Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Hyperthermic Intraperitoneal Chemotherapy for Select Intra-abdominal and Pelvic Malignancies

Policy #:11.00.13g

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

PSEUDOMYXOMA PERITONEI (PMP) AND MALIGNANT PERITONEAL MESOTHELIOMA
Hyperthermic intraperitoneal chemotherapy (HIPEC) following cytoreductive surgery is considered medically necessary and, therefore, covered for pseudomyxoma peritonei (PMP), and diffuse malignant peritoneal mesothelioma.

EPITHELIAL OVARIAN OR FALLOPIAN TUBE CANCER
Hyperthermic intraperitoneal chemotherapy (HIPEC) following cytoreductive surgery is considered medically necessary and, therefore, covered in newly diagnosed epithelial ovarian or fallopian tube cancer at the time of interval cytoreductive surgery when ALL of the following criteria are met:
  • The individual has stage III disease
  • The individual is not eligible for primary cytoreductive surgery, or surgery had been performed but was incomplete and individual will receive neoadjuvant chemotherapy and subsequent interval debulking surgery and
  • It is expected that complete or optimal cytoreduction can be achieved at time of the interval debulking surgery.

EXPERIMENTAL/INVESTIGATIONAL

All other uses, including but not limited to stage IIIC or IV ovarian cancer, peritoneal carcinomatosis from colorectal cancer, gastric cancer, or endometrial cancer; ovarian cancer; and goblet cell tumors of the appendix, for HIPEC following cytoreductive surgery are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, hyperthermic intraperitoneal chemotherapy (HIPEC), in conjunction with cytoreductive surgery, is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Mitomycin, carboplatin, and other drugs used for HIPEC have not been US Food and Drug Administration (FDA)‒approved for this indication. Cyclophosphamide and nitrogen mustard are FDA approved for intraperitoneal administration, but neither drug is used regularly for this purpose.

Several peritoneal lavage systems (Product Code LGZ) have been FDA-cleared to provide “warmed, physiologically compatible sterile solution” (e.g., Performer® HT perfusion system; RanD S.R.L., Medolla, Italy). None has received marketing approval or clearance to administer chemotherapy. FDA has issued warning letters to manufacturers of devices that are FDA cleared for peritoneal lavage using sterile saline solutions when these devices are marketed for off-label use in HIPEC (e.g., ThermaSolutions Inc., Minneapolis, MN; Belmont Instrument Corp., Billerica, MA).

OVARIAN CANCER STAGING

Ovarian cancer staging is as follows:
  • Stage I: The cancer is confined to the ovary or fallopian tube.
  • Stage II: The cancer involves one or both ovaries with pelvic extension.
  • Stage III: The cancer has spread within the abdomen.
  • Stage IV: The cancer is widely spread throughout the body.

ELIGIBILITY FOR NEOADJUVANT CHEMOTHERAPY AND INTERVAL DEBULKING

Eligibility for neoadjuvant chemotherapy and interval debulking surgery is based on a high perioperative risk profile (i.e., the individual is a poor candidate to withstand an aggressive initial cytoreductive procedure) or a low likelihood of achieving cytoreduction to less than 1 cm (i.e., the individual has extensive disease that precludes upfront optimal cytoreduction) or surgery has been performed but was incomplete (i.e., after surgery, one or more residual tumors measuring >1 cm in diameter were present).

DEFINITION OF COMPLETE CYTOREDUCTION

Complete cytoreduction is defined as no visible disease and optimal cytoreduction as one or more residual tumors measuring 10 mm or less in diameter remaining.

Description

CYTOREDUCTIVE SURGERY (CRS) AND HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (HIPEC)

Gastrointestinal, gynecological, and other malignancies often progress and spread through the peritoneal cavity, causing peritoneal carcinomatosis. Because of the limited benefit achieved with current treatment options, a procedure called hyperthermic intraperitoneal chemotherapy (HIPEC), also known as intraoperative hyperthermic peritoneal perfusion, has been introduced to treat peritoneal carcinomatosis. When performed, this procedure delivers heated chemotherapy intraperitoneally, immediately following the cytoreductive surgery (i.e., debulking or macroscopically removing all visible tumors).

