Guidance is as guidance does, the Department of Justice said recently.
The DOJ said guidance documents can no longer be used as a basis for bringing civil enforcement actions. The policy may tamp down the risk companies could face catastrophic punitive damages, particularly in False Claims Act cases.
“In the past, the Department of Justice and other agencies had blurred the distinction between regulations and guidance documents,” the DOJ said in a Jan. 25 statement announcing the policy.
“To the extent the guidance is the basis for enforcement-type actions against life sciences companies, this could have significant impact, but time will tell,” Karla L. Palmer, a life sciences lawyer at Hyman, Phelps & McNamara, P.C. in Washington told me Jan. 26.
The guidance shows the Trump administration’s regulatory reform task force is taking on important issues that will have an impact, Katie McDermott, a health-care fraud attorney with Morgan, Lewis & Bockius LLP in Washington told me Jan. 26.
There are many example of reliance on guidance documents, McDermott said.
In health care, for example, local coverage determinations (LCDs) issued by local Medicare contractors, which are often relied upon notwithstanding substantial inconsistencies, which allows for unfair discriminatory enforcement,” she said. It can also have the effect of creating different benefits for Medicare patients depending on where they reside, she added.
The new policy follows on the heels of a November 2017 memo issued by Attorney General Jeff Sessions, which prohibited agency guidance documents from being converted into binding rules.
Read my full story here.
Stay on top of new developments in health law and regulation, and learn more, by signing up for a free trial to Bloomberg Law.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)