Gastroenterologists, however, must be careful to apply the correct diagnosis code and obtain precertification with carriers for the procedure.
Some payers are still being cautious, but for the most part they recognize that the procedure has been successful, and we arent having much trouble getting our claims reimbursed, says Mark Noar, MD, a gastroenterologist in Towson, Md., who has performed the Stretta procedure over 70 times in the past six months.
FDA Approved Stretta for GERD
The Food and Drug Administration (FDA) approved the procedure in April 2000 for the electrosurgical coagulation of tissue and it is intended for use specifically in the treatment of gastroesophageal reflux disease, according to official documents from the agency.
The Stretta procedure, which is performed with special equipment manufactured by Curon Medical, is a minimally invasive treatment using radio-frequency energy to treat patients with symptomatic GERD by destroying the nerve-afferent pathways believed to be responsible for the reflux. Everyone has reflux, but when a patient has GERD, the sphincter muscle is constantly relaxing and causing constant reflux, Noar says. You have to have a nerve impulse for the muscle to relax and loosen. When there is a lack of nerve impulses, the muscle tightens.
An upper gastrointestinal endoscopy is first performed to visualize the esophagus and upper gastrointestinal tract, Noar continues. The scope is then removed and an endoscopic catheter with a balloon at the tip is inserted into the patient. The balloon is inflated, and needles containing radio-frequency probes are deployed into the mucosa. The radio-frequency energy turns to heat, creates a burn 1 to 2 millimeters in size, and destroys some of the nerve-afferent pathways. The catheter is retracted and repositioned before the process is repeated. About 40 to 80 burns are created in one session, ablating nerves in both the lower esophageal sphincter AND the cardia.
1. Report 64640 Twice
Gastroenterologists should use the following codes when reporting the Stretta procedure, according to Karin Bolinger, director of reimbursement at Curon Medical, headquartered in Sunnyvale, Calif.
Code 43258 (upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with ablation of tumor[s], polyp[s], or other lesion[s] not amenable to removal by hot biopsy forceps, bipolar cautery or snare technique) should be used to report the upper gastrointestinal endoscopy. Code 64640 (destruction by neurolytic agent; other peripheral nerve or branch) should be used to report the destruction of nerves in the lower esophageal sphincter. To receive reimbursement for this code from Medicare, the procedure must be performed in an outpatient hospital setting. For patients with a commercial insurer, it may be done in an ambulatory surgery center.
Code 64640 should also be used a second time to report the destruction of nerves in the cardia. Modifier -51 (multiple procedures) should be attached to this second listing of the code to indicate that multiple procedures were performed during the same operative session.
Code 99141 (sedation with or without analgesia [conscious sedation]; intravenous, intramuscular or inhalation) may also be billed to private payers, says Bolinger. However, this code should not be reported to Medicare carriers, which have bundled this service into all endoscopy codes and will not reimburse separately for it. In fact, it may be fraudulent to bill a Medicare carrier for conscious sedation.
2. Apply Correct Procedure and Diagnosis Codes
HCFA sent a letter to representatives of Curon Medical last year confirming that 64640 could be used when reporting the Stretta procedure because its underlying action in treating gastric reflux disease is primarily due to partial destruction of nerves, which falls under this code.
In a subsequent letter, HCFA stated that two ICD-9 codes, 530.11 (reflux esophagitis) and 530.81 (esophageal reflux), would be appropriate primary diagnoses for the procedure. (The FDA has cleared the procedure only for use on GERD patients at this time, stresses Bolinger.)
The HCFA letter on appropriate CPT and ICD-9 codes should not, however, be construed as a national reimbursement policy for the Stretta procedure. The letter is not binding on the carrier, says Bolinger, who adds that only a local medical review policy is binding. Missouri and Arkansas, for example, are two states whose carriers Bolinger knows wont cover the procedure.
3. Precertify Stretta With Commercial Payers
Coverage will also vary among commercial insurers. Bolinger states that the commercial insurers she has had contact with do not have a problem with the CPT codes used to report the Stretta procedure, but they may disagree with whether it is a covered benefit of the patient. Overall, however, she estimates that 72 percent to 75 percent of all Stretta procedures she has monitored have been reimbursed by payers. There are also expectations that more payers will cover this service once long-term efficacy studies on the procedure begin to appear in medical journals. The first such study is expected to be published this spring.
In addition, some commercial insurers have stated that while the Stretta procedure does not meet their standard criteria for coverage due to the lack of efficacy studies, they would be willing to consider coverage on a case-by-case basis for certain patients for whom the procedure has been determined to be the treatment of choice.
It may be useful for gastroenterologists to precertify coverage of the Stretta procedure with a private payer to determine if it will be reimbursed. Bolinger, whose company has been helping gastroenterologists with the prior-authorization process, recommends that the following information be included with the insurers precertification form:
patient history and physical documentation;
progress notes; and
results of any diagnostic testing including diagnostic EGDs and motility and Ph tests, if available.
4. GIs Must Prove Medical Necessity
The payer will also consider whether the Stretta procedure is medical necessarily. While an estimated 14 million Americans suffer from GERD, the new procedure is not an appropriate treatment for all patients with this diagnosis, Noar says. It may be medically necessary in the following situations:
The patient has chronic GERD, and his or her symptoms are resistant to current medical therapy. Either the patients symptoms cannot be controlled despite the use of medication, or the patient is taking two or three types of medication to control the disease, Noar says.
There are external manifestations such as a chronic cough or sinusitis that might compromise the lungs and vocal cords; or
The patient wants to avoid major surgery such as an esophagogastric fundoplasty.
Not all gastroenterologists find it necessary to precertify the procedure, however. We always call to ask if the payer wants us to precertify, says Cathi Coscia, an insurance clerk with Gastrointestinal Associates P.C. in Knoxville, Tenn., which has recently begun performing and billing the Stretta procedure. Most of them dont ask us to do that for the Stretta because these codes have been in existence for a while.
Coscia says that her practice has the patient sign a waiver acknowledging financial responsibility for the procedure before it is performed, in case the payer does not cover it.
Finally, most Medicare carriers will not precertify the Stretta procedure, according to Bolinger. With Medicare carriers, its harder and takes them longer to respond, she says. They wont do a proactive review of a case; you have to wait until they get the claim.