Legislation and Public Policy


Rivkin Attorneys to Speak on CBD
April 8, 2019 | Marc S. Ullman | Steven Shapiro | Cannabis | 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 | Cannabis | 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 | Nursing Homes | 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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CMS Accepting Applications for AI Contest
March 28, 2019 | Electronic Health Records | Hospitals | Legislation and Public Policy | Medicare and Medicaid

On March 27, the Innovation Center at the Centers for Medicare & Medicaid Services (CMS) announced an artificial intelligence contest. The CMS Artificial Intelligence (AI) Health Outcomes Challenge, in collaboration with the American Academy of Family Physicians and the Laura and John Arnold Foundation, is looking for innovative technology and strategies to predict health outcomes,

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Medtronic Warns of Defibrillator Hacking Vulnerability
March 27, 2019 | Eric D. Fader | Cybersecurity | Electronic Health Records | FDA | Legislation and Public Policy | Medical Devices and Wearables | Telehealth

Medtronic PLC self-disclosed last week to the U.S. Food and Drug Administration (FDA) that an unspecified problem in the wireless technology of 19 models of the company’s defibrillators makes them vulnerable to being hacked. The company said it is not aware of any cyberattacks, privacy breaches, or patient harm related to the 750,000 vulnerable devices.

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New Jersey to Set Up State Health Insurance Exchange
March 26, 2019 | Eric D. Fader | Affordable Care Act | Legislation and Public Policy | Private Insurers

New Jersey Governor Phil Murphy announced on March 22 that the state will create its own health insurance exchange for plan year 2021, replacing the federally run healthcare.gov marketplace. Gov. Murphy also gave notice of the change by sending a Declaration of Intent Letter to the federal government’s Center for Consumer Information and Insurance Oversight.

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“Surprise Bill” Solution is on Senate’s To-Do List
March 20, 2019 | Eric D. Fader | Hospitals | Legislation and Public Policy | Private Insurers

A bipartisan group of U.S. senators is at work on federal “surprise bill” legislation that may be officially proposed within weeks. The proposal will target the common scenario in which an insured individual receives covered healthcare services from an in-network hospital, surgery center, imaging center or laboratory, while an out-of-network healthcare provider also provides non-emergency

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EHR Exposé Shakes Up Industry
March 19, 2019 | Eric D. Fader | Electronic Health Records | False Claims Act | Fraud and Abuse | Hospitals | Legislation and Public Policy | Litigation | Medicare and Medicaid

A three-month joint investigation of electronic health records (EHR) systems has culminated in a release of a March 18 article in Kaiser Health News (KHN) and Fortune Magazine, “Death By 1,000 Clicks: Where Electronic Health Records Went Wrong.” The lengthy, meticulously sourced article calls EHR systems “an unholy mess.”

KHN and Fortune have made the

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Managing “Social Determinants of Health” a Key Issue for Health Systems
March 14, 2019 | Rivkin Rounds Staff | Home Health | Hospitals | Legislation and Public Policy | Medicare and Medicaid

The World Health Organization (WHO) defines social determinants of health (SDOH) as the conditions in which people are born, grow, live, work and age that are primarily responsible for differences in health status. Rivkin Radler’s Robert Iseman recently penned a Thought Leaders’ Corner column for Population Health News in which he made suggestions regarding how healthcare organizations

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CMS to Propose Significant Changes to Stark Law
March 7, 2019 | Fraud and Abuse | Legislation and Public Policy | Medicare and Medicaid

At the Federation of American Hospitals’ 2019 Public Policy Conference on March 4, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced the agency’s plan to make dramatic changes to the federal physician self-referral prohibition, commonly known as the Stark Law. The changes are designed to support a value-based model of care in

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