RECENT HEALTH LAW NEWS


Diabetes Pill Marketers Settle FTC Complaint
December 14, 2018 | Steven Shapiro | Fraud and Abuse | Litigation | Pharmaceuticals
On December 4, the Federal Trade Commission (FTC) announced the settlement of a complaint against Nobetes Corporation, which marketed and sold a pill that supposedly treats diabetes. The FTC complaint had alleged that the company made false or unsubstantiated health claims, engaged in illegal billing practices, and used deceptive endorsements in the marketing and sale …
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DOJ Files Amicus Brief Declaring Intention to Dismiss FCA Case
December 12, 2018 | Geoffrey R. Kaiser | False Claims Act | Fraud and Abuse | Legislation and Public Policy | Litigation | Pharmaceuticals
On November 30, the U.S. Department of Justice (DOJ) filed an amicus curiae brief urging the U.S. Supreme Court to deny a petition for a writ of certiorari filed by Gilead Sciences, Inc. from a Ninth Circuit Court of Appeals decision which had revived a declined False Claims Act (FCA) lawsuit brought by two former …
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Overlooked BAA Costly for Florida Group
December 11, 2018 | Margarita Christoforou | Cybersecurity | Electronic Health Records | HIPAA
Advanced Care Hospitalists, PL (ACH), a Florida physician group, has learned that failing to enter into a proper business associate agreement (BAA) with a vendor can be a very costly mistake. As a result of that failure, ACH has paid a penalty of $500,000 to the U.S. Department of Health and Human Services’ Office for …
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OMIG Issues Changes to December 2018 Certification
December 10, 2018 | Ashley S. Osadon | Fraud and Abuse | Medicare and Medicaid
The New York State Office of the Medicaid Inspector General (OMIG) has issued updates to its certification process for applicable Medicaid and Managed Medicaid providers, which may have a significant impact on providers who are required to certify by December 31, 2018. OMIG has expanded its certification to adopt five separate categories listed on the …
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DOJ Revisits the Yates Memo
December 5, 2018 | Geoffrey R. Kaiser | Fraud and Abuse | Legislation and Public Policy | Litigation
In remarks delivered on November 29 at the American Conference Institute’s 35th International Conference on the Foreign Corrupt Practices Act, Deputy Attorney General Rod J. Rosenstein announced that the U.S. Department of Justice (DOJ) had revised its policy concerning individual accountability in corporate cases. That policy, previously set forth in a September 2015 memorandum issued by …
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Florida Physicians Group Exposed 9,000 Patients’ Data to Web
December 5, 2018 | Rivkin Rounds Staff | Cybersecurity | Electronic Health Records | HIPAA
A December 4 article in Bloomberg Law’s Health Law & Business, “Florida Physicians Group Exposed 9,000 Patients’ Data to Web,” discussed a $500,000 HIPAA settlement entered into by Advanced Care Hospitalists (ACH), a Florida physician group, with the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR). Rivkin Radler’s Eric Fader was quoted …
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Think HIPAA When Talking to Reporters: A Case Example
December 3, 2018 | Cassandra Rivais | Carol A. Hyde | HIPAA | Litigation
Allergy Associates of Hartford, P.C. has agreed to pay $125,000 to the Office for Civil Rights as a settlement for HIPAA violations. The physician practice has also agreed to implement a two-year corrective action plan to monitor its HIPAA compliance. The Resolution Agreement is available on the U.S. Department of Health & Human Services’ website. …
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FDA Reviews Clinical Research Approval Process
November 28, 2018 | Cassandra Rivais | Legislation and Public Policy | Pharmaceuticals
The U.S. Food & Drug Administration (FDA) has contracted with Eastern Research Group, Inc. (ERG) to review the FDA’s investigational new drug (IND) approval process. The IND phase of drug development is when human trials of new drugs are conducted. The FDA receives 4,000 IND requests a year. In order for a new drug to …
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Allergy Practice Discloses Patient Info to Reporter, Pays $125,000
November 27, 2018 | Rivkin Rounds Staff | HIPAA | Litigation
An article in Bloomberg Law’s Health Law & Business, “Allergy Practice Discloses Patient Info to Reporter, Pays $125,000,” discussed a recent HIPAA settlement arising out of a physician’s disclosure of a patient’s protected health information (PHI) to a television reporter. Rivkin Radler’s Eric Fader was quoted in the article. The settlement was announced on November 26 …
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CMS Finalizes Reimbursement for New Virtual Services
November 21, 2018 | Eric D. Fader | Legislation and Public Policy | Medicare and Medicaid | Telehealth
The final 2019 Medicare Physician Fee Schedule released on November 1, 2018 by the Centers for Medicare & Medicaid Services (CMS) includes a section entitled “Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services.” Effective January 1, 2019, physicians may be reimbursed for certain virtual interactions with patients using several new billing codes. One new …
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