Chiding parties, court grants doctor sanctions for manufacturer’s failure to disclose witnesses

In an animated opinion, a judge grants a request for sanctions against Boston Scientific for failure to disclose witnesses after a long history of discovery disputes.

Noting that it was “[c]learly. . . not enamored with the parties’ conduct,” a district court judge in Minnesota found that Boston Scientific Corporation (BSC), a medical device manufacturer, failed to fully disclose certain witnesses and therefore granted, in part, a doctor’s motion for sanctions in a False Claims Act (FCA) (31 U.S.C. §3729 et seq.) action. Although the court found that both parties “share the blame as to certain discovery woes,” it found that the medical device manufacturer engaged in a shell game by failing to disclose four individuals as having specific knowledge of certain relevant information (U.S. ex rel Higgins v. Boston Scientific Corp., October 16, 2019, Rau, S).

Discovery proceedings

Initially, the doctor filed a qui tamaction on behalf of the government, alleging that the manufacturer violated the FCA. The doctor claimed that the manufacturer sold defective medical devices and that it provided kickbacks. Following the outcome of several procedural motions, the doctor filed his Second Amended Complaint. The court began the road of guiding the parties through discovery. Initially, the parties appeared to work cooperatively and productively, parsing out electronically stored information (ESI) search terms and custodians. However, later, the parties reported that they were at an “impasse” regarding certain issues. The court provided a step-by-timeline of discovery, including agreements and disputes. At some point, it became apparent that discovery had broken down. During the course of discovery, the doctor filed several motions to compel. In each instance, the court found in the doctor’s favor.

Later, the doctor raised several issues, including the manufacturer’s last-minute amendment to its initial disclosure. Specifically, on the last day of discovery, the manufacturer disclosed seven new individuals it might use to support its claims or defenses, four of which had information about FDA correspondence and submissions. Those four, along with others, were not disclosed as custodians. The doctor subsequently filed this motion for sanctions.

The court found that the manufacturer left off from its initial disclosure the individual who was a “central witness” regarding the manufacturer’s communications with the FDA about the relevant medical devices, along with several other individuals. The court rejected the manufacturer’s contention that it had no affirmative obligation to amend its disclosure to add the individuals. With respect to one individual, the manufacturer claimed he was referenced in hundreds of documents, but according to the court, those represented only a small number of the total documents produced. In its ruling, the court found the manufacturer’s logic was flawed. Among other things, the court questioned how, if the manufacturer made a truthful and fulsome response to the government’s FCA investigation, it failed to recognize the import of the newly-disclosed individual’s knowledge. Instead, the court said it was convinced that the manufacturer engaged in malfeasance.

According to the court, manufacturer misled the doctor. The initial disclosures were the foundation for all discovery, and the manufacturer’s failure to disclose the newly-disclosed individuals prejudiced the doctor throughout discovery. The court suggested that the manufacturer knew what it was doing. The court claimed that the manufacturer’s failure to disclose was not an oversight, but a strategy that coincided with baseless legal arguments regarding that and other discovery issues, leading to gamesmanship the court said it wound not reward.

Turning to the sanctions to be levied, the court said that rules of procedure makes exclusion of evidence the default, self-executing sanction in the event a party fails to comply disclosure rules. However, the rule permits imposition of alternative sanctions. In this instance, exclusion of the witnesses’ testimony would be detrimental to the doctor and would reward the manufacturer. Accordingly, the court ordered the manufacturer to produce documents from the newly-disclosed witnesses and the doctor was granted leave to depose the four individuals. Additionally, the manufacturer was barred from using documents or testimony that it could not affirmatively show was produced to the doctor during discovery or in light of the ruling at hand. The manufacturer was also ordered to pay the doctor’s costs and attorneys’ fees incurred in filing the motion for sanctions and for the additional discovery.

