Tuesday, January 8, 2019

CPT 81225, 81226, 81227, 81599 - Genotype-Guided Tamoxifen Treatment

Policy Coverage Criteria  Test Investigational  Cytochrome P450 2D6 (CYP2D6) testing 

Coding 
 

Genotyping to determine cytochrome P450 2D6 (CYP2D6) variants is considered investigational for the purpose of managing treatment with tamoxifen for women at high risk for or with breast cancer.

Code Description CPT


81225 CYP2C19 (cytochrome P450, family 2, subfamily C, polypeptide 19) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *8, *17)

81226 CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *5, *6, *9, *10, *17, *19, *29, *35, *41, *1XN, *2XN, *4XN) 

81227 CYP2C9 (cytochrome P450, family 2, subfamily C, polypeptide 9) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *5, *6) 

81479 Unlisted molecular pathology procedure 

81599
Unlisted multianalyte assay with algorithmic analysis 





Introduction
Certain types of breast cancer are affected by hormones. Cancer cells that are said to be estrogen receptor positive (ER-positive) have receptors that attach to estrogen. Once attached, estrogen then acts like a fertilizer to help the cancer grow. Hormone therapy is used to prevent estrogen from connecting to the receptors. Tamoxifen is a type of hormone therapy that can be used for ER-positive breast cancer to prevent it from coming back and to treat breast cancer that’s already spread to other parts of the body. It’s also used for ER-positive ductal carcinoma in situ (DCIS). To process tamoxifen into its more active form, the body uses a specific, important enzyme (CYP2D6) that’s made by a particular gene. A small percentage of people (about 10%) have a form of the gene that doesn’t make as much of this important enzyme as most other people make. A genetic test has been developed to try to see if a person has the gene form that makes a smaller amount of the needed enzyme. This genetic test is investigational (unproven). Large, well-designed medical studies don’t show a strong link between this gene and tamoxifen’s effectiveness. More studies are needed. 




Related Information 

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. It is being implemented for genetic testing medical evidence review updates starting in 2017 (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.

Table 1. Nomenclature to Report on Variants Found in DNA 

Previous  Updated  Definition
Mutation Disease-associated variant
Disease-associated change in the DNA sequence
Variant Change in the DNA sequence 
Familial variant Disease-associated variant identified in a proband for use in subsequent targeted genetic testing in first-degree relatives

Table 2. ACMG-AMP Standards and Guidelines for Variant Classification
Variant Classification Definition
Pathogenic Disease-causing change in the DNA sequence
Likely pathogenic Likely disease-causing change in the DNA sequence 
Variant of uncertain significance Change in DNA sequence with uncertain effects on disease
Likely benign Likely benign change in the DNA sequence
Benign Benign change in the DNA sequence
ACMG: American College of Medical Genetics and Genomics; AMP: Association for Molecular Pathology. 


Description

Tamoxifen is prescribed as a component of adjuvant endocrine therapy to prevent endocrine receptor-positive breast cancer recurrence, to treat metastatic breast cancer, and to prevent disease in high-risk populations and in women with ductal carcinoma in situ. Tamoxifen is a prodrug that undergoes extensive metabolism to yield its active form: 4-hydroxy tamoxifen and endoxifen (primary active form) via the CYP2D6 enzyme. Variants in the CYP2D6 gene are associated with significant alterations in endoxifen concentrations leading to the hypothesis that CYP2D6 variation may affect the clinical outcomes of women treated with tamoxifen but not with drugs not metabolized by CYP2D6, such as anastrozole.

Background  Tamoxifen Metabolism 

Tamoxifen is a pro-drug that undergoes extensive metabolism to yield its active form: 4hydroxytamoxifen (4-OH tamoxifen) and 4-hydroxy-N-desmethyltamoxifen (endoxifen).

Among these 2 metabolites, endoxifen is thought to be the major metabolite that exerts the pharmacodynamic effect of tamoxifen. The metabolism of tamoxifen into 4-OH tamoxifen is catalyzed by multiple enzymes, while endoxifen is formed predominantly by the CYP2D6 enzyme. Plasma concentrations of endoxifen exhibit high interindividual variability, as described in breast cancer patients.

Because CYP2D6 enzyme activity is known to vary across individuals, variants in the CYP2D6 gene are of great interest for understanding tamoxifen metabolism variability and variation in levels of circulating active metabolites. Moreover, known variability in endoxifen levels has been hypothesized to result in variable response to tamoxifen treatment.

Metabolic Enzyme Genotypes 

The CYP2D6 gene exhibits a high degree of polymorphism, with more than 100 allelic variants identified. The relations among genotype, phenotype, and clinical implications are summarized in Table 3.

The prevalence of CYP2D6 poor metabolizers is approximately 7% to 10% in whites of Northern European descent, 1.9% to 7.3% in blacks, and 1% or less in most Asian populations studied. The poor metabolizer phenotype in whites is largely accounted for by CYP2D6*3 and *4 nonfunctional variants, and in black and Asian populations, by the *5 nonfunctional variant. Some poor metabolizers may have 1 nonfunctional allele and 1 reduced-function allele. Among reduced function variants, CYP2D6*17, *10, and *8 are the most important in blacks, Asians, and whites, respectively. Few studies have investigated the frequency of CYP2D6-variant alleles or of poor metabolizers in the Hispanic population.

Endocrine Therapy Regimens 

Tamoxifen has several labelled indications


* Chemoprevention of invasive breast cancer in high-risk women without current disease or with ductal carcinoma in situ
* Adjuvant treatment of primary breast cancer
* Treatment of metastatic disease


In women with breast cancer, endocrine receptor-positive disease predicts a likely benefit from tamoxifen treatment. Tamoxifen is currently the most commonly prescribed adjuvant treatment to prevent recurrence of endocrine receptor-positive breast cancer in premenopausal or perimenopausal women. 

For post-menopausal women with osteoporosis or at high risk for invasive breast cancer, raloxifene is an alternative treatment for invasive cancer risk reduction. Currently, raloxifene is indicated for treatment of reduction in the “risk of invasive breast cancer in postmenopausal women with osteoporosis” or those at “high risk for invasive breast cancer.”

Pharmacologic Inhibitors of Metabolic Enzymes 

CYP2D6 activity may be affected not only by genotype but also by co-administered drugs that block or induce CYP2D6 function. Studies of selective serotonin reuptake inhibitors, in particular, have shown that fluoxetine and paroxetine, but not sertraline, fluvoxamine, or venlafaxine, are potent CYP2D6 inhibitors.

Some individuals treated with fluoxetine or paroxetine have changed from extensive metabolizer phenotype to poor metabolizer.

The degree of inhibition may depend on selective serotonin reuptake inhibitors dose.
Thus, CYP2D6 inhibitor use must be considered in assigning CYP2D6 functional status, and potent CYP2D6 inhibitors may need to be avoided when tamoxifen is administered.

Summary of Evidence

For individuals who are treated with tamoxifen for breast cancer or are high risk for breast cancer who receive CYP2D6 genotype-guided tamoxifen treatment, the evidence includes multiple retrospective cohort studies and nonconcurrent prospective studies. Relevant outcomes include overall survival, disease-specific survival, medication use, and treatment-related morbidity. Data in most of these studies derived from a convenient sample, which was further limited by relatively small numbers of patients and lack of comprehensive genotype data, patient data (eg, concomitant medications), and detailed clinical outcomes data. Three influential nonconcurrent prospective studies nested within large prospective, randomized double-blind clinical trials in postmenopausal women with hormone receptor–positive earlystage breast cancer also reported contradictory results. Two larger studies failed to show statistically significant associations between phenotype (patients classified as poor, intermediate, or extensive metabolizer) and recurrence of breast cancer. No trials of genotype-directed dosing or drug choice that compared health outcomes for patients managed with and without the test were identified. It is not known whether CYP2D6 genotype-guided tamoxifen treatment results in the selection of a treatment strategy that would reduce the rate of  breast cancer recurrence, improve disease-free survival or overall survival, or reduce adverse events. The evidence is insufficient to determine the effects of the  technology on health outcomes.

Thursday, December 27, 2018

CPT G9143, 0030U - Genotype-Guided Warfarin Dosing


Code Description CPT

0030U Drug metabolism (warfarin drug response), targeted sequence analysis (ie, CYP2C9, CYP4F2, VKORC1, rs12777823) (new code effective 1/1/18)

HCPCS
G9143 Warfarin responsiveness testing by genetic technique using any method, any number of specimen(s)




Introduction

Warfarin (Coumadin) is a blood thinner that works by reducing the blood’s ability to clot. It’s often prescribed to prevent blood clot formation in people who have conditions like atrial fibrillation. Finding the correct dose can be complicated. Too high a dose can cause bleeding. Too low a dose can result in blood clots being formed. Factors such as age, weight, use of other medications, and smoking go into the calculation of how much is prescribed. Once the drug is prescribed, the doctor then adjusts the dose based on blood tests. Two genes have been associated with how well the body processes warfarin. Genetic tests have been developed to look at these genes to try to determine warfarin dosing. These genetic tests are investigational (unproven). Medical studies do not show whether genetic testing to try to adjust warfarin doses leads to better health results. More studies are needed.



Test Investigational 

Testing of cytochrome p450 2C9 (CYP2C9), P450 4F2 (CYP4F2), and vitamin K epoxide reductase subunit C1 (VKORC1)

Coding Genotyping for CYP2C9, CYP4F2, and VKORC1 variants is considered investigational to manage the administration and dosing of warfarin, including: * Guiding the initial  warfarin dose  * Decreasing the time needed to achieve a stable international  normalized ratio (INR) * Reducing the risk of serious bleeding




Related Information 

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.

