Hyperbaric Medicine: Feeling Pressure in the Wound Clinic

The practice of hyperbaric medicine has been firmly under the healthcare compliance microscope in recent years, and for good reason. Government and commercial health insurers have increasingly sensed hyperbaric medicine’s overuse and misuse. This has prompted several initiatives to identify unnecessary (and costly) care, as well as the establishment of strategies to limit future abuse — the most significant of which has been a decision by the Centers for Medicare & Medicaid Services (CMS) to implement a prior authorization mandate. While commonplace within the commercial space, this was the first such clinical requirement in the more than five-decade history of the Medicare program, a measure of just how significant these abuses are perceived. Prior authorization came into force in 2015 for a three-year period in Illinois, Michigan, and New Jersey — the states considered to be among the highest abusers of hyperbaric oxygen therapy (HBOT). Providers were now required to submit documentation to support medical necessity before treating elective conditions. Its effect was telling in that a significant percentage of requests failed to comply with CMS reimbursement policy. Contrary to popular belief, CMS had not created new documentation standards. Rather, necessary information now occurred earlier in the process. Numerous providers and related businesses cried foul, arguing that this process served to delay medically necessary care and put patients at risk. As noted, pre-approval for elective care is standard procedure for non-governmental insurers and has long been unchallenged, so these complaints failed to impact policy. This article will provide a brief history of what has led to the current state of hyperbaric medicine regulation and offer guidance to assist in raising potential red flags in the wound clinic. 

PRE-PAYMENT CLAIM REVIEW 

Preliminary prior authorization data were compelling enough for several Medicare Administrative Contractors (MACs) not involved in this mandate. Without waiting for a final report on the initiative’s full impact, they introduced pre-payment reviews. Arguably, these would have greater impact on providers, as patients had already been treated (and resources expended). Now, providers had to await payment decisions. One MAC (Palmetto GBA®) reported that $9 million of $12 million in hyperbaric medicine claims within their four-state jurisdiction had been denied. It should be noted that not all of these denials were appropriate, as claim review guidance criteria were not always correct. It became apparent, for example, that the template used to assess provision of late radiation tissue injury was being channeled into the diabetic foot ulcer (DFU) template, with resulting erroneous determinations. Appeals for these denials have, in most cases, been favorably considered. 

RETURN OF INCORRECT PAYMENTS 

Another MAC went even further. Based upon an audit of selected claims by the Office of Inspector General (OIG, the body charged with protecting the integrity of the U.S. Department of Health & Human Services/CMS programs), WPS® Health Insurance was determined to have incorrectly reimbursed for hyperbaric services 69% of the time. The OIG recommended that WPS contact all providers in its jurisdiction and instruct them to self-investigate and return overpayments. Based upon extrapolation from the OIG sample size, the potential repayment could be in the order of $42 million. One can only surmise the greater financial impact on providers if they fail to fully account for overpayments and Recovery Audit Contractor (RAC) or other government auditors electing to investigate. The OIG recently identified a similar degree of probable overpayment involving a second MAC (First Coast Service Options Inc.®). They too have been directed to recover in the order of $39 million in inappropriate HBOT payments. This latter initiative was one component of the OIG Work Plan for 2017, which intended to investigate hyperbaric medicine due to concerns that “beneficiaries received treatments for non-covered conditions and more treatments were being given than medically necessary.” 

CODING MANIPULATION 

National Baromedical Services Inc. (NBS), an organization that offers wound center and hyperbaric medicine management, contracting, consulting, and related administrative support, became involved in its capacity as an advocate for the cost-effective application of HBOT and has long been dismayed at the level to which overutilization and related abuse has permeated hyperbaric medicine.¹ Volunteering its services, NBS undertook a series of webinars, conference calls, and in-person meetings with several MACs, essentially all major commercial purchasers of healthcare, and one RAC audit group. Common diagnosis codes filed for provision of elective HBOT formed the focus of these discussions. Having accrued considerable insight over the years, specific misuse examples were well known.¹ Chronic refractory osteomyelitis (CROM), compromised skin flaps, acute peripheral arterial ischemia (APAI), necrotizing soft tissue infections, and DFUs were conditions most likely to be associated with coding irregularities and overuse. Respective audit and medical teams were guided through the documentation needed to be evident to substantiate a diagnosis and support its treatment. 

For CROM, an all-too-common scenario is a patient presenting with a chronic foot lesion that is not otherwise reimbursable. If exposed bone is apparent, a provider might be inclined to diagnose it as CROM, thereby becoming reimbursable. For a chronic condition to exist, of course, it would first need to be acute, and first-line therapy should not be HBOT. An eradication attempt, if amenable (otherwise debridement), and bone-cultured antibiotics represent standard care and are presumably documented in the medical record. A diagnosis of CROM would represent failure of this care over a period commonly referenced as “six weeks.” It is only at this stage that HBOT is considered. In many instances, consultation with specialists most associated with the management of persistent bone infections — orthopedic surgeons and infectious disease physicians — would not have occurred. 

Compromised skin flaps are another potential diagnosis manipulation, intentional or otherwise. For such a diagnosis, there must have first been a skin flap procedure. Some providers, however, consider dehiscence of a surgical wound closure, such as a saphenous vein donor site, abdominal incision, or digit amputation with or without primary closure, to represent a failing skin flap. These are problem wounds and are generally not reimbursable from a hyperbaric medicine perspective. Those who audit these claims are advised that there must be documentation of a skin flap, classified by either its blood supply, tissue composition, or method of movement. Specific credentialing criteria exist for those who perform these procedures, so the surgeon’s name and flap type would be documented in the medical record. When queried, hyperbaric providers may offer that it was an “advancement” flap, seemingly basing this on the tissues in question being “advanced” for approximation. This does not meet the definition of an advancement flap, one that involves a specific technique and expertise to perform.  

