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.

Kusserow on Compliance: EHR incentive program attestation is serious business

The American Recovery and Reinvestment Act of 2009 (ARRA) (P.L. 111-5) authorized providing incentive payments to eligible health care professionals, hospitals, and Medicare Advantage Organizations (“MAOs”) to promote the adoption and “meaningful use” of health information technology and electronic health record (“EHR”) systems. CMS established the Medicare and Medicaid Electronic Health Record Incentive Programs (EHR Incentive Programs) to make incentive payments to health care professionals and providers that meet specified requirements for the meaningful use of certified EHR technology (CEHRT). The EHR Incentive Programs are intended to bring about improved clinical outcomes and population outcomes, increase transparency and efficiency in health care, empower individuals to make decisions regarding their care, and generate additional research data on health systems. Program participants must report on their performance pertaining to certain clinical quality measures (CQMs) and objectives to CMS (for Medicare) or the authorized state agency (for Medicaid) through an attestation process. Since 2011, the EHR Incentive Programs have made incentive payments to numerous eligible professionals, eligible hospitals, and critical access hospitals (CAHs) that qualify as “meaningful users” by meeting the objectives and CQMs outlined in the various stages of the applicable programs.

Annual attestations required

Eligible providers must annually attest to meeting the specified objectives and measures in order to receive incentive payments under the EHR Incentive Programs. Once they have attested to meeting the identified objectives and measures, they are deemed to be meaningful users and eligible for incentive payments.  CMS, its contractor, and state Medicaid agencies conduct both random and targeted audits to detect inaccuracies in eligibility, reporting, and receipt of payment with respect to the EHR Incentive Programs.  Eligible hospitals may be selected for pre- or post-payment audits. CMS has required that eligible hospitals retain all supporting documentation used in completing the Attestation Module responses in either paper or electronic format for six years post-attestation. Eligible hospitals are responsible for maintaining documentation that fully supports the meaningful use and CQM data submitted during attestation. Those hospitals undergoing pre-payment audits will be required to provide supporting documentation to validate submitted attestation data before receiving payment.

Unsupported and false attestations

Making false statements, including attestations to the federal government, could implicate federal law (18 U.S.C. § 1001), which generally prohibits knowingly and willfully making false or fraudulent statements or concealing information. Although eligible hospitals receiving incentive payments under the Medicare and Medicaid EHR Incentive Programs are not required to follow any particular parameters when spending the payments, they must annually attest to meeting the relevant measures and objectives in order to be entitled to incentive payments. It is critical that eligible hospitals maintain documentation that supports their attestations.  Supporting documentation needs to make clear that the hospital is meeting the terms and conditions of the EHR Incentive Program. A checklist document by itself would be insufficient as supporting documentation. Failure to maintain such supporting documentation creates potential liability. Although no significant enforcement activity has taken place, compliance officers are advised to verify that proper supporting documentation is maintained.  In fact, the responsible program manager should be maintaining documentation as part of ongoing monitoring. As part of ongoing auditing, the compliance office should ensure that monitoring is conducted and validate that it is adequately meeting regulatory requirements.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2017 Strategic Management Services, LLC. Published with permission.

 

 

340B a small program with tricky compliance field

Although drug spending under the 340B program is a small fraction of drug spending in the country overall, compliance remains important for all entities involved: hospitals, pharmacies, and manufacturers. In a Health Care Compliance Association webinar entitled “340B Program: Finding Clarity in Uncertain Times,” presenters Karolyn Woo and Tony Lesser, both from Deloitte & Touche LLP, advised listeners to allocate the necessary resources to ensure compliance in light of increased audit activity.

340B program

Created by section 340B of the Public Health Service Act (PHSA), the program requires drug manufacturers participating in the Medicaid program to provide outpatient drugs to participating health care organizations at reduced prices. These discounts allow providers to save between 25-50 percent on outpatient drug costs. However, for perspective, 340B spending only accounted for just over $12 billion of the $310 billion spent on drugs in 2015.

Oversight and audits

Despite the program’s relatively small size, Woo and Lesser underscored the necessity of compliance, noting the Health Resources and Services Administration’s (HRSA) increased oversight activity. The agency has recently contracted experienced auditors, who focus on eligibility, drug diversion, duplicate discounts, and billing accuracy. If issues are found during the audit, the HRSA Office of Pharmacy Affairs (OPA) will review these issues, present a corrective action plan to HRSA, and finalize its report. Drug diversion is the most common issue, and repayment to manufacturers was required in over half of the completed audits in fiscal years (FYs) 2015 and 2016. Although there has been no uptick in the number of manufacturer audits recently, HRSA may contact an entity to request certain information outside of an audit, which should be presented as clearly as possible. In addition, specialty pharmacies, which often represent a high percentage of a manufacturer’s 340B revenue, may fall under particular scrutiny.

