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A set of seven accompanying qui tam accomplishments against biologic architect Novo Nordisk Inc. (and added affiliated entities, collectively referred to as “Novo Nordisk”) were apparent and acclimatized in September 2017. Novo Nordisk, which is headquartered in Princeton, New Jersey, is a accessory of the Danish aing Novo Nordisk A/S, and sells three drugs targeted at diabetes populations: Novolog, Levemir, and Victoza. The qui tam cases abbreviated beneath all anxious declared apocryphal claims primarily arising from sales of Victoza (liraglutide), a non-insulin, once-daily injectable decree medication acclimated in the analysis of adults with blazon 2 diabetes.

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Complaint Filed: December 28, 2010 (transferred to the District of Columbia from the District of Massachusetts on September 15, 2011)

Complaint Unsealed: September 1, 2017 (in part)

Intervention Status: On July 27, 2017, the United States intervened in part.

Claims: Apocryphal statements, records, and claims in abuse of the FCA, 31 U.S.C. 3729-33 (“FCA”), as able-bodied as analogue claims for violations of accompaniment apocryphal claims acts. Additionally, claims were brought under the California Insurance Frauds Prevention Act (Cal. Ins. Code 1871) and the Illinois Insurance Claims Fraud Prevention Act (740 Ill. Comp. Stat. 92), analogues to the FCA that are applicative to clandestine parties rather than the government.

Relator: Peter Dastous

Relator’s Relationship to Defendant: Dastous was a sales adumbrative (“Diabetes Care Specialist”) for Novo Nordisk who was amenable for selling the company’s diabetes articles to endocrinologists throughout an assigned region.

Relator’s Counsel: Phillips & Cohen LLP

Complaint Filed: February 22, 2016 (transferred to the District of Columbia from the Northern District of Texas on April 28, 2017)

Complaint Unsealed: September 1, 2017 (in part)

Intervention Status: On July 27, 2017, the United States intervened in part.

Claims: Apocryphal statements and counterfeit billing in abuse of the FCA as able-bodied as analogue claims for violations of accompaniment apocryphal claims acts, and additionally allegations of violations of the Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)(2)(A)-(B)) (“AKS”).

Relator: John Doe

Relator’s Relationship to Defendant: Doe 1 was active by co-defendant Convenance Therapeutics as a Registered Nurse and served as a certified diabetes drillmaster for Novo Nordisk’s “Changing Life with Diabetes” program. Doe 2 was active by Novo Nordisk as a certified diabetes educator.

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Relator’s Counsel: Kendall Law Group LLC

Complaint Filed: November 4, 2015

Complaint Unsealed: September 1, 2017 (in part)

Intervention Status: On July 27, 2017, the United States intervened in part.

Claims: Apocryphal or counterfeit claims for acceding in abuse of the FCA as able-bodied as analogue claims for violations of accompaniment apocryphal claims acts, and additionally allegations of violations of the AKS. Additionally, claims were brought under Chicago and New York City’s apocryphal claims acts and Ohio’s bigmouth statute, as were assorted claims for discrimination (, age, and religion) and backfire in abuse of federal law.

Relator: Lesley Ferrara & Shelly Kelling

Relator’s Relationship to Defendant: Ferrara and Kelling were both sales assembly for Novo Nordisk.

Relator’s Counsel: Murphy Anderson PLLC

Complaint Filed: October 15, 2010 (transferred to the District of Columbia from the Southern District of Texas on October 3, 2013)

Complaint Unsealed: September 1, 2017 (in part)

Intervention Status: On July 27, 2017, the United States intervened in part.

Claims: Apocryphal or counterfeit claims for acceding in abuse of the FCA as able-bodied as analogue claims for violations of accompaniment apocryphal claims acts, and additionally allegations of violations of the AKS. Additionally, a backfire affirmation was brought beneath the FCA.

Relator: Elizabeth Kennedy

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Relator’s Relationship to Defendant: Kennedy was a sales adumbrative for Novo Nordisk.

Relator’s Counsel: Berg & Androphy

Complaint Filed: September 25, 2012

Complaint Unsealed: September 1, 2017 (in part)

Intervention Status: On July 27, 2017, the United States intervened in part.

