Nutritional Assessment & Prior Authorization of Hyperbaric Oxygen Therapy

The prior authorization of nonemergent hyperbaric oxygen model that the Centers for Medicare & Medicaid Services (CMS) implemented in three states (Illinois, Michigan, and New Jersey) has many implications for the care of potential hyperbaric patients. Among patients living with severe diabetic foot ulcers (DFUs), one of the criterion required to satisfy the requirement for 30 days of standard care before initiating hyperbaric oxygen therapy (HBOT) is a nutritional assessment. 

The definition of a “nutritional assessment” within national coverage determination (NCD) 20.29 - HBOT is vague. Although an assessment of nutritional status should be routinely performed on all patients seen in the outpatient wound clinic, the protocol for it is not well defined and most wound care practitioners do not have an organized approach to it. Diagnosing a patient’s nutritional needs (through laboratory testing, physical examination, and history taking), prescribing appropriate interventions (through oral or parenteral supplementation), and performing ongoing monitoring are often deferred to the primary care physician or registered dietician (RD). However, since the NCD requires this to be addressed as part of conservative care, documentation of nutritional assessment must be part of the wound care and hyperbaric chart that is available for review by the Medicare intermediaries involved in the prior authorization project. Although it may not be clear exactly what type of documentation is required, failure to include this information could result in a patient being denied HBOT. The following probes are specific to nutrition: 

A general overview of the nutritional documentation required for the nonemergent hyperbaric prior authorization is available.¹ National Government Services Inc. has the following listed on its website for Illinois:² “Optimization of nutritional status,” but nothing more specific, referring back to the electronic submission of medical documentation. Of the three Medicare Administrative Contractors, Novitas Solutions Inc. has the most detailed guidance available, stating medical records should “support optimization of nutritional status: Example: lab work, dietetic teaching, etc.”³

Optimization of Nutritional Status

How do you define “optimization of nutritional status”?³ The requirements are not well defined by any intermediary, but one can infer that laboratory documentation of the nutritional assessment of the patient living with a diabetic ulcer should include (at a minimum) albumin, transferrin, and/or prealbumin levels, with vitamin and trace mineral levels as clinically indicated. Since inflammation alters the levels of these markers, C-reactive protein may be of use in interpreting results. Protein deficiencies are thought to contribute to poor healing rates. In venous leg ulcers,⁴ these markers of protein malnutrition were correlated to increased wound size at 12 weeks. Similar studies in pressure ulcers demonstrated better healing after enhanced nutritional support.⁵ Once the diagnosis is established, the intervention must be documented and follow up scheduled. DFUs require 30 days of optimization of all parameters. Using this timeframe, transferrin and prealbumin levels would show the greatest changes in the time period that is being reviewed. 

The initial intervention should consist of oral nutritional supplements such as high protein/high-calorie food items (eg, eggs, meats, nuts, cheese, and prepackaged dietary supplements that include arginine, glutamine, and/or hydroxyl-methyl-buterate). Patients who are unable to adequately increase their protein consumption by simple oral nutritional supplements should be considered for tube feedings or parenteral nutritional support. Evaluation by an RD should be considered if there is an inadequate response to first-line oral interventions. 

It’s evident a more systematic approach to identifying inadequate nutritional status for optimal healing must become integrated into the initial evaluation of the patient that presents to the wound clinic. Patients who live with diabetes and experience delayed wound healing represent a more complex clinical scenario, as enhanced nutritional support must be balanced with glycemic control. Those patients who are also on renal dialysis are more challenging. A multidisciplinary approach, including endocrinology, nephrology, and RDs becomes necessary to improve clinical outcomes. Initial screening and repetitive testing to assess the success of the dietary intervention should be documented to support the optimization of nutritional status and support affirmation of the request for adjunctive HBOT.

Helen Gelly is emeritus medical director of Hyperbaric Physicians of Georgia and chief executive officer of HyperbaRXs, Marietta, GA.

References

1.  Prior Authorization of Non-emergent Hyperbaric Oxygen. Centers for Medicare & Medicaid Services. Accessed online: www.cms.gov/research-statistics-data-and-systems/monitoring-programs/medicare-ffs-compliance-programs/prior-authorization-initiatives/prior-authorization-of-non-emergent-hyperbaric-oxygen.html

2.  HBO Supplemental Prior Authorization Tool for Diabetic Wounds of the Lower Extremities. National Government Services. Accessed online: https://bit.ly/2fDt51X

3.   Licenses and Notices. Novitas Solutions. Accessed online: https://bit.ly/2eM5zk4

4.  Legendre C, Debure C, Meaume S, Lok C, Golmard JL, Senet P. Impact of protein deficiency on venous ulcer healing. J Vasc Surg. 2008;48(3):688–93.

5.  van Anholt RD, Sobotka L, Meijer EP, at al. Specific nutritional support accelerates pressure ulcer healing and reduces wound care intensity in non-malnourished patients. Nutrition. 2010;26(9):867–72.

6. Nutritional Status Assessment in Adults Laboratory Medicine. Medscape. Accessed online: https://emedicine.medscape.com/article/2141861-labs