If you’ve ever attended a meeting at the Centers for Medicare & Medicaid Services (CMS) in Baltimore, you know the security drill includes a vehicle and luggage search at the gate by guards, walking through a metal detector at the building entrance, and an airport-style bag scanner before signing in to receive a badge restricting you to the conference area. After the meeting, you can head to the airport to navigate the familiar security procedures where long lines are now the norm. However, some of us are old enough to remember the days when there was no airport security, and you could just walk into the airport and up your gate without even an ID check. There’s an analogy between our “lost way of life” and the current climate of Medicare coverage policy. There’s a reason we have to endure the misery of security screening at airports. Threats to our safety are real, and without these procedures we wouldn’t be able to travel. There are reasons we have to deal with increasingly restrictive Medicare coverage policies too. Sadly, abuse and overuse of many therapies have happened. Unfortunately, the result is Medicare, or its regional Medicare Administrative Contractors (MACs), is crafting coverage policies that dictate how physicians should practice medicine. This is particularly true in the field of hyperbaric medicine. The Undersea and Hyperbaric Medical Society’s Committee on Quality, Utilization, Authorization, Reimbursement, and Coverage has been coordinating the response to the MACs about these policies (thanks to the leadership of Helen Gelly, MD, FACCWS, UHM/ABPM, FUHM, and Marc Robbins, DO, MPH). If you have not been following these issues, you will probably be surprised about the degree to which the MACs now control the practice of hyperbaric medicine.
The trend began in 2015, when the MAC Novitas Solutions Inc. published its draft local coverage determination (LCD) for hyperbaric oxygen therapy (HBOT), which was subsequently copied by First Coast Service Options Inc. and has now been reproduced almost verbatim by Noridian Healthcare Solutions LLC. Due to the large geographic area represented by these three MACs, more than 60% of covered Medicare beneficiaries will be affected by the language in these LCDs. When multiple MACs implement LCDs that are exactly the same, the effect is to create a new national coverage policy for HBOT. These LCDs define parameters for dosing HBOT, including treatment frequency as well as details regarding patient selection. It’s imperative for clinicians practicing hyperbaric medicine to actually read each line of their hyperbaric LCD and ensure they are compliant with every requirement. In the past, although we had written national coverage determinations as well as local MAC policies, the specifications were broad and were generally limited to the diagnoses covered (and not covered). Physicians could use their common sense and clinical judgment to interpret coverage policies. Today, these policies are being interpreted verbatim as Medicare implements an unprecedented number of programs designed to recoup “improper payments.” The current Noridian draft LCD is unprecedented because it specifies exactly how physicians are to practice hyperbaric medicine. The ramifications of this HBOT LCD are far-reaching. Consider hip replacement surgery, a common procedure that has been much scrutinized by CMS due to the significant percentage of the Medicare trust fund spent on it annually. Depending upon the patient’s age, body habitus, and activity level the surgeon may choose an anterior, posterior, or lateral approach. However, imagine the reaction by orthopedic surgeons if an LCD mandated all hip replacements had to be performed via the posterior approach regardless of these factors. Or, can you imagine the outcry if an LCD mandated that for the treatment of endocarditis an infectious disease specialist must provide 1,000 mg of intravenous vancomycin every 12 hours with no adjustments based on age, body weight, or concomitant renal dialysis? Although you may think those examples are ridiculous, that’s exactly what the Noridian hyperbaric LCD does. Historically, carbon monoxide (CO) patients who are alert but symptomatic (eg, headache) may have been treated safely with HBOT while in the emergency department and then discharged home with outpatient follow up. The decision of whether to hospitalize was left to the physician. However, the Noridian LCD stipulates all CO-poisoning patients must be treated as inpatients. Inpatient diagnosis-related group data from 2011 for the codes representing CO poisoning show the average inpatient cost to treat a CO case without major complication is $5,524 (and with major complications is $11,607). Under the current outpatient pricing, a course of three hyperbaric treatments for a CO patient would be about $1,650. At a time of