Claims: Apocryphal or counterfeit claims for acceding in abuse of the FCA, as able-bodied as counterpart claims for violations of accompaniment apocryphal claims acts, and also backfire in abuse of the FCA.

Relator: David Myers

Relator’s Relationship to Defendant: Myers was a “Direct Business Manager” for Novo Nordisk.He supervised bounded sales representatives.

Relator’s Counsel: Bailey & Glasser, LLP and Bailess Law, PLLC

Complaint Filed: August 8, 2016

Complaint Unsealed: September 1, 2017 (in part)

Intervention Status: On July 27, 2017, the United States intervened in part.

Claims: N/A

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Relator: Greg Smith, Clint Houck, and Brent Shirkey

Relator’s Relationship to Defendant: N/A

Relator’s Counsel: Lee R. Glass & Neal A. Roberts

Complaint Filed: May 24, 2012 (transferred to the District of Columbia from the District of New Jersey on February 21, 2013)

Complaint Unsealed: September 1, 2017 (in part)

Intervention Status: On July 27, 2017, the United States intervened in part.

Claims: Apocryphal or counterfeit claims for acceding in abuse of the FCA as able-bodied as analogue claims for violations of accompaniment apocryphal claims acts, violations of the AKS, and additionally backfire in abuse of the FCA.

Relator: Mckenzie Stepe

Relator’s Relationship to Defendant: Stepe was a sales adumbrative for Novo Nordisk.

Relator’s Counsel: N/A

These cases all circuitous claims adjoin Novo Nordisk and certain of its business affiliates in affiliation with alleged “off-label” business of Victoza, which had been approved for use in adults with blazon 2 diabetes but was not accustomed for pediatric use. In fact, Victoza’s characterization especially warned that the biologic was not recommended for use in children. Also, the drug was not accustomed for weight accident purposes.

Although capricious as to the specific conduct at issue, relators in anniversary of these cases about declared that Novo Nordisk began to bazaar the biologic for off-label break anon afterwards it was accustomed in 2010. They claimed that Novo Nordisk deliberately courted, as abeyant customers, pediatric diabetes affliction providers. The relators additionally declared that Novo Nordisk marketed Victoza for weight accident through a cardinal advertisement activity meant to work about acknowledged restrictions on Novo Nordisk’s adeptness to market Victoza for off-label, crooked uses. Novo Nordisk allegedly able this by allotment analysis about the abeyant weight accident applications of the drug, which was after appear and then broadcast to alleviative physicians.

The government intervened in allotment in July 2017 and again promptly acclimatized the Victoza cases adjoin Novo Nordisk in September 2017. The DOJ issued a columnist absolution on September 5, 2017 advertisement the $58 actor all-around settlement. In its announcement, the DOJ did not abode relators’ allegations about declared off-label business practices of Novo Nordisk. Instead, the DOJ emphasized that Novo Nordisk had bootless to comply with the Accident Appraisal and Mitigation Activity (“REMS”) appropriate by the Food and Biologic Administration (“FDA”) in affiliation with its approval of Victoza. Specifically, the REMS appropriate that Novo Nordisk put prescribing physicians on apprehension of the abeyant accident that Victoza presented for a attenuate anatomy of thyroid cancer. Allegedly, Novo Nordisk “instructed its sales force to accommodate statements to doctors that blocked the risk admonition and bootless to accede with the REMS” requirements. The adjustment bound both the federal and accompaniment apocryphal claims act allegations apropos to Novo Nordisk’s declared advance of Victoza for crooked pediatric and weight-loss uses.

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The Novo Nordisk cases are constant with the government’s continuing focus on biologic business practices, yet also abode absolute issues apropos to commitment of accommodating care. While off-label business claims of the blazon brought by relators actuality are common, the government’s activity ultimately focused on the declared abortion of Novo Nordisk to accede with the REMS requirements imposed by the FDA. Perceived failures to respect business restrictions generally draw government scrutiny. But here, as in contempo FCA cases axis on questions of medical necessity, the government acclimated the FCA to abode affairs involving clinical judgment. In such cases, the FCA is actuality active as a apparatus to access not alone how claims are paid, but additionally how and on what base physicians exercise their analytic judgment. Application the FCA to accomplish the Victoza REMS may arresting an accretion alertness by the government to use its administration admiral to appearance and adviser the commitment of accommodating care.

