News & Announcements

UHMS member alerts the Society on problems with CMS coverage of radiation proctitis

The Case of the Disappearing Indication

Thomas M. Bozzuto, DO, FACEP, FFACHM, UHM

            On May 15, 2018, Palmetto GBA conducted an “Ask the Contractor Teleconference” (ACT) with Dr. Leland Garrett, Medical Director of Palmetto GBA of Columbia, South Carolina. On a side note, several times it appeared that Dr. Garrett did not know the difference between transcutaneous oxygen measurements and topical oxygen therapy – commenting several times that TCOM was not covered under the national coverage determination (NCD). A clarification update had to be issued on July 6, 2018, stating that Dr. Garrett “misunderstood the question” and that TCOM is covered.

            Later in that teleconference, he made the statement that radiation proctitis was not covered. When asked what providers could do about it, he said that the only provider option would be the Appeal Process. I sent an email to Dr. Garrett on August 21, 201,8 asking how Palmetto could deny payment for an indication listed in the NCD. He stated that “radiation proctitis is not covered per our instructions from CMS.”

            A week later on August 27 I sent an email to Drs. Susan Miller and James Rollins from the Coverage and Policy Group of CMS regarding coverage of radiation proctitis. They invited me to a conference call to discuss. The teleconference took place on October 9 between Drs. Miller, Rollins and me, with Dr. Garrett listening in.

I was informed that this decision is an “interpretation” of the NCD, NOT a revision. By doing this, they bypassed the required publication in the Federal Register and the 45-day public comment period. I send Drs. Miller and Rollins the article from the Association of Colon and Rectal Surgeons on the Clinical Practice Guidelines for the Treatment of Radiation Proctitis 1 along with the chapter in the UHMS indications manual and Dr. Feldmeier’s article on delayed radiation injury.

            Dr. Miller said that their definition of soft tissue was: “tissue (such as tendon, muscle, skin, fat and fascia) that typically connects, supports, or surrounds bone and internal organs and that not all collagen-containing tissues are included. I pointed out to her that the National Cancer Institute definition of soft tissue: “Refers to muscle, fat, fibrous tissue, blood vessels, or other supporting tissue of the body” and that the bowel wall contains blood vessels, muscle and fat. I thought it was appropriate to use the NCI definition because the reason for the radiation treatment was cancer.

            She told me that the only way we could get it put back into the NCD was to request a reopening of the NCD from CMS. They would consider the medical literature and make a determination. This is a double-edged sword. If we request reopening we could ask them to include central retinal artery occlusion and idiopathic sudden sensorineural hearing loss, BUT they could also review the other indications. If so, we risk a change in their coverage as well as the potential to see them determine that other indications have less-than-optimal evidence and we might lose others.

            On February 25 I send them an abstract of a study done at our facility2 comparing medical treatment, argon plasma coagulation therapy, and hyperbaric oxygen therapy, the results showed that, on average, proctitis resolved at 12 months with medicinal use, 6 months after APC, and 4.5 months after HBO2 therapy. This clearly shows that radiation proctitis resolves faster with HBO2 therapy – and with decreased costs. The reply I received from Dr. Miller was “Thank you.”

            On March 7, 2019, I received a letter from Dr. Kate Goodrich, Director, Center for Clinical Standards and Quality and Chief Medical Officer of CMS. She thanked me for my conversations with Drs. Miller and Rollins. Dr. Goodrich stated: “While it is true that the bowel wall contains muscle, blood vessels and nerves just as many anatomic structures do, that does not qualify the bowel itself, a hollow organ with distinctive absorption and excretory functions as soft tissue.”

            I have written letters to several people pointing out this arbitrary and capricious decision by CMS, including Alex Azar, Secretary of Health and Human Services, Senator Pat Toomey (R-PA), Chairman of the Senate Subcommittee on Health Care, and my local senator. To date I have received no replies.

            I suggest that everyone take time to write these individuals to express your displeasure in CMS’s arbitrary decision.

Alex Azar, II                                                                          
Secretary, Health and Human Services
200 Independence Avenue, SW
Washington, DC, 20201
Email: secretary@hhs.gov

Senator Pat Toomey
Chairman, Senate Subcommittee on Health
248 Russell Senate Office Building
Washington, DC 20510

If anyone would like a copy of the letter I sent to Mr. Azar or a copy of our abstract please email me at tbozzuto@phoebehealth.com

You can also contact your local senators and representatives.

References

  1. Paquette IM, Vogel JD, Maher AA, Feingold, DL, Steele SR: Clinical Practice Guidelines for the Treatment of Radiation Proctitis. Diseases of the Colon and Rectum 2018;61:1135-1140.
  2. Rao A, Bonner MR, Myers S, Morris CG, Bozzuto TM, et al. Incidence and course if Grade 2 proctitis treated with the use of modern IRMT and brachytherapy for localized prostate cancer in a community cancer center. Abstract.