Regulatory Guide 8.39

[Darnell Rempe]

Thisdocument addresses the medical necessity of an inpatient admission for radiation treatment for cervical and thyroid cancer. Radiation implants, also called brachytherapy, may be placed in interstitial or intracavitary spaces for the treatment of cervical cancer. Thyroid cancer may be treated with radioactive iodine such as I-131. Individuals are discharged from the hospital after the radiation implants are removed and the levels of radioactivity are deemed safe and appropriate for discharge.

Coding edits for medical necessity review are not implemented for this guideline. Where a more specific policy or guideline exists, that document will take precedence and may include specific coding edits and/or instructions. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Brachytherapy, or cervical radiation implants, is a component of therapy for those with primary cervical cancer who are not surgical candidates. High-dose rate (HDR) brachytherapy, which involves exposing the target area to strong radiation for short periods of time, is done on an outpatient basis. The implant remains only an hour or less and is done weekly repeated three to five times. Low-dose rate (LDR) brachytherapy requires that the radiation source be left in place from approximately 1 to 4 days. LDR brachytherapy is applied using an intracavitary, interstitial or a combination approach (Banerjee, 2014). Interstitial implants containing the radioactive material are placed next to the target area using either an applicator or catheters. The individual may remain hospitalized until the implants are removed and the individual meets discharge criteria.

Individuals are encouraged to drink fluids to help the I-131 pass quickly through the body. I-131 is excreted in all body fluids. Therefore, all objects coming into contact with the individual that may be contaminated with sweat, urine, feces, blood or other body fluids are considered radioactive. Within a few days, most of the radiation has been excreted.

U.S. Nuclear Regulatory Commission (USNRC). Release of Patients Administered Radioactive Material. Regulatory Guide 8.39 Revision 1. Issue Date: April 2020. Available at: Accessed on November 2, 2023.

1.1 Release of Patients Based on the Administered Activity: One means that licensees may use to comply with the dose limit in 10 CFR 35.75(a) is to release patients from licensee control if the dosage administered is not greater than the activity in Column 1 of Table 1.1.2 Release of Patients Based on the Measured Dose Rate: Licensees may release patients to whom radionuclides have been administered in amounts greater than the activities listed in Column 1 of Table 1 as long as the measured dose rate at 1 meter (from the surface of the patient) is no greater than the value in Column 2 of Table 1 for that radionuclide.

If the release is based on the dose rate at 1 meter in Column 2, the licensee must maintain a record as required by 10 CFR 35.75(c), because the measurement includes shielding by tissue. See Staff Regulatory Guidance3.1, "Records of Release," for information on records.

Activity and dose rate limits do not apply to these radionuclides because of the minimal exposures to members of the public resulting from dosages normally administered for diagnostic or therapeutic purposes.

The millicurie (mCi) values in Table 1 were calculated using Equation 2 or 3 and the physical half-life. The gigabecquerel (GBq) values were calculated based on the mCi values and the conversion factor from mCi to GBq. The dose rate values were calculated based on the mCi values and the exposure rate constants. In general, the values were rounded to two significant figures. However, values less than 0.37 GBq (10 mCi) or 0.1 mSv (10 millirem (mrem)) per hour were rounded to one significant figure. NUREG-1492 describes the calculations in detail. Agreement State regulations may vary. Agreement State licensees should check their State regulations before using these values.

Federal and State law, as well as contract language including definitions and specific coverage provisions/exclusions, and Medical Policy take precedence over Clinical UM Guidelines and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Clinical UM Guidelines, which address medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Clinical UM Guidelines periodically. Clinical UM guidelines are used when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether or not to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the back of the member's card.

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