Home / Health Care / February 2019 Health Care Qui Tam Update – The National Law Review

February 2019 Health Care Qui Tam Update – The National Law Review

Overview of Qui Tam Activity

  • We recognized 49 health care-related qui tam instances that have been unsealed in September and October 2018.

  • The authorities intervened in entire or partially in 10 of these 49 unsealed instances, which is according to the general intervention price of 20% throughout 2018.

  • Twelve of the 49 unsealed instances have been dismissed of their entirety.

  • The 49 unsealed instances have been filed in 27 totally different courts. The district with probably the most unsealed instances was the Southern District of Ohio (Cincinnati) with six instances. The Eastern District of Pennsylvania (Philadelphia) and the Eastern District of New York (Brooklyn, Queens, and Long Island) every had 4 unsealed instances. The Northern District of Georgia (Atlanta) had three unsealed instances.

  • Fourteen of the 49 unsealed instances have been introduced towards pharmaceutical and biotech corporations. Six instances have been unsealed towards hospitals and hospital methods, whereas one other six unsealed instances named physicians and doctor apply teams as the first defendants.

  • Current or former staff introduced 27 of the 49 instances. Two instances have been filed by sufferers.

  • None of instances was unsealed inside the 60-day interval specified by statute. The shortest time underneath seal was 124 days, whereas the longest time underneath seal was six years and 4 months. The common time beneath seal for this group of unsealed instances was 763 days, or simply over two years. However, 12 instances – or simply a few quarter of the 49 unsealed instances – have been unsealed inside one yr of submitting.

Featured Cases

United States ex rel. Allstate Ins. Co. v. Ameritox, Ltd., No. 1:14-cv-03855 (E.D.N.Y.)

Complaint Filed: June 20, 2014

Complaint Unsealed: September 12, 2018

Intervention Status: The authorities declined to intervene on this case.

Claims: False Claims Act (“FCA”), 31 U.S.C. § 3729 et seq.; cost beneath mistake of reality; unjust enrichment

Defendant’s Businesses: The defendant owns and operates laboratories in Texas and North Carolina and performs urine drug testing on specimens collected from sufferers throughout the United States.

Relators: Allstate Insurance Company and Lawrence Okay. Spitz, M.D.

Relator’s Relationship to Defendant: Ameritox submitted payments and claims for urine drug testing to Allstate. Allstate employed Dr. Spitz as an skilled to take part in its investigation of Ameritox’s payments.

Relators’ Counsel: Richard D. King, Nathan A. Tilden, and Jacquelyn McEttrick of Smith & Brink, P.C.

Summary of Case: Allstate, a property and casualty insurer, used Ameritox for urine drug testing. Allstate retained Dr. Spitz as an professional to evaluate Ameritox’s payments to the insurer. The relators alleged that Ameritox engaged in a scheme to defraud the United States by submitting reimbursement claims for providers that weren’t offered, not medically vital, or each. Specifically, Ameritox purportedly 1) billed for quantitative urine drug testing that was not truly carried out, 2) billed for confirmatory drug testing that was pointless and carried out in violation of the usual of care relevant within the medical laboratory group, three) billed for duplicative and pointless urine drug screening, and four) used fraudulent billing practices, together with unbundling and billing a number of models of a “per patient encounter” billing code. According to the relators, Ameritox “exploited its superior knowledge of esoteric laboratory and billing practices and took advantage of [the government’s] lack of familiarity with the same” to hold out its allegedly fraudulent scheme. The relators additional alleged, with supporting affidavits from former Ameritox staff, that Ameritox incentivized its staff to strain doctor shoppers to refer extra samples and to refer sufferers with insurance coverage extra more likely to pay Ameritox’s claims for testing, specifically Medicare. The relators claimed that Ameritox paid kickbacks to doctor shoppers within the type of free or discounted specimen cups, present playing cards, money funds, and placement of Ameritox staff in physicians’ workplaces freed from cost, in change for, or to encourage, referrals. In addition, Ameritox supposedly required physicians to submit specimens for testing that was not medically crucial, by requiring that such physicians choose a panel comprised of at the least eight checks, even when a number of of these eight checks was not essential.

Current Status: The relators voluntarily dismissed the motion with out prejudice on December 19, 2018. The authorities assented to the dismissal, stating that “the matter does not warrant the continued expenditure of government resources to pursue or monitor the action based on currently available information.”

Reasons to Watch: Although this case was dismissed, it highlights two probably fascinating tendencies. The first is the position of a giant company insurance coverage firm serving as a FCA whistleblower. Private insurance coverage firm audits of suppliers supply the potential to uncover points resembling over-utilization, upcoding, or lack of medical necessity, all of which might probably have an effect on authorities payors and personal payors alike. It is feasible that non-public payors that uncover such supplier conduct might more and more pursue FCA claims along with personal cures. Such was the case right here, the place Allstate filed its personal grievance towards Ameritox asserting direct claims underneath the Racketeer Influenced and Corrupt Organizations (“RICO”) statute, 18 U.S.C. §§ 1961-68. See Allstate Insurance Co. v. Ameritox Ltd., No. 1:16-cv-00939 (E.D.N.Y.). That declare was additionally dismissed voluntarily. Nonetheless, these instances towards Ameritox exhibit how personal payors can open a multifront battle towards a supplier accused of false or fraudulent billing practices.

Also of curiosity right here is the give attention to billing practices associated to drug testing for substance abuse-associated points. The rising effort to fight opioid abuse signifies that the quantity spent on these sorts of providers will proceed to develop, so it’s doubtless that an growing variety of instances will contain providers to display for and deal with opioid abuse.

United States ex rel. Doe v. Singulex, Inc., No. four:16-cv-05241 (N.D. Cal.)

Complaint Filed: May 22, 2017

Complaint Unsealed: August 22, 2018

Intervention Status: The authorities intervened for functions of settlement on August 22, 2018.

Claims: FCA, 31 U.S.C. § 3729 et seq.

Defendant’s Business: Clinical laboratory providing greater than 100 blood exams to physicians for functions of diagnosing and treating numerous medical circumstances.

Relators: Relators initially proceeded anonymously as Jane and John Doe, however later have been recognized as Vicki Swartzell and Jim Vandermeer.

Relator’s Relationship to Defendant: The relators have been gross sales representatives for Singulex.

Relators’ Counsel: Daniel R. Miller, and Joy P. Clairmont of Berger & Montague, P.C.; and Joe Siegal

Summary of Case: In May 2016, Singulex allegedly launched a scheme to defraud Medicare by growing orders of purportedly medically pointless exams, which it referred to as the “Medical Necessity Coding Project.” According to the relators, administration redesigned Singulex’s check requisition types by including further exams in a fashion that purportedly manipulated analysis codes to maximise Medicaid reimbursement. Management allegedly pressured its gross sales staff to strain physicians to order medically pointless testing, by directing the whole gross sales drive to “instruct all providers to pick at least three” of the analysis codes obtainable on the entrance web page of the newly redesigned type. When physicians didn’t order sure analysis codes, Singulex gross sales representatives and phlebotomists purportedly checked off the omitted codes on the order varieties. Relators alleged that this scheme resulted in a rise in Medicare reimbursements of “6,000-13,000%.”

Current Status: The United States intervened on August 22, 2018, and the grievance was unsealed that very same day. On September 18, 2018, the events entered right into a Joint Stipulation of Voluntary Dismissal of the FCA claims, which the courtroom entered on January 16, 2019. According to the federal government’s press launch, the settlement requires Singulex to pay $1.25 million. In agreeing to the settlement, Singulex disclaimed any wrongdoing or violation of the FCA. Relator Swartzell, nevertheless, continues to advance claims towards Singulex for retaliation and nonpayment of wages.

