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Proove Bioscience

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My opinion is to stay away from this scam. Reps are not getting paid. "manager" out of Ohio is the number one scam artist. He signs reps on; reps do all the work and never get paid a dime. Medicare not reimbursing, but company telling offices Medicare reimburses. This company is a house of cards with "crooks" running it. Again, Just my humble opinion. If it sounds to good to be true.......
 
































How are they getting away with this? No pay? I bet the husband and wife team at the top are raking in the dollars; bleeding the company, double dipping. Is the company guy in ohio still scamming reps he brings on? " Okay go out an close business and I'll keep any money coming your way". Said the cincinati con man. Can you tell I got burned by Joe?
 




Unfortunaley all this is mis information here. This is why these reps posting all this WRONG information have been terminated. I have work with these groups and get paid monthly. There is no truth to anything on here just a few disgruntled reps that had mis represented the company and were let go as they are doing now. I know many sales reps geting paid every month and doing well with the company. So do not believe anything on here. I work for the Rep out of Ohio and have been trained well and get paid each and every month for the work I do. Good luck. Your posts have no truth or merit to them.
 
















I have sold thousands of tests and then i was terminated when i probed about proove's methods of testing and billing
i was terminated
I sold over 5,000 tests and now the distributor from KY refuses to pay me - what a scam
 




The whole thing is a scam starting from proove corporate and trickling down to the distributors. the guy in ohio is supposedly the regional sales director, yet how does he still have a distributorship as well with reps under him, wouldn't this be double dipping?
Also, I don't even believe they are affliated with medicare - even tho they boast they recieve 90 percent reimbursement ratio with them. does anyone know how i can find out if they are?
Also, I just preformed a lexus nexus serach for proove and 33 pages of lawsuits came up
 




Just so everyone is aware:

