Knowledge Base Article

In all the years I have been writing articles for this newsletter, I am sure that I have at least once referenced the saying, “the devil is in the details” because this saying so perfectly fits in the Medicare world. It is often all about the details. A perfect example of this is from the recent OIG report on payments for hyperbaric oxygen (HBO) therapy that did not comply with Medicare requirements. Specifically, the OIG looked at HBO therapy services paid by the Medicare Administrative Contractor (MAC), First Coast, during calendar years 2012 through 2015. The OIG selected First Coast, the MAC for Jurisdiction N, because it paid the second largest amount for HBO therapy in 2013 and 2014; the highest MAC payor, WPS, had already been audited by the OIG (OIG Review of WPS HBO Payments). The OIG found that First Coast made payments for HBO that did not comply with Medicare requirements for 110 of 115 claims – a denial rate of 92%. Based on these findings, the OIG estimates First Coast has “overpaid providers in Jurisdiction N $39.7 million during the audit period for HBO therapy that did not comply with Medicare requirements.”

The OIG Report of First Coast HBO Overpayments gives three examples of ways providers did not comply with Medicare requirements. These examples mirror issues I often see when reviewing HBO records. Also interesting is the fact that the errors are associated with the most common Medicare coverage conditions for HBO therapy. Medicare’s requirements for HBO therapy can be found in the National Coverage Determination (NCD) 20.29 for Hyperbaric Oxygen Therapy. Below is a summary of what the OIG found, along with additional information from other Medicare resources.

HBO Covered Condition – Chronic Refractory Osteomyelitis, unresponsive to conventional medical and surgical management:

The OIG example about osteomyelitis was for ‘Medicare Payment for HBO Therapy Without Failing Conventional Treatment,’ and it specifically noted “HBO therapy treatment began before the conventional

treatment had been completed.”

The First Coast HBO LCD (Local Coverage Determination) states concerning osteomyelitis, “(it) must be chronic and refractory to usual standard of care management (i.e., prolonged antibiotics therapy preferably directed by appropriate culture and sensitivity information, drainage of the abscesses, immobilization of the affected extremity, and surgical debridement with removal of infected bone). HBO for osteomyelitis that is not documented to be chronic and refractory to conventional treatment, and HBO not provided in an adjunctive fashion, is not covered.”

The medical record must also contain documentation that supports the diagnosis of chronic refractory osteomyelitis. For example, Palmetto GBA in findings and education from their reviews of HBO, requires the diagnosis be supported by imaging studies or bone description and positive cultures. When reviewing such records, I notice it is often difficult to determine how long the patient has had osteomyelitis, how the diagnosis of OM was confirmed, and exactly what treatments have been tried.

HBO Covered Condition – Preparation and preservation of compromised skin grafts (not for primary management of wounds):

In the OIG report, “there was no evidence that the beneficiary ever received a flap procedure. She had surgery that resulted in a wound that became infected and did not heal, but there was no evidence that she ever received a flap.” The OIG listed this as ‘HBO therapy That Was Not Medically Necessary.’

Additional guidance concerning HBO for skin grafts/flaps can again be found in the First Coast LCD and from Palmetto GBA education. From the FC LCD, “Preparation and preservation of compromised skin grafts utilizes HBO therapy for graft salvage in cases where hypoxia or decreased perfusion has compromised viability.” The LCD reiterates that per the NCD, coverage under this indication is “not for primary management of wounds.” The LCD also points out HBO for this indication requires the presence of a compromised skin graft, and does not include HBO treatment that is empiric treatment or prophylactic maintenance of grafts or solely for preparation of a wound bed for receiving a graft.

