AUGUST 4, 1998


Welcome and thank you for joining us today. We have invited you here for three reasons:

-- First and foremost, to unveil and explain the comprehensive compliance program guidance we have developed for the home health industry;

-- Second, to announce that the general public will be given the opportunity to take part in the development of future compliance program guidance; and

-- Third, to release an updated version of the clinical laboratory guidance that was revised to reflect recent policy changes.

After briefing you on these three actions, we will be pleased to field questions you may have.Simply put, the Compliance Program Guidance for Home Health Agencies describes the fundamentals of an effective program of provider compliance with the rules governing participation in the government's health care programs. It is voluntary guidance designed to help companies prevent fraud, waste and abuse by promoting a high level of ethical and lawful corporate conduct. It was developed in cooperation with the Health Care Financing Administration, Department of Justice, and representatives of the home health industry. I want to personally thank all of them for their valuable contributions to this effort.

Like the guidance issued earlier for clinical laboratories and hospitals, the guidance for home health agencies includes principles that apply to all sectors of the health care provider community as well as ones that are industry specific. The guidance includes seven fundamental elements to an effective compliance program:

1. Implementing written policies, procedures, and standards of conduct;

2. Designating a compliance officer and compliance committee;

3. Conducting effective training and education;

4. Developing effective lines of communication;5. Enforcing standards through well-publicized disciplinary guidelines;

6. Conducting internal monitoring and auditing; and

7. Responding promptly to detected offenses and developing corrective action initiatives.

Besides these fundamental principles, there are numerous industry-specific measures. They address risk areas of concern both to the government and the industry. For example, several measures are recommended to help agencies ensure that services are provided only to Medicare beneficiaries who are homebound, require medically necessary services and are under physician-certified plans of care.

Others provisions caution agencies against:

* Billing for services not provided;

* Falsifying records;

* Paying kickbacks for patient referrals;

* Hiring individuals with criminal records; and

* Failing to refund overpayments.

Additionally, the guidance points out that although it is a physician that determines medical necessity, a home health agency has an obligation to make certain that services it provides are medically necessary and meet other coverage criteria. An agency shares a responsibility for ensuring that the services it delivers and bills for are appropriate. It cannot avoid liability for improper claims simply because a physician has ordered the services.

In issuing this guidance, we recognize the size-differential that exists between operations of the different home health agencies and organizations that compose the home health industry. Appropriately, this guidance is pertinent for all home health agencies, whether for-profit or non-profit, large or small, urban or rural.

The applicability of the recommendations and guidelines provided in this document depends on the circumstances of each particular home health agency. Given the diversity within the industry, there is no single "best" home health agency compliance program.

Regardless of a home health agency's size and structure, we believe that every home health agency can and should strive to accomplish the objectives and principles underlying all of the compliance policies and procedures recommended within this guidance.

While this document presents basic procedural and structural guidance for designing a compliance program, it is not in itself a compliance program. Rather, it is a set of guidelines to be considered by a home health agency interested in implementing a compliance program.

We believe compliance programs are significant because when Medicare or Medicaid fraud is discovered, both the Department of Justice and my office seek to determine whether reasonable precautions were taken by the provider to avoid and detect internal wrongdoing.

The release today of this Compliance Guidance for Home Health Agencies is the third time that the OIG has provided guidance on the elements of an effective compliance program. We first offered compliance program guidance for clinical laboratories, and then to hospitals.

Each of these three programs of guidance was developed in collaboration with a limited number of representatives of the provider group for whom the guidance was intended. That process worked reasonably well and resulted in the production of three documents of guidance that have been favorably received by the health care industry.

However, to better ensure that all viewpoints are taken into account, we are opening up the process to the general public. In the future, a notice will be published in the Federal Register announcing our intentions to develop compliance program guidance for a specific provider group.

Interested parties will be asked to submit suggestions or to comment on the proposal, after which we will develop a draft of the proposed compliance program guidance. The draft will then be printed in the Federal Register for public comment before the guidance is finalized.

The process will be initiated within the next few days with the publication of a notice in the Federal Register soliciting public comment, input and recommendations for our development of guidance for the durable medical equipment industry. The public will be allowed 45 days from the date of publication to respond to the solicitation. Final guidance for the DME industry is expected to be issued before next spring.

In the meantime, work is continuing on the development of guidance for third-party billing companies. It is tentatively scheduled for release this fall. Because this project is in progress, it will not be subject to the new public-comment process.

In conclusion, let me note that your press packets include a copy of the revised clinical laboratory guidance. Various clarifications, changes and additions have been made to the guidance since the original was issued in February 1997.

The most significant change relates to the coding for certain tests. Our original lab guidance referenced codes to be used in billing for certain automated multi-channel chemistry tests.

The codes were later deleted by the AMA from the 1998 Current Procedural Terminology (CPT) book. Consequently, HCFA no longer recognizes these as billable or reimbursable codes. This policy change is reflected in the updated guidance.