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Proove Bioscience

Quote




Proove taking advantage of workers comp????????

The reason lawmakers and regulators create rules that seem onerous and ponderous to the vast majority of us is because there are "outliers" that ruin it for everyone else because of indescribably selfish behavior.

There's always someone taking a new angle to take advantage of the liberal rules of workers' compensation for their own profit regardless of the social consequences. This seems particularly acute in California, but nevertheless occurs in other jurisdictions too.

Recently posted in the WorkCompCentral Forums was an inquiry as to whether anyone else in the community is starting to see bills for unsolicited services related to genetic testing for drug addition predisposition.

The author of the post, an attorney for the employer/carrier, says that the case in question had been settled. In preparing the settlement documents a review of California's Electronic Adjudication Management System database was conducted to identify all parties. Nearly all lien claims had been settled, but one remained stubbornly immovable (and I'm not even clear that the parties were ever properly served and/or noticed of this particular vendor until the end of the case).

For this one particular lien the claim file notes apparently show a request for billing and report after discovery of the vendor in the EAMS search. The carrier got fax copies of a bill and report with a demand for payment.

The bill was for $3,626.00 for the genetic testing.

According to the post, the initial report, based on an exam 5 months post injury, is silent about any request. There was nothing about the injured worker previously having any problem with any type of medication which might make a doctor want to see if a predisposition existed.

The reason given in the report for the genetic testing was the patient "presenting with clinically-validated, and established risk factors."

I wonder if the injured worker actually knew that he had presented "clinically-validated, and established risk factors" of drug addiction...

The forum post further says that buried in the documents including the Explanation of Benefits is an unsigned form by the doctor, quoting ACOEM without citation stating genetic testing is supported "when it is clear that the genetic trait directly affects job performance, when the trait being screened for predisposes a worker to significant, constant adverse outcome following an otherwise acceptable workplace exposure. Clearly, opioid abuse is such a significant consistent adverse outcome following acceptable exposure to prescribed pain medication."

Apparently the lien claimant also forwarded to the defense attorney an EOB from some company in Wisconsin claiming a value of $2,352.00.

Here's the really sad part - the attorney admits that it is a real possibility that the carrier will just settle rather than take the issue to trial.

This testing in my opinion is just another new attempt to milk a comp claim by an unscrupulous provider. There is no reason, no justification whatsoever, for genetic testing to determine predisposition to addiction. Please... there is no valid medical science that can justify this.

It's a shame if the carrier settles. Doing so just provokes more of this BS, and frankly it would show that the carrier doesn't really care about the employer, or about the work comp system in general because the cost just gets passed through to the employer via x-mod. My guess is if this were a vigilant self-insured there would be no question about a challenge and putting an end to such madness before it escalates.

This is the kind of crap that absolutely should not be tolerated in work comp. I'm all for treating an injured worker with the benefit of a doubt and providing medical TREATMENT and benefits that are reasonable, necessary, and supported by valid science.

Genetic testing for pre-disposition to addiction is silly, unwarranted, with no valid basis whatsoever. If the physician is concerned about addiction then the remedies are already available: ACOEM, ODG and the others all have guidelines for the APPROPRIATE prescription of pain medication, including opioids; OR just don't make such prescriptions!

Maybe I'm wrong. Maybe there really is some valid, justifiable reason for over $3,000 of genetic testing ... beyond someone's shameless, unconscionable profiteering off the backs of injured workers and their employers.

I try to keep an open mind. But I just can't in this case.

Postscript: The case number involved is ADJ8124670, and I understand the vendor is*SALUGEN MEDICAL GROUP - the case is set for a lien conference on 10/23.
 




worker comp doc giving his opinion

Maybe I'm wrong. Maybe there really is some valid, justifiable reason for over $3,000 of genetic testing ... beyond someone's shameless, unconscionable profiteering off the backs of injured workers and their employers.

SPORTSFANS....THIS SAYS IT ALL...
 




Maybe I'm wrong. Maybe there really is some valid, justifiable reason for over $3,000 of genetic testing ... beyond someone's shameless, unconscionable profiteering off the backs of injured workers and their employers.
 




future of Proove Bioscience?????

Question...........How would the results of the testing change the MD/DO's treatment plan? It is the same question that we should be asking our physicians whenever they request diagnostic testing of any kind, especially at the first or second visit.Would you "just say no" to those with the genetic pre-disposition? Would the test be utilized by the doctor to just pat the chronic pain patient on the hand and tell them, "here is you heating pad, ice pack, and a bottle of 600 ibuprophen? That's all I can give you because of your genetic test results?"In addition, the way that these tests are being administered, mostly "in the closet" without prior authorization from the IC/TPA/self insured, without explanation to the patient, and with only one very nondiscript sentences in the report. No wonder these tests are questioned, and are automatically red-flagged by all except for the doctors who charge a boatload of $$ to administer.Let's also ask another question. What is the relationship between the lab doing the testing and the doctor who performs the collection? Does money change hands there?***********How about this for controlling narcotics - stop prescribing outside label! These meds weren't designed for back pain or any of the other off-label uses they are being Rx'd for and for which the problems arise. They are for cancer patients, not back pain issues.

We don't need genetic testing.
 
















Anonymous said:
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.......
Click to expand...

How do you know this manager?
Are you sure he is a scam artist?
Any proof?
Anyone suing for breach of contract?
 








Anonymous said:
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
Click to expand...


Class action Lawsuit?
Received any payments yet?
Suing the distributor in Kentucky or Proove or both?
 




Anonymous said:
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?
Click to expand...

Who is Joe?
Is he the same "scam artist" refered in another post?
What did he say or do that is unethical?
 








Question...........How would the results of the testing change the MD/DO's treatment plan? It is the same question that we should be asking our physicians whenever they request diagnostic testing of any kind, especially at the first or second visit.Would you "just say no" to those with the genetic pre-disposition? Would the test be utilized by the doctor to just pat the chronic pain patient on the hand and tell them, "here is you heating pad, ice pack, and a bottle of 600 ibuprophen? That's all I can give you because of your genetic test results?"In addition, the way that these tests are being administered, mostly "in the closet" without prior authorization from the IC/TPA/self insured, without explanation to the patient, and with only one very nondiscript sentences in the report. No wonder these tests are questioned, and are automatically red-flagged by all except for the doctors who charge a boatload of $$ to administer.Let's also ask another question. What is the relationship between the lab doing the testing and the doctor who performs the collection? Does money change hands there?***********How about this for controlling narcotics - stop prescribing outside label! These meds weren't designed for back pain or any of the other off-label uses they are being Rx'd for and for which the problems arise. They are for cancer patients, not back pain issues.*We don't need genetic testing.
 








Which states are investigating them? There must be a lot of former reps and employees out there that could file a hell of a class action suit...so where are the attorneys if these guys are really as bad as they are portrayed?
 




Anonymous said:
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.
Click to expand...
 




He better watch out... Their are very seasoned people- ex reps. looking into a law suit. I think he would throw is mother under the bus to get a sale and not pay her a commission for the referral! You cannot treat people this way, the word will get around town.
 




Anonymous said:
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.
Click to expand...
 




Anonymous said:
He better watch out... Their are very seasoned people- ex reps. looking into a law suit. I think he would throw is mother under the bus to get a sale and not pay her a commission for the referral! You cannot treat people this way, the word will get around town.
Click to expand...


Anyone interested in joining us with a class action lawsuit coming soon?
Respond with your alias, and we will round everyone up that have been screwed by Proove!
 




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