Table 1. Nomenclature to Report on Variants Found in DNA
Previous  Updated  Definition

Mutation Disease-associated variant
 

Disease-associated change in the DNA sequence
Variant Change in the DNA sequence 
Familial variant Disease-associated variant identified in a proband for use in subsequent targeted genetic testing in first-degree relatives
Table 2. ACMG-AMP Standards and Guidelines for Variant Classification
Variant Classification Definition
Pathogenic Disease-causing change in the DNA sequence
Likely pathogenic Likely disease-causing change in the DNA sequence 
Variant of uncertain significance Change in DNA sequence with uncertain effects on disease
Likely benign Likely benign change in the DNA sequence
Benign Benign change in the DNA sequence
ACMG: American College of Medical Genetics and Genomics; AMP: Association for Molecular Pathology.

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.



Evidence Review 

Description

Using information about an individual’s genotypes may help in guiding warfarin dosing and could reduce the time to dose stabilization and selection of an appropriate maintenance dose that might avoid the consequences of too much or too little anticoagulation.

Background

Warfarin is administered to prevent and treat thromboembolic events in high-risk patients;   warfarin dosing is a challenging process due to the narrow therapeutic window, variable response to dosing, and serious bleeding events in 5% or more of patients (depending on definition). Patients are typically given a starting dose of 2 to 5 mg and are frequently monitored with dose adjustments until a stable international normalized ratio value (a standardized indicator of clotting time) between 2 and 3 is achieved. During this adjustment period, a patient is at high risk of bleeding.
Stable or maintenance warfarin dose varies among patients by more than an order of magnitude. Factors influencing stable dose include body mass index, age, interacting drugs, and  indication for therapy. 

Warfarin, which is primarily metabolized in the liver by the CYP2C9 enzyme, exerts an anticoagulant effect by inhibiting the protein vitamin K epoxide reductase complex, subunit 1 (VKORC1). Three single nucleotide variants, two in the CYP2C9 gene and one in the VKORC1 gene play key roles in determining the effect of warfarin therapy on coagulation.

 CYP2C9*1 metabolizes warfarin normally, CYP2C9*2 reduces warfarin metabolism by 30%, and CYP2C9*3 reduces warfarin metabolism by 90%. Because warfarin given to patients with *2 or *3 variants will be metabolized less efficiently, the drug will remain in circulation longer, so lower warfarin doses will be needed to achieve anticoagulation. CYP2C9 and VKORC1 genetic variants account for approximately 55% of the variability in warfarin maintenance dose.
1,11

 Recent genome-wide association studies have also identified that a single nucleotide variant in the CYP4F2 gene has been reported to account for a small proportion of the variability in stable dose (the CYP4F2 gene encodes a protein involved in vitamin K oxidation).

Medicare National Coverage

In 2009, the Centers for Medicare and Medicaid Services published a national coverage determination on pharmacogenomic testing for warfarin response.

The Centers for Medicare & Medicaid Services stated that “the available evidence does not demonstrate that pharmacogenomic testing of CYP2C9 or VKORC1 alleles to predict warfarin responsiveness improves health outcomes in Medicare beneficiaries outside the context of CED, and is therefore not reasonable and necessary….” 
However, the Centers also “believes that the available evidence supports that coverage with evidence development (CED) …. is appropriate for pharmacogenomic testing of CYP2C9 or VKORC1 alleles to predict warfarin responsiveness by any method, and is therefore covered only when provided to Medicare beneficiaries who are candidates for anticoagulation therapy with warfarin who:
* Have not been previously tested for CYP2C9 or VKORC1 alleles; and

* Have received fewer than five days of warfarin in the anticoagulation regimen for which the testing is ordered; and
* Are enrolled in a prospective, randomized, controlled clinical study when that study meets described standards.”


Wednesday, December 5, 2018

What is CPC+ - General Guide


GENERAL

Q: Why is CMS testing CPC+?

CMS believes that through multi-payer payment reform and practice transformation, primary care practices will be able to build capabilities and care processes to deliver patient-centered, high quality care and lower the use of unnecessary services that drive total costs of care. Payment redesign by payers, both public and private, will offer the ability for greater cash flow and flexibility for primary care practices.

Q: When will CPC+ Round 2 start and how long will it last? Can my practice join later? CPC+ Round 2 is expected to begin on January 1, 2018. Eligible practices located in the CPC+ Round 2 regions can apply from May 18-July 13, 2017.

CPC+ Round 2 consists of five performance years, as identified in the table below. CMS expects practices to participate for the full five years of their respective round of the model and will not allow practices to join the model after CMS selects practices to participate in each round of the Model.

PERFORMANCE YEARS FOR CPC+ Round 2 Calendar Year Round 2 Performance Year

2018 1
2019 2
2020 3
2021 4
2022 5

Q: Are practices required to participate in CPC+ for the full five years?

CMS expects practices to participate in CPC+ for the full five years. However, participation in CPC+ is voluntary and practices may withdraw from the model without penalty during the fiveyear performance period. Practices are required to notify CMS at least 90 calendar days before the planned day of withdrawal. Departing the model before completion of a performance year (PY) puts a practice at risk for recoupment of unearned CPC+ payments.

