ll of us sometimes use “law,” “legislation,” “rule” and other names for norms interchangeably. The label we choose may identify the source of a particular requirement or prohibition, however, and also the manner in which it might be changed. Choosing with discernment will enhance the credibility of a speech, article, letter, slide presentation or even an oral inquiry to a government official. Some of the words are blanket terms and many of them can be either specific or generic depending on the context. How do you perform on the quiz below?

Select only one answer for each of the following questions. Compare your answers with those below.

Answers:
1. e) A law is an Act of Congress, which is a statute, but it is never “a regulation.” “The law” means the totality of laws and rules.

In our system, the two houses of Congress or both houses of the state legislature must agree to adopt a new “Act of Congress” or “law” or “statute.” “The law” usually means the whole set of governmental rules — generally, or by subject, e.g., “the HIPAA law” or “the antitrust law.” For why “a regulation” is the wrong answer, see Question 3.

2. c) A law is sometimes the same thing as legislation. When a bill is proposed in Congress, it is “legislation,” and when it is passed, it becomes a law, i.e., a statute. Sometimes, however, we will refer to a specific law as “the HIPAA legislation” or the “Medicare legislation.” This often indicates that the speaker remembers the lobbying and the process by which the legislation became law.

3. b) “Law” and “regulation” are not synonymous. Congress or the state legislature passes a law, which the president or governor signs, and then typically the relevant agency of the Executive Branch implements that law through more specific regulations (although some laws are self-executing). Example: Congress added a provision to the Social Security Act directing the Secretary of Health and Human Services (HHS) to pay for Medicare medical services using a relative value-based Physician Fee Schedule, beginning in 1992. Each year since then, HHS has published a hefty regulation describing, changing and updating the Physician Fee Schedule.

4. d) A regulation can be changed by a law or by a subsequent regulation or by a court decision.
Thus a) and c) are correct. Answer b) is correct because courts can tell legislatures how they must fix a law, but they cannot rewrite the statute themselves — unless they are declaring part of a law unconstitutional, which changes that law automatically by excising the unconstitutional portion.

5. c) “Regulation” means a formally adopted rule, but it also covers standards that appear without notice in agency interpretations and instructions.

Technically, regulations are norms adopted after they have been published in proposed form, commented upon by any interested parties and reconsidered by the agency. Give yourself half a point if you answered that “regulation” is synonymous with “rule” because that is the truth, just not the whole truth. If you are reaching the conclusion that all of these terms have fluid meanings — but within definite bounds — give yourself a full bonus point.

6. c) “Interpretations” and “instructions” issued by an agency contain rules and are ignored at your peril.
Anesthesiologists who bill for medical direction of nurse anesthetists or anesthesiologist assistants know that the Medicare rules prevent them from involvement in concurrent activities other than additional surgical anesthesia cases, or labor epidurals, or any of the other so-called “permissible sins.” Those rules do not appear in the medical direction regulation; they are instructions to the local Medicare carriers and are published in the Centers for Medicare & Medicaid Services (CMS) Claims Processing Manual. Billing for services that do not conform to the instructions can lead to an investigation by the Office of the Inspector General (OIG) or even the Department of Justice.

As for CMS interpretations, consider the medication security/locked carts issue. The regulation says only, “All drugs and biologicals must be kept in a locked storage area.” The “Interpretive Guidelines” contain all the details on who must be in the operating room with an anesthesia cart that is unlocked. As appended to the CMS State Operations Manual, they are couched merely as instructions to agents or Joint Commission on Accreditation of Healthcare Organizations surveyors checking hospitals for compliance with the Conditions of Participation. Is there an anesthesiologist whose hospital has received or been threatened with a citation who does not see the Interpretive Guidelines as enforceable, inflexible rules — not just as “guidelines?”

7. a) A proposed rule matters a great deal. The agency gives notice that it plans to issue or update a regulation by publishing a proposed rule in the Federal Register (“Notice of Proposed Rule-Making,” or NPRM). Publication triggers a 30-, 60- or 90-day period running for interested parties to file comments urging the agency either to adopt the proposal or to modify it. Many members of the Society of Academic Anesthesiology Chairs/Association of Anesthesiology Program Directors recently submitted extensive comments in response to the 2005 proposed rule on the Physician Fee Schedule, as did ASA. We were all very disappointed in the final rule that once again denied teaching anesthesiologists parity with teaching surgeons.

Another proposed rule of great interest was the one published in March last year indicating that CMS intended to make the necessary changes to the medication security regulation. (Changing the regulation itself, and not just the Interpretive Guidelines, would give more permanence to the new standard.) Unfortunately, although the comment period ended in May, we do not know when the final rule is likely to appear in the Federal Register.

8. a) The term “ruling” does not really fit in here, although c) is the correct definition. Judges issue rulings, lawmakers issue legislation and government agencies issue regulations. One way to complicate the simple answer is to compare a ruling to an “advisory opinion” from an agency enforcement unit such as the OIG. An advisory opinion is a formal response to a request for an interpretation. It applies only to the party or parties who requested it, but it often takes on a normative life of its own. For an illustration, see the discussion of the OIG’s advisory opinions on gainsharing in the “Practice Management” column in the October 2005 NEWSLETTER.

9. d) The Medicare, Government Printing Office and ASA Web sites are among the top resources for laws and rules affecting the practice of anesthesiology, as is the NEWSLETTER.

10. a) Some anesthesiologists do care about civics and administrative law.
An ASA member recently sent an e-mail asking for an update on the status of the proposed rule on medication security and on postanesthesia evaluations, stating: