Pathology/Lab Coding Alert

Coverage for hepatitis tests generally depends on appropriate documentation of signs and symptoms of disease, as explained in the September 2001 Pathology/Lab Coding Alert, "Know Laboratory Methods and Coverage Indications for Payment of Hepatitis Tests." However, special coverage rules allow testing in certain asymptomatic patients who are considered high-risk for contracting hepatitis.
 
Special coverage rules for hepatitis testing have been established for individuals undergoing repeat dialysis for end-stage renal disease (ESRD). Laboratories should be aware that the Office of Inspector General (OIG) identified "hepatitis tests to dialysis patients that were not reasonable and necessary for the diagnosis or treatment of illness at the frequency provided" as part of its 2001 work plan (available on the Internet at www.dhhs.gov/progorg/oig/wrkpln/2001/wp2001.pdf. You will need Adobe Acrobat -- available free at www.medville.com). Following approved hepatitis testing guidelines for these patients is imperative to avoid investigation for fraud.
 
Other asymptomatic patients, such as those exposed to infected blood, are subject to special coverage for hepatitis testing also. This includes certain transfusion recipients identified as part of the hepatitis C (HCV) "look-back" under Food and Drug Administration (FDA) guidelines. These patients received a blood transfusion prior to routine testing for HCV in 1992 and, based on subsequent testing, are believed to have received HCV-infected blood. 

 
Many services for patients undergoing repeat dialysis for ESRD are reimbursed by Medicare at a composite rate. "However, hepatitis tests are not included in the ESRD composite rate and are billed separately," says Michelle Phillips, RHIT, medical records specialist for Gambro Healthcare Inc. in Nashville, Tenn., which operates more than 500 dialysis facilities throughout the United States. "Prior to the initial dialysis, patients are routinely tested to establish their immune status and susceptibility to hepatitis, and the results are used to determine future hepatitis testing requirements."
 
Initial testing for hepatitis B includes hepatitis B surface antigen (87340, HBsAg), the first indicator of acute infection or the indicator of chronic infection if the level remains elevated; and hepatitis B surface antibody (86706, HBsAb), the indicator for seroconversion from past infection or immunization, Phillips says.
 
Because patients who are tested for hepatitis before beginning dialysis do not necessarily exhibit signs or symptoms of disease, using the proper diagnosis code is crucial for the tests to be covered. "We report both 585 (chronic renal failure) and V45.1 (renal dialysis status) as the diagnosis codes for these patients," Phillips says. Billing for hepatitis B surface antibody and antigen for ESRD beneficiaries requires these dual diagnoses, according to Medicare direction. In its recent "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients" in Morbidity and Mortality Weekly Report (MMWR, April 27, 2001), the Centers for Disease Control and Prevention (CDC) also recommends an initial test for total hepatitis B core antibody (86704, HBcAb; total), which is the indicator of acute, chronic or past hepatitis B infection. The CDC guidelines also call for an initial test for hepatitis C antibody (anti-HCV) (86803), and a confirmatory test (86804) if the first test is positive, as well as serum ALT (alanine aminotransferase) (84460) levels. 
 
"As is often the case with new practice guidelines, the CDC guidelines are not yet implemented into the Medicare rules," says Evelyn Butera, MS, RN, CNN, expert consultant for the updated CDC guidelines and quality-improvement manager for Satellite Healthcare Inc., operators of 14 dialysis facilities in Northern California. "Although Medicare has adopted previous CDC guidelines for hepatitis testing of ESRD patients, the new CDC guidelines do not automatically supplant current Medicare direction. The chief discrepancy between Medicare coverage and the CDC guidelines is the question of routine hepatitis C testing." Unlike the CDC recommendations, Medicare policy does not allow routine hepatitis C screening for ESRD patients.
 
"To my knowledge, dialysis units cannot follow the CDC guidelines and expect Medicare coverage," Butera says. "Hepatitis C testing is not covered by Medicare for these patients unless it is part of a diagnostic workup ordered because there is reason to think that the patient has hepatitis C." 
 
If physicians at the dialysis center determine a need for hepatitis testing more often than allowed by Medicare, whether based on CDC or other guidelines, they should submit additional documentation and petition their local carrier for coverage of those tests. Obtaining a signed advance beneficiary notice (ABN) will allow the physician to bill the patient if it is a noncovered service.    

According to CDC recommendations and Medicare Coverage Issues Manual (MCIM) section 50-17, follow-up testing for hepatitis should be based on the chronic hemodialysis patient's immune status, as determined by the initial testing. Hepatitis testing is covered according to the following guidelines, with variations between CDC and MCIM noted. Check with your local carrier for specific coverage policies.
 