Q: Where will CPC+ Round 2 be implemented?

CPC+ Round 2 will be implemented in four regions throughout the U.S.:

1. Louisiana: Statewide
2. Nebraska: Statewide
3. North Dakota: Statewide
4. New York: Greater Buffalo Region

The CPC+ Round 2 regions were selected based on payer alignment and market density to ensure that CPC+ practices have sufficient payer support to make fundamental changes in their primary care delivery.

Q: How is CMS defining the “Greater Buffalo Region (NY)”? 

Based on payer alignment and market density, CMS is defining the Greater Buffalo region with the following counties:

• New York: Greater Buffalo Region: Erie County, NY; Niagara County, NY Only practices located in these counties are eligible to apply and participate in CPC+ Round 2.

Q: Which payers have been selected to partner in CPC+ Round 2?

 CPC+ Round 2 payer partners in the four new CPC+ Round 2 regions:

1. Louisiana: Amerigroup Louisiana, Inc., AmeriHealth Caritas Louisiana, Inc., Blue Cross Blue Shield of Louisiana

2. Nebraska: Blue Cross Blue Shield of Nebraska

3. New York: Greater Buffalo Region: HealthNow New York Inc., Independent Health Association, Inc.

4. North Dakota: Blue Cross Blue Shield of North Dakota

Q: When and how can a practice apply to participate in CPC+ Round 2? 

Based on payer interest and proposed alignment, CMS announced four regions for CPC+ Round

2. Practices located in these regions are eligible to apply via an online portal (https://app1.innovation.cms.gov/cpcplus/) from May 18-July 13, 2017. For questions about the Model or the solicitation process, please email CPCPlusapply@telligen.com or call 1-877-309- 6114.

Q: How many practices will be accepted in CPC+ Round 2? 

CMS expects to accept up to 1,000 practices in CPC+ Round 2.

Q: Why will new practice applications only be accepted in CPC+ Round 2 regions? CPC+ is a voluntary test of primary care payment and delivery system changes at the practice level, and will be independently evaluated throughout the five years of each Round of the model. The evaluation compares practices in each region to similar practices in the same region. CMS is unable to add new practices in the existing regions without potentially compromising the evaluation. Therefore, new practices will only be able to apply for participation in CPC+ in new regions selected for CPC+ Round 2, not in the 14 Round 1 regions.

Q: What is expected of the control group practices in CPC+ Round 2?

CMS will randomly assign eligible practices to an intervention group and a control group. The control group practices will not be required to implement the CPC+ care delivery practice changes, will not receive CPC+ Payments, and will not participate in the CPC+ learning communities, and will sign a different CPC+ Participation Agreement with CMS than the   intervention group. Additionally, they will not be considered participants in an Advanced APM through participation in the CPC+ control group, but may otherwise be Advanced APM participants through their participation in other CMS models or programs. Control group practices may be compensated for their participation in CPC+ evaluation-related activities. CMS also expects to promulgate a rule that could allow for control group practices to potentially receive favorable scoring under the Improvement Activities category of the Merit-based Incentive Payment System (MIPS), subject to notice and comment rulemaking. More details for control group practices will be announced in late 2017.

Q: Are practices outside of the CPC+ Round 2 regions eligible to apply and participate in CPC+?

Practices will only be eligible to apply to Round 2 if they are located in one of the selected Round 2 regions. The purpose of the CPC+ multi-payer design is to ensure that primary care practices receive the adequate support from multiple payers to change care delivery for a practice’s entire panel of patients. The CPC+ regions were carefully selected to ensure adequate payer support for participating practices.

a Greater Kansas City Region is defined as Johnson County, KS; Wyandotte County, KS; Clay County, MO; Jackson County, MO; Platte County, MO

b North Hudson-Capital Region of New York is defined as Albany County, NY; Columbia County, NY; Dutchess County, NY; Greene County, NY; Montgomery County, NY; Orange County, NY; Rensselaer County, NY; Saratoga County, NY; Schenectady County, NY; Schoharie County, NY; Sullivan County, NY; Ulster County, NY; Warren County, NY Washington County, NY

c Ohio-Northern Kentucky Region is defined as all counties in Ohio; Boone County, KY; Campbell County, KY; Grant County, KY; Kenton County, KY

d Greater Philadelphia Region is defined as Bucks County, PA; Chester County, PA; Delaware County, PA; Montgomery County, PA; Philadelphia County, PA

e Greater Buffalo Region is defined as Erie County, NY and Niagara County, NY

Q: Is CPC+ an Advanced APM under the Quality Payment Program?

CPC+ is included on the list of Advanced APMs. This determination was based on medicalhome model-specific requirements. For payment years 2019 through 2024, clinicians who meet the threshold for sufficient participation in Advanced APMs and who meet requirements, as applicable for 2018 onward, regarding parent organization size are excluded from the Meritbased Incentive Payment System (MIPS) reporting requirements and payment adjustments and qualify for a five percent APM incentive payment.