Response to HIPEC treatment varies among individuals with peritoneal carcinomatosis due to factors such as the grade of the tumor, the presence of metastases, and the success of the cytoreductive surgery. Two methods have been used to estimate the stage of peritoneal carcinomatosis and to estimate the likelihood for complete cytoreduction surgery. These are the Gilly method and the Peritoneal Cancer Index (PCI). As described by Sugarbaker, the PCI is used in the decision-making process and is a clinical summary of both lesion size and extent of peritoneal surface malignancy.

The thoroughness of the cytoreductive surgery plays a significant role in treatment because of the limited 1-3 mm penetration of cytostatic drugs into the peritoneal tissue. The goal of HIPEC is to eliminate microscopic metastases that are too small to be identified and removed during cytoreductive surgery. The intra-abdominal lavage with heated chemotherapy usually takes 90 to 120 minutes and may utilize an open or closed technique. It is theorized that the chemotherapy lavage serves to wash from the peritoneum any cancer cells that may have been dislodged by the surgical removal of the primary tumor before the cells are fixed within scar tissue, and that the heated chemotherapy increases cytotoxicity and will enhance penetration of the chemotherapy agent into any residual tumor. Additionally, hyperthermia itself has a cytotoxic effect on tumor tissue.

Previous research reported significant morbidity and mortality associated with the procedure, particularly for individuals with advanced tumor distribution. Therefore, the extent of tumor distribution and the success of the cytoreductive surgery were identified as the most important factors for predicting prolonged survival and as fundamental criteria for selecting individuals for this procedure. The literature also reported that additional predictors of prognosis are location, stage, and histopathology (aggressiveness) of the primary cancer; the extent of peritoneal carcinomatosis; and the technical skills of the surgeon.

Due to the evolving complex aspects of HIPEC, such as the selection and optimal temperature of the chemotherapeutic agents, the length of time for the HIPEC perfusion, and its associated morbidity and mortality, current research recommends that procedures are done in facilities with personnel experienced in the scientific, technical, and surgical aspects of peritoneal surface oncology.

In sum, cytoreductive surgery (CRS) includes peritonectomy (i.e., peritoneal stripping) procedures and multivisceral resections, depending on the extent of intra-abdominal tumor dissemination. CRS may be followed intraoperatively by infusion of intraperitoneal chemotherapy with or without heating, which is intended to improve the tissue penetration of the chemotherapy. When heated, this is referred to as hyperthermic intraperitoneal chemotherapy (HIPEC). CRS and HIPEC have been proposed for a number of intra-abdominal and pelvic malignancies such as pseudomyxoma peritonei and peritoneal carcinomatosis from colorectal, gastric, or endometrial cancer. CRS and HIPEC have a sizeable amount of ongoing and unpublished clinical trials for a number of indications for which peer-reviewed evidence supporting routine clinical usage for HIPEC may be lacking.

PSEUDOMYXOMA PERITONEI

Pseudomyxoma peritonei is not a diagnosis, but rather a descriptive term used for the clinical presentation of extracellular mucin within the peritoneum with or without a malignancy. Disease classification should be based on the pathological characteristics of the primary tumor. Several case studies and a systematic review on the use of CRS and hyperthermic intraperitoneal chemotherapy (HIPEC) have been published. Although no randomized trials or comparative studies have been published, data have shown consistent, long-term disease-free survival (DFS) and overall survival (OS) with the use of this technique. Procedure-related morbidity and mortality have decreased over time. Because the prevalence of pseudomyxoma peritonei is very low, the conduct of high-quality trials is difficult. Therefore, the available and published peer-reviewed literature support the use of HIPEC for pseudomyxoma peritonei (PMP) with the presence of extracellular, intraperitoneal mucin.

PERITONEAL MESOTHELIOMA

The conventional treatment of peritoneal mesothelioma (diffuse malignant type) has resulted in a median survival of approximately 12 months. Although data on the use of CRS and HIPEC comprises nonrandomized case series without control groups, these have shown a significant prolongation of median survival ranging from 29.5 to 92 months. Procedure-related morbidity and mortality has remained relatively steady over time at approximately 35% and 5%, respectively. Because the prevalence of peritoneal mesothelioma is low, the conduct of high-quality trials is difficult. Therefore, the currently available peer-reviewed literature has demonstrated that the combination of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy results in significant improvement in the prolongation of survival when compared to conventional treatment for diffuse malignant peritoneal mesothelioma (DMPM).

