Corporate Integrity Agreements (CIA)
Frequently Asked Questions

What is the OIG's policy regarding the reporting of Federal health care program overpayments by providers under CIAs?

Providers under CIAs must promptly notify the appropriate payor of all identified overpayments and must promptly repay the overpayment amount in a manner consistent with the payor's policies. Although all identified overpayments should be refunded to the appropriate payor, a provider under a CIA does not need to report to the OIG all identified overpayments at the time it reports such amounts to the payor. Rather, the provider must report to the OIG the yearly aggregate overpayment amount in its annual report. Further, the provider must report to the OIG within 30 days all "material deficiencies" as defined by the CIA. "Material Deficiency" generally means anything that involves: (i) a substantial overpayment; or (ii) a matter that a reasonable person would consider a potential violation of criminal, civil, or administrative laws applicable to any Federal health care program for which penalties or exclusion may be authorized.

A material deficiency may be the result of an isolated event or a series of occurrences.

If the provider's annual or periodic review also identified underpayments, the provider may work with the Federal payor to determine whether those underpayments may be offset from the identified overpayment(s). Nonetheless, because the OIG is interested in the identification of potential billing problems, regardless of how reporting and repayment is handled with the payor(s), in its annual report, the provider must report to the OIG a gross overpayment total. Thus, the provider should not report to the OIG an overpayment amount that is reduced (or "netted") based on underpayments. The reporting of only net overpayments does not provide the OIG with a sufficient indication of potential billing problems.

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Does the OIG endorse or assist a provider in choosing a compliance vendor or Independent Review Organization (IRO)?

The OIG does not endorse any proprietary products. Moreover, the OIG will not indicate which IROs it believes are most qualified. It is up to the provider to determine the most appropriate CPA firm, law firm, or consultant to engage as its IRO. If, following the annual review, the OIG has concerns about the quality of the review, or the independence of the IRO based on the totality of the circumstances, the OIG may make those concerns known to the provider.

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The OIG's CIAs require that the provider report all “material deficiencies” or “reportable events.” Providers often ask the OIG whether a certain percentage or dollar threshold is appropriate for determining if a violation is reportable. Does the OIG believe such percentage or numeric thresholds are appropriate for determining if there was a “material deficiency” or “reportable event?”

No. The OIG defines the terms “material deficiency” and “reportable event” in its CIAs by noting that it could be (i) a substantial overpayment or (ii) a matter that a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable to any Federal health care program for which penalties or exclusion may be authorized. Such a situation may be the result of an isolated event or a series of occurrences. In short, a provider under a CIA must determine if an identified matter requires disclosure under the CIA based on the totality of the facts and the context of the surrounding circumstances. The OIG believes that a percentage or numeric threshold simply constitutes the initial step in determining materiality and therefore reliance solely on such a “rule of thumb” threshold is inappropriate and should not replace a detailed analysis of all the relevant facts and circumstances.

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CIA Claims Reviews: Background and Purpose

Background:

Most Corporate Integrity Agreements (CIAs) or Settlement Agreements with integrity provisions (Agreements) require that a Claims Review be conducted, either by an independent review organization (IRO) or in some cases by the provider, with a verification review performed by the IRO. Over the past several years, the language and the claims review methodology used in these CIAs and Agreements to describe the Claims Reviews have changed.

Previous language required the review to consist of a statistically valid sample of claims or required the reviewer to review a Probe Sample and based on the results of the Probe Sample to review a Full Sample in accordance with certain confidence and precision levels.

In response to the potential financial impact of the previous Claims Review approaches, the OIG has modified its Claims Review requirements. Briefly, the new Claims Review procedures require a Discovery Sample of 50 sampling units to be randomly selected for review. If the net financial error rate of those 50 sampling units equals or exceeds 5%, then a Full Sample must be reviewed and a Systems Review must be conducted. The Full Sample must include a sufficient number of sampling units to yield results that estimate the overpayment in the population within a 90% confidence and 25% precision level. As indicated in the Inspector General's November 20, 2001, Open Letter, the OIG is reviewing each provider's CIA or Agreement to determine whether it is appropriate to incorporate the new Claims Review procedures into the existing CIA or Agreement.

In those cases where the OIG determines that the new Claims Review provisions may be appropriate, the provider will be offered the option to accept these new provisions or maintain its current provisions.

Purpose of Claims Review FAQs:

The following is a list of questions the OIG is frequently asked by providers or their IROs regarding the Claims Review. These questions are intended to provide guidance to all providers under CIAs and Agreements, regardless of the specific Claims Review provisions used in the provider's CIA or Agreement.

Please note: Previous CIA or Agreement review language may have been referred to as "Billing Review" or "Billing Engagement" instead of "Claims Review." For consistency with the OIG's current review provisions, we use the term "Claims Review" throughout this document.

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If a CIA or Settlement Agreement does not include detailed Claims Review requirements, what guidelines should a provider follow?

Although not expressly required by all CIAs, the OIG suggests that Claims Reviews be conducted in accordance with the following guidelines:

A Discovery Sample, of at least 50 sampling units, should be examined. The units for the Discovery Sample should be randomly selected using a random number generator or a statistically valid manual selection process (e.g., a random numbers table). For each unit reviewed, the reviewer should determine the dollar difference between the provider's actual reimbursement and the amount the provider should have been reimbursed (based on contractor and the Centers for Medicare and Medicaid Services ("CMS") policies). Once all sampling units have been reviewed, the results of each sampling unit are added together (underpayments may be netted or offset from overpayments). The resulting calculation is the net overpayment. The reviewer divides the net overpayment by the total dollar amount of the sample. The resulting calculation is the net financial error rate.

If the net financial error rate equals or exceeds 5%, we recommend that the reviewer conduct a Full Sample. Based on the results of the Discovery Sample, the reviewer should estimate how many sampling units will need to be reviewed to estimate the overpayment in the population within certain confidence and precision levels. A 90% confidence and 25% precision level is required in current CIAs. If a provider's Agreement or CIA does not specify confidence and precision levels, the OIG recommends that the Full Sample results achieve a 90% confidence and 25% precision level.

The reviewer may use the Discovery Sample as a whole, as part of its Full Sample, if statistically appropriate. For example, if the reviewer must examine 200 sampling units in the Full Sample, the reviewer may use the results from each of the 50 units in the Discovery Sample. Therefore, the reviewer only has to randomly select and review an additional 150 sampling units. The results of all units reviewed as part of the complete Full Sample should be reported, i.e., 200 sampling units.

If a Full Sample was conducted, the OIG also recommends that the provider conduct a Systems Review. Specifically, for each sampling unit in the Full Sample (which may include the Discovery Sample) that resulted in an overpayment, the reviewer should perform a "walk through" of the system(s) and process(es) that generated the sampling unit to identify any problems or weaknesses. See response to question 28 for more details about the Systems Review.

The results of the Discovery Sample and, if applicable, the Full Sample and Systems Review, should be reported to the OIG in the provider's Annual Report. See response to the next question for recommendations regarding what to include in the report.

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What information should be reported to the OIG in the Claims Review findings, as part of an entity's Annual Report?

In addition to including a narrative description of the findings, which describes the results of the Claims Review, the OIG recommends that for each sample the following information also be included in the Claims Review Report:

  1. Name and credentials of the person(s) who conducted the review;
  2. Name and credentials of the person who designed the sampling plan;
  3. Copy of the sampling plan;
  4. Time frame covered by the review;
  5. The objective of the review;
  6. Definition of the sampling unit (e.g., beneficiary, claim, service);
  7. Description of the sample universe (e.g., the list of the codes/services that comprise the universe);
  8. Description of how the universe was determined;
  9. Description of the documentation relied upon to perform the review;
  10. Narrative description of how the Claims Review was conducted and what information was evaluated, including an indication as to whether the sample was generated in a statistically valid manner;
  11. Total number of sampling units that comprised the universe;
  12. Methodology used to determine the strata (if the universe is stratified);
  13. Methodology used to select the sample from the universe;
  14. Number of sampling units included in each sample;
  15. Total number of Medicare sampling units selected in the Probe or Discovery Sample and the total number of Medicare sampling units selected in the Full Sample (if applicable);
  16. Total number of Medicaid sampling units selected in the Probe or Discovery Sample (as applicable) and the total number of Medicaid sampling units selected in the Full Sample (if applicable);
  17. Total number of other Federal health care payor sampling units selected in the Probe or Discovery Sample (as applicable) and the total number of other Federal health care payor sampling units selected in the Full Sample (if applicable);
  18. If the OIG's Office of Audit Services Statistical Sampling Software (RAT-STATS) was used for the Probe or Discovery Sample, the IRO should provide the seed number assigned by the random number generator. If a Full Sample was required, the reviewer should provide: (1) the seed number for the Full Sample; (2) a printout of the variable appraisal results for both the Probe or Discovery Sample and the Full Sample; (3) a printout of the data file used as input into the RAT-STATS Variable Appraisals program; and (4) a printout of the sample size estimate results;
  19. If a statistical software sampling package other than RAT-STATS was used, the reviewer should provide: (1) a copy of the printout of the random numbers generated by the 'Random Numbers' function for the Probe or Discovery Sample and for the Full Sample, if applicable; (2) a copy of the printout estimating how many sampling units are to be included in the Full Sample, if applicable; and (3) a description of the software package used to conduct the sample;
  20. Total number of sampling units in error;
  21. Percentage of sampling units in error;
  22. Total number of sampling units in error that resulted in an overpayment;
  23. Percentage of sampling units in error that resulted in an overpayment;
  24. Total dollar amount of the sampling units in the sample;
  25. Gross overpayment received as a result of the errors;
  26. Dollar amount of the underpayments as a result of the errors;
  27. Net overpayment received as a result of the errors (subtract the underpayments from the gross overpayment);
  28. Net financial error rate of the sample (amount of net overpayment divided by the total dollars in the sample);
  29. Description of the provider's billing and coding system(s), including the identification, by position description, of the personnel involved in coding and billing;
  30. Narrative explanation of the findings and supporting rationale (including reasons for errors, patterns noted, etc.) regarding the Claims Review;
  31. Description of the provider's response and corrective action plan related to any deficiencies uncovered as a result of the Claims Review; and
  32. Documentation indicating that the overpayment was refunded to the appropriate payor.

The OIG also finds it helpful if a spreadsheet of the reviewer's determinations for each sampling unit is included in the report. The spreadsheet should include the following elements:

  1. Federal health care program billed;
  2. Beneficiary health insurance claim number;
  3. Date of service;
  4. Code submitted;
  5. Code reimbursed;
  6. Amount reimbursed;
  7. Correct code as determined by the reviewer;
  8. Correct reimbursement amount as determined by the reviewer; and
  9. Dollar difference between the amount reimbursed and the correct reimbursement amount.

Please note: Most current CIAs and all amended Review Procedures require that this information be submitted to the OIG in the Annual Report.

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Is there a standard format for submitting the Claims Review findings to the OIG?

The OIG does not have a standard format for reporting Claims Review findings as part of an Annual Report. The content and length of reports vary based on, among other factors, provider type, compliance initiatives and corporate structure. The OIG does recommend that the report include the elements listed in the response to the question above.

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Many past CIAs and Agreements contain language requiring that a statistically valid sample of claims be reviewed. How does the OIG interpret this provision?

The intent of this provision, as used in Settlement Agreements and CIAs, is that the provider will randomly select through a statistically valid method an adequate number of sampling units to be reviewed. The number of units selected must be large enough to draw reasonable conclusions regarding overpayments that exist in the population from which the sample was selected. (Note: The sampling unit does not have to be a claim. Therefore, the reviewer should define the sampling unit.)

If the reviewer is not using the Probe or Discovery Sample approach to determine the number of sampling units to be reviewed, the rationale for selecting the number of sampling units that were reviewed should be included in the report.

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Does the OIG require certain statistical software to be used when performing a Claims Reviews?

In the past, the OIG required the reviewer to use RAT-STATS, a statistical software package developed by the OIG's Office of Audit Services. RAT-STATS is designed to run on personal computers using Microsoft's Disk Operating System (MS-DOS) and is publicly available in downloadable form. The users manual can be downloaded from the same site. Both the software and the users manual are free.

The OIG no longer requires RAT-STATS to be used when performing Claims Reviews. If the reviewer chooses to use a statistical software program other than RAT-STATS, in its report to the OIG, the reviewer should provide a description of the software package used to conduct the Claims Review and should provide the supporting documentation generated from the software package (e.g., random number printouts and sample size estimate printouts) to support its sampling methodology and results.

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If a reviewer chooses to use RAT-STATS, what features of RAT-STATS should be used to perform a CIA Claims Review?

The following components of RAT-STATS should be used to perform a CIA Claims Review:

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How is RAT-STATS used to select a random sample?

Before RAT-STATS can be used to generate the sample, the sampling unit and the population from which the sample will be selected must be defined. Once the sampling unit and the population have been identified, each sampling unit in the population should be assigned a number (these assigned numbers will correspond to the numbers generated by RAT-STATS). Begin by selecting the "Random Numbers" component of RAT-STATS. The programs then asks for:

The generated results will be a list of numbers. The numbers generated by RAT-STATS are the numbers of those sampling units that have been selected for review.

Once the sampling units have been reviewed, a text file detailing the amount of the overpayment for each sampling unit must be created. If there is no overpayment or if there is an underpayment, a zero should be associated with the corresponding unit. Each line of the text file should include the sample unit number, a space, and the amount of the overpayment (dollar sign is not necessary).

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How is the Variable Appraisals component of RAT-STATS used for the probe sample analysis?

After creating the text file of overpayments based on the results of the Probe or Discovery Sample, select the Variable Appraisals component of RAT-STATS to calculate the mean and standard deviation of the overpayment amount in the sample. To calculate the mean and standard deviation of overpayments in the sample, the sampling units from the Probe or Discovery Sample should be reviewed and a dollar difference determination should be made on each sampling unit (i.e., the difference between what was reimbursed and what should have been reimbursed based on the reviewer's determination). The mean and standard deviation of the overpayment amount in the Probe or Discovery Sample is used to determine the Full Sample size.

To use the Variable Appraisals feature:

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How is RAT-STATS used to determine the sample size?

Once the mean and standard deviation of the overpayment amount in the Probe or Discovery Sample have been calculated, the Full Sample size can be determined. Select the "Utility File" component from the main menu. Select the "Sample Size Estimators" component.

RAT-STATS will ask for the following information:

The results indicate the estimated number of units that should be sampled to achieve various confidence and precision levels. The number of sampling units to be selected for the Full Sample should correspond to the 90% confidence and 25% precision levels, as required by current CIAs. Note: Sample sizes vary according to the variability of the overpayments in the Probe or Discovery Sample and the population size. Therefore, the results of one Probe or Discovery Sample may not be applied to another population.

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What sampling units should be included in the population?

The reviewer determines the sampling unit, keeping in mind that the sampling unit chosen should be consistent with the objective of the Claims Review. For example, if the objective is to examine only a certain type of service, sampling units for other types of services should not be included in the population. Further, only services for which the provider has submitted a bill/claim AND has received reimbursement (full or partial) should be included in the population.

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What sampling unit should be used?

A sampling unit is any discrete unit that can be sampled (e.g., code, line item, beneficiary, patient encounter). For any sampling methodology used, each sampling unit in the population should have a known chance of selection.

The sampling unit is selected and defined by the reviewer and should be consistent with the objective of the Claims Review. The manner in which a provider maintains its records may influence the sampling unit to be used. For example, if a provider keeps all information in the patient's chart and cannot easily retrieve the information by claim or line item, the better sampling unit is the beneficiary (e.g., patient chart or record), because an accurate population based on another characteristic could not be easily determined.

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What guidelines should the reviewer use to evaluate the sampling units?

As part of its Claims Review, a reviewer should ensure that the sampling units were correctly coded, submitted, and reimbursed. Documentation to make these determinations include, but are not limited to: national policies, local policies, CMS program memoranda, Medicare carrier or intermediary manuals or bulletins, medical records, claim forms, and any other supporting documentation. Only those sampling units for which payment (either full or partial) has been received should be included in the population from which the sample is selected.

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What is the purpose of a Probe Sample for a CIA Claims Review?

The objective of conducting a Probe Sample as part of the Claims Review is to establish an estimate of the variability of the overpayment amount in the population from which the sample was drawn. The results of the Probe Sample allow the reviewer to estimate how many sampling units need to be reviewed to estimate the overpayment in the population within a 90% confidence and 25% precision level.

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What is the purpose of a Discovery Sample for a CIA Claims Review?

The purpose of conducting a Discovery Sample as part of the Claims Review is to determine the net financial error rate of the sample that is selected. If the net financial error rate equals or exceeds 5%, the results of the Discovery Sample are used to determine the Full Sample size. The Full Sample size is based on an estimate of the variability of the overpayment amount in the population from which the sample was drawn. The results of the Discovery Sample allow the reviewer to estimate how many sample units need to be reviewed in order to estimate the overpayment in the population within certain confidence and precision levels (e.g., generally, a 90% confidence and 25% precision level).

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If a sampling unit in the Probe or Discovery Sample has been underpaid and a Full Sample is required, how should the underpaid sampling unit(s) be counted in terms of the unit's dollar difference when determining the Full Sample size?

For purposes of calculating the Full Sample size (note: If conducting a Discovery Sample, a Full Sample size is only required if the net financial error rate of the Discovery Sample equals or exceeds 5%. If conducting a Probe Sample, a Full Sample is only required if there is one or more overpayment errors in the Probe Sample), sampling units that have been underpaid in the Probe or Discovery Sample should be considered as a zero. This is because the objective of the Claims Review is to determine the amount of overpayments in the population. Given this objective, neither a dollar difference of zero nor an underpayment are considered to be overpayments, thus a zero should be entered into the calculation for that particular sampling unit.

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When conducting a Discovery Sample, how is the error rate determined?

In a Discovery Sample, as in a Probe Sample, each sampling unit is evaluated to determine the dollar difference between the amount that was reimbursed and the amount that should have been reimbursed. Once all sampling units have been reviewed, the results of each sampling unit are added together (underpayments may be netted or offset from overpayments). The resulting calculation is the net overpayment. The reviewer divides the net overpayment by the total dollar amount of the sample. The resulting calculation is the error rate.

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In what circumstances should the reviewer review a Full Sample?

When conducting a Discovery Sample, if the net financial error rate of this sample equals or exceeds 5%, the reviewer must conduct a Full Sample. The Full Sample should consist of a sufficient number of sampling units to yield results that estimate the overpayment in the population to be within a 90% confidence and 25% precision level. Please note, if the net financial error rate of the Discovery Sample is below 5%, the review is complete.

When conducting a Probe Sample, if there is at least one overpayment error in the Probe Sample, the reviewer must conduct a Full Sample. The Full Sample should consist of a sufficient number of sampling units to yield results that estimate the overpayment in the population to be within a 90% confidence and 25% precision level. If there are no errors in the Probe Sample, some more recent CIAs or Agreements require that a second Probe Sample be conducted, while older CIAs and Agreements do not. If the provider is not required to conduct a second Probe Sample, the provider should contact its OCIG monitor for guidance on determining the Full Sample size. If a second Probe Sample is required, the reviewer should perform this review. If there is at least one overpayment error in the second Probe Sample, the reviewer should conduct a Full Sample in accordance with the required confidence and prevision levels. If there are no errors in the second Probe Sample, the review is complete.

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How many units must be reviewed as part of a Full Sample under a CIA Claims Review?

