FCA Statistics March 3, 2019

Department of Justice Recovers $2.8 Billion from FCA Cases in 2018

The United States Department of Justice has announced that it has recovered $2.8 Billion from False Claims Act (FCA) cases during fiscal year 2018 (the 12 months ending on September 30, 2018). The DOJ’s overall recovery in fiscal 2018 remained substantial; however, it marks a decline from the DOJ’s recoveries in fiscal year 2016 ($4.7 Billion) and fiscal year 2017 ($3.7 Billion).

The substantial majority of the DOJ’s recoveries came from the healthcare industry. In fiscal 2018, almost 90% ($2.5 Billion) of the DOJ’s recoveries came from the healthcare industry (including hospitals, physicians, laboratories, drug companies, and pharmacies). The DOJ has now recovered more than $2 Billion from the healthcare industry in each of the past 9 years.

Whistleblowers continued to play a role in a substantial number of the cases that led to the DOJ’s recoveries. There were 645 claims filed by whistleblowers in fiscal 2018. The Government recovered approximately $2.1 Billion from these cases, as well as from cases that were filed by whistleblowers in prior years.

Uncategorized December 31, 2018

Certiorari Granted in Eleventh Circuit Case Interpreting Tolling Provision of FCA Statute

By Brett Barnett and Sarah Rashid

The Supreme Court recently granted certiorari in an Eleventh Circuit False Claims Act (FCA) case, Cochise Consultancy, Inc. v. U.S. ex rel. Hunt, No. 16-12836 (11th Cir. 2018). The Supreme Court will decide how the FCA’s statute of limitations applies in qui tam actions that are brought by a private relator, particularly in cases where the government has declined to intervene, resolving a long standing split among the circuit courts.

The FCA’s statute of limitations provision is contained at 31 U.S.C. § 3731(b) and provides that:

“(b) A civil action under section 3730 may not be brought—

(1) more than 6 years after the date on which the violation of section 3729 is committed, or

(2) more than 3 years after the date when facts material of the right of action are known or reasonably should have been known by the official of the United States charged with responsibility to act in the circumstances, but in no event more than 10 years after the date on which the violation is committed,

whichever occurs last.”

Although § 3731(b)(2) operates as a tolling provision to the six-year statute of limitations period in § 3731(b)(1), there has been a historical split among the circuits regarding whether this tolling provision applies when the government declines to intervene in a relator’s action. The key question the Supreme Court will decide is whether the relevant trigger for the limitations period is the government’s knowledge of the material facts or the relator’s knowledge of the material facts.

Eleventh Circuit Reverses United States District Court for the Northern District of Alabama

In Hunt, the district court below ruled that § 3731(b)(2)’s tolling provision was inapplicable in qui tam cases where the government declined to intervene. However, the Eleventh Circuit reversed the Northern District of Alabama, holding that the alternative 3-year limitations period can apply when the government declines to intervene in a relator’s qui tam action.

The Eleventh Circuit also held that the 3-year limitations period is triggered by the government’s knowledge of the alleged fraud, not the relator’s. It also held for purposes of applying the limitations period, the relator’s knowledge of the alleged fraud was irrelevant to the analysis.

Supreme Court Decision May Resolve Years of Circuit Split on this Issue

There are currently three approaches to handling the tolling provision:

The provision only applies in FCA cases filed by the government or in which the government has intervened (followed by the Fourth, Fifth, and Tenth Circuits),
The provision applies in cases where the government has not intervened, but the clock begins to run when the relator learned of the fraud (followed by the Third and Ninth Circuits), and
The provision applies in cases where the government has declined to intervene, and the clock begins to run when the government learned of the fraud.

The Supreme Court’s decision in Hunt could resolve this split and create a uniform national standard that eliminates confusion and uncertainty for FCA defendants.

