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Qui Tam Update Highlights Failed Compliance Program and Dermatology Sweetheart Deals
July 21, 2015 | Blog
Mintz Levin’s Health Care Enforcement Defense Practice has published its most recent Qui Tam Update, analyzing overall trends in 36 recently unsealed health care related whistleblower cases.
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Government Finalizes Religious Accommodation, But What About Health Plans, TPAs and PBMs?
July 20, 2015 | Blog | By Bridgette Keller
In a set of rules published last week, the government finalized a July 2010 interim final rule (“IFR”) related to coverage of certain preventive services and an August 2014 IFR regarding the definition of an eligible organization and the process by which an eligible organization can provide notice of its religious objection to the coverage of contraceptive services.
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Trinity Homecare Settlement: Five False Claims Trends
July 15, 2015 | Blog
New York State Attorney General Eric Schneiderman recently announced that his office had reached a $2.5 million settlement in a federal False Claims Act (FCA) case with Trinity HomeCare and its related entities.
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American Academy of Pediatrics Recommends Limits on Telemedicine
July 14, 2015 | Blog | By Carrie Roll
On June 29, 2015, the American Academy of Pediatrics (AAP) published a policy statement supporting the use of telemedicine in the practice of pediatrics as long as telemedicine technologies are used “in support of and integrated with” the patient-centered medical home (PCMH) – not in place of it.
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Telehealth Roundup: Federal Bill Seeks to Expand Medicare Use of Telehealth; Delaware and Connecticut Update Telemedicine Laws
July 13, 2015 | Blog | By Alexander Hecht, Carrie Roll
On July 7th, the House introduced much anticipated bipartisan telehealth legislation.
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Delivery System Reform 2.0: Scaling Alternative Payment Models is the New Normal
July 13, 2015 | Blog
For some health care providers, a pair of recent announcements made by the Obama Administration to implement mandatory alternative payment models (APMs) for home health value-based purchasing and bundled payments for hip and knee episodes of care will come as a shock.
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Final Drug Shortage Reporting Rules Will Go Into Effect September 2015
July 9, 2015 | Blog | By Joanne Hawana, Lauren Moldawer
Earlier this week, FDA issued its final rule implementing statutory requirements for drug manufacturers to report the permanent discontinuation or temporary interruption in the manufacturing of certain drugs and biological products to FDA.
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OIG Adds New Litigation Unit Focused on Fines and Exclusions
July 8, 2015 | Blog
On June 30, 2015, the Department of Health and Human Services' Office of Inspector General (OIG) announced that it would be staffing a new specialty litigation unit whose sole focus will be on levying civil monetary penalties (CMPs) and excluding individuals and entities from participation in Medicare and Medicaid.
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Government’s Objections to Non-Intervened FCA Settlement Are Unreasonable – Now What?
July 7, 2015 | Blog
Recently, South Carolina U.S. District Judge Joseph Anderson, Jr. issued an opinion in which he struggled with how to handle a non-intervened qui tam brought under the Federal False Claims Act (FCA).
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Part D Woes, According to the OIG
July 1, 2015 | Blog | By Carrie Roll, Tara E. Dwyer
On June 23, 2015, the OIG issued two reports focusing on fraud, waste, and abuse in the Part D program, the first “Ensuring the Integrity of Medicare Part D” and the second “Questionable Billing Practices and Geographic Hotspots Point to Potential Fraud and Abuse in Medicare Part D.”
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FDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies
June 30, 2015 | Blog | By Joanne Hawana
On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until November 1, 2015 (Compliance Policy).
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FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies
June 26, 2015 | Blog | By Joanne Hawana
Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA).
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Massachusetts Health Care Regulatory Review – Opportunity for Industry Comment
June 25, 2015 | Blog | By Ellen Janos
Health care is big business in Massachusetts, and it is a highly regulated business. But Governor Charlie Baker hopes to simplify the Massachusetts regulatory regime.
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HRSA Takes its First Steps on 340B Rules
June 22, 2015 | Blog | By Bridgette Keller
The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B Program.
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Latest Medicare Fraud Strike Force Takedown Is The Most Significant To Date
June 19, 2015 | Blog | By Bridget Rohde
As we discussed yesterday, the Medicare Fraud Strike Force’s eighth annual nationwide takedown resulted in charges in 17 districts against 243 individuals for approximately $712 million in false billings.
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Government Announces Health Care Fraud “Takedown”
June 18, 2015 | Blog | By Brian Dunphy, Bridgette Keller
Earlier today, Attorney General Loretta Lynch announced the largest coordinated crackdown in the Medicare Fraud Strike Force’s eight-year history. The government brought charges against 243 individuals for approximately $712 million in alleged Medicare fraud.
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AMA Ethical Guidelines on Telemedicine Tabled for Further Review
June 10, 2015 | Blog | By Carrie Roll
On Monday, during the annual meeting of the American Medical Association (AMA) House of Delegates, the delegates voted to table a proposed measure to adopt ethical guidelines for physicians who provide telemedicine services.
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CMS Finally Releases Proposed Rules for Medicaid Managed Care
June 10, 2015 | Blog | By Ryan Cuthbertson, Pamela Kramer
On Friday, Mintz Levin published an advisory on CMS’s proposed Medicaid Managed Care rules. This advisory provides contextual background, a helpful overview of the rule’s contents, and an in-depth discussion of some of the rule’s key provisions.
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Mintz Advisory: Hard Switch Between Drugs Likely Violates the Sherman Act
June 10, 2015 | Blog | By Samantha Kingsbury
Last week, Mintz attorneys Bruce Sokler and Timothy Slattery published an advisory regarding the Second Circuit's highly anticipated decision in State of New York v. Actavis PLC.
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Physician Compensation Arrangements – OIG Fraud Alert Warns of Potential Anti-kickback Statute Violations
June 9, 2015 | Blog | By Daria Niewenhous
In a fraud alert released today, the OIG warns that physician compensation arrangements, such as medical directorship compensation, may potentially violate the anti-kickback statute.
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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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