There is no set number of units that the reviewer is required to examine in the Full Sample. The Full Sample size is based on the mean and standard deviation of the overpayment amount as calculated in the Probe or Discovery Sample. As a result, the Full Sample must include a sufficient number of sampling units to yield results that estimate the overpayment in the population to be within certain confidence and precision levels (e.g., 90% confidence and 25% precision). The sample size will vary according to the variability of the Probe or Discovery Sample and the size of the population.

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Can the units reviewed as part of the Probe or Discovery Sample be used as part of the Full Sample?

Historically, the OIG has not allowed the Probe Sample (as a whole) to be used as part of the Full Sample. However, the OIG will now allow, if statistically appropriate, the Probe or Discovery Sample (as a whole) to be used as part of the Full sample.

For example, if the reviewer must examine 200 sampling units in the Full Sample, the reviewer may use the results from each of the 50 units in the Discovery Sample. Therefore, the reviewer only has to randomly select and review an additional 150 sampling units. The results of all units reviewed as part of the complete Full Sample should be reported, i.e., 200 sampling units.

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If a sampling unit in the Full Sample has been underpaid, how should this be assessed when determining the amount of the overpayment?

For purposes of reporting the overpayment to the OIG, underpayments may be netted (or offset) from overpayments. However, in terms of repaying the overpayment to the appropriate payor, the provider should consult with that payor as to whether it will allow underpayments to be netted from overpayments for collection purposes.

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If the actual precision for the Full Sample does not meet the 90% confidence and 25% precision threshold (as stipulated in most CIAs), do additional sampling units need to be reviewed in order to achieve the specified confidence and precision levels?

If the sample size of the Claims Review was determined by RAT-STATS or another statistical software package to reach a 90% confidence and 25% precision level, and if the actual precision level exceeds 25% at the 90% confidence level, the reviewer does not need to continue the review. The number of sampling units identified by statistical software for review is an estimate that is based on the results of the Probe or Discovery Sample. Because this is an estimate, some samples will achieve a precision better than 25% and some worse than 25%.

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What if the number of sampling units estimated to yield the required confidence and precision levels is unreasonably large?

When there are few errors in the Probe or Discovery Sample, it is not uncommon for the Full Sample size to be quite large. The reason for this is because, generally, the fewer errors in the sample, the greater the variability of the sample. When the variability is large, the reviewer needs to review more units to reach a reasonable level of confidence and precision. If the provider believes the Full Sample size is unreasonably large, it should contact its OCIG monitor for further guidance.

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Can the Full Sample size be estimated based on paid amounts rather than overpayments (the dollar difference between what was paid and what should have been paid)?

No. Estimating the sample size based on paid amounts will yield an estimate of the sample size needed to determine the actual amount paid, a figure already known. Instead, the objective is to estimate the amount of the overpayment, thus the figures entered into the Full Sample size calculation must be overpayment amounts.

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When performing a Claims Review, if supporting documentation for the unit that was randomly selected is not available, how should this unit be evaluated?

If the provider cannot produce supporting documentation for a unit that was selected, this unit should be considered an error and the total amount paid should be considered the overpayment. It is NOT permissible for the provider to remove this unit from the sample, to replace this unit with a spare, or to consider that the service was properly coded, billed, and reimbursed.

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Is it appropriate to use "alternate" or "spare" records in the Claims Review?

Generally, the use of alternates or spares is not permissible for CIA Claims Reviews, as stipulated in current CIAs. If a record or supporting documentation cannot be located, the reviewer should consider this item (e.g., claim, line item, encounter) to be an error/overpayment.

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If the Claims Review provisions in the CIA are no longer applicable due to changes in the Federal payment methodology, how should the provider apply or implement the billing review provisions?

CMS has implemented several payment changes to meet requirements mandated by the Balanced Budget Act (BBA) of 1997. These requirements have an impact on the manner in which skilled nursing homes, home health agencies, and hospital outpatient services are reimbursed. As a result, the CIA Claims Review provisions established prior to implementation of the BBA may no longer be appropriate. In these circumstances, the provider should contact the OCIG to discuss revising the Claims Review provisions to honor the intent and spirit of the CIA or Agreement.