FCA Litigation November 8, 2018

Eleventh Circuit Weighs In On FCA’s Alternate Remedies Provision

By David Pivnick and Brett Barnett

Due to the infrequency in which the situation arises, the FCA’s “alternate remedy” provision is infrequently invoked or discussed. In short, this provision states that when the relator presents information about a potential FCA claim for the Government to investigate, the Government has the option to pursue this claim through “any alternate remedy available to the Government.” The provision goes on to explain that if the Government pursues an “alternate remedy,” the relator has the same rights as though the action was still being pursued under the FCA (i.e., the relator will still be able to recover a bounty).

The alternate remedy provision’s scope and application to criminal forfeiture statutes was recently addressed by the Eleventh Circuit in United States v. Couch, No. 17-13402, —F.3d—-, 2018 WL 5019480 (11th Cir. Oct. 17, 2018). In Couch, a former employee filed a qui tam action against the pain management clinic she worked for, as well as a couple of physicians who ran the clinic. The Government declined intervention and the qui tam case remains pending.

The Government, however, investigated the physicians and ended up charging them (and others) for racketeering, violations of the AKS, wire fraud, and illegal drug distribution. The criminal charges included forfeiture counts. The charges partially overlapped with the qui tam complaint. The physicians were found guilty on several of the charges, and the court entered a preliminary forfeiture order. Thereafter, the relator moved to intervene claiming that she had a right in the assets at issue pursuant to, amongst other statutes, the alternate remedies provision.

The trial court denied the relator’s motion to intervene and the 11th Circuit affirmed. The Circuit Court first noted that whether a criminal fraud prosecution constitutes an “alternate remedy” is an issue about which courts are divided. The 11th Circuit did directly weigh in on this dispute, however, as it found that the forfeiture statutes at issue here each specifically precluded – absent certain circumstances – a third party from intervening. Because the forfeiture statutes specifically addressed this issue, they controlled over the more general “alternate remedy” provision.

Notably, however, the government did indicate that where a defendant is found liable under the FCA after being found criminally liable for the same conduct, the defendant is entitled to deduct the criminal restitution paid as a credit against the FCA damage, and the relator would be entitled to a share from this offset amount.

Defense Arguments, FCA Litigation October 27, 2018

Third Circuit Finds that FCA Retaliation Claims Require a Showing of “But-For” Causation

By David Pivnick and Chris DeGrande

Earlier this year, the Third Circuit Court of Appeals affirmed the decision of the United States District Court for the Eastern District of Pennsylvania in the case of DiFiore v. CSL Behring, LLC. DiFiore v. CSL Behring, LLC, 879 F.3d 71, 73 (3d Cir. 2018). The opinion set forth the precedent that “but-for causation” is required for an FCA retaliation claim. The litigation involved the claims of a former employee of CSL Behring, Marie Difiore, who was asserting a claim for retaliation under the FCA. The case was before the Third Circuit on an appeal by Difiore after a March 17, 2016 dismissal of her case by the District Court.

DiFiore’s case was centered on claims that she had been constructively discharged from her employment at CSL Behring in retaliation for raising concerns about certain marketing practices of CSL Behring. CSL Behring is a pharmaceutical company that markets plasma and protein biotherapeutics. DiFiore had worked at CSL Behring since April of 2008, receiving a promotion to be the Director of Marketing in August of 2011. In this position, DiFiore became concerned about CSL Behring’s activities in marketing drugs for off-label use. Difiore expressed such concerns to her supervisors, and DiFiore contends that these concerns were at least partially responsible for the initiation of a third-party compliance audit. DiFiore then alleged that as a result of her conduct, which is protected from retaliation by the FCA, she suffered several employment actions that led to her constructive discharge at CSL Behring. These actions included warning letters regarding her work conduct, disagreements with another co-worker, non-payment of her company credit card, unfavorable performance reviews, hostile interactions from her superiors, removal of certain of DiFiore’s responsibilities, and the institution of a performance improvement plan, all of which DiFiore alleged had never been issues before she raised her concerns regarding the off label promotional activities.

