Millennium Health may pay $250 million to settle whistleblower allegations

Millennium Health logo

Urine drug toxicology giant Millennium Health (MH) is reportedly negotiating a settlement with the federal government for as much as $250 million according to the Wall Street Journal.  In addition, another outlet has reported MH is meeting with restructuring consultants and bracing for potential additional lawsuits from its lenders and private payors.

A source told me about a month ago that MH and the federal government were working on a settlement that could reach $250 million, but I was unable to obtain independent confirmation, so I did not proceed with an article at that time.

What did Millennium allegedly do?

I was able to get ahold of a Civil Investigative Demand (CID) letter the Department of Justice (DOJ) sent to a physician back in August 2014 that required the physician to “provide documents and testimony to the Federal Government, and to answer the attached interrogatories.”

The CID stated the DOJ was investigating allegations that the physician “… and/or [MH] submitted, or caused to be submitted, false claims to federal health care payors […] for medically unnecessary urine drug testing (“UDT”)” and that MH “provided kickbacks or other forms of unlawful remuneration to health care providers […] in order to induce UDT referrals to [MH]”.

The DOJ told the physician its primary areas of inquiry were:

  1. Submission of claims for UDT services and reimbursement for those claims;
  2. Medical necessity of UDT generally and for specific patients;
  3. Ordering of UDT, including, but not limited to, the documents and forms used to order UDT;
  4. Sales practices concerning UDT directed towards you or the entities for which you work, including, but not limited to, promises or provision of free goods and services; and
  5. Remuneration by urine drug laboratories to you or the entities for which you work

The documents requested and interrogatories also provide additional insight into the government’s investigation.  Among the documents requested were:

  • All contracts and agreements including custom profiles and/or standing orders
  • All documents concerning payments or other remuneration (including meals, staffing assistance, discounted equipment, assistance with CLIA certifications and electronic medical records, and speaker fees)
  • All documents concerning waiver of co-pays by MH
  • All documents submitted to MH including requisition forms, custom profiles, and standing orders
  • All documents concerning medical necessity of UDT, including confirmatory or quantitative testing of negative UDT screen results performed at the point-of-care
  • All patient records and billing files for eleven patients listed

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Kickback allegations against LabCorp in Georgia whistleblower suit dismissed

(examiner.com)

(examiner.com)

A US district court judge in Atlanta has dismissed the federal kickback allegations made against LabCorp in a whistleblower suit filed by Chris Riedel, former owner of Hunter Laboratories.  At the same time, the judge remanded the suit’s state law claims back to Georgia state court.

Background

Mr. Riedel originally filed the current whistleblower suit against both LabCorp and Quest Diagnostics in January 2008, and alleged the two lab giants made false claims to Georgia Medicaid by submitting claims for payment that were significantly higher than the maximum allowable reimbursement rates under Georgia’s Medicaid program.

Mr. Riedel also accused Quest and LabCorp of “provid[ing] kickbacks in the form of deeply discounted private rates to draw in large volumes of ‘pull through’ Medicaid and other referrals” and argued this is a violation of the federal Anti-Kickback Statute (AKS).

The state of Georgia declined to intervene in the suit in August 2012, but Mr. Riedel continued with the action on his own.  Because of the distinctly federal question raised by the AKS allegation, the case was removed to federal court on May 31, 2013.

Quest and LabCorp filed motions to dismiss the suit in July 2013, which Mr. Riedel opposed.  Then in November 2013, the court was notified Mr. Riedel and Quest had agreed on the financial terms of a settlement, but still needed to negotiate non-financial terms.  Apparently those negotiations were eventually successful, because according to court documents, the settlement agreement between Mr. Riedel and Quest was executed on March 5, 2014.  To my knowledge, the contents of that agreement have never been made public.

Mr. Riedel amended his complaint against LabCorp (which was not a party to the settlement agreement) in January 2015, but still alleged LabCorp offered deeply discounted rates to parties other than Georgia Medicaid, and made false claims to Georgia Medicaid by “falsely representing that the fees being charged were no greater than the maximum fees payable pursuant to Georgia regulations.”

