Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Venable LLP
FDA poses a series of questions seeking information that may inform regulatory actions regarding nicotine exposure warnings and child-resistant packaging for liquid nicotine and nicotine-containing e-liquid(s)...
McDermott Will & Emery
On June 9, 2015, the OIG issued a new fraud alert primarily aimed at warning physicians about how their financial arrangements can create personal risk of liability under the AKS.
McDermott Will & Emery
In its guidance notice, the FDA explained that some dispensers had expressed concern that electronic systems used to exchange, capture and maintain product tracing information would not be operational by July 1.
McDermott Will & Emery
The federal government's health care fraud enforcement efforts expanded this week with an announcement by the Office of the Inspector General (OIG)...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The OIG highlights that after conducting multiple investigations, it believes that the Part D program continues to suffer from two shortcomings that result in fraud and abuse not being detected or avoided as effectively as possible.
While King v. Burwell provided significant assurance to the health industry and insurance markets, the political and legal fallout seems far from over.
Foley & Lardner
As detailed below, each of the audits identified a significant portion of employees reviewed to be "unqualified," ranging from 11 percent (New York) to 70 percent (Puerto Rico).
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
In the Compliance Policy, FDA notes that dispensers have expressed concern that electronic systems used to exchange, capture, and maintain product tracing information will not be operational by the original July 1 deadline.
Thompson Coburn LLP
The question of whether patients should be permitted to record interactions with their doctors, and when and how it is best to do so, has become a highly contentious issue to navigate in today's increasingly complex medical terrain.
Cadwalader, Wickersham & Taft LLP
Today the U.S. Supreme Court handed down its much anticipated decision in King v. Burwell, a case challenging the legality of Federal subsidies provided to individuals in the 34 States that did not establish State-based American Health Benefit Exchanges, and instead provide individual marketplace coverage through "Federally-facilitated Exchanges."
Fox Rothschild LLP
This is the second in a series of posts on practical and legal considerations for physicians in deciding whether to sell, merge or stay the same.
McDermott Will & Emery
On Tuesday, June 23, the U.S. Department of Health & Human Services Office of Inspector General (OIG) released two reports that hone in on data patterns showing potential fraud and abuse in the Medicare Part D program.
McDermott Will & Emery
On June 25, 2015, the Supreme Court of the United States upheld one of the main pillars of the Affordable Care Act (ACA)...
McGuireWoods LLP
The question before the Supreme Court was whether Internal Revenue Service regulations could extend tax-credit subsidies to health insurance coverage purchased through exchanges established by the federal government...
Sheppard Mullin Richter & Hampton
One of the most highly anticipated decisions of the term—at least among the Sheppard Mullin Healthcare team—was issued today by the Supreme Court: King v. Burwell.
Barnes & Thornburg
The U.S. Supreme Court has upheld the use of subsidies in all 50 states to help finance insurance policies through tax credits for those citizens earning up to 400 percent of poverty-level income...
Troutman Sanders LLP
The U.S. Supreme Court has today upheld another challenged provision of the Affordable Care Act, this time related to government subsidies.
Day Pitney LLP
On June 25, the U.S. Supreme Court ruled in a 6-3 decision that consumers who purchase health insurance in "federally facilitated exchanges" established under the Affordable Care Act (ACA) can continue receiving subsidies.
Duane Morris LLP
One requirement of the equipment rental exception, which is both statutory and regulatory (42 C.F.R. 411.357(b)), is that the rental charges be "set in advance."
Foley & Lardner
The '540 Patent was awarded to inventors Yuk-Ming Dennis Lo and James Stephen Wainscot for "Non-invasive prenatal diagnosis."
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Fox Rothschild LLP
As discussed in prior postings, there are animal and public health concerns associated with the growing practice of feeding raw food to pets.
Jones Day
On May 19, 2015, Alabama and Minnesota became the seventh and eighth states, respectively, to enact the Interstate Medical Licensure Compact, joining Idaho, Montana, Utah, South Dakota, Wyoming, and West Virginia.
Proskauer Rose LLP
On June 1, 2015, the Department of Health and Human Services Center for Medicaid and Medicare Services published a proposed rule at 80 Fed. Reg. 31097 that will fundamentally change state Medicaid Managed Care programs.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
On May 22, the Massachusetts Senate unanimously approved a $38.1 billion budget for FY2016.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Yesterday, before a packed courtroom, Judges Newman, Lourie, and Chen of the U.S. Court of Appeals for the Federal Circuit heard oral arguments in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. June 3, 2015).
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
In the previous Congress, we saw a burst of policy and industry attention to telehealth as lawmakers and stakeholders alike recognized the cost, quality, and accessibility benefits of telehealth.
Anderson Kill
With the legalization for medical use in 21 states, and for adult use in Colorado, Washington, Alaska and the District of Columbia (and Oregon, effective July 1, 2015), the cannabis industry is said to be the fastest growing industry in the United States.
McGuireWoods LLP
Abilify®'s blocking Patent No. 5,006,528 ("the '528 patent") expired on April 20, 2015, and Otsuka had already attempted to enjoin generic entry based on some of its other patents, but had so far been unsuccessful.
Frommer Lawrence & Haug LLP
Less than three years after implementation of the Inter Partes Review process, the life science industry is already calling upon Congress for significant reform.
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