Final Audit Report of Atlantic Diagnostic Laboratories' Medicaid Billing Practices

Final Audit Report of Atlantic Diagnostic Laboratories' Medicaid Billing Practices

Table of Contents

Executive Summary

The Office of the State Comptroller, Medicaid Fraud Division (OSC) conducted this audit to determine whether Atlantic Diagnostic Laboratories, LLC (ADL) billed for drug tests during the audit period of January 1, 2015 through June 30, 2018, in accordance with applicable state and federal laws, regulations, and guidance. OSC selected a probability sample of ADL's claims from a population of 615,648 paid claims (304,546 episodes) totaling $31,200,172 that Medicaid paid to ADL for presumptive and/or definitive drug testing. OSC found that all of the sampled claims reviewed failed to meet one or more legal requirements. From these findings, OSC determined that ADL received overpayments and, when those amounts are combined with civil penalties, OSC seeks a total recovery of $7,352,961.

OSC's audit found that in 88 of the 261 sample episodes ADL either billed for tests that the physician or licensed practitioner had not ordered or billed for tests that lacked required documentation or signatures. For these documentation deficiencies, OSC calculated that ADL received an extrapolated overpayment of $2,943,586.^[1]

OSC also found that ADL "unbundled" claims, a practice that is prohibited and typically results in a higher reimbursement rate for a provider than a bundled claim. Specifically, ADL improperly unbundled 231,091 claims for specimen validity testing separate from presumptive and definitive drug testing. For these unbundled claims, OSC determined that ADL received an overpayment totaling $1,140,043.

ADL also violated N.J.A.C. 10:61-1.7, the Basis of Reimbursement (BOR) regulation, which is intended to protect the Medicaid program from being charged rates by independent clinical laboratories that exceed the rates such laboratories charged other payers for the same services, as well as N.J.A.C. 10:61-2.4, a regulation that prohibits independent clinical laboratories from offering discounts or rebates. OSC found that ADL charged other payers as little as $2.38 per test, while it charged Medicaid between $125 and $1,035, and Medicaid paid ADL the program's fee schedule rate of between $63.40 and $180.40 for these same services. ADL continued this practice for the entirety of OSC's audit period, charging referring providers rates for thousands of drug tests that, in some cases, were so significantly discounted that they were nearly free. ADL's consistent failure to charge Medicaid its lowest rate throughout the audit period violated both the BOR regulation and the anti-rebate regulation. Despite the fact that it was violating these Medicaid regulations for the duration of OSC's review period, ADL continually submitted Medicaid claims, accepted Medicaid payments, and, in each such instance, certified pursuant to N.J.A.C. 10:49-9.8(a) that "the services billed on any claim were rendered by or under [ADL's] supervision (as defined and permitted by program regulations)" - and thus in conformity with all Medicaid laws and rules. ADL further certified under N.J.A.C. 10:49-9.8(a) that its Medicaid claims were true, accurate, and complete. For this conduct, which ADL knew violated multiple Medicaid regulations, pursuant to N.J.S.A. 30:4D-57(d)(2), N.J.S.A. 30:4D-17(e)(3), and N.J.S.A. 2A:32C-3, OSC is seeking a civil penalty of $3,269,332 from ADL for the 261 episodes in the audit sample that violated Medicaid regulations in the audit period.

OSC also found that for 75 percent of the episodes in OSC's sample, ADL did not perform at least one specific drug test that the physician or licensed practitioner ordered based on a determination of its medical necessity. In these cases, ADL improperly substituted its medical judgment for that of the ordering physician or licensed practitioner. While OSC is not seeking a monetary recovery for these deficiencies because they did not cause economic harm to the Medicaid program, OSC highlights these failings because they may have had an adverse impact on patient care.

