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6-Month Notice from a Biosimilar Sponsor Always Required -- Says Federal Circuit
July 6, 2016 | Blog | By Joanne Hawana
Our long-time readers know that there are many legal, regulatory, and scientific questions surrounding the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the ACA and created a new abbreviated FDA licensure pathway for highly similar biological products called biosimilars.
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OIG Advisory Opinion Approves Drug Discount Program
July 5, 2016 | Blog | By Tara E. Dwyer
Last week, the OIG posted favorable advisory opinion (16-07) regarding a proposed discount program for Part D beneficiaries who are prescribed a statutorily excluded erectile dysfunction drug.
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DOJ Announces Dramatic Increase in False Claims Act Penalties
June 30, 2016 | Blog | By Samantha Kingsbury, Laurence Freedman
On May 6th, we posted about the possibility that the Department of Justice (“DOJ”) might dramatically increase False Claims Act (“FCA”) penalties after the Railroad Retirement Board (“RRB”) nearly doubled the per-claim penalties it imposed under the FCA.
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Texas Medical Board Seeks State Action Immunity Protection in Fifth Circuit Brief
June 30, 2016 | Blog | By Dionne Lomax, Carrie Roll
On June 17, the Texas Medical Board (“Board”) filed a brief with the Fifth Circuit Court of Appeals reiterating that the Board’s rulemaking processes are protected under the state action immunity doctrine, noting that the case could significantly impair state agencies in carrying out their governmental functions.
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Congress Proposes Legislative "Fixes" to Drug Industry Rules Believed to Be Contributing to High Costs
June 30, 2016 | Blog | By Joanne Hawana
We spend a lot of time covering prescription drug costs on this blog (and here), and even convened a Pharmacy Industry Summit earlier this year focusing on the various pressures that are contributing to higher drug prices.
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In Wake of Escobar, Cases Return to Circuit Courts
June 28, 2016 | Blog
On Monday, the U.S. Supreme Court issued summary dispositions vacating the judgments in three cases brought under the False Claims Act ("FCA"). The Court remanded the cases back to their respective circuit courts for reconsideration in light of the Court's decision in Universal Health Services, Inc. v. United States ex rel. Escobar, 579 U. S. ___ (2016).
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Jury Acquits Former Pharma Exec in One of the First Post-Yates Memo Health Care Fraud Prosecutions
June 27, 2016 | Blog | By Samantha Kingsbury, Eoin Beirne
Like many before it, this year has been one to watch in government health care fraud enforcement efforts. In September 2015, the Department of Justice (DOJ) released the “Yates Memo,” which reaffirmed the government’s commitment to investigating and prosecuting culpable individuals in cases involving suspected corporate fraud.
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UK Data Protection in a Post-Brexit World
June 24, 2016 | Blog
After waking to news that the UK had voted to leave the EU, our London-based colleague Susan Foster provided insight on what the Brexit will mean for UK data protection laws.
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NIH Signals “Paradigm Shift” with Policy on Multi-Site Studies
June 23, 2016 | Blog | By Dianne Bourque
Federally-funded clinical trials conducted at multiple sites will move to a single Institutional Review Board (IRB) review scheme under a new National Institutes of Health (NIH) Policy.The NIH has finalized its policy to have a single IRB (sIRB) of record conduct the required ethics review for multi-site studies.
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Upcoming Webinar to Address Critical Issues and Latest Trends on TCPA
June 22, 2016 | Blog | By Alexander Hecht, Joshua Briones, Russell Fox
On June 28 at 1:00pm ET, please join me and my Mintz Levin colleagues, Joshua Briones and Russell Fox, for our webinar, “A Year Since the FCC's Declaratory Ruling — Critical Issues and Latest Trends on TCPA.”
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OCR Continues to Emphasize Individuals' Rights to Access Health Information
June 21, 2016 | Blog
Earlier this month, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced the release of three YouTube videos and an infographic on individuals' rights to access health information.
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At Long Last, CMS Issues Final Rule for Lab Fee Schedule Changes
June 20, 2016 | Blog | By Karen Lovitch
Last Friday afternoon CMS released its eagerly anticipated final rule (the Final Rule) implementing the Protecting Access to Medicare Act of 2014 (PAMA), which, together with the Final Rule, will make sweeping changes to the rate-setting process under the Medicare Clinical Laboratory Fee Schedule (MCLFS).
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Health Care Enforcement Defense Advisory on Escobar Holding
June 20, 2016 | Blog | By Bridgette Keller
Earlier today, my colleagues Tom Crane and Larry Freedman released a Health Care Enforcement Defense Advisory regarding the Supreme Court's long-awaited, unanimous decision in Universal Health Services v. United States ex rel. Escobar (“Escobar”).
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New York DOH Proposes Updated Provider Contract Guidelines
June 17, 2016 | Blog
The NYS Department of Health (DOH) has proposed new guidelines for the provider contract submission and review process to reflect Value Based Payment arrangements pursuant to the New York State Value Based Payment (VBP) Roadmap (Roadmap) and the Regulatory Impact Subcommittee.
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The Supreme Court Adopts Broad Scope of False Claims Act Liability
June 16, 2016 | Blog | By Brian Dunphy
A unanimous Supreme Court issued its long-awaited and closely watched decision today on the scope of the False Claims Act (“FCA”), and the Court affirmed the FCA’s long reach. Universal Health Services, Inc. v. United States ex rel. Escobar et al., No 15-7.
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FTC Suffers Another Hospital Merger Loss in Advocate-NorthShore
June 15, 2016 | Blog | By Dionne Lomax
On Tuesday, June 14, 2016, the U.S. District Court for the Northern District of Illinois declined to temporarily block the proposed merger of Advocate Health Care Network and NorthShore University HealthSystem in the Chicago area, handing the FTC its second hospital merger loss this year.
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New Rules for ACOs in the MSSP
June 15, 2016| Blog|
Anti-Steering Restrictions in Payor Contracts Face Antitrust Challenge by DOJ and NC
June 10, 2016 | Blog | By Dionne Lomax
A popular weapon used to contain health care expenditures is the creation by payors and employers of tiered provider networks, which by differentiated co-pays attempt to steer insureds to less expensive choices.
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Legislation to Reduce Consumer Cost-Sharing Takes a Back Burner in the Drug Pricing Debate
June 9, 2016 | Blog | By Carrie Roll
As discussed in our recent post, states have turned up the heat on drug companies through both legislation and voter initiatives that would require drug companies to disclose their pricing mechanisms for certain high-cost drugs.
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Employers, Join Us for a Webinar: The New White-Collar Overtime Rule
June 9, 2016 | Blog | By Brian Dunphy
Is your company trying to understand the Department of Labor’s (DOL) new white-collar overtime rule before the rule’s December 1st effective date? My colleagues from Mintz Levin’s Employment, Labor, and Benefits group are hosting a one-hour webinar on June 21, 2016 at 2pm (ET) to discuss the DOL’s recently released overtime rule.
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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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