In addition, Mr. Riedel again argued these deeply discounted rates, which were lower than LabCorp’s cost to perform the tests, were a kickback designed to induce the referral of tests for beneficiaries of government health care programs, which were then billed out at much higher rates.

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Two pain docs arrested for urine drug toxicology testing fraud

PPSA patients waiting in line (Fox10 News)

Patients waiting in line outside PPSA on May 21, 2015 (Fox10 News)

“We are committed to the highest standard of patient care.”  That is a quote from the website of Dr. John Patrick Crouch and Dr. Xiulu Ruan of Physicians’ Pain Specialists of Alabama (PPSA), who were arrested on May 20, 2015 by federal agents after being indicted on charges of unlawful distribution of controlled substances and healthcare fraud related to urine drug toxicology (UDT) testing.

Unfortunately, not many details are available in the indictment, Department of Justice press release, and various media reports, but I am sure more will come out as the case progresses.  Like other cases involving health care fraud (alleged, proven and/or admitted) I have discussed on the site, the lifestyles of the involved parties is quite fascinating (see below).

Drs. Couch and Ruan were arrested as part of “Operation Pillution”, a federal law enforcement effort aimed at prescription drug abuse in the southern US. On the day the two were taken into custody, federal agents conducted raids on multiple pain clinics and pharmacies in Arkansas, Alabama, Louisiana and Mississippi.

Indictment Contents

Distribution of Controlled Substances

In addition to owning PPSA, Drs. Couch and Ruan also own C&R Pharmacy, which I believe is located in the same building as PPSA.

Couch

Dr. John Patrick Couch (fox10tv.com)

Starting in about January 2011, Drs. Couch and Ruan allegedly conspired to distribute and dispense numerous Schedule II controlled substances “outside the usual course of professional practice and not for a legitimate medical purpose”.

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Whistleblower allegations against Family Dermatology/Nelson Dermatopathology

Dr. Paula Nelson being confronted by a reporter (CBS46.com)

Dr. Paula Nelson being confronted by a reporter (CBS46.com)

A couple of weeks ago I wrote about the Department of Justice press release that announced Family Dermatology, which also operates a dermatopathology laboratory called Nelson Dermatopathology, had agreed to pay a little more than $3.2 million to settle allegations it violated the False Claims Act.

At the time, the whistleblower suits that contained the allegations were not yet on PACER, so I could not get into any more detail than was provided by the DOJ.  But now I have the three suits in hand and can discuss the allegations that were brought against Family Dermatology/Nelson Dermatopathology that led to the settlement.

The whistleblower suits were filed by three different dermatologists (Scott Ross, Harold Milstein and Mark Baucom); Dr. Ross’ is the longest and most detailed and will be discussed first.

Dr. Scott Ross’ Facts/Allegations

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Aetna sues Health Diagnostic Laboratory and Bluewave Healthcare Consultants

Aetna

In a lawsuit filed earlier this month, health insurer Aetna seeks to recover “tens of millions” of dollars from Health Diagnostic Laboratory (HDL) and its sales contractor Bluewave Healthcare Consultants, claiming they paid illegal kickbacks to physicians and encouraged them to order unnecessary tests, and provided unlawful inducements to patients.

This lawsuit follows closely on the heels of the announcement from the Department of Justice that HDL will pay at least $47 million and could pay as much as $100 million to settle similar allegations in three separate qui tam lawsuits.

Factual Allegations

Aetna begins with a brief discussion of its network and how Aetna members have to pay substantially more copayment or coinsurance if they use an out-of-network provider.  This obviously serves as an incentive to stay in-network, which then leads to lower health care costs for the company, since the providers within the network have already agreed to a set fee for their services.

If an out-of-network provider is used, Aetna will have to pay far more for services since the providers do not have a contract.

HDL is not in Aetna’s network.  In order to secure referrals from Aetna physicians (who are contractually obligated to refer patients/services to in-network providers, including laboratories, whenever possible) to go outside Aetna’s network, HDL and Bluewave paid physicians $20 per specimen.  Aetna points out this is more than 6 times what Medicare allows.

