Frequently Asked Questions

MIST Therapy Coverage:

Does Medicare cover MIST Therapy®?

Several Medicare contractors cover CPT 97610/previously CPT0183T. Local Medicare contractors determine coverage for providers in their jurisdiction. If you have questions about your coverage, please contact the Celleration Reimbursement Department through email.

We were told that MIST Therapy is experimental. Is that true?

MIST Therapy was cleared by the FDA in 2004 and it is supported by over 20 peer-reviewed published articles.  It has been used to treat over 75,000 patients in over 800 locations throughout the United States.

Effective January 1st, 2014, MIST Therapy was granted a Category I CPT code, 97610, based on the clinical benefits on MIST.  Prior to this, MIST Therapy had a Category III designation (CPT  0183T), an “emerging technology” code issued by the American Medical Association.  Both the AMA and CMS (Medicare) write that these codes are not investigational or experimental, but are rather more specific, more functional versions of unlisted codes that many payers cover.  If you were told that MIST Therapy was experimental, it may be a carry-over from the previous CPT 0183T code.

What is the Medicare Advance Beneficiary Notice (ABN) and how should it be used?

This written notice may be given to patients before receiving certain items or services and notifies the patient that Medicare may deny payment for that procedure or treatment.  For more information, please contact our Reimbursement Department through email.

Do you have documentation of specific payer coverage policies for MIST Therapy?

Yes.  Celleration has researched this extensively and has coverage/medical policy documents from local Medicare contractors and commercial payers. To obtain coverage information for your specfic area, contact the Reimbursement Department through email.


Our clinic researched CPT 97610 and discovered that we will not be reimbursed. What should we do now?

Request a Prior Authorization, and appeal the Prior Authorization if denied. Ask the patients to advocate for their health care by contacting their insurance company or employer. Complaints about non-coverage coupled with clinical evidence can prompt payers to overturn their non-coverage policy. Online forms and additional information can be found here in the Document Library.

How can we treat all patients equally when some payers will not cover MIST Therapy?

As a healthcare provider, you have chosen to prescribe MIST Therapy to your patients. It is the insurance company, not you, that is restricting access.  Offer MIST Therapy to your patients as an out-of-pocket  expense and make them aware of their insurance company’s non-coverage.  You may also provide them with information they can use with their insurance company.  Online forms and additional information can be found here in the Document Library.

What have other new wound care technologies done to gain coverage?

A combination of clinician advocacy, patient advocacy, and clinical research is critical to gaining insurance coverage for new technologies.  Over 85,000 patients have benefited from MIST Therapy, over 1000 are included in peer-reviewed, published studies.  Clinicians and patients must advocate for coverage by contacting payers, requesting Prior Authorization, and appealing any non-coverage determinations. Online forms and additional information can be found here in the Document Library.


Prior Authorization:

We are worried about denied claims if we bill MIST Therapy treatments. What should we do?

The first step is to submit a prior authorization.  Online forms and additional information can be found here in the Document Library.

Do you have a simple Prior Authorization Request Form?

Yes. You can download an electronic copy here.

Coding, Billing and Payment:

We billed for MIST Therapy in the past and were reimbursed, but now we are not being reimbursed.  What has changed?

Medicare Contractors have the right to establish and modify coverage policies at their discretion.  Refer to the CMS website to determine if a Local Coverage Decision (LCD) has been implemented by your Medicare Contractor

How much is the reimbursement for our location?

For providers reimbursed under the Medicare APC rate, your locally adjusted amount may vary ±15% based on your wage index.  For providers reimbursed under the Medicare Physician Fee Schedule (MPFS), Medicare has set a rate for facility and non-facility settings.  These rates will vary ±30% depending on your regions geographic adjustment.  Please check your Medicare Administrative Contractor (MAC) fee schedule for the appropriate amount in your region.


When can a Skilled Nursing Facility (SNF) be paid separately for MIST Therapy treatments performed on a Medicare patient in a Part B stay?

Physical therapy is a billable service for SNF Medicare patients’ episodes who no longer qualify under part A.  these part B stays must be billed by the SNF even when another entity renders the services under an arrangement with the SNF.  Part B rehabilitation services must be billed by the SNF for Part B residents.  The MPFS is the payment basis for these services.  Please see Medicare’s Claims Processing Manual, Chapter 7 for more information.

