New test profiles, Model Compliance Plan for Clinical Laboratories, prothrombin time self-testing.

New test profiles

The Health Care Financing Administration has issued a Program Memorandum to its carriers specifying the approval of new automated chemistry panels. The following four panels were issued with "G" temporary billing codes:

1. G0095, hepatic function panel A (paid as 80005 under the current billing codes), which includes albumin, bilirubin--total and direct, alkaline phosphatase, aspartate aminotransferase (AST), and alanine aminotransferase (ALT)

2. G0096, basic metabolic panel (paid as 80007), which includes carbon dioxide, chloride, creatinine, glucose, potassium, sodium, and blood urea nitrogen (BUN)

3. G0097, electrolytes panel (paid as 80004), which includes carbon dioxide, chloride, potassium, sodium

4. G0098, comprehensive metabolic panel (paid as 80012), which includes albumin, bilirubin--total, calcium, chloride, creatinine, glucose, potassium, alkaline phosphatase, protein--total, sodium, AST, and BUN

Implementation of the "G" temporary billing codes is optional until January 1998, when the existing automated chemistry profile current procedural terminology codes 80002-80019, and G0058-G0060 will be deleted and new CPT codes will be issued. The "G" temporary codes were to be effective for all carriers April 1, 1997, but implementation was plagued with unforeseen problems that resulted in a new effective date of July 1, 1997. Within HCFA, speculation is that it will be later than July before all carriers can implement processing the temporary codes due to the intricacies of the varying application systems among carriers. Each carrier is responsible to inform providers of the carrier's implementation dates.

HCFA's memorandum encourages labs to bill using the temporary codes as soon as possible because that will be the only method available beginning January 1998. It is acceptable when billing Medicare to use either the current CPT codes for automated chemistry profiles or the new temporary codes, but not a combination of the two. Carriers have been instructed to reject a claim as incorrectly coded if they receive code combinations.

Payments for the new panels are based on the payments of current automated chemistry tests and profiles. In other words, the new electrolyte panel (G0097) will be paid at the same rate as any combination of four automated chemistry tests (80004). Using the temporary codes, the billing of two panels at the same time is appropriate as long as there is no duplication in the analytes tested. Medical necessity documentation is required and multiple ICD.9 codes are acceptable with one panel.

Let's think about effective implementation. These codes are "temporary," so if your facility goes to the expense of printing requisitions or converting billing systems now, the process and expense must be repeated when the permanent CPT codes are issued for 1998. But considering that educating providers to change ordering habits is no easy task, to begin the process yesterday would not be soon enough to achieve conformance by January 1998. At a minimum, HCFA stresses to begin adopting the new panels as soon as possible and apply whichever billing scheme is most effective in your practice (remember that if you use the temporary codes, your carrier must be able to process them).

Corporate compliance manual

In February, the Office of the Inspector General (OIG) issued its Model Compliance Plan for Clinical Laboratories. The Model was established in response to many healthcare providers seeking guidance for developing customized compliance programs. The OIG's plan is specific to lab services and Federally funded healthcare programs.

The purpose of a compliance program is to eliminate fraud and abuse within a system. The OIG has a zero-tolerance policy for fraud and abuse and recommends providers voluntarily adopt a compliance program.

Although not mandatory for the average lab, the benefits of an implemented program can be rewarding if the facility is faced with penalties. Labs found in violation of Medicare's rules have been required to establish and implement specific compliance programs as part of penalty negotiations. The OIG wants to ensure those facilities do not continue such behavior. But note, implementing a compliance program does not render a facility immune to prosecution.

For a compliance program to be effective it must be implemented. The OIG warns that programs that are merely cosmetic may harm the lab in the long run. Any compliance program should also be reviewed thoroughly by a legal expert, preferably one knowledgeable of clinical lab regulations. At a minimum, a program should include:

1. written code of conduct for employees

2. the development and distribution of written policies that promote the lab's commitment to compliance and that address specific areas of potential fraud, such as billing, marketing, and claims processing

3. the designation of a high-level corporate structure or official (e.g., a chief compliance officer) responsible for running the compliance program

4. the development and offering of education and training programs to all employees

5. the use of audits and/or other evaluation techniques to monitor compliance and ensure a reduction in identified problem areas

6. the development of a code of improper/illegal activities and the use of disciplinary action against employees who have violated internal compliance policies or applicable laws or who have engaged in wrongdoing 

7. the investigation and remediation of identified systemic and personnel problems

8. the promotion of, and adherence to, compliance as an element in evaluating supervisors and managers

9. the development of policies addressing the non-employment or retention of sanctioned individuals

10. the maintenance of a hotline to receive complaints, and the adoption of procedures to protect the anonymity of complainants

11. the adoption of requirements applicable to record creation and retention.

Each element is spelled out in greater detail in the Model, which can be obtained in the March 3, 1997 Federal Register or at the OIG's web site: http://www.sba.gov/ignet/ internal/hhs/hhs.html.

Though POLs were not specifically mentioned in the Model's introduction, that does not exclude them as a prime candidate to develop a compliance program. In light of the recent events where Federal agents raided Columbia/HCA Healthcare Corporation in El Paso to uncover suspected violations of prohibited referrals (see this month's "Washington Report"), every POL should have someone working to develop a compliance program.

Breaking US ground: Prothrombin time self-testing

Boehringer Mannheim Corp's CoaguChek System and International Technidyne Corp's ProTime Microcoagulation System have been approved by the FDA for marketing prothrombin time (PT) testing for self-testers and/or their care givers. For many laboratorians, this may be hard to swallow, but the fact is, more individuals are being prescribed warfarin (Coumadin) therapy, which requires regular PT monitoring. Providing the modality for self-testing for PTs creates an easier, more cost-effective, and healthier way to manage warfarin therapy.

The goal of warfarin therapy is to maintain a particular PT, which prevents excessive clot formation or bleeding. PT self-testing has been available in Europe for several years where studies have shown PT self-testers have excellent compliance with treatment regimens.

C. Anne Pontius is a member of MLO's Advisory Board and president of Laboratory Compliance Consultants, a laboratory consulting firm in Raleigh, N.C.