Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Jones Day
The new guidance also reflects recent EU legislation on GM food and feed by addressing new requirements for the authorization of GM plants for the European market.
Jones Day
According to EFSA, the changes are intended to increase the efficiency and consistency of the application process.
Seyfarth Shaw LLP
An attractive source of lower cost financing, the EB-5 Immigrant Investor program can help fill the capital stack for many senior living projects.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The Third Circuit affirmed a lower court's dismissal of a suit filed by a hospital alleging an illegal exclusive dealing arrangement by a competing hospital and physician group.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has unveiled proposed regulations that constitute an ambitious and long overdue overhaul of the DoN Program regulations.
Fox Rothschild LLP
Hence, the ability to modify animal genes to protect them from disease infection has been an area of increased interested.
Foley Hoag LLP
On August 12, 2016, the Health Resources and Services Administration (HRSA) published a proposed rule entitled "340B Drug Pricing Program; Administrative Dispute Resolution".
Sheppard Mullin Richter & Hampton
The use of telemedicine has expanded access to care to patients in rural areas and provided a convenient alternative to battling congested physician offices and emergency department waiting rooms.
Carlton Fields
Hospitals must use the Medicare Outpatient Observation Notice (MOON) to provide standardized written notice.
Day Pitney LLP
On July 29, the U.S. Food and Drug Administration issued a final guidance document entitled "General Wellness: Policy for Low Risk Devices".
Wilson Elser Moskowitz Edelman & Dicker LLP
A rescheduling would have been the green light to enter a growth industry when the market could be on the verge of exploding.
Reed Smith
The OIG has issued a report entitled "MACs Continue to Use Different Methods to Determine Drug Coverage," which reviews how Medicare Administrative Contractors make Medicare Part B drug coverage determinations.
McDermott Will & Emery
The trial court dismissed the case, concluding that the law was not preempted by ERISA.
Jones Day
The import conditions are based on internationally accepted scientific literature and are intended to align U.S. regulations with guidelines set out in the World Organization for Animal Health's Terrestrial Animal Health Code.
Jones Day
The rule implements a recommendation from the Peanut Standards Board.
Reed Smith
A recent GAO report, "Medicare Part B: CMS Should Take Additional Steps to Verify Accuracy of Data Used to Set Payment Rates for Drugs," questions the reliability of pricing for Medicare Part B drugs reimbursed based on average sales price.
Duane Morris LLP
On August 5, 2016, CMS published a Survey and Certification Memorandum urging State health departments to enforce violations by nursing homes in posting patient images on social media.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
In another procedural defeat for the Texas Medical Board over its embattled telemedicine rule, last week, a federal judge held that the Board waited too long to request certification of appeal to the Fifth Circuit.
McDermott Will & Emery
McDermott's Managing the Transition to Transformation series is designed to help health systems and other health care industry leaders address the many challenges presented by the transformation in payment and care delivery models.
Reed Smith
CMS is putting health care providers on notice that it considers it "inappropriate" for providers to offer premium or cost-sharing assistance to Medicare or Medicaid beneficiaries in order to "steer" the patient to an individual market plan "for a provider's financial gain."
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Kaye Scholer LLP
This technology is already being used to generate liver tissue for use in drug testing.
Orrick
There is no doubt that companies face unprecedented volume and variation in both disruptive and intrusive cyberattacks on their networks.
Day Pitney LLP
Advocate Health Care Network, the largest health system in Illinois, has agreed to pay $5.55 million to settle allegations of multiple potential HIPAA violations arising out of three separate data breaches that it reported in 2013.
Carlton Fields
With the adoption of the 2009 Patient Protection and Affordable Care Act, Public Law 111-148 (affectionately known as "Obamacare"), hundreds of new acronyms came for health care lawyers to study.
MSPC
The Patient Protection and Affordable Care Act of 2010 (the "ACA") imposes significant information reporting responsibilities on certain employers starting with the 2015 calendar year.
Reed Smith
We've been remiss in updating our cheat sheet devoted to ediscovery for defendants. Because of the broad nature of the topic we have to research them separately to find what we need.
Seyfarth Shaw LLP
That "win-win" in contract negotiation wherein employees are paid to opt out of employer insurance has become much more complicated thanks to the IRS.
Reinhart Boerner Van Deuren S.C.
On July 6, 2016, the Federal Trade Commission decided to dismiss its administrative complaint challenging Cabell Huntington Hospital's proposed acquisition of St. Mary's Medical Center in Huntington, West Virginia.
Dentons
On Friday, July 29, US President Obama signed into law S. 764, which overturns Vermont's GMO label law and establishes a national standard for GMO (genetically modified organism) labeling.
Foley & Lardner
Louisiana's governor signed into law, HB 570, (the "Act"), eliminating a prior requirement that physicians practicing telemedicine maintain an office in Louisiana or contract with in-state providers.
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