Complying With Government Regs a Challenge for Marketers

The federal government's issuance of a model compliance plan provides healthcare marketing executives with an important opportunity to help their companies develop compliance programs that can limit their possible exposure for criminal or civil liability for Medicare or Medicaid fraud or abuse.

Earlier this year, a deputy attorney general stated that one of the primary goals that the Department of Justice has this year is to significantly increase the number of both civil and criminal prosecutors' handling of healthcare fraud.

This statement obviously is significant for all healthcare providers and their executives and employees. It also is important to healthcare marketers and public relations professionals, because they can play a major role in limiting their company's exposure.

That should be evident from the model compliance program for clinical laboratories issued recently by the Office of the Inspector General of the Department of Health and Human Services as part of its attack on Medicare and Medicaid fraud and abuse.

Although intended for clinical laboratories, the model plan has elements of value to all healthcare providers. It also contains numerous provisions that are directly relevant to healthcare marketers.

In general, the model plan recommends, among other things, that corporate compliance programs include a wide range of provisions intended to establish a code of conduct for employees; inform employees of the company's desire to comply with all applicable rules; develop and offer education and training programs to all employees; and use audits and other mechanisms to monitor compliance.

The model plan emphasizes the use of written procedures and policies, including rules of conduct and company ethics; this is one of the areas to which marketers must pay particular attention.

For instance, the model plan specifically states that laboratory compliance programs should require honest, straightforward, fully informative, and non-deceptive marketing.

"It is in the best interests of patients, physicians, laboratories and Medicare alike that physicians fully understand the services offered by the laboratory, the services that will be provided when tests are ordered, and the financial consequences for Medicare, as well as other payers, for the tests ordered.

Accordingly, laboratories that market their services should ensure that their marketing information is clear, correct, non-deceptive and fully informative."

Pricing Issues

The model plan also deals with pricing, which is another issue with which healthcare marketers frequently are involved. The model plan notes that laboratories are paid for their services by a variety of payers in addition to Medicare and other federally funded health care programs, such as health insurers, other health care providers, and physicians.

According to the model plan, the prices that laboratories charge, particularly to physicians and especially for profiles, raise compliance issues that should be addressed in a laboratory's written compliance policies.

For example, in the government's view, compliance policies should ensure that as tests are included in or added to profiles, the price for the enhanced profile increases and the overall price for the profile is never below cost.

The model plan notes that, to ensure that corporate integrity rises to the level of importance required of laboratories participating in Medicare or other federally funded healthcare programs, compliance programs should require that the promotion of and adherence to compliance be an element in evaluating the performance of managers and supervisors.

The model plan also specifically provides that managers and supervisors involved in the sale, marketing, or billing of laboratory services should discuss with all supervised employees the compliance policies and legal requirements applicable to their function; inform all supervised personnel that strict compliance with these policies and requirements is a condition of employment; and disclose to all supervised personnel that the laboratory will take disciplinary action up to and including termination for violation of these policies or requirements.

In addition, the model plan imposes education and training obligations on marketers. In particular, it states that there should be compliance and ethics training for all employees, "especially personnel involved in billings, sales, [and] marketing."

This training should emphasize the company's commitment to compliance with all laws, regulations and guidelines of federal and state programs, and the training of sales and marketing personnel "should highlight the prohibition against offering remuneration in return for referrals" and the fact that the laboratory will take appropriate disciplinary action up to and including termination for violations of the laws or failure to report a potential violation by another employee, supervisor, or outside contractor or provider.

Marketing executives should take the initiative to either propose the adoption of a compliance plan or to work with senior management on the parts of such a plan related to their responsibilities and expertise. Because, at least for now, adoption of a compliance plan is voluntary, a healthcare provider that does adopt such a plan may find that adoption also is an advantage that it can highlight in its marketing materials.