Q: Where can practices find more information about the QPP and Advanced APMs? 

More information about the QPP and Advanced APMs can be found on the new website from CMS: https://qpp.cms.gov.

Q. What role do other payers play in CPC+?

Multi-payer engagement is an essential goal of CPC+, as it enables both public and private payers to sponsor comprehensive primary care reform. CMS will partner with payers that share Medicare’s interest in strengthening primary care in each of the CPC+ regions. Payer partners, both public and private, will provide their own financial support to practices, separate from that of Medicare Fee-for-Services (FFS). Any questions regarding non-Medicare payer support should be directed to the payer partner.

Thursday, September 6, 2018

APG payment - part 2 , Grouping and use of modifiers


2.4 GROUPING ELEMENTS OF THE APG PAYMENT SYSTEM:

The APG System uses three methods for grouping different services provided into a single payment unit: ancillary packaging, significant procedure consolidation or bundling; and multiple significant procedure and ancillary discounting.

Ancillary Packaging: Ancillary packaging refers to the inclusion of certain ancillary services in the APG payment rate for a significant procedure or a medical visit. When ancillaries are packaged, the costs of the ancillaries are included in the payment amount for the significant procedure or medical visit. Under APGs, ancillary lab and radiology services that are inexpensive or frequently provided are generally packaged into the payment for the significant procedure or medical visit. Other ancillary services, particularly those that are expensive or infrequently ordered such as MRIs are paid as separate ancillary APGs. Uniform packaging of ancillaries is used in the APG payment system. Ancillaries that are uniformly packaged include ancillaries that are performed for a wide range of different visits and which are relatively low cost in comparison with the average cost of the significant procedure and medical visit APGs.

To view the list of ancillaries which are always packaged, called the Uniform Packaged Ancillary List, please visit: www.nyhealth.gov/health_care/medicaid/rates/apg/docs/apg_uniform_packaging.pdf.

Significant Procedure Consolidation: Significant procedure consolidation refers to the collapsing of multiple related significant procedure APGs into a single APG for the purpose of determining payment. The APG system relies on a significant procedure consolidation list developed on the basis of clinical judgment which identifies for each significant procedure APG, the other significant procedure APGs that are an integral part of the procedure and which can be performed with relatively little additional effort. The APG grouping logic consolidates related significant procedures. (Example: a Level I (primarily diagnostic) lower gastrointestinal endoscopy is consolidated into the Level II (primarily therapeutic) gastrointestinal endoscopy.) Unrelated significant procedures are not consolidated. Multiple unrelated significant procedures on the same date of service also are not consolidated in the APG classification system, but payment for additional unrelated significant procedures will be discounted.

Discounting: Discounting refers to a reduction in the standard payment rate for an APG. The APG payment system applies discounting when multiple unrelated significant procedures are performed or the same ancillary service is performed multiple times during a visit. Discounting recognizes that the marginal cost of providing a second procedure to a patient during a single visit is less than the cost of providing the procedure itself (e.g. the cost of doing two procedures at the same time is less than the cost of doing those same procedures at two different times).

In summary, the APG payment system is a visit-based prospective payment system with uniform ancillary packaging, significant procedure consolidation and multiple unrelated procedure discounting. Packaged ancillaries, incidental procedures, and lower cost drugs, biologicals and supplies are included in the payment amount for a significant procedure and medical visit. Exceptions are identified in Chapter 4. Effective January 1, 2010, medical visits will no longer package with higher intensity significant ancillary procedures (e.g., mammograms, MRIs, CAT scans, etc.) and will pay separately at the line level. Similarly, medical visits will no longer package with dental procedures; physical, speech and occupational therapy; and counseling services. When provided on the same date as an E&M visit, these services will pay at the line level.

Effective January 1, 2010, multiple same APG discounting (rather than consolidation) which currently applies to most dental services (e.g., APG 352 Periodontics) will be expanded to include occupational therapy ( APG 270), physical therapy (APG 271), speech therapy (APG 272) and most mental hygiene APGs (APG 323). For a complete list of APGs that will discount rather than consolidate when combined with other same or similar APGs, visit: http://www.nyhealth.gov/health_care/medicaid/rates/apg/docs/apg_multiple_discounting.pdf Also, effective April 1, 2010, some APGs will discount at rates other than 50%.

For a complete list of “variable discounting’ APGs, please visit: http://www.nyhealth.gov/health_care/medicaid/rates/apg/docs/apg_discounting_percentage.pdf

2.5 USE OF MODIFIERS IN APGS:

Use of modifiers provides the means by which providers can indicate that a service or procedure has been altered by some specific circumstances while not changing the definition or the code for the service. The APG system recognizes the following seven billing modifiers.

CPT Modifier 25 (Distinct Service): This modifier is used when there is a significant, separately identifiable evaluation and management service by the same physician on the same date of service as a significant procedure.