Reasons to Watch: This case typifies the growing focus in FCA instances on problems with medical necessity. In its intervention discover, the federal government particularly predicated its motion on allegations that “Singulex knowingly pressured health care providers to select” analysis codes with out regard to sufferers’ medical circumstances or to order checks with out regard to medical necessity. Although Singulex denies any wrongdoing, the federal government’s consideration to this case demonstrates the willingness of the federal government to make use of the FCA as a device to police over-utilization of federally reimbursed health care providers, even the place a case activates points like medical necessity that require evaluating physicians’ subjective medical judgments. Programs by laboratories that may be depicted as makes an attempt to affect doctor ordering practices will doubtless face shut scrutiny.

United States ex rel. Goldman v. Primus Healthcare LLC, No. 1:18-cv-00062-BAH (D.D.C.)

Complaint Filed: January 11, 2018

Complaint Unsealed: October three, 2018

Intervention Status: The authorities declined to intervene on October 1, 2018.

Claims: FCA, 31 U.S.C. § 3729 et seq.

Defendant’s Business: Defendant is a administration agency that gives persistent care administration and annual wellness go to providers to doctor practices.

Relator: Bryant Goldman

Relator’s Relationship to Defendant: The relator is a medical billing and compliance marketing consultant who suggested one in every of defendant’s contract physicians.

Relator’s Counsel: Kenneth Joel Haber of the Law Office of Kenneth Joel Haber, P.C.

Summary of Case: According to the relator, Primus, the defendant, marketed its telemedicine providers as a “turnkey” program. As a part of this system, Primus instantly recognized a contract doctor’s qualifying sufferers, contacted sufferers by phone, offered telephonic affected person monitoring providers, and billed Medicare. The relator, a medical billing and compliance marketing consultant, alleged that Primus defrauded Medicare as a result of Primus didn’t adjust to Medicare’s doctor supervision necessities whereas offering its continual care administration and annual wellness go to providers. Primus purportedly educated unqualified name middle staff to maintain continual care administration sufferers on the telephone for the 20-minute minimal required to invoice the service to Medicare, no matter whether or not a 20-minute name was required based mostly on the affected person’s particular medical situation. The relator additional alleged that Primus employees carried out wellness visits with out the legally required doctor supervision and incentivized advertising agent contractors by way of a quantity-based mostly cost program that elevated the prospect of Medicare fraud.

Current Status: Relator entered a discover of voluntary dismissal on October 29, 2018. The case was dismissed with out prejudice on November 7, 2018.

Current Status: Health care providers are more and more offered on a broad scale by way of telemedicine suppliers. As this case highlights, telemedicine suppliers will in all probability draw shut scrutiny with respect to employees qualifications and doctor supervision. The rising prevalence of these kinds of providers makes it possible that claims like these superior on this case will turn into extra prevalent.

United States ex rel. Mohatt v. Healthcenter Northwest LLC, No. 9:18-cv-00080-DWM (D. Mont.)

Complaint Filed: April 30, 2018

Complaint Unsealed: September 28, 2018

Intervention Status: The authorities intervened on September 25, 2018.

Claims: FCA, 31 U.S.C. § 3729 et seq.; Montana False Claims Act, (“MFCA”), Mont. Code Ann. § 17-Eight-403 et seq.

Defendants’ Businesses: Defendant HealthCenter Northwest, LLC is a basic acute care hospital situated on the campus of Kalispell Regional Healthcare System (KRHS). Defendant Flathead Physicians Group, LLC is a gaggle of investor physicians. Defendants Northwest Horizons, LLC and Applied Health Services, Inc. are wholly owned subsidiaries of KRHS. Defendant Northwest Orthopedics & Sports Medicine, LLC is an orthopedic doctor group apply owned by HealthCenter and Applied Health.

Relator: Jon Mohatt

Relator’s Relationship to Defendants: Relator is the previous chief monetary officer for KRHS, an entity associated to the defendants.