PERITONEAL CARCINOMATOSIS OF GASTROINTESTINAL ORIGIN (COLORECTAL, GASTRIC)

For individuals who have peritoneal carcinomatosis of colorectal origin who receive CRS plus HIPEC, the evidence includes a randomized controlled trial (RCT), systematic reviews, and a large number of observational studies. Relevant outcomes are overall survival, disease-specific survival, quality of life, and treatment-related mortality and morbidity. A meta-analysis of controlled studies found that CRS plus HIPEC, compared with traditional therapy without HIPEC, was associated with significantly higher survival rates and was not associated with significantly higher treatment-related morbidity rates. The RCT, in which patients with peritoneal carcinomatosis due to colorectal cancer were followed for at least 6 years, demonstrated improved survival in patients who received CRS plus HIPEC and systemic chemotherapy compared with patients who received systemic chemotherapy alone. However, procedure-related morbidity and mortality rates were relatively high, and systemic chemotherapy regimens did not use currently available biologic agents. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have peritoneal carcinomatosis of gastric origin who receive CRS plus HIPEC, the evidence includes 2 small RCTs, observational studies, and a systematic review. Relevant outcomes are overall survival, disease-specific survival, quality of life, and treatment-related mortality and morbidity. A 2017 meta-analysis identified 2 RCTs and 12 controlled nonrandomized studies comparing surgery plus HIPEC with standard surgical management in patients who had peritoneal carcinomatosis due to gastric cancer. The meta-analysis found significantly better survival in the surgery plus HIPEC group at 1 year but not at 2 or 3 years. An RCT found better survival in patients who received CRS plus HIPEC compared with an alternative treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.


PERITONEAL CARCINOMATOSIS OF ENDOMETRIAL ORIGIN

For individuals who have peritoneal carcinomatosis of endometrial origin who receive CRS plus HIPEC, the evidence includes cohort studies. Relevant outcomes are overall survival, disease-specific survival, quality of life, and treatment-related mortality and morbidity. Only uncontrolled studies with small sample sizes were available (<25 individuals). Randomized trials that compare CRS plus HIPEC with standard treatment (e.g., CRS alone or systemic chemotherapy alone) are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

OVARIAN CANCER

NEWLY DIAGNOSED STAGE III OVARIAN CANCER
For individuals who have newly diagnosed stage III ovarian cancer who receive CRS plus HIPEC, the evidence includes an RCT. Relevant outcomes are overall survival, disease-specific survival, quality of life, and treatment-related mortality and morbidity. For patients with newly diagnosed stage III ovarian cancer who had received neoadjuvant chemotherapy, HIPEC increased the time to disease recurrence and reduced mortality. HIPEC did not increase serious adverse events compared with surgery alone. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

STAGE IIIC OR IV OVARIAN CANCER
For individuals who have recurrent stage IIIC or IV ovarian cancer who receive CRS plus HIPEC, the evidence includes an RCT and systematic review. Relevant outcomes are overall survival, disease-specific survival, quality of life, and treatment-related mortality and morbidity. For recurrent stage IIIC or IV disease (second-line setting), evidence from an RCT indicated that CRS plus HIPEC improved survival compared with CRS without HIPEC. However, interpretation of this study is limited because treatment groups in this RCT were unbalanced at baseline (variation in the completeness of cytoreduction), which has been shown to be associated with survival. The evidence is insufficient to determine the effects of the technology on health outcomes.


APPENDICEAL GOBLET CELL TUMORS

For individuals who have appendiceal goblet cell tumors who receive CRS plus HIPEC, the evidence includes a case series. Relevant outcomes are overall survival, disease-specific survival, quality of life, and treatment-related mortality and morbidity. One retrospective series was identified. Additional studies—preferably controlled and ideally RCTs—are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.