DiFiore argued that thecde District Court erred in dismissing her case by requiring DiFiore to show that her protected activity was the “but-for” cause of the alleged adverse action against her. DiFiore contended that she was only required to show that her protected activity was a “motivating” factor in the adverse actions taken by CSL. DiFiore’s argument was based upon the Court’s decision in Hutchins v. Wilentz, which she argued used the lower “motivating factor” standard to link protected conduct and adverse action in an FCA claim. However, the Court did not accept this argument, pointing to the fact that the “motivating factor” standard was not a determining factor in the Hutchins case, and the case was dismissed because the employee failed to prove that he engaged in protected conduct. The Court instead relied on two other U.S. Supreme Court cases, Gross v. FBL Fin. Servs., Inc. and Univ. of Texas Sw. Med. Ctr. v. Nassar, to hold that “but-for” causation must be shown to link the protected conduct and the adverse action in order to support an FCA retaliation claim. The Court upheld the ruling of the District Court that such “but-for” causation had not been demonstrated by DiFiore and thus, affirmed the ruling favor of CSL Behring.

FCA Litigation October 15, 2018

Caris Healthcare Pays $8.5M to Settle FCA Case

By David Pivnick and Katie Campbell

Caris Healthcare, L.P. has entered an agreement with the DOJ in which it has agreed to pay $8.5 million to resolve allegations that it violated the False Claims Act. The qui tam action was filed in the Eastern District of Tennessee by a registered nurse who was formerly an employees of Caris Healthcare.

The former employee alleged that Caris Healthcare submitted false claims and retained overpayments in connection with claims for hospice services. The patients at issue were allegedly ineligible for hospice benefits under Medicare because such patients were not terminally ill. According to the complaint, Caris Healthcare was made aware of the ineligibility of the patients, yet continued to submit the claims to Medicare. Allegedly, in an effort to meet the aggressive admissions and census targets set by the company, Caris Healthcare admitted patients whose medical records did not support a terminal prognosis.

The settlement provides another reminder for healthcare entities to ensure that they are billing accurately for services that are covered by Medicare and our properly rendered. In light of the scrutiny on the healthcare industry it is important to separately assess each patient and make individualized determinations regarding care. Moreover, healthcare entities should carefully review internal concerns that are raised both to ensure that the company truly has a top-down culture of compliance, but also to identify and resolve potential issues that may arise.

Uncategorized September 27, 2018

HHS “Sprints” Toward New AKS Safe Harbors and Penalty Exceptions

By Tim Fry and Brian King

The U.S. Department of Health and Human Services (HHS) has launched its “Regulatory Sprint to Coordinated Care” to accelerate the healthcare system’s transformation to a value-based system rewarding coordinated care. This “regulatory sprint” focuses on identifying regulatory provisions that may act as unnecessary obstacles to coordinated care and issuing guidance to address such obstacles.

Specifically, the HHS Office of the Inspector General (OIG) requested industry input on Aug. 27 to “identify ways in which it might modify or add new safe harbors to the Anti-Kickback Statute [(AKS)] and exceptions to the beneficiary inducements Civil Monetary Penalty (CMP) definition of ‘remuneration’ in order to foster arrangements that would promote care coordination and advance the delivery of value-based care, while also protecting against harm caused by fraud and abuse.” To this end, HHS may issue guidance and revise regulations to address such obstacles and to encourage and incentivize coordinated care in response to this request for information.

This is not the first HHS request for information under this “regulatory sprint.” On June 25, 2018, the Centers for Medicare & Medicaid Services (CMS) published a request for information seeking industry input regarding the physician self-referral law, commonly known as the Stark Law. The strict liability Stark Law prohibits a physician from referring certain Medicare- and Medicaid-designated health services to an entity where that physician or his or her family has a financial relationship, absent an exception. This relationship could include certain value-based or care coordination arrangements. CMS sought comments to revise or add exceptions or redefine terminology of the Stark Law to structure arrangements between parties that participate in alternative payment models or other novel financial arrangements. In this June request, CMS presented 20 topics for comment.

