Legal opinions on health care issues

 Legal opinions on health care issues

a. Frequently occurring areas for opinions

i. Law firms are often asked to render legal opinions regarding various health care laws, regulations, case law and other guidance. Frequently encountered areas include:

(1) Stark Law

(2) Anti-Kickback Statute

(3) Tax-exempt Status

(4) Antitrust

(5) State law

(6) Medicare and Medicaid Reimbursement

(7) Over- and under-payment issues

(8) Licensure

(9) Certificate of Need

(10) Outcomes of litigation regarding all of the above

ii. Generally, these areas do not lend themselves to unqualified opinions that a certain set of facts does not violate the applicable law and regulations. Rather, most opinions addressing these issues are “reasoned” opinions as discussed in the following section. Likewise, many sets of facts and circumstances which potentially implicate health care regulations are not clearly illegal or otherwise violative of the regulations. There is a tremendous number of scenarios where the activity is neither clearly violating of or clearly compliant with the applicable law and regulations.

b. “Reasoned opinions”

 i. When a client asks a health care lawyer for a legal opinion in one of these areas, it is rare that an unqualified opinion can be given. Even assuming certain facts to be in existence, it is unusual for an unqualified opinion to be possible. Instead, what is frequently rendered to the client is a reasoned opinion that analyzes the risk of the fact situation presented by the client. ii. Reasoned opinions generally do not give an opinion whether a given action is in compliance with the applicable health care regulations. Rather, the opinion will reach varying types of conclusions. Some examples of these conclusions follow:

(1) Reasonable/strong arguments can be made that the activity does not violate the applicable law and regulations.

(2) It is unlikely that the activity, if investigated by a government entity, would be prosecuted.

(3) It is unlikely that a judge/jury would conclude that the activity violates the applicable law and regulations.

iii. There are many other formulations that are used in “reasoned” opinions. Often the type of expression used is based on give-and-take discussions with the client, through which the attorney can learn the question that the client would like answered.

 iv. When a reasoned opinion is rendered, the most important parts of the opinion are the statement of facts, particularly including the facts assumed to be true, the exceptions and the analysis on which the conclusion is based. Reasoned opinions do not give an absolute guaranty or assurance of a particular result or outcome. However, they should give comfort to the recipient that the drafter of the opinion has exercised reasonable care to identify the types and levels of risks that the subject activity could generate under the applicable regulations.

v. Clients sometimes ask for opinions on Stark Law questions that are unqualified. Many “reasoned” opinions are issued on Stark Law questions, but it is often impossible to issue unqualified opinions. This is an area of particular difficulty for in-house and outside attorneys, because the penalties for noncompliance with the Stark Law are so severe.