Clinical UM Guideline


Subject: Inpatient Admission for Radiation Therapy for Cervical or Thyroid Cancer
Guideline #:  CG-MED-38 Publish Date:    09/20/2018
Status: Reviewed Last Review Date:    02/27/2018

Description

This document 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 intracavity 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 or when the levels of radioactivity are deemed safe and appropriate for discharge.

This document does not address the use of I-131, a radioactive substance when used as a diagnostic tool in an I-131 scan.  

Note:

Clinical Indications

Medically Necessary:

An inpatient admission for radiation treatment for cervical or thyroid cancer is considered medically necessary for the period of time the individual’s calculated level of radioactivity is greater than the discharge guidelines set by the U.S. Nuclear Regulatory Commission (USNRC, 20013). See Appendix A.

Not Medically Necessary:

An inpatient admission for radiation treatment for cervical cancer or thyroid cancer is considered not medically necessary when the above criteria are not met.

Goal Length of Stay

 Goal Length of Stay:  Generally 1-2 days. The Radiation Safety Department will clear the individual for discharge when the individual emits a safe level of radiation. 

Coding

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.

Discussion/General Information

Cervical radiation implants, sometimes called brachytherapy, may be administered by loading a surgically placed device into the cervix with radiation material in a form such as capsules.  This type of implant is left in place for several days in which time the individual is hospitalized.  Another type of procedure for cervical radiation implants is done on an outpatient basis called high-dose rate (HDR) brachytherapy.  In this method, the implant remains only an hour or less, and is done weekly repeated three to five times.  A third type of treatment involves interstitial implants in which needles are inserted into the cervical tissue around the cancer and loaded with radioactive material.  The individual may remain hospitalized until the implants are removed and the individual meets discharge criteria.

Generally, for thyroid cancer, I-131 therapy is done after a total or a partial thyroidectomy.  The thyroid absorbs almost all of the body’s iodine.  I-131 is used to destroy cancer cells that take up iodine and were not removed by surgery and those that have spread beyond the thyroid (American Cancer Society [ACS], 2016).  Therapy is given in either liquid or pill form.  Dosing of the therapy can be calculated using an empiric or fixed dosing, quantitative dosimetry, or upper bound limits set by blood dosimetry (National Comprehensive Cancer Network® [NCCN®], 2017).  The most widely used and the simplest method is the empiric or fixed dose.  The individual’s dose is determined by the extent of their disease with typical doses within 30-200 mCi (NCCN, 2017).  In the past, individuals were routinely hospitalized for I-131 radiation therapy.  Hospitalization is no longer routinely required because a change in federal legislation permits the use of much larger doses in ambulatory individuals (NCCN, 2017; U.S. Nuclear Regulatory Commission [USNRC], 2013).

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.

According to the U.S. Nuclear Regulatory Commission regulations (2013), individuals treated with various forms of radioactive implants must remain in the hospital until all the implant material has been removed and accounted for.  A source count and radiation survey must be done prior to discharge.  The radiation survey is calculated according to the maximum exposure rate radiation level at a distance of one meter from the individual.  This occurs when total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5mSv (0.5 rem).  Local or State regulations may differ from the U.S. Nuclear Regulatory Commission (USNRC, 2013).  For safety, the survey requires exposure rate radiation levels be determined in the individual's room and the surrounding area, recorded, and maintained for inspection by the department.

References

Peer Reviewed Publications:

  1. Al-Shakhrah IA. Radioprotection using iodine-131 for thyroid cancer and hyperthyroidism: a review. Clin J Oncol Nurs. 2008; 12(6):905-912.
  2. Brooks SE, Chen TT, Ghosh A, et al. Cervical cancer outcomes analysis: impact of age, race, and comorbid illness on hospitalizations for invasive carcinoma of the cervix. Gynecol Oncol. 2000; 79(1):107-115.
  3. de Carvalho J, Sapienza M, Ono C, et al. Could the treatment of differentiated thyroid carcinoma with 3.7 and 5.55 GBq of (131I)NaI, on an outpatient basis, be safe? Nucl Med Commun. 2009; 30(7):533-541.
  4. Willegaignon J, Sapienza M, Ono C, et al. Outpatient radioiodine therapy for thyroid cancer: a safe nuclear medicine procedure. Clin Nucl Med. 2011; 36(6):440-445.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Thyroid Association Taskforce on Radioiodine Safety. Radiation safety in the treatment of patients with thyroid diseases by radioiodine 131I: practice recommendations of the American Thyroid Association. Thyroid. 2011; 21(4):335-346.
  2. Henkin RE, Del Rowe JD, Grigsby PW, et al. ACR-ASTRO practice guideline for the performance of therapy with unsealed radiopharmaceutical sources. Clin Nucl Med. 2011; 36(8):e72-e80.
  3. Luster M, Clarke SE, Dietlein M, et al.; European Association of Nuclear Medicine (EANM). Guidelines for radioiodine therapy of differentiated thyroid cancer. Eur J Nucl Med Mol Imaging. 2008; 35(10):1941-1959.
  4. National Cancer Institute (NCI). Available at: http://www.cancer.gov/publications/pdq.  Accessed on January 12, 2018.
    • Cervical Cancer Treatment. Modified January 31, 2017.
    • Thyroid Cancer Treatment. Modified January 12, 2018.
  5. National Comprehensive Cancer Network® (NCCN). Clinical Practice Guidelines in Oncology®. © 2017 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on January 12, 2018.
    • Cervical Cancer (V.1.2018). October 25, 2017.
    • Thyroid Carcinoma (V.2.2017). May 17, 2017.
  6. Spratt D, Zaki BI, Franc BL, et al. ACR practice parameter for the performance of therapy with unsealed radiopharmaceutical sources. Clin Nucl Med. 2016 Feb;41(2):106-17.
  7. U.S. Nuclear Regulatory Commission (USNRC). § 35.75 Release of individuals containing unsealed byproduct material or implants containing byproduct material. Page updated August 29, 2017. Available at: http://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-0075.html. Accessed on January 12, 2018.
  8. U.S. Nuclear Regulatory Commission (USNRC). Consolidated guidance about materials licenses. Program-specific guidance about medical use licenses. Final report. NUREG-1556, Vol. 9, Rev 2. Page updated March 29, 2017. Available at: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v9/r2/. Accessed on January 12, 2018.
  9. U.S. Nuclear Regulatory Commission (USNRC). NRC policy on release of iodine-131 therapy patients under 10 CFR 35.75 to locations other than private residences. RIS 2011-01. January 25, 2011. Available at: http://pbadupws.nrc.gov/docs/ML1036/ML103620153.pdf. Accessed on January 12, 2018.
Websites for Additional Information
  1. American Cancer Society. Available at: http://www.cancer.org. Accessed on January 12, 2018.
  2. National Cancer Institute. Available at: http://www.nci.nih.gov. Accessed on January 12, 2018.
  3. National Cancer Institute (NCI). Radiation therapy for cancer: questions and answers. Reviewed June 30, 2010. Available at: http://www.cancer.gov/cancertopics/factsheet/Therapy/radiation. Accessed on January 12, 2018.
Index

Brachytherapy for Cervical Cancer
I-131 Ablation
I-131 Radioiodine
I-131 Swallow
Interstitial Cervical Radiation
Intracavity Cervical Radiation
Radiation Implant for Cervical Cancer
Radiotherapy for Cervical Cancer

History

Status

Date

Action

  09/20/2018

Updated Coding section; removed procedure and diagnosis codes as specific coding is not applicable.

Reviewed

02/27/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Discussion, References and Websites sections.

Reviewed

02/02/2017

MPTAC review. Updated Description, Discussion, References and Websites sections.

Reviewed

02/04/2016

MPTAC review. Updated Description, Discussion, References and Websites sections.

 

01/01/2016

Updated Coding section with 01/01/2016 CPT changes, removed 77776, 77777 deleted 12/31/2015; also removed ICD-9 codes.