Special Fraud Alert: Laboratory Payments to Referring Physicians
June 25, 2014
Summary
This Special Fraud Alert addresses compensation paid by laboratories to referring physicians and physician group practices (collectively, physicians) for blood specimen collection, processing, and packaging, and for submitting patient data to a registry or database. OIG has issued a number of guidance documents and advisory opinions addressing the general subject of remuneration offered and paid by laboratories to referring physicians, including the 1994 Special Fraud Alert on Arrangements for the Provision of Clinical Laboratory Services, the OIG Compliance Program Guidance for Clinical Laboratories, and Advisory Opinion 05-08. In these and other documents, we have repeatedly emphasized that providing free or below-market goods or services to a physician who is a source of referrals, or paying such a physician more than fair market value for his or her services, could constitute illegal remuneration under the anti-kickback statute. This Special Fraud Alert supplements these prior guidance documents and advisory opinions and describes two specific trends OIG has identified involving transfers of value from laboratories to physicians that we believe present a substantial risk of fraud and abuse under the anti-kickback statute.
I. The Anti-Kickback Statute
One purpose of the anti-kickback statute is to protect patients from inappropriate medical referrals or recommendations by health care professionals who may be unduly influenced by financial incentives. Section 1128B(b) of the Social Security Act (the Act) makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce, or in return for, referrals of items or services reimbursable by a Federal health care program. When remuneration is paid purposefully to induce or reward referrals of items or services payable by a Federal health care program, the anti-kickback statute is violated. By its terms, the statute ascribes criminal liability to parties on both sides of an impermissible “kickback” transaction. Violation of the statute constitutes a felony punishable by a maximum fine of $25,000, imprisonment up to 5 years, or both. Conviction will also lead to exclusion from Federal health care programs, including Medicare and Medicaid. OIG may also initiate administrative proceedings to exclude persons from the Federal health care programs or to impose civil money penalties for fraud, kickbacks, and other prohibited activities under sections 1128(b)(7) and 1128A(a)(7) of the Act.
II. Remuneration From Laboratories to Referring Physicians
Arrangements between referring physicians and laboratories historically have been subject to abuse and were the topic of one of the OIG’s earliest Special Fraud Alerts.1 In that Special Fraud Alert, we stated that, “[w]henever a laboratory offers or gives to a source of referrals anything of value not paid for at fair market value, the inference may be made that the thing of value is offered to induce the referral of business.” More generally, we have, on various occasions, repeated our position that arrangements providing free or below-market goods or services to actual or potential referral sources are suspect and may violate the anti-kickback statute, depending on the circumstances.2
Likewise, when a laboratory pays a physician more than fair market value for the physician’s services or for services the laboratory does not actually need or for which the physician is otherwise compensated, the anti-kickback statute is implicated. Such payments are suspect under the anti-kickback statute because of the implication that one purpose of the payments is to induce the physician’s Federal health care program referrals. OIG also historically has been concerned with arrangements in which the amounts paid to a referral source take into account the volume or value of business generated by the referral source.
Arrangements in which laboratories provide free or below-market goods or services to physicians or make payments to physicians that are not commercially reasonable in the absence of Federal health care program referrals potentially raise four major concerns typically associated with kickbacks—corruption of medical judgment, overutilization, increased costs to the Federal health care programs and beneficiaries, and unfair competition. This is because such transfers of value may induce physicians to order tests from a laboratory that provides them with remuneration, rather than the laboratory that provides the best, most clinically appropriate service. Such transfers of value also may induce physicians to order more laboratory tests than are medically necessary, particularly when the transfers of value are tied to, or take into account, the volume or value of business generated by the physician. We are particularly concerned about these types of arrangements because the choice of laboratory, as well as the decision to order laboratory tests, typically is made or strongly influenced by the physician, with little or no input from patients.
Although physicians may order any tests they believe are appropriate to diagnose and treat their patients, Medicare will pay for laboratory tests only if they meet Medicare coverage criteria and are reasonable and necessary.3 Moreover, claims that include items or services resulting from a violation of the anti-kickback statute are not payable by Medicare and may constitute false claims under the False Claims Act, even if the items or services are medically necessary.4 OIG recognizes that the lawfulness of any particular arrangement under the anti-kickback statute depends on the intent of the parties. Such intent may be evidenced by the arrangement’s characteristics, including its legal structure, its operational safeguards, and the actual conduct of
1 Special Fraud Alert: Arrangements for the Provision of Clinical Laboratory Services (Oct. 1994), reprinted at 59 Fed. Reg. 65,372, 65,377 (Dec. 19, 1994). 2 See, e.g., Advisory Opinion 11-07, p. 7. 3 Section 1862(a)(1)(A) of the Act.
4 31 U.S.C. 3729 et seq.
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the parties to the arrangement. Nonetheless, we believe the following types of arrangements between laboratories and physicians are suspect under the anti-kickback statute.
A. Blood-Specimen Collection, Processing, and Packaging Arrangements
OIG has become aware of arrangements under which clinical laboratories are providing remuneration to physicians to collect, process, and package patients’ specimens. This Special Fraud Alert addresses arrangements under which laboratories pay physicians, either directly or indirectly (such as through an arrangement with a marketing or other agent) to collect, process, and package patients’ blood specimens (Specimen Processing Arrangements).5 Specimen Processing Arrangements typically involve payments from laboratories to physicians for certain specified duties, which may include collecting the blood specimens, centrifuging the specimens, maintaining the specimens at a particular temperature, and packaging the specimens so that they are not damaged in transport. Payments under Specimen Processing Arrangements typically are made on a per-specimen or per-patient-encounter basis and often are associated with expensive or specialized tests.
