What is Cervical-Stim

Cervical-Stim is a new, noninvasive, Pulsed ElectroMagnetic Field (PEMF) bone growth stimulator indicated for adjunctive use to increase the frequency of cervical fusion success by six months in high-risk (i.e., multilevel fusion, smoking, allograft) patients.

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Which patients are considered high-risk?

The Cervical-Stim was clinically studied in high-risk subjects who had undergone cervical fusion with allograft for degenerative conditions and were smokers (one pack per day or more), multilevel fusion or both. Other conditions that may put a patient at high risk for a failed fusion are diabetes, obesity, osteoporosis, chronic oral steroid use, and any metabolic bone disease. A high-risk patient may have difficulty with bone healing due to any of these risk factors.

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How does Cervical-Stim work?

Cervical-Stim Cervical Fusion System is an external, low-level Pulsed ElectroMagnetic Field (PEMF) treatment device, which helps activate and augment the body's natural bone healing process after fusion surgery.

The device contains a microprocessor (computer chip) that generates the therapeutic treatment signal. The Cervical-Stim is battery-powered and has an integrated control unit and treatment transducer combined in a single piece device, which allows the patient ambulatory treatment. The system is placed on the neck and may be worn with or without a brace.

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What is PEMF and how does it work?

PEMF stands for Pulsed ElectroMagnetic Field and is a low-energy, time-varying magnetic field that has been proven effective in promoting bony arthrodeses in fracture nonunions. Application of PEMF activates the body's natural repair mechanism when it is absent or not fully functional in certain patients, and enhances bone growth for successful fusion outcomes.

The technology and design utilized is the same as that of Orthofix's other FDA-approved bone growth stimulators currently marketed by Orthofix International, N.V.

The clinical success of PEMF bone growth stimulation has been clinically proven and used successfully on more than 200,000 spine patients since 1990.

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Can I bill private health plans or other third party payors (non-Medicare/Medicaid) for stimulation products?

Yes, in many situations you may bill and obtain reimbursement from private health plans (and in some cases, workers' compensation programs) for stimulation products. Please be advised, however, that some health plans may require that you be a credentialed participating Durable Medical Equipment (DME) supplier in the plan to bill for and collect reimbursement for these devices. Such plans conduct audits to verify the physician's contract status and will deny payment (or recoup payments already made) for DME if the physician or physician group is not contracted as a network DME supplier.

In addition, there are laws in certain states that govern physician "self-referrals." If your state has such a law, it could affect your provision of, and billing for, our stimulation products.

We recommend that you: (i) check with each health plan to identify the requirements, if any, which you need to meet in order to bill for and collect reimbursement for our stimulation products; and (ii) consult with your health care attorney to assess compliance with applicable state law (if any).

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Can I bill Medicare and Medicaid for stimulation products that I purchased and prescribed to my patients?

No, the federal physician self-referral prohibition, known as the "Stark Law," effectively prohibits physicians from self-referring most items of DME payable by a federal healthcare program. This means that physicians cannot bill Medicare and/or Medicaid for our stimulation products, even in situations where the physician or physician group has obtained a Medicare DME supplier number from the National Supplier Clearinghouse.

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Are there general coverage criteria for stimulation products?

Many health plans and other private insurers have medical policies and coverage criteria specific to noninvasive bone growth stimulators, including our stimulation products. We recommend that you check with the applicable health plan or payor to identify these coverage requirements.

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What HCPCS codes should I use with health plans and other third party payors for the stimulation products?

The following HCPCS codes are recommended for use with our stimulation products:

  • Cervical-Stim: E0748 – Osteogenesis stimulator, electrical, noninvasive, spinal applications.
  • Physio-Stim: E0747 - Osteogenesis stimulator, electrical, noninvasive, other than spinal applications.
  • Spinal-Stim: E0748 - Osteogenesis stimulator, electrical, noninvasive, spinal applications.

 

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I have been asked by a health plan to provide an invoice. Why is this necessary?

While many health plans reimburse stimulation products pursuant to a fee schedule, there are several plans that reimburse them on a cost basis (e.g., actual cost + 10%). In these situations, the health plan requires the physician to submit the manufacturer invoice to determine reimbursement.

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Do I have to collect copayments or coinsurance from patients?

Generally, yes. In fact, the routine waiver of coinsurance amounts owed by patients covered through Medicare and/or Medicaid is unlawful and can result in fines and penalties for the party that waived the coinsurance. There is an exception for waivers of coinsurance that are offered or provided based on financial hardship.

For a patient enrolled in a private health plan, the waiver of such out-of-pocket obligations could violate the participation agreement with the plan. In one such case, and based on a theory that the health plan's obligation to reimburse the provider is contingent on the patient's obligation to pay, a court ordered a provider to repay to a plan all reimbursement made on behalf of enrollees whose copayments are waived.

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Are there documentation requirements?

Yes. Depending on the health plan, you may be required to submit and/or retain the following documentation: prescription order form, letter of medical necessity, X-ray reports, and medical records. Again, we suggest that you check with the applicable health plan or payor to ascertain your documentation requirements.

As you can see, physician billing for items of DME, including our stimulation products, sometimes can get complicated. For this reason alone, we recommend that you discuss the propriety of any billing arrangement with your legal counsel.

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