Archive for April, 2019
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.
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.
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.