CPT code 81334, 81432 - 81438, 0013U - Hereditary Breast cancer


Code Description CPT
 
0013U Oncology (solid organ neoplasia), gene rearrangement  detection by whole genome  next - generation sequencing, DNA, fresh or frozen tissue or cells, report of specific  gene rearrangement(s)  (MatePair Targeted Rearrangements, Oncology, Mayo Clinic)

0014U Hematology (hematolymphoid neoplasia), gene rearrangement  detection by whole  genome next - generation sequencing, DNA, whole blood or bone marrow, report of  specific gene rearrangement(s) ( MatePair Targeted Rearrangements, Hematologic,  Mayo Clinic)

0017U Oncology (hematolymphoid neoplasia), JAK2 mutation, DNA, PCR amplification of  exons 12 - 14 and sequence analysis, blood or bone marrow, report of JAK2 mutation  not detected or detected ( JAK2 Mutation University of Iowa, Department of Pathology)

81334 RUNX1 (runt related transcription factor 1) (eg, acute myeloid leukemia, familial  platelet disorder with associated myeloid malignancy),gene   analysis, targeted sequence analysis (eg, exons 3 - 8) (new code effective 1/1/18)

81432 Hereditary breast cancer - related disorders (  eg , hereditary breast cancer, hereditary  ovarian cancer, hereditary endometrial cancer); genomic sequence analysis panel, must include sequencing of at least 14 genes, including ATM, BRCA1, BRCA2, BRIP1, CDH1,  MLH1, MSH2, MSH6, NBN, PALB2, PTEN, RAD51C, STK11, and TP53

81433 Hereditary breast  cancer - related disorders ( eg , hereditary breast cancer, hereditary  ovarian cancer, hereditary endometrial cancer);  duplication/deletion analysis panel,  must include analyses for BRCA1, BRCA2, MLH1, MSH2, and STK11

81433 Hereditary breast  cancer - related disorders ( eg , hereditary breast cancer, hereditary  ovarian cancer, hereditary endometrial cancer); duplication/deletion analysis panel, must include analyses for BRCA1, BRCA2, MLH1, MSH2, and STK11

81434 Hereditary retinal disorders (eg, retinitis pigmentosa, Leber congenital amaurosis, cone-rod dystrophy), genomic sequence analysis panel, must include sequencing of atleast 15 genes, including ABCA4, CNGA1, CRB1, EYS, PDE6A, PDE6B, PRPF31, PRPH2,  RDH12, RHO, RP1, RP 2, RPE65, RPGR, and USH2 A

81435 Hereditary colon cancer syndromes (eg, Lynch syndrome, familial adenomatosis  polyposis); genomic sequence analysis panel, must include analysis of at least 7 genes, including APC, CHEK2, MLH1, MSH2, MSH6, MUTYH, and PMS2

81437 Hereditary  neuroendocrine tumor disorders (eg , medullary thyroid carcinoma,  parathyroid carcinoma, malignant pheochromocytoma or paraganglioma); genomic  sequence analysis panel, must include sequencing of at least 6 genes, including MAX,  SDHB, SDHC, SDHD, TMEM127, and VHL

81438 Hereditary neuroendocrine tumor disorders ( eg , medullary thyroid carcinoma,  parathyroid carcinoma, malignant pheochromocytoma or paraganglioma);
duplication/deletion analysis panel, must include analyses for SDHB, SDHC, SDHD, and  VHL

81455 Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm,  DNA and RNA analysis when performed, 51 or greater genes (eg, ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed

81479 Unlisted molecular pathology procedure


Introduction

A genetic panel is a test that measures many genes at one time. Next - generation sequencing  (NGS) is specific technology that conducts the test very  quickly and can look at many genes at once. NGS panels are made to find changes in genes (variants ) that might show more risk to  certain cancers, including inherited form s of cancer. NGS panels report  a huge volume of data.  However, it is not known how to use the data to make medical decisions.  Often a lot of unusable  data is reported. Published medical studies  have not shown that using the information from  NGS panels improve a person’s medical care. Genetic panels that use NGS are considered  investigational and unproven. The health plan does not pay for investigational services.