increasing concern over the health of the Medicare trust fund, crafting policies that increase the cost of patient care seems counterintuitive. We should allow the physician to decide who is sick enough to be admitted with CO poisoning. Similarly, if a case of acute arterial thrombosis presents (usually with the picture of critical limb ischemia developing over the span of a few days), adjunctive HBOT cannot be used with an outpatient thrombectomy because the Noridian LCD mandates patients must be hospitalized to undergo adjunctive HBOT. For patients developing late effects of radiation resulting from cancer treatment, the Noridian LCD mandates the chart contain documented proof of the cancer as well as the radiotherapist’s note providing the details of the radiation protocol. Many of these patients underwent radiation more than 10 years ago, and some states only require medical records to be held for seven years. However, the inability to produce these documents could result in HBOT being denied. This requirement is particularly chilling because the implication is physicians (and patients) may lie about the medical history of cancer, and thus proof is required before CMS will cover HBOT for late effects of radiation. The Noridian LCD further specifies the hyperbaric treatment pressure and schedule for various conditions. Consider what this means: A medical reviewer can recoup payment for a gas gangrene treatment if it is not performed at 3.0 atmospheres absolute, three times per day. What if the patient was on high-dose steroids or had a seizure disorder and the clinician felt the patient should be treated at a lower pressure? Or what if the patient was too unstable or had to go to the operating room, and the patient was not able to undergo three treatments in the first 24 hours? Does that mean coverage for all treatments will be denied? (Keep in mind this protocol translates to > 12 hyperbaric treatment segments in 24 hours, even though Medicare policy limits coverage to five segments in 24 hours). Does a MAC have the right to determine the dose, duration, and frequency of a drug? A pregnant woman cannot be treated with HBOT because the Noridian LCD states treatment during pregnancy is contraindicated. Had such a policy been in effect a few years ago, it would have resulted in the complete blindness of a young pregnant woman whom I treated for bilateral central retinal vein occlusions and whose vision was restored with HBOT. Without HBOT she would have been left to care for her first child with only light perception vision. Because of HBOT she regained 20/20 vision in both eyes and three months later delivered a healthy baby. Without any evidence basis for the decision, Noridian, First Coast, and Novitas have decided pregnancy is a contraindication to HBOT, except in the case of CO poisoning. Incredibly, these MACs require documentation of fetal distress to justify HBOT for CO poisoning in pregnancy. Of note, the LCD provides no instructions regarding how fetal distress is to be determined in the first trimester. Although it may seem ridiculous to provide pregnancy guidelines for Medicare patients, remember Medicare also covers all people on dialysis and the disabled, without regard to age. Since many commercial insurance carriers use Medicare guidelines to craft their coverage policies, the shadow cast by these LCDs is a long one. Without a doubt, in this era of cost containment it’s reasonable for CMS or the MACs to establish some parameters regarding the use of expensive interventions, as well as potential treatment caps. However, it is not reasonable for a MAC to define dosing parameters of a drug. Pre-defining the drug dose for a patient is fraught with medico-legal ramifications. And, when Noridian, Novitas, and First Coast require inpatient admission for a variety of diagnoses, they are making decisions that increase the total cost of care in addition to preventing physicians from exercising clinical judgment.
While the issues detailed here may be surprising, precedent-setting, and ominous, they are not the most worrisome aspect of these three LCDs. The most worrisome aspect is the shocking lack of involvement by physicians practicing hyperbaric medicine. Even when specifically asked to comment on their area of expertise, hyperbaric practitioners have been largely silent on issues that will have a direct effect on patient care. The comment period for the Noridian LCD closed Aug. 8. However, it is likely other MACs will roll out nearly identical policies in the future. There is a saying that people “get the government they deserve.” The same may be true about Medicare coverage policies. Read more about this issue at: www.uhms.org/call-to-action-noridian-draft-policy-dl36686-is-currently-in-comments-phase-until-aug-8-2016.html
Helen Gelly and Marc Robbins contributed to this commentary.