Clinical UM Guideline


Subject:Inpatient Admission for Radiation Therapy for Cervical or Thyroid Cancer
Guideline #:  CG-MED-38Current Effective Date:  04/15/2014
Status:ReviewedLast Review Date:  02/13/2014

Description

Radiation implants may be placed in interstitial or intracavity spaces for the treatment of cervical cancer.  In stage I cervical cancer, radiation implants may be used alone or used after surgery to eliminate remaining cancer cells.  In stage IB-IVA cervical cancer, radiation implants are frequently administered with chemotherapy.  Individuals are discharged from the hospital after the radiation implants are removed.

I-131 is a radioactive substance that is used as a diagnostic tool in an I-131 scan and as a treatment to ablate thyroid cells.  This guideline addresses the medical necessity of an inpatient admission for radiation treatment for cervical and thyroid cancer.

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, 2002). 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

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  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.

CPT 
55920Placement of needles or catheters into pelvic organs and/or genitalia (except prostate) for subsequent interstitial radioelement application
57155Insertion of uterine tandem and/or vaginal ovoids for clinical brachytherapy
57156Insertion of a vaginal radiation afterloading apparatus for clinical brachytherapy
58346Insertion of Heyman capsules for clinical brachytherapy
77470Special treatment procedure (eg, total body irradiation, hemibody radiation, per oral or endocavitary irradiation)
77761Intracavitary radiation source application; simple
77762Intracavitary radiation source application; intermediate
77763Intracavitary radiation source application; complex
77776Interstitial radiation source application; simple
77777Interstitial radiation source application; intermediate
77778Interstitial radiation source application; complex
79005Radiopharmaceutical therapy, by oral administration
  
HCPCS 
A9517Iodine I-131 sodium iodide capsule(s), therapeutic, per millicurie
A9530Iodine I-131 sodium iodide solution, therapeutic, per millicurie
  
ICD-9 Procedure[For dates of service prior to 10/01/2014]
92.28Injection or instillation of radioisotopes
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
179Malignant neoplasm of uterus, part unspecified
180.0Malignant neoplasm of cervix uteri, endocervix
180.1Malignant neoplasm of cervix uteri; exocervix
180.8Malignant neoplasm of cervix uteri; other specified sites of cervix
180.9Malignant neoplasm of cervix uteri; unspecified
182.0Malignant neoplasm of body of uterus; corpus uteri, except isthmus
182.1Malignant neoplasm of body of uterus; isthmus
182.8Malignant neoplasm of other specified sites of body of uterus
193Malignant neoplasm of thyroid gland
198.82Secondary malignant neoplasm of other genital organs
233.1Carcinoma in situ of cervix uteri
233.2Carcinoma in situ of other and unspecified parts of uterus
234.8Carcinoma in situ, other specified sites (thyroid)
V10.41Personal history of malignant neoplasm of cervix uteri
V10.42Personal history of malignant neoplasm of other parts of uterus
V58.0Encounter for radiotherapy
  
ICD-10 Procedure[For dates of service on or after 10/01/2014]
CW7GGZZSystemic nuclear medicine therapy of thyroid using iodine 131 (I-131)
DWY5GDZIsotope administration to whole body using iodine 131 (I-131)
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2014]
C53.0-C53.9Malignant neoplasm of cervix uteri
C54.0-C54.9Malignant neoplasm of corpus uteri
C55Malignant neoplasm of uterus, part unspecified
C73Malignant neoplasm of thyroid gland
C79.82Secondary malignant neoplasm  of genital organs
D06.0-D06.9Carcinoma in situ of cervix uteri
D07.0Carcinoma in situ of endometrium
D07.39Carcinoma in situ of other female genital organs
D09.3Carcinoma in situ of thyroid and other endocrine glands
Z51.0Encounter for antineoplastic radiation therapy
Z85.41Personal history of malignant neoplasm of cervix uteri
Z85.42Personal history of malignant neoplasm of other parts of uterus
Z85.850Personal history of malignant neoplasm of thyroid
  
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], 2013).  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®], 2013).  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, 2013).  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, 2013; 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/cancertopics. Accessed on November 24, 2013.
    • Cervical Cancer. Modified May 15, 2013.
    • Thyroid Cancer. Modified February 13, 2013.
  5. National Comprehensive Cancer Network® (NCCN). Clinical Practice Guidelines in Oncology™. © 2013 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on November 24, 2013.
    • Cervical Cancer (V.3.2013). July 16, 2013.
    • Thyroid Carcinoma (V.2.2013). April 9, 2013.
  6. 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 July 24, 2013. Available at: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v9/r2/. Accessed on November 24, 2013.
Websites for Additional Information
  1. American Cancer Society. Available at: http://www.cancer.org. Accessed on December 12, 2013.
  2. National Cancer Institute. http://www.nci.nih.gov. Accessed on November 24, 2013.
  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 November 24, 2013.
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

Reviewed02/13/2014Medical Policy & Technology Assessment Committee (MPTAC) review. Updated References and Websites sections.
Reviewed02/14/2013MPTAC review. Updated References and Websites sections.
Reviewed02/16/2012MPTAC review. Updated References and Websites sections.
 01/01/2012Updated Coding section with 01/01/2012 CPT descriptor revisions.
Reviewed02/17/2011MPTAC review. Updated References and Websites sections.  Updated Coding section with 04/01/2011 HCPCS changes; removed S2270 deleted 03/31/2011.
 10/14/2010Category changed from CG-RAD-19 to CG-MED-38. Updated Website information.
Reviewed02/25/2010MPTAC review. References and websites updated.
Revised02/26/2009MPTAC review. References, websites and coding updated. Clinical indications clarified and Appendix A added. Place of Service Section removed.
Reviewed02/21/2008MPTAC review. References, websites updated. No change to position.
 01/01/2008Updated Coding section with 01/01/2008 CPT changes.
New03/08/2007MPTAC 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 July 24, 2013. Available at: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v9/r2/. Accessed on November 24, 2013.

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.