NATIONAL COMPREHENSIVE CANCER NETWORK (NCCN)
  • National Comprehensive Cancer Network (NCCN) guidelines include the following relevant recommendations for colon cancer (v.2.2018) and rectal cancer (v.2.2018): “The panel currently believes that complete cytoreductive surgery and/or intraperitoneal chemotherapy can be considered in experienced centers for selected patients with limited peritoneal metastases for whom R0 resection can be achieved. The panel recognizes the need for randomized clinical trials that will address the risks and benefits associated with each of these modalities.”
  • NCCN guidelines on gastric cancer (v.2.2018) and for uterine neoplasms (v.2.2018) do not discuss cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC).
  • NCCN guidelines on ovarian cancer (v.2.2018) state that “patients with low volume residual disease after surgical debulking for stage II or II invasive epithelial ovarian or peritoneal cancer are candidates for intraperitoneal (IP) chemotherapy.” Use of HIPEC is not specified.

References


Abu-Zaid A, Azzam AZ, Alomar O, et al. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for managing peritoneal carcinomatosis from endometrial carcinoma: a single-center experience of 6 cases. Ann Saudi Med. Mar-Apr 2014;34(2):159-166. PMID 24894786

Alexander HR, Jr., Bartlett DL, Pingpank JF, et al. Treatment factors associated with long-term survival after cytoreductive surgery and regional chemotherapy for patients with malignant peritoneal mesothelioma. Surgery. Jun 2013;153(6):779-786. PMID 23489943

Bakrin N, Cotte E, Sayag-Beaujard A, et al. Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for the treatment of recurrent endometrial carcinoma confined to the peritoneal cavity. Int J Gynecol Cancer. Jul 2010;20(5):809-814. PMID 20973274

Baratti D, Kusamura S, Deraco M. Diffuse malignant peritoneal mesothelioma: systematic review of clinical management and biological research. J Surg Oncol. Jun 2011;103(8):822-831. PMID 21283990

Chua TC, Yan TD, Smigielski ME, et al. Long-term survival in patients with pseudomyxoma peritonei treated with cytoreductive surgery and perioperative intraperitoneal chemotherapy: 10 years of experience from a single institution. Ann Surg Oncol. Jul 2009;16(7):1903-1911. PMID 19387742

Delotte J, Desantis M, Frigenza M, et al. Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for the treatment of endometrial cancer with peritoneal carcinomatosis. Eur J Obstet Gynecol Reprod Biol. Jan 2014;172:111-114. PMID 24300558

Desiderio J, Chao J, Melstrom L, et al. The 30-year experience-A meta-analysis of randomised and high-quality non-randomised studies of hyperthermic intraperitoneal chemotherapy in the treatment of gastric cancer. Eur J Cancer. Apr 26 2017;79:1-14. PMID 28456089

Elias D, Gilly F, Quenet F, et al. Pseudomyxoma peritonei: a French multicentric study of 301 patients treated with cytoreductive surgery and intraperitoneal chemotherapy. Eur J Surg Oncol. May 2010;36(5):456-462. PMID 20227231

Elias D, Honore C, Ciuchendea R, et al. Peritoneal pseudomyxoma: results of a systematic policy of complete cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Br J Surg. Sep 2008;95(9):1164-1171. PMID 18690633

Esquivel J, Sticca R, Sugarbaker P, et al. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in the management of peritoneal surface malignancies of colonic origin: a consensus statement. Society of Surgical Oncology. Ann Surg Oncol. Jan 2007;14(1):128-133. PMID 17072675

Food and Drug Administration (FDA). Warning letter: Belmont Instrument Corporation, 5/7/2012. https://www.fdalabelcompliance.com/letters/ucm306771. Accessed October 5, 2018.

Food and Drug Administration (FDA). Warning letter: Therma Solutions, Inc., 5/7/2012. https://www.fdalabelcompliance.com/letters/ucm307258. Accessed October 5, 2018.

Glehen O, Gilly FN, Boutitie F, et al. Toward curative treatment of peritoneal carcinomatosis from nonovarian origin by cytoreductive surgery combined with perioperative intraperitoneal chemotherapy: a multi-institutional study of 1,290 patients. Cancer. Dec 15 2010;116(24):5608-5618. PMID 20737573

Glockzin G, Ghali N, Lang SA, et al. Results of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for peritoneal carcinomatosis from colorectal cancer. J Surg Oncol. Sep 15 2009;100(4):306-310. PMID 19697436

Helm JH, Miura JT, Glenn JA, et al. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: a systematic review and meta-analysis. Ann Surg Oncol. May 2015;22(5):1686-1693. PMID 25124472