Medicare allows the person who collects a specimen to bill Medicare for a nominal specimen collection fee in certain circumstances, including times when the person draws a blood sample through venipuncture (i.e., inserting into a vein a needle with syringe or vacuum tube to draw the specimen).6 Medicare allows such billing only when: (1) it is the accepted and prevailing practice among physicians in the locality to make separate charges for drawing or collecting a specimen and (2) it is the customary practice of the physician performing such services to bill separate charges for drawing or collecting the specimen.7 Only one collection fee is allowed for each type of specimen for each patient encounter, regardless of the number of specimens drawn.8 Physicians who satisfy the specimen collection fee criteria and choose to bill Medicare for the specimen collection must use Current Procedural Terminology (CPT) Code 36415, “Routine venipuncture – Collection of venous blood by venipuncture.”9, 10
5 The same principles described in this Special Fraud Alert apply to arrangements that are similar or analogous to Specimen Processing Arrangements, including arrangements under which clinical laboratories pay physicians to collect and package patients’ buccal swabs or urine specimens or provide free or below-market point of care urine testing cups to health care providers who use the cups to perform billable in-office testing.
6 Section 1833(h)(3) of the Act; Medicare Claims Processing Manual, CMS Pub. 100-04, Chapter 16, section 60.1. 7 Medicare Claims Processing Manual, CMS Pub. 100-04, Chapter 16, section 60.1.1. 8 Medicare Claims Processing Manual, CMS Pub. 100-04, Chapter 16, section 60.1. 9 The five character codes and descriptions included in this document are obtained from Current Procedural Terminology (CPT®), copyright 2014 by the American Medical Association (AMA). CPT is developed by the AMA as a listing of descriptive terms and five character identifying codes and modifiers for reporting medical services and procedures. Any use of CPT outside of this document should refer to the most current version of the Current Procedural Terminology available from AMA. Applicable FARS/DFARS apply.
10 CPT code 36415 is included on the clinical laboratory fee schedule. As of the date of issuance of this Special Fraud Alert, Medicare pays a specimen collection fee of $5 for samples collected from individuals in skilled nursing facilities and by laboratories on behalf of home health agencies and a specimen collection fee of $3 for all other samples. See, e.g., Clinical Laboratory Fee Schedule – January 2014 Release, available at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/clinlab.html; specifically CLAB2014.EffJan1.Full.xlsx (the 2014 Clinical Diagnostic Laboratory Fee Schedule), available at http://www.cms.gov/apps/ama/license.asp?file=/ClinicalLabFeeSched/downloads/14CLAB.zip; and Protecting Access to Medicare Act of 2014, Pub. L. No. 113-93, § 216(a), 128 Stat. 1040 and 1053-1059 (to be codified at 42 U.S.C. § 1395m-1(b)(5)) (2014).
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Medicare reimburses physicians for processing and packaging specimens for transport to a clinical laboratory through a bundled payment.11 Physicians who wish to report the work involved in preparing a specimen to send to a laboratory may use CPT code 99000, “Handling and/or conveyance of specimen for transfer from the office to a laboratory.”12 CPT code 99000 is intended to reflect the work involved to prepare a specimen prior to sending it to a laboratory, including centrifuging a specimen, separating serum, labeling tubes, packing the specimens for transport, filling out laboratory forms, and supplying necessary insurance information and other documentation.13
The anti-kickback statute is implicated when a clinical laboratory pays a physician for services. Whether an actual violation of the statute occurs depends on the intent of the parties—the anti- kickback statute prohibits the knowing and willful payment of such amounts if even one purpose of the payment is to induce or reward referrals of Federal health care program business. This is true regardless of whether the payment is fair market value for services rendered. The probability that a payment is for an illegitimate purpose is increased, however, if a payment exceeds fair market value or if it is for a service for which the physician is paid by a third party, including Medicare.
When determining the fair market value of a physician’s services, a clinical laboratory should consider whether the services for which it may compensate the physician have been, or may be, paid for, including through a bundled payment, by Medicare. Additionally, the laboratory should consider whether payment is appropriate at all; if the services for which the laboratory intends to compensate the physician are paid for by a third party through other means, such as payments intended to reimburse the physician for overhead expenses, any payment by the laboratory to the physician may constitute double payment for the physician’s services and, consequently, provide evidence of unlawful intent.
Characteristics of a Specimen Processing Arrangement that may be evidence of such unlawful purpose include, but are not limited to, the following:
 Payment exceeds fair market value for services actually rendered by the party receiving the payment.
11 Since 2003, CPT code 99000 has been listed as a “Bundled Code” in the Medicare Physician Fee Schedule (MPFS). See, e.g., Physician Fee Schedule – January 2014 Release, available at http://www.cms.gov/Medicare/Medicar...t/PhysicianFeeSched/PFS-Relative-Value-Files- Items/RVU14A.html; specifically PPRRVU14_V1219.xlsx (the 2014 National Physician Fee Schedule Relative Value File) and RVUPUF14.pdf (containing information on services covered by the MPFS, including fee schedule status indicators), available at http://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/PhysicianFeeSched/Downloads/RVU14A.zip. A “Bundled Code” means that “[p]ayment for covered services are always bundled into payment for other services not specified.” RVUPUF14.pdf, Attachment A.
12 Even though physicians are not directly reimbursed under this code, as they are with CPT code 36145, they may choose to report this CPT code so that the costs associated with the services they perform are taken into account in CMS’s calculation of the practice expense component of a procedure’s relative value unit. See Overview, MPFS, available at https://www.cms.gov/apps/physician-fee-schedule/overview.aspx.
13 Coding Clarification: Handling and/or Conveyance of Specimen for Transfer from the Physician’s Office to a Laboratory, CPT Assistant (AMA), Oct. 1999, at 11.
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 Payment is for services for which payment is also made by a third party, such as Medicare.
 Payment is made directly to the ordering physician rather than to the ordering physician’s group practice, which may bear the cost of collecting and processing the specimen.
 Payment is made on a per-specimen basis for more than one specimen collected during a single patient encounter or on a per-test, per-patient, or other basis that takes into account the volume or value of referrals.
 Payment is offered on the condition that the physician order either a specified volume or type of tests or test panel, especially if the panel includes duplicative tests (e.g., two or more tests performed using different methodologies that are intended to provide the same clinical information), or tests that otherwise are not reasonable and necessary or reimbursable.
 Payment is made to the physician or the physician’s group practice, despite the fact that the specimen processing is actually being performed by a phlebotomist placed in the physician’s office by the laboratory or a third party.