The latest OIG request for information seeks input from the public on ways it might modify or add new safe harbors to the AKS and exceptions to the beneficiary inducements CMP definition of remuneration. The AKS is a broad criminal prohibition against the offer or exchange of anything of value to induce or reward the referral of federal healthcare program business. Similarly, the CMP law acts as a catch-all as it authorizes the OIG to impose civil monetary penalties (and other remedies) for various types of fraud and abuse under the Medicare and Medicaid programs, including beneficiary inducement. As both laws have broad language, OIG has issued safe harbors and exceptions to protect certain relationships that do not pose a high risk of fraud or abuse. In this request for information, the OIG again considers this balance between risks to federal programs with acceptable provider relationships. In particular, OIG seeks input on the following topics:

Promoting Care Coordination and Value-Based Care

OIG requests information about potential arrangements the industry is interested in pursuing, such as care coordination, value-based arrangements, alternative payment models, arrangements involving innovative technology, and other novel financial arrangements that may implicate the AKS or beneficiary inducements CMP. OIG wants to gain a better understanding of the structure and terms of such agreements and requested that stakeholders identify additional AKS safe harbors or exceptions to the definition of “remuneration” under the beneficiary inducements CMP that may be necessary to protect such arrangements.

Beneficiary Engagement (Beneficiary Inducements and Cost-Sharing Obligations)

OIG requests industry input regarding the types of incentives providers, suppliers and others are interested in providing to engage beneficiaries to improve their care. OIG wants to understand how providing such incentives would contribute to or improve quality of care, care coordination and patient engagement, and whether the types of entities that furnish the incentives matter from an effectiveness and program integrity perspective.

In addition, OIG seeks input about how reducing beneficiary cost-sharing obligations might improve care delivery, enhance value-based arrangements and promote quality of care.

Current Fraud and Abuse Waivers

OIG solicits feedback on the current waivers developed for the purposes of testing models by the Center for Medicare and Medicaid Innovation and carrying out the Medicare Shared Savings Program. These waivers have been specific to these limited programs to date and would not apply to other relationships the providers have for other third-party payor programs. OIG hopes to gain insight about what waiver structures work well and whether any waiver requirements are particularly burdensome.

Cybersecurity-Related Items and Services

OIG is aware of the industry’s interest in donating or subsidizing cybersecurity-related items and services to providers and others with whom they share information. It seeks information about the types of cybersecurity-related items or services entities wish to donate or subsidize, and how existing fraud and abuse laws may pose barriers to such arrangements. Under current law, CMS and OIG allow certain health information and electronic health record donations and support, but this would go beyond to an ongoing related service.

Accountable Care Organization (ACO) Beneficiary Incentive Program

Section 50341(b) of the Bipartisan Budget Act of 2018 states that “illegal remuneration” under the AKS does not include “an incentive payment made to a Medicare fee-for-service beneficiary by an ACO under an ACO Beneficiary Incentive Program” but allowed OIG to add other conditions on such payment. For the purposes of implementing this new statutory exception, OIG requests input regarding what, if any, “other conditions” a regulatory safe harbor should include as additional program protections or safeguards.

Telehealth

Section 50302(c) of the Bipartisan Budget Act of 2018 creates a new exception to the definition of “remuneration” in the beneficiary inducements CMP. This exception applies to “telehealth technologies” provided on or after Jan. 1, 2019, to an individual with end-stage renal disease (ESRD) who is receiving home dialysis for which payment is being made under Medicare Part B. The exception stipulates that (i) the telehealth technologies not be offered as part of any advertisement or solicitation; (ii) the telehealth technologies be provided for the purpose of furnishing telehealth services related to the patient’s ESRD; and (iii) that the technologies meet any other requirements mandated by OIG.

