Thursday, May 2, 2019

CPT code 99231, 99232. 99233 - Medical necessity tips

Define Medical necessity:

Medical necessity of a service is the overarching criterion for payment in addition to the individual requirements of a CPT code. It would not be medically necessary or appropriate to bill a higher level of evaluation and management service when a lower level of service is warranted. The volume of documentation should not be the primary influence upon which a specific level of service is billed. Documentation should support the level of service reported.

Practice that is reporting a higher number of these 99233 and 99214 codes than their peers may
substantially increase their risk of audit and review. the CERT study gives the opportunity identify potential errors the same way that the auditor's do.

This article focuses on the most common coding errors identified in the report to help you understand how to prevent them from occurring at your practice.

The key point to using 99233 is the provider must be sure to meet two of the three components:
• Detailed interval history
• Detailed examination
• High complexity Medical decision making (MDM)

Alternatively, they could spend 35 minutes or more of face-to-face time with the patient. Comorbidities and other underlying diseases cannot be considered when selecting 99233 unless their presence significantly increases the complexity of the medical decision making. Also if the provider chooses to use time to base the assignment of 99233, the time must be documented in the patient’s medical record and the documentation must have sufficient detail to justify the code selection.

Documentation Tips:

1. Documentation must be entered in a timely manner and must be decipherable to members of the healthcare team as well as other individuals who may need to review the information (e.g., auditors). Proper credit cannot be given for documentation that is difficult to read.

2.Information should include historical review of past/interim events, a physical exam, medical decision-making as related to the patient’s progress/response to intervention, and modification of the care plan (as necessary). The reason for the encounter should be evident to support the medical necessity of the service. Because various specialists may participate in patient care, documentation for each provider’s encounter should demonstrate personalized and non-duplicative care.

3.Each individual provider must exhibit a personal contribution to the case to prevent payors from viewing the documentation as overlapping and indistinguishable from care already provided by another physician. Each entry should be dated and signed with a legible identifier (i.e., signature with a printed name).

Consider Patient's condition:

Neither guidelines provide fully objective, quantitative criteria by which medical necessity for an E/M Service may be judged. Understanding the medical necessity for ordering a lab or radiologic exam is comparatively easy:

Example: A provider orders a chest x-ray for suspected pneumonia, or serial troponins are ordered for chest pain to rule out acute coronary syndrome. Connecting the dots between a 99233 and medical necessity is not as clear.

Fortunately, CPT provides a clue in the full descriptor for CPT 99233. Usually, the patient is unstable or has developed a significant complication or new problem.

''Usually'' statement referencing the stability of the patient
• 99231 “Usually, the patient is stable, recovering or improving.”
• 99232 “Usually, the patient is responding inadequately to therapy or has developed a minor complication.”
• 99233 “Usually, the patient is unstable or has developed a significant complication or a significant new problem
Based on these statements, it is the documented stability of the patient that determines the medical necessity of these subsequent care levels (when not billing based on time)

Differentiate between ''Significant'' and ''Unstable'':

''Significant'' and ''Unstable'' these terms are not specifically defined, we can use Medicare's 1995 and 1997 Documentation guidelines for E/M services to point us in the right direction—Specifically, the examples for a high level of risk under the presenting problem in the table of risk:
• One or more chronic illnesses with mild exacerbation, progression, or side effects of treatment.
• Acute or chronic illnesses or injuries that pose a threat to life or bodily function, e.g., multiple trauma, acute MI, pulmonary embolus, severe respiratory distress, progressive severe rheumatoid arthritis, psychiatric illness with potential threat to self or others, peritonitis, acute renal failure.
• An abrupt change in neurologic status, e.g., seizure, TIA, weakness, sensory loss.

For a new complication or problem to be considered “Significant” it should be comparable to the table of risk examples.

''Unstable'' also follows this guideline, but for ongoing conditions rather than new problems or complications.
CPT CODE 99231, 99232, 99233, 99291 - PATIENT STABILITY

Example: A patient admitted yesterday for sepsis with respiratory failure and acute kidney injury, who today remains presents tachypnea and tachycardic, with worsening oxygen requirements and significantly elevated blood urea nitrogen (BUN), creatinine and lactate levels. Accounting for the presenting problems and the usually statements in the CPT and factoring in critical care, you can create a spectrum of patient stability that points to the medical necessity requirements for each subsequent care code level, as shown mentioned below table.

One condition documented as ''Improving'' does not mean the patients overall condition is stable.

Time-based coding changes the Criteria:

The physician may document time spent with the patient in conjunction with the medical decision-making involved and a description of the coordination of care or counseling provided.

Documentation must be in sufficient detail to support the claim:

Physicians must document both the counseling/coordination of care time and total visit time. The format may vary: “Total visit time = 35 minutes; more than 50% spent counseling/coordinating care,” or “30 of 35 minutes spent counseling/coordinating care.” Any given payer may prefer one documentation style over another. It always is best to query payers and review their documentation standards to determine the local preference.

In addition to the time, physicians must document the medical decision-making and details of the counseling/coordination of care. For example, patients with newly diagnosed diabetes need to be educated about their condition, lifestyle, and medication requirements. Physicians should include information regarding these factors in their progress notes as necessary.


The Centers for Medicare and Medicaid Services (CMS) released the results from their Comprehensive Error Rate Testing (CERT) earlier this year. The results showed a 9.5% overall improper payment rate for 2017, representing $36.21 billion in improper payments.

Friday, March 29, 2019

Arizona Long Term Care System (ALTCS) program Basic information



All Arizona residents can apply for AHCCCS services or the Arizona Long Term Care System (ALTCS) program. There are many programs that individuals may qualify for in order to receive AHCCCS medical or behavioral health services or ALTCS coverage.

The programs have a number of different financial and non-financial requirements that applicants must meet, including, but not limited to:

1. Proof of Arizona residency at the time of application.
2. Proof of U.S. citizenship and identity or proof of qualified alien status.

 If a non-citizen does not meet the qualified alien status requirements for full services, but meets all other requirements for the Caretaker Relative, SOBRA Child, SOBRA Pregnant Woman, Young Adult Transitional Insurance (YATI), Adult, or SSI-MAO category, the individual is eligible to receive Federal Emergency Services (FES) only.

3. An income test that requires applicants to identify all individual and/or family earned and unearned income and to provide documentation if needed.

4. A resource test that requires applicants to identify resources (e.g., homes, other property, liquid assets, vehicles, and any other item of value) and provide documentation of their value.

NOTE: A resource test is only required for the ALTCS program.

5. Other requirements
    * Each program has certain non-financial and/or financial requirements that are unique to the program and are aimed at servicing specific groups of people.


Eligibility determination is not performed under one roof, but by various agencies, depending on the eligibility category.

For example:

* Pregnant women, caretaker relatives, children, and single individuals enter AHCCCS by way of the Department of Economic Security.

* The blind, aged or disabled, who receive Supplemental Security Income, enter through the Social Security Administration.

* Eligibility for categories such as ALTCS, SSI – Medical Assistance Only (Aged, Blind and Disabled, who do not qualify for Supplemental Security Income cash payment),

KidsCare, Freedom to Work, Breast and Cervical Cancer Treatment Program and Medicare Cost Sharing programs are handled directly by the AHCCCS Administration.

Each eligibility category has its own eligibility criteria.

1. Coverage for parents and caretaker relatives is provided under Caretaker Relatives.
2. Coverage for children is provided under the following eligibility categories:
b. KidsCare
i. KidsCare is Arizona’s version of the Title XXI State Children’s Health
Insurance Program.
ii. It covers low-income children under age 19, if the family income is less
than 200 percent of the Federal Poverty Level (FPL).
c. Child Group
d. SSI Cash (Title XVI) or SSI MAO
e. Young Adult Transitional Insurance (YATI) for former Foster Care Children
aged 18 to 26
f. Foster Care Children
g. Adoption Subsidy Children
h. Newborns

All babies born to AHCCCS-eligible mothers are also deemed to be AHCCCS eligible and may remain eligible for up to one year, as long as the newborn continues to reside in Arizona.
i. Newborns born to mothers receiving Federal Emergency Services (FES) also are eligible up to one year of age. While the mother will be covered on a Fee-For-Service basis under FESP, the newborn will be enrolled with a health plan.

ii. Newborns born to mothers enrolled in KidsCare will be approved for KidsCare beginning with the newborn’s date of birth, unless the child is Medicaid eligible.

iii. Newborns receive separate AHCCCS ID numbers and services for them must be billed separately using the newborn's ID. Services for a newborn that are included on the mother's claim will be denied.

3. Coverage for single individuals and couples is provided under the following eligibility  categories:

b. Breast and Cervical Cancer Treatment Program
c. Family Planning Services (FPS) provides family planning services for up to 24
months to SOBRA pregnant women after a 60-day post partum period.
d. SOBRA Pregnant Women
e. SSI Cash (Title XVI) or SSI MAO
f. Adults
g. Freedom to Work
h. Transplants
i. Medicare Cost Sharing
j. Hospital Presumptive Eligibility (HPE)

Various Medicare Savings Programs help members pay Medicare Part A & B premiums,deductibles, and coinsurance.
1. Qualified Medicare Beneficiary (QMB)
2. Qualified Individual 1 (QI-1)
3. Specified Low Income Medicare Beneficiary (SLMB)

Thursday, January 10, 2019

CPT 81538 - Proteomic Testing for Targeted Therapy in Non-Small Cell Lung Cancer

Coding Code DescriptionCPT

81538 Oncology (lung), mass spectrometric 8-protein signature, including amyloid A, utilizing serum, prognostic and predictive algorithm reported as good versus poor overall survival

Proteomic Testing for Targeted Therapy in Non-Small Cell Lung Cancer


Genes in our DNA tell a cell how to make proteins. The study of proteins in a cell is called “proteomics.” Doing tests on the proteins in a cell (“proteomic testing”) may help to identify which drugs might be helpful in treating non-small cell lung cancer and how aggressive the cancer is. Proteomic testing used for this and all other reasons is unproven (investigational). Medical studies have not determined the types of patients in which proteomic testing could predict the course of the disease. Studies also have not shown that patients whose treatments were chosen based on proteomic testing survived longer than those whose treatments were selected without proteomic testing.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Policy Coverage Criteria

Testing Investigational
Proteomic testing The use of proteomic testing, including but not limited to the VeriStrat® assay, is considered investigational for all uses in the management of non-small cell lung cancer.

Related Information N/A Evidence Review Description

Proteomic testing has been proposed as a way to predict survival outcomes, as well as the response to and selection of targeted therapy for patients with non-small cell lung cancer (NSCLC). One commercially available test (the VeriStrat® assay) has been investigated as a predictive marker for response to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs).

