Allergan To Pay $600M For Off-Label Marketing Of Botox

IRVINE, Calif. (Mealey's) - Allergan Inc. said Sept. 1 that it will plead guilty to a federal misdemeanor charge related to off-label marketing of Botox and will pay a total of $600 million to the federal government in criminal and civil penalties. In addition, Allergan said it will dismiss its...

Arkansas Plaintiffs Move To Dismiss Lawsuit Challenging Health Care Reform Act

LITTLE ROCK, Ark. - (Mealey's) Arkansas residents challenging the recently passed Patient Protection and Affordable Health Care Act (PPACA) on Sept. 8 in Arkansas federal court moved to dismiss their class action complaint without prejudice ( Jeannie Burlsworth, et al. v. Eric Holder, in his official...

Heart Device Maker ELA Medical Pays $9.1M To Settle Kickback Allegations

MIAMI -- Heart device maker ELA Medical Inc. will pay $9,178,000 to settle a False Claims Act lawsuit alleging that it paid kickbacks through a distributor to doctors to induce them to use the company's products, according to a settlement filed Nov. 1 in a Florida federal court ( United States of...

Florida Judge Finds Individual Mandate In Health Care Act Unconstitutional

PENSACOLA, Fla. -- (Mealey's) A Florida federal judge on Jan. 31 struck down as unconstitutional the individual mandate portion of the Patient Protection and Affordable Care Act (PPACA) and, finding that the provision is not severable, held that the entire act must be declared void ( State of Florida...

Pennsylvania Federal Judge: Individual Mandate In Health Care Act Violates Constitution

HARRISBURG, Pa. -- A Pennsylvania federal judge on Sept. 13 held that the individual mandate contained in the Patient Protection and Affordable Care Act (PPACA) is an unconstitutional extension of authority granted to the federal government under the U.S. Constitution's commerce clause ( Barbara...

Federal Judge Says Health Care Reform Act's Individual Mandate Is Unconstitutional

HARRISBURG, Pa. -- A Pennsylvania federal judge on Sept. 13 held that the individual mandate contained in the Patient Protection and Affordable Care Act (PPACA) is an unconstitutional extension of authority granted to the federal government under the U.S. Constitution's commerce clause ( Barbara...

C.R. Bard Takes $51 Million Charge, Agrees To Settle Federal Civil, Criminal Probes

MURRAY HILL, N.J. - (Mealey's) C.R. Bard Inc. on Jan. 27 reported that it has taken a $51 million charge in connection with a preliminary agreement with the civil and criminal divisions of the U.S. Attorney's Office for the Northern District of Georgia to resolve an investigation into the medical...

State Net Capitol Journal: States Look to Answer 'Essential' Health Question

Although 35 of the 50 states have yet to create the marketplaces known as health benefits exchanges required by the Affordable Care Act, they aren't completely ignoring the law's impending requirements. A majority, in fact, are moving forward on another key component of federal health reform...

Federal Government Offers Rulemaking For Compromise On Birth Control Coverage

WASHINGTON, D.C. - (Mealey's) The U.S. Department of Health and Human Services on Feb. 1 issued a notice of proposed rulemaking on recommended changes to the preventive services policy contained in the Patient Protection and Affordable Care Act (PPACA). ( Proposed rules available. Document #31...

U.S. Supreme Court OKs Attorney Fees In Untimely, Good Faith Vaccine Cases

WASHINGTON, D.C. - (Mealey's) A federal vaccine compensation petitioner who filed an untimely claim may qualify for attorney fees if her claim was filed in good faith and there was a reasonable basis for it, the U.S. Supreme Court ruled May 20 ( Kathleen Sebelius, et al. v. Melissa Cloer , No. 12...

FDA Lifts All Restrictions On Plan B One-Step Contraceptive, Will Drop Appeal

BROOKLYN, N.Y. - (Mealey's) The federal government on June 10 told a federal judge that it will make the one-pill Plan B One-Step emergency contraceptive available without age or point-of-sale restrictions and intends to voluntarily withdraw its appeal of the judge's order requiring the lifting...

Williams Mullen: OIG 2014 Work Plan Focuses On Compounded Pharmaceuticals Reimbursed By Medicare

By Brian C. Vick The Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) included two items in its recently-released 2014 Work Plan indicating a new focus on the quality and safety of compounded pharmaceuticals reimbursed by Medicare. Pharmaceutical...

Barnes & Thornburg LLP: OIG Work Plan 2014: Takeaways for Hospitals

By Gayland Hethcoat With the release of its work plan for fiscal year 2014 on Jan. 31, 2013, the U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG) has provided insight on the agency’s current enforcement priorities in Medicare, Medicaid, and other HHS programs...

The Hobby Lobby Primer: How A Craft Store Changed The Legal Landscape

Now that the United States Supreme Court has issued its decision in Burwell v. Hobby Lobby Stores, Inc. , 2014 U.S. LEXIS 4505 (U.S. June 30, 2014) , many are left with questions on the breadth of the decision and what it means going forwards. Below is a brief primer . [lexis.com subscribers may access...

11th Circuit Cites Hobby Lobby, Enjoins Mandate During Appeal

MONTGOMERY, Ala. — (Mealey’s) A Catholic media outlet is entitled to an injunction while it appeals rejection of its Patient Protection and Affordable Care Act (ACA)’s contraceptive mandate challenge in light of Burwell v. Hobby Lobby (Nos. 13-354, 13-356, U.S. Sup. [lexis.com subscribers...

HHS Urges Top Court Not To Grant Emergency Injunction During ACA Appeal

WASHINGTON, D.C. — (Mealey’s) The Supreme Court should deny a nonprofit Christian liberal arts college’s request for an emergency injunction of the Patient Protection and Affordable Care Act (ACA) contraceptive mandate while it appeals an adverse ruling, the government said July 2 in...

Ballard Spahr LLP: Government Agencies Release Further Accommodations to Organizations Opposing Mandated Contraceptive Coverage

By Jean Hemphill and Brian Pinheiro In response to the recent U.S. Supreme Court decision in Burwell v. Hobby Lobby, Inc., [ enhanced opinion available to lexis.com subscribers ], the U.S. Departments of Health and Human Services (HHS) and Labor (DOL) published proposed rules on August 22, 2014, expanding...

HHS Issues Alteration To ACA Contraceptive Mandate Accommodation Rule

WASHINGTON, D.C. — (Mealey’s) Eligible employers opposed to Patient Protection and Affordable Care Act (ACA) provisions mandating insurance coverage for contraceptives may notify the U.S. Department of Health and Human Services (HHS), which will in turn notify the employer’s insurer...