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Health Care Enforcement Defense Practice Publishes Most Recent Qui Tam Update
November 26, 2014 | Blog
Our Health Care Enforcement Defense Practice has published its most recent Qui Tam Update analyzing 68 recently unsealed health care related whistleblower cases. In this issue, the team analyzes overall trends in the 68 cases, and looks more closely at three notable cases.
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No Private Right to Recoup Funds Based on Corporate Practice of Medicine Violation
November 24, 2014 | Blog
The United States District Court for the Western District of Washington ruled recently that the state’s corporate practice of medicine doctrine does not provide a private right of action, either express or implied, and dismissed claims brought by State Farm Mutual Automobile Insurance Company and State Farm Fire and Casualty Company.
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Hospital Executive Pleads Guilty to False Meaningful Use Attestation for EHR Incentive Payments
November 21, 2014 | Blog
The former CFO of Shelby Regional Medical Center, Joe White, pleaded guilty to knowingly making a false statement related to the hospital’s meaningful use of electronic health records (“EHR”).
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Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices
November 20, 2014 | Blog | By Samantha Kingsbury
Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food and Drug Administration (FDA); and (2) conspiring to defraud the U.S. government by concealing their illegal activities.
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D.C. Circuit Upholds Contraceptive Coverage Mandate
November 20, 2014 | Blog | By Bridgette Keller
Last week, a unanimous three-judge panel of the D.C. Circuit upheld the religious accommodation to the Affordable Care Act’s (“ACA”) contraceptive coverage mandate (Priests for Life v. HHS, D.C. Cir. No. 13-5368, Nov. 14, 2014).
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Strategies for Efficiently Obtaining Antitrust Clearance
November 20, 2014 | Blog | By Dionne Lomax
The health care industry remains an enforcement priority for the Federal Trade Commission ("FTC"). In a recent interview, the Director of the FTC’s Bureau of Competition, Debbie Feinstein, stated that the Bureau’s top three priorities for health care antitrust enforcement.
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The Seventh Circuit Rejects Medicaid False Claims Act Suit
November 19, 2014 | Blog | By Brian Dunphy
The United States Court of Appeals for the Seventh Circuit affirmed the dismissal of a False Claims Act (“FCA”) case against Shopko Operating Stores, LLC, in which a former Shopko pharmacist asserted Medicaid billing violations.
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The 340B Mega-Reg is Dead
November 19, 2014 | Blog | By Theresa Carnegie
With all due credit to the Coroner from the Wizard of Oz, like the Wicked Witch of the East crushed by Dorothy’s house, the 340B Drug Discount Program mega-reg is “not only merely dead, it’s really most sincerely dead.” And to quote one of my favorite sports commentators, Tony Kornheiser, “I believe I had that.”
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OCR's New Bulletin on Ensuring Privacy in Public Health Emergencies
November 12, 2014 | Blog
This week, the HHS Office of Civil Rights (OCR) issued a bulletin (Bulletin) to remind covered entities and business associates that "the protections of the Privacy Rule are not set aside during an emergency."
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Hospital Alliance Deemed a Single Entity, Incapable of Conspiring
November 12, 2014 | Blog | By Dionne Lomax
On October 21, 2014, the U.S. District Court for the Southern District of Ohio granted Defendants’ motion for summary judgment, holding that Premier Health Partners and its affiliate hospitals were operating under a joint operating agreement, constituted a single entity incapable of conspiring in violation of Section 1 of the Sherman Act.
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CMS Finalizes OPPS Rule Packaging Pathology Services Ordered for Hospital Outpatients
November 6, 2014 | Blog | By Karen Lovitch
As part of the Outpatient Prospective Payment System (OPPS) Rule issued last week, the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to conditionally package certain ancillary services assigned to APCs with a “geographic mean cost” of $100 or less.
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Key Takeaways from OIG’s 2015 Work Plan
November 4, 2014 | Blog | By Kimberly Gold
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to HHS programs and operations during the current fiscal year and beyond.
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CME Payments Largely Remain Excluded From Sunshine Act Reporting
November 4, 2014 | Blog | By Brian Dunphy
The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”).
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The Contraception Coverage Controversy Continues…
October 31, 2014 | Blog | By Bridgette Keller
As we have been discussing, the Affordable Care Act (“ACA”) requires all health plans to cover preventive health services for women, including all Food and Drug Administration (“FDA”)-approved contraceptives, at no cost (i.e. no deductibles, coinsurance, or co-payments).
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Managing Antitrust Risks in Pre-Transaction Planning
October 30, 2014 | Blog | By Theresa Carnegie
Dynamic changes in the nation’s health care delivery systems have been prompted, in part, by the implementation of the Patient Protection and Affordable Care Act (“ACA”). In the wake of the ACA, hospitals and other health care industry participants have been undergoing significant consolidation.
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HHS Announces $840 Million Initiative to Improve Patient Care and Lower Healthcare Costs
October 30, 2014 | Blog | By Theresa Carnegie
Last week, the Department Health and Human Services (HHS) announced that it will invest $840 million over the next four years to support 150,000 clinicians through a combination of incentives, tools, and information to encourage clinicians and other health care providers “to move from volume-driven systems to value-based, patient-centered, and coordinated health care services.”
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Office for Human Research Protections Releases Draft Guidance
October 29, 2014 | Blog
On October 24, 2014, the Office for Human Research Protections (OHRP) announced in the Federal Register that it has released, and is seeking comment on, its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (“Draft Guidance”).
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Ebola Exclusions from Commercial Insurance Policies
October 29, 2014 | Blog | By Theresa Carnegie
Last week we wrote about a new business interruption insurance policy that is being rolled out to healthcare providers which will provide specific coverage for various ebola-related losses. This week we note that some business insurers are beginning to specifically exclude ebola-related losses from their standard commercial insurance policies.
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NYS Department of Health Proposes Changes to Certificate of Need Process
October 28, 2014 | Blog | By Theresa Carnegie
On October 15, 2014, the New York State Department of Health (DOH) released proposed changes that will simplify the certificate of need (CON) process.
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ML Strategies Posts Weekly Health Care Update on October 27, 2014
October 28, 2014 | Blog | By Theresa Carnegie
ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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