Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Jones Day
The European Medicines Agency has recommended the suspension of approximately 700 medicinal products distributed in Europe due to irregularities in their approval process.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
A vote by EU lawmakers in mid-January gave individual governments within the 28-nation bloc the authority to decide whether genetically modified organisms can be grown and cultivated within their borders.
Reed Smith
On January 27, 2015, the House Energy and Commerce Subcommittee on Health held a hearing on bipartisan public health legislation, including:
Jones Day
FDA recently issued two draft guidance documents intended to reduce oversight for low-risk medical devices...
Reed Smith
The HHS Office of Inspector General estimates that CMS made $4.6 million in incorrect Medicare outpatient payments to hospitals for established patients’ clinic visits in 2012.
Jones Day
President Obama Paid Special Attention To Medical Innovation During His State Of The Union Address last week when he highlighted a "precision medicine initiative" aimed at finding cures for cancer, diabetes, and other diseases.
Reed Smith
On January 22, 2015, the Centers for Medicare & Medicaid Services (CMS) added star ratings to the Dialysis Facility Compare (DFC) website.
Reed Smith
The Government Accountability Office released a report entitled "Private Health Insurance: Geographic Variation in Spending for Certain High-Cost Procedures Driven by Inpatient Prices."
Troutman Sanders LLP
Indiana Attorney General Greg Zoeller and the Indiana legislature are working closely to pass legislation that would increase state regulation of electronic cigarettes and vaping products.
Reed Smith
On January 27, 2015, the House Energy and Commerce Committee released its "21st Century Cures Act" discussion draft, the product of a year-long, bipartisan effort by the Committee to accelerate the pace of medical cures in the United States.
BakerHostetler
Drug manufacturers may no longer be required to distribute prescribing information on paper—with limited exceptions—and instead may have to distribute that same information electronically.
Duane Morris LLP
I have been concerned about the difficulty of projecting revenue and determining valuations for new and existing healthcare companies based on risk based reimbursement models.
BakerHostetler
On the heels of a loss in federal court last fall, the FDA recently announced a clarification of its policy concerning orphan drug exclusivity.
Fox Rothschild LLP
The Centers for Medicare and Medicaid Services announced today that it intends to adopt regulations modifying the Medicare Electronic Health Record Meaningful Use Program requirements as early as the Spring of 2015.
Reed Smith
The OIG recently issued a report that examined the extent to which Quality Improvement Organizations duplicate other CMS hospital quality improvement efforts.
Fox Rothschild LLP
According to various news outlets, physicians at the University of California student health centers went on strike this week in protest of what they believe are unfair labor practices by the University.
Reed Smith
The OIG has defended its hospital compliance review policies in response to objections raised by the American Hospital Association (AHA).
Duane Morris LLP
The Federal False Claims Act (and many similar state false claims acts) allow an individual—called a "relator"—to file a lawsuit on behalf of the United States Government.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Last week, Congressional leaders held hearings in advance of their next push to pass legislation that would permanently replace the Medicare physician payment formula known as the SGR.
McGuireWoods LLP
This Week: Upcoming E&C Health Subcommittee Hearing on Permanent SGR Fix…Administrator Tavenner to Leave CMS Next Month…CA Exchange Board Implements Adjustments for New Insurance Market Entrants
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Foley & Lardner
The Centers for Medicare & Medicaid Services (CMS) issued the 2015 Medicare Physician Fee Schedule (Medicare PFS) on October 31, 2014.
Littler Mendelson
On August 28, the IRS released draft instructions for completing health insurance reporting forms required under the Affordable Care Act.
Proskauer Rose LLP
On October 31, 2013, the Internal Revenue Service (IRS) released Notice 2013-71 (Notice), which modifies the "use or lose" rule for health flexible spending accounts (health FSAs) to allow a $500 annual carryover of unused contributions, provided that cafeteria the plan offering the health FSA does not incorporate the "grace period" rule.
Jones Day
The Affordable Care Act ("ACA") infuses new complexities into collective bargaining negotiations over health insurance benefits.
Littler Mendelson
On January 10, 2014, the Internal Revenue Service released final regulations governing the employer shared responsibility provisions of the Affordable Care Act.
Littler Mendelson
For several years, nurses’ unions have lobbied, with varying success, for legislation implementing nurse-patient ratios.
Fox Rothschild LLP
As she had done in 2014, Marla Durben Hirsch interviewed my partner Elizabeth Litten and me for her annual Medical Practice Compliance Alert article on compliance trends for the New Year.
Fox Rothschild LLP
Nearly a year ago, as described in an earlier blog post, one of my favorite health industry journalists, Marla Durben Hirsh, published an article in Medical Practice Compliance Alert predicting physician practice compliance trends for 2014.
Ropes & Gray LLP
On December 26, 2013, the Office of Management and Budget ("OMB") published final guidance in the Federal Register entitled "Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards" ("Final Guidance"), to be located at Title 2 of the Code of Federal Regulations ("C.F.R.").
McDermott Will & Emery
More than 80 percent of all deals in the pharmaceutical industry include an earnout structure that provides some type of contingent or delayed payment of proceeds to the sellers.
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