OIG’s concerns regarding Specimen Processing Arrangements are not abated when those arrangements apply only to specimens collected from non-Federal health care program patients. Arrangements that “carve out” Federal health care program beneficiaries or business from otherwise questionable arrangements implicate the anti-kickback statute and may violate it by disguising remuneration for Federal health care program business through the payment of amounts purportedly related to non-Federal health care program business. Because physicians typically wish to minimize the number of laboratories to which they refer for reasons of convenience and administrative efficiency, Specimen Processing Arrangements that carve out Federal health care program business may nevertheless be intended to influence physicians’ referrals of Federal health care program business to the offering laboratories.
Finally, because the anti-kickback statute ascribes criminal liability to parties on both sides of an impermissible “kickback” arrangement, physicians who enter into Specimen Processing Arrangements with laboratories also may be at risk under the statute.
B. RegistryPayments
OIG has become aware of arrangements under which clinical laboratories are establishing, coordinating, or maintaining databases, either directly or through an agent, purportedly to collect data on the demographics, presentation, diagnosis, treatment, outcomes, or other attributes of patients who have undergone, or who may undergo, certain tests performed by the offering laboratories. Typically these are specialized and expensive tests paid for by Federal health care programs. This Special Fraud Alert addresses such “Registries” or “Registry Arrangements,” whether they are referred to as “registries” or “observational outcomes databases” or by other terminology.
Laboratories that participate in Registry Arrangements often assert that they are intended to advance clinical research to promote treatment, to provide physicians with valuable clinical
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knowledge for patients with similar disease profiles, and to provide other benefits to physicians or the health care industry generally. Registry Arrangements may take various forms; however, they typically involve payments from laboratories to physicians for certain specified duties, including, by way of example only, submitting patient data to be incorporated into the Registry, answering patient questions about the Registry, and reviewing Registry reports.
Registry Arrangements may induce physicians to order medically unnecessary or duplicative tests, including duplicative tests performed for the purpose of obtaining comparative data, and to order those tests from laboratories that offer Registry Arrangements in lieu of other, potentially clinically superior, laboratories. OIG recognizes that whether any particular Registry Arrangement violates the anti-kickback statute depends on the intent of the parties to the arrangement. Payments from a laboratory to a physician to compensate the physician for services related to data collection and reporting may be reasonable in certain limited circumstances. However, the anti-kickback statute prohibits the knowing and willful payment of such compensation if even one purpose of the payments is to induce or reward referrals of Federal health care program business.
Characteristics of a Registry Arrangement that may be evidence of such unlawful purpose include, but are not limited to, the following:
 The laboratory requires, encourages, or recommends that physicians who enter into Registry Arrangements perform the tests with a stated frequency (e.g., four times per year) to be eligible to receive, or to not receive a reduction in, compensation.
 The laboratory collects comparative data for the Registry from, and bills for, multiple tests that may be duplicative (e.g., two or more tests performed using different methodologies that are intended to provide the same clinical information) or that otherwise are not reasonable and necessary.
 Compensation paid to physicians pursuant to Registry Arrangements is on a per-patient or other basis that takes into account the value or volume of referrals.
 Compensation paid to physicians pursuant to Registry Arrangements is not fair market value for the physicians’ efforts in collecting and reporting patient data.
 Compensation paid to physicians pursuant to Registry Arrangements is not supported by documentation, submitted by the physicians in a timely manner, memorializing the physicians’ efforts.
 The laboratory offers Registry Arrangements only for tests (or disease states associated with tests) for which it has obtained patents or that it exclusively performs.
 When a test is performed by multiple laboratories, the laboratory collects data only from the tests it performs.
 The tests associated with the Registry Arrangement are presented on the offering laboratory’s requisition in a manner that makes it more difficult for the ordering physician to make an independent medical necessity decision with regard to each test for which the laboratory will bill (e.g., disease-related panels).
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Other characteristics not listed above may increase the risk of fraud and abuse associated with a Registry Arrangement or provide evidence of unlawful intent. For example, the risk of fraud and abuse would be particularly high if a laboratory were to pay, and collect data for its Registry from, only a subset of physicians who were selected on the basis of their prior or anticipated referral volume, rather than their specialty, sub-specialty, or other relevant attribute.
The anti-kickback statute does not prohibit laboratories from engaging in, or paying compensation for, legitimate research activities. However, claims that Registries are intended to promote and support clinical research and treatment are not sufficient to disprove unlawful intent. Even legitimate actions taken to substantiate such claims, including, for example, retaining an independent Institutional Review Board to develop study protocols and participation guidelines, will not protect a Registry Arrangement if one purpose of the arrangement is to induce or reward referrals. Furthermore, for the reasons set forth in section II.A above, OIG’s concerns regarding Registry Arrangements are not abated when those arrangements apply only to data collected from tests performed on non-Federal health care program patients’ specimens.
Finally, because the anti-kickback statute ascribes criminal liability to parties on both sides of an impermissible “kickback” arrangement, physicians who enter into Registry Arrangements with laboratories also may be at risk under the statute.
III. Conclusion
OIG is concerned about the risks that Specimen Processing Arrangements and Registry Arrangements pose under the anti-kickback statute. This Special Fraud Alert reiterates our longstanding concerns about payments from laboratories to physicians in excess of the fair market value of the physicians’ services and payments that reflect the volume or value of referrals of Federal health care program business. Should interested parties continue to have questions about the structure of a particular Specimen Processing Arrangement or Registry Arrangement, the OIG Advisory Opinion process remains available. Information about the process may be found at: http://oig.hhs.gov/faqs/advisory-opinions-faq.asp.
To report suspected fraud involving Registry Arrangements, Specimen Processing Arrangements, or similar arrangements, contact the OIG Hotline at https://forms.oig.hhs.gov/hotlineoperations/ or by phone at 1-800-447-8477 (1-800-HHS-TIPS).
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From Legal Counsel:

