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LCD Reference Article Response To Comments Article

Response to Comments: Radiation Therapies

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A59547
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Article Title
Response to Comments: Radiation Therapies
Article Type
Response to Comments
Original Effective Date
10/19/2023
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The comment period for the Radiation Therapies DL39553 Local Coverage Determination (LCD) began on 06/08/23 and ended on 07/22/23. The notice period for L39553 begins on 10/19/23 and will become effective on 12/3/23.

The comments below were received from the provider community.

Response To Comments

Number Comment Response
1

This updated LCD is much needed. We have been receiving denials for some of our services because the treatment modality that our Radiation Oncologists have determined to be best for our patients are not covered for the diagnosis. This new LCD along with the draft article Billing and Coding: Radiation Therapies include these diagnosis. The last LCD for radiation oncology offered by Palmetto is from 2018 and is now retired.

Thank you for your comment.
2

We thank you for the opportunity to comment on the proposed local coverage determination (LCD) on Radiation Therapies published for comment by Palmetto GBA on June 8, 2023. We are an independent nonprofit organization founded in 1990 to educate and increase awareness about the clinical benefits of proton therapy. Its members include 45 of the nation’s leading cancer centers, many of which are NCI- designated comprehensive cancer centers and NCCN members. Our mission is to work collaboratively to raise public awareness of proton therapy, ensure patient choice and access to affordable treatment, and encourage cooperative research and innovation to advance proton therapy’s appropriate and cost-effective utilization.

Proton therapy is a radiation treatment modality that has the proven ability to reduce side effects for patients by limiting the amount of normal tissue exposed to radiation. Unlike conventional x-ray radiation, which has both entrance and exit doses, proton therapy delivers radiation to the target, with little to no radiation extending beyond the target. In addition to these acute and late toxicity benefits of proton therapy over conventional radiation therapy, proton beam therapy has been shown across multiple disease sites to improve overall survival, either by reducing life-threating toxicities, being more biologically potent at tumor killing, or allowing for more targeted and escalated doses of irradiation to be delivered directly to the tumor. More than 900 publications have validated the efficacy of proton therapy – showing lower tumor recurrence rates, higher survival rates, fewer short-term and late toxicities, and better preservation of patient quality-of-life both during and after treatment.

We are concerned by the non-coverage position on intensity-modulated radiation therapy (IMRT) used in conjunction with proton beam radiation therapy in the proposed LCD. There is a long history, and many peer-reviewed publications, describing combined proton and photon radiation plans in diverse diseases.

These studies outline a number of reasons why treated patients have received combined proton and photon radiation treatment plans, including but not limited to equipment downtime or periods of unavailability of proton therapy, limited availability of pencil-beam scanning, as a planned twice-daily radiation regimen using both modalities, to reduce the radiation dose to skin when treating with passively scattered proton radiation, and to reduce the dosimetric impact of spine stabilization hardware.

Combined modality treatment plans are also of interest to address resource constrained settings with limited access to gantry-based proton therapy treatment slots, and to optimize utilization of lower-cost fixed horizontal beam lines for proton therapy. Several studies have explored combined photon-proton radiation plans for patients with locally advanced non-small lung cancer, breast cancer, and head and neck cancer, finding that optimally combined photon-proton treatment plans could improve treatment plan quality and make proton therapy available to more patients.

Independent of limited resource allocation, novel treatment planning optimization approaches with mixed protons and photons suggest that new approaches can improve treatment plan quality by combining both radiation modalities in diverse disease sites including abdomen, lung, head and neck, and brain. Such hybrid plans would only be possible when it is clinically feasible to deliver either photon or proton treatment on a day-to-day basis.

This proposed non-coverage position could restrict physicians from optimizing radiation treatment plans for select Medicare beneficiaries where the combination therapy is reasonable and necessary. We are concerned that this restriction could impede the appropriate care of certain complex patients with a variety of tumors who need urgent initiation of treatment or continuation of care when proton therapy is not available. This is especially important for patients with tumors such as head and neck, lung, and GI when treatment start time is critical and can impact local tumor control in patient outcomes. If this LCD is finalized, as proposed, please consider one or more exceptions for combined therapy that is necessary for limited practical reasons that are appropriately documented by the rendering provider.