Background Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200new cases and 158,040 deaths due to the disease in 2015.1 Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancer cases and includes nonsquamous carcinoma (adenocarcinoma, large cell carcinoma, other cell types) and squamous cell carcinoma.


The stage at which lung cancer is diagnosed has the greatest impact on prognosis.2 Localized disease confined to the primary site has a 55.6% relative 5-year survival but accounts for only 16% of lung cancer cases at diagnosis. Mortality increases sharply with advancing stage. Metastatic lung cancer has a relative 5-year survival of 4.5%. Overall, advanced disease, defined as regional involvement and metastatic, accounts for approximately 80% of cases of lung cancer at diagnosis. These statistics are mirrored for the population of NSCLC, with 85% of cases presenting as advanced disease and up to 40% of patients with metastatic disease.

In addition to tumor stage; age, sex, and performance status are independent prognostic factors for survival particularly in early-stage disease. Wheatley-Price et al (2010) reported on a retrospective pooled analysis of 2349 advanced NSCLC patients from 5 randomized chemotherapy trials.3 Women had a higher response rate to platinum-based chemotherapy than men. Greater overall survival (OS) than men were among those with adenocarcinoma histology.

A small survival advantage exists for squamous cell carcinoma over non-bronchiolar nonsquamous histology.4

The oncology clinical care and research community use standard measures of performance status: Eastern Cooperative Oncology Group scale and Karnofsky Performance Scale.


Treatment approaches are multimodal and generally include surgery, radiotherapy, and chemotherapy (either alone or in combination with another treatment, depending on disease stage and tumor characteristics). The clinical management pathway for stage I or II NSCLC is\ shown in Figure

The clinical management pathway for newly diagnosed advanced NSCLC is shown in Figure 2.1 Treatment recommendations are based on the overall health or performance status of the patient as well as the presence or absence of a treatment-sensitizing genetic variant. The latter is  used to select for targeted therapy or platinum-based chemotherapy.The clinical management pathway for advanced NSCLC after progression on first-line treatment or recurrence is shown in Figure 3. Treatment options are based on objective response to prior therapy, duration of response, as well as the type of and duration of prior therapy (either targeted therapy or chemotherapy).

Genomic Alterations

Several common genetic alterations in NSCLC have been targets for drug therapy, the most well-established of which are tyrosine kinase inhibitors (TKIs) targeting the epidermal growth factor receptor (EGFR) and crizotinib targeting the anaplastic lymphoma kinase (ALK) gene rearrangement.

EGFR Variants

EGFR, a tyrosine kinase receptor (TK), is frequently overexpressed and activated in NSCLC. Drugs that inhibit EGFR-signaling either prevent ligand-binding to the extracellular domain (monoclonal antibodies) or inhibit intracellular TK activity (small molecule TKIs). These targeted therapies dampen signal transduction through pathways downstream to the EGFR, such as the RAS/RAF/MAPK cascade. RAS proteins are G proteins that cycle between active and inactive

forms in response to stimulation from cell surface receptors such as EGFR, acting as binary switches between cell surface EGFR and downstream signaling pathways. These pathways are important in cancer cell proliferation, invasion, metastasis, and stimulation of neovascularization. Variants in 2 regions of the EGFR gene, including small deletions in exon 19 and a point mutation in exon 21 (L858R), appear to predict tumor response to TKIs such as erlotinib. The prevalence of EGFR variants in NSCLC varies by population, with the highest prevalence in nonsmoking, Asian women with adenocarcinoma; for that subpopulation EGFR variants have been reported as high as 30% to 50%. The reported prevalence of EGFR variants in lung adenocarcinoma patients in the United States is approximately 15%.5

ALK Variants

In 2% to 7% of NSCLC patients in the United States, tumors express a fusion gene comprising portions of the echinoderm microtubule-associated protein-like 4 (EML4) gene and the ALK gene (EML4-ALK), which is created by an inversion on chromosome 2p.6 The EML4 fusion leads to ligand-independent activation of ALK, which encodes a receptor TK whose precise cellular function is not completely understood. EML4-ALK variants are more common in never-smokers or light smokers, tend to be associated with younger age of NSCLC onset, and typically do not occur in conjunction with EGFR variants.

Testing for the EML4-ALK fusion gene in patients with adenocarcinoma-type NSCLC is used to predict response to the small molecule TKI crizotinib.

Other Genetic Variants

Other genetic variants, identified in subsets of patients with NSCLC, are summarized in Table 1.

The role of testing for these variants to help select targeted therapies for NSCLC is less wellestablished than for EGFR variants

Non-EGFR Mutations in NSCLC Gene Gene Function Estimated Mutation Prevalence in NSCLC Patient and Tumor Characteristics KRAS Encodes RAS proteins; variants associated with constitutively activated protein
20%-30% Adenocarcinomas Heavy smokers ROS1 Encodes a receptor TK in the insulin receptor family
0.9%-3.7% Adenocarcinoma Never smokers RET Proto-oncogene that encodes a receptor TK growth factor
0.6%-2% MET Oncogene that encodes a receptor TK that is activated in response to binding of hepatocyte growth factor
2-4% of previously untreated NSCLC; 5%-20% of patients with acquired resistance to EGFR TKIs Patients with acquired resistance to EGFR TKIs BRAF Serine-threonine kinase downstream from RAS in RAS-RAF-ERK-MAPK pathway
1%-3% of adenocarcinomas Heavy smokers HER HER (EGFR) family of TK receptors; dimerizes with EGFR family members when activated
1%-2% of NSCLC Adenocarcinomas Nonsmoking women

PIK3CA Intracellular signaling pathway *4% of NSCLC

EGFR: epidermal growth factor receptor; HER: human epidermal growth factor receptor; NSCLC: non-small cell lung cancer; TK: tyrosine kinase; TKI: tyrosine kinase inhibitor.

