Legislation and Public Policy


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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NYS Senate Bill Would Expand Medical Marijuana Program
May 21, 2019 | Cannabis | Hospitals | Legislation and Public Policy | Pharmaceuticals

On May 10, a new bill was introduced into the New York Senate to expand the state’s medical marijuana program. The overall goal of the bill is to reduce the burdens on patients seeking access to medical marijuana.

The current version of the applicable statute requires that a medical condition be designated as “serious” in

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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 | 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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