Background

Atlantic Diagnostic Laboratories, LLC (ADL), located in Bensalem, Pennsylvania, has participated as an independent clinical laboratory in the New Jersey Medicaid program since March 10, 2010. N.J.A.C. 10:61-1.2 states that "'[c]linical laboratory services' means professional and technical laboratory services provided by an independent clinical laboratory when ordered by a physician or other licensed practitioner of the healing arts within the scope of his or her practice as defined by the laws of the state in which he or she practices." During the audit period, ADL was one of the New Jersey Medicaid program's highest-paid providers of independent clinical laboratory services.

ADL submitted claims to the Medicaid program primarily for presumptive and definitive drug tests and, to a lesser extent, for specimen validity tests. Presumptive procedures are used to screen for the possible use or non-use of a drug or drug class. Definitive procedures are used to identify drugs or metabolites (byproducts of a drug). Specimen validity tests are conducted primarily to ensure that a specimen sample is unaltered and usable for testing.

Audit Objective, Scope, and Methodology

The objective of this audit was to evaluate claims for services billed by and paid to ADL by the New Jersey Medicaid program to determine whether ADL billed these claims in accordance with applicable state and federal laws, regulations, and guidance.

The scope of this audit was January 1, 2015 through June 30, 2018. This audit was conducted pursuant to the authority of the Office of the State Comptroller (OSC) as set forth in N.J.S.A. 52:15C-1 to -23, and the Medicaid Program Integrity and Protection Act, N.J.S.A. 30:4D-53 to -64.

To accomplish the audit objective, OSC reviewed a probability sample of 261 episodes with 554 unique paid claims for presumptive and/or definitive drug tests for which the Medicaid program paid ADL a total of $31,167. This sample was selected from a population of 304,546 episodes with 615,648 paid claims for presumptive and/or definitive drug tests for which the Medicaid program paid ADL a total of $31,200,172. (See Exhibit A for the procedure code descriptions.)

OSC reviewed ADL's service agreements with its referring providers, test requisitions, test results, billing claim forms, and invoices to ensure that ADL's charges to Medicaid did not exceed ADL's charges for identical services to other groups or individuals. OSC also reviewed ADL's service agreements with its referring providers, physician acknowledgment forms, test requisitions, and test results to determine whether ADL possessed documentation to substantiate the claims for these tests. Further, OSC identified and reviewed claims for specimen validity tests performed in conjunction with a presumptive and/or definitive drug test for the same beneficiary on the same date of service that ADL billed separately and received payment under Current Procedural Terminology (CPT) codes 82570, 83986, and 84311. (See Exhibit A for these code descriptions.)

Discussion of Auditee Comments

The release of this Final Audit Report concludes a process during which OSC afforded ADL multiple opportunities to provide input regarding OSC's findings. Specifically, OSC provided ADL a Summary of Findings (SOF) and offered ADL an opportunity to discuss the findings at an exit conference. OSC and ADL, represented by counsel, held an exit conference during which the parties discussed OSC's findings in the SOF. After the exit conference, ADL provided OSC with additional records. After considering ADL's submission, OSC provided ADL with a Draft Audit Report (DAR) and ADL provided a formal response to the DAR. OSC considered ADL's response and modified its overpayment amount for the Basis of Reimbursement finding, which is discussed below, from calculating an extrapolated overpayment to assessing a civil monetary penalty. Following this modification, OSC provided ADL with a Revised DAR. ADL provided a formal response to the Revised DAR, which is attached as Appendix A. After receipt of ADL's formal response to the Revised DAR, at ADL's request, OSC held another meeting with ADL's counsel to discuss the audit findings and ADL's response.