For the purposes of this exception, OIG requests input on how “telehealth technologies” should be defined as well as examples of telehealth technologies that may be used to furnish telehealth services related to a beneficiary’s ESRD.

The Intersection of the AKS and the Stark Law

Lastly, OIG requests feedback regarding specific circumstances in which (i) exceptions to the Stark Law and safe harbors to the AKS should align for purposes of accelerating the transformation to a value-based system; and (ii) where exceptions to the Stark Law should not have a corresponding AKS safe harbor. As mentioned above, the Stark Law is a strict liability statute while the AKS is a criminal statute requiring intent. Thus, OIG and CMS historically have considered each other’s respective guidance but have not adopted it by default in their respective rulemaking. That said, OIG clarifies here that they want to reconsider certain areas of overlap in the care coordination space and asks that commentators re-comment with respect to this request if they provided CMS comments earlier this year.

* * * * *

HHS recognizes that reimbursement is shifting away from fee-for-service to value-based and care coordination models. Through this OIG request for information and the previous CMS request, HHS appears to also recognize that the current fraud and abuse rules may need updating for this shift.

The public can comment until 5 p.m. (ET) on Oct. 26, 2018. We would welcome the opportunity to work with you on submitting ideas to OIG. If you wish to submit comments, please contact a McGuireWoods attorney.

Defense Arguments, FCA Litigation September 21, 2018

Eleventh Circuit Expands the Divide on the FCA’s Statute of Limitations

By David Pivnick and Brett Barnett

The FCA’s statute of limitations, 31 U.S.C. § 3731(b), has been a source of confusion and disagreement amongst the courts and litigants for years. The disagreement is focused primarily on whether a relator in a non-intervened case can take advantage of the three-year government knowledge/ten-year lookback provision under subsection (b)(2) or whether the relator is limited to the six-year limitation in subsection (b)(1). The majority of courts have held that the relator is bound by the latter provision, and cannot take advantage of the 10-year lookback period in cases where the government has declined to intervene.

This split was recently expanded by the 11th Circuit, which found in U.S. ex rel. Hunt v. Cochise Consultancy, Inc., 887 F.3d 1081 (11th Cir. 2018) that a relator could take advantage of the longer statute of limitations period in subsection (b)(2) even where the government has declined to intervene.

Hunt involved an allegedly fraudulent award of a government defense subcontract for the clearing of excess munitions in Iraq that were left by retreating or defeated forces. While the underlying allegations are sordid – including assertions that a blind military officer was allegedly deceived into signing the wrong contract – the salient allegations are as follows: Defendant Parsons was awarded a government contract to clear excess munitions and sought subcontractors to provide the attendant security services. The contract was initially awarded to ArmorGroup, but this selection was overridden through the efforts of an officer who had allegedly been bribed to award the contract to Defendant Cochise – the purveyor of the bribes. From February 2006 to September 2006, Cochise performed the subcontracting services.[1] The relator – who worked for Parsons – informed the government about the scheme in 2010, but waited until November 27, 2013 to file his claims under the FCA.

The government declined intervention and the defendants subsequently moved to dismiss on statute of limitations grounds, arguing that the claims were untimely under the six-year provision in subsection (b)(1). The district court agreed with defendants and dismissed the action.

On appeal, the Eleventh Circuit reversed, holding that while the claims were facially barred under subsection (b)(1), the relator could rely upon the longer statute of limitations period in subsection (b)(2) despite the government having declined to intervene. The defendants argued that allowing the relator to rely on subsection (b)(2) would lead to absurd results as the limitations period is triggered by the knowledge of the government, which is not a party to the litigation in a declined case. The court rejected this argument, reasoning that in the “unique context” of an FCA action the government remains the real party in interest and retains control over the action. The court explained that the government stands to obtain the majority of the recovery even in declined cases, is allowed to intervene at a later date upon a showing of good cause, and remains actively involved in the case by receiving filings and discovery.

The court also reasoned that nothing in the text of subsection (b)(2) indicates that it is inapplicable where the government has declined to intervene. Furthermore, the court found that its conclusion was bolstered by the absence of legislative history indicating that subsection (b)(2) is inapplicable where the government has declined intervention.

In so holding, the Eleventh Circuit recognized that its decision was at odds with decisions from the Fourth and Tenth Circuits, but rejected these holdings, arguing that these appellate decisions were not persuasive because they failed to account for the “unique role the United States plays even in a non-intervened qui tam case.”

The Cochise opinion crystallizes the circuit split that exists in connection with the FCA’s statute of limitations in non-intervened cases. This divide is particularly notable in light of the importance of the statute of limitations as both a potential defense and as a means to cut off liability as to dated claims. This is an issue that should ultimately be resolved by the Supreme Court (or by a statutory amendment to clarify the statute of limitations), but, in the interim, it bears monitoring this area of law carefully and being cognizant of the applicable authority in the jurisdiction in which a case is pending.

[1] Cochise’s services were limited to seven months because the bribed officer was rotated out of Iraq in September 2006 after which the contract bidding was reopened and awarded to ArmorGroup.

FCA Litigation September 6, 2018

Healogics Settles False Claims Case Involving Allegations of Medically Unnecessary Procedures

By David Pivnick and Sarah Rashid

The United States Attorney’s Office for the Middle District of Florida recently settled a False Claims Act case against Healogics, Inc. (“Healogics”) in which it was alleged that Healogics had knowingly billed Medicare for medically unnecessary and unreasonable hyperbaric oxygen therapy (“HBO therapy”). Under the settlement, Healogics agreed to pay $17.5 million, plus an additional $5.01 that is dependent upon certain financial contingencies. The settlement also provides for a whistleblower share of up to $4,276,000. Healogics also entered into Corporate Integrity Agreement (“CIA”) with the OIG. Pursuant to the five-year CIA, Healogics is subject to both a claims review and a systems review, which are to be performed by an Independent Review Organization.

Healogics manages almost 700 hospital-based wound care centers across the country. The litigation centered around HBO therapy, in which the entire body is exposed to oxygen under increased atmospheric pressure. HBO therapy can be used to treat certain types of chronic wounds.

The allegations against Healogics stemmed from two separate lawsuits: one filed by relator James Wilcox, a former Healogics employee, and a separate lawsuit filed by Dr. Benjamin Van Raalte, Dr. Michael Cascio, and John Murtaugh, who were respectively physicians and a program director who had worked at Healogics-affiliated wound care centers. The relators alleged that, from 2012 to 2015, Healogics knowingly submitted, or caused the submission of, false claims to Medicare for medically unnecessary or unreasonable HBO therapy.

In a Third Amended Complaint that was filed in May 2016, there were allegations of multiple representative instances in which false claims for HBO therapy were purportedly submitted to the government for reimbursement. It was also alleged that patients were subjected to unnecessary procedures, and that “The Healogics Way” – the company’s mission statement for its employees – actually “meant, among other things, fraudulently upcoding debridements, falsifying HBOT eligibility in order to bill for unnecessary but expensive treatments, and requiring all patients to undergo unnecessary testing called transcutaneous oxygen measurement or TCOM.” See United States ex. rel. Van Raalte, et al. v. Healogics, Inc., 14-CV-283 (M.D. Fla. 2014). Notably, the litigation brought by Mr. Wilcox, United States ex rel. Wilcox v. Healogics, Inc., et al., 15-CV-1510 (M.D. Fla. 2015), involved similar accusations against Healogics.

This litigation provides an example of the Government’s focus on cases involving allegations of medially unnecessary treatments being provided to patients. The Government often demonstrates particular interest in such cases both because of the potential financial harm to the public fisc, but also because of the risk of patient harm from patients being exposed to unnecessary medical treatments. The case emphasizes the importance of providers offering medically necessary treatment, and of making individualized decisions about patient care that are tied to the specific circumstances of each particular patient.

Regulatory March 6, 2018

Civil and Criminal Fraud and Abuse Penalties Increase and Stark Law Changes

By Brett Barnett and Tim Fry

The Bipartisan Budget Act of 2018 (the Act) continues to ratchet up penalties for fraud and abuse violations under the Medicare and Medicaid programs. The Act doubles statutory civil fines and quadruples some criminal fines, including for actions brought under the Anti-Kickback Statute (AKS). It also increases maximum jail time. On the other hand, cognizant of the strict liability nature of the Stark Law, the Act codifies certain regulatory protections.

On February 9, 2018, Congress passed the Act by a vote of 240-186 in the House, and 71-28 in the Senate. President Trump signed it into law the same day. The Act funds the government through March 2018 with a two-year budget deal, and increases federal funding for discretionary programs.

For healthcare, this increased funding for federally qualified health centers and certain research and public health initiatives. Amongst other reforms, the Act also continued funding the Children’s Health Insurance Program through 2027, extended a number of Medicare payment provisions (often called the “Medicare Extenders”), and repealed Medicare therapy caps. It also gave Congress another chance to address the healthcare fraud and abuse statutes and regulations. Several of the more noteworthy amendments to these statutes and regulations are addressed below:

Increasing Civil and Criminal Penalties.

Congress doubled the statutory civil fines for certain AKS and Civil Monetary Penalty Law (CMPL) violations. The CMPL operates as a catch-all of sorts as it authorizes the Office of Inspector General to impose civil monetary penalties (and other remedies) for various types of fraud and abuse under the Medicare and Medicaid programs. The Act included a number of adjustments for certain fines. For instance, $10,000 fines increased to $20,000, $15,000-$30,000 and $50,000-$100,000. Notably, many of these increases are not as dramatic as they seem as the prior budget act had mandated inflationary adjustments, and therefore, the amount of the fines had increased in the interim. Under this clarified framework, the increases actually average approximately: $15,000-$20,000, $22,000-$30,000, and between $55,000 and $74,000-$100,000. On the whole, the increase is closer to a 33%-50% than the doubling provided in the statute.

The Act also ramped up certain criminal penalties under the AKS. The AKS is an intent-based statute, prohibiting remuneration to induce or reward referrals. Violations can include fines, jail time and False Claims Act liability (the latter of which was not addressed by the Act). The Act increased criminal penalties from no more than a $25,000 fine to a maximum $100,000 fine, and increased the maximum incarceration period from five years to ten years. These penalties became effective upon enactment of the Act.

Codification of Stark Law Changes.

Section 50404 of the Act also codifies three technical fixes to the Stark Law with respect to writing and signature requirements and holdover arrangements previously addressed in regulations. Commonly known as the Stark Law, the Physician Self-Referral Law, located at 42 U.S.C. § 1395nn, and its regulations at 42 C.F.R. § 411.350 et seq., prohibits a physician from referring a patient for Medicare- and Medicaid-designated health services to an entity where that physician or his or her family has a financial relationship, absent an exception. Because the Stark Law is a strict liability statute, meeting the very technical exceptions is critical as violations can lead to False Claims Act liability and recoupment obligations. Over time, the industry has heavily criticized the technical nature of the Stark Law and policymakers have taken note. Indeed, Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma recently stated that an inter-agency review would consider reducing Stark Law burdens.

Despite passage, the technical Stark Law reality is not changing significantly. The first change codifies that the writing requirement shall be “satisfied by such means as determined by the Secretary, which can consist of a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties involved.” This change comes directly from a statement of CMS’s existing policy with respect to the exceptions with a writing requirement. See 80 Fed. Reg. 71315.