Device manufacturer’s misrepresentations result in $12.5M FCA settlement

Medical device manufacturer AngioDynamics, Inc., settled with the United States for $12.5 million following allegations that the company caused health care providers to submit false claims related to the use of the LC Bead® and the Perforator Vein Ablation Kit® (PVAK) to Medicare, Medicaid, and other federal health care programs. The government alleged that the manufacturer both provided instructions to use inaccurate billing codes and misrepresented Medicare billing policy related to the devices. The settlement came as a result of a suit filed under the whistleblower provision of the False Claims Act (FCA) (31 U.S.C. § 3729).

LC Bead allegations

The medical device manufacturer will pay $11.5 million—$10.9 million paid to the federal government and $600,000 paid to state Medicaid programs—to resolve allegations that the company caused the submission of false claims for procedures involving an unapproved drug delivery device marketed with false and misleading promotional claims. The government alleged that between 2006 and 2011, AngioDynamics served as the distributor for the manufacturer of the LC Bead and marketed the product for use as a drug delivery device in combination with chemotherapy drugs. Employees of the manufacturer routinely claimed that this use of the LC Bead was “better,” “superior,” “safer,” and “less toxic” than alternative treatment, despite lack of clinical evidence to support the statements and despite the FDA’s repeated declination to approve the product. Knowing that many insurers did not provide coverage for certain LC Bead procedures, the company instructed health care providers to use inaccurate billing codes for claims related to these uses.

PVAK allegations

AngioDynamics will also pay $1 million to resolve allegations that the company caused the submission of false claims in connection with the use of PVAK, used to close or collapse malfunctioning veins and which was approved by the FDA only for use in treating superficial veins and not for perforator veins. The manufacturer voluntarily recalled the PVAK and reissued the product under the name “the 400 micron kit.” Despite the recall and rebranding, certain AngioDynamics employees took part in a continued campaign to market the device to treat perforator veins, falsely representing to providers that Medicare would cover this use

Report shows management of CMS payment program shows vulnerabilities

While CMS has made some progress towards addressing problems with the Quality Payment Program (QPP), a new report shows vulnerabilities remain regarding technical assistance for clinicians and the potential for fraud and improper payments. The HHS Office of the Inspector General (OIG) report noted that if CMS fails to sufficiently address these issues, clinicians may struggle to success under the QPP or choose not to participate. The report also found that CMS needs to put systems in place to effectively prevent, detect, and address fraud and improper payments.

CMS is implementing core provisions of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (P.L. 114-10) as the QPP, a set of clinician payment reforms designed to put increased focus on the quality and value of care. The QPP is a significant shift in how Medicare calculates payment for clinicians and requires CMS to develop a complex system for measuring, reporting, and scoring the value and quality of care.

Technical assistance

The report shows that if clinicians do not receive sufficient technical assistance, they may struggle to succeed under the QPP or choose not to participate. Clinician feedback collected by CMS demonstrates widespread basic awareness of the QPP, but also indicates uncertainty regarding details of participation such as who must report and how to submit data. CMS contractors have focused largely on general education initiatives, with fewer resources devoted to more customized, practice-specific technical assistance. CMS has established a Service Center to answer questions about the QPP by phone or email. Service Center data indicate that clinicians continue to have questions about both eligibility and scoring criteria, and that small practices, in particular, need information and assistance. Small practices and clinicians in rural or medically underserved areas, who may have fewer administrative resources and less experience with prior CMS quality programs, should be prioritized for assistance. The report stated, “Clinician feedback collected by CMS demonstrates widespread awareness of the QPP, but also uncertainty about eligibility, data submission, and other key elements of the program.”

Fraud

The report also found that if CMS does not develop and implement a comprehensive QPP program integrity plan, the program will be at greater risk of fraud and improper payments. To ensure that the QPP succeeds, CMS must effectively prevent, detect, and address fraud and improper payments. QPP payment adjustments are intended to reward high-value, high-quality care. Safeguarding the validity of Merit-based Incentive Payment System (MIPS) data and the accuracy of QPP payment adjustments is critical to ensure that these payments are based on clinicians’ actual performance. Appropriate oversight is critical to prevent fraud and improper payment adjustments. CMS needs to clearly designate leadership responsibility for QPP program integrity. CMS also needs to develop a comprehensive program-integrity plan for the GPP to ensure the accuracy of MIPS data submitted by clinicians. CMS said that it “is currently in the early stages of developing an oversight plan to QPP data.”