ADL, in its response to the Revised DAR, generally did not agree with OSC's findings. ADL also provided OSC with a corrective action plan to address OSC's recommendations, which referenced corrections that ADL claimed it made after OSC's audit review period. Furthermore, despite providing its corrective action plan, ADL generally disagreed with OSC's recommendations. In its corrective action plan, ADL referenced the New Jersey Department of Medical Assistance and Health Services Newsletter Vol. 31, No. 11, which instituted changes in Medicaid reimbursement for drug testing by limiting the frequency of presumptive and definitive testing as well as limiting the number of definitive drug classes that may be billed. ADL stated that following this change, it no longer matters how many drug classes it lists on its drug test orders since there would only be one reimbursement rate. OSC notes that ADL's position does not alter OSC's findings because drug testing is requested by the ordering physician, not the testing laboratory, and tests are requested based on the patient's medical needs. Accordingly, regardless of the reimbursement rate for its services, as a Medicaid provider, ADL's documentation must clearly and accurately reflect the drug testing ordered and performed. OSC addresses each argument raised by ADL in more detail in Appendix B.

Audit Findings

A. Deficient Documentation and Billing Irregularities for Presumptive and Definitive Drug Testing

OSC reviewed ADL's documentation to determine whether ADL properly documented the services it billed to the Medicaid program. OSC found that 88 of the 261 sample episodes (33.7 percent) resulted in 88 exceptions. (See Exhibit B.) OSC extrapolated the error dollars, $3,997 of $31,167 for the sample episodes, to the sample universe of 304,546 episodes (615,648 claims), totaling $31,200,172. Applying this process, OSC calculated that ADL received an overpayment of at least $2,943,586,^[2] for which OSC is seeking recovery. Set forth below is a discussion of each type of deficiency that OSC found.

Missing Documentation

ADL could not provide OSC with a test requisition for 1 of the 261 sample episodes.

N.J.A.C. 10:49-9.8(b) requires providers to keep such records as are necessary to disclose fully the extent of services provided for a minimum of five years from the date the service was rendered. Further, in accordance with N.J.A.C. 10:61-1.6(a), orders shall be on file with the billing laboratory and shall be available for review by Medicaid/NJ FamilyCare representatives upon request.

Invalid Standing Orders

OSC found that in 7 of the 261 sample episodes, ADL processed standing orders that failed to comply with N.J.A.C. 10:61-1.6 and N.J.A.C. 10:49-9.8(a) and (b). Standing orders are patient-specific drug test orders that are effective for up to 12 months for patients who need regular and recurring drug tests as part of their treatment plan. The standing orders at issue were invalid because the dates of service for the drug tests were outside the effective date range of each of the standing orders.

N.J.A.C. 10:61-1.6(c) states that standing orders shall be:

1. Patient-specific and not blanket requests from the physician or licensed practitioner;
2. Medically necessary and related to the diagnosis of the recipient; and
3. Effective for no longer than a 12-month period from the date of the physician's/practitioner's order.

N.J.A.C. 10:49-9.8(a) states that "all providers shall certify that the information furnished on the claim is true, accurate, and complete." Pursuant to N.J.A.C. 10:49-9.8(b), providers shall "keep such records as are necessary to disclose fully the extent of services provided . . . for a minimum period of five years from the date the service was rendered."

Missing Signatures

OSC found that test requisitions for 1 of the 261 sample episodes failed to include the signature of the physician or other licensed practitioner who ordered the services in a written requisition.

Pursuant to N.J.A.C. 10:61-1.6(a), "orders for clinical laboratory services shall be in the form of an explicit order personally signed by the physician or other licensed practitioner requesting the services." Pursuant to N.J.A.C. 10:61-1.2, "'[c]linical laboratory services' means professional and technical laboratory services provided by an independent clinical laboratory when ordered by a physician or other licensed practitioner of the healing arts within the scope of his or her practice as defined by the laws of the state in which he or she practices." Moreover, under N.J.A.C. 10:49-9.8(b), providers shall "keep such records as are necessary to disclose fully the extent of services provided . . . for a minimum period of five years from the date the service was rendered."

Definitive Testing Billed but Not Performed

In 4 of the 261 sample episodes, ADL billed and was reimbursed for a definitive test even though the physician or licensed practitioner had not ordered a definitive test and ADL had not performed one.

