May 18, 1999
Grant Bagley, MD, JD
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Health Care Financing Administration
S-02-01
7500 Security Boulevard
Baltimore, MD 21244-1850RE: Transmittal No. AB-99-21 - Hyperbaric Oxygen Therapy
Dear Dr. Bagley:
The American Association for Respiratory Care (AARC), a 37,000 member professional association of respiratory therapists is greatly concerned with the recently revised provisions to the coverage policy for hyperbaric oxygen therapy (HBO).
COMMENT:
The changes that the amended hyperbaric oxygen therapy policy requires will have significant impact on the operational structure of all HBO programs. Because the implementation date of this new coverage policy was May 1, 1999, most HBO programs are not in compliance with the regulations. While we have heard that the implementation date has been moved to July 1 1999, there has been no official confirmation of this.
HCFA has provided little or no opportunity for public comment prior to the issuance of this final coverage policy, a policy which will dramatically affect the provision of hyperbaric oxygen therapy across the country. HCFA should have provided the opportunity for the public and interested parties to critique and provide comments on the significant changes contained within the policy.
COMMENT:
Physician Supervision Requirement
The AARC objects to the unnecessary and medically unsubstantiated requirement that the physician be in constant attendance during the entire hyperbaric oxygen therapy procedure.
The health care professionals, including respiratory therapists, who traditionally comprise the health care team administering hyperbaric oxygen therapy are specifically educated, trained and credentialed in this very specialized medical modality. Physicians, who must also have specialized credentials in hyperbaric oxygen therapy, provide medical direction to these specialized health care teams. Physician overview and monitoring of the patient is critical. What is not critical, is medically unjustifiable, and is extremely costly to the Medicare program is the enforcement of the requirement that demands the physician's attendance during the entire hyperbaric oxygen therapy procedure regardless of the medical stability of the patient. We understand that, historically, the hyperbaric oxygen therapy coverage policy has contained the reference requiring a physician's constant attendance. The physician attendance provision has, however, been interpreted for decades by both facilities providing HBO, and Medicare Intermediaries as requiring the physician be within the procedure vicinity and immediately available if any adverse medical situation should develop (i.e. "direct physician supervision").
We can only assume that the requirement for the literal interpretation and strict enforcement in the coverage policy provisions that..." the physician must be in constant attendance during the entire treatment," has been based on objective outcomes evidence that documents patients undergoing hyperbaric oxygen therapy have been harmed or their safety compromised because a physician has not been in constant attendance. Please provide the AARC with the patient outcomes data that we assume HCFA has used to justify making this coverage policy enforcement decision.
COMMENT:
Credentialing Requirements
It is unclear whether the policy requires physicians to be certified in Advanced Cardiac Life Support (ACLS) through the American Heart Association, or whether training and/or experience in advanced cardiac life support is sufficient. If physician certification in ACLS by the American Heart Association is required, many physicians will be unable to meet this requirement even if the coverage policy implementation deadline is moved to July 1, 1999. Please clarify this provision.
COMMENT:
Credentialing Requirements
We also question the need to single out "emergency myringotomy" in the statement under "Training, experience and privileges...". This procedure is covered in the required hours of training, and is rarely, if ever, required to be performed. We believe it is unnecessary to reference "emergency myringotomy" in the policy.
COMMENT:
Credentialing Requirements
The new coverage policy requires physicians to complete 60 hours of training/programs in hyperbaric medicine established by either the American College of Hyperbaric Medicine or the Undersea and Hyperbaric Medical Society. It is our understanding that these organizations provide core curriculum courses of 40, not 60 hours of training. Furthermore, the coverage policy fails to recognize comparable training, such as military training in hyperbaric medicine or completion of fellowships in hyperbaric medicine as acceptable training.
The AARC supports the need to require 60 hours of hyperbaric medicine training. The credentialing courses offered by certified organizations should be viewed as core curriculum hours. Additional hours of training in hyperbaric medicine with documentation of completion should comprise the remainder of the 60 hours. Recognition of other comparable training courses including, but not limited to, military training in hyperbaric medicine or documentation of the completion of a fellowship in hyperbaric medicine should be included in the coverage policy.
COMMENT:
Credentialing Requirements
This new coverage policy requires that the "physician credentialing documentation must be kept in the patient's medical file/record". It is inappropriate for Medicare to require physicians or other health-care professionals to insert into patients' medical records or files, their professional credentials. We do agree that the Health Care Financing Administration, its Medicare contractors, and Peer Review Organizations have the right to require access to the documentation of the credentials of the health care professionals involved in providing hyperbaric oxygen therapy. The patient's medical record or file is, however, the inappropriate place for placement of these credentials. Credentialing documentation packets can be provided upon request to the Medicare Intermediary. Credentialing information is also available as part of each institution's Peer Review Process.
CONCLUSION:
There are serious flaws in the requirements of this new coverage policy for hyperbaric oxygen therapy. We again request that the AARC and other organizations involved in the provision of hyperbaric medicine be provided with the patient outcomes data that we believe must have been used by HCFA to justify its new literal interpretation of a physician "constant attendance" during hyperbaric oxygen therapy procedures. Alterations and clarifications must also be made by HCFA regarding the requirements for the hours of documented training. Certainly, credentialing documentation should not be required to be placed within a patient's medical record or file.
We look forward to hearing your response.
Sincerely,
Dianne N. Kimball, RRT
President