On June 25, 2014, OIG published a document entitled “Special Fraud Alert: Laboratory Payments to Referring Physicians” (the “OIG Fraud Alert”). OIG identified two different types of arrangement in the health care marketplace involving alleged remuneration from clinical laboratories to referring physicians. The first arrangement addressed blood-specimen collection, processing and packaging arrangements. That type of arrangement is inapplicable to the Proove Biosciences’ PSA. The second issue raised in the OIG Fraud Alert addressed what OIG characterized as “Registry Payments.” OIG identified arrangements under which clinical laboratories are establishing, coordinating or maintaining databases, either directly or through an agent, purportedly to collect data on the demographics, presentation, diagnosis, treatment, outcomes or other attributes of patients who have undergone, or may undergo, certain tests performed by the offering laboratories. The OIG Fraud Alert calls these “Registry Arrangements.”

The first point addresses OIG’s apparent suspicion about the typical Registry Arrangement. OIG stated:

Laboratories that participate in Registry Arrangements often assert that they are intended to advance clinical research to promote treatment, to provide physicians with valuable clinical knowledge for patients with similar disease profiles, and to provide other benefits to physicians or the health care industry generally. Registry Arrangements may take various forms; however, they typically involve payments from laboratories to physicians for certain specified duties, including, by way of example only, submitting patient data to be incorporated into the Registry, answering patient questions about the Registry and reviewing Registry reports.

