Compliance Update

Pharma-Funded FDA Gets Drugs Out Faster, But Some Work Only ‘Marginally’ and Most Are Pricey

Dr. Steven-Huy Han, a UCLA liver specialist, has prescribed Ocaliva to a handful of patients, although he’s not sure it helps. As advertised, the drug is lowering levels of an enzyme called alkaline phosphatase in their blood, and that should be a sign of healing for their autoimmune disease, called primary biliary cholangitis. But “no one knows for sure,” Han said, whether less enzyme means...

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FDA and Stem Cells: Update

There was a big update in the stem cell industry recently as a California judge issued a favorable order on behalf of a California based stem cell treatment provider. California Stem Cell Treatment Center, Inc., is a California based medical company offering SVF surgical procedures and MSC surgical procedures. A few years ago, the Food and Drug Administration (FDA) sought an injunction against...

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Feds Hot on the Trail of PPP Fraud

On August 19, a Kansas chiropractor was convicted on multiple charges for Paycheck Protection Program (PPP) loan fraud. According to the U.S. Department of Justice, Timothy Dale Warren was charged with four counts of bank fraud, two counts of money laundering, and four counts of false statements. According to court documents, as owner of Titan Medical Center LLC Warren fraudulently obtained PPP...

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No Surprise Act AKA Good Faith Estimates

The Centers for Medicare & Medicaid Services (CMS) effective January 1, 2022 has ramped up the new No Surprise Act (NSA) or often called the “Good Faith Law.” This law shall apply to group health plans, health insurers, health care providers and health care facilities (Providers). The NSA requires health care providers to be proactive and reactive as it relates to providing patients who are...

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Florida Legislature Revises Assistance with Self-Administration of Medications Statute

The Florida Legislature recently revised Section 400.488, F.S which details what constitutes ‘Assistance with Self-Administration of Medications’ (ASAM) as it applies to home care organizations. The definition has expanded the tasks an unlicensed person in a home health setting may perform to assist a patient with the same kinds of self-administration of medication tasks that are allowed in an...

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Florida Doctor Sentenced for Role in Sober Home Fraud

A Florida psychiatrist and medical director of two South Florida addiction treatment facilities was recently sentenced to four-and-a-half years in prison for his role in a fraud scheme in which he billed $112 million for services that were never provided or were medically unnecessary. After a 15-day trial in March, Jose Santiero of Miami Lakes was found guilty of conspiracy to commit healthcare...

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