HDL logoReaders may recall one of the qui tam suits I covered on April 13th (United States ex rel. Riedel v. Health Diagnostic LaboratoryInc., et al.) alleged physicians could increase the payments they received from HDL, Bluewave and Singulex depending on how they packaged the samples and ordered the tests:

A physician can draw four vials of blood, order four tests, ship them in four packages to defendants, and receive an $80 packaging fee.

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Contributor to Palmetto GBA ancillary stain local coverage determination speaks out

Palmetto

I received this comment from a (frustrated) member of the College of American Pathologists (CAP) House of Delegates who helped write the ancillary stain local coverage determination (LCD) policy for Medicare Administrative Contractor Palmetto GBA.

With the member’s permission, I am posting the comment in its entirety. Hopefully there will be a good discussion on this topic at the House of Delegates meeting that begins March 21st, because it is a very important issue.


When I was in college I brought a 1961 Ford Falcon. I truly think it was one of the worst cars ever built. But it was all I could afford.

Not long after buying the car it developed an emission problem. Large amounts of smoke came out the tail pipe. Since I grew up in rural Montana and we had to fix a lot of our cars ourselves, I knew the car was doomed. There was probably a split in the manifold or some other very costly area of the innards. I checked with a mechanic who told me it would cost me more than the car was worth to fix it.

Since the car only smoked visibly when idling, I made it a practice of driving only at night and only on less heavily travelled streets.

One Saturday morning I absolutely had to drive to the pharmacy in daylight. So I took a potato from the kitchen commons and stuffed it in the tail pipe. Voila! No smoke from the tail pipe. I drove to the pharmacy but had to stop at a red light. Idling, black smoke started to come out from under the hood and the car coughed, sputtered, and died.

The Falcon was towed to the car mortuary where it was pronounced dead.

I am reminded of that story as I watch the CAP fail by trying to stuff really important issues into the tailpipe of our collective professional car.

I am one of many actively practicing community and academic pathologists (CAP members) who contributed to the Palmetto GBA LCD on special stains and immunohistochemistry (IHC).  Instead of working with the LCD, the College rejected the LCD outright and asked for it to be withdrawn.  By doing so, the College has squandered a wonderful opportunity to address serious issues facing our profession.  In essence, the College made a potato out of it and stuffed it in the tailpipe.

Across the country every day there are pathologists and other physicians who are abusing the system in a systematic fashion. They are ordering tests (special stains and IHCs) that are not medically needed, and are doing so for financial gain. Patients financially suffer, Medicare gets pillaged.  And the College turns a blind eye.

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46 month prison sentence given to Polaris Allergy Labs owner for faking test results

gavel

Mr. Rahsaan Garth, owner of Polaris Allergy Labs in East Point Georgia, has been sentenced to 3 years 10 months in prison followed by 3 years of supervised release, and has been ordered to pay approximately $246,000 in restitution for faking the results of allergy tests.

According to the Criminal Information filed by federal prosecutors, Mr. Garth opened Polaris, which provided skin “scratch” and blood allergy testing for food and environmental allergens in both children and adults, in March 2011. Polaris employed an unspecified number of phlebotomists, who were placed in referring physician offices to perform the scratch tests as well as draw blood.

Ordinarily, the phlebotomists would send a requisition form which contained the specific allergens the physician wanted to be tested along with the blood back to Polaris, where a laboratory technician would test the patient’s serum on an Immulite 2000 analyzer.

But, starting in September 2012 and continuing until February 2014, Mr. Garth instructed his lab technician to forego the requested testing if the patient was older than 12 years of age or was an adult who did not have a “reported highly allergic” scratch test so as to save money on testing reagents.

The lab tech was instructed in these cases to simply throw the patient’s blood away and send a blank test report form to Mr. Garth, who would fabricate the test results and send them to the requesting physician.  Mr. Garth would sometimes generate reports that indicated the patient did not have a reaction to any of the allergens requested, but, in an effort to keep physicians from growing suspicious, would also occasionally report positive results as well.

In other instances, if Polaris did not have certain allergen reagents in stock, Mr. Garth would instruct the lab tech to perform tests with the reagents Polaris did have, and Mr. Garth would simply falsify the results for the allergens not in stock.