OIG Fraud Alert, pp. 5-6 (emphasis added).

The highlighted text suggests that OIG may not believe the physician work actually advances clinical research. On the contrary, Proove Biosciences contends its PSA is completely legitimate for the commercially reasonable business purpose to advance highly complex genetic testing research. Proove Biosciences has developed a proprietary portfolio of genetic tests that provide physicians with information necessary to improve the selection, dosing and evaluation of patients’ medications, and has undertaken significant effort to research and present data at several major scientific meetings in its field for the past two years, including meetings of the American Academy of Pain Medicine, the American Society of Interventional Pain Physicians, the American Pain Society, PainWeek, and more. In addition to presenting data at major scientific meetings, Proove Biosciences is in the midst of publishing data from its studies in peer-reviewed professional journals analyzing the efficacy of its genetic testing protocols, identifying new genetic testing clinical concepts, and developing methods to reduce health care costs and improve quality of health care by providing physicians the necessary information to genetically predict potential abuse or dependence. Proove Biosciences takes the position that it is not merely “asserting” that the data gathered by physicians subject to the PSA advances research, but the PSA is solely and exclusively designed to obtain necessary clinical data that indeed advances legitimate and highly technical clinical research. Unlike “Registries”, Proove Biosciences’ research is actually presented at major scientific meetings, is frequently published in peer-reviewed medical journals, and is intended to meet the clinical validity criteria for regulatory compliance in its filings with the Food and Drug Administration.

OIG also states that the extent to which any particular Registry Arrangement violates the Anti-Kickback statute depends on the intent of the parties and adds: “Payments from a laboratory to a physician to compensate the physician for services related to data collection reporting may be reasonable in certain limited circumstances.” Proove Biosciences contends that its structure, organization and operation fits those circumstances and is reasonable and lawful.

OIG identified eight specific and two general characteristics of a Registry Arrangement that may evidence an unlawful purpose. Each will be addressed separately.

The OIG Fraud Alert states: “The Laboratory requires, encourages or recommends that physicians who enter into Registry Arrangements perform the tests with the stated frequency (e.g. four times per year) to be eligible to receive, or to not receive a reduction in, compensation.” OIG Fraud Alert, p. 6. Since all of Proove Biosciences’ testing involves genetic tests of DNA, all of its current testing can only be performed once during the lifetime of a patient. Therefore, Proove Biosciences never expressly or impliedly requires, states or even recommends a stated frequency of repeated tests from referring physicians.

