FDA Warns 15 More Companies on CBD
November 26, 2019 | Eric D. Fader | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals
On November 25, the U.S. Food and Drug Administration announced the issuance of warning letters to 15 companies that it says are violating the Federal Food, Drug, and Cosmetic Act by selling cannabidiol (CBD) products. The FDA’s views on the recent CBD marketing frenzy have been no secret, as previously discussed here. The FDA also …
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Class Action Claims Reinstated on “Adulterated” Dietary Supplements
November 25, 2019 | Marc S. Ullman | Cannabis | FDA | Legislation and Public Policy | Litigation | Pharmaceuticals
The 11th Circuit Court of Appeals recently reversed a Florida lower court decision that dismissed class action claims under the Florida Deceptive and Unfair Trade Practices Act, the Illinois Consumer Fraud and Deceptive Business Practices Act, and the New York General Business Law alleging that the defendants defrauded the putative class by selling adulterated dietary …
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Sutter Health to Pay $45 Million for Stark Law Violations
November 22, 2019 | Eric D. Fader | False Claims Act | Fraud and Abuse | Hospitals | Litigation | Medicare and Medicaid
The U.S. Department of Justice (DOJ) announced on November 15 that Sutter Health, a northern California health system, agreed to pay a total of $45.6 million to settle allegations that it violated the Stark Law in submitting claims to Medicare for services. Sacramento Cardiovascular Surgeons Medical Group Inc. (Sac Cardio), whose physicians referred patients to Sutter, also …
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HHS Releases Price Transparency Rules
November 21, 2019 | Eric D. Fader | Hospitals | Legislation and Public Policy | Medicare and Medicaid | Private Insurers
On November 15, the U.S. Department of Health and Human Services (HHS) announced the release of two healthcare price transparency rules. One is a final rule requiring hospitals to make available online all standard charges for items and services, including discounted rates negotiated with third-party payers. The second is a proposed rule that would require …
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Another HIPAA Penalty: $1.6 Million for Breach of ePHI
November 12, 2019 | Ada Kozicz | Cybersecurity | Electronic Health Records | HIPAA | Litigation
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced on November 7 that it imposed a $1.6 million monetary penalty against the Texas Health and Human Services Commission for violations of the HIPAA Privacy and Security Rules. The Commission operates several health and public need facilities and also administers many …
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HHS Releases Updated HIPAA Risk Assessment Tool
November 8, 2019 | Eric D. Fader | Cybersecurity | Electronic Health Records | HIPAA
The U.S. Department of Health and Human Services (HHS) recently released a new version of its security risk assessment (SRA) tool that helps smaller healthcare providers conduct and document risk assessments, as required by the HIPAA Security Rule. The update incorporates new features to make the tool more user-friendly. The SRA tool, available on HHS’s …
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NY Hospital Pays $3 Million HIPAA Settlement
November 6, 2019 | Eric D. Fader | Electronic Health Records | HIPAA | Hospitals | Litigation
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced on November 5 that the University of Rochester Medical Center (URMC) agreed to pay $3 million to settle violations of the HIPAA Privacy and Security Rules. URMC is one of the largest health systems in New York State, with more than …
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Primary Care Payment Model Delayed to 2021
November 4, 2019 | Eric D. Fader | Hospitals | Legislation and Public Policy | Medicare and Medicaid | Private Insurers
The Center for Medicare & Medicaid Innovation, part of the Centers for Medicare & Medicaid Services, recently released its Request for Applications for the new “Primary Care First” payment model. The program will now begin in 2021 rather than the 2020 start date that was originally proposed in April, as discussed here. CMS said it …
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