Pharmaceuticals


Kaiser to Present at PLI Life Sciences Program
September 17, 2019 | Rivkin Rounds Staff | Cybersecurity | Electronic Health Records | FDA | False Claims Act | Fraud and Abuse | Legislation and Public Policy | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Private Insurers
On October 10, Rivkin Radler’s Jeff Kaiser will be a panelist at the Practising Law Institute (PLI) program, “Life Sciences 2019: Navigating Legal Challenges in the Drug and Device Industries.” Jeff will speak on “Enforcement Trends Impacting the Drug and Device Industries,” including developments under the False Claims Act, federal Anti-Kickback Statute, off-label promotion, and …
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CVS Announces Home Dialysis Machine Trials
July 22, 2019 | Eric D. Fader | FDA | Home Health | Medical Devices and Wearables | Pharmaceuticals | Private Insurers
On July 17, CVS Health Corp. announced the beginning of human trials of a new home dialysis machine called the HemoCare Hemodialysis System. The company’s CVS Kidney Care unit hopes to shift some of the $35 billion market for end-stage kidney care from outpatient dialysis clinics to patients’ homes. The HemoCare device was designed by …
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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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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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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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Pharma Companies Sue to Block Drug Price Disclosure Rule
June 17, 2019 | Eric D. Fader | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals
Three of the largest pharmaceutical companies in the U.S. filed suit on June 14 against the U.S. Department of Health and Human Services (HHS), claiming that HHS doesn’t have the power to compel companies to include list prices of prescription drugs in television advertisements. HHS’s new rule is set to take effect on July 9. …
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