Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Jones Day
This development illustrates the medical device industry's focus on high ethical standards for industry–health care professional relationships.
McGuireWoods LLP
This Week: Energy and Commerce Committee holds hearing on Ebola. CMS publishes 2015 Star Ratings for Medicare Advantage and Medicare Rx drug plans.
Barnes & Thornburg
The FDA recently issued a final guidance document titled, "Distinguishing Medical Device Recalls from Medical Device Enhancements."
McGuireWoods LLP
Connecticut requires prior notification of any transaction that will result in a material change of the business or corporate structure of a medical group practice.
Robins Kaplan Miller & Cirese
For almost 40 years the FDA has regulated in vitro diagnostics (IVDs) as medical devices.
Reed Smith
On October 29, 2014, the OMHA is hosting its second OMHA Medicare Appellant Forum.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The Fox cases are significant because they illustrate that whistleblowers can come not only from their current and former employees, but also from their business relationships.
Jones Day
On November 5, 2014, the FDA will hold a webinar to explain the guidance and to provide a forum for asking questions.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The OIG has delayed the release of a final rule regarding applicable fraud and abuse law waivers for ACOs participating in the Medicare Shared Savings Program.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers.
Hooper, Lundy & Bookman, P.C.
The CMS and ONC released a final rule modifying the Medicare and Medicaid Electronic Health Record Incentive program for 2014.
McGuireWoods LLP
Hospitals have until October 31, 2014, to consider an offer by CMS to settle pending appeals of denied Medicare claims for 68 percent of the net allowable amount.
Arent Fox LLP
The US Department of Justice (DOJ) intervened in a False Claims Act (FCA) suit against Continuum Health Partners and Mount Sinai Health System.
Jones Day
Since August 2014, FDA has warned consumers to beware of products sold online claiming to prevent or treat the Ebola virus.
Jones Day
About 60 health IT industry groups recently joined to ask Congress to provide more clarity in health IT laws by codifying a risk-based regulatory framework.
Jones Day
FDA intends to survey pharmacists and patients to find out whether the shape, size, or color of a pill influences adherence to the prescribed dosing regimen.
Troutman Sanders LLP
The New York City Council has recently proposed a measure that would prohibit so-called "characterizing flavors" in e-cigarettes.
Troutman Sanders LLP
A group of tobacco retailers has challenged a Chicago ordinance that generally bans the sale of flavored tobacco products within 500 feet of a school.
The U.S. Department of Health and Human Services Office of Inspector General published an unexpected, yet long-awaited, set of proposed rules.
Day Pitney LLP
In the latest in a string of recent notable HIPAA settlements, Concentra Health Services and QCA Health Plan, Inc. have agreed to pay the U.S. Department of Health and Human Services (HHS) $1,725,220 and $250,000, respectively, "to resolve potential violations" of HIPAA’s Privacy and Security Rules. The settlements are described in an April 22 press release by HHS.
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Littler Mendelson
On August 28, the IRS released draft instructions for completing health insurance reporting forms required under the Affordable Care Act.
McDermott Will & Emery
There are two types of employer shared responsibility payments, also known as pay or play penalties, under the Affordable Care Act (ACA).
Littler Mendelson
On January 10, 2014, the Internal Revenue Service released final regulations governing the employer shared responsibility provisions of the Affordable Care Act.
Although HIPAA does not create a private cause of action, a recent Indiana Superior Court jury verdict demonstrates that HIPAA still could play an important role in private causes of action in state court based on negligence and professional liability as it relates to confidentiality.
Jones Day
The Affordable Care Act ("ACA") infuses new complexities into collective bargaining negotiations over health insurance benefits.
Littler Mendelson
For several years, nurses’ unions have lobbied, with varying success, for legislation implementing nurse-patient ratios.
Waller Lansden Dortch & Davis
The United States Department of Justice recently filed a suit against Vitas Hospice Services, L.L.C. and its subsidiary entities, alleging that Vitas submitted false claims for hospice services which were excessive, unnecessary, or not provided, and also alleging that Vitas admitted patients to hospice who were not terminally ill.
Dickinson Wright PLLC
In today’s healthcare industry, information technology systems play an ever-expanding role in the success of a medical practice.
Foley & Lardner
As the end of 2013 approaches, it is time to look back at 2013 and recall the top 10 legal developments affecting hospitals and health care providers.
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.
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