Alliance Update: Comments Submitted to Novitas LCD Addressing Hyperbaric Oxygen Therapy Protection Status
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By The Alliance of Wound Care Stakeholders

The Alliance of Wound Care Stakeholders submitted formal comments in response to the Novitas draft local coverage determination (LCD) for Hyperbaric Oxygen Therapy (HBOT) (DL35021).

HBOT is a valuable treatment option for improving wound healing in patients with diabetes, radiation complications, compromised flaps and grafts, and complex non-healing wounds. It has contributed to a decrease in the national amputation rate. The Alliance supports the need for a LCD to ensure the safe and effective use of HBOT but also one that minimizes administrative burdens while still easy to implement and enforce. The Alliance focused its comments on the wound care aspects of HBOT, noting that there are areas in the draft policy in which Novitas provides specific dose and frequency parameters which are contrary to current standards of practice and, in several instances, cites outdated evidence to substantiate provisions.

Novitas Solutions is a Medicare Administrative Contractor (MAC) – a private organization contracted by the Centers for Medicare & Medicaid Services (CMS) to carry out the administrative responsibilities of Traditional Medicare Parts A and B ("A/B MACs"). Novitas covers more than 10 states, the Indian Health Service and Veterans Affairs via its contracts with CMS. Collectively in the US, the MACs and the other Medicare administrative contractors process nearly 4.9 million Medicare claims each business day, and disburse more than $365 billion annually in program payments. Each Medicare contractor has the discretion to establish which treatments, procedures and services are covered as a Medicare benefit. These coverage policies are issued in a document called a Local Coverage Determination. LCDs are important to providers as they provide guidance on topics such as which services are covered and reimbursable; how to properly code the services provided and submit claims for payment; documentation requirements; and utilization guidelines. However, clinically inaccurate, unclear and/or overly restrictive LCDs can compromise patient care.

The Alliance regularly reviews draft LCDs related to wound care, and submits comprehensive comments which reflect the inputs of clinical societies involved in wound care, in order to promote quality wound care and ensure patient and provider access to wound care technologies and procedures. The comments submitted to Novitas were written with the advice of Alliance clinical specialty societies and organizations that not only possess expert knowledge in complex chronic wounds, but also in wound care research. Many Alliance members utilize HBOT in their practices as an adjunctive therapy when treating a patient with a chronic non-healing wound and especially when treating patients with diabetic foot ulcers. As such, the Alliance and its membership have a vested interest in the Novitas policy.

Specific areas of Alliance comment include:

  • Addressing provider qualifications, the policy states, "the Scope of Practice for a physician supervising HBOT must include neurologic, cardiothoracic, critical care and internal medicine components." The Alliance notes that this excludes podiatrists. The two certifying boards in podiatry, the American Board of Podiatric Medicine (ABPM) and the American Board of Foot and Ankle Surgery (ABFAS), include items on their board exams to evaluate a podiatrist's knowledge on the indications of HBOT and emergency management, the Alliance commented, recommending that based on their training and their state practice act, podiatrists should be permitted to supervise HBOT services.
  • For skin grafts or flaps, the policy states "The number of sessions provided to enhance graft survival is not expected to exceed 12." The Alliance notes in its comments that the decision as to the treatments depths, time and frequency should be made by the treating physician and based, not on a predetermined number of treatments, but on how well the patient is responding to them. The Alliance recommends that a review of the patient's progress be done after 12-15 treatments and if the patient is responding to HBOT, that the sessions continue and allow for the clinician to appropriately determine the number of sessions their individual patient requires.
  • For diabetic wounds, the policy states "Adjunctive treatment of an ulcer of the lower extremity deemed to be secondary to the neuropathic effects of diabetes will be allowed no more than 30 treatments (60-90 minutes daily) without documentation of improvement." The Alliance comments that the accepted number of treatments identified in this draft policy is insufficient: the standards of practice as well as the evidence suggests it is more appropriate for there to be 40 treatments, not the 30 identified in this draft LCD. Furthermore, oxygen breathing times are not total treatment times. Most clinicians include a 10 minute pressurization time, a 10 minute depressurization time, and two 5-minute air breaks in the treatment protocol. This results in a total treatment time of 120-150 minutes, of which 90-120 minutes is breathing 100% oxygen. As such the treatment time identified in the policy, 60-90 minutes daily, is insufficient.
  • Regarding failure to respond assessment, the policy states "failure to respond to standard wound care occurs when there are no measurable signs of healing for at least 30 consecutive days." The Alliance notes in its comments: Failure to respond to standard wound care does not always manifest itself by a lack of any healing, but by slow or delayed wound healing. The industry standard is to use a 4 week healing percentage to predict which wound will heal with standard care in 12 weeks, and which will not. The Alliance recommended that the policy language be amended to "failure to respond to standard wound care occurs when the wound area has not reduced by 50% or greater over 4 weeks of standard care."

To see the Alliance's submitted comments, click here.

About the Author
The Alliance of Wound Care Stakeholders: The Alliance is a nonprofit multidisciplinary trade association of health care professional and patient organizations whose mission is to promote quality care and access to products and services for people with wounds through effective advocacy and educational outreach in the regulatory, legislative, and public arenas.

The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.

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