The OIG Fraud Alert states: “The laboratory collects comparative data for the Registry from, and bills for, multiple tests that may be duplicative (e.g. two or more tests performed using different methodologies that are intended to provide the same clinical information) or that otherwise are not reasonable and necessary.” Id. Proove Biosciences contends that none of its clinical laboratory tests are duplicative.

The OIG Fraud Alert states: “Compensation paid to physicians pursuant to Registry Arrangements is on a per-patient or other basis that takes into account the volume or value of referrals.” Id. Proove Biosciences contends its PSA is structured in a manner that compensates the physician only for actual services rendered. Proove Biosciences’ PSA contains seven different components of services provided by physicians. Physicians are paid a flat fair market value (“FMV”) hourly rate based upon an amount established independently by Huron Consulting Services, LLC d/b/a Huron Healthcare, a nationally reputable health care valuation firm. Huron Consulting conducted a national analysis using comparable data and information to develop a range of FMV payments through various physician specialists with whom Proove Biosciences contracts. Proove Biosciences adopted the Huron Healthcare FMV analysis and included it in the PSA. The compensation structure is set in advance, and does not vary or fluctuate depending on the volume or value of referrals. Physicians, as a condition of payment, are obligated to document the services they perform and the time spent performing each service on a time sheet that is prepared by the physician, signed by the physician, submitted to Proove Biosciences and audited. Proove Biosciences contends its FMV, set-in-advance compensation paid to physicians is not a per-patient fee. Proove Biosciences contends the independent Huron Consulting expert valuation report and analysis establishes FMV payments for actual and commercially reasonable services rendered and does not take into account the actual or anticipated value or volume of referrals. In fact, Proove Biosciences currently compensates physicians who have never ordered a test from Proove Biosciences for providing various forms of clinical research services across seven categories.

The OIG Fraud Alert states: “Compensation paid to physicians pursuant to Registry Arrangements is not fair market value for the physicians’ efforts in collecting and reporting patient data.” Id. Proove Biosciences contends the Huron Healthcare report establishes fair market value based upon a nationwide analysis of comparable compensation data.

The OIG Fraud Alert states: “Compensation paid to physicians pursuant to Registry Arrangements is not supported by documentation, submitted by the physicians in a timely manner, memorializing the physicians’ efforts.” Id. Proove Biosciences contends its time sheet physicians must prepare documenting actual services performed on behalf of Proove Biosciences and including the time spent on such services establishes the requisite documentation memorializing the physicians’ efforts.

The OIG Fraud Alert states: “The laboratory offers Registry Arrangements only for tests (or disease states associated with tests) for which it has obtained patents or that it exclusively performs.” Id. Proove Biosciences contends the proprietary portfolio of genetic tests it has developed, and the commercially reasonable need to gather clinically based data, advances its legitimate, commercially reasonable business purpose to publish studies regarding the validity, clinical efficacy, cost savings and improvement of quality of care with respect to its genetic testing protocols. Moreover, Proove Biosciences is working to refine additional tests, and expand genetic testing protocols. Through its clinical research efforts, Proove Biosciences has been conducting various clinical studies that provide it with unparalleled preparation for the new guidance issued by the Food and Drug Administration to regulate laboratory developed tests – a stated commercially reasonable purpose in its PSA.

Most important, Proove Biosciences does not operate Registry Arrangements. Instead, its research protocols subject to the PSA are based upon Institutional Review Board (“IRB”) approved study protocols. Each study is reviewed, approved, and overseen by an independent, private IRB licensed by the U.S. Department of Health and Human Services’ Office of Human Research Protections (“OHRP”). A researcher who signs the Proove Biosciences’ PSA and wishes to become a study investigator must also sign a Clinical Study Rider for one of these IRB-approved protocols, and complete a certification that the researcher is qualified and not barred by the FDA from doing so. Proove Biosciences contends that its process of having all studies reviewed, approved, and overseen by a private, licensed IRB is substantively different from Registry Arrangements because it involves bona fide research consistent with OHRP standards.

