The Centers for Medicare and Medicaid Services (CMS) have ruled that all outpatient hospital services will be under general supervision. This author discusses the impact of the rule on wound clinics, particularly those that offer hyperbaric oxygen therapy (HBOT).
Déjà vu all over again is how some hyperbaric leaders most likely reacted when the CMS proposed to put all outpatient services in the hospital, including HBOT, under general supervision.1
Tom Bozzuto, DO, the Past President and a founding fellow of the American College of Hyperbaric Medicine (ACHM), noted that in the early 1990s, the Health Care Financing Administration (HCFA) evaluated whether to reimburse physicians at all for supervision of HBOT.2 When HCFA deleted Current Procedural Technology (CPT) Codes 99180 and 99182, there was a period of time when physicians were not being reimbursed for supervision. Caroline Fife, MD, is all too aware of this subject, as she has been writing to CMS on this subject for nearly three decades.
Hyperbaric physicians like me actively see and treat patients with HBO therapy on a daily basis. Below are examples of two patients, which highlight why direct supervision is important while treating patients with HBO therapy.
1. The first patient was a 43-year-old female with a history of hypertension, hyperlipidemia, atrial fibrillation, and bilateral breast cancer. The patient had right breast cancer 23 years previous, and her course of treatment included having a mastectomy, chemotherapy and removal of axillary lymph nodes. She had a right breast implant in November 2017. In May 2019, she required a left mastectomy for breast cancer on the left side. She had another surgery on the right, which included removal of the implant; subsequently, the patient’s wound did not heal, and she was sent for HBO therapy. The patient had cardiomyopathy from prior chemotherapy, and her left ventricle ejection fraction (LVEF) was 30%. The patient’s cardiologist was consulted to make sure the patient was cleared/a candidate for HBO therapy. Prior to admission into the HBOT chamber, I thoroughly check this patient and check her lungs before she goes in the HBOT chamber. Her HBOT dose was adjusted so she would not have any potential side effects of pulmonary edema.
2. The second patient was a 74-year-old female with a history of type 2 diabetes mellitus, hypertension, hyperlipidemia, neuropathy, and chronic kidney failure on dialysis. She also had severe peripheral vascular disease, and she was being treated with HBO therapy for a Wagner grade 3 diabetic foot ulcer that failed standard wound care for more than 30 days. I check the patient and examine her lungs before she goes in the HBOT chamber. I ask her about her dry weight at dialysis. I ensure that the patient was taking her medications, as her high blood pressure and fluid imbalance may cause pulmonary edema. I also check her blood sugar and make sure she will not become hypoglycemic or have hypoglycemic seizures in the HBOT chamber.
Although complications with HBOT are not that common, when they do occur, there is a real potential for a life-threatening event. Patients who require HBO therapy can have multiple medical problems and comorbidities, and these patients will most likely require direct supervision.
Several members of ACHM and the Undersea and Hyperbaric Medical Society (UHMS) provided both oral and written testimony on behalf of ACHM and UHMS in opposition to changing direct supervision to general supervision for HBOT under the proposed Outpatient Prospective Payment System rule. The “Physician’s Duties in Hyperbaric Medicine” position statement developed by ACHM in 1993 spelled out the significant work involved in supervising HBOT, not just while the patient was in the chamber, but also pre- and post-treatment.2 This document contributed to HCFA’s decision to add CPT 99183 and assign a Relative Value Unit to this CPT code.
ACHM and UHMS were not the only ones concerned about this change. Even the Medicare Payment Advisory Commission (MedPAC) submitted comments and were concerned about the quality of care that beneficiaries could would receive. MedPAC stated, “MedPAC strongly encourages CMS to diligently monitor the impacts of the CMS proposal on the quality and safety of outpatient therapeutic services that Medicare beneficiaries receive to ensure their quality of care is not compromised and that beneficiaries do not experience higher rates of medical errors.”3
The American Medical Association (AMA) passed Resolution 221 in the interim meeting at San Diego on November 19, 2019, which, in part, states:4
That our American Medical Association advocate that radiation therapy services and hyperbaric oxygen services should be exempted from the Hospital Outpatient Prospective Payment System (HOPPS) rule requiring only general supervision of hospital therapeutic services; and be it further
That our AMA advocate that direct supervision of hyperbaric oxygen therapy services by a physician trained in hyperbaric oxygen services should be required by the Centers for Medicare and Medicaid Services.
CMS acknowledged the concerns that were raised and made the following statement:1
We agree with the commenters about the importance of ensuring the quality of outpatient therapeutic services and the health and safety of the beneficiaries who receive those services. We also appreciate the concerns several commenters raised about how this proposal will affect the quality and safety of outpatient therapeutic services including radiation therapy, hyperbaric oxygen treatments, and wound care services. We believe our supervision requirements continue to provide the safeguards Medicare beneficiaries need to ensure they receive quality care when they receive outpatient hospital therapeutic services and that health and safety of beneficiaries is protected.
Providers have the flexibility to establish what they believe is the appropriate level of physician supervision for these procedures, which may well be higher than the requirements for general supervision.
The final rule, effective January 1, 2020, states that hospital billing of all outpatient services (which includes hyperbaric medicine) will be under general supervision.1
Consider for a moment that this change from direct to general supervision was not intended specifically for hyperbaric medicine; and does not state that a physician does not need to personally perform a hospital outpatient service. In fact, most hospital outpatient services are actually performed by a physician, with the hospital billing for the technical component of the physician service provided. Therefore, this change may be nothing more than simplifying the audit process. Rather than requiring the hospital to have specific documentation of direct physician supervision for each outpatient service (which is cumbersome for Medicare contractors to audit), the Medicare contractor’s computer can simply look at the claims filed to see if there is a corresponding physician claim. In addition, Medicare contractors Novitas and First Coast Service Options have had physician/provider education, training, and supervision requirements well beyond the federal requirement of direct supervision for many years. Based on the position of these two Medicare contractors on physician/provider supervision, it seems very unlikely they would simply change their Local Coverage Determinations to just general supervision.
What does this mean for us? At this time, it seems prudent for physicians to continue direct supervision of hyperbaric treatments, which is consistent with ACHM and UHMS guidelines. This also means that AMA and hyperbaric specialty organizations, like ACHM and UHMS, will have a greater role in setting the standards of clinical practice. n
Jayesh B. Shah is president of the American College of Hyperbaric Medicine and serves as medical director for two wound centers based in San Antonio, TX. In addition, he is president of South Texas Wound Associates, San Antonio. He is also past president of both the American Association of Physicians of Indian Origin and the Bexar County Medical Society.
1. Centers for Medicare & Medicaid Services. Medicare program: changes to hospital outpatient prospective payment and ambulatory surgical center payment systems and quality reporting programs. Federal Register. Available at https://www.federalregister.gov/d/2019-24138/page-61362. Published November 12, 2019. Effective January 1, 2020.
2. American College of Hyperbaric Medicine. Physician’s duties in hyperbaric medicine. Available at https://www.achm.org/amsimis/ACHM/News___Events/Article_Archive/Physician_s_Duties_in_Hyperbaric_Medicine.aspx . Published 1993.
3. Medicare Payment Advisory Commission. Available at http://www.medpac.gov/docs/default-source/comment-letters/09132019_opps_asc_2020_medpac_comment_v2_sec.pdf?sfvrsn=0
4. American Medical Association. Ref Com B Report I-19 pre annotated PHW. Available at https://www.ama-assn.org/system/files/2019-11/i19-refcomm-b-annotated.pdf. Published November 2019.