APAI is a recognized medical emergency that suggests a sudden occlusion/perfusion decrease within a major lower extremity artery, secondary to thrombus or embolus. Immediate surgery (catheter-directed clot removal or lysis) is imperative if the extremity is to be saved. Commonly, these procedures take place on an outpatient basis. Previously, open surgery was the norm with patients hospitalized in the immediate postoperative period. So how is this condition squared with an outpatient wound clinic? It only exists, of course, as the submitted diagnosis code. The very term “acute” involving this elective-care-only clinic should serve as an auditing red flag. Again, a patient has likely presented with a chronic foot lesion that does not otherwise meet the hyperbaric reimbursement standard. Providers have been inclined to diagnose this condition as an APAI so that it does, on paper at least, meet the standard. Guidance to insurer audit and medical teams is straightforward. For an APAI to have occurred, there would be a supporting surgical procedure and imaging codes for this same patient. It is not out of the realm of possibility that HBOT has been used to support incompletely recovered tissues in the immediate postoperative period. This would be very much the exception. 

As a metric, the hyperbaric medicine program at Palmetto Health Richland Hospital, a Level I trauma center and major tertiary institution in Columbia, SC, enjoys good rapport with surgical and interventional colleagues. Throughout its 33-year history, just three APAI patents have reportedly been referred and treated. Conversely, numerous outpatient-based wound healing and hyperbaric clinics have reported high annual volumes.

Necrotizing soft tissue infection is another diagnosis associated with an outpatient wound center and should immediately raise a red flag. A severe “flesh eating” infection, it tends to spread quickly and is sometimes fatal. These infections always necessitate hospitalization and aggressive multidisciplinary management. They are also another example of diagnosis code manipulation when a wound does not otherwise meet hyperbaric reimbursement criteria. In the years prior to the current level of insurance company and OIG oversight, which now readily identify these conditions not to exist, reimbursement frequently occurred on the strength of the submitted diagnosis code alone, as it did for the other aforementioned examples. Compliance criteria for the DFU as a hyperbaric indication across governmental and commercial payors alike have tightened considerably in recent years and center on a period of unimproved, well-defined standard care. This has had the effect of reducing the use of HBOT to only those DFUs considered to be supported by prevailing medical literature. Audit confirmation of appropriate patient selection has since become relatively straightforward. 

Overutilization in the context of the number of treatments rendered per DFU, however, remains an issue. For such a wound to benefit from hyperbaric oxygenation, there presumably must be an underlying state of correctable local hypoxia. This is best determined by tissue oximetry screening, which serves to identify abnormal oxygenation states and the equally important physiologic capacity to respond at the lesion site during oxygen breathing. While some providers claim “Medicare doesn’t require this type of testing to select DFU patients,” which is only partially correct, such testing represents good medicine and is anticipated to be part of DFU case management by a leading hyperbaric medical society.² One might also counter the “testing not required” position by citing a failure to demonstrate improved DFU healing and reduced amputation rates reported in one large study.³ Better outcomes may have resulted from better patient selection. Wounds fail to heal for a host of reasons, hypoxia being just one. If local hypoxia were not demonstrated/present, what would be the basis for provision of HBOT? 

Too Many Treatments?
Overutilization relates to a failure to determine therapeutic endpoint. It is rarely, if ever, necessary to use HBOT to wound closure. The goal of HBOT should be to normalize the environment around the wound through induction of a critical mass of angiogenesis, so that a healing response develops. At this point, standard wound care alone is likely to suffice. Beyond this point, wounds are likely healing despite any additional (medically unnecessary and costly) HBOT. The referenced medical society’s position is that a typical DFU hyperbaric course is in the order of 15-20 treatments, with utilization review recommended at 30. 

This is consistent with the concept of normalizing wound repair versus treatment to complete closure and addresses one aspect of the OIG concerns regarding overuse. Claims filed for 50, 60, and more hyperbaric treatments have been all too common and raise questions regarding provider intent. 

SUMMARY

The government is not alone in the recent focus on hyperbaric medicine’s clinical practice behavior, with scrutiny extending to leading commercial health insurers. Each has revised respective medical policy bulletins, enhanced templates to better identify claim irregularities, and increased frequency of peer-to-peer involvement during prior authorization requests. One insurer recently went as far as to make its concerns publicly known.⁴ As frustrating as current compliance requirements might appear, they are self-inflicted secondary to long-standing overuse and abuse. In this current climate, one would do well to be guided by the medication administration dictum: Provide HBOT to the right patient, for the right indication, at the right time, and only for the right amount of time.

Dick Clarke is president of National Baromedical Services and the National Board of Diving & Hyperbaric Medical Technology, Columbia, SC.

1. Clarke R. Hyperbaric medicine today: an historically noble discipline challenged by loss of critical access and overutilization – invited commentary. Undersea Hyperb Med. 2017;44(1):5-10.

2. Weaver LK. Hyperbaric oxygen therapy indications. 13th ed. 2014. UHMS. Accessed online: www.uhms.org/images/indications/UHMS_HBO2_Indications_13th_Ed._Front_Matter__References.pdf

3. Margolis DJ, Gupta J, Hoffstad O, et al. Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and the prevention of amputation: a cohort study. Diabetes Care. 2013;36(7):1961-6.   

4. Popp G, Clarke D, Rothstein S. Primum non nocere and the 5 rights. Adv Skin Wound Care. 2017;30(10):473-8.