Applying lessons learned when conducting FCA investigations after Escobar

The Supreme Court opinion in Universal Health Services v. U.S. ex rel Escobar established that the implied certification theory may be a basis for False Claims Act (FCA) (31 U.S.C. §3729) liability if allegations satisfy both the FCA’s materiality and scienter (knowledge) requirements, Joan W. Feldman, partner at Shipman & Goodwin LLP explained during a Health Care Compliance Association webinar on June 26, 2017. She noted that the focus in FCA cases going forward will be whether the government would have refused to pay the allegedly false claim if it had known of the information allegedly omitted or misrepresented.

The Supreme Court’s opinion and remand

The Supreme Court granted certiorari in Escobar to answer whether the implied certification theory was viable and if it could only apply when a provider violated a legal requirement that the government explicitly designated as a condition of payment. Although the Court determined that implied certification is a valid theory, it stated that the FCA should not be considered a vehicle for “punishing garden-variety breaches of contract or regulatory violations…” The Court further concluded that “a misrepresentation about legal compliance does not become material simply because the Government labeled the legal requirement as a ‘condition of payment,’ but whether the defendant knowingly violated a requirement the defendant knows is material to the Government’s payment decision.” The Court remanded the case to the First Circuit (see Implied certification liability confirmed, limited to material compliance violations, Health Law Daily, June 16, 2016).

Feldman pointed out that upon remand, the First Circuit identified three factors that had to be considered when evaluating materiality and knowledge: (1) was compliance a condition of payment, (2) was compliance with a specific regulation the essence of the agreement; and (3) did the government pay the claim even though it was aware of the issue?

The First Circuit concluded, if Medicaid’s decision to reimburse Universal Health Service would have been unaffected by knowledge of the regulatory violations, the violations would not be material, and the implied false certification lawsuit could not proceed. In this case, however, the complaint stated that regulatory compliance was a condition of payment, licensing and supervision requirements were central to the regulation of mental health treatment facilities generally, and the factual allegations were limited to reimbursement claims filed during treatment (see Implied false certification lawsuit under the FCA stated a valid cause of action, Health Law Daily, November 29, 2016).

Lessons from Escobar

The Escobar case illustrates that the FCA is nuanced and complex, Feldman said. She noted that courts will closely scrutinize and evaluate materiality on a fact specific, case-by-case basis to determine whether the alleged violations are sufficient to constitute a false claim. Although she said it is not clear how the Supreme Court’s opinion will play out in the courts, she stressed the importance of claimants clearly stating their materiality and knowledge claims under the implied certification theory. She also emphasized the importance of reacting appropriately and promptly to FCA complaints or concerns.

Investigations

Feldman provided the details of several steps in conducting an FCA investigation, including where to start, maintaining attorney client-privilege, working with the government, planning and conducting an investigation, and mitigating the risk of a FCA qui tam action. She emphasized the importance of maintaining confidentiality throughout the investigation. In addition, she

  • Where to start. When confronted with a false claim allegation, providers must respond promptly. The date and time that the allegation was made must be documented and the allegation must be communicated to leadership. Legal counsel experienced with false claims should be engaged and the Medicare administrative contractor or Medicaid agency must be notified. The compliance officer must assign responsibility for the investigation but must limit the number of individuals in the sphere of knowledge and communication. Accountability and follow-up are essential as well as the preservation of documents.
  • Maintaining attorney client privilege. Consult with counsel to protect the attorney-client privilege. Ensure document production is done with counsel who creates a privilege log for documents that will not be turned over to the government. Interview witnesses separately to protect communications.
  • Working with the government. When working with the government compliance officers must be cooperative, responsive, and timely; yet maintain an advocate position for the organization. They must understand the issue, facts, and relevant law as well as the settlement if there is one. Feldman encouraged compliance officers not to be intimated by the government or assume its position is correct. She explained that the government only knows the case from the qui tam relator. She told compliance officers to “push back” and advocate the organization’s position with facts and laws when presented with the government’s case.
  • Planning the investigation. An investigative plan must be developed, a timeline created, and records of the investigation must be maintained, including the process, interview notes, and witness log. Witnesses must be identified and interviews must be scheduled.
  • Conducting the investigation. The attorney should conduct the investigation and may have deputized staff to assist. When a complaint of subpoena is received, litigation hold must be communicated throughout the organization. Documents are reviewed and interviews conducted. When appropriate, engage auditors or experts. Leadership should be kept informed throughout the process.

Additional tips

Other advice Feldman provided included circling back to complainant, avoiding whistleblower retaliation, and being mindful of the collateral effect of an investigation on employees. In addition, she emphasized that concerns raised by an individual must be taken seriously. Compliance officers should give them full attention and document the concern and how it was addressed. If the individual is not satisfied with the findings, the compliance officer should document why no further action will be taken and notify counsel. If attention is not given when a concern is raised, the individual may pursue an action.

Billions in ‘transfers of value’ to physicians, hospitals by industry get DOJ attention

In calendar year (CY) 2015, over $7.5 billion in “transfers of value” were made by pharmaceutical companies to physicians and hospitals through the federal Open Payments program, which in turn has caused the Department of Justice (DOJ) to focus on this area while investigating fraud in the health care system. In an HCCA sponsored seminar titled “Sunshine, Open Payments, and Potential Conflicts of Interest,” Senior Compliance Executive C.J. Wolf, M.D., of Healthicity, noted that under the Open Payments program, CMS has now accumulated over 28 million records of transfer of value. Within this vast repository of data, CMS uses it to uncover outliers in payments, and as a result, industry and providers, alike, are very interested in how the open payment system affects their operations.

