Archive for April, 2019
Measuring the Effectiveness of the 340B Program
From: Center for Regulatory Effectiveness via SSRN
Virtually every aspect of the 340B drug discount program has been evaluated except its effectiveness at improving healthcare access for medically underserved populations. This paper seeks to fill this information gap by using federal data to measure changes in the ability of impoverished and uninsured patients to afford needed healthcare, relative to the general population. The paper finds that the 340B program is harming the relative affordability of needed prescription drugs, needed medical care, and needed dental care for the most medically underserved communities. The causes of this decline in affordability is traced to a three-fold process that 340B hospitals are using to take maximum advantage of the program’s financial incentives.
Soft Law for Hard Problems: The Governance of Emerging Technologies in an Uncertain Future
From: Colorado Technology Law Journal via SSRN
Ryan Hagemann, Jennifer Skees, Adam D. Thierer
For a great many emerging technologies, as well as many existing ones, we are witnessing the twilight of the traditional regulatory system and its gradual replacement by an amorphous and constantly-evolving set of informal “soft law” governance mechanisms. This has profound ramifications for the future of statutory law, administrative regulation, and the evolution of a wide variety of technology sectors.
OMB Leveraging the CRA to Add to Its Oversight of Independent Regulatory Agencies
From: Notice & Comment | A Blog from the Yale Journal on Regulation and the ABA Section of Administrative Law & Regulatory Practice
Despite the language of the CRA that clearly includes guidance documents as rules subject to its provisions, many, if not most, agencies did not send guidance documents to the House and Senate as the CRA required. The Government Accountability Office opined in 2017 that guidance documents were subject to the CRA, and at least two district courts have entertained suits claiming that an agency violated the CRA by not submitting guidance documents to Congress. The new OMB memo specifically notes that guidance documents are subject to CRA requirements.
Extraterritoriality in the Public and Private Enforcement of U.S. Regulatory Law
From: Indiana Legal Studies Research Paper No. 408
Forthcoming in The Continuing Relevance of Private International Law and Its Challenges (F. Ferrari & D. Fernandez Arroyo eds., Elgar)
Indiana University Bloomington Maurer School of Law
Date Written: 2019