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If a provider receives payment under a Medicare or Medicaid Managed Care plan, should the managed care claims be included in the Claims Review?

No. Because the payment methodology of managed care plans typically differs from the traditional Medicare and Medicaid payment methodologies, the reviewer should not include managed care claims in its population of claims to be reviewed in the context of a CIA Claims Review.

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What is a Systems Review?

The purpose of the Systems Review is to identify problems and weaknesses that resulted in overpayments. A Systems Review is a ‘walk through' of the systems(s) and process(es) that generated the sampling unit in error.

For example, if a sampling unit was overpaid, the reviewer should begin by determining whether it was initially coded correctly. If it was incorrectly coded, the provider should discuss the incorrect code assignment with the person responsible for assigning the code and take appropriate actions (e.g., training). If the code was correctly assigned on the source document, the reviewer should verify that it was correctly entered into the system. If correctly entered into the system, the reviewer may need to review the Chargemaster or other computer software to ensure the code entered was correctly ’cross-walked’ to the code that should have been billed. The goal of the Systems Review is to identify at what point the error that resulted in the overpayment occurred and to determine why. The provider should then take any necessary steps to prevent such problems in the future.

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When should a Systems Review be performed?

If a Full Sample is required, regardless if the reviewer has performed a Probe Sample or a Discovery Sample, a Systems Review should be performed. See question 17 to determine when a Full Sample is required.

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What should be reported to the OIG as a result of the Systems Review?

The Systems Review Report should include the reviewer's observations, findings and recommendations on possible improvements to the system(s) and process(es) that generated the overpayments.

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OIG Site Visits

The OIG monitors hundreds of providers, practitioners, suppliers, payors and other entities that operate under CIAs. Since 1999, the OIG has conducted site visits as part of its CIA monitoring efforts. The following are frequently asked questions regarding these site visits.

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What is the purpose of a site visit?

The primary purpose of a site visit is to verify the entity's compliance with the terms of its OIG integrity agreement or CIA and to provide the OIG with an opportunity to observe an entity's compliance program in practice. The first hand observations obtained while on site provide the OIG with a more accurate and comprehensive assessment of an entity's compliance program. The site visit also offers the entity the unique, one on one opportunity to educate the OIG regarding the entity's operations. Additionally, the OIG has found that site visits help foster increased and more effective communication between the entity and the OIG.

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Who is subject to an OIG site visit?

Any provider, practitioner, or entity currently under a CIA or other integrity agreement with the OIG is potentially subject to a site visit. Additionally, the OIG occasionally conducts site visits to assess an entity's compliance program during the course of settlement agreement and CIA negotiations. Entities previously visited include hospitals, physician offices, nursing facilities, laboratories, third party billing companies, Medicare contractors, ambulance companies, DME suppliers and home health agencies.

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How are entities selected for an OIG site visit?

Entities selected for a site visit are chosen both at random and based on specific criteria developed by OIG. Factors considered by the OIG in determining whether to conduct a site visit include: issues raised in CIA annual reports, the reporting of deficiencies, comprehensiveness of the compliance program, size of operation, provider type, and degree of cooperation when reporting or responding to OIG requests for information.

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Who from the OIG conducts the site visit?

The visits are conducted by attorneys and/or program analysts from the Office of Counsel to the Inspector General. In the past, a number of site visits were also conducted on the OIG's behalf by a Program Safeguard Contractor for the Centers for Medicare and Medicaid Services (CMS), formerly known as the Health Care Financing Administration.

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How long does a site visit typically last?

The average site visit lasts between one and a half to two days. Occasionally, for large entities, site visits may last for three days or more.

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What typically occurs during a site visit?