N.J.A.C. 10:49-9.8(b) requires providers to keep such records as are necessary to disclose fully the extent of services provided for a minimum of five years from the date the service was rendered. Additionally, N.J.A.C. 10:49-5.5(a)13 states that Medicaid will not cover services billed for which the corresponding records do not adequately and legibly reflect the requirements of the procedure code utilized by the billing provider.

Definitive Testing Billed but Not Ordered

OSC found that for 1 of the 261 sample episodes, ADL failed to provide documentation to support that the referring physician or licensed practitioner had ordered the definitive drug testing that was performed by ADL. For this sample episode, the referring provider's requisition to ADL did not include any definitive tests, but ADL submitted a claim and was paid for definitive testing.

Pursuant to N.J.A.C. 10:49-5.5(a)13, Medicaid will not cover services billed for which the corresponding records do not adequately and legibly reflect the requirements of the procedure code utilized by the billing provider. In accordance with N.J.A.C. 10:49-5.5(a)13(i), "[f]inal payment shall be made in accordance with a review of those services actually documented in the provider's health care record." Further, N.J.A.C. 10:61-1.6(d)4 states that laboratories must ensure that all orders contain the tests to be performed. N.J.A.C. 10:49-9.8(b) requires providers to "keep such records as are necessary to disclose fully the extent of services provided . . . for a minimum period of five years from the date the service was rendered."

Improper Billing of Presumptive and Definitive Testing

OSC found that in 71 of the 261 sample episodes, ADL billed and was paid for a greater level of definitive drug testing than ordered by the referring physician or licensed practitioner or billed for an incorrect procedure code.

Referring providers submitted test requisitions to ADL either electronically or manually. When a referring provider submitted a manual test requisition, the test requisition listed the drug tests ordered, including the type of testing (i.e., presumptive/definitive) and the specific drugs to be tested. Because these manual requisitions provided a clear description of what the referring provider ordered, OSC did not have to perform any additional steps to validate the testing ordered. When a referring provider submitted a test requisition electronically, however, the test requisition did not specify the type of testing (i.e., presumptive/definitive) or the specific drugs to be tested, but instead listed a test code that corresponded to a pre-determined list of drugs to be tested. After finding that the electronic test requisitions did not contain enough information to validate these claims, OSC reviewed additional documentation to ascertain whether ADL properly submitted each claim. ADL advised that its referring providers completed a service agreement that listed the type of drug test ordered (i.e., presumptive/definitive) for specified drugs or drug classes. Additionally, ADL explained that as part of its service agreement process with referring providers, ADL required referring providers to complete a physician acknowledgment form through which the physician or licensed practitioner created the drug test panel(s) that would be used for testing. ADL assigned these panels a unique test code that the physician or licensed practitioner would select when ordering a drug test. OSC found that despite this process, the testing ADL performed and the claims ADL billed in these 71 sample episode claims were inconsistent with the respective service agreements or physician's acknowledgment forms.

The American Medical Association's (AMA) Healthcare Common Procedure Coding System (HCPCS) codes recognize multiple levels of definitive drug testing. The definitive codes identify drugs or metabolites (byproducts of a drug) that will be tested, with billing categories that increase in cost based on the number of drug classes that will be tested. The lowest level of definitive testing, which has the lowest Medicaid reimbursement rate, covers 1 to 7 drug classes, with progressively higher reimbursement levels for 8 to 14 drug classes, 15 to 21 drug classes, and, finally, 22 or more drug classes, which has the highest Medicaid reimbursement rate. Additionally, each drug or drug class is separately identified by a distinct AMA CPT code that is used to bill a specific definitive drug test. OSC found that ADL billed and was reimbursed for higher-level definitive drug tests than were ordered by the referring physician or licensed practitioner. OSC adjusted or downcoded these claims to conform to the level of definitive drug testing that the referring physician or licensed practitioner ordered, as supported by the documentation reviewed. OSC then used the corresponding Medicaid reimbursement rate for the downcoded level of testing to determine the amount that ADL should have been paid by Medicaid.

