FDA Warns on CBD Dietary Supplements
July 17, 2019 | Marc S. Ullman | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals
In a July 9 Warning Letter to Ceba-Tek, Inc. focused mainly on issues relating to failure to comply with regulations on Good Manufacturing Practices for Dietary Supplements, the U.S. Food and Drug Administration (FDA) again commented on the issues confronting companies producing and marketing CBD as an ingestible: “It is a prohibited act to introduce …
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OCR Releases New HIPAA FAQs on Care Coordination
July 16, 2019 | Ada Kozicz | HIPAA | Legislation and Public Policy | Private Insurers
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently issued new guidance on its HIPAA FAQs webpage regarding permissible use and disclosures of protected health information (PHI) by health plans for purposes of care coordination and continuity of care. Health plans are covered entities under HIPAA. The guidance explains that, …
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States Pick Up ACA Slack
July 12, 2019 | Eric D. Fader | Affordable Care Act | Legislation and Public Policy | Private Insurers
With the political battle over the future of the Affordable Care Act (ACA) dragging on in Washington, a number of states have recently taken steps to protect their residents from potential instability in the health insurance market. New Jersey is setting up its own state health insurance exchange to replace the federally run marketplace, …
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Anesthesiologist Charged with Telemedicine Fraud
July 11, 2019 | Eric D. Fader | Fraud and Abuse | Litigation | Medicare and Medicaid | Pharmaceuticals | Telehealth
A New York anesthesiologist was indicted on July 9 for conspiring with pharmacies and medical equipment suppliers to defraud the Medicare program and other insurers. Anna Steiner, also known as Hanna Wasielewska, allegedly wrote prescriptions for drugs and durable medical equipment for patients supposedly seen via telemedicine without ever having actually examined or evaluated the …
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Drug Price Disclosure Rule Vacated
July 10, 2019 | Eric D. Fader | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals
A new federal regulation that would have required companies to disclose wholesale prices of prescription drugs in television advertisements was rejected by a federal court on July 8, one day before the rule would have taken effect. Amgen Inc., Eli Lilly & Co. and Merck & Co. Inc. had filed suit challenging the rule, claiming …
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Pharma Ads Target Smartphone Users in Waiting Rooms
July 9, 2019 | Eric D. Fader | HIPAA | Hospitals | Pharmaceuticals
FiercePharma reports that patients in doctor’s office waiting rooms who use the office Wi-Fi network may now receive targeted pharmaceutical ads on their smartphones. Semcasting, Inc., a Massachusetts-based data provider, uses a technology called Smart Zones that can deliver messages to the entire audience at a business’s IP address. The digital ad delivery is far …
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Proposed Stark Law Revisions Expected Soon
June 28, 2019 | Eric D. Fader | Fraud and Abuse | Legislation and Public Policy | Medicare and Medicaid
The Centers for Medicare & Medicaid Services (CMS) expects to release proposed revisions to the federal physician self-referral prohibition (Stark Law) before Labor Day, according to Kim Brandt, CMS’s principal deputy administrator for operations. Brandt was speaking at an industry conference. Potential Stark Law changes were recently discussed here. CMS had requested input from the …
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NY AG Enforces Pharmacy Drug Price Disclosure Law
June 26, 2019 | Eric D. Fader | Legislation and Public Policy | Pharmaceuticals
New York State Attorney General Letitia James announced on June 13 that her office had sent cease-and-desist letters to 44 pharmacies that violated the law requiring them to maintain drug retail price lists. State law requires each pharmacy to maintain a list of prices for the 150 most commonly prescribed drugs, update the list at …
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FDA in Fact-Finding Mode on CBD
June 20, 2019 | Eric D. Fader | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals
The U.S. Food and Drug Administration (FDA) released a Consumer Update regarding cannabidiol (CBD) on June 14. Observing that CBD “seems to be available almost everywhere,” the FDA noted that the science, safety, and quality of CBD-containing products are unproven and said that it is working to learn more about the safety of CBD. Unapproved …
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Physician Jailed for Prescribing Drugs to Non-Patients
June 18, 2019 | Margarita Christoforou | Fraud and Abuse | Litigation | Pharmaceuticals
A physician who operated weight-loss clinics in Georgia is facing 33 months in prison after pleading guilty to Conspiracy to Unlawfully Dispense Controlled Substances (Oxycodone), according to a June 13 press release issued by the U.S. Department of Justice. Dr. Johnny Di Blasi was arrested at Miami International Airport as he was attempting to flee …
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