In a Palmetto Ask the Contractor teleconference from May 2018, Dr. Leland Garrett, Medical Director, responded to questions concerning HBO coverage and documentation requirements. Per Dr. Garrett, for Medicare coverage, skin grafts and flaps treated with HBO should not be a chronic wound that had a flap performed several months ago and has reopened as a new (non) healing wound. It is for more acute situations where the flap or graft area has dehisced or is lost partially or fully. Preservation would be to use HBO to prevent (or repair) the dehisced side, and preparation would be the use of HBO to a site where the previous graft or flap was completely lost and is being oxygenated with HBO as an attempt to promote granulation tissue for the site for a new graft or flap …”.  The physician’s documentation should include information about the original graft or flap procedure including the date of the procedure, or preferably, a copy of the operative note. The documentation should also describe what has happened to the graft/flap site since the procedure that would cause the patient to need HBO.

HBO Covered Condition – Diabetic Wounds of the Lower Extremities in patients who meet the following three criteria:

1. “Patient has type I or type II diabetes and has a lower extremity wound that is due to diabetes;
2. Patient has a wound classified as Wagner grade III or higher; and
3. Patient has failed an adequate course of standard wound therapy.

The use of HBO therapy is covered as adjunctive therapy only after there are no measurable signs of healing for at least 30 –days of treatment with standard wound therapy and must be used in addition to standard wound care. Standard wound care in patients with diabetic wounds includes: assessment of a patient’s vascular status and correction of any vascular problems in the affected limb if possible, optimization of nutritional status, optimization of glucose control, debridement by any means to remove devitalized tissue, maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings, appropriate off-loading, and necessary treatment to resolve any infection that might be present. Failure to respond to standard wound care occurs when there are no measurable signs of healing for at least 30 consecutive days. Wounds must be evaluated at least every 30 days during administration of HBO therapy. Continued treatment with HBO therapy is not covered if measurable signs of healing have not been demonstrated within any 30-day period of treatment.” (NCD 20.29)

These plentiful NCD requirements seem to be a challenge to providers. The OIG’s 3rd and final example is ‘HBO Therapy With Insufficient Documentation.’ In this case, the medical records did not contain sufficient documentation to support that there were at least 30 days of standard wound care therapy provided prior to HBO therapy. Since the NCD provides so many details for diabetic wounds, there is not a lot to add from the First Coast LCD or Palmetto findings. I recommend making a check list for diabetic wounds from the NCD requirements looking at each requirement from two perspectives – 1) does the patient meet the criterium and 2) is there documentation to support it. For example, your checklist would be:

• Is the patient diabetic? Is there documentation of such in the medical record?
• Does the patient have a lower extremity wound due to diabetes? Is the record clear that the wound is a diabetic wound?
• Is the wound a Wagner Grade III or higher and is that clearly documented in the record? Check for consistency in the documentation of the Wagner grade in physician’s progress notes and nursing assessments.
• Has the patient been receiving conservative wound care for treatment of the wound for at least 30 days? Does the medical record describe the different types of assessments and interventions that have been done to promote wound healing?
• Has there been no measurable signs of healing for at least 30 consecutive days? For example, the wound may fail to decrease in size as one indication of lack of healing, or there may be other wound characteristics signifying lack of healing. The First Coast LCD contains this statement – “Documentation of all aspects of optimization defined by the NCD (clarified by this LCD) and the absence of improvement in the wound characteristics constitutes stalled wound healing and suggests that it may benefit from adjunctive HBOT.”

The conditions addressed above are frequent reasons for a need for HBO therapy and providers need to ensure the coverage criteria and documentation requirements are met to receive appropriate reimbursement. Also remember to include other required elements in your HBO therapy – make sure you have:

• A physician’s (or practitioner’s) order for the HBO therapy,
• The physician/NPP’s explanation of the reason for HBO therapy (diagnosis or condition warranting the HBO treatment),
• The expected benefits of HBO treatment – these are the HBO treatment goals, and
• An evaluation of the patient’s progress from HBO therapy at least every 30 days.

This sounds like a lot of documentation but it is really just the basics of what is wrong with the patient, what is being done to help the patient, what is the expected outcome, and what is the actual outcome. The difficulty is, the devil is in the details.