Eighteen Hundred and Thirty-Two Pages

William HymanWilliam A. Hyman
Professor Emeritus, Biomedical Engineering
Texas A&M University, w-hyman@tamu.edu
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When the Executive Order was signed which requires that two old rules (or regulations) be withdrawn for each new one issued I for one thought of several possible approaches that agencies might take that admittedly might not address the presumed intent of the Order. The simplest approach is to indeed find some old, forgotten, unenforced and/or irrelevant rules that can be withdrawn. This of course would not necessarily be a bad thing since no one benefits from rule clutter, no matter how obscure and unused those rules may be. On the other hand, withdrawing such rules does nothing to reduce the so-called regulatory burden.

My second approach is to withdraw some rules but roll their content into a new and expanded rule. This can satisfy the withdraw two requirement while also keeping their intent and allowing for new material in a bigger and potentially more complex package. On the other hand, it might also be a simplification if the combined contents has good integration and allows for a single rule rather than having to dig through multiple rules that cover the same topic. This might be especially true for related rules that do not cite each other.

A third approach which seems to have recently been taken by CMS with respect to various payment issues in a new proposed rule1 is to write really really long rules. This proposed rule is 1832 pages in manuscript form, which exceeds the number of pages in a standard edition of War and Peace. However certain Tables are not included but can be reviewed via the internet. In addition, there are various references, but no links, to other material such as this gem:

“We refer readers to the Hospital IQR Program (76 FR 51651 through 51652, 78 FR 50836 through 50837, 79 FR 50277, 81 FR 57181 through 57182, and 42 CFR 412.140(c)(2)), Hospital OQR Program (77 FR 68489, 78 FR 75119 through 75120, 79 FR 66966, and 80 FR 70524), and ASCQR Program (77 FR 53642 through 53643 and 78 FR 75140 through 75141) as well as the HAC Reduction Program (80 FR 49579 through 49581), Hospital Readmissions Reduction Program (80 FR 49542 CMS-1677-P).”

The title of the rule is 72 words and the rule addresses 9 different parts of 42 CFR. A section on how to get further information references close to 30 different individuals spread over multiple offices. There are about 12 pages of acronyms ranging from 3M (3M Health Information System) to VTE (venous thrombosis). Interestingly, using search 3M never occurs in the remaining 1800 pages, nor does VTE. The main Table of Contents is 33 pages. But wait, there is an Addendum and two Appendices with another Table of Contents of 7 pages. Helpfully, the Tables of Contents do not provide the pagination for the large number of subsections (which I didn’t count).

I will point out a few sections that I found intriguing. One is the extensive discussion of various proprietary drugs and devices with respect to their newness and coding, and associated add-on payments if they are new enough. These types of considerations provide a classic example of the regulatory perspective that a rule that helps me is astute governmental analysis while a rule that hurts me is an example of the government run amuck. Another aspect of interest is that various cost estimates are presented to what we technical folks call an excess of significant figures (eg $532,948,318). Some salary figures are given to 10 significant figures (eg $38.84760578 per hour), and uncompensated care is given to the penny, notwithstanding that the total is over $5 billion ($5,977,483,146.86). There are also some charming multiple factor mathematical formulas for assessing budget neutrality considerations.

But there is no real need to worry about the number of pages or the depth of detail because you have until June 13th to respond.

The rule will be published in the Federal Register on 4/28/17.