An implanted infusion pump for chronic pain is covered by Medicare when used to 1) administer opioid drugs, singly or in combination with other opioid or non-opioid drugs, 2) intrathecal or epidural route; 3) for treatment of severe chronic intractable pain of malignant or nonmalignant origin in patients who have a life expectancy of at least three (3) months, and 4) the pain has been proven to be unresponsive to less invasive medical therapy.
In order to be considered medically reasonable and necessary, all of the following criteria must be met and clearly documented in the beneficiary’s medical record:
- The administration of the medication must require the intrathecal or epidural route and be effective on a long-term basis and
- Oral or subcutaneous medication treatment are ineffective or complicated by unacceptable side effects and
- The patient's medical condition must require the use of an infusion pump for pain relief due to failure of other treatment modalities and
- The type and dosage of the medication must reasonably be expected to alleviate or reduce the pain effects.
In addition, an evaluation by an orthopedic surgeon, neurologist, neurosurgeon, oncologist or other specialist familiar with the underlying disease is required to validate that other treatments have failed to alleviate the pain and no other reasonable options are available at the time of the evaluation. Documentation that the patient is unresponsive to less invasive medical therapy shall be kept in the patient's medical record and made available upon Medical Review request.
If the above criteria have been met, a preliminary trial of intraspinal opioid or non-opioid drug administration must be undertaken with a temporary intrathecal/epidural catheter to substantiate acceptable pain relief, degree of side effects including effects on the activities of daily living, and patient acceptance and compliance.
Any drug(s) used to fill the implantable pump must be appropriate for the treatment of the individual patient. Drugs compounded for the special needs of a patient may be covered. Drugs filling the pump are often obtained singly or mixed with other drugs from compounding pharmacies. Unless the medications are administered in the exact concentrations available from national pharmaceutical companies, the medications will be considered as compounded.
FDA approved drugs used for indications other than what is accepted on the official Prescribing Information label may be covered under Medicare if the contractor determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature, and/or accepted standards of medical practice. The following are examples of medications that are approved for off-label intrathecal use. This list of drugs is not an all-inclusive list.
- Clonidine (Duraclon) (J0735-KD)
Contraindications to coverage: Implantation of an infusion pump is contraindicated under the following circumstances:
1.The patient has a known allergy or hypersensitivity to the drug being used;
2. Patients who have an infection in particular an infection at or near the implantation site; and
3. Patients whose body size is insufficient to support the weight and bulk of the device.
The patient’s medical record documentation must support the reasonable and necessary requirements as outlined under the indications and limitations of coverage. The patient’s history must indicate that he/she has not responded adequately to noninvasive methods of pain control such as:
- Combination of oral analgesics (including opioids) plus other drugs known to relieve pain such as:
- anti-seizure medication or
- others known to medicate pain; or
- Attempts to eliminate physical and behavioral abnormalities which may cause an exaggerated reaction to pain.
All of the procedure codes that are related to the refilling and the management of the pump must be billed and documented on the same claim form, including the drugs that are being administered through the pump. The drugs are not to be billed on a separate claim form. IOM Medicare Claims Processing Manual, Publication 100-04, Chapter 17 - Drugs and Biologicals at Chapter 17 MCPM. Chapter 32 Billing Requirements for Special Services at Chapter 32 MCPM.
At the time of the pump refill and/or the pump interrogation and/or the pump reprogramming, documentation should include at a minimum:
- The pump status before and after the refill,
- The patient’s response to the current medication dose and rate,
- The reasons for any change in dose or the types of medications,
- A reassessment of the patient's overall condition and treatment goals (this may be reported as an E&M service),
- Proof that all applicable "incident to" requirements are met, and
- Proof that any medication billed to Medicare represents a cost to the physician or group accepting Medicare payment.
A preliminary trial of the intrathecal/epidural opioid drug or non-opioid administration must be undertaken with a temporary intrathecal/epidural catheter to substantiate adequate acceptable pain relief. The degree of side effects (including the effects on the activities of daily living) and the patient’s acceptance of and compliance with the therapy must be documented in the patient's record.
Legible physician’s medical documentation must be maintained in the patient’s medical record and meet the criteria contained in this article. The subsequent determination that the medical record is lacking the justification for the services and/or that the documentation of the services are illegible will result in a denial as not reasonable and necessary.
A periodic reassessment of the patient should be performed according to the needs of the patient and the applicable medical standards. The frequency for interrogating and/or reprogramming the pump (62367 and 62368) should be supported by the patient's symptoms. The frequency for refill must take into account the size of the pump and dosage of the medicine. Noridian has seen problems in the past that included unnecessary frequency of interrogation and refills of the pump every month despite having a pump of 2 or 3 month capacity.
Compounded drugs are contractor priced under Medicare Part B. Noridian will reimburse compounded drugs for use in implanted infusion pumps by multiplying the price per mcg or mg in the table below by the total number of mcg or mg of each drug used to refill the pump. In addition to the combined allowable calculated by the dosage detailed, a pharmacy compounding fee of $60 per refill will be included in the total allowable for the refill. When these drugs are provided in the hospital outpatient department by providers paid under OPPS, no separate payment is made for these drugs. The payment allowance is packaged into the payment for other services provided on the claim.
| Drug Name |
Drug Fee |
Measure |
|
|
|
| Baclofen |
$0.0030 |
per mcg |
|
|
|
| Bupivacaine |
$0.0400 |
per mg |
|
|
|
| Clonidine |
$0.0010 |
per mcg |
|
|
|
| Droperidol |
$0.0013 |
per mcg |
|
|
|
| Fentanyl PF |
$0.0072 |
per mcg |
|
|
|
| Hydromorphone |
$0.1300 |
per mg |
|
|
|
| Ketamine |
$0.0048 |
per mcg |
|
|
|
| Lidocaine |
$0.0400 |
per mg |
|
|
|
| Meperidine |
$0.0600 |
per mg |
|
|
|
| Methadone |
$0.0600 |
per mg |
|
|
|
| Midazolam Hcl |
$1.1500 |
per mg |
|
|
|
| Morphine Sulfate |
$0.0500 |
per mg |
|
|
|
| Ropivacaine |
$0.068 |
per mg |
|
|
|
| Sufentanyl |
$0.0900 |
per mcg |
|
|
|
| Tetracaine |
$0.0400 |
per mg |
|
|
|
| Ziconotide |
$9.041 |
per mcg |
|
|
|
| Compounding Fee |
$60.000 |
per cartridge |
|
|
|
Resources
- Angel IF, Gould HJ, Carey ME. Intrathecal morphine pump as a treatment option in chronic pain of nonmalignant
origin. Surg Neurol. Jan 1998;49(1):92-8.
- Chang HM. Chronic Pain, Cancer Pain Management. Med. Clinics of North America. May 1999;83(3):712-36.May 1999;83(3):712-36.
- Dougherty P, Staats PS. Intrathecal Drug Therapy for Chronic Pain: From Basic Science to Clinical Practice. Anesthesiology. Dec 1999;91(6):1891-918.
- Fanciullo GJ, Rose RJ, Lunt PG, Whalen PK, Ross E. The state of implantable pain therapies in the United States: a
nationwide survey of academic teaching programs. Anesth Analg. Jun 1999;88(6):1311-6.
- Gilmer-Hill HS, Boggan JE, Smith KA, Frey CF, Wagner FC, Eein LS. Intrathecal morphine delivered via
subcutaneous pump for intractable pain in pancreatic cancer. Surg Neurol. Jan 1999:51(1):6-11.