Complaint Filed: April 1, 2015

Complaint Unsealed: August 18, 2017

Intervention Status: Partial activity by the United States on August 14, 2017, as adjoin Sightpath Medical, Inc. and TLC Vision Corporation for the purposes of settlement, and adjoin Precision Lens, Paul Ehlen, and Jitendra Sawrup to book a complaint in intervention.

Claims: FCA, 31 U.S.C. 3729 et seq.

Defendants’ Businesses: Actor Sightpath Medical, Inc. (“Sightpath”) provides both adaptable cataract and glaucoma surgical casework and equipment, and LASIK and other refractive surgical casework and equipment. The Cameron-Ehlen Group, Inc. d/b/a Precision Lens (“Precision Lens”) distributes intraocular lenses and added eye-related surgical products.

Relator: Kipp Fesenmaier

Relator’s Relationship to Defendants: The relator formed in assorted capacities for Midwest Surgical Services, Inc., a aggregation that alloyed with addition commodity in 2007 to form Sightpath. The relator larboard Midwest Surgical Casework in 2007 and again formed for a adversary in the aforementioned industry.

Relator’s Counsel: Susan M. Coler of Halunen Law, Jennifer M. Verkamp and Frederick M. Morgan of Morgan Verkamp, LLC

The relator declared that defendants Sightpath and Precision Lens paid actionable kickbacks to physicians to incentivize them to use defendants’ articles and services. These incentives purportedly took such forms as adulterated consulting agreements, discounted equipment, travel, and entertainment.

The complaint asserted, for example, that defendants paid physicians aloft fair bazaar amount and commercially unreasonable account stipends alignment from $ 5,000 to $8,000 for consultancy casework and questioned whether defendants provided any casework at all. Defendants additionally allegedly provided chargeless and discounted use of their adaptable anaplasty equipment. Further, the complaint detailed abundant examples of defendants’ accouterment to physicians of high-end dinners, chargeless fishing and golfing, and trips to luxury resorts to hunt. The relator declared that these extensive remunerations were advised to and did abet physicians to utilize the defendants’ articles and services.

On Monday, August 21, 2017, the DOJ issued a press absolution advertence that Sightpath Medical, TLC Vision Corporation, and their aloft CEO, James Tiffany, had agreed to pay added than $12 actor to the United States to dness this FCA case, predicated on declared kickback violations. In the settlement acceding the United States arguable that amid January 1, 2006, and January 1, 2015, Sightpath provided physicians with items of amount to abet the use of Sightpath’s ophthalmologic products and services, appropriately appointment apocryphal claims to the United States for them. The relator will accept 19.5% of the amounts recovered in affiliation with the adjustment agreement.

As declared in the columnist release, the United States intervened in the qui tam clothing adjoin Precision Lens and owners Paul Ehlen and Jitendra Sawrup, and the United States will abide to accompany its claims adjoin those defendants. On November 15, 2017, the cloister accepted the government’s Request for an Extension of Time to Serve the United States’ Complaint in Activity on defendants Precision Lens, Paul Ehlen and Jitendra Sawrup until mid-January 2018. The United States beneath to arbitrate in the case adjoin added physician defendants called in the complaint. On November 16, 2017, pursuant to a Apprehension of Partial Voluntary Dismissal with the government’s consent, the cloister dismissed the relator’s claims in the activity adjoin the physician defendants as to whom the government had beneath to intervene.

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As this case shows, the government is continuing to focus administration activity on conduct that potentially raises questions about whether physicians accept acclimatized absolute clinical acumen in affiliation with acclimation casework for patients. Meals, travel, and ball allowances provided to physicians by artefact suppliers or account providers can be considered accomplishment in barter for referrals. Particular affliction should be taken to ensure that business activities do not cantankerous that line.

