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Personalized Medicine and Alternative Payment Models

August 19, 2015 | Blog | By Bridgette Keller

Earlier this month, my colleague Andy Shin at ML Strategies co-authored an article in the American Journal of Managed Care for a special issue of Evidence–Based Oncology, focusing on personalized medicine.
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First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

August 17, 2015 | Blog | By Brian Dunphy, Joanne Hawana

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency).
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This Week’s ML Strategies Health Care Update: Big Changes (Possibly) Ahead for Drug Manufacturers

August 13, 2015 | Blog | By Samantha Kingsbury

On Monday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health care-related topics like implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and state and federal health regulatory developments.
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FDA Cites Drug Company for Kim Kardashian Endorsement

August 12, 2015 | Blog | By Joanne Hawana

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites.
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Court Enforces Arbitration Agreement and Requires Employees to Arbitrate FCA Claims

August 11, 2015 | Blog | By Brian Dunphy

On Mintz Levin's Employment Matters blog, my colleague David Barmak recently discussed in a blog post a notable case in which a federal court compelled the arbitration of three nurses’ False Claims Act (FCA) retaliation claims against the hospital that employed them.
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Your Input, Please: ABA Blawg 100 Amici Nominations Due August 16

August 9, 2015 | Blog | By Karen Lovitch, Theresa Carnegie

As the co-editors of Health Law & Policy Matters, we are pleased to report that our blog was recently ranked as the No. 1 Health Law Blog in LexBlog’s AmLaw 200 Blog Benchmark Report based on overall traffic.
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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 | By Theresa Carnegie, Joanne Hawana

As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market.
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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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