Pursuant to N.J.A.C. 10:49-5.5(a)13, Medicaid will not cover services billed for which the corresponding records do not adequately and legibly reflect the requirements of the procedure code utilized by the billing provider. In accordance with N.J.A.C. 10:49-5.5(a)13(i), "[f]inal payment shall be made in accordance with a review of those services actually documented in the provider's health care record."

In addition to downcoding claims where ADL billed for more tests than its documentation supported, OSC's review of the sample episodes also revealed that ADL did not always perform drug tests that referring providers ordered. OSC found that in 195 of 261 sample episodes (74.7 percent), ADL did not perform at least one specific drug test included on the drug test order. (See Exhibit C.) For example, ADL often failed to perform definitive tests ordered following positive and/or negative methadone presumptive test results. OSC notes this because it highlights the inconsistencies among the test services ordered, the tests that ADL performed, and the tests for which ADL billed the Medicaid program. OSC is not seeking a monetary recovery for these omissions because they did not lead to any economic harm to the Medicaid program but highlights this finding because ADL's lack of oversight of its testing procedures was improper and may have had an adverse effect on patient care.

Underbilled Presumptive and Definitive Testing

OSC found that in 3 of 261 sample episodes, ADL underbilled, which means that it billed a lower amount than it should have for the test ordered and performed. OSC accounted for these underbilled claims in its extrapolation calculation by giving credit for the correct amount that ADL should have billed.

B. Improper Billing of Specimen Validity Testing

OSC found that ADL improperly submitted claims for specimen validity testing separately from claims submitted for presumptive and definitive drug tests for the same beneficiary on the same date of service. A laboratory is not permitted to seek payment for specimen validity tests and presumptive and/or definitive tests performed on the same day for the same beneficiary when specimen validity tests are performed to confirm that the specimen is unadulterated. Instead, in such cases, the laboratory shall seek payment only for the presumptive and/or definitive tests. Submitting claims and receiving payment for specimen validity tests and presumptive and/or definitive tests performed on the same day constitutes improper unbundling. During the audit period, ADL unbundled 231,091 specimen validity claims for which it received an overpayment of $1,140,043. (See Summary Table I below and Exhibit D.) OSC is seeking a direct recovery of this amount.

Table I: Paid Specimen Validity Claims by Year

Year	Number of Paid Claims	Total Dollars Paid
2015	159,427	$ 786,501
2016	71,664	$ 353,542
	231,091	$ 1,140,043

In accordance with N.J.A.C. 10:49-9.8(a), "all providers shall certify that the information furnished on the claim is true, accurate, and complete." In addition, pursuant to the 2016 HCPCS and CPT guidelines, presumptive and definitive drug tests include sample validation or specimen validity testing. Additionally, the Medicaid National Correct Coding Initiative (NCCI), which requires correct coding methodologies and thereby seeks to reduce inappropriate Medicaid payments, states that specimen validity testing is not separately billable from drug tests. The 2015 and 2016 Medicaid NCCI Chapter X(E) states:

Providers performing validity testing on urine specimens utilized for drug testing should not separately bill the validity testing. For example, if a laboratory performs a urinary pH, specific gravity, creatinine, nitrates, oxidants, or other tests to confirm that a urine specimen is not adulterated, this testing is not separately billed.

C. Charge to Medicaid Exceeded Charge to Other Groups or Individuals for Identical Services

OSC reviewed ADL's service agreements with its referring providers, monthly billing invoices, test requisitions (a referring provider's order for testing), and test results. From this review, OSC found that ADL charged Medicaid an amount significantly greater than the amount it charged other groups for presumptive and definitive drug tests. An independent clinical laboratory is prohibited from charging the Medicaid program more for a test or service than the laboratory charges another group or individual for an identical test or service. N.J.A.C. 10:61-1.7 provides that "[i]n no event shall the charge to the Medicaid/NJ FamilyCare program exceed the provider's charge for identical services to other groups or individuals."