Hepatitis B Guidelines (based on patient immune status)

 
1. Hepatitis B-susceptible patients (negative HBsAg, negative HBcAb, and negative or low HBsAb) (CDC defines low HBsAb titer as < 10 mIU/mL):
 

Monthly HBsAg testing.

Vaccinate against hepatitis B (90747). Continue to test as susceptible during vaccination series.

Test for HBsAb one to two months after last vaccine dose. If positive, patient is immunized (see number 4); if negative or low, repeat the monthly HBsAg and the vaccination series.

If patient remains susceptible following multiple vaccinations (non-responder to vaccine), continue monthly HBsAg testing. According to MCIM guidelines, but not according to CDC recommen-dations, these patients should also be followed with semiannual HBsAb testing.

 
2. Acute HBV-infected patients (initial test results may vary depending on the stage of infection):
 

Early incubation (positive HBsAg, negative HBcAb and negative HBsAb). Retest HBsAg and test HBcAb IgM (86705) and HBcAb total at one to two months following initial HBsAg positive test. At six months, retest HBsAg and test for HBsAb to determine resolution of infection. For recovered patients (HBsAg negative, HBsAb positive) follow number 3. If HBsAg is not negative in six months, see number 5.
 

Later infection (positive HBsAg, positive HBcAb and negative HBsAb). Retest HBsAg and test HBsAb at four to six months to determine resolution of infection. For recovered patients (HBsAg negative, HBsAb positive) follow number 3. If HBsAg is not negative in six months, see number 5.
 

Resolving infection (negative HBsAg, positive HBcAb and negative HBsAb). Retest HBcAb total and test HBcAb IgM on new serum specimen. If either test is negative, follow number 1 for susceptible patients. If both are positive, test for HBsAb in four to six months to determine resolution of infection. For recovered patients (HBsAg negative, HBsAb positive) follow number 3.

 
3. Past HBV-infected patients -- recovered and immune (negative HBsAg, positive HBcAb and positive HBsAb):
 

Annual HBsAb testing, according to MCIM guidelines (no further testing according to CDC).

 
4. Immunized HBV patients -- immune (negative HBsAg, negative HBcAb and positive HBsAb):
 

Annual HBsAb testing. If HBsAb is low, return to number 1.

 
5. Chronic HBV-infected patients -- carrier (positive HBsAg, positive HBcAb and negative HBsAb, when these results persist beyond initial six-month testing period):
 

Annual HBsAg testing. If HBsAg becomes negative, follow number 3.
 
Hepatitis C (CDC Recommendations)

 
1. HCV-negative patients:
 

Monthly ALT testing to identify new infections
 

Semiannual anti-HCV.

 
2. HCV-positive patients:
 

No additional HCV testing necessary except for treatment of disease.

 
Although HCV is the most common cause of post-transfusion hepatitis, blood was not routinely tested for the virus prior to 1992. In an effort to protect the blood supply and inform patients of past exposure, the FDA issued guidelines for testing and quarantining blood and notifying patients who may have received HCV-infected blood (go to www.fda.gov/cber and click on Regulatory Guidance).
 
In program memorandum A-99-4, CMS stated the expectation that all Medicare-participating hospitals would follow these guidelines. Since that time, the Department of Health and Human Services issued a joint proposed rule of FDA and CMS in the Nov. 16, 2000, Federal Register regarding the HCV look-back (information is available at www.nara.gov/fedreg/index.html, go to indexes to connect to that date). These regulations require hospitals to search their records to identify and notify recipients of HCV-infected blood.
 
Because Medicare does not generally cover screening tests in the absence of signs and symptoms of disease, some have questioned Medicare's coverage for testing patients identified through the HCV look-back. However, in program memorandum AB-99-12, HCFA clarified that "Medicare covers HCV testing for patients believed to have been exposed to HCV-infected blood, including those identified by the FDA look-back process."
 
The memorandum further defines patients who have been exposed as "(1) those receiving blood from a donor who tested negative at the time of donation but subsequently tests repeatedly reactive for the antibody to HCV on later donation; or (2) those receiving blood from a donor who tested positive on the FDA-licensed, more specific test or other follow-up testing recommended or required by FDA and for whom the timing of seroconversion cannot be precisely estimated."
 
The CDC outlined recommendations for HCV testing of asymptomatic patients in MMWR, April 27, 2001. The anti-HCV test recommended for screening involves enzyme immunoassay (EIA) for anti-HCV and, if positive, a confirmatory test using recombinant immunoblot assay (RIBA). Patients with positive results may be further tested using reverse transcription polymerase chain reaction (RT-PCR) for HCV RNA (87521) to eliminate false-positive results. Additional testing (e.g., ALT), may be required for patients with indeterminate results.
 
Because patients identified through the HCV look-back are often asymptomatic, coders must use the correct diagnosis code to identify the reason for the test, V15.85 (exposure to potentially hazardous body fluids).