Mondaq USA: Food, Drugs, Healthcare, Life Sciences
McGuireWoods LLP
On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human use.
Reed Smith
The Office of Inspector General (OIG) of the Department of Health and Human Services has issued a report on "Overlap Between Physician-Owned Hospitals and Physician-Owned Distributors."
Reed Smith
On August 25, 2015, the Centers for Medicare & Medicaid Services (CMS) published technical and typographical corrections to its July 14, 2015 proposed rule to establish a Comprehensive Care for Joint Replacement Model.
Ice Miller LLP
Attorneys resolving worker's compensation claims with Medicare beneficiaries have been required for many years to consider Medicare's interests before entering into a settlement agreement.
Jones Day
In the August 6, 2015, Federal Register, AMS announced a pilot test of the International Trade Data System ("ITDS") involving the electronic submission of data related to importations of fruits, vegetables, and specialty...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing.
Seyfarth Shaw LLP
On July 16, 2015, for the first time in almost 25 years, the Centers for Medicare and Medicaid (CMS) released a proposed rule regarding long-term care facilities' eligibility to participate in the Medicare and Medicaid programs.
Reed Smith
CMS recently provided an update on its education and enforcement strategies related to its "Two Midnight" policy, which addresses when surgical procedures, diagnostic tests and other treatments ..
Jones Day
In the July 30, 2015, Federal Register, USDA's AMS issued a proposed rule addressing recommendations by the National Organic Standards Board ("NOSB") to the Secretary of Agriculture...
Reed Smith
CMS is inviting comments on voluntary home health electronic and paper "progress note" templates intended to assist physicians with documenting a face-to-face examination for purposes of the Medicare home health benefit.
Bradley Arant Boult Cummings LLP
During the July 30, 2015, Certificate of Need meeting, Dr. Mary Currier, State Health Officer, concurred with the health and planning staff analysis and approved the following applications for Certificate of Need...
McGuireWoods LLP
CMS recently announced that it would be releasing Medicare hospital utilization and payment data, as well as physician and supplier utilization and payment data.
Foley & Lardner
Congress is reviewing legislation designed to permit telemedicine providers to treat Medicare patients across state lines without the need for separate state licensure.
Patterson Belknap Webb & Tyler LLP
Today, FDA published notice of Janssen's lawsuit against Celltrion and Hospira on March 6, 2015 under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in the Federal Register.
McGuireWoods LLP
FDA will begin its device user fee talks with patients and consumers on Sept 15. The agency has scheduled six patient and consumer stakeholder meetings required as part of the Medical Device User Fee Act reauthorization.
Jones Day
In the August 6, 2015, Federal Register, USDA's AMS announced a public hearing to consider and take evidence on a proposal to establish a federal milk marketing order to regulate the handling of milk in the entire state of California.
Jones Day
The petitioner has requested a categorical exclusion from preparing an environmental assessment or environmental impact statement, for which FDA requests comments be submitted by September 14, 2015.
Jones Day
This action advises marketing order board and committee members and personnel of the restrictions, limitations, and liabilities imposed by those laws.
Foley & Lardner
Alex Hurd, Senior Director, Product Development, Growth and Payer Innovation for Health & Wellness at Walmart, said his team's mission is to be the "#1 retail provider of affordable health care."
Jones Day
In the August 3, 2015, Federal Register, FDA published a request for comments and scientific data and information that would assist in identifying and evaluating intervention measures...
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Fisher & Phillips LLP
Staff members who fail to meet those standards are subject to discipline, up to and including termination, and may also be reported to the appropriate licensing board or agency.
On June 1, 2015, Texas Governor Greg Abbott signed House Bill 574 into law protecting physicians and other providers from having their participating provider agreements terminated by an insurer ...
Fisher & Phillips LLP
The number of claims filed under the Health Insurance Portability and Accountability Act (HIPAA) have skyrocketed in recent years.
Thompson Coburn LLP
Companies that use staffing agencies to supply workers face special issues in determining their risk for the significant penalties under the Affordable Care Act's "play or pay" rules.
McDermott Will & Emery
On June 29, 2015, President Barack Obama signed the Trade Preferences Extension Act (the Act) into law.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
AIA established post-grant proceedings in the U.S. Patent and Trademark Office (USPTO) that have emerged as a battleground for pharmaceutical patent challenges in addition to the usual district court venue.
Proskauer Rose LLP
This month's article by Lindsey Chopin discusses Affordable Care Act ("ACA") litigation. Just five years old, the Supreme Court has considered issues related to the ACA numerous times.
Reed Smith
On July 8, 2015, the Centers for Medicare & Medicaid Services ("CMS") released proposed regulations "to reduce burden and to facilitate compliance" under the physician self-referral law known as the Stark Law. See 80 Fed. Reg. 41686, 41910 (July 15, 2015).
Ice Miller LLP
The National Institute of Standards and Technology (NIST) has released a draft of Securing Electronic Records on Mobile Devices, the institute's first practice guide in a series designed to help organizations improve cybersecurity.
Dykema Gossett
A fundamental goal of the ACA is providing affordable and quality health care coverage to Americans.
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