The CPT Modifier 25 should be used on an E&M code only when the patient’s condition requires a significant, separately identifiable E&M service above and beyond the significant procedure performed on the same date of service. This modifier should not be used to report an E&M service that resulted in a decision to perform the significant procedure.

** Note: During the initial phase of APGs, Modifier 25 will be disabled and the use of Modifier 25 will have no effect on payment. The EAPG Grouper/Pricer will package the cost of the medical visit flagged with a Modifier 25 in the payment for the significant procedure APG (i.e., the initial APG weights were developed taking into account the disabling of Modifier 25 logic). In the future, Modifier 25 may be activated and the APG weights will be modified accordingly.

CPT Modifier 27 (Multiple E&M visit): This modifier is used when there are multiple outpatient E&M encounters on the same date of service. The CPT Modifier 27 should be used when a patient receives multiple E&M services performed by different physicians in multiple outpatient settings (e.g. hospital emergency department and clinic) on the same date of service. Modifier 27 should be appended to the second E&M code

when reporting more than one E&M service to indicate that the E&M service is a “separate and distinct” encounter provided the same day.

** Note: This Modifier should not be used for reporting of multiple E&M services performed by the same physician on the same date of service.

** Note: Normally, the second E&M will group into APG 449, “additional undifferentiated medical visit,” when Modifier 27 is used. However, during the initial phase of APGs, the weight for APG 449 will be set to zero, which will disable Modifier 27. The initial APG weights for medical visits were developed taking into account the disabling of Modifier 27 (i.e., payment for additional medical visits on the same date of service was packaged in the payment for the primary medical visit). In the future, Modifier 27 may be activated by re-weighting APG 449, with the other medical visit APG weights revised accordingly.

CPT Modifier 50 (Bilateral Procedure): CPT Modifier 50 should be used to report bilateral procedures that are performed during the same operative session.

** Note: This modifier should not be used to report surgical procedures that are identified in code terminology as “bilateral” or to report procedures identified in code terminology as “unilateral or bilateral.” When Modifier 50 is used, both procedures will be reimbursed, but the APG Grouper/Pricer calculates the payment at 100% rate for the first procedure and at 50% of the rate for the second procedure.

CPT Modifier 52 (Reduced Services): CPT Modifier 52 should be used when a service or procedure is partially reduced or eliminated at the physician’s discretion or when an initial bilateral procedure cannot be performed as such. As with CMS, NYSDOH does not allow the use of Modifier 52 when the endoscopic procedure is incomplete and there is a CPT or HCPCS/level II code to describe the actual service performed. If a code is available that fully describes the outpatient procedure performed, this code choice supersedes the reporting of a code describing the intended, albeit not performed, procedure. When Modifier 52 is used, the payment for the procedure will be discounted by 50%.

CPT Modifier 59 (Separate Procedures or Distinct Procedural Service): CPT Modifier 59 should be used to designate instances when distinct and separate multiple services with the same APG are provided to the patient on a single date of service (eg. separate encounters, different surgeries, different sites or organ systems, separate incisions). Modifier 59 may also be used to report those procedures/services considered a component of another procedure, when the service is carried out independently or considered unrelated or distinct from the other procedures/services provided at the same time. Normally when multiple procedures map to the same APG, the additional occurrences (beyond the first) will consolidate (i.e., no payment at the line level). However, when Modifier 59 is used, the additional same APG procedures will pay at 50% of the amount paid for the first procedure.

CPT Modifier 73 (Terminated Procedure): CPT Modifier 73 should be used when a surgical procedure is cancelled subsequent to the patient’s surgical preparation (but prior to the administration of anesthesia) due to extenuating circumstances or those that threaten the well-being of the patient. ** Note: Modifier 73 should not be used for elective cancellation of a procedure before administration of anesthesia. If Modifier 73 is reported and the procedure is an approved Ambulatory Surgery Center service, the payment will be discounted by 50%.

CPT Modifier UD (340B Drugs): Drugs obtained at the 340B price are identified by the UD modifier and it is not required that an NDC code be provided when submitting a claim. However, the actual acquisition cost of the drug should be listed on the claim. See the Medicaid Update (December 2007 and April 2008) articles entitled ‘National Drug Code Required on Medicaid Claims’ and ‘Coming Soon: Easy Identification of 340B Priced Claims’ for details at the following links:

http://nyhealth.gov/health_care/medicaid/program/update/2007/index.htm.
http://nyhealth.gov/health_care/medicaid/program/update/2008/index.htm.

3.2 SERVICES NOT PAID UNDER APGS:

Certain rate codes and claims remain outside of APGs and will continue to be paid under existing Medicaid payment mechanisms. These include:
** Services provided outside of a facility’s licensure under Article 28 of the Public Health Law (e.g. Mental Hygiene and OMRDD specialty services);
** Child rehabilitation;
** Payments made to Medicaid Obstetrical & Maternal Services (MOMS) Programs and Health Supportive Services providers;
** Payments for HIV Counseling/Testing;
** Payments for Tuberculosis/Directly Observed Therapy;
** Payments for Ordered Ambulatory Services;
** Monthly billings of Medicare co-pays and deductibles for dual eligible enrollees;
** Payments for Screening for Orthodontic Treatment;
** Payments for Comprehensive Medicaid Case Management/Targeted Case Management.

