RECENT HEALTH LAW NEWS


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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Insys Settles Kickback Case, Files for Bankruptcy
June 12, 2019 | Eric D. Fader | False Claims Act | Fraud and Abuse | Litigation | Pharmaceuticals

The U.S. Department of Justice announced on June 5 that Arizona-based opioid manufacturer Insys Therapeutics agreed to pay $225 million to settle civil and criminal kickback charges. Last month, Insys’s founder and former CEO John Kapoor was found guilty on federal racketeering charges arising out of a bribery scheme that rewarded the company’s sales managers

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CMS Issues RFI to Reduce Paperwork
June 11, 2019 | Electronic Health Records | Legislation and Public Policy | Medicare and Medicaid | Nursing Homes

On June 6, the Center for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) regarding its Patients over Paperwork Initiative. CMS is seeking public input on ways to reduce administrative and regulatory burdens on healthcare providers, with an overall goal of reducing healthcare costs and increasing the time providers spend with their

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Medical Practitioners Call for Change to Massachusetts Marijuana Regulations
June 10, 2019 | Behavioral Health | Cannabis | Hospitals | Legislation and Public Policy

More than 40 physicians, clinicians and researchers from Harvard Medical School, Massachusetts General Hospital and other institutions issued a 16-page Statement of Concern to Massachusetts lawmakers requesting that the Commonwealth’s Cannabis Control Commission suspend processing new business licenses and conduct a public health assessment of its “Social Equity Program.” These practitioners are criticizing the inadequacy

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Supreme Court Sides with Hospitals on Change in Medicare DSH Payments
June 6, 2019 | Margarita Christoforou | Hospitals | Legislation and Public Policy | Litigation | Medicare and Medicaid

In a 7-1 decision, the U.S. Supreme Court ruled on June 3 that the Department of Health and Human Services (HHS) may not adjust the rates it pays hospitals for serving low-income patients without first giving them an opportunity to comment on the changes. The Medicare Act requires public notice and a 60-day comment period

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CMS Issues Final Rule to Improve PACE Program for Frail and Elderly
June 5, 2019 | Ada Janocinska | Employer/Employee | Home Health | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals

On May 28, the Centers for Medicare and Medicaid Services (CMS) issued a final rule to improve and modernize the Programs of All-Inclusive Care for the Elderly (PACE). The rule is the first major change to the program since 2006. CMS expects that the changes will help incorporate current best practices in the care rendered

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Rivkin Radler Lawyers Edit HIPAA Chapter of Treatise
May 30, 2019 | Rivkin Rounds Staff | Cybersecurity | Electronic Health Records | HIPAA | Legislation and Public Policy

Rivkin Radler’s Eric Fader and Margarita Christoforou edited the “Health Care Privacy and the Health Insurance Portability and Accountability Act of 1996” chapter in the June 2019 edition of the Thomson Reuters Data Security and Privacy Law treatise. Eric has edited this chapter of the treatise since its 2014 edition.

New material in this year’s

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Data Breach Leads to $1 Million in Settlements for IN Company
May 28, 2019 | Eric D. Fader | Cybersecurity | Electronic Health Records | HIPAA | Litigation

The U.S. Department of Health and Human Services (HHS) announced on May 23 that Medical Informatics Engineering, Incorporated (MIE), an Indiana-based online electronic health records company, had agreed to pay HHS’s Office for Civil Rights (OCR) $100,000 to settle HIPAA violations. MIE’s April 23 Resolution Agreement with HHS also provided for the company to enter

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