Carticel, Patented TechniqueExperts Disagree
In September 1997, Genzyme Corporation won FDA approval for its ACI technique (Carticel), which promises a culture return of 12 million cells. So far, the procedure has approval only for hyaline cartilage on the femur.
Glen Booma, associate director of marketing and reimbursement in outcomes research at Genzyme, explains the recommendations Genzyme makes for coding the procedure. Booma notes the two-step coding requires the use of a code for the biopsy/harvesting and another for the implant that occurs several weeks later. He says practices typically lump [harvesting] together with another procedure.
Blair Filler, MD, expert coder and director of medical education at Los Angeles Orthopedic Hospital, says, The only safe and reasonable way to code this procedure is with 27599 (unlisted procedure, femur or knee) in both the first and second surgery. He explains that modifier -58 (staged or related procedure or service by the same physician during the postoperative period) is also usually in order for the implantation (second) surgery.
Working with payers on a regional basis, Genzyme has come up with specific coding recommendations according to Booma. But Filler and Susan Callaway-Stradley, CPC, CCS-P, an independent coding consultant and educator in North Augusta, S.C., see the use of the codes for harvesting as far too much of a stretch. Filler and Callaway-Stradley do not advise using the unique CPT codes Genzyme recommends for harvesting. Instead, they say coders should stay with the unlisted code.
Booma says in many cases one of three arthroscopic codes can be used to describe the harvesting. They are 29870 (arthroscopy, knee, diagnostic, with or without synovial biopsy, separate procedure), 29874 (arthroscopy, knee, surgical; for infection, lavage and drainage for removal of loose body or foreign body, e.g., osteochondritis dissecans fragmentation, chondral fragmentation), or 29877 (debridement/shaving of articular cartilage, chondroplasty).
Callaway-Stradley gives one example of why she would not use any of the unique codes for harvesting. The definition for 29874 implies that some ongoing disease process is being treated, that in other words, chondral fragmentation has occurred and is being removed because it is problematic, not that a sample of healthy tissue is being removed. She recommends calling the carrier first.
How Do Payers Respond to Carticel?
Roughly three-quarters of patients [via their physicians] who ask for approval get it, says Booma. And that is with mandated third-party reviews.
Standing BlueCross BlueShield of Massachusetts (BCBS-Mass.) policy regarding ACI, effective April 1998 (reviewed March 1999) illustrates one carriers approach.
Note: ACI coverage is very much a carrier-by-carrier call. No one over 55 is a candidate for the procedure. Age limits may rise late with more successful trials.
BCBS-Mass. sets the age cap at 45 years or less at the time of surgery. There are many conditions that must be met, including the size of the cartilage defect (which must be at least 2 centimeters across), absence of bone involvement, absence of degenerative arthritis, presence of symptoms for more than a year, a stable knee. Note: FDA approval does include the use of Carticel for degenerative arthritis and carriers will not consider paying for the technique in cases of osteoarthritis or rheumatoid arthritis.
The BCBS-Mass. policy does not cover meniscal allograft (using foreign tissue, or cells from another individual for the implant) under any circumstances. BCBS-Mass. guidelines for approval are not unusual, although many carriers are more flexible on the age cap.
Cartilage disappears for many reasons. Tissue damage from a microinjury is one. Osteoarthritis as a primary or secondary condition is another.
Scraping existing cartilage (chondroplasty) to encourage growth is a traditional treatment for reversing the loss. Cartilage plugs constitute a newer approach. Note: For more on both procedures see Coding for ACL Repair and Microfracture Chondroplasty, on page 83 of the November 1999 Orthopedic Coding Alert.
A newer way perhaps to halt the progression of vanishing cartilage is a technique called autologous chondrocyte implantation (ACI). The ACI procedure takes advantage of the abilityfirst demonstrated by Swedish researchers in 1994to culture cartilage cells outside the body.
ACI involves a multistep process. Cartilage cells are removed (harvested) from a joint, cultured outside the body (in vitro), and when they reach a large number, implanted at the site where they are needed.
What makes ACI so attractive is that it may increase the amount of true hyaline cartilage in articular areas, whereas chondroplasty tends to encourage the growth of fibrocartilage as substitutes for hyaline cartilage. That is not the most desirable outcome because hyaline cartilage is structured to absorb shock and to tolerate forces such as compression. Yet hyaline cartilage lacks blood vessels (is avascular) and mends itself very haphazardly, if at all.
ACI may give surviving hyaline cartilage chondrocytes the boost they needin vitroto multiply. When the approximately 5 to12 million cells that were cultured (for 4 to 5 weeks) are implanted in the articular area where they were needed, they give a joint a good chance of recovering its nearly frictionless contact points.