Personal service care fraud; a growing problem for Medicaid

Medicaid personal care service (PCS) fraud cases made up a “substantial and growing” portion of cases investigated by the Medicaid Fraud Control Units (MCFUs) and greater oversight is recommended by the HHS Office of the Inspector General (OIG). In a report covering the PCS work of MFCUs over fiscal years 2012-2015, the OIG found that these cases comprised over 12 percent of the total investigations and accounted for 34 percent of the convictions (OIG Report, OEI-12-16-00500, December 6, 2017).

Background

Personal care services are those services that support consist daily living activities, including bathing and dressing, meal preparation, and transportation. PCS providers assist the elderly, people with disabilities, and individuals with chronic or temporary health conditions, allowing these persons to remain living in their homes and communities. PCS are typically delivered through either an agency-directed PCS or a self-directed PCS, through which beneficiaries hire and supervise their own provider. PCS are offered either as an optional benefit through a Medicaid State plan or through demonstration projects and waiver programs. States are required to develop their requirement and qualification standards for PCS providers, resulting in widely varying requirements across the country.

Growing percentage

The OIG found that during the three-year review period, PCS fraud cases made up a substantial and increasing number of MFCU cases and outcomes. In FY 2015, such cases made up 12 percent of total investigations and over the review period, they made up 38 percent of indictments, and 34 percent of convictions. Furthermore, during the review period, indictments increased 56 percent and convictions increased 33 percent. Payments to PCS providers represented $13 billion out of $524 billion total Medicaid expenditures during FY 2015.

Recommendations and challenges

MCFUs have recommended that State Medicaid either enroll PCS attendants as Medicaid providers, or include PCS attendants in a provider registry. This would allow for the assignment of unique provider identification number to PCS attendants to include on claims for reimbursement. Some form of enrollment or registration is needed, as the inability to identify individual PCS attendants restricts the ability to identify fraudulent providers. MCFUs have suggested that enrolling PCS attendants in Medicaid would better inform them about Medicaid procedures and requirements.

MCFUs have also recommended the use of background checks for attendants. They found that the current, minimal, background check requirements could put vulnerable beneficiaries at risk. For example, a PCS attendant in Arizona pleaded guilty to theft and financial exploitation of a vulnerable adult, after having stolen checkbooks, cash, credit cards, and personal items belonging to the beneficiaries. The PCS agency checked for felony arrests and found none; the attendant had, however, numerous misdemeanor convictions and had previously lost her nursing assistant license.

The MCFUs have also recommended using additional documentation requirements, such as requiring require PCS attendants to provide detailed or standardized timesheets and to show the start and stop times for the services. The currently minimal PCS documentation means that PCS claims data may not contain the identity of the PCS attendant, the number of hours worked, or the time of day during which the services were provided.

Lastly, the MCFUs recommended that State Medicaid agencies implement a variety of controls regarding oversight of PCS providers and their services. These controls include more frequent in-home supervisory visits, training for PCS attendants and cross-reference attendant and beneficiary location. For a variety of reasons, beneficiaries may be reluctant to report abuses and more frequent in-home visits could curtail fraud.

Funding issues

The units reported that their efforts to protect beneficiaries are hamstrung by their ineligibility to receive Federal funding to investigate and prosecute complaints in nonfacility settings. Such complaints are often referred to other agencies. Those agencies often do not receive the same level of training on patient abuse and neglect that MCFU staff receives and may have severely strained resources.

Conclusions

The report found that the volume and increase of MFCU investigations and prosecutions indicates that PCS remain vulnerable to fraud. The report noted that the recommendations are similar to those made in previous reports and states that it is crucial that federal funding authority be expanded to allow MFCUs to investigate and prosecute cases of patient abuse and neglect in nonfacility settings.