Rate codes which have not been subsumed by APG rate codes are referred to as carved out rate codes.

Thursday, August 16, 2018

What is APG paymnet - how its calculated. type and classification

BACKGROUND AND INTRODUCTION TO AMBULATORY PATIENT GROUPS (APGS)

PURPOSE:


The purpose of this document is to provide Medicaid policy and billing guidance to Article 28 providers billing under the Ambulatory Patient Groups Payment methodology to the extent this methodology is applicable to hospital-based outpatient, ambulatory surgery, and emergency departments, and to free-standing diagnostic and treatment centers and free-standing ambulatory surgery centers.



1.4 SCOPE OF SERVICES:

The APG payment methodology is applicable to outpatient, ambulatory surgery and emergency department services provided by general hospitals and to ambulatory care services provided by diagnostic and treatment centers and free-standing ambulatory surgery centers.

The APG payment methodology is not applicable to:
** services provided outside of a facility’s licensure under Article 28 of the Public Health Law (e.g. APGs are not currently applicable to services certified under the Mental Hygiene Law)
** capitated payments made on behalf of Medicaid managed care or Family Health Plus enrollees;
** payment for Ordered Ambulatory services
** payment for physicians’ services in hospital settings billed using the Physician Fee Schedule;
** payment to Federally Qualified Health Centers (FQHCs), except when the FQHC has voluntarily agreed to participate in the APG reimbursement system, or;
** payment for long term care, home care, personal care.



BLENDING OF APG PAYMENT:

Both hospital-based ambulatory surgery and emergency department services received 100% APG payment with the implementation of the APG reimbursement methodology. However, APG reimbursement for hospital  outpatient departments, diagnostic and treatment centers and free-standing ambulatory surgery centers is phased-in as required by law. In the initial phase of blending, reimbursement for each individual visit is based on 25% of the full amount that the APG methodology would calculate for the visit (based on coded procedures and diagnoses) and 75% of a provider-specific existing payment for the blend amount. The existing payment used for blending purposes is based on a provider’s average per visit reimbursement for services moving to APGs for calendar year 2007.

The APG portion of the blend increases on December 1, 2009, January 1, 2011,and January 1, 2012 according to the following schedule:


Hospital Outpatient Department December 1, 2008 Starting Dec 1, 2008, 25% of payment will be based on APGs. The percentage will increase to 50% on December 1, 2009; to 75% on Jan 1, 2011; and to 100% on Jan 1, 2012.

Hospital Emergency Room January 1, 2009 100% of payment will be based on APGs starting Jan 1, 2009.

Hospital-Based Ambulatory Surgery December 1, 2008 100% of payment will be based on APGs starting Dec 1, 2008.

Free-standing Diagnostic and Treatment Center September 1, 2009 Starting on September 1, 2009, 25% of payment will be based on APGs. The percentage will increase to 50% on December 1, 2009; to 75% on Jan 1, 2011; and to 100% on Jan 1, 2012.

Free-standing Ambulatory Surgery September 1, 2009 Starting on September 1, 2009, 25% of payment will be based on APGs. The percentage will increase to 50% on December 1, 2009; to 75% on Jan 1, 2011; and to 100% on Jan 1, 2012.

When APGs are implemented in facilities licensed under the Mental Hygiene Law, free standing mental hygiene providers (not hospital based providers) will have an APG phase-in period that is distinct from the phase-in schedule for D&TC clinic services listed above. The variable blend percentages will be linked to the APG rate code.


APG GROUPING LOGIC AND USE OF MODIFIERS

2.1 MORE ON THE APG PAYMENT METHODOLOGY:


As previously discussed, APGs are a patient classification system designed to pay providers based on the amount and type of resources used during a patient encounter. Patients in a given APG have similar clinical characteristics as well as similar resource use and cost. APGs require facilities to report all services provided during the patient encounter. Provider payments are directly related to the actual services provided based on patient diagnosis and the CPT/HCPCS codes reported on the Medicaid claim. Medical services requiring a higher level of professional and ancillary care are paid a higher rate than those of a lower intensity.

APG processing uses software that examines the procedure codes and any associated modifiers reported in each of a claim’s service lines and assigns each line an APG code, along with other relevant values (e.g. APG weights, packaging flags, discounting percentages, etc.). Each APG code carries a “weight” based on the group’s average cost, from which appropriate payment levels are established. The APG “weight” can be multiplied by a percentage to reduce or increase the weight, depending on the APG grouper’s evaluation of the service line, resulting in the service line’s final “weight.” For medical visits, the assignment of an APG is dependent on the ICD-9 Primary Diagnosis Code recorded on the claim.