During OSC's audit period, ADL charged groups other than the Medicaid program a flat fee for presumptive and definitive drug tests that was significantly lower than the fee ADL charged Medicaid for these same tests. OSC reached this determination after reviewing ADL's charges to multiple referring providers for thousands of drug tests during the audit period, which ensured that these were not isolated incidents but rather demonstrated a pattern of conduct. For example, as shown in Table II below, ADL charged one referring provider, labeled Provider D, a rate as low as $2.38 for presumptive and definitive drug tests, while it charged Medicaid between $125 and $1,035 for identical services. Medicaid, pursuant to its fee schedule, paid ADL between $63.40 and $180.40 for these services.

Table II: Comparison of ADL's Charges for Presumptive and/or Definitive Tests

	Charge to Medicaid	Amount Paid by Medicaid	Lowest Charge to Other Group or Individual*	Earliest Drug Test Billed to Provider During Audit Period*
Provider A	$ 70.25 - 527.00	$ 20.37 - 215.07	$ 5.00	1/2/2015
Provider B	$ 125.00 - 590.00	$ 16.80 - 153.67	$ 5.00	1/2/2015
Provider C	$ 125.00 - 160.00	$ 20.33 - 86.28	$ 5.00	3/27/2015
Provider D	$ 125.00 - 1,035.00	$ 63.40 - 180.40	$ 2.38	4/30/2015
*Based on information received from ADL and its referring providers

For all 261 sample episodes reviewed, ADL improperly charged Medicaid an amount that exceeded ADL's charge to other non-Medicaid payers for identical services during the same periods.

The extrapolated overpayment amount that ADL would owe, if OSC held ADL to the lowest charges and sought a recovery, is roughly $29.7 million, almost the entire Medicaid payment to ADL for the audit period. Given that the extrapolated overpayment, due to ADL's consistent violations of the BOR regulation, would result in ADL being required to return almost all the funds it received from the Medicaid program during the audit period, and since OSC does not allege that ADL failed to provide all of the billed services, OSC did not to seek the extrapolated overpayment. Instead, in accordance with its authority under N.J.S.A. 30:4D-57(d)(2), N.J.S.A. 30:4D-17(e)(3), and N.J.S.A. 2A:32C-3, OSC is assessing a civil penalty based on ADL's pervasive pattern of misconduct throughout the audit period. Specifically, for the entire audit period, ADL submitted hundreds of thousands of claims to the Medicaid program and received payment for these claims despite knowingly charging the Medicaid program far more for services than it charged other non-Medicaid payers for identical services. Despite the fact that it knew that each time it charged this marked difference for identical services, it violated the BOR regulation, as part of each Medicaid claim, ADL represented that its claims were in conformity with all laws and regulations and were true, accurate, and complete, which was not the case. For these reasons, OSC is assessing ADL a civil penalty of $3,269,332 for the 261 episodes in the audit sample that violated Medicaid regulations in the audit period.^[3]

D. ADL Provided Improper Rebates

OSC found that ADL violated N.J.A.C. 10:61-2.4, a regulation that prohibits rebates, including money discounts and other considerations, whether or not a rebate is involved. As discussed above, ADL charged referring providers an amount much lower than it charged Medicaid for identical services. Compared to the rate charged to Medicaid, the lower rates that ADL charged referring providers constituted a "discount" in violation of N.J.A.C. 10:61-2.4. In short, the same overall course of conduct that violated N.J.A.C. 10:61-1.7, which is discussed above, also violated N.J.A.C. 10:61-2.4.

In addition, although OSC did not request nor did it otherwise perform an in-depth review of ADL's documentation for the purpose of identifying rebate related practices, OSC found that ADL advertised on its social media that it would be a returning sponsor of the third annual golf outing for one of its referring providers on September 16, 2019, which was organized to raise funds for this provider to construct a new facility. OSC contacted this referring provider and confirmed that ADL made contributions of $10,000 dollars each year in May 2017, May 2018, and August 2019 for sponsorship of this referring provider's annual golf outings. OSC notes that the August 2019 contribution fell outside of the audit review period but nonetheless considers the contributions violations of N.J.A.C. 10:61-2.4 because these actions constitute forms of "other considerations" that are prohibited by N.J.A.C. 10:61-2.4.

