Questions about this Action Flashcards

Question

What does the AKS prohibit regarding inducements to purchase products?

Answer 1

It prohibits offering any remuneration to induce the purchase of goods or services for which payment may be made under a Federal health care program ## Footnote 42 U.S.C. 1320a-7b(b)(2)(B)

Answer 2

Offering something at no charge or reduced charge to induce purchases of different items is a violation ## Footnote This is considered a quid pro quo arrangement.

Answer 3

If the reduction in price is **properly disclosed** and **reflected** in the costs claimed under a Federal health care program ## Footnote 42 U.S.C. § 1320a-7b(b)(3)(A)

Answer 4

A comprehensive and specific written **lease agreement** for at least one year at fair market value, not taking into account the volume or value of referrals ## Footnote 42 C.F.R. § 1001.952(c)

Answer 5

Claims including **items or services resulting from an AKS violation** are considered false or fraudulent claims under the FCA ## Footnote Public Law No. 111-148, 42 U.S.C. § 1320a-7(b)(g)

Answer 6

Liability is imposed on anyone who knowingly submits or causes to be submitted kickback-tainted claims for payment ## Footnote 31 U.S.C. § 3729(a)(1)(A)

Answer 7

PAL®: a power-assisted liposuction handpiece ## Footnote It includes devices for fat filtration and pumping, a surgical cart called the 'LipoTower,' and liposuction cannulas.

Answer 8

Primarily composed of independent contractors, with only two territory managers as internal employees ## Footnote The independent contractors have been used for sales for over ten years.

Answer 9

The relationship is that of independent contractors, with no agency or joint venture relationship ## Footnote The contractor retains control over its business operations.

Answer 10

Commissions are based on sales performance, which can violate the AKS if tied to the value of referrals ## Footnote The commission percentage increases once the contractor exceeds a predetermined quota.

Answer 11

Anti-Kickback Statute

Answer 12

The Sales Agreement outlines the responsibilities of MicroAire and the Contractors, including self-monitoring and compliance with laws and ethical standards. ## Footnote The agreement emphasizes independence and self-regulation for Contractors.

Answer 13

Contractors must: * Represent the Products ethically * Abide by the AdvaMed Code of Ethics * Comply with applicable laws * Certify annual compliance with the Sales Agreement ## Footnote Contractors are prohibited from making illegal payments to obtain business.

Answer 14

Failure to meet sales quota may result in: * Additional monitoring by MicroAire * Termination of the Sales Agreement * Changes in territory or products available for sale ## Footnote This is outlined in Article 7, § 7.3.

Answer 15

Contractors have the right to decide whether to sell all or selected MicroAire products in their territories. ## Footnote If sales expectations are not met, MicroAire can allow others to sell those products.

Answer 16

The SmartRelease System is primarily used for endoscopic carpal tunnel surgery, offering benefits like less postoperative pain and minimal scarring. ## Footnote It was first manufactured in 2011 and is designed for precise ligament cutting.

Answer 17

$7,000 - $8,000 ## Footnote This is the cost for the system itself, excluding ongoing costs for single-use blades.

Answer 18

Ongoing costs include: * Single-use blades sold in packages of 6 * Total cost for blades: $1,200 - $1,400 ## Footnote These costs are typically included in the facility cost for ECTR procedures.

Answer 19

To overcome capital purchase barriers by allowing customers to purchase blades while loaning the ECTR System for free for 12 months. ## Footnote This program targets facilities that cannot afford a capital purchase.

Answer 20

A rent-to-own option where customers pay monthly and own the system after one year, while receiving free blades at the end of the year. ## Footnote The monthly payment was $600 in 2016.

Answer 21

Newly trained surgeons, encouraging them to use the system soon after training by offering free rentals and blades. ## Footnote This program aims to convert new users to the SmartRelease System.

Answer 22

To recapture blade sales lost to third-party reprocessors by offering a safe alternative and discounted prices. ## Footnote Customers must regularly return used MicroAire blades for disposal.

Answer 23

To encourage facilities using competitor systems to switch to MicroAire by offering blade exchanges and leasing options. ## Footnote This program includes a no-charge exchange of competitive blades for MicroAire blades.

Answer 24

$6,845 (2016), $7,370 (2018), $7,593 (2019) ## Footnote This value represents the free use of the consigned ECTR System.

Answer 25

True ## Footnote Contractors must represent products ethically and report any unethical conduct.

Answer 26

carpal tunnel syndrome ## Footnote It is designed for endoscopic surgery related to this condition.

Answer 27

2019-surgeons who wish to try the Onyx low profile blade ## Footnote The promotion aims to convert surgeons who have not switched from the Slimline blade.

Answer 28

$480 (2018); $600 (2018) ## Footnote This remuneration was linked to the promotional strategy for the Slimline blade.

Answer 29

Sales in excess of $32 million ## Footnote This information was reviewed by MicroAire in November 2021.

Answer 30

1.71 boxes of blades ## Footnote This includes the cost plus commission to the Contractor.

Answer 31

To maximize the volume of procedures on OR days and limit downtime due to sterilization ## Footnote Multiple sets facilitate completion of more procedures.

Answer 32

* Continue Consignment As Is, with improvements * Investigate solution to eliminate consignments ## Footnote Both options would continue illegal remuneration.

Answer 33

Compliance Director ## Footnote Relator began her tenure in March 2022.

Answer 34

Train and develop compliance tools for key business groups ## Footnote This included working closely with senior management to mitigate business risk.

Answer 35

It did not involve a consignment at all, but rather free use of the ECTR Smart Release System in exchange for blade purchases ## Footnote This realization raised compliance concerns.

Answer 36

The claimed 'lease' had a value attributed to it in sales materials ## Footnote This was part of the illegal remuneration concern.

Answer 37

Proper transfer of title to the provider, with a rebate structure earned on actual purchases ## Footnote This was part of Relator's proposals to change programs.

Answer 38

* An equipment rental program at fair market value * A discount/rebate equipment purchase program ## Footnote Both aimed to eliminate the capital barrier for providers.

Answer 39

Ellis had unpaused the consignment program ## Footnote This led to new non-AKS compliant consignment contracts being signed.

Answer 40

They would impact MicroAire's bottom line ## Footnote He compared it to the Gillette razor model of giving away handles.

Answer 41

She was excluded from consignment meetings and project communications ## Footnote This hindered her ability to monitor compliance.

Answer 42

Her termination from MicroAire ## Footnote This occurred after she raised concerns about AKS violations.

Answer 43

It was intended for use with new customers, and additional compliance issues would arise when used with current customers.

Answer 44

Ellis was the head of finance and the Relator's manager.

Answer 45

The dissolution of certain partnerships sanctioned by the U.S. Office of Foreign Assets Control.

Answer 46

He demanded that Relator participate in monthly in-person meetings to strategize compliance.

Answer 47

She felt that the amount of travel required would not work for her.

Answer 48

Typically bi-weekly.

Answer 49

31 U.S.C. § 3730(h)(1) under the False Claims Act.

Answer 50

Loss of back and front pay, denial of substantial benefits, and emotional distress.

Answer 51

False Claims Act.

Answer 52

* Presenting a false or fraudulent claim for payment * Making or using a false record or statement material to a false claim.

Answer 53

To strategize compliance.

Answer 54

False Claims Act

Answer 55

Marwah had effectively blocked her out of all her significant responsibilities.

Answer 56

She would be viewed as responsible for non-compliance despite having little control over enforcement.

Answer 57

Minnesota Whistleblower Act, Minn. Stat. § 181.932.

Answer 58

* Judgment for the United States Government and Relator * Cease and desist from FCA violations * Damages for violations of the FCA * Civil penalties * Relator's share * Prejudgment interest * Attorney fees and costs * Compensation for emotional distress * Front pay * Punitive damages.