Compliance plan

Repayment requires that the covered entity and the manufacturer work out a financial remedy in good faith. The process is hampered by outdated OPA information, lack of deadline guidance, and differing repayment calculations. To avoid being placed in this situation, covered entities should create a compliance plan that ensures close oversight of 340B activity, starting with educating staff and reviewing 340B policies and procedures. Entities should perform internal audits to find areas of non-compliance, and learn how to prevent and detect identified issues. When areas of non-compliance are found, they should be reported to manufacturers, HRSA, or other entities as required.

Webinar gives tips on navigating physician peer review process

Hospitals and compliance officers should know the reporting requirements of the Health Care Quality Improvement Act (HCQIA) (42 U.S.C §11101 et seq.) and be “very strict” in complying with the four standards to obtain immunity from damages. In a Health Care Compliance Association webinar entitled, Physician Peer Review: 10 Steps to Navigating the Process, Theresamarie Mantese and Fatima M. Bolyea, health care attorneys at Mantese Honigman, PC, gave practical tips on dealing with the process of physician peer review.

Federal and state reporting requirements

HCQIA (42 U.S.C. §11133) requires health care entities to report the following “reportable events” to the applicable state board of medical examiners: (1) a professional review action that adversely affects the clinical privileges of a physician for a period longer than 30 days; (2) the surrender of clinical privileges while the physician is under an investigation by the entity relating to possible incompetence or improper professional conduct, or in return for not conducting such an investigation or proceeding; or (3) in the case of a professional society, a professional review action by the professional society that adversely affects the membership of a physician in the society.

Mantese noted that it is important to know both federal and state requirements, since state requirements can be more stringent. For example, in Michigan reporting requirements are triggered when a disciplinary action affects a health professional’s privileges for more than 15 days.

Compliance officers must also clearly define “investigation” so that they know when reporting requirements are triggered. While the NPDB Guidebook defines “investigation” broadly, a general review of physicians for overall performance in relation to each other is not an investigation.

Immunity from damages

HCQIA (42 U.S.C. §11112(a)) provides that hospitals and other participants are immune from damages if the professional review action was taken: (1) in the reasonable belief that the action was in the furtherance of quality health care; (2) after a reasonable effort to obtain the facts of the matter; (3) after adequate notice and hearing procedures; and (4) in the reasonable belief that the action was warranted by the facts. Compliance officers should, said Mantese, be “very strict” is attempting to comply with these standards. She said the third prong is where the most litigation happens and one of physicians’ strongest arguments in challenging a professional review action.

HCQIA immunity applies to money damages only, not to equitable relief such as reinstatement or the striking of a report. Mantese said, however, that if immunity applies, a request for equitable relief usually fails, too.

Notices

Under 42 U.S.C. §11112(b), the hospital is required to give the physician notice of a proposed action. If the notice is deficient, the physician should challenge it. Mantese encouraged compliance officers to have a template of a notice to ensure that the fundamental features are included. She emphasized that each notice should be compliant, even if the same information is repeated across notices; several notices cannot be taken together to create completeness.

Hospital policies

The presenters emphasized the importance of adequate hospital policies and bylaws, including the appeal rights of physicians after a peer review hearing. For example, the bylaws are critical in determining what records the physician can obtain from the hospital. A fair hearing plan is also a good idea in case the physician claims that the hospital arbitrarily denied a request for documents. According to Mantese, hospitals should consider providing the physician with as much information as possible—the more information the physician has about an issue, the less likely he or she is to bring litigation, and the case is more likely to be dismissed if litigation does ensue.

Peer review hearing

If the physician requests a hearing on a timely basis, then a hearing must be held (as determined by the health care entity) before: (1) an arbitrator mutually acceptable to the physician and health care entity; (2) a hearing officer who is appointed by the entity and who is not in direct economic competition with the physician; or (3) a panel of individuals who are appointed by the entity are not in direct competition with the physician involved. A panel usually consists of other physicians on staff at the hospital.

During the hearing, the physician has the following rights: (1) representation by an attorney; (2) a record of the proceedings; (3) the ability to call, examine, and cross-examine witnesses; (4) to present relevant evidence regardless of its admissibility in a court of law; and (5) the ability to submit a written statement at the close of the hearing.

A question that usually emerges is whether the panel members are in direct economic competition with the physician. If the physician raises this issue and the hospital has a number of people to serve on the panel, it should simply replace that person.

The presenters strongly recommended having a court reporter at the hearing. Because a common point of contention is which party will cover the costs, they recommended splitting the cost between the provider and the physician. Mantese also emphasized that hearing “exhibits are very, very important.” One person should maintain control of the exhibits during the hearing, and no one should leave until all are marked and accounted for.

Post-hearing

After the hearing the parties should submit a brief written statement with proposed findings of fact. Pursuant to HCQIA, upon completion of the hearing, the physician involved has the right to receive (1) the written recommendation of the arbitrator, officer, or panel, including a statement of the basis for the recommendations; and (