

Bill of Health

Contreras On July 2, 2024, the High Court of the United Kingdom issued a decision in Moderna’s mRNA vaccine patent litigation against Pfizer and BioNTech. As I previously discussed in October of 2020, Moderna pledged not to enforce its patents against makers of COVID-19 vaccines during the pandemic. By Jorge L.

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Nursing Home Update: CMS Unwinds Vaccine Mandate and More Regulations as Public Health Emergency End Nears

Hall Render

In May 2021, CMS issued an interim final rule that required SNFs to educate staff and residents on the risks and benefits of COVID vaccination and to offer or assist in accessing COVID vaccination for staff and residents. COVID Staff Vaccine. COVID SNF Notification Requirements.

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Weekly Roundup – September 21, 2024

Healthcare IT Today

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. Read more… FDA FHIR Pilot Automates Adverse Events Reporting and Validation.

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November 2023 Regulatory Compliance Updates

Verisys

AL BOP Rule Updates California: Beginning August 1, 2024, all California dispensers of controlled substances will be required to report dispensations to the Controlled Substance Utilization Review and Evaluation System (CURES) using version 4.2B Practice agreements will no longer be valid on January 1, 2024.

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FTC Approves Final Rule Banning Nearly All Non-Competes

Hall Render

On April 23, 2024, the Federal Trade Commission (“FTC”) voted 3-2 along party lines to adopt a final rule (the “Final Rule”) banning most companies from entering into or enforcing non-compete clauses. On April 24, 2024, one day after publication, business groups led by the U.S. What Happens Next?

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Weekly HCRE Briefing: Rural Hospitals Improve Margins Through M&A | Concord, MA Seeks to Implement PILOT on Non-Profit Hospitals

Hall Render

Large outpatient investments in 2024 included over $1B by HCA, $760M by Jefferson Health and $500M by Tenet. CMS released significant revisions to its nursing home surveyor guidance, including requirements for COVID-19 vaccine education, opioid and psychotropic prescribing and medical director responsibilities.

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Nursing Home Update: CMS Confirms Acute Respiratory Illness Reporting Requirements

Hall Render

The Final Rule was published on November 7, 2024, with an effective date of January 1, 2025. NHSN Module Is Updated The NHSN Long-Term Care Facility COVID-19 Module is available and has been updated to include the new data elements that LTC Facilities must report.