Complaint Filed: July 11, 2016

Complaint Unsealed: August 16, 2017 (unsealed with Court’s Order of Dismissal)

Intervention Status: United States intervened on August 16, 2017.

Claims: FCA, 31 U.S.C. 3729 et seq.

Defendant’s Business: The actor St. Agnes Healthcare, Inc. (“St. Agnes”) operates an acute affliction accepted hospital in Baltimore, Maryland and offers inpatient and outpatient casework to patients.

Relator: Dr. Jonathan Safren

Relator’s Relationship to Defendants: Dr. Safren was active as a cardiologist by St. Agnes from June 3, 2011, to June 20, 2013.

Relator’s Counsel: Jonathan Biran of Biran Kelly, LLC

This amount involves appraisal and management (“E&M”) casework provided by physicians to new and abiding patients. The Healthcare Accepted Procedure Coding System (“HCPCS”) is a connected coding arrangement advised to ensure that federal bloom affliction programs pay for casework rendered to patients in accordance with the akin of assets all-important to accommodate such care. Physicians use Accepted Procedural Terminology Codes (“CPT Codes”) to bill their casework provided to patients beneath the HCPCS system. HCPCS has two altered alternation of CPT Codes for (1) E&M casework performed on a new accommodating and (2) E&M casework provided to an accustomed patient. The CPT Codes for new patients backpack college reimbursements ante to atone physicians for the advancing added time it will booty to accommodate a abundant and absolute assay of a new patient. The CPT Manual defines a new accommodating as a accommodating who has not accustomed able casework from the physician or physician accumulation aural the antecedent three years.

The relator’s complaint arguable that anew hired cardiologists at St. Agnes Healthcare, Inc., break submitted claims to Medicare application new accommodating CPT Codes area the physician should accept submitted the CPT Codes for absolute patients. In June 2011, St. Agnes acquired the convenance accumulation of twelve mid-Atlantic cardiovascular associates, and the cardiologists became employees of St. Agnes. During the time of their alteration to St. Agnes, St. Agnes’ Director of Compliance allegedly directed the cardiologists to bill appointment visits application the new accommodating CPT Codes behindhand of whether a physician in the accumulation had apparent the patient aural the aftermost three years. The relator asserted that alike after he aloft a affair about this announcement practice, St. Agnes reached a accord that physicians would chase the announcement charge and bill the antecedent accommodating appointment as a new accommodating visit, alike if the physician had provided casework to that accommodating aural the prior three years.

On Wednesday, August 23, 2017, the DOJ issued a columnist absolution advertence that St. Agnes Healthcare agreed to pay the United States $122,928 to dness claims that St. Agnes submitted apocryphal claims to Medicare by announcement for E&M casework at a college acceding amount than federal bloom affliction programs allowed. The United States contended, in the adjustment agreement, that amid June 3, 2011, and June 3, 2014, St. Agnes break accustomed added acceding than it was advantaged to beneath Medicare due to these abnormal announcement practices. The relator will accept $20,000.

Although this was a baby dollar amount case, this adjustment is an archetype of administration activity directed against miscoding or “upcoding” of claims. Proper coding of claims is often difficult and judgmental. This complication offers opportunities to try to bill for added accelerated or astute casework than might commonly be warranted. However, such announcement practices invite aing administration scrutiny, which creates a accident that acceptable faith judgments about coding in circuitous cases may be accountable to authoritative challenge. Providers, therefore, should be accurate in coding procedures and services, so as to abstain such scrutiny. And, as this activity indicates, in ambiguous cases the government is acceptable to amusement claims with greater skepticism area a provider elects to cipher casework as a added accelerated – and added highly compensated – level.

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Mintz Levin maintains a database of apparent bloom affliction qui tam actions. This enables us to chase and assay trends in the cases that accept been unsealed. We afresh provided an analysis of the trends during 2017 as allotment of our Bloom Affliction Enforcement Year in Review and 2018 Outlook. See actuality for that discussion.

The agreeable of this commodity is advised to accommodate a general adviser to the accountable matter. Specialist admonition should be sought about your specific circumstances.

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