Mr. Garth also apparently sometimes falsified results in patients younger than 12 and in patients who had reactive skin tests.

[Read more…]

CFO of pain management clinics pleads guilty to receiving laboratory kickbacks

Gavel

Vic Wadhwa, former Chief Financial Officer (CFO) of Advanced Pain Management Services in central Maryland, has pled guilty to soliciting and accepting kickbacks from an unnamed laboratory in northern New Jersey totaling almost $1.4 million from July 2011 to July 2012.

Those who read the plea agreement will notice Advanced Pain’s name, as well as the name of Advanced Pain’s CEO, Muhammad Khan, do not appear in the text.  Those names, however, are disclosed in a separate civil lawsuit filed by Advanced Pain against Misters Wadhwa and Khan in 2012. Unfortunately, neither document contains the name of the New Jersey laboratory in question.

Kickback Scheme Details in Plea Agreement

Mr. Wadhwa was the CFO of Advanced Pain, which generated “hundreds” of urine drug toxicology specimens every month, from December 2009 until August 2012.  In February or March 2011, Mr. Khan told Mr. Wadhwa there was a urine drug toxicology laboratory in northern New Jersey that was willing to “pay a kickback for every urine toxicology specimen”.

Mr. Wadhwa conducted the negotiations with the laboratory owner, who agreed to kick back half of the lab’s after-expense profit for every urine toxicology sample referred.  In March 2011, Advanced Pain stopped sending specimens to the laboratory that to that point had provided “satisfactory” service and switched to the New Jersey lab.  The kickback payments did not begin until July 2011.

The kickback arrangement lasted 16 months, and during that time, the laboratory received a total of $4,033,846.70 in reimbursement from private insurers (~$3.5 million), Medicare ($530,191.13), and the Federal Employees Health Benefit Program ($7,562.83).  It cost the laboratory $690,602.69 to perform the tests referred to it by Advanced Pain.

The laboratory paid a total of $1,376,540.85 in kickback payments between July 2011-July 2012.  Of this, Mr. Wadhwa received $459,245.92, Mr. Khan received “more than $400,000″, and the rest was distributed to “other persons associated with [Advanced Pain].”

After all expenses and kickback payments, the laboratory still netted “substantially in excess of $1 million” in profit during the 16 month scheme.

Mr. Wadhwa faces a maximum of 5 years in prison and a $250,000 fine when he is sentenced on April 2, 2015.

Laboratory-Related Allegations in Advanced Pain Management Services, LLC v. Vic Wadhwa, et al.

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Health Diagnostic Laboratory asks court to dismiss $84 million fraud suit filed by Cigna

HDL logo

Health Diagnostic Laboratory (HDL) has filed a motion to dismiss the $84 million fee-forgiving fraud suit filed by Cigna, arguing the insurer’s use of the amended Employment Retirement Security Act of 1974 (ERISA) is fatally flawed.

Allegations

Very briefly, Cigna, in its suit filed in October 2014claims HDL:

…lures patients from health plans that are administered or insured by Cigna by misrepresenting those patients’ responsibilities under the plans, by promising not to collect any co-payment, co-insurance or deductible obligation, and by further promising not to seek reimbursement for any other portion of its bill that the plan does not cover. HDL then misleadingly bills the plans themselves at exorbitant and unjustified “phantom” rates—rates that misrepresent what HDL actually intended to collect.

HDL’s memo of law in support of its motion to dismiss

The bulk of HDL’s argument centers around Cigna’s use of ERISA as the basis for its claims and offers six reasons why the suit should be dismissed:

  1. Cigna lacks standing as a fiduciary under ERISA
  2. Cigna failed to comply with ERISA’s administrative process for adverse benefit determinations
  3. Cigna failed to identify any ERISA provisions that were violated and resulted in harm
  4. Cigna failed to allege damages that can be compensated under ERISA
  5. Cigna’s state law claims are preempted by ERISA
  6. Cigna failed to “allege fraud with particularity”

What follows is a summary of HDL’s arguments in its Memorandum of Law in Support of Motion to Dismiss.

