Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Lee H. Rosebush and Lindsay P. Holmes have authored a white paper on "Select Issues in Negotiating Drug Pricing and Reimbursement Contracts"...
Although most False Claims Act (FCA) cases involve some fraudulent scheme to submit claims to the government, liability may also arise from retaining a Medicare or Medicaid overpayment.
The HHS Office of the National Coordinator for Health Information Technology (ONC) recently published a contracting Guide to assist healthcare providers...
The Food and Drug Administration (FDA) and National Institutes of Health (NIH) have recently finalized or signaled intent to finalize numerous proposals that promise to change the landscape of clinical trial reporting...
Dickinson Wright PLLC
Over the last decade, the craft brewing industry has exploded in popularity. Small micro-breweries and brewpubs have cropped up across Michigan and the United States—many obtaining regional and national popularity.
Holland & Knight
The Centers for Medicare & Medicaid Services has released the highly anticipated Final Rule implementing the Medicare physician payment reforms enacted as part of the Medicare Access and CHIP Reauthorization Act of 2015.
McDermott Will & Emery
The HHS OCR posted guidance clarifying that a business associate generally may not block or terminate access by a covered entity customer to PHI maintained by the vendor on behalf of the customer.
Day Pitney LLP
On October 17, the Centers for Medicare & Medicaid Services (CMS) announced that its Comprehensive Primary Care (CPC) initiative generated a total of $57.7 million in gross savings in Medicare Part A and Part B expenditures in its second performance year.
Reed Smith
The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have announced that they are making permanent their "Program for Parallel Review of Medical Devices," which is now operating as a pilot program.
Reed Smith
We never heard the term "slack fill" before we started writing for this blog, but it seems to be getting a lot of attention lately. We enjoyed a podcast from NPR's Planet Money the other day discussing slack fill in black pepper containers, and we blogged on the FDA's regulation of slack fill a little more than a year ago.
Duane Morris LLP
Since shortly after the U.S. Food and Drug Administration ("FDA") began publishing FDA Form 483 inspectional observations of Section 503B outsourcing facilities, many State Boards of Pharmacy have inappropriately relied upon the FDA's findings as a basis to pursue outsourcing facilities for violations of state law.
Reed Smith
On September 28, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a final rule comprehensively updating and extensively revising the requirements for participation (ROPs) for long-term care (LTC) facilities participating in the Medicare and Medicaid programs (the Final Rule).
Reed Smith
Reed Smith's Life Sciences Health Industry Group is hosting a Life Sciences CLE Day at our Philadelphia office on Thursday, November 10.
Duane Morris LLP
Continuing the drumbeat of increased regulatory scrutiny on long-term care providers, the OIG of the Department of Health and Human Services in early October 2016 released an Investigative Advisory on Medicaid Fraud and Patient Harm Involving Personal Care Services.
Reed Smith
When we first set foot on the University of Chicago Law School campus back in 1982, Chicago sports were a mess.
Seyfarth Shaw LLP
As the race to the Presidential Election draws near, The Blunt Truth turns its attention to a second round of ballot measures in North Dakota and Maine, which seek to expand both medical and recreational marijuana use.
Holland & Knight
CMS has established new requirements for long-term care facilities (LTC) participating in Medicare and Medicaid, the first set of comprehensive revisions to the participation requirements in 25 years.
Sheppard Mullin Richter & Hampton
On July 25, 2016, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule that promises to deliver coordinated, high-quality care for Medicare beneficiaries.
Sheppard Mullin Richter & Hampton
On Friday, October 14, 2016, CMS released the much-anticipated final rule (the "Final Rule") implementing the Quality Payment Program, mandated by the MACRA of 2015.
Reed Smith
Remember Frye v. United States, the case from 1922 that created the "general acceptance" standard for expert testimony?
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Reinhart Boerner Van Deuren S.C.
Plan administrators must distribute SARs to participants and beneficiaries within nine months of the plan's year end. For plan years that end December 31, the SAR is due September 30, 2016.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH's Hospital Licensure Regulations (105 CMR 130.00).
Jones Day
Data breach notification requirements in Arizona, Nebraska, and Tennessee took effect in July and August.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The Massachusetts Department of Public Health has proposed a number of amended regulations in connection with the regulatory review and overhaul mandated by Governor Baker's Executive Order 562.
Fish & Richardson
A research report released last week on the supposed cyber vulnerabilities of St. Jude Medical's devices opens a worrisome new front on cybersecurity-related risk.
Paul Hastings LLP
For this reason, the inability of marijuana businesses to open bank accounts has become a growing point of contention between state and federal regulators.
Arnold & Porter LLP
In early August 2016, the US FDA's Center for Device and Radiological Health issued a Draft Guidance for industry entitled Deciding When to Submit a 510(k) for a Software Change to an Existing Device.
Lewis Brisbois Bisgaard & Smith LLP
In a case of first impression, the Louisiana Supreme Court addressed the question of allocation of defense expenses in long latency disease cases and adopted the "pro rata" approach...
Foley & Lardner
The FDA approved Inflectra–Celltrion's biosimilar version of Janssen's Remicade® (infliximab) product–in April 2016, but according to Pfizer's press release it's commercial launch still "depend[s] on a number of factors"...
Jones Day
On September 12, 2016, in an unpublished disposition, the Ninth Circuit reversed in part a district court's ruling that "All Natural Fruit" labeling on Dole Food Co. products was unlikely to deceive consumers.
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