80 Journal of Regulatory Compliance Vol. I
It may be easier to take the second question first since most of us already
have a sense of compliance. Compliance on its face involves conforming to
a rule or standard. In the law, compliance purports to be conformance to law
or those rules which have the force of law. The challenge in complying with
the law today is not just whether the law is practical enough to be complied
with but also a basic challenge of figuring out what the law is. Already now
we see that compliance is starting to mean not just the action of conforming
to a rule but also to mean an organized effort to identify the rules. 3 The
challenge of locating the rule is made even more challenging since there are
many rules and expectations which are not set out in the style we usually
associate with law ( i.e., a codified command of the legislator). In the field of
health care, taking one regulated industry as an example, much of the legal
requirements an organization must follow are not statutes or formal
regulations, but take the form of agency determinations, 4 manuals, 5
guidances, 6 and a host of other sub-law regulatory proscriptions. 7 Identifying
these commands, rules, and expectations that govern an organization is, at a
minimum, what a compliance program must focus an organization to
conform to. Compliance in this sense is an organization’s actions being in
accord with a set of expectations.
Now let’s turn back to the first question. By “regulatory” I mean the entire
array of commands, rules, orders, and standards with which a person or entity
is expected to conform. I do not mean merely statutes set out in the United
States Code or formal regulations promulgated in the Code of Federal
Regulations. Law in the United States has, for better or worse, moved beyond
these two traditional vehicles when establishing an individual or entity’s
“Regulatory” also by no means refers only to a push down of obligation
from the state. “Regulatory” can also mean the voluntary adoption of policies
3. See, e.g., David A. Hindin & Jon D. Silberman, Designing More Effective Rules and
Permits, 7 GEO. WASH. J. ENERGY & ENVTL. L. 103, 104 (2016) (“Rules and permits must be
sufficiently clear and understandable for regulated entities to know they are being regulated. . .
understand their obligations, and be able to determine how to comply.”).
4. E.g., NMS Healthcare of Hagerstown Decision No. 2603, DEPARTMENTAL APPEALS
BD., DEP’T HEALTH & HUM. SERVICES (Nov. 24, 2014),
5. E.g., Medicare Benefit Policy Manual, CMS Pub. 100-02, CTR. FOR MEDICARE &
MEDICAID SERVICES, http://www.cms.hhs.gov (follow “Regulations & Guidance” hyperlink;
then follow “Manuals” hyperlink; then follow “Internet-Only Manuals (IOMs)” hyperlink;
then follow “Medicare Benefit Policy Manual” hyperlink) (last visited on Sept. 19, 2016).
6. E.g., OFFICE OF THE INSPECTOR GENERAL, UPDATED SPECIAL ADVISORY BULLETIN ON
THE EFFECT OF EXCLUSION FROM PARTICIPATION IN FEDERAL HEALTH CARE PROGRAMS (2013).
7. E.g., OFFICE OF THE INSPECTOR GENERAL, PRACTICAL GUIDANCE FOR HEALTH CARE
GOVERNING BOARDS ON COMPLIANCE OVERSIGHT (2015).