Legislation and Public Policy


New Rule Requires Drug Price Disclosure in TV Ads
May 15, 2019 | Eric D. Fader | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals
On May 8, the U.S. Department of Health and Human Services announced a final rule from the Centers for Medicare & Medicaid Services requiring pharmaceutical companies to disclose the list prices of prescription drugs in television advertisements. The rule will apply to all drugs covered by Medicare or Medicaid that cost at least $35 per …
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DOJ Issues New FCA Guidance on Cooperation Credit
May 8, 2019 | Geoffrey R. Kaiser | False Claims Act | Fraud and Abuse | Legislation and Public Policy | Litigation
On May 7, the U.S. Department of Justice (DOJ) introduced important new guidance for government attorneys explaining how DOJ will award credit to defendants who cooperate during a False Claims Act (FCA) investigation through voluntary self-disclosure, remediation (e.g., disciplining wrongdoers or others who failed in oversight, or implementing or improving an effective compliance program) and/or …
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NYS Reaffirms Support for No-Fault Fraud Law
May 6, 2019 | Rivkin Rounds Staff | Fraud and Abuse | Legislation and Public Policy | Litigation | Private Insurers
The New York State Department of Financial Services has filed an amicus brief with the New York Court of Appeals reaffirming its position that a medical professional corporation “is not eligible for reimbursement” under the state’s No-Fault Law “if the provider fails to meet any applicable New York State or local licensing requirement necessary to …
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WHO Issues Guidance on Digital Health Tools
April 25, 2019 | Cassandra Rivais DiNova | Electronic Health Records | Legislation and Public Policy | Medical Devices and Wearables | Telehealth
The World Health Organization (WHO) recently issued its first-ever recommendations on how digital health interventions may be used to improve health systems and patient care. Digital communication technologies covered by the report include apps, SMS text messages, and interactive voice response, and may involve the use of mobile devices, tablets, and desktop computers. The guidance …
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FDA Plans New Review Framework for AI-Based Medical Devices
April 24, 2019 | Eric D. Fader | FDA | Legislation and Public Policy | Medical Devices and Wearables
An April 2 Statement from Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration (FDA), announced that the FDA is considering creating a new review framework to promote development of medical devices that use artificial intelligence (AI) algorithms. The FDA also released a Discussion Paper and Request for Feedback on the proposed regulatory …
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HHS Announces New Primary Care Pay Models
April 23, 2019 | Eric D. Fader | Hospitals | Legislation and Public Policy | Medicare and Medicaid | Private Insurers
On April 22, U.S. Department of Health and Human Services (HHS) officials announced the introduction of five optional value-based care models for large and small primary care physician practices. The new payment models will incorporate incentives for keeping Medicare patients healthy, as alternatives to traditional fee-for-service payment structures. Alex Azar, HHS Secretary, and Seema Verma, …
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New Plan Designs for Medicare Parts C and D are Coming
April 9, 2019 | Christopher J. Kutner | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals | Private Insurers
On April 5, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (CMS-4185-F) that updates the Medicare Advantage (MA or Part C) and Medicare Prescription Drug Benefit (Part D) programs by promoting innovative plan designs, improved quality, and choices for patients. The final rule will increase MA plan choices for the 2019 …
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Rivkin Attorneys to Speak on CBD
April 8, 2019 | Marc S. Ullman | Steven Shapiro | FDA | Legislation and Public Policy | Pharmaceuticals
Rivkin Radler’s Marc Ullman and Steven Shapiro will be addressing the question “What Is the Regulatory Current State of Play With CBD?” on Wednesday, April 10, at the SupplySide East trade show in Secaucus, NJ.  Marc’s article “Regulations Remain Hazy Around CBD Use in Supplements” was recently published in the Spring/Summer 2019 issue of USLAW …
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FDA and FTC Warn CBD Marketers
April 8, 2019 | Marc S. Ullman | FDA | Legislation and Public Policy | Pharmaceuticals
On March 28, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) sent joint Warning Letters to three marketers of products represented as cannabidiol (popularly known as CBD) dietary supplements. According to the letters, the products are being marketed with questionable claims indicating that they can be used to treat a variety …
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New York State Budget Includes ACA-Type Protections
April 3, 2019 | Eric D. Fader | Affordable Care Act | Home Health | Hospitals | Legislation and Public Policy | Medicare and Medicaid | Private Insurers
New York’s state budget for the 2019-2020 fiscal year, approved by the State Legislature on March 31, included provisions that codify into state law the primary consumer protections of the federal Affordable Care Act. In a public announcement, Gov. Andrew Cuomo said, “We have codified many of the protections of Obamacare, so regardless of what …
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