Targeted Treatment Options

EGFR-Selective Small Molecule TKIs

Three orally administered EGFR-selective small molecule TKIs have been identified for treating NSCLC: gefitinib (Iressa), erlotinib (Tarceva®), and afatinib (Gilotrif™). Although the Food and Drug Administration (FDA) approved gefitinib in 2004, a phase 3 trial suggested gefitinib was not associated with a survival benefit. In 2003, the FDA revised gefitinib labeling, further limiting its use to patients who had previously benefitted or were currently benefiting from the drug; no new patients were to be given gefitinib. However, in 2015, the FDA approved gefitinib as firstline treatment for patients with metastatic NSCLC for patients with EGFR-mutated tumors. Erlotinib and afatinib also have approval by the FDA.

In 2015, osimertinib (Tagrisso), an irreversible selective EGFR inhibitor that targets T790M variant-positive NSCLC, received FDA approval for patients with T790M-variant-positive NSCLC who have progressed on an EGFR TKI.

A meta-analysis by Lee et al (2013) assessing 23 trials on the use of erlotinib, gefitinib, and afatinib in patients with advanced NSCLC reported improved progression-free survival (PFS) in EGFR variant*positive patients treated with EGFR TKIs in the first- and second-line settings and as maintenance therapy.7 Comparators were chemotherapy, chemotherapy and placebo, and placebo in the first-line, second-line, and maintenance therapy settings. Among EGFR variant*
negative patients, PFS was improved with EGFR TKIs compared with placebo for maintenance therapy but not in the first- and second-line settings. Overall survival (OS) did not differ between treatment groups in either variant-positive or variant-negative patients. Statistical heterogeneity was not reported for any outcomes. Reviewers concluded that EGFR mutation testing is indicated to guide treatment selection in NSCLC patients.

On the basis of the results of 5 phase 3 randomized controlled trials, the American Society of  Clinical Oncology recommended that patients with NSCLC being considered for first-linetherapy with an EGFR TKI (patients who have not previously received chemotherapy or an EGFR TKI) should have their tumor tested for EGFR variants to determine whether an EGFR TKI or chemotherapy is the appropriate first-line therapy.

The primary target population for TKIs in NSCLC is for EGFR variant*positive patients with  advanced NSCLC. The use of TKIs in NSCLC in EGFR variant*negative patients is controversial. The TITAN trial as reported by Ciuleanu et al (2012) demonstrated no significant differences in OS between erlotinib and chemotherapy as second-line treatment for patients unselected on the basis of EGFR mutation status, with fewer serious adverse events in erlotinib-treated patients.8 Karampeazis et al (2013) reported similar efficacy between erlotinib and standard chemotherapy (pemetrexed) for second-line therapy in patients unselected on the basis of EGFR mutation status.9 By contrast, in the TAILOR trial as reported by Garassino et al (2013), standard chemotherapy was associated with longer OS than erlotinib for second-line therapy in patients with wild-type EGFR.10 Auliac et al (2014) compared sequential erlotinib plus docetaxel with docetaxel alone as second-line therapy among patients with advanced NSCLC and EGFR wildtype or unknown status.11 Based on Simon’s optimal 2-stage design, the erlotinib plus docetaxel strategy was rejected. Despite the rejection, it is worth noting that in the erlotinib plus docetaxel arm 18 of 73 patients achieved PFS at 15 weeks; comparatively, in the docetaxel arm, 17 of 74 patients achieved PFS at 15 weeks.

Cicenas et al (2016) reported results of the IUNO randomized controlled trial, which compared maintenance therapy using erlotinib followed by second-line chemotherapy if progression occurred to placebo followed by erlotinib if progression occurred in 643 patients who had advanced NSCLC and no known EGFR variant.12 Because there were no significant differences between groups in terms of PFS, objective response rate, or disease control rate, maintenance therapy with erlotinib in patients without EGFR variants was not considered efficacious.

Anti-EGFR Monoclonal Antibodies

For the treatment of KRAS-mutated NSCLC, anti-EGFR monoclonal antibodies have been investigated as possible treatment options. Available anti-EGFR monoclonal antibodies include cetuximab and panitumumab. Neither drug has an established role in the treatment of NSCLC either as a component of initial therapy or as second-line therapy.

Programmed Death Ligand 1 Inhibitors

Some tumors, including some NSCLCs, express a programmed death-ligand 1 (PD-L1) on the cell surfaces to interact with host T cells and evade the immune system. Several humanized monoclonal antibodies have been developed to act as immune checkpoint inhibitors by interferingwith this interaction, to interact with the PD-L1, block the cancer/T-cell interaction, and thus act as immune checkpoint inhibitors. Pembrolizumab, nivolumab, and atezolizumab, which inhibit the programmed death 1 receptor, and atezolizumab, which inhibits the PD-L1, are used in NSCLC that have PD-L1 expression on its cells. Durvalumab also targets the PD-L1 protein but is used in unresectable, stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiotherapy.

