Regulatory Pacesetters

The critical shortage of ventilators which occurred in Italy is an imminent occurrence in the US.  As our hospitals become flooded with patients which ones are going to receive life saving devices such as ventilators?

CRE notes that any number of states (and possibly hospitals within a state) are working on guidelines dealing with the allocation of scarce medical equipment among particular patient classes; these triage guidelines could determine which patients live and those that die. Many might consider the said guidelines as “binding” and at times are based upon mathematical models. These guidelines are of paramount interest to the public.  CRE will continue its work to promote the input from a comprehensive set of stakeholders during the development of triage guidelines with full recognition of the observation that serious questions have been raised about the efficacy of ventilators.

Editor’s Note: The following is an abbreviated version of a letter to Mr. Gideon Levy, a correspondent with Haaretz, from a friend of his, Rosita Poloni, who is presently a residence of Italy.  Complete Article here.

 An article in the Washington Post reaches conclusions similar to those reached by Ms. Polini.  Italy’s coronavirus deaths are staggering. They might be a preview and not an anomaly: “Doctors and health officials say other countries should regard Italy not as an outlier or an example of missteps, but as a warning of the hardships that could soon be at hand. By Chico Harlan, Stefano Pitrelli and Claudia Cavaliere.”

“Cambridge published its first book in 1584 making it the oldest publishing house in the world.”

CRE was most fortunate to have its most recent, and last, peer reviewed study published by Cambridge University Press.

Professor Michael Uhlmann passed this past October in the year of 2019. Michael was a person of deep intelligence and with a unique pedigree which he never flaunted. There have been any number of excellent tributes written about Michael. Consequently the Editor thought he would wait six months until he reproduced the one that he thought most accurately captured his experience with Michael. The tribute was written by Susannah Patton  and George Marlin.

Notable quotes include:

Statement of the Issue

Recently there has been a flurry of concern regarding regulatory guidance documents notwithstanding their multi-decade review by experts in the field. In response to the release and resultant public discussion of the aforementioned documents, both inside and outside of government, CRE has received and has responded to a number of comments from its readers, most of which are captured in the statements which follow.

Heretofore the demonstration that the benefits of a proposed rule exceeded its costs was the only ticket needed to have it promulgated as a final rule.

With the advent of regulatory budgeting the demonstration of positive net benefits for a proposed rule is a necessary but not sufficient condition for its promulgation as a final rule. Furthermore the advent of a regulatory budget harbors the introduction of Social Welfare Functions different from the maximization of national income benefits as the mechanism for ranking proposed rulemakings. The introduction of alternative Social Welfare Functions occurs because the implementation of a regulatory budget requires a public review of the totality of available rulemakings on a government-wide basis and the resultant debates result in the introduction of non-national efficiency considerations such as income distribution and stakeholder segmentation.

Dr. Michael Stumborg, a principal scientist at the Center for Naval Analysis, has published a paper in which he concludes:

Congress should make the data quality provisions of the Information Quality Act applicable to all federal government data, not just publicly disseminated data. The Office of Management and Budget guidelines should provide clear, binding, and quantifiable definitions of “utility,” “objectivity,” and “integrity.” Compliance then becomes measureable, and thus, enforceable.

Congress should also define the terms “influential scientific information,” and “affected parties” to make congressional intentions clear, thereby preventing circumvention of the law by discretionary interpretation.

Here is an easy Miller Analogy question for attorneys and economists: judicial review is to attorneys  as ____ is to economists?

Answer:  benefit-cost analysis

Nonetheless the answer is more complex because attorneys tend to emphasize judicial review and economists tend to emphasize benefit-cost analysis when it comes to both managing the administrative state and in challenging it.

The influence of academicians in our society is underestimated; through their constant flow of publications they establish the administrative record on issues of public policy. Articles in the press come and go but journals are around forever.

Academicians teach future Presidents, Members of Congress, entrepreneurs, judges and their staff as well as future academicians, reporters and other opinion leaders. That said, the administrative record established by academicians could, in some instances, lack completeness. If the resultant void is be closed it is the responsibility of practitioners to do so.

Nonetheless,

Academicians survive because they publish.

The Quality of Life Review (QLR) was the term given to the first centralized regulatory review process administered by OMB. It predated OIRA review by a decade and was utilized by the Nixon and Ford Administrations.

The Quality of Life Review process differed significantly from the one currently in use by OIRA:

(1) Although its two primary components, OMB review and agency analysis of the benefits and cost of rules are the building blocks of all future Executive Orders on centralized regulatory review, the QLR was conducted by the “budget side” of OMB not a standalone office (OIRA) dedicated exclusively to implementing centralized regulatory review.