Is CPT 97610 for MIST Therapy and CPT codes for other wound care procedures bundled?

The National Correct Coding Initiative (CCI) edits are lengthy and complex, and different for physician billing and hospital outpatient billing. As of January 1, 2015, CPT 97610 is allowed with CPTs 11000, 11004, 11005, 11006, 11010, 11011, 11012, 11042, 11043, 11044, 11720, 11721, 97035, 97597, 97598, 97602, 97605, 97606, 97607, and 97608 only when an appropriate modifier is needed and used on the second code reported.  CPT Code 97610 is never allowed to be billed with CPTs G0245-G0247 (Podiatric Codes for Evaluation and Management of Patients with LOPs). There are no CCI edits for CPT 29580 (Unna Boot) or CPT 29581 (Multi- Layer Compression), when billed with CPT 97610. Remember that coverage and payment of CPT 97610 is always subject to a payer’s coverage determination regardless of CCI edits. CCI edits are updated quarterly; consult the CMS website for current information on both the physician and hospital billing edits for CPT 97610.


Does Celleration seek payment from payers for MIST Therapy equipment and supplies?

Unlike negative pressure wound therapy, the MIST Therapy ultrasound device is used on multiple patients in a given month.  Furthermore, it is recommended that MIST Therapy be performed by a licensed, trained clinician.  In most cases, MIST Therapy is not considered a DME item, thus Celleration cannot bill payers as a DME supplier.


Appealing Denied Claims:

I received a claim denial.  What should I do next?

Online forms and additional information to assist you in preparing your appeal can be found here in the Document Library.  If you require assistance in preparing your appeal, contact the Celleration Reimbursement Department through email.

Will it take a long time to prepare the appeal?

No.  Celleration will provide you documentation for your appeal based on the reason for the denial.  Information specific to the patient (which you likely already have in the patient’s file) should accompany the MIST Therapy / CPT 97610 evidence.   Simply combine these pieces and mail to the payer. Online forms and additional information can be found here in the Document Library.

Is it worth it to appeal the denial? It was only for one MIST Therapy treatment.

Yes, for a number of reasons.  First, the easiest thing for a payer to do is deny a claim, especially on the basis of “new and experimental.”  Appealing a claim denial gets the attention of a higher level clinician who reviews the MIST Therapy evidence, patient history, and medical necessity.  Second, appealing claim denials is a “grass roots” effort to change payer coverage policy.

With enough appeals and overturning of denied claims, payers will revise their coverage policy.  Finally, you are appealing not a single MIST Therapy treatment, but usually several treatments over the course of the patient’s wound care.


How often do payers overturn their original denials?

Very often.  In 2006, America’s Health Insurance Plans reported that ~40% of appeals are overturned.  A 2007 report from the New York Insurance Department reported that over 46% of appeals are overturned.

Can I ask the patient to submit the appeal?

If the payer requires the patient to submit the appeal, then please inform your patient.  Your patient may contact the Celleration Reimbursement Department through email for help in preparing the appeal.  Patient appeals can be very compelling to a payer and to the patient’s employer, especially when that employer is a “self-insured” group. An online Patient Reimbursement Brochure can be found here in the Document Library.


What is a “self-insured” employer?

Many large employers are self-funded or self-insured, meaning the employer ultimately pays for the medical care of its employees and their covered dependents.  The insurance company only acts as an administrator by providing a preferred network of healthcare providers and processing claims.  Patients with a “self-insured” employer should  contact their benefits manager, with Celleration’s assistance, to explain their desire to receive MIST Therapy for their non-healing wound.

What should I send to the payer with my appeal?

Celleration will provide you customized, electronic documents to appeal the claim based on the denial reason. Online forms and additional information can be found here in the Document Library.


How do I appeal a Medicare denial?

Medicare has three steps for appealing any denial, including a denial based on a Medicare contractor’s non-coverage policy.  Each step must be followed in sequence and has deadlines for submitting the appeal.  If you require assistance in preparing your appeal, contact the Celleration Reimbursement Department through email.  Online forms and additional information can be found here in the Document Library.