Relator’s Counsel: Paul D. Odegaard of Odegaard Braukmann Law, PLLC

Summary of Case: The relator, John Mohatt, introduced six claims towards the defendants underneath federal and state False Claims Acts. Mohatt alleged that, in violation of the federal Stark Law, 42 U.S.C. § 1395nn(a)(1), and Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b(b), the defendants’ funding association unlawfully incentivized collaborating physicians to refer sufferers to HealthCenter and overpaid 5 gynecological surgeons based mostly on the worth of their referrals. The Stark Law prohibits physicians from referring sufferers for laboratory or different designated health providers to an entity with which they’ve a monetary relationship, absent compliance with an out there exception. In addition, the contested preparations additionally purportedly resulted in cost of illegal remuneration to the physicians in violation of the AKS.

As chief monetary officer of KHRC, Mohatt claimed that he was in an advantageous place to watch and doc these Stark regulation violations. Mohatt allegedly uncovered a scheme of secrecy across the identities of doctor buyers in HealthCenter and alleged that this scheme was maintained to keep away from public controversy concerning the physicians’ conflicts of curiosity. These investor physicians purportedly each referred sufferers to HealthCenter and shared in revenues generated by these referrals. This failure to adjust to the federal Stark Law allegedly resulted within the submission of hundreds of false claims to federal and state health care packages.

On September 25, 2018, the case was consolidated with an earlier case introduced by the identical relator towards two entities associated to the defendants, KRMC and Kalispell Regional Medical Center.

Current Status: The United States intervened on September 25, 2018 for functions of settlement. The events within the consolidated instances settled for $24 million, which was the most important False Claims Act restoration in Montana historical past. The relator acquired $5.four million as his share of the restoration. The case was dismissed with prejudice on September 26, 2018.

Reasons to Watch: This case illustrates the dangers for hospitals and physicians within the structuring of possession pursuits and compensation. Hospitals in rural and low-inhabitants areas can face specific challenges in recruiting and compensating physicians. Physician-owned amenities are widespread, however correct structuring of such preparations have to be carried out to keep away from violations of the Stark Law. Here, the alleged failure to construction the physicians’ possession pursuits in accordance with the necessities of the Stark Law supported the massive settlement that the federal government obtained. As this case highlights, the place physicians have possession pursuits in hospitals or outpatient clinics to which referrals are made, correct structuring is crucial to keep away from Stark Law and AKS violations.

Health Care Qui Tam Litigation Trends

Mintz maintains a database of unsealed health care qui tam actions. This database allows us to comply with and analyze tendencies within the instances which were unsealed. The following are some developments in qui tam filings towards health care-related entities within the 12 months that ended on January 31, 2019:

Where have been instances filed? Although instances have been unsealed in jurisdictions all through the nation, some fascinating tendencies have emerged as to jurisdictions the place probably the most instances have been unsealed:

Qui Tam 2019-02 Court Jurisdiction-2

For the 12-month interval that ended on January 31, the Middle District of Florida (Tampa, Orlando, and Jacksonville) continued to be the main jurisdiction for unsealed instances, adopted by the Eastern District of Pennsylvania (Philadelphia), the Central District of California (together with Los Angeles and Santa Barbara), the Southern District of Florida (Miami, Fort Lauderdale, and West Palm Beach), the Southern District of New York (Manhattan, Bronx, and Westchester County), and the Northern District of Georgia (Atlanta).
 

Who introduced the instances? The ranks of relators are starting to diversify.

Qui Tam 2019-02 Relators Relationship-2

In the 12 months that ended January 31, 2019, present and former staff – principally the latter – continued to dominate the ranks of relators, accounting for 67% of all instances. But vital numbers of relators at the moment are discovered amongst clients, business specialists, enterprise companions, consultants, and sufferers.
 

How incessantly did the federal government intervene?

Qui Tam 2019-02 Govt Intervention-2

Intervention charges proceed to be extraordinarily low, with the federal government electing to intervene in solely 20.four% of instances unsealed within the 12 months that ended January 31, 2019.

©1994-2019 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.


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