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Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

FDA 2017 Year in Review

by McDermott Will & Emery on

The US Food and Drug Administration’s (FDA’s) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration. Since FDA Commissioner Scott Gottlieb’s Senate confirmation in May 2017, the...more

Corporate Law & Governance Update - January 2018

by McDermott Will & Emery on

Technology-Driven Disruption - Recent news stories and governance publications serve to underscore the challenge to health systems posed by innovation-based business model disruption. Health care boards will be expected to...more

Stanford Medical Center Seeks FAA Approval for Blood Delivery by Drone

Stanford Medical Center (Stanford) is pursuing a new concept in the health care world—blood delivery to hospitals by drones. Currently, Stanford is seeking the Federal Aviation Administration’s (FAA) approval for this type of...more

Low Volume Appeals settlement option announced

by Bricker & Eckler LLP on

The Centers for Medicare & Medicaid Services (CMS) recently announced the Low Volume Appeals (LVA) settlement agreement option, which allows Medicare Fee-For-Service providers, physicians and suppliers (Appellants) to receive...more

ML Strategies Outlook for 2018

With the start of a new year, Congress returns to Washington for the second session of the 115th Congress, while President Trump readies for his first State of the Union on January 30, 2018. The legislative agenda for the...more

Can a license issued by Health Canada for producing or dealing cannabis be assigned as security?

by Dentons on

The last year has been filled with sensational headlines relating to the spectacular growth and rise to prominence of Licensed Producers (as defined below) in response to the federal government's plan to legalize recreational...more

ML Strategies Outlook: Health Care

“We’re going to have to get back next year at entitlement reform, which is how you tackle the debt and the deficit” Paul Ryan, Speaker of the House. Happy New Year!?! - 2017 was an eventful year for health care, and...more

Cannabis Chaos: Justice Department Revokes Obama-Era Guidance on Marijuana Enforcement

by McDermott Will & Emery on

On January 4, 2018, Attorney General Jefferson B. Sessions announced, in a memorandum to all US Attorneys, the immediate revocation of five Obama Administration policies on federal marijuana enforcement, including Guidance...more

Florida Agencies Reissue Emergency Generator Rules Pending Ratification of Permanent Rules by the Florida Legislature

by Holland & Knight LLP on

The Agency for Health Care Administration and the Department of Elder Affairs have reissued Emergency Rules 59AER17-1 "Nursing Home Emergency Power Plan" and 58AER17-1 "Procedures Regarding Emergency Environmental Control for...more

What’s Past is Prologue - NLRB Restores the Common Sense Meaning of Past Practice

In Raytheon Network Centric Systems, 365 NLRB No. 161 (December 15, 2017), the National Labor Relations Board (NLRB) jumped back into the quagmire of past practice, dynamic status quo, and impasse to create firmer ground for...more

Rx IP Update - December 2017

by Smart & Biggar on

PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

CMS Issues Update for Contractors Defending Medical Review Decisions at Medicare ALJ Hearings

by Arnall Golden Gregory LLP on

On October 13, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a CMS Transmittal to update the Medicare Program Integrity Manual (MPIM) on recent regulatory changes in the Office of Medicare Hearings and...more

Health Update - December 2017

Part 1: Megatrends Reinventing How Patients Think - Editor’s Note: In a recent webinar for PharmaVOICE, Manatt Health revealed the megatrends reinventing the life sciences industry—and how they relate to new thinking by...more

“Micro-Units” Eliminated: NLRB Overturns Specialty Healthcare

by Proskauer - Labor Relations on

Adding to the list of falling precedents in the waning days of Chairman Miscimarra’s term, on Friday, the NLRB reversed another of the seminal decisions of the Obama-Board when it overruled the highly controversial Specialty...more

Clarifying Digital Health and Software Regulation: FDA Releases Three New Guidance Documents

by Hogan Lovells on

On December 7, 2017, the Food and Drug Administration (FDA or the Agency) released three guidance documents that together aim to clarify the framework for the regulation of software and digital health products to bring FDA...more

Update on Florida's Emergency Generator Rules

by Baker Ober Health Law on

On September 15, 2017, Florida Governor Rick Scott directed that by November 15, 2017, all nursing homes and assisted living facilities in the state were to install generators capable of powering air conditioning systems for...more

FDA Issues Guidance on Digital Health

by Stinson Leonard Street on

The Food and Drug Administration (FDA) issued two guidance documents last week clarifying its approach to certain health-related software in response to the addition of Section 520(o) to the Food, Drug and Cosmetic Act, which...more

Workers’ Advocacy Group Seeks to Invalidate Emergency Regulation Relating to Live-In Aides

by Hodgson Russ LLP on

The Urban Justice Center, a not-for-profit advocacy group, has filed a petition with the New York State Industrial Board of Appeals, seeking to invalidate the Department of Labor’s emergency regulation regarding live-in...more

Massachusetts Health Care Update: Senate Bill, Medication Switching, and Opioids

by Mintz Levin - ML Strategies on

Massachusetts policymakers continue to debate health care reform proposals with important implications for industry stakeholders. This month the Senate passed sweeping health care reform legislation, a special commission held...more

Lawsuit Seeks to Shut Down Pennsylvania’s Medical Marijuana Program Before It Even Sets Up Shop

by Cozen O'Connor on

A lawsuit accusing Pennsylvania’s fledgling medical marijuana program of running a faulty permitting process could stonewall patients looking for relief. Keystone ReLeaf (Keystone), a Bethlehem-based medical marijuana...more

Canada releases proposed amendments to Regulations governing patented medicines pricing

by Smart & Biggar on

On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more

CMS Announces New Nationwide ‘Targeted Probe and Educate’ Medical Review Strategy

by Morgan Lewis on

The Centers for Medicare & Medicaid Services recently expanded its national audit strategy, titled “Targeted Probe and Educate,” for Medicare billing review after pilot programs with four Medicare Administrative Contractors...more

FDA Releases Stem Cell Guidance Documents

by Foley & Lardner LLP on

Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing them to the same or a matched patient, for example, as done in bone marrow...more

Manatt on Health: Medicaid Edition: CMS Administrator Highlights Medicaid Policy Goals and New Guidance

Since assuming office last January, the Trump administration has signaled a shift in Medicaid policy. In early November, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma made the administration’s...more

Superior Court Upholds Retirement Board's Provision of Due Process Through Administrative Hearing Process

by Nossaman LLP on

Due process-based claims have taken center stage in several claims against some California public retirement systems of late. A recent ruling by the Superior Court for the County of Marin, however, held that the Board of...more

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