Answer 59

Charlottesville.

Answer 60

Two times.

Answer 61

Programs that were compliant with the AKS.

Answer 62

June 23, 2023.

Answer 63

MicroAire did not place anyone else in the position she held.

Answer 64

To initiate the civil docket sheet and provide necessary information to the Clerk of Court.

Answer 65

Names (last, first, middle initial) of plaintiff and defendant, or full name and standard abbreviations if it's a government agency.

Answer 66

In the section for 'County of Residence'.

Answer 67

Firm name, address, telephone number, and attorney of record.

Answer 68

U.S. plaintiff, U.S. defendant, federal question, diversity of citizenship.

Answer 69

Suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution, acts of Congress, or treaties.

Answer 70

The residence (citizenship) of the principal parties.

Answer 71

To place an 'X' in the appropriate box for the nature of the suit.

Answer 72

Original Proceeding - cases that originate in the United States district court.

Answer 73

Proceedings initiated in state courts that may be removed to the district courts.

Answer 74

The civil statute directly related to the cause of action and a brief description.

Answer 75

That you are filing a class action under Rule 23, F.R.Cv.P.

Answer 76

The actual dollar amount being demanded or other demands like a preliminary injunction.

Answer 77

To reference related cases, if any, by inserting docket numbers and corresponding judge names.

Answer 78

[civil complaint]

Answer 79

Check the box for 'Transferred from Another District'.

Answer 80

That a multidistrict case is transferred into the district under authority of Title 28 U.S.C. section 1407.

Answer 81

It indicates the procedural history and status of the case.

Answer 82

31 U.S.C. § 3729 et seq.

Answer 83

42 U.S.C. § 1320a-7b.

Answer 84

Intentional and knowing deception or misrepresentation made to obtain an unauthorized benefit or payment from a federal healthcare program. The key element is the **intent to defraud** ## Footnote Healthcare fraud can include various actions such as billing for services not rendered or misrepresenting services provided.

Answer 85

Abusive practices in the context of healthcare are those that are inconsistent with accepted practices that result in unnecessary healthcare costs to a federal health program. Abuse differs from fraud where abuse does **not** require a specific intent to deceive or misrepresent, but rather often involves improper or excessive practices. ## Footnote Abuse can lead to unnecessary costs and may not necessarily involve fraudulent intent.

Answer 86

Prevented HCPs from making the best decision on behalf of the patient ## Footnote This indicates a conflict between corporate practices and patient care.

Answer 87

Financial loss by the government due to billing for services not medically necessary ## Footnote FCA stands for the False Claims Act.

Answer 88

Prevent potential abuse by prohibiting financial incentives for business/referrals ## Footnote AKS stands for the Anti-Kickback Statute.

Answer 89

Overutilization of services and clouded medical judgment ## Footnote This can inflate healthcare costs and compromise patient care.

Answer 90

Imposes liability on individuals and entities that knowingly submit false claims to the government.

Answer 91

Claims for services resulting from a violation of the AKS are considered false claims under the FCA. ## Footnote If a provider receives a kickback for referring a patient for a service, any claims submitted for that service can be deemed fraudulent under the FCA.

Answer 92

The intent behind financial arrangements – to induce or reward referrals. ## Footnote AKS stands for the Anti-Kickback Statute.

Answer 93

The false or fraudulent nature of the claim submitted for payment.

Answer 94

AKS violations lead to claims for potentially unnecessary or improperly influenced services.

Answer 95

Intentionally lying or misrepresenting facts to get paid by a federal healthcare program.

Answer 96

Improper or excessive practices that lead to unnecessary costs for federal healthcare programs.

Answer 97

kickbacks.

Answer 98

They are made 'false' under the FCA.

Questions about this Action Flashcards

These questions cover larger concepts about the complaint (128 cards)