Huang CQ, Min Y, Wang SY, et al. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy improves survival for peritoneal carcinomatosis from colorectal cancer: a systematic review and meta-analysis of current evidence. Oncotarget. Aug 15 2017;8(33):55657-55683. PMID 28903452

Huo YR, Richards A, Liauw W, et al. Hyperthermic intraperitoneal chemotherapy (HIPEC) and cytoreductive surgery (CRS) in ovarian cancer: A systematic review and meta-analysis. Eur J Surg Oncol. Dec 2015;41(12):1578-1589. PMID 26453145

Jimenez W, Sardi A, Nieroda C, et al. Predictive and prognostic survival factors in peritoneal carcinomatosis from appendiceal cancer after cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. Ann Surg Oncol. Dec 2014;21(13):4218-4225. PMID 24986239

Lord AC, Shihab O, Chandrakumaran K, et al. Recurrence and outcome after complete tumour removal and hyperthermic intraperitoneal chemotherapy in 512 patients with pseudomyxoma peritonei from perforated appendiceal mucinous tumours. Eur J Surg Oncol. Mar 2015;41(3):396-399. PMID 25216980

Maggiori L, Elias D. Curative treatment of colorectal peritoneal carcinomatosis: current status and future trends. Eur J Surg Oncol. Jul 2010;36(7):599-603. PMID 20605396

Marcotte E, Dube P, Drolet P, et al. Hyperthermic intraperitoneal chemotherapy with oxaliplatin as treatment for peritoneal carcinomatosis arising from the appendix and pseudomyxoma peritonei: a survival analysis. World J Surg Oncol. Nov 07 2014;12:332. PMID 25380618

McConnell YJ, Mack LA, Gui X, et al. Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy: an emerging treatment option for advanced goblet cell tumors of the appendix. Ann Surg Oncol. Jun 2014;21(6):1975-1982. PMID 24398544

National Comprehensive Cancer Network (NCCN). NCCN Clinical practice guidelines in oncology: colon cancer. Version 2.2018. http://www.nccn.org/professionals/physician_gls/PDF/colon.pdf. Accessed July 5, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical practice guidelines in oncology: rectal cancer. Version 2.2018. http://www.nccn.org/professionals/physician_gls/pdf/rectal.pdf. Accessed July 5, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical practice guidelines in oncology: gastric cancer. Version 2.2018. http://www.nccn.org/professionals/physician_gls/pdf/gastric.pdf. Accessed July 5, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical practice guidelines in oncology: uterine neoplasms. Version 2.2018. http://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf. Accessed July 5, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical practice guidelines in oncology: ovarian cancer including fallopian tube cancer and primary peritoneal cancer. Version 2.2018. http://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Accessed July 5, 2018.

Robella M, Vaira M, Mellano A, et al. Treatment of diffuse malignant peritoneal mesothelioma (DMPM) by cytoreductive surgery and HIPEC. Minerva Chir. Feb 2014;69(1):9-15. PMID 24675242

Rudloff U, Langan RC, Mullinax JE, et al. Impact of maximal cytoreductive surgery plus regional heated intraperitoneal chemotherapy (HIPEC) on outcome of patients with peritoneal carcinomatosis of gastric origin: results of the GYMSSA trial. J Surg Oncol. Sep 2014;110(3):275-284. PMID 25042700

Sardi A, Jimenez WA, Nieroda C, et al. Repeated cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in peritoneal carcinomatosis from appendiceal cancer: analysis of survival outcomes. Eur J Surg Oncol. Nov 2013;39(11):1207-1213. PMID 24007834

Seretis C, Youssef H. Quality of life after cytoreductive surgery and intraoperative hyperthermic intraperitoneal chemotherapy for peritoneal surface malignancies: A systematic review. Eur J Surg Oncol. Dec 2014;40(12):1605-1613. PMID 25242382

Shan LL, Saxena A, Shan BL, et al. Quality of life after cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy for peritoneal carcinomatosis: A systematic review and meta-analysis. Surg Oncol. Oct 28 2014;23(4):199-210. PMID 25466850