Other Targeted Therapies

Crizotinib is a novel MET, ROS1, and ALK TKI, and associated with improved PFS in patients with advanced NSCLC who are ALK gene rearrangement*positive.13 Crizotinib is considered first-line therapy for advanced ALK-positive lung adenocarcinoma.1 Other small molecule TKIs, designed to selectively bind to and inhibit ALK activation, have FDA approval: ceritinib, alectinib, and brigatinib.

Proposed targeted therapies for other genetic alterations in NSCLC are trastuzumab for HER2 variants, crizotinib for MET amplification and ROS1 rearrangement, vemurafenib and dabrafenib for BRAF variants, and cabozantinib for RET rearrangements.

Proteomics Testing in Selecting Targeted Treatment for NSCLC

The term proteome refers to the entire complement of proteins produced by an organism or cellular system and proteomics refers to the large-scale comprehensive study of a specific proteome. The proteome may differ from cell to cell and may vary over time and in response to selected stressors.

A cancer cell’s proteome is related to its genome and to genomic alterations. The proteome may be measured by mass spectrometry (MS) or protein microarray. For cancer, proteomic signatures in the tumor or in bodily fluids (ie, pleural fluid or blood) other than the tumor have been investigated as a biomarker for cancer activity. A commercially available serum-based test (VeriStrat) has been developed and proposed to be used as a prognostic tool to predict expected survival for standard therapies used in the treatment of NSCLC. The test is also proposed to have predictive value for response to EGFR TKIs.14

The test uses matrix-assisted laser desorption ionization MS analysis, and a classification algorithm was developed on a training set of pretreatment sera from 3 cohorts (Italian A, Japan A, Japan B) totaling 139 patients with advanced NSCLC who were treated with second-line gefitinib.15 The classification result is either “good” or “poor. Two validation studies using pretreatment sera from 2 cohorts of patients (Italian B, Eastern Cooperative Oncology Group 3503) totaling 163 patients have been reported.

This assay uses an 8-peak proteomic signature; 4 of the 8 have been identified as fragments of serum amyloid A protein 1.16 This protein has been found to be elevated in individuals with a variety of conditions associated with acute and chronic inflammation.17-21 The specificity for malignant biologic processes and conditions has not been determined.22 With industry support, Fidler et al (2018) used convenience biorepository samples to investigate 102 analytes for potential correlations between the specific peptide and protein biomarkers and VeriStrat classification.23

Although the VeriStrat matrix-assisted laser desorption ionization MS-based predictive algorithm has the largest body of literature associated with it, other investigators have used alternative MS methods, such as surface-enhanced laser desorption ionization/time-of-flight MS, and alternative predictive algorithms, to assess proteomic predictors of lung cancer risk.24 Best practices for peptide measurement and guidelines for publication of peptide and protein identification have been published for the research community.

Saturday, December 29, 2018

CPT 0003u, 81503 - Multimarker Serum Testing Related to Ovarian Cancer

Coding Code Description CPT

0003U Oncology (ovarian) biochemical assays of five proteins (apolipoprotein A-1, CA 125 II, follicle stimulating hormone, human epididymis protein 4, transferrin), utilizing serum, algorithm reported as a likelihood score – is specific to the Overa test 81500 Oncology (ovarian), biochemical assays of two proteins (CA-125 and HE4), utilizing serum, with menopausal status, algorithm reported as a risk score – is specific to the ROMA test

81503 Oncology (ovarian), biochemical assays of five proteins (CA-125, apoliproprotein A1 beta-2 microglobulin, transferrin and pre-albumin), utilizing serum, algorithm reported as a risk score – is specific to OVA1 test

Multimarker Serum Testing Related to Ovarian Cancer


When a mass of tissue is found next to the uterus (adnexal mass) it usually isn’t cancer. The OVA1. ROMA, and Overa tests are a combination of several lab tests that some doctors order to try to see how likely it is that a mass is cancer. Other reasons doctors may order these tests are to try to decide if a patient should be referred to a gynecological oncologist (a doctor who specializes in women’s cancers); to try to screen for ovarian cancer; to try to determine if previous surgery was successful in removing ovarian cancer; or to try to find out if ovarian cancer has come back.

The OVA1, ROMA, and Overa tests are still being studied. There is little evidence in published medical studies to show how these tests will lead to improved diagnoses or patient care. Thereare no studies that show how information from these tests will impact health outcomes. These tests are investigational (unproven) for all uses.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Policy Coverage Criteria Test Name Investigational OVA1® Overa™ ROMA™

All uses of the OVA1®, Overa™, and ROMA™ tests are investigational, including but not limited to:

* Preoperative evaluation of adnexal masses to triage for malignancy OR
* Screening for ovarian cancer OR
* Selecting patients for surgery for an adnexal mass OR
* Evaluation of patients with clinical or radiologic evidence of malignancy O
* Evaluation of patients with nonspecific signs or symptoms suggesting possible malignancy OR
* Postoperative testing and monitoring to assess surgical outcome and/or to detect recurrent malignant disease following treatment

Evidence Review


A variety of serum biomarkers have been studied for their association with ovarian cancer. Of particular interest have been tests that integrate results from multiple analytes into a risk score to predict the presence of disease. Three tests based on this principle, OVA1, Overa (the secondgeneration OVA1 test), and ROMA have been cleared by the U.S. Food and Drug Administration. The intended use of OVA1 and Overa is to use them as an aid to further assess whether malignancy is present - even when the physician’s independent clinical and radiologic evaluation does not indicate malignancy. The intended use of ROMA is to use it as an aid, in conjunction with clinical assessment, to assess whether any woman who presents with an ovarian adnexal mass has a high or low likelihood of having malignancy found at surgery.