Changes to the signature requirement and holdover arrangements are similarly lacking significant change. In 2015, when CMS revised Stark Law regulations, we wrote that “under the personal service arrangement and lease exceptions . . . CMS is considering an indefinite holdover period [as long as] the holdover [is] on the same terms and conditions as the original agreement.” This adopted regulatory language (see 42 C.F.R. 411.357(a), (b), (d)) finds its way directly into the Act. Similarly, CMS adopted language around signatures in 42 C.F.R. § 411.353(g) that provides a 90-day period of temporary noncompliance. This same period and same language is codified by the Act.

Overall, policymakers continue to attack healthcare fraud and abuse concerns by ratcheting up punishments for violations. Healthcare providers need to continue to ensure compliance to avoid significant penalties. At the same time, Stark Law changes to modernize and remove technical concerns, largely implements shifts that were already recognized in the regulations. If it is the start of further reforms — as could be suggested through the actions of other members of Congress, Administrator Verma, and others — this could be good news. However, if changes amount to little other than a way for policymakers to declare victory over the technical Stark Law, healthcare providers may be disappointed.

The authors of this legal alert are happy to further discuss the implications and potential ramifications from the Bipartisan Budget Act.

Uncategorized January 30, 2018

DOJ Memorandum Sets Out FCA Dismissal Factors

By Benjamin Christenson

A January 10 internal memorandum from the director of the fraud section of the DOJ’s civil division commercial litigation branch, which has recently become public, sets out the factors the government should consider in dismissing False Claims Act (FCA) cases in which it has declined to intervene, and may suggest a greater possibility that the DOJ will seek to dismiss such cases. The memo also provides defense counsel reacting to a government investigation related to a qui tam complaint with a roadmap for arguing for non-intervention and dismissal.The FCA gives the government authority to dismiss an action brought by a qui tam relator over the objection of the relator, as long as the court provides the relator an opportunity to be heard. 42 U.S.C. § 3730(c)(2)(A). The memo notes that the DOJ has rarely used this provision when it has declined to intervene in qui tam cases and instead allowed relators to proceed with lawsuits. Going forward, the memo instructs government attorneys, when they make a decision not to intervene, to also consider whether dismissal is appropriate.The memo describes several reasons the government may want to dismiss qui tam actions, including that monitoring of cases requires government resources and that weak cases can result in law that harms the government’s own enforcement. Accordingly, the memo sets out several factors for government attorneys to consider when evaluating whether to dismiss a qui tam action:

Whether the complaint is facially lacking in merit for either legal or factual reasons.
Whether the qui tam complaint duplicates a preexisting government investigation and adds no new information to the investigation.
Whether the action interferes with agency policies or programs. The government specifically notes that dismissal may be appropriate when “an action is both lacking in merit and raises the risk of significant economic harm that could cause a critical supplier to exit the government program or industry.”
Whether the action interferes with the government’s efforts to control its own litigation.
Whether the action implicates classified information or national security interests.
Whether the expected gain from allowing the litigation exceeds the expected cost to the government.
Whether the relator has made “egregious procedural errors” that frustrate the ability of the government to litigate the case.

The memorandum should be of great interest to any company or in-house counsel involved in areas, such as healthcare and government contracting, where the risk of FCA claims is high. The memo provides guidelines for the types of arguments that the government attorney must consider in deciding whether to dismiss, and also presumably in determining whether to intervene in the first instance. The memo also suggests that the initial stages of a government investigation, before the intervention decision, will be of even more importance to defendants who have the opportunity not only to avoid government intervention but also to have the government affirmatively aid the defendant by dismissing the action and saving the defendant the costs and burdens of litigating the claim against the relator. Defendants facing FCA claims and their counsel should take into account the factors set out in the memo as they strategize a response to government inquiries connected to qui tam complaints.

This post initially appeared on the McGuireWoods blog Subject to Inquiry.

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