Reviewed

02/05/2015

MPTAC review. Updated Description, Coding, References and Websites sections.

Reviewed

02/13/2014

MPTAC review. Updated References and Websites sections.

Reviewed

02/14/2013

MPTAC review. Updated References and Websites sections.

Reviewed

02/16/2012

MPTAC review. Updated References and Websites sections.

 

01/01/2012

Updated Coding section with 01/01/2012 CPT descriptor revisions.

Reviewed

02/17/2011

MPTAC review. Updated References and Websites sections. Updated Coding section with 04/01/2011 HCPCS changes; removed S2270 deleted 03/31/2011.

 

10/14/2010

Category changed from CG-RAD-19 to CG-MED-38. Updated Website information.

Reviewed

02/25/2010

MPTAC review. References and websites updated.

Revised

02/26/2009

MPTAC review. References, websites and coding updated. Clinical indications clarified and Appendix A added. Place of Service Section removed.

Reviewed

02/21/2008

MPTAC review. References, websites updated. No change to position.

 

01/01/2008

Updated Coding section with 01/01/2008 CPT changes.

New

03/08/2007

MPTAC review. Initial guideline development. Combined CG-RAD-03 Inpatient Admission for I-131 Radiation Treatment for Thyroid Cancer with CG-RAD-17 Radiation Implants for Cervical Cancer Length of Stay. Description, discussion, references and coding updated.

Appendix A

U.S. Nuclear Regulatory Commission (USNRC). Consolidated guidance about materials licenses. Program-specific guidance about medical use licenses. Final report. NUREG-1556, Vol. 9, Rev 2. Page updated March 29, 2017. Available at: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v9/r2/. Accessed on January 12, 2018.

Table U.1 Activities and Dose Rates for Authorizing Patient Release†

 

Radionuclide

 

Column 1
Activity at or Below Which 

Patients 
May be Released

Column 2
    Dose Rate at 1 Meter, at or Below
     Which Patients May be Released*

(GBq)

(mCi)

  (mSv/hr)

(mrem/hr)

Ag-111

19

520

0.08

8

Au-198

3.5

93

0.21

21

Cr-51

4.8

130

0.02

2

Cu-64

8.4

230

0.27

27

Cu-67

14

390

0.22

22

Ga-67

8.7

240

0.18

18

I-123

6

160

0.26

26

I-125

0.25

7

0.01

1

I-125 implant

0.33

9

0.01

1

I-131

1.2

33

0.07

7

In-111

2.4

64

0.2

20

Ir-192 implant

0.074

2

0.008

0.8

P-32

**

**

**

**

Pd-103 implant

1.5

40

0.03

3

Re-186

28

770

0.15

15

Re-188

29

790

0.2

20

Sc-47

11

310

.017

17

Se-75

0.089

2

0.005

0.5

Sm-153

26

700

0.3

30

Sn-117m

1.1

29

0.04

4

Sr-89

**

**

**

**

Tc-99m

28

760

0.58

58

T1-201

16

430

0.19

19

Y-90

**

**

**

**

Yb-169

0.37

10

0.02

2

   
The activity values were computed based on 5 millisieverts (0.5 rem) total effective dose equivalent.
* 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 Item U.3.1, "Records of Release," for information on records.  
** Activity and dose rate time limits are not applicable in this case because of the minimal exposures to members of the public resulting from activities normally administered for diagnostic or therapeutic purposes.  

Notes:

The millicuric values were calculated using Equations U.2 or U.3 and the physical half-life. The gigabecquerel values were calculated using the millicuric values and the conversion factor from millicuric to gigabecquerels. The dose rate values are calculated using the millicuric values and the exposure rate constants.

In general, the values are rounded to two significant figures; however, values less than 0.37 gigabecquerel (10 millicuries) or 0.1 millisievert (10 millirems) per hour are rounded to one significant figure. Details of the calculations are provided in NUREG-1492.

Although non-byproduct materials are not regulated by NRC, information on non-by product material is included for the convenience of the licensee.

Agreement State regulations may vary. Agreement State licensee should check with their State regulations before using these values.