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.

Coding


Note : CPT codes, descriptions and materials are copyrighted by the  American Medical Association (AMA). HCPCS  codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

Genetic Counseling

Experts recommend formal genetic counseling for patients who are at risk for inherited  disorders and who wish to undergo genetic testing. Interpreting  the results of genetic tests and understanding risk factors can be very difficult  for some patients; genetic counseling helps individuals understand
the impact of  genetic testing, including the possible effects the test results could have on the individual or their family members. It should be noted that genetic counseling may alter the utilization of genetic testing substantially and may reduce  inappropriate testing . Further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods


Commercially available cancer susceptibility gene panels can test for multiple variants associated  with a specific type of cancer or can include variants associated with a wide variety of cancers. While some patients may have a personal and/or family history of cancer that suggests the  cancer is syndrome -related, numerous genetic variants are associated with inherited cancer  syndromes. It has been proposed that variant testing using next - generation sequencing technology to analyze multiple genes at one time (panel testing) can optimize genetic testing in  these patients compared with sequencing single genes.

Genetic Testing for Cancer Susceptibility

Genetic testing for cancer susceptibility may be approached by a focused method that involves testing for well-characterized variants based on a clinical suspicion of which gene(s) may be the cause of the familial cancer. Panel testing involves testing for multiple variants in multiple genes at one time.
Several companies, including Ambry Genetics (Aliso Viejo, CA) and GeneDx (Gaithersburg, MD), offer genetic testing panels that use next-generation sequencing (NGS) methods for hereditary cancers. NGS refers to one of several methods that use massively parallel platforms to allow the sequencing of large stretches of DNA. Panel testing is potentially associated with greater efficiencies in the evaluation of genetic diseases; however, it may provide information on genetic variants of uncertain clinical significance or which would not lead to changes in patient management. Currently available panels do not include all genes associated with hereditary cancer syndromes. Also, these panels do not test for variants (ie, single-nucleotide variants [SNVs]), which may be associated with a low, but increased cancer risk.


CPT 81404, 81420, 81422, 00009M - Moleular pathology, Melanoma, Fetal aneupolidy

Code Description
CPT 81404 Molecular pathology procedure, Level 5 (eg, analysis of 2 - 5 exons by DNA sequence  analysis, mutation scanning or  duplication/deletion variants of 6 -10 exons, or characterization of a dynamic mutation disorder/triplet repeat by Southern blot analysis)

0009M Fetal aneuploidy (trisomy 21 and 18) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy

81420 Fetal chromosomal aneuploidy (eg, trisomy 21, monosomy X) genomic sequence analysis panel, circulating cell-free fetal DNA in maternal blood, must include analysis of chromosomes 13, 18 and 21

81422 Fetal chromosomal microdeletion(s) genomic sequence analysis (eg, DiGeorge syndrome, Cri-du-chat syndrome), circulating cell-free fetal DNA in maternal blood

81479 Unlisted molecular pathology procedure

81507 Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy

81599 Unlisted chemistry procedure

84999 Unlisted chemistry procedure

Introduction

Melanoma is one type of skin cancer. It begins in the melanocyte cells of the skin. These cells produce a pigment(melanin) that gives the skin its color, all the way from pink to dark. Damage to the DNA in melanocytes can cause the cells to grow out of control, leading to melanoma. It’s believed the main cause of melanoma is too much exposure to ultraviolet light, such as getting bad sunburns or using tanning lamps. Another risk factor is family history.If one person has melanoma then there’s a greater chance that the parent, child, brother, or sister could also develop melanoma.For those at high risk of getting melanoma , medical experts say the best ways to reduce the risk are to limit sun exposure, use sunscreen, and watch for unusual moles or other unusually colored areas of the skin. Genetic tests have been created to look for genetic changes related to melanoma. But results from these genetic tests wouldn’t change  recommendations for high risk people. Medical studies don’t show how genetic testing will lead to better health results.  Genetic testing for melanoma is considered unproven .

