Health Care

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. 

This week, Congress returns to D.C. with 11 days to pass a government funding bill that may touch on issues such as CHIP, the minibus, DACA, and disaster relief. How this all comes together by January 19th will start to play out this week.

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”).

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.

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.

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.

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. 

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.

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).

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.

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.

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.

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.

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.

A draft bill recently introduced in the U.S. Senate serves as a good reminder that compliance with data breach reporting requirements is critical.

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.

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. 

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).

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.

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).