Cigna lacks standing under ERISA

Under ERISA, only “participants, beneficiaries, and fiduciaries” may seek relief.  ERISA further states a fiduciary may only recover funds for the plan(s) it administers, and not for the fiduciary itself.

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Cigna sues Health Diagnostic Laboratory for fee-forgiving fraud

HDL logo

Health insurance provider Cigna has filed suit against Health Diagnostic Laboratory (HDL), alleging HDL unlawfully obtained at least $84 million from it through a “fraudulent fee-forgiving scheme”.

Readers will recall HDL is one of the laboratories being investigated by the Office of the Inspector General (OIG) for the Department of Health and Human Services for possibly paying kickbacks to physicians in exchange for referrals. Not soon after that fact came to light, the HDL CEO, Tonya Mallory, resigned.

Allegations

Cigna states one of its responsibilities is to control health care costs for its benefit plans.  It accomplishes this in part by offering incentives to its members to use providers that are in Cigna’s network, who generally charge lower rates than out-of-network providers.

If a member chooses to utilize an out-of-network provider, Cigna requires that member to pay a higher portion of the costs than it would if an in-network provider were used.

HDL, which is not in Cigna’s network, allegedly:

…lures patients from health plans that are administered or insured by Cigna by misrepresenting those patients’ responsibilities under the plans, by promising not to collect any co-payment, co-insurance or deductible obligation, and by further promising not to seek reimbursement for any other portion of its bill that the plan does not cover. HDL then misleadingly bills the plans themselves at exorbitant and unjustified “phantom” rates—rates that misrepresent what HDL actually intended to collect.

Cigna explains that because no member is paying anything for HDL’s services, its members have “no incentive to moderate their demand for HDL’s services or to consider the higher costs of any particular out-of-network service” and this leads to higher costs for the entire plan.

CignaNot only that, but Cigna states fee-forgiveness undermines the insurance industry as a whole, as members will preferentially use out-of-network providers, for whose services they are charged nothing, rather than in-network providers, whose services require the member to pay something.  This would lead fewer providers to join insurance networks, which would make health care more expensive overall.

Cigna argues the American Medical Association, the federal government and the courts have long recognized fee forgiveness as a form of medical billing fraud.

Cigna also accuses HDL of encouraging physicians to order “a litany of medical tests, regardless of whether the provider believes such tests are needed to diagnose or treat the patient”, and also of paying kickbacks to physicians in exchange for referrals (the OIG investigation).

The complaint states HDL did not disclose its fee forgiveness program to Cigna, and that it only became aware of the existence of the program when it came across patient flyers and brochures that explain the program.  Cigna then began investigating HDL by sending questionnaires to Cigna members who utilized HDL.

The 27 responses it received confirmed Cigna members were not paying anything for HDL’s services.  In addition, Cigna claims the members relayed false information provided to them by their physicians and HDL about HDL’s billing practices and Cigna’s policy.

When Cigna confronted HDL about its billing practices, then-CEO Tonya Mallory assured Cigna that HDL will not engage in fee forgiveness as “a general practice” and that all claims forms submitted to Cigna will reflect “the actual charge for the services(s) provided.”

Causes of Action

  • Claim for Overpayments Under ERISA
  • Unjust Enrichment
  • Fraud
  • Negligent Misrepresentation
  • Tortious Interference with Contract
  • Claim for Unfair and Deceptive Business Practices Under Connecticut’s Unfair Trade Practices Act and Unfair Insurance Practices Act
  • Declaratory Relief

Jury Demand

Cigna is asking for a jury trial for all non-ERISA claims.

Prayer for Relief

  • A declaration that the products and services provided by HDL do not constitute covered services under the employee health and welfare benefit plans administered or insured by Cigna and that HDL is not entitled to receive any payments on the claims for reimbursement that it has submitted or may submit in the future as part of the fee-forgiving practices
  • Return of any all monies paid to HDL on claims for reimbursement submitted by HDL
  • Monetary, exemplary and punitive damages
  • Pre- and post-judgement interest
  • Court costs and attorney fees

The full complaint is here.