Spiliotis J, Halkia E, Lianos E, et al. Cytoreductive surgery and HIPEC in recurrent epithelial ovarian cancer: a prospective randomized phase III study. Ann Surg Oncol. May 2015;22(5):1570-1575. PMID 25391263

Vaira M, Cioppa T, G DEM, et al. Management of pseudomyxoma peritonei by cytoreduction+HIPEC (hyperthermic intraperitoneal chemotherapy): results analysis of a twelve-year experience. In Vivo. Jul-Aug 2009;23(4):639-644. PMID 19567401

van Driel WJ, Koole SN, Sikorska K, et al. Hyperthermic intraperitoneal chemotherapy in ovarian cancer. N Engl J Med. Jan 18 2018;378(3):230-240. PMID 29342393

Verwaal VJ, Bruin S, Boot H, et al. 8-year follow-up of randomized trial: cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy in patients with peritoneal carcinomatosis of colorectal cancer. Ann Surg Oncol. Sep 2008;15(9):2426-2432. PMID 18521686

Verwaal VJ, van Ruth S, de Bree E, et al. Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer. J Clin Oncol. Oct 15 2003;21(20):3737-3743. PMID 14551293

Vogel JD, Eskicioglu C, Weiser MR, et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Treatment of Colon Cancer. Dis Colon Rectum. Oct 2017;60(10):999-1017. PMID 28891842

Yan TD, Black D, Savady R, et al. A systematic review on the efficacy of cytoreductive surgery and perioperative intraperitoneal chemotherapy for pseudomyxoma peritonei. Ann Surg Oncol. Feb 2007;14(2):484-492. PMID 17054002

Yan TD, Cao CQ, Munkholm-Larsen S. A pharmacological review on intraperitoneal chemotherapy for peritoneal malignancy. World J Gastrointest Oncol. Feb 15 2010;2(2):109-116. PMID 21160929

Yan TD, Deraco M, Baratti D, et al. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: multi-institutional experience. J Clin Oncol. Dec 20 2009;27(36):6237-6242. PMID 19917862

Yang XJ, Huang CQ, Suo T, et al. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy improves survival of patients with peritoneal carcinomatosis from gastric cancer: final results of a phase III randomized clinical trial. Ann Surg Oncol. Jun 2011;18(6):1575-1581. PMID 21431408

Yonemura Y, Endou Y, Shinbo M, et al. Safety and efficacy of bidirectional chemotherapy for treatment of patients with peritoneal dissemination from gastric cancer: Selection for cytoreductive surgery. J Surg Oncol. Sep 15 2009;100(4):311-316. PMID 19697437

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

THE FOLLOWING CODES ARE USED TO REPRESENT HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (HIPEC), IN CONJUNCTION WITH CYTOREDUCTIVE SURGERY:


77620, 96446

THE FOLLOWING CODE IS USED TO REPRESENT HIPEC PERFORMED USING A TEMPORARY CATHETER:

96549



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

C45.1 Mesothelioma of peritoneum

C48.0 Malignant neoplasm of retroperitoneum

C48.1 Malignant neoplasm of specified parts of peritoneum

C48.2 Malignant neoplasm of peritoneum, unspecified

C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C56.1 Malignant neoplasm of right ovary

C56.2 Malignant neoplasm of left ovary

C56.9 Malignant neoplasm of unspecified ovary

C56.1 Malignant neoplasm of right ovary

C56.2 Malignant neoplasm of left ovary

C56.9 Malignant neoplasm of unspecified ovary

C57.00 Malignant neoplasm of unspecified fallopian tube

C57.01 Malignant neoplasm of right fallopian tube

C57.02 Malignant neoplasm of left fallopian tube

C78.6 Secondary malignant neoplasm of retroperitoneum and peritoneum



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 11.00.13g
01/21/2019This version of the policy is effective as of 01/21/2019.

Major update for this version includes the following:

Hyperthermic intraperitoneal chemotherapy (HIPEC) following cytoreductive surgery is considered medically necessary and, therefore, covered in newly diagnosed epithelial ovarian or fallopian tube cancer at the time of interval cytoreductive surgery when specific criteria, (described in this policy) are met.

Revisions from 11.00.13f
09/12/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Hyperthermic Intraperitoneal Chemotherapy (HIPEC).


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/21/2019
Version Issued Date: 01/22/2019
Version Reissued Date: N/A

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