The umbrella term “epithelial ovarian cancer” collectively includes high-grade serous epithelial ovarian, fallopian tubal, and peritoneal carcinomas due to their shared pathogenesis, clinical presentation, and treatment. We use the term “epithelial ovarian cancer” to refer to this group of malignancies in the discussion that follows. There is currently no serum biomarker that can distinguish between these types of carcinoma. An estimated 22,440 women in the United Stateswere diagnosed in 2017 with ovarian cancer, and approximately 14,080 will die of the disease.1

The mortality rate depends on three variables:

1. Patient characteristics
2. Tumor biology (grade, stage, type)
3. Treatment quality (nature of staging, surgery, and chemotherapy used)2
In particular, comprehensive staging and completeness of tumor resection appear to have a positive impact on patient outcome.

In 1997, the Society of Surgical Oncology recommended that ovarian cancer surgery and followup treatment be performed by physicians with ovarian cancer expertise.3 Numerous articles have been published on the application of this recommendation examining long- and short-term outcomes, as well as process measures (eg, types of treatment such as complete staging or tumor debulking). At least two meta-analyses have concluded that outcomes are improved when patients with ovarian cancer are treated by gynecologic oncologists.4,5 The available data are most convincing for patients with advanced-stage disease.

Adult women presenting with an adnexal mass have an estimated 68% likelihood of having a benign lesion.6 About 6% have borderline tumors, 22% possess invasive malignant lesions, and 3% have metastatic disease. Surgery is the only way to diagnose ovarian cancer; this is because biopsy of an ovary with suspected ovarian cancer is usually not performed due to the risk of spreading cancer cells. Most clinicians agree that women with masses that have a high likelihood of malignancy should undergo surgical staging by gynecologic oncologists. However, women with clearly benign masses do not require referral to a specialist. Therefore, criteria and tests that help differentiate benign from malignant pelvic masses are desirable.

In 2005, the American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists jointly released guidelines that address criteria for referring women  with pelvic masses that are suspicious for ovarian cancer to gynecologic oncologists.7 Separate criteria were developed for premenopausal and postmenopausal women. In premenopausal women, referral criteria included at least one of the following: elevated cancer antigen 125 (CA 125; >200 U/mL), ascites, evidence of abdominal or distant metastasis, or a positive family history. The referral criteria in postmenopausal women were similar, except that a lower threshold for an elevated CA125 test was used (35 U/mL); moreover, a nodular or fixed pelvic mass was an added criterion.

Three multimarker serum-based tests specific to ovarian cancer have been cleared by the Food and Drug Administration (FDA) with the intended use of triaging patients with adnexal masses (see Regulatory Status). They are summarized in Table 1. The proposed use of the tests is to   identify women with a substantial likelihood of malignant disease who may benefit from referral to a gynecologic oncology specialist. Patients with positive results may be considered candidates for referral to a gynecologic oncologist for treatment. The tests have been developed and evaluated only in patients with adnexal masses and planned surgeries. Other potential uses, such as selecting patients to have surgery, screening asymptomatic patients, and monitoring  treatment, have not been investigated. Furthermore, the tests are not intended to be used as stand-alone tests, but in conjunction with clinical assessment. Other multimarker panels and longitudinal screening algorithms are under development; however, these are not yet commercially available.8,9 epididymis secretory protein 4. Summary of Evidence

For individuals with adnexal mass(es) who have multimarker serum testing with clinical assessment in order to assess their ovarian cancer risk prior to undergoing surgery, the evidence includes studies assessing the test’s technical performance and diagnostic accuracy. Relevant outcomes are overall survival and test accuracy. OVA1 and Overa are intended for use in patients for whom clinical assessment does not indicate cancer. When used in this manner, OVA1’s sensitivity for ovarian malignancy was 92% and specificity was 42%; with Overa, sensitivity for malignancy was 94% and specificity was 65%. ROMA is intended for use with clinical assessment, but no specific method has been defined. One study, which used clinical assessment and ROMA results, showed a sensitivity of 90% and specificity of 67%. However, there is no direct evidence in terms of assessing patient outcomes based on the use of such testing prior to undergoing surgery. Moreover, it is uncertain whether discrimination is sufficient to alter decision making based on clinical assessment alone and offer meaningful benefit. Thus, the chain of evidence supporting improved outcomes is therefore incomplete. The evidence is insufficient to determine the effects of the technology on health outcomes. Ongoing and Unpublished Clinical Trials

A search of in November 2017 did not identify any ongoing or unpublishedtrials that would likely influence this policy. Clinical Input Received from Physician Specialty Societies and Academic

Medical Centers

While the various physician specialty societies and academic medical centers may provide appropriate reviewers who collaborate with and make recommendations during this process, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

In response to requests, input was received while this policy was under review in 2012. Input was mixed in support of these tests as a tool for triaging patients with an adnexal mass. Reviewers agreed that the evidence was insufficient to determine the impact of these tests on referral patterns. For indications other than triaging patients with an adnexal mass, there was a lack of support for use of these tests. Practice Guidelines and Position Statements

American Congress of Obstetricians and Gynecologists

The American Congress of Obstetricians and Gynecologists (ACOG) addressed the use of the OVA1 test in its 2011 guidelines on the role of the obstetrician-gynecologist in the early detection of epithelial ovarian cancer.25 In 2013, the Society for Gynecologic Oncology endorsed these ACOG guidelines.26 This ACOG document included the following comments, which were not specific guidelines about the use of the test:

* The OVA1 test “appears to improve the predictability of ovarian cancer in women with pelvic masses.”
* “This is not a screening test, but it may be useful for evaluating women with a pelvic mass.”
* “Clinical utility is not yet established.”

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (NICE) issued guidance in 2011 on the identification and management of ovarian cancer.28 This guidance is currently being updated and is under review.

National Comprehensive Cancer Network

National Comprehensive Cancer Network (NCCN) guidelines on ovarian cancer (v.4.2017) include the following statement:29

It has been suggested that specific biomarkers (serum HE4 [human epididymis secretory protein 4] and CA-125 [cancer antigen 125]) along with an algorithm (Risk of Ovarian Malignancy Algorithm [ROMA]) may be useful for determining whether a pelvic mass is malignant or benign. The FDA [Food and Drug Administration] has approved the use of HE4 and CA-125 for estimating the risk of ovarian cancer in

women with a pelvic mass. Currently, the NCCN Panel does not recommend the use of these biomarkers for determining the status of an undiagnosed pelvic mass. Regarding the OVA1 test, NCCN guidelines state:

The OVA1 test uses 5 markers (including transthyretin, apolipoprotein A1, transferrin, beta-2 microglobulin, and CA-125) to assess who should undergo surgery by an experienced gynecologic oncologist and who can have surgery in the community…. Based on data documenting an increased survival, NCCN Guidelines Panel Members recommend that all patients should undergo surgery by an experienced gynecologic oncologist (category 1). U.S. Preventive Services Task Force Recommendations In 2012, The U.S. Preventive Services Task Force recommended against screening women for ovarian cancer (D recommendation).30 The task force has not addressed multimarker serum testing related to ovarian cancer. The 2012 statement is currently in update.

Medicare National Coverage

There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

Regulatory Status

In July 2009, the OVA1® test (Aspira Labs [Austin, TX]) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. OVA1® was designed as a tool to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy.

In September 2011, the Risk of Ovarian Malignancy Algorithm (ROMA™ test; Fujirebio Diagnostics [Sequin, TX]) was cleared for marketing by the FDA through the 510(k) process. The intended use of ROMA™ is as an aid, in conjunction with clinical assessment, in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low risk of having malignancy at surgery.

In March 2016, a second-generation test called Overa™ (also referred to as next-generation
OVA1®), in which 2 of the 5 biomarkers in OVA1® are replaced with human epididymis
secretory protein 4 (HE4) and follicle-stimulating hormone, was cleared for marketing by the
FDA through the 510(k) process. Similar to OVA1®, Overa™ generates a low or high risk of
malignancy on a scale from 0 to 10.

Black Box Warning

In December 2011, the FDA amended its regulation for classifying ovarian adnexal mass assessment score test systems. The change required that off-label risks be highlighted by a black box warning. The warning is intended to mitigate the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery. Considering the history and currently unmet medical needs for ovarian cancer testing, the FDA concluded that there is a risk of off-label use of this device.10 To address this risk, the FDA requires that manufacturers provide notice concerning the risks of off-label uses in the labeling, advertising, and promotional material of ovarian adnexal mass assessment score test systems. Manufacturers must address the following risks:

* Women without adnexal pelvic masses (ie, for cancer “screening”) are not part of the intended use population for the ovarian adnexal mass assessment score test systems. Public health risks associated with false-positive results for ovarian cancer screening tests are well described in the medical literature and include morbidity or mortality associated with unneeded testing and surgery. The risk from false-negative screening results also includes morbidity and mortality due to failure to detect and treat ovarian malignancy.

* Analogous risks, adjusted for prevalence and types of disease, arise if test results are used to determine the need for surgery in patients who are known to have ovarian adnexal masses.

* If used outside the “OR” rule that is described in this special control guidance, results from ovarian adnexal mass assessment score test systems pose a risk for morbidity and mortality  due to nonreferral for oncologic evaluation and treatment.

Saturday, December 8, 2018

CPT 0345T, 0483T, 0484T, 33418, 33419 - Transcatheter Mitral Valve Repair

Code Description CPT

0345T Transcatheter mitral valve repair percutaneous approach via the coronary sinus

0483T Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; percutaneous approach, including transseptal puncture, when performed (new code effective 1/1/18)

0484T Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; transthoracic exposure (eg, thoracotomy, transapical) (new code effective 1/1/18)

33418 Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; initial prosthesis

33419 Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; additional prosthesis(es) during same session (List separately in addition to code for primary procedure)

Transcatheter Mitral Valve Repair


The heart has four chambers, two upper and two lower. The mitral valve is between the upper and lower left chambers. After blood has been pumped from the upper left chamber to the lower left chamber, the mitral valve closes. The mitral valve is made up of small pieces of tissue called leaflets. If the leaflets don’t close properly when the left lower chamber pumps blood out to the body some of the blood can leak back into the upper left chamber. This is known as mitral valve regurgitation. Medication can be used to help manage the symptoms of mitral valve regurgitation. Open heart surgery is a treatment option. If a person is too sick for surgery, a nonsurgical procedure may be used to place a clip to close the leaky mitral valve. In this procedure, a long, hollow tube (a catheter) is threaded through a specific vein into the heart. The catheter then becomes the pathway for getting the clip to the mitral valve. Imaging is used to make sure the device is correctly placed. This policy describes when transcatheter mitral valve repair is considered medically necessary.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Policy Coverage Criteria Service Medical Necessity Transcatheter mitral valve repair (eg, MitraClip® Clip Delivery System)

Transcatheter mitral valve repair using a device approved by the U.S. Food and Drug Administration for use in mitral valve repair may be considered medically necessary for patients with symptomatic, primary mitral regurgitation who are considered at prohibitive risk for open surgery. Prohibitive risk for open mitral valve repair surgery may be determined based on:

* The documented presence of a Society for Thoracic Surgeons predicted mortality risk of 12% or greater AND/OR

* The documented presence of a logistic EuroSCORE of 20% or greater

Transcatheter mitral valve repair is considered investigational in all other situations.

Documentation Requirements

The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include the following:
* Name of the Food and Drug Administration (FDA) approved device to be used
* Documentation that patient has symptomatic primary mitral regurgitation AND
* Patient is at greater risk for open mitral valve repair surgery based on:
o The documented presence of a Society for Thoracic Surgeons predicted mortality risk of 12% or greater AND/OR
o The documented presence of a logistic EuroSCORE of 20% or greater

Related Information

Indications for Use

The FDA summary of safety and effectiveness data (SSED) from 2013 states the indications for use below: The MitraClip Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR of 3+ or greater) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team that includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.12

Repair Device

MitraClip® Clip Delivery System has the U.S. Food and Drug Administration (FDA) approval for the treatment of severe symptomatic degenerative mitral regurgitation (see Regulatory Status).

Evidence Review Description

Transcatheter mitral valve repair (TMVR) is an alternative to surgical therapy for mitral regurgitation (MR). MR is a common valvular heart disease that can result from a primary structural abnormality of the mitral valve (MV) complex or a secondary dilatation of an anatomically normal MV due to a dilated left ventricle caused by ischemic or dilated cardiomyopathy. Surgical therapy may be underutilized, particularly in patients with multiple comorbidities, suggesting that there is an unmet need for less invasive procedures for MV repair. One device, MitraClip, has approval from the U.S. Food and Drug Administration for the treatment of severe symptomatic MR due to a primary abnormality of the MV (primary MR) in patients considered at prohibitive risk for surgery.


Mitral Regurgitation

Epidemiology and Classification

Mitral regurgitation (MR) is the second most common valvular heart disease, occurring in 7% of  people older than age 75 years and accounting for 24% of all patients with valvular heart disease.1-2

Patients with MR generally fall into 2 categories — primary (also called degenerative) and secondary (also called functional) MR. Primary MR results from a primary structural abnormality in the valve, which causes it to leak. This leak may result from a floppy leaflet (called prolapse) or a ruptured cord that caused the leaflet to detach partially (called flail).3 Because the primary cause is a structural abnormality, most cases of primary MR are surgically corrected. In contrast, secondary MR results from left ventricular dilatation due to ischemic or dilated cardiomyopathy. This causes the mitral value (MV) leaflets not to coapt or meet in the center.4 Because the valves are structurally normal in secondary MR, correcting the dilated left ventricular using medical therapy is the primary treatment strategy used in the United States.

MR severity is classified as mild, moderate, or severe disease on the basis of echocardiographic and/or angiographic findings (1+, 2+, and 3-4+ angiographic grade, respectively). MR with accompanying valvular incompetence leads to left ventricular volume overload with secondary ventricular remodeling, myocardial dysfunction, and left heart failure. Clinical signs and symptoms of dyspnea and orthopnea may also present in patients with valvular dysfunction.4 Standard Management

Medical Management

Medical management has a primary role in secondary MR. Patients with chronic secondary MR  should receive standard therapy for heart failure with reduced ejection fraction; standardmanagement includes angiotensin converting enzyme inhibitor (or angiotensin II receptor blocker or angiotensin receptor-neprilysin inhibitor), *-blocker and mineralocorticoid receptor antagonist, and diuretic therapy as needed to treat volume overload.3,4

Surgical Management

In symptomatic patients with primary MR, surgery is the main therapy. In most cases, MV repair is preferred over replacement, as long as the valve is suitable for repair and personnel with appropriate surgical expertise are available. The American College of Cardiology and the American Heart Association have issued joint guidelines for the surgical management of MV, which are outlined in Table 1.3

Table 1. Guidelines on Mitral Value Surgery Recommendation COR LOE

MV surgery is recommended for the symptomatic patient with acute severe MR. I B
MV surgery is beneficial for patients with chronic severe MR and NYHA functional class II, III, or IV symptoms in the absence of severe LV dysfunction (severe LV dysfunction is defined as ejection fraction less than 0.30) and/or end-systolic dimension greater than 55 mm. I B
MV surgery is beneficial for asymptomatic patients with chronic severe MR and mild-tomoderate
LV dysfunction, ejection fraction 0.30 to 0.60, and/or end systolic dimension greater than or equal to 40 mm. I B
MV repair is recommended over MV replacement in the majority of patients with severe chronic
MR who require surgery, and patients should be referred to surgical centers experienced in MV I C

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