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Preventing Genetic Testing Fraud: 5 Actions for Health Plans

Healthcare IT Today

The following is a guest article by Erin Rutzler, Vice President of Fraud, Waste, and Abuse at Cotiviti In Delaware, more than 250 Medicare patients underwent unnecessary genetic testing based on telehealth consultations that often lasted less than two minutes— costing Medicare thousands of dollars per patient. In 2021, a U.S.

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Migraine Company Fails to Avoid Own Headache: Jet Medical and Others to Pay $745,000 to Resolve Allegations that Medical Device was not Approved or Cleared before Commercialization

Healthcare Law Today

The government alleged that, between April 2014 and April 2019, Jet Medical introduced devices into interstate commerce that were misbranded under the Federal Food, Drug and Cosmetic Act (FDCA) because Jet Medical did not obtain approval or clearance from the U.S. Food and Drug Administration (FDA) prior to distribution.

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Navigating the Maze of Who Regulates Healthcare Compliance

MedTrainer

Healthcare compliance is the process of following the laws, regulations, and ethical standards that govern the healthcare industry. Department of Health and Human Services focuses on preventing fraud, abuse, and waste in federal healthcare programs. What is Healthcare Compliance?

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Incorporation by Reference Does Not Create a Material Condition of Payment

Hall Render

Defendant pharmaceutical manufacturers applied for and received approval from the FDA to manufacture Gamunex at a facility converted for that purpose. FDA regulations require current Good Manufacturing Practices [cGMP] to be met or the drug shall be deemed adulterated and prohibited from sale. United States ex rel. at *1 & fn.

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Top 5 Legal Issues in Digital Health to Watch for in 2022

Healthcare Law Blog

In the attached article , we highlight some of the key legal considerations that the digital health industry can expect in the coming year from the perspective of: (1) telehealth related laws and regulations, (2) FDA, (3) privacy and cybersecurity, (4) fraud and abuse, and (5) antitrust issues.

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Understanding A FACIS Level 3 Background Check

Verisys

A check of government exclusion lists is essential because many healthcare groups receive financing from federal sources. FDA Disbarment. The goal of healthcare professionals, organizations, and others is to give patients high-quality care while safeguarding them against fraud and abuse. SAM ( including SDN ). Treasury Dept.

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Federal Judge Refuses to Dismiss Florida Compounding Pharmacy’s FCA Suit

Pharmacy Law Blog

The federal judge refused the dismissal on the grounds that the government had sufficiently backed its allegations against both the company and its owner. The government had also adequately backed its allegations that RS knew it had been overpaid but had made no attempt to refund the difference to Tricare, according to the judge.

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