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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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State Action May Block Big Savings on Biosimilars
June 9, 2015 | Blog
The recent influx of state legislation on biologics and biosimilars may actually hinder rather than advance the use of biosimilars. Our colleagues Theresa Carnegie, Joanne Hawana, and Ellyn Sternfield discuss this issue in a recent article published in BNA’s Medicare Report.
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Fingerprint-Based Background Checks Begin August 1st for Medicaid Providers
June 4, 2015 | Blog | By Lauren Moldawer
On June 1st, the Centers for Medicare and Medicaid Services (CMS) released a State Medicaid Director Letter (SMD Letter) providing guidance to states on the criminal background check and fingerprinting requirements for Medicaid provider enrollment.
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Injunction Blocks Implementation of Texas Telemedicine Regulations
June 4, 2015 | Blog | By Dionne Lomax
Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that would have prevented prescribing via telemedicine.
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ML Strategies: Health Care Update & Telehealth Policy Alert
June 3, 2015 | Blog | By Carrie Roll
Yesterday, ML Strategies posted its Health Care Update and Telehealth Policy Alert. This publication provides timely information for those who are already in, or contemplating entering, the telehealth space.
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OIG Releases Semiannual Report to Congress
June 3, 2015 | Blog | By Matthew Levitt
The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently released its Semiannual Report to Congress (“Report”), summarizing OIG’s activities for the six-month period ending on March 31, 2015.
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Supreme Court Decides Qui Tam First-to-File Issues
June 3, 2015 | Blog | By Laurence Freedman
Whether you are on the defense side or the relator side of the qui tam world, you can count the Supreme Court’s opinion in Kellogg, Brown & Root Services, Inc. v. United States ex. Rel. Carter as a win and a loss.
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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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