The OIG Fraud Alert states: “When a test is performed by multiple laboratories, the laboratory collects data only from the tests it performs.” Id. Proove Biosciences contends that for the purposes of research in the PSA, and consistent with its IRB-approved clinical study protocols, it does collect data from proprietary tests it only performs, as well as data from tests it does not perform.

The OIG Fraud Alert states: “The tests associated with the Registry Arrangement are presented on the offering laboratory’s requisition in a manner that makes it more difficult for the ordering physician to make an independent medical necessity decision with regard to each test for which the laboratory will bill (e.g. disease-related panels).” Id. Proove Biosciences contends that physicians retain, and actually represent and warrant pursuant to the PSA, that they shall not refer or recommend any genetic testing or clinical diagnostic laboratory testing supplied or provided by Proove Biosciences to any patient unless the physicians have documented the medical necessity and clinical indications of the genetic testing or clinical laboratory testing. The PSA further requires physicians subject to the PSA to provide Proove Biosciences with written medical necessity and clinical documentation to justify all decisions and recommendations for genetic or clinical laboratory testing.

The OIG Fraud Alert states:

Other characteristics not listed above may increase the risk of fraud and abuse associated with a Registry Arrangement or provide evidence of unlawful intent. For example, the risk of fraud and abuse would be particularly high if a laboratory were to pay, and collect data for its Registry from, only a subset of physicians who are selected on the basis of their prior or anticipated referral volume, rather than their specialty, subspecialty or other relevant attribute.

Id. at p. 7. Proove Biosciences contends its selection criteria for physicians offered to participate in its PSA are based upon physician specialties and subspecialties directly and extensively involved in the type of medical treatment and interventions with patients who might meet the inclusion or exclusion criteria of its IRB-approved study protocols. Proove Biosciences contends that its selection criteria do not include physicians based on their prior or anticipated referral volumes.

The OIG Fraud Alert states:

Even legitimate actions taken to substantiate such claims, including, for example, retaining an independent Institutional Review Board to develop study protocols and participation guidelines, will not protect the Registry Arrangement if one purpose of the arrangement is to induce or reward referrals.

Id. Proove Biosciences asserts the sole and exclusive purpose of the PSA is to provide fair market value compensation to physicians for commercially reasonable clinical research services actually performed and documented by physicians to advance Proove Biosciences’ legitimate business need to obtain clinical data for purposes of conducting research that is submitted, peer-reviewed and presented at major scientific meetings, and published in peer-reviewed medical journals, and for regulatory compliance. Proove Biosciences asserts no purpose of the PSA arrangement is to pay for the referral of clinical diagnostic testing laboratory services or to induce future referrals.

One other statement in the blood specimen collection portion of the OIG Fraud Alert will be addressed. It suggests that the physician cannot be paid for work performed by someone other than the physician. Proove Biosciences contends that the PSA is structured in a manner to pay exclusively for the commercially reasonable services personally performed by the physician subject to the PSA.

Based on the foregoing, Proove Biosciences contends that its PSA arrangement with referring physicians is lawful and does not involve the suspicious characteristics articulated in the OIG Fraud Alert.

A recently published federal court decision dismissing alleged violations of the Anti-Kickback statute establishes the legal context of the OIG’s Fraud Alert, as follows:

OIG Advisory Opinions do not establish rules of decision, and are not to receive judicial deference.

* * * * *

OIG’s identification of a practice as “suspect” merely triggers further investigation by OIG; it does not render a practice per se illegal or unlawful.

U.S. ex rel. McDonough v. Symphony Diagnostic Services, Inc., ____ F.Supp.2d ____ (S.D. Ohio 2014) (2014 WL 3906461). Accordingly, an OIG Fraud Alert technically is not the law and a “suspect” practice identified by OIG does not render an arrangement per se illegal or unlawful. Nevertheless, Proove Biosciences takes the OIG Fraud Alert quite seriously and invests significant resources in its efforts to comply with all federal laws and regulations.
 








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