Open Payments

Under Section 6002 of the Affordable Care Act (ACA), manufacturers must disclose to CMS payments made to physicians and teaching hospitals. Manufacturers and group purchasing organizations must also report ownership and investment interests held by physicians. The HHS Office of Inspector General (OIG) included these aspects into its list of priorities in its 2017 Work Plan, with Medicare and Medicaid payments high on the list (see Focus remains on Medicare, Medicaid payments in 2017 OIG Work Plan, Health Law Daily, November 10, 2016).

The 2017 Work Plan also stressed that the OIG will also determine how much Medicare paid for drugs and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) ordered by physicians who had financial relationships with manufacturers and group purchasing organizations.

Wolf noted the DOJ has taken a keen interest in this area of open payments, as evidenced by actions such as Teva Pharmaceuticals USA, Inc., and its subsidiary IVAX, LLC, agreeing to pay a total of $27.6 million to the federal government and the State of Illinois in a settlement regarding allegations of false billing practices under the False Claims Act (see Teva Pharmaceutical to pay federal and state government $27.6 million to resolve false billing allegations, Health Law Daily, March 11, 2014).

Conflicts of interest

There are 11 payment “categories” that must be reported under the Open Payments program: (1) consulting fees, (2) honoraria, (3) gift, (4) entertainment, (5) food and beverage, (6) travel and lodging, (7) education, (8) charitable contribution, (9) royalty or license, (10) grant, and (11) research.

As part of the transparency initiatives under the ACA, the dollars that physicians receive from industry is reported and documented. Physicians and providers should be aware that these categories touch upon even compensation for serving as faculty or as a speaker for a non-accredited and noncertified continuing education program.

Because the Open Payments program also includes ownership interests that physicians or their immediate family members have in various companies and the data is then made available to the public each year, reporting often is paramount.

Mental health services provider enters into $4M FCA settlement

A provider of in-home mental health services and two of its leaders agreed to pay a total of $4.5 million to settle allegations that they violated the federal False Claims Act (FCA) and the Minnesota False Claims Act by billing Medicaid for services that violated clinical supervision requirements. Under the agreement, Complementary Support Services (CSS) and related entities will pay $4 million, its president will pay $400,000, and an executive will pay $120,000.

According to Acting U.S. Attorney Gregory G. Brooker and Minnesota Attorney General Lori Swanson, CSS provided in-home mental health services to children and adults through two Medicaid programs that restrict reimbursement to time spent providing face-to-face services with the patient and prohibit reimbursement for a therapist’s time completing paperwork. Both programs also require a licensed therapist such as a social worker or psychologist to clinically supervise patient care to ensure that the services are appropriate and medically necessary.

Between 2007 and 2016, however, CSS failed to submit claims that reflected signature by licensed professionals serving as clinical supervisors. Instead, CSS’ president “batch signed” progress notes that formed the basis for billing Medicaid. In addition, CSS employees routinely added an extra billable unit for paperwork time for each client visit.

Local news reported that this case reflected a longstanding gap in Minnesota’s oversight of mental health services because CSS, like 200 other agencies, was unlicensed and not subject to routine regulatory oversight. In the wake of these allegations, the state began reviewing its oversight of mental health agencies.

As a part of the settlement, CSS is permanently excluded from participating in federal and state health care programs. The president agreed to an exclusion of at least eight years, and the executive agreed to an exclusion of at least five years.

U.S. intervenes in UnitedHealth billing scheme suit

The federal government intervened in a qui tam lawsuit alleging that UnitedHealth Group entities (UnitedHealth) and Medicare Advantage organizations (MAOs) with which it contracted, including HealthCare Partners, deliberately concealed from the Medicare Part C program that they had submitted bills not supported by medical documentation, resulting in inflated risk adjustment payments that were never repaid to CMS. The U.S.’s intervention in this False Claims Act (FCA) (31 U.S.C. § 3729, et seq.), U.S. ex rel. Swoben v. Secure Horizons, is emblematic of its “commitment to ensure the integrity of the Medicare Part C program.” It is expected to file a complaint in another risk-adjustment-related FCA case, U.S. ex rel. Poehling v. UnitedHealth Group. Inc., no later than May 16, 2017.

MAOs must submit diagnosis codes for each enrollee for a particular calendar year to CMS (42 U.S.C. § 1395w-23(a)(3)). CMS uses the codes to create Hierarchical Condition Category (HCC) risk scores to adjust the capitated payment rates it pays to each MAO, increasing payment rates to MAOs with patient populations with more severe illnesses and decreasing payments to MAOs with patient populations with less severe illnesses. MAOs typically submit data to CMS and then perform a retrospective review of medical charts to ensure that the charts support the claims submitted. If an MAO discovers a diagnosis code for a patient that was not already submitted, it may do so at that time. However, MAOs are also required to withdraw previously submitted codes that they determine were not supported by medical documentation.

A former employee of Senior Care Action Network (SCAN) Health Plan and a consultant to the risk adjustment industry filed the qui tam suit and the government filed an intervening complaint, alleging that UnitedHealth, HealthCare Partners, and other defendants knowingly concealed the fact that previously submitted codes were not supported by medical documentation, resulting in higher risk adjustment payments. Specifically, the defendants hired coders to perform retrospective reviews, but knowingly concealed information about previously submitted codes so that the coders would not be able to identify codes that were not supported by medical documentation. In addition, certain employees created spreadsheets that did not permit the entry of previously submitted codes that should be withdrawn, as required by CMS.