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. On a side note, several times, 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 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, 2018 asking how Palmetto could deny payment for an indication listed in the National Coverage Determination (NCD). He stated that ‘radiation proctitis is not covered per our instructions from CMS”.
On 8/27/18, I sent an email to Drs. Susan Miller and James Rollins from the Coverage and Policy Group of CMS. They invited me to a conference call to discuss. The teleconference took place on October 9, 2018 between Drs. Miller, Rollins and me with Dr. Garrett listening in. I was told 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 is “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 and they would consider the medical literature and make a determination. This is a double-edged sword. If we request re-opening we could ask them to include central retinal artery occlusion and idiopathic sudden sensorineural hearing loss, BUT they could also review the other indications and we risk the change of them determining 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 HBOT. This clearly shows that radiation proctitis resolves faster with HBOT 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 (evidently, they were getting tired of corresponding with me). 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 had written letters to several people pointing out the 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
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 email@example.com
You can also contact your local senators and congresspeople.
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.