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Drug Pumps Are Vulnerable to Hacking, FDA Warns
August 6, 2015 | Blog
Last Friday, the Food and Drug Administration (FDA) issued a statement warning that certain drug infusion pumps that administer medication to patients are vulnerable to being hacked.
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ML Strategies: CMS Releases Final Payment Rules and Lawmakers target CMS’ Mandatory Home Health Value-Based Purchasing Pilot
August 6, 2015 | Blog | By Lauren Moldawer
Earlier this week, ML Strategies 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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OIG Issues Favorable Advisory Opinion of Hospital Leasing Arrangement
August 3, 2015 | Blog | By Samantha Kingsbury
Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services published Advisory Opinion 15-10 (Opinion). The Opinion addressed a hospital system’s proposal to lease non-clinician employees and provide operational and management services to a related psychiatric hospital.
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The Corporate Practice Prohibition in New York: What We Can Learn From the ADMI Settlement
July 30, 2015 | Blog
One of the most frequently asked questions posed to healthcare lawyers is whether State X has a prohibition on the corporate practice of medicine, nursing or other profession, and if so, whether the prohibition is enforced.
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Emerging State Biosimilar Laws – Reference Chart and Five Issues to Watch
July 28, 2015| Blog|
FCC Ruling Addresses Robocalls by Health Care Providers
July 27, 2015 | Blog
Mintz Levin's Communications Practice recently released a Communications Advisory discussing a Declaratory Ruling and Order released by the Federal Communications Commission (FCC).
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Class Action Suit Filed Against UCLA After It Suffers Massive Data Breach Affecting 4.5 Million Individuals
July 23, 2015 | Blog
In yet another data breach affecting millions of individuals, UCLA Health System ("UCLA") reported on July 17, 2015, that hackers had accessed portions of its health network that contained personal information, including names, addresses, dates of birth, social security numbers, medical record numbers, Medicare or health plan ID numbers, and some medical information.
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Federal Circuit Issues a Key Decision About Biosimilars and the BPCIA
July 23, 2015 | Blog | By Brian Dunphy
Biosimilars continue to be a topic to watch in 2015 as the law around biosimilar products evolves. In March 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products, shortly after the FDA’s approval of a biosimilar version of Amgen’s drug Neupogen®.
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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|
FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies
June 26, 2015| Blog|
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