Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Arnold & Porter Kaye Scholer LLP
The European Commission has finally published the draft amendment to Regulation No 847/2000 regarding the concept of "similar medicinal product" for the purposes of the Orphan Medicinal Products Regulation.
Seyfarth Shaw LLP
The Fourth Circuit found that the medical necessity of a given service constitutes a material element of representations regarding submissions for payment, potentially providing payors ...
Foley Hoag LLP
Back in July, my colleague Tom Barker told you about a CMS proposal to institute a fundamental reimbursement methodological change for 340B drugs used in the hospital outpatient setting.
Ford & Harrison LLP
A cornerstone of Governor-elect Phil Murphy's campaign platform was the decriminalization of marijuana in New Jersey.
Morrison & Foerster LLP
Today's post is the first of two installments on protest grounds related to discussions. This post will focus on the requirement that discussions be meaningful and not misleading, and treat offerors equally.
Reed Smith
The Centers for Medicare & Medicaid Services (CMS) has published its final Medicare physician fee schedule (PFS) rule for CY 2018.
Reed Smith
CMS is redistributing the $1.6 billion in savings from this change by increasing by 3.2% conversion factor for non-drug items and services for 2018.
Seyfarth Shaw LLP
On November 8, 2016, Maine voters approved "Question 1 – An Act to Legalize Marijuana" ("Act"), and joined a handful of other states, including California...
Carlton Fields
The Centers of Medicare and Medicaid Services released a proposed rule that would update the 2018 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System.
BakerHostetler
The year-end schedules of the Senate HELP and Finance committees just became more clogged, as the two panels will lead the review of President Trump's nominee to be Health & Human Services (HHS) secretary.
Reed Smith
On November 8, 2017, following many years of investigation, the U.S. Department of Justice dismissed a billion-dollar False Claims Act (FCA) case against our long-standing client HCR ManorCare, the industry leader in post-acute rehabilitation care.
Holland & Knight
Alex Azar, a former executive of Eli Lilly was nominated by President Trump today to be Secretary of the Department of Health and Human Services (HHS). Azar would replace former Secretary Tom Price...
Carlton Fields
On June 14, 2017, the Centers for Medicare and Medicaid Services ("CMS")' Office of the Actuary ("OACT") released data detailing health care spending by state for the years 1991 through 2014.
McDermott Will & Emery
Attendees at the Health Care Compliance Association's Health Care Enforcement Compliance Institute are reporting that, Michael Granston, Director, Civil Frauds, Commercial Litigation Branch...
Foley Hoag LLP
The long awaited amendments to the medical marijuana regulations are finally final. The draft amendments to 105 CMR 725.000, Implementation of an Act for the Humanitarian Medical Use of Marijuana ...
Holland & Knight
With its decision in Weaver v. Myers, issued on Nov. 9, 2017, the Florida Supreme Court struck a significant blow to Florida's medical malpractice pre-suit process...
Lowndes, Drosdick, Doster, Kantor & Reed, P.A.
Though over 71% of Florida voters in 2016 approved Amendment 2 to allow medical marijuana, the numbers were higher in Orange County.
Reed Smith
This guidance highlights FDA's increasing interest in Digital Health issues
Seyfarth Shaw LLP
The notices are coming. As described in Issues 45 and 48, the Affordable Care Act requires large employers to pay a penalty if they fail to offer qualifying health coverage.
Seyfarth Shaw LLP
Welcome back to The Week in Weed, your Friday look at what's happening in the world of legalized marijuana.
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Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
EIP allows municipalities like the City to pay providers directly for EIP services and then seek reimbursement from other payors, like third party payors and New York Medicaid.
Foley Hoag LLP
This is the first of a multi-part end-of-year series examining important trends in data privacy and cybersecurity during the coming year.
Lowndes, Drosdick, Doster, Kantor & Reed, P.A.
Notwithstanding what we consider a well-reasoned and proper ruling by an Administrative Law Judge against Governor Scott's emergency rule on generators and fuel, cautious senior living facility...
Troutman Sanders LLP
Recent filings in the cigar industry's challenge to the FDA's Deeming Regulations involve outside support and opposition. The case is Cigar Association of America v. FDA, No. 1:16-cv-01460 (D.D.C.).
Seyfarth Shaw LLP
The Republicans made a last ditch effort to repeal the Affordable Care Act (ACA) the last week of September when they floated the latest iteration of proposed legislation under the Graham-Cassidy bill.
Carlton Fields
On November 2, Humana filed a lawsuit in the United States Court of Federal Claims to recover approximately $600 million allegedly owed by the United States government. See Humana Inc. v. U.S., case number 1:17-cv-01664.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Consumers are increasingly turning to health apps for a variety of medical and wellness-related purposes. This has in turn caused greater amounts of data ...
Thompson Coburn LLP
The fate of crucial federal legislation protecting medical cannabis producers, retailers and consumers from prosecution by the U.S. Department of Justice has recently become uncertain due to...
Day Pitney LLP
The Connecticut General Assembly adjourned in June and now – 123 days later – Governor Dannel Malloy last Tuesday signed into law a two-year state budget.
Stites & Harbison PLLC
Do Kentucky patients have a cause of action against a hospital for the negligent credentialing of a non-employee physician who is given staff privileges by the hospital? In March of 2016, the Court of Appeals answered that question in the affirmative, recognizing a new, stand-alone tort and avenue for recovery against Kentucky hospitals.
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