Lastly, the literature cited by Palmetto to support this proposed non-coverage position, a paper by Morgan et al., is the 2018 ASTRO/ASCO/AUA practice guideline on hypofractionated radiation for prostate cancer. That guideline is not about radiation modalities and makes no comments about combining IMRT and proton therapy for prostate cancer.

Proton therapy is a proven treatment that must be made available to patients who need it most. Our members value the responsible use of proton and photon therapy and participate in multi-institutional research efforts demonstrating that this treatment improves outcomes for patients.

Again, we appreciate the opportunity to comment on the proposed LCD. As noted above, we have significant concerns with the proposed restrictions on coverage for IMRT in conjunction with proton therapy and believe that such a restriction will be detrimental to patient access and care.

References were provided for review.

Thank you for your comment. This LCD only covers IMRT (Interventional Modulated Radiation Therapy), SRS (stereotactic radiosurgery) and SBRT (stereotactic Body Radiation Therapy). If deemed reasonable and necessary, with proper peer reviewed literature for support, and information on indications and limitations, usage can be determined on a case-by-case basis, or you may submit this therapy for review as a new LCD.
3

I am writing this in response to the draft LCD and Article for Radiation Therapies. The Article references General Supervision does not apply when:

  • Radiation therapy is delivered in a freestanding center;
  • The work of radiation treatment management is performed;
  • Brachytherapy (CPT® codes 77770-77772), stereotactic radiation therapy (CPT® codes 77371-77373) and other services described by CPT® codes requiring that the radiation oncologist personally provide the services are performed;
  • Diagnostic services, such as image guidance, are performed; or
  • A hospital determines that radiation therapy services require direct supervision.

The Article then addresses codes 77427, 77431, 77432, 77435 and 77469 as examples where the services must be provided personally by the radiation oncologist. In my many years of experience in the field of radiation oncology and my experience as an auditor of radiation oncology services, I would highly recommend to expand this to also address the professional components of codes with a professional and technical component (PC/TC indicator of 1). Examples of these codes would be items such as simulations (77280, 77285, 77290) and treatment devices (77332, 77333, 77334). CPT® 77280-26 is assigned a physician work time of 37 minutes for CY 2023. As the professional component represents the professional work valued by the assumption of an amount of time spent performing the procedure, personal attendance or performance of the procedure by the physician should be expected in order to reimburse the professional component billed on the CMS 1500 claim form with a 26 modifier.

Many radiation oncologists have incorrectly applied the hospital supervision rules applicable to the technical component of a charge reported on the hospital claim form to their own professional services. With this incorrect interpretation, many radiation oncologists are no longer present for procedures performed where they are billing a professional component. When instructing radiation oncologists on requirements for their participation in patient procedures, I refer to the 2010 HOPPS Final Rule, which states, “We also noted that Medicare does not make a payment to a physician under MPFS when the physician solely provides the direct physician supervision of hospital outpatient therapeutic services but furnished no direct professional services to a patient.”

As this was stated for Direct Supervision, it would be expected that with even a lesser level of supervision, the physician would not be expected to be reimbursed by CMS for merely provided supervision but not professional work. As radiation oncologists will likely interpret your article to only require the physician to be present for treatment management visits (77427, 77431, 77432, 77435, 77469) due to the omission of any codes with a professional / technical component, it is recommended to expand the information to also include procedures with professional components to avoid overpayments and manipulation.

I hope my suggestions are well received.

Thank you for your comment. The definition and requirements of treatment, supervision and physician role are clearly defined and stated within the body of the article.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L39553 - Radiation Therapies
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Updated On Effective Dates Status
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Keywords

  • IMRT
  • SRS
  • SBRT
  • SABR

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