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Health Care Enforcement Review and 2018 Outlook: Criminal and Civil Enforcement Trends

January 8, 2018 | Blog | By Eoin Beirne, Samantha Kingsbury, Karen Lovitch

In both civil and criminal enforcement proceedings, 2017 was perhaps most notable for the cases brought against individual health care providers and small physician practice owners. 
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ML Strategies - 2018 Health Care Preview

January 4, 2018 | Blog

2017 was an eventful year for health care, and now we can all sit back and relax with very little concern that major health policy will be on the table in 2018. Right? Not so fast. Talks of entitlement reform, upcoming regulatory action in Medicare, Medicaid, FDA and the Marketplace, and let's not forget the still lingering health care minibus. Lots to do in 2018 and we are just getting started.
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Health Care Enforcement Year in Review and 2018 Outlook: The False Claims Act’s Materiality Standard as Established by Escobar Continues to Evolve

January 4, 2018 | Blog | By Laurence Freedman

Throughout 2017, the lower courts built upon the standard for determining immateriality under the False Claims Act (FCA) established by the U.S. Supreme Court in Universal Health Servs., Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016) (“Escobar”).
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Sessions Memo Resets Federal Marijuana Enforcement Policy

January 4, 2018 | Blog | By Daria Niewenhous

The U. S. Department of Justice (DOJ) issued a memo dated January 4, 2018 regarding federal marijuana enforcement policy, directing all U.S. Attorneys to enforce the laws enacted by Congress and to follow well-established principles when pursuing prosecutions related to marijuana activities.
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Health Care Enforcement Year in Review and 2018 Outlook: Major Case Law Developments

January 3, 2018 | Blog | By Brian Dunphy

Like prior years, 2017 saw large government recoveries and a high volume of False Claims Act (“FCA”) cases, which remain the government’s primary health care enforcement tool.
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Health Care Enforcement Year in Review and 2018 Outlook: Trends In Health Care False Claims Act Cases

January 2, 2018 | Blog | By Kevin McGinty

The volume of health care–related qui tam litigation under the False Claims Act (FCA) remained robust in 2017. Based on our review of the data in Mintz Levin's Health Care Qui Tam Database, we identified over 150 qui tam lawsuits that were unsealed in the twelve months ended November 30, 2017. 
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ML Strategies Health Care Preview - Week of January 2nd

January 2, 2018 | Blog

Happy New Year and welcome to 2018! Our first weekly preview of the year dives into the issues left unresolved in 2017. Where does CHIP and the minibus fit into the developing government funding bill, which Congress will have to finalize or pass another continuing resolution by January 19th.
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FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality

December 26, 2017 | Blog | By Benjamin Zegarelli

This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments pertain to FDA actions on drugs and biologics, this post will address developments related to “traditional” medical devices and diagnostics (i.e., not software devices).
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Bah, Humbug! HIPAA Compliance Isn’t Getting Any Easier

December 21, 2017 | Blog | By Dianne Bourque, Ellen Janos

As we look back on 2017, one message is clear: don’t be a Scrooge when it comes to HIPAA compliance. With ever-evolving security threats and unrelenting enforcement, regulated entities must maintain a spirit of compliance that lasts the whole year through.
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FDA 2017 Year in Review: Therapeutic Products, Part 2

December 19, 2017 | Blog | By Joanne Hawana

Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space.  Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug competition issues, with the end goal of affecting drug prices, as well as current figures related to this year's new drug and biologic approvals.
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ML Strategies Health Care Preview - Week of December 18th

December 18, 2017 | Blog

Republicans enter this week on target to pass a sweeping tax reform package after securing support from Senators Corker (TN) and Rubio (FL). Additionally Susan Collins (ME) applauded the “inclusion of multiple amendments,” but stopped short of publicly supporting the measure.
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FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership

December 18, 2017 | Blog | By Joanne Hawana

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments.  For those of us who monitor the Food and Drug Administration (FDA or the Agency) and counsel FDA-regulated entities, it has certainly been a whirlwind of a year.
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Mintz’s Health Care Enforcement Defense Group Publishes New Qui Tam Update

December 14, 2017 | Blog | By Samantha Kingsbury

Earlier this week, Mintz Levin’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam update. This update covers 34 health care-related qui tam cases that were unsealed in July 2017.
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Proposed Law Would Criminalize Failures to Report Data Breaches

December 12, 2017 | Blog | By Dianne Bourque, Ryan Cuthbertson

A draft bill recently introduced in the U.S. Senate serves as a good reminder that compliance with data breach reporting requirements is critical.
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ML Strategies Health Care Preview - Week of December 11th

December 11, 2017 | Blog

This week, Republicans will ramp up efforts to pass a tax reform package. We should also get signs that a year-end spending deal is coming together. How things play out this week -- both inside and outside the Beltway -- will have implications for taxes, health care, and funding the government.
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Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes on the Opioid Epidemic

December 5, 2017 | Blog | By Bridgette Keller

Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D  Proposed Rule (Proposed Rules) by setting out a framework for Part D plans to monitor and reduce the potential misuse of frequently abused prescription drugs. 
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ML Strategies Weekly Health Care Preview – Week of December 4th

December 4, 2017 | Blog

Following weekend passage of the Senate tax bill, we return this week with Congress needing to pass a government-spending bill. While it’s widely expected that this will be a two-week continuing resolution (CR), giving lawmakers time to hash out a long-term deal, a short-term extension still requires Democratic votes since spending measures can be filibustered (e.g., October 2013).
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Fifth Circuit Limits FCA Liability Due to Lack of “Materiality” in Highway Guardrails Case

November 30, 2017 | Blog | By Laurence Freedman, Samantha Kingsbury

Earlier this week we released a Health Care Enforcement Advisory about a recent decision from the U.S. Court of Appeals for the Fifth Circuit that may have a significant impact on the element of “materiality” in False Claims Act (FCA) cases.
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Proposed Medicare Advantage and Part D Regulations for CY 2019 - CMS Tries to Clarify Any Willing Pharmacy Rules

November 29, 2017 | Blog | By Lauren Moldawer, Tara E. Dwyer

Medicare Part D plan sponsors and pharmacies are often confused by the program's any willing pharmacy (AWP) requirements while allowing any pharmacy willing to accept the terms and conditions to participate in the sponsor’s network (AWP Requirements).
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Proposed Medicare Advantage and Part D Regulations for CY 2019 - CMS Takes Aim at Drug Prices

November 27, 2017 | Blog | By Tara E. Dwyer

The rising cost of drugs in the U.S. is frequently in the news. So it is not surprising that in its contract year 2019 Proposed Medicare Advantage and Part D Regulations (Proposed Rule), the Centers for Medicare & Medicaid Services (CMS) seeks to address Part D drug prices.
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