There are a number of procedures (primarily pertaining to eyeglasses, mental hygiene services, rehabilitation therapies and hearing aids) which are assigned a procedure-based weight that is different from the APG weight. In the APG payment methodology, the procedure based weight overrides the APG weight. Additionally, if a procedure is assigned a procedure-based

weight it will pay even if it groups to a Never Pay APG. However, if the procedure groups to an “If Stand Alone Do Not Pay APG”, it will not pay if it is the only procedure on the claim or is accompanied by non-paying procedures. Discounting and consolidating logic will still occur where applicable. Some of the procedure-based weights also recognize units. For example, the physical therapy APG includes units based and non-units based procedures. The units based physical therapy procedures are assigned a procedure based weight that is different from the physical therapy APG weight. When coding a unit- based procedure, the number of units should also be reported on the claim. The procedure-based weight and the number of units are both used in the APG payment calculation for the units based procedure.

The “final weight” for a given visit is multiplied by a provider-associated base rate as part of the APG payment calculation. For hospital outpatient departments and diagnostic and treatment centers, the APG payment is “blended” with a historical weighted average payment of the provider’s pre-APG rates to arrive at the final payment amount. A single claim can be assigned one or more APG values, each of which carries its own “weight,” depending on the service line procedure codes, modifiers, and in some cases, diagnosis codes. The eMedNY system will use the EAPG Grouper/Pricer for processing institutional outpatient claims upon the effective dates of APG implementation as identified in section 1.5 of this document. Affected providers are required to use new rate codes on and after those effective dates. Use of the new rate codes results in payments for services based on the APG classification and payment rules. When a visit consists entirely of “no capital add-on APGs” or “no capital add on procedures” a capital add-on payment is not included in the final APG payment for the visit.

For a complete list of “no capital add-on APGs and procedures” please visit:
http://www.nyhealth.gov/health_care/medicaid/rates/apg/docs/apg_no_capital_add.pdf.
http://www.nyhealth.gov/health_care/medicaid/rates/apg/docs/apg_no_capital_procedures.pdf.

APG TYPES:

The EAPG Grouper/Pricer maps CPT and HCPCS procedure codes and ICD-9 diagnosis codes reported on a claim to APGs to define the ambulatory visit. Multiple APGs may be assigned to a visit. The four primary types of APGs are described below.

Significant Procedures: A procedure/service which constitutes the reason for the visit and dominates the time and resources expended during the visit. (Examples: excision of skin lesion, stress test, insertion of a central venous catheter, treating fractured limb)

Medical Visits: A visit during which a patient receives medical treatment but does not have a significant procedure performed. Evaluation and management codes are assigned to one of the medical visit APGs based on the primary diagnosis reported on the claim. (Examples: follow-up visit for patient with congestive heart failure, chronic obstructive pulmonary disease, hypertension)

Ancillary Tests and Procedures: A test or procedure ordered by the primary physician to assist in patient diagnosis or treatment. (Examples: immunizations, plain film x-rays, laboratory tests) Incidental Procedures: An integral part of a medical visit usually associated with professional services being given to the recipient. (Example: range of motion measurements)

 APG CLASSIFICATION LOGIC:

In the APG classification system, the patient is described by a list of APGs that corresponds to services provided to the patient. The significant procedure (rather than diagnosis) is the initial classification variable. Procedures that could be performed on an ambulatory basis are categorized as either significant procedures or ancillary services. Patients who undergo a significant procedure are assigned to a significant procedure APG on the basis of the CPT code that describes the precise significant procedure. Patients receiving medical treatment that does not involve a significant procedure are assigned to a medical APG based on the ICD-9 diagnosis code. In some instances, a patient may receive a significant procedure and a medical visit, in which case the visit would be assigned to a significant procedure APG. Under the default APG logic, the procedure would be paid at the line level and the medical visit payment would be included (packaged) in the payment for the significant procedure. A patient who neither received medical treatment nor underwent a significant procedure but had an ancillary service performed would be assigned an ancillary service APG. Patients with any significant procedures or therapies are assigned to one or more significant procedure APGs.

If there are no significant procedures present and there is a medical visit (Evaluation and Management CPT code reported), the patient is assigned to a medical visit APG. If there is neither a significant procedure nor a medical visit code, but there are ancillary test(s) or procedure(s) present, then the patient is assigned one or more ancillary APGs.

If there is no significant procedure CPT code, medical visit (evaluation and management CPT) code or ancillary code, the claim is considered an error.

The figure below provides an overview of the APG assignment logic as discussed above. Effective January 1, 2010, the EAPG grouper logic was revised to recognize a list of significant procedures with which medical visits will no longer package. Medical visits will no longer package with: the more significant ancillaries; dental procedures; physical, speech and occupational therapy; and counseling services. When certain significant procedures are performed on the same day as a medical visit, no packaging would occur and payments would be received by the provider for both the medical visit and significant procedure at the line level.

For a complete list of “significant procedures with which medical visits do not package,” please visit: http://www.nyhealth.gov/health_care/medicaid/rates/apg/docs/apg_not_package.pdf.

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