Each site visit is tailored to reflect the particular structure of the entity and the issues identified by the OIG in monitoring the entity's compliance with the CIA. Therefore, no two site visits are exactly alike. In general, discussions and issues during an OIG site visit often include:

A presentation by the entity that includes:

Because one of the primary purposes of a site visit is to provide the OIG with an opportunity to observe the daily operations of the entity and its compliance program, the OIG does not expect or encourage entities to spend excessive time or resources developing slide presentations or preparing employees for interviews. Instead, the OIG's main recommendation regarding site visit preparation is that the entity arrange to have employees reasonably available for discussions or to answer questions. Typically, the entity's Compliance Officer and often one other member of senior management accompany the OIG representatives throughout the site visit and are available to answer questions. Through this less formal approach, the OIG has found that its site visits cause minimal disruption to the entity's normal business operations.

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Who is present during the employee interviews?

During its site visits, the OIG encourages a candid exchange of information. Thus, the OIG often conducts employee interviews in a one on one format. Employees may, if they so choose, have a representative from the entity present during the interview. The OIG often requests that the entity representative be someone other than the Compliance Officer because questions asked during the interview may specifically relate to the performance of the Compliance Officer and the Compliance Department.

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Does the OIG conduct a claims review during the site visit?

The OIG typically does not conduct claims reviews during site visits. However, the OIG or a duly authorized representative does have the authority in accordance with the OIG Inspection, Audit, and Review Rights section of the CIA to conduct a claims review at any time during the course of the CIA. In the past the OIG used a contractor to perform such reviews and often these reviews were performed and finalized before the OIG went on site so the OIG could discuss the results with the provider during the site visit. The OIG continues to use the OIG’s Office of Audit Services and applicable Medicare contractors to conduct claims reviews on an as needed basis.

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If a provider under a corporate integrity agreement (CIA) is engaged in Federal health care program business with a contractor, such as an auditing or CPA firm, that is subject to a government-wide suspension imposed by the General Services Administration (GSA), what are the provider's obligations?

As a general rule, the suspension of a contractor by GSA invokes the "Ineligible Persons" provision of a provider's CIA. The CIA would require a provider to remove an Ineligible Person from "responsibility for, or involvement with" the provider's "business operations related to the Federal health care programs." A provider is also required to remove an Ineligible Person from any position for which its compensation would be "paid in whole or part, directly or indirectly, by Federal health care programs or otherwise with Federal funds." This issue has arisen as a result of GSA's recent suspension of Arthur Andersen (Andersen), an auditing firm that has been engaged as an independent review organization (IRO) by a number of providers under CIAs.

The OIG recognizes the difficult and unusual circumstances Andersen's suspension has created. In the interest of causing minimal disruption to providers' ongoing business operations and reducing the financial burden to providers of having to engage another firm to duplicate work already performed by Andersen, the OIG has decided to waive the CIA requirements that would result in immediate cessation of Andersen's involvement in the provider's Federal health care program operations. The intent of this waiver is to allow Andersen to continue existing IRO and other engagements, but consistent with Federal regulations regarding the effect of suspension, would bar a provider from entering into, renewing, or extending engagements with Andersen. This waiver applies only to this particular situation involving GSA's suspension of Andersen. Pursuant to providers' Settlement Agreements with the OIG and the U.S. Department of Justice, providers generally are not permitted to charge any of their IRO costs to the Federal health care programs. This requirement is unchanged as a result of OIG's decision to allow a provider to continue using Andersen to complete an existing IRO engagement. In addition, if a provider has other engagements with Andersen, the provider should confirm with the Centers for Medicare and Medicaid Services whether the provider has any additional obligations with respect to Andersen flowing from its Medicare provider agreement.

If the OIG is aware that a particular provider has previously retained Andersen as its IRO, the provider can expect to receive a letter from the Compliance Unit of the Civil Recoveries Branch in the Office of Counsel to the Inspector General evaluating the provider's CIA to determine the application of the Ineligible Persons provisions to Andersen's suspension. If a provider has any questions or concerns regarding (i) this FAQ, or (ii) any existing or potential relationships with Andersen or any other contractor subject to a suspension by GSA, the provider should contact the Compliance Unit by calling (202) 619-2078.

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