Anesthesia Coding Alert

Basically, the work involved in a medical trial is divided between treatment that is part of the research trial and other supporting treatment that is medically necessary for the patient. All medically necessary treatments and monitoring during a clinical trial are covered if the condition being treated is usually covered under normal circumstances.

"If you're having a nose job to look better and are enrolled in a study that looks at an improvement in either anesthesia or surgical technique, you would not be covered because the nose job (cosmetic surgery) is a non-covered service by Medicare and most other carriers," explains Scott Groudine, MD, director of clinical research for the department of anesthesiology at Albany Medical Center in Albany, N.Y. "But if you're having a below-knee amputation under spinal anesthesia, and a new spinal drug is being tested in an approved clinical trial, then the anesthesia and all medically necessary treatment would be covered by Medicare."

Note: If the patient's nose job in the first part of this example is performed for a noncosmetic reason (such as 738.0, Acquired deformity of nose), it would be a covered service.

In addition to determining which services are medically necessary, you also need to know which services to bill to the research sponsor versus the patient's insurance carrier. For example, if there were concerns that the new spinal drug in Groudine's example could cause EKG or liver function changes, these would be monitored during the patient's procedure. Any charges for EKG or liver function tests specifically to monitor for this possibility would be study-related expenses and would be billed to the study sponsor instead of the insurance carrier. But if an EKG was performed because of chest pain or another medically indicated reason (not because of concerns related to the drug under study), it would be covered by the patient's insurance as medically necessary.

As with any patient, the anesthesia record from a clinical trial must include a medical diagnosis code related to the care. Primary diagnoses can vary widely, depending on why the trial is being conducted. For example, Groudine is involved with a clinical trial studying a new epidural drug used for lower abdominal surgery and has also looked at new pain medications for people in chronic pain from HIV, cancer or other conditions. Primary diagnosis codes for these patients include conditions such as 789.07 (Abdominal pain; generalized) for the abdominal surgery patients; V08 (Asymptomatic human immunodeficiency virus [HIV] infection status) or 042 (Human immunodeficiency virus [HIV] disease) for the patients with HIV; and 786.51 (Chest pain; precordial pain) or 162.3 (Malignant neoplasm of trachea, bronchus, and lung; upper lobe, bronchus or lung) for the cancer patients.

You also must include a secondary diagnosis of V70.5 (Health examination of defined subpopulations) for patients participating in clinical trials that you expect Medicare to cover. You can assign a maximum of four diagnosis codes to document the patient's problems, depending on the physician's preferences and the extent of the patient's problems.

In addition to the appropriate diagnosis codes, modifier -QV (Item or service provided as routine care in a Medicare qualifying clinical trial) is also reported for Medicare trials. Because the modifier is line-item specific, use it to identify each item or service that represents medically necessary care or treatment of complications during the clinical trial. Any services provided during the same session that do not qualify for Medicare coverage (such as routine postoperative care or starting peripheral IV lines) should not be appended with modifier -QV.

Groudine gives this example of how several different codes can come into play for a research situation: A patient with ovarian cancer is scheduled for a radical hysterectomy. The hospital where her surgery will be performed is participating in a study on blood substitutes. She elects to enroll in the study and is accepted for it because she is expected to lose enough blood during the surgery to require a transfusion. Codes associated with her surgery include:

The blood-substitute manufacturer may want to know how the blood substitute affects the wedge pressures and cardiac output and might require placement of a Swan-Ganz catheter for the procedure. If so, code 93503 (Insertion and placement of flow directed catheter [e.g., Swan-Ganz] for monitoring purposes) would be billed. Medicare (or the commercial carrier) would pay for the catheter's insertion if the patient requires it for care. But if the catheter is placed in a patient without an ICD-9 code that warrants such a procedure, it becomes a study-related expense rather than a medically necessary expense.

"I would use the -QV modifier only on procedures that are not usually performed but become medically necessary because of the known effects of the drug (e.g., a new anticancer drug that also causes rhythm disturbances)," Groudine adds. "If the Medicare patient is to benefit from this experimental drug, then safe medical practice mandates cardiac monitoring, which would not usually be medically necessary, but is now."

Because -QV is a Medicare modifier, it isn't used for patients who are on other insurance plans. But all other modifiers are appended as in any other situation, according to Valerie Puckett, BS, CPC, manager of compliance and reimbursement, professional services, of St. Jude Children's Research Hospital in Memphis, Tenn. The anesthesia services are also coded with CPT surgical or anesthesia codes as the carrier prefers, as are any other cases.

Getting appropriate reimbursement from carriers is one of the biggest challenges of billing for research care.

"We have some carriers who deny our work as investigational care, but others realize that the research is being done to benefit the patient," Puckett explains. "Any diagnostic imaging or other examinations that the study's principal investigator has determined are purely investigational (that is, they don't provide additional medically necessary care to the patient) are not billed to the insurance company. Anything else in the protocol that is medically necessary to treat the patient is billed to the insurance company."

Because St. Jude is a children's hospital, Puckett says, the hospital does not bill to Medicare. But Medicaid and commercial carriers from across the country are billed for the hospital's services. "All carriers have their own ways of paying for what they determine to be research," Puckett adds

She and Groudine offer these guidelines for successful billing of research care:

Do not bill diagnostic tests (such as an MRI, CT scan, blood test, EKG or other procedures) to the insurance company if they don't provide any additional clinical value toward treating the patient.

Work closely with the study's principal investigator to determine which services were medically necessary for care (and will be covered by insurance) versus which services were performed to gather information for the researchers or vendor (and will be covered by grants or other fees with the study).

Prove that the clinical trial conforms to what Groudine terms "good clinical practice." This requires approval by an Institutional Review Board (IRB) and appropriate documentation of patient consent for participation in the study, as well as other items including appropriate record keeping, notification of the IRB of serious adverse effects, and retention of source documents.

Prevent clinical trials from being confused with investigational trials when you are billing for anesthesia's involvement in these situations. Clinical trials often compare two effective treatments to each other to see whether one is better than the other; the patient is being treated with something that should help him, and carriers will usually reimburse for his care. In many investigational studies, a technique or drug that might help someone is being investigated; reimbursement for these studies can be hit or miss. Since the NCD outlined above became effective, Medicare must pay for studies that meet the directive's research criteria.

Some commercial carriers also may reimburse for investigational trials, but others will reject payment for services that are part of unproven therapies. Work closely with your carrier to know its policies, and clearly document all work with trials to distinguish clinical from investigational work, and which services should be reimbursed by the carrier versus the study's sponsor. Finally, Groudine advises that "If you will be billing for a treatment that is not FDA-approved or has not been shown to be effective, it is prudent to speak to the principal investigator of the study about how you are to be paid. [The principal investigator] will either reimburse you for services provided or help you get compensation from third-party payers."