Pursuant to N.J.A.C. 10:61-2.4, "[r]ebates by reference laboratories, service laboratories, physicians or other utilizers or providers of laboratory service are prohibited under the Medicaid/NJ FamilyCare program. Rebates shall include refunds, discounts or kickbacks, whether in the form of money, supplies, equipment, or other things of value. Laboratories shall not rent space or provide personnel or other considerations to a physician or other practitioner, whether or not a rebate is involved."

As outlined in Section C above, OSC is assessing a civil penalty of $3,269,332 for the 261 episodes in the sample that violated both N.J.A.C. 10:61-1.7 and N.J.A.C. 10:61-2.4.

Recovery and Penalties

As explained above, OSC found that based on ADL's deficient documentation, improper unbundling of claims, and knowingly applying improper billing practices, ADL received overpayments from the Medicaid program. OSC seeks to recover from ADL a total of $7,352,961, which is comprised of a $2,943,586^[4] extrapolated recovery for documentation deficiencies, a $1,140,043 direct recovery for unbundling specimen validity claims, and a $3,269,332 civil penalty for knowingly submitting claims that violated the BOR and anti-rebate regulations.

Recommendations

ADL shall:

1. Reimburse the Medicaid program $7,352,961.
2. Ensure that the charge to the Medicaid program does not exceed ADL's charge for identical services to other groups or individuals.
3. Ensure that all orders for clinical laboratory services and all records and documentation are maintained by ADL and comply with applicable state and federal laws, regulations, and guidance, including the regulations cited above.
4. Maintain the necessary documentation and ensure that only those drug tests ordered by the physician or other licensed practitioner requesting services are tested and billed. ADL must contemporaneously document all changes to the tests ordered.
5. Ensure all test orders indicate the test(s) to be performed, including the specific drugs or class of drugs as defined by AMA.
6. Ensure that all drug testing ordered by a physician or licensed practitioner is performed and reported on the drug test results.
7. Ensure that all claims for drug tests comply with all applicable state and federal laws, regulations, and guidance.
8. Ensure that it refrains from separately submitting claims for specimen validity testing from claims submitted for presumptive and definitive drug tests.
9. Refrain from offering rebates, including refunds, discounts, or kickbacks, whether in the form of money, supplies, equipment, or other things of value to its referring providers or any other entities. ADL shall not rent space or provide personnel or other considerations to a physician or other practitioner, whether or not a rebate is involved.
10. Provide training to staff to foster compliance with Medicaid requirements under applicable state and federal laws and regulations.
11. Provide OSC with a Corrective Action Plan indicating the steps it will take to implement procedures to correct the deficiencies identified in this report.

[1] OSC can reasonably assert, with 90% confidence, that the total overpayment in the universe is greater than $2,943,585.67 (18.43% precision) with the error point estimate as $3,608,674.89.

[2] See Footnote 1.

[3] N.J.S.A. 30:4D-17(e)(3) provides OSC authority to penalize conduct in accordance with the civil penalty range allowed under the federal False Claims Act (FCA), 31 U.S.C. 3729 et seq., as adjusted for inflation. Pursuant to 28 C.F.R. 85.3(a)(9), the minimum penalty for FCA violations occurring on or before November 2, 2015, is $5,500 per violation. The minimum applicable penalty for a FCA violation after November 2, 2015, is $13,508 per violation. 28 C.F.R. 85.5. Thirty-two episodes in the sample occurred before November 2, 2015, with the remaining 229 occurring after that date. By applying the applicable penalty rate to the sample episodes, the minimum penalty for ADL's conduct is $3,269,332.

[4] See Footnote 1.