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.



Genetics Nomenclature Update

The Human Genome Variation Society nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics (see Table 1). The Society’s nomenclature is recommended by the Human Variome Project, the Human Genome Organization, and by the Human Genome Variation Society itself.

The American College of Medical Genetics and Genomics and the Association for Molecular Pathology standards and guidelines for interpretation of sequence variants represent expert opinion from both organizations, in addition to the College of American Pathologists. These recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes. Table 2 shows the recommended standard terminology—“pathogenic,” “likely pathogenic,” “uncertain significance,” “likely benign,” and “benign”—to describe variants identified that cause Mendelian disorders

Genetic Counseling


Experts recommend formal genetic counseling for patients who are at risk for inherited disorders and who wish to undergo genetic testing. Interpreting the results of genetic tests and understanding risk factors can be difficult for some patients; genetic counseling helps individuals understand the impact of genetic testing, including the possible effects the test results could have on the individual or their family members. It should be noted that genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing; further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

Benefit Application
Genetic testing for genes associated with cutaneous malignant melanoma will likely be performed at specialty laboratories.

Description

Cutaneous melanoma is the third most common type of skin cancer, but the most lethal. Some cases of cutaneous malignant melanoma are familial. Potential genetic markers for this disease are being evaluated in affected individuals with a family history of disease and in unaffected individuals in a high -risk family

Cutaneous Malignant Melanoma

A genetic predisposition to Cutaneous Malignant Melanoma (CMM)is suspected in these specific clinical situations:
*Melanoma has been diagnosed in multiple family members

*Multiple primary melanomas are identified in a single patient

*Melanomas began at an early age

A positive family history of melanoma is the most significant risk factor. It is estimated that approximately 10% of patients with melanoma have a first -or second -degree relative with melanoma. Although some of the familial risk may be related to shared environmental factors, 3 main genes involved in CMM susceptibility have been identified. Cyclin-dependent kinase inhibitor 2A (CDKN2A), located on chromosome 9p21,encodes proteins that act as tumor suppressors. Variantsat this site can alter the tumor suppressor function. The second gene, cyclin-dependent kinase 4 (CDK4), is an oncogene located on chromosome 12q13 and has been identified in about 6 families worldwide. A third gene, not fully characterized, maps to chromosome 1p22. The incidence of CDKN2A variants in the general population is very low. For example, it is estimated that in Queensland, Australia, an area with a high incidence of melanoma, only 0.2% of all patients with melanoma will harbor a CDKN2A variant. Variants are also infrequent in those with an early age of onset or those with multiple primary melanomas.However, the incidence of CDKN2A variants increases with a positive family history; CDKN2A variants will be found in 5% of families with first -degree relatives, rising to 20% to 40% in kindreds with 3 or more affected first-degree relatives.Variant detection rates in the CDKN2A gene are generally estimated as 20% to 25% in hereditary CMM but can vary between 2% and 50%, depending on the family history and population studied. Validated clinical risk prediction tools to assess the probability that an affected individual carries a germline CDKN2A variant are available.


Familial CMM has been described in families in which either 2 first -degree relatives are diagnosed with melanoma or a family with 3 melanoma patients, irrespective of the degree of relationship.Others have defined familial CMM as having at least 3 (first-, second-, or third-degree) affected members or 2 affected family members in which at least one was diagnosed before age 50 years, or pancreatic cancer occurred in a first-or second-degree relative or 1
member had multiple primary melanomas.Other malignancies associated with familial CMM, specifically those associated with CDKN2A variants, have been escribed. The most pronounced associated malignancy is pancreatic cancer. Other associated malignancies include other gastrointestinal malignancies, breast cancer, brain cancer, lymphoproliferative malignancies, and lung cancer. It is also important to recognize that other cancer susceptibility genes may be
involved in these families. In particular, germline BRCA2 gene variants have been described in families with melanoma and breast cancer, gastrointestinal cancer, pancreatic cancer, or prostate cancer.

CMM can occur either with or without a family history of multiple dysplastic nevi. Families with both CMM and multiple dysplastic nevi have been referred to as having familial atypical multiple mole and melanoma syndrome (FAMMM). This syndrome is difficult to define because there is no agreement on a standard phenotype, and dysplastic nevi occur in up to 50% of the general population. Atypical or dysplastic nevi are associated with an increased risk for CMM. Initially, the phenotypes of atypical nevi and CMM were thought to cosegregate in FAMMM families, leading to the assumption that a single genetic factor was responsible. However, it was subsequently shown that in families with CDKN2A variants , there were family members with multiple atypical nevi who were non-carriers of the CDKN2A familial variant. Thus, the nevus phenotype cannot be used to distinguish carriers from non -carriers of CMM susceptibility in these families.

Some common allele(s) are associated with increased susceptibility to CMM but have low to moderate penetrance. One gene of moderate penetrance is the Melanocortin 1 receptor gene (MC1R). Variants in this gene are relatively common and have low penetrance for CMM. This gene is associated with fair complexion, freckles, and red hair, all risk factors for CMM. Variants in MC1R also modify the CMM risk in families with CDKN2A variants.
.

Summary of Evidence 


For individuals who have CMM and a family history of this disease who receive genetic testing for genes associated with familial CMM, the evidence includes genetic association studies correlating variants in certain genes and the risk of developing cutaneous melanoma. Relevant outcomes are overall survival, disease - specific survival, test accuracy, and test validity. Limitations with clinical validity include difficulties with variant interpretations, variable  penetrance of a given variant, and residual risk with a benign variant. Currently, management of melanoma patients does not change based on genetic variants identified in genes associated with familial CMM, therefore, clinical utility is lacking. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are asymptomatic and in a family at high -risk of developing CMM who receive genetic testing for genes associated with familial CMM, the evidence includes genetic association studies correlating variants in certain genes and the risk of developing CMM. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and test validity. Limitations with clinical validity include difficulties with variant interpretations, variable

penetrance of a given variant, and residual risk with a benign variant. Currently, management of patients considered high risk for CMM focuses on the reduction of sun exposure, use of sunscreens, vigilant cutaneous surveillance of pigmented lesions, and prompt biopsy of suspicious lesions. It is unclear how genetic testing for variants associated with increased risk of CMM would alter these management recommendations; therefore, clinical utility is lacking. The evidence is insufficient to determine the effects of the technology on health outcomes.


Chromosomes are found in each cell and hold all of the genetic material —the DNA —of each person. Each cell usually contains 23 pairs of chromosomes, including the pair that determines the person’s sex. Having more or fewer chromosomes —known as aneuploidy —results in birth defects. Screening for aneuploidies is recommended during pregnancy. In the past, this screening was typically done by examining cells from the fetus. The cells were obtained either by taking a sample of the placenta or the amniotic fluid surrounding the baby. Newer tests that require only a blood sample from the mother can be used to screen for aneuploidies. This test looks at pieces of the fetus’s DNA that are naturally circulating in the mother’s blood. This policy describes when this type of blood test may be medically necessary. This blood test is investigational —unproven —when it’s used to look for missing pieces of chromosomes that are too small to be seen without a microscope. It’s also investigational when it’s used early in the pregnancy to look at the sex Chromosomes.  

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.


Karyotyping would be necessary to exclude the possibility of a false -positive, nucleic acid sequencing–based test. Before testing, women should be counseled about the risk of a false-positive test.In Committee Opinion No. 640, the American College of Obstetricians and Gynecologists (2015) recommended that all patients receive information on the risks and benefits of various methods of prenatal screening and diagnostic testing for fetal aneuploidies, including the option of no testing.

Studies published to date on noninvasive prenatal screening for fetal aneuploidies have reported rare but occasional false-positives. False-positive findings have been found to be associated with factors including placental mosaicism, vanishing twins, and maternal malignancies. Diagnostic testing is necessary to confirm positive cell-free fetal DNA tests, and management decisions should not be based solely on the results of cell-free fetal DNA testing. The American College of Obstetricians and Gynecologists further recommended that patients with indeterminate or uninterpretable (ie, “no call”) cell -free fetal DNA test results be referred for genetic counseling and offered ultrasound evaluation and diagnostic testing because “no call” findings have been associated with an increased risk of aneuploidy

Cell -free fetal DNA screening does not assess risk of neural tube defects. Patients should continue to be offered ultrasound or maternal serum
*-fetoprotein screening.

Genetics Nomenclature Update

The Human Genome Variation Society nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics (see Table 1). The Society’s nomenclature is recommended by the Human Variome Project, the HUman Genome Organization, and by the Human Genome Variation Society itself.The American College of Medical Genetics and Genomics and the Association for Molecular Pathology standards and guidelines for interpretation of sequence variants represent expert opinion from both organizations, in addition to the College of American Pathologists. These recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes.
Table 2 shows the recommended standard terminology—“pathogenic,” “likely pathogenic,” “uncertain significance,” “likely benign,” and “benign”—to describe variants identified that cause Mendelian disorders.

Genetic Counseling

Experts recommend formal genetic counseling for patients who are at risk for inherited disorders and who wish to undergo genetic testing.Interpretating the results of genetic tests and understanding risk factors can be difficult for some patients; genetic counseling helps individuals understand the impact of genetic testing, including the possible effects the test results could have on the individual or their family members. It should be noted that genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing; further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods

Description

National guidelines recommend that all pregnant women be offered screening for fetal chromosomal abnormalities, most of which are aneuploidies, an abnormal number of chromosomes. Trisomy syndromes are aneuploidies involving 3 copies of 1 chromosome. Trisomies 21 (T21), 18 (T18), and 13 (T13) are the most common forms of fetal aneuploidy. Fetuses with T18 and T13 generally do not survive to birth. There are numerous limitations to standard screening for these disorders using maternal serum and fetal ultrasound. Noninvasive prenatal screening (NIPS) analyzing cell-free fetal DNA in maternal serum is a potential complement or alternative to conventional serum screening. NIPS using cell-free fetal DNA has also been proposed to screen for microdeletions.

Fetal Aneuploidy

Fetal chromosomal abnormalities occur in approximately 1 in 160 live births. Most fetal chromosomal abnormalities are aneuploidies, defined as an abnormal number of chromosomes. The trisomy syndromes are aneuploidies involving 3 copies of 1 chromosome. The most important risk factor for trisomy syndromes is maternal age. The approximate risk of a trisomy 21 (T21; Down syndrome)*affected birth is 1 in 1100 at age 25 to 29. The risk of a fetus with T21 (at 16 weeks of gestation) is about 1 in 250 at age 35 and 1 in 75 at age 40.1T21 is the most common chromosomal aneuploidy and provides the impetus for current  maternal serum screening programs. Other trisomy syndromes include T18 (Edwards syndrome) and T13 (Patau syndrome), which are the next most common forms of fetal aneuploidy, although the percentage of cases surviving to birth is low and survival beyond birth is limited. Detection of T18 and T13 early in pregnancy can facilitate preparation for fetal loss or early intervention.

Fetal Aneuploidy Screening

Standard aneuploidy screening involves combinations of maternal serum markers and fetal ultrasound done at various stages of pregnancy. The detection rate for various combinations of noninvasive testing ranges from 60% to 96% when the false-positive rate is set at 5%. When tests indicate a high risk of a trisomy syndrome, direct karyotyping of fetal tissue obtained by amniocentesis or chorionic villous sampling (CVS) is required to confirm that T21 or another  trisomy is present. Both amniocentesis and CVS are invasive procedures and have procedure-associated risks of fetal injury, fetal loss, and infection.

A new screening strategy that reduces unnecessary amniocentesis and CVS procedures or increases detection of T21, T18, and T13 could improve outcomes. Confirmation of positive noninvasive screening tests with amniocentesis or CVS is recommended; with more accurate tests, fewer women would receive positive screening results.

Commercial, noninvasive, sequencing-based testing of maternal serum for fetal trisomy syndromes is now available. The testing technology involves detection of cell-free fetal DNA fragments present in the plasma of pregnant women. As early as 8 to 10 weeks of gestation, these fetal DNA fragments comprise 6% to 10% or more of the total cell -free DNA in a maternal plasma sample. The tests are unable to provide a result if the fetal fraction is too low, (ie, <4 .="" affected="" and="" at="" be="" br="" by="" can="" characteristics.="" crown-rump="" example="" fetal="" for="" found="" fraction="" higher="" increasing="" length.="" lower="" maternal="" nd="" the="" to="" was="" weights="" with="">
Cell-Free Fetal DNA Analysis Methods

Sequencing-based tests use 1 of 2 general approaches to analyzing cell-free DNA. The first category of tests uses quantitative or counting methods. The most widely used technique to date uses massively parallel sequencing (MPS; also known as next-generation sequencing). DNA fragments are amplified by polymerase chain reaction; during the sequencing process, the amplified fragments are spatially segregated and sequenced simultaneously in a massively parallel fashion. Sequenced fragments can be mapped to the reference human genome to obtain numbers of fragment counts per chromosome. The sequencing-derived percent of fragments from the chromosome of interest reflects the chromosomal representation of the maternal and fetal DNA fragments in the original maternal plasma sample. Another technique is direct DNA analysis, which analyzes specific cell-free DNA fragments across samples and requires approximately a tenth the number of cell-free DNA fragments as MPS. The digital analysis of selected regions (DANSR™) is an assay that uses direct DNA analysis.

The second general approach is single nucleotide variant-based methods. These use targeted amplification and analysis of approximately 20,000 single nucleotide variants on selected chromosomes (eg, 21, 18, 13) in a single reaction. A statistical algorithm is used to determine the number of each type of chromosome. At least some of the commercially available cell-free fetal DNA prenatal tests also test for other abnormalities including sex chromosome abnormalities and selected microdeletions.

Copy Number Variants and Clinical Disorders

Microdeletions (also known as submicroscopic deletions) are chromosomal deletions that are too small to be detected by microscopy or conventional cytogenetic methods. They can be as small as 1 and 3 megabases long. Along with microduplications, microdeletions are collectively known as copy number variants. Copy number variants can lead to disease when the change in copy number of a dose-sensitive gene or genes disrupts the ability of the gene(s) to function  and affects the amount of protein produced. A number of genomic disorders associated with microdeletion have been identified, which may be associated with  serious clinical features, such as cardiac anomalies, immune deficiency, palatal defects, and developmental delay as in DiGeorge syndrome. Some of the syndromes (eg, DiGeorge) have complete penetrance yet marked variability in clinical expressivity. A contributing factor is that the breakpoints of the  microdeletions may vary, and there may be a correlation between the number of haplo-insufficient genes and phenotypic severity.

CPT 99082 - Paymnet guide - Rural health clinic

 Rural Health Clinic and Federally Qualified Health Center Services

Payment may be made under Part B for the medical and other health services furnished by a qualified rural health clinic (RHC) and Federally qualified health centers (FQHCs). The covered services RHCs/FQHCs may offer are divided into two basic groups: RHC/FQHC services (defined below) and other medical and other health services covered under Part B.

Items and services which meet the definition of RHC services or FQHC services are reimbursed either by designated RHC intermediaries, or a national FQHC FI in the case of independent RHCs/FQHCs, or by the provider’s FI in the case of provider based clinics. In either case, the carrier does not pay claims for services defined as RHC/FQHC services. The FI pays for such services through a prospectively determined encounter rate.

Where an RHC or a FQHC is approved for billing other medical and health services to the carrier, the RHC or FQHC bills the carrier and is paid according to the method of payment for the service provided.

Rural health clinic and Federally qualified health center services are described in the Medicare Benefit Policy Manual, Chapter 13. That chapter provides that the following

services usually performed by physicians are included as services included in the encounter rate and therefore are not separately billable for RHC/FQHC patients. They are:

*Professional services performed by a physician for a patient including diagnosis, therapy, surgery, and consultation (See the Medicare Benefit Policy Manual, Chapter 15);

*Services and supplies incident to a physician’s services, as described in the Benefit Policy Manual, Chapter 15;

*Nurse practitioner and physician assistant services (including the services of specialized nurse practitioners and nurse midwives) that would be covered if furnished by a physician, provided the nurse practitioner or physician assistant is legally permitted to perform the services by the State in which they are performed;

*Services and supplies incident to the services of nurse practitioners and physician assistants that would be covered if furnished incident to a physician’s services, and

*Visiting nurse services to the homebound.

However, the technical component of diagnostic services may be billed separately by the physician to the carrier, if provided. See Chapter 9, and the Medicare Benefit Policy Manual, Chapter 13, for additional information on the definition of RHC/FQHC services.

Also, an RHC or FQHC may provide other items and services which are covered under Part B, but which are not defined as RHC or FQHC services. They are listed in the Medicare Benefit Policy Manual, Chapter 13. Independent RHCs/FQHCs bill the carrier for such services. Provider-based RHC/FQHC services are billed to the FI as services of the parent provider.

Independent RHCs/FQHCs must enroll with the carrier in order to bill.

80.3- Unusual Travel (CPT Code 99082)

In general, travel has been incorporated in the MPFSDB individual fees and is thus not separately payable. Carriers must pay separately for unusual travel (CPT code 99082) only when the physician submits documentation to demonstrate that the travel was very unusual.

How to use CCI edit when procedure denied as bundled service

If I receive a denial for a procedure bundled into another service, and I cannot find this code pair in the column 1/column 2 correct coding list of edits, where else should I look?


Look in the mutually exclusive code list. The mutually exclusive code edits in the printed version of the CCI Edits Manual are in the same chapter but separate from the column 1/ column 2 correct coding edits. The electronic version of the mutually exclusive code edits that is available on the CMS website can be found in a separate listing at http://www.cms.hhs.gov/NationalCorrectCodInitEd/01_overview.asp, which are arranged by specific chapters.


What exactly does "column 1" mean in the column 1/column 2 correct coding edits table and in the mutually exclusive edits table?

Formerly known as the "comprehensive code" within the column 1/column 2 correct coding edits table, the column 1 code generally represents the major procedure or service when reported with the column 2 code. When reported with the column 2 code, "column 1" generally represents the code with the greater work RVU of the two codes.

However, within the mutually exclusive edits table, "column 1" code generally represents the procedure or service with the lower work RVU, and is the payable procedure or service when reported with the column 2 code




Claims Review for Global Surgeries


A.Relationship to Correct Coding Initiative (CCI)


The CCI policy and computer edits allow A/B MACs (B) to detect instances of fragmented billing for certain intra-operative services and other services furnished on the same day as the surgery that are considered to be components of the surgical procedure and, therefore, included in the global surgical fee. When both correct coding and global surgery edits apply to the same claim, A/B MACs (B) first apply the correct coding edits, then, apply the global surgery edits to the correctly coded services.

B.Prepayment Edits to Detect Separate Billing of Services Included in the Global Package

In addition to the correct coding edits, A/B MACs (B) must be capable of detecting certain other services included in the payment for a major or minor surgery or for an endoscopy. On a prepayment basis, A/B MACs (B) identify the services that meet the following conditions:

*Preoperative services that are submitted on the same claim or on a subsequent claim as a surgical procedure; or

*Same day or postoperative services that are submitted on the same claim or on a subsequent claim as a surgical procedure or endoscopy;

and -
*Services that were furnished within the prescribed global period of the surgical procedure;

*Services that are billed without modifier “-78,” “-79,” “-24,” “25,” or “-57” or are billed with modifier “-24” but without the required documentation; and

*Services that are billed with the same provider or group number as the surgical procedure or endoscopy. Also, edit for any visits billed separately during the postoperative period without modifier “-24” by a physician who billed for the postoperative care only with modifier “-55.”

A/B MACs (B) use the following evaluation and management codes in establishing edits for visits included in the global package. CPT codes 99241, 99242, 99243, 99244,
99245, 99251, 99252, 99253, 99254, 99255, 99271, 99272, 99273, 99274, and 99275
have been transferred from the excluded category and are now included in the global surgery edits.

Evaluation and Management Codes for A/B MAC (B) Edits
92012    92014    99211    99212    99213    99214
99215    99217    99218    99219    99220    99221
99222    99223    99231    99232    99233    99234
99235    99236    99238    99239    99241    99242
99243    99244    99245    99251    99252    99253
99254    99255    99261    99262    99263    99271
99272    99273    99274    99275    99291    99292
99301    99302    99303    99311    99312    99313
99315    99316    99331    99332    99333    99347
99348    99349    99350           
99374    99375    99377    99378       

NOTE: In order for codes 99291 or 99292 to be paid for services furnished during the preoperative or postoperative period, modifier “-25” or “-24,” respectively, must be used to indicate that the critical care was unrelated to the specific anatomic injury or general surgical procedure performed.

If a surgeon is admitting a patient to a nursing facility for a condition not related to the global surgical procedure, the physician should bill for the nursing facility admission and care with a “-24” modifier and appropriate documentation. If a surgeon is admitting a patient to a nursing facility and the patient’s admission to that facility relates to the global surgical procedure, the nursing facility admission and any services related to the global surgical procedure are included in the global surgery fee.

C.Exclusions from Prepayment Edits

A/B MACs (B) exclude the following services from the prepayment audit process and allow separate payment if all usual requirements are met:
Services listed in §40.1.B; and
Services billed with the modifier “-25,” “-57,” “-58,” “-78,” or “-79.” Exceptions

See §§40.2.A.8, 40.2.A.9, and 40.4.A for instances where prepayment review is required for modifier “-25.” In addition, prepayment review is necessary for CPT codes 90935, 90937, 90945, and 90947 when a visit and modifier “-25” are billed with these services.

Exclude the following codes from the prepayment edits required in §40.3.B.

92002    92004    99201    99202    99203    99204
99205    99281    99282    99283    99284    99285
99321    99322    99323    99341    99342    99343
99344    99345                

Patient waiver form - Example and requirements

WAIVER FORM


NOTE: The waiver cannot be utilized for services considered to be content of another service provided.

A. SITUATIONS REQUIRING A WAIVER

1. Medical necessity denials
2. Utilization denials
3. Deluxe features (Applicable to deluxe orthopedic or prosthetic appliances as specified in the member contract)
4. Patient demanded services
5. Experimental/investigational procedures

B. THE WAIVER FORM MUST BE

1. Signed before receipt of service.
2. Patient, service, and reason specific.
3. Date of service and dollar amount specific.
4. Retained in the patient's file at the provider's place of business. (The waiver form is no longer required with claims submission. Use the GA modifier for all electronic and paper claims.)
5. Presented on an individual basis to the patients. It may not be a blanket statement signed by all patients.
6. Acknowledged by patient that he or she will be personally responsible for the amount of the charge, to include an approximate amount of the charge at issue.

NOTE: If the waiver is not signed before the service being rendered, the service is considered a contracting provider write-off, unless there are extenuating circumstances

LIMITED PATIENT WAIVER Form

Patient’s Name:
Provider Name:
Identification Number:
Provider Address:
Provider Number:
The provider must document in the patient record the discussion with the patient regarding the following service(s).


patient waiver form

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