Earlier this year, I commented on state drug pricing transparency laws in effect and/or enacted during 2017. I also opined that it was likely more states would pass similar transparency laws requiring drug manufacturers to disclose pricing and/or price increases during 2018. While proposed drug pricing transparency and disclosure legislation has been introduced and is pending in numerous states, during the first half of 2018 only two states (Oregon and Connecticut) passed new laws imposing price disclosure requirements on drug manufacturers. Maine expanded its existing disclosure law. Also of note was the United States Court of Appeals for the Fourth Circuit finding Maryland’s Anti-Gouging law unconstitutional. Continue reading “Drug Manufacturer Pricing Disclosures: Mid-Year 2018 Update”
On March 23, 2018, the Centers for Medicare & Medicaid Services (“CMS”) announced the introduction of a new Medicaid National Drug Rebate Agreement. The new Agreement incorporates legislative and regulatory changes, including, for example, the Affordable Care Act, which have occurred since the original Agreement was published in 1991.
Manufacturers currently participating in the Medicaid Program have until October 1, 2018, to sign the new Agreement. Failure to enter into a new Agreement by October 1, will result in termination of a manufacturer’s existing Agreement.
While the new Agreement does not contain significant changes from the existing Agreement, several changes are worth noting and repeating: Continue reading “New Medicaid Rebate Agreement”
Although several bills were introduced in Congress and President Trump has complained that drug prices are way too high, during 2017, the federal government did not pass any law nor implement any policy requiring drug manufacturers to disclose information concerning price increases. As a result, state legislatures have stepped in to fill this void. Unlike Congress, state legislatures have been much more aggressive in taking on drug price increases. Continue reading “2017 Was a Busy Year for State Imposition of Drug Manufacturer Price Disclosure Obligations and 2018 Isn’t Looking Much Better”
In the first two parts of this series, we covered companies’ obligations under U.S. export control laws, such as the Export Administration Regulations (“EAR”) governed by the Department of Commerce, Bureau of Industry and Security (“BIS”), and military or defense exports governed by the International Traffic in Arms Regulations (“ITAR”) under the auspices of the State Department’s Directorate of Defense Trade Controls (“DDTC”), and common ways to mitigate your organization’s risk against violations. Unfortunately, no compliance program can prevent all violations, and this final part of our series addresses the key considerations your organization should keep in mind in the event you discover that an apparent violation may have occurred. How your company addresses apparent violations are as important as anything else, because they end up determining the repercussions that your organization may face from these and other enforcement agencies. Continue reading “Navigating Violations in the Export Controls Minefield (Part 3 in a Series)”
With yet another government shutdown looming, contractors face a number of uncertainties and challenges that warrant close attention—regardless of whether a shutdown takes place or how long it lasts. Among other challenges, contractors may face a lack of incremental funding; the inability to enter into new contracts or contract modifications; closed government facilities; furloughed government employees; delayed payments; increased indirect costs; and unexercised and deferred contract options. Below we offer six suggestions to help address key areas impacted by a shutdown, including contract funding, internal and external communications, recordkeeping, and deadlines. Continue reading “Government Contractor Shutdown Advisory”
The Department of Justice (“DOJ”) reported $3.7 billion in False Claims Act (“FCA”) settlements and judgments for fiscal year 2017, the 8th straight year of 3-plus-billion-dollar recoveries and 700-plus new cases filed. Healthcare, mortgage, and procurement fraud once again dominated recoveries. This article analyzes DOJ’s FCA statistics, and includes our predictions for continued strong enforcement in 2018. Continue reading “Another Banner Year for False Claims Act Recoveries Signals More of the Same for 2018”
The National Defense Authorization Act (“NDAA”) for Fiscal Year 2018 was signed into law on December 12, 2017, and authorizes a topline national defense budget of $700 billion. While the 2018 NDAA makes a number of changes to Department of Defense (“DOD”) policy and programs, in this article we explain five major changes to acquisition policy and how they will impact the way companies do business with DOD. Continue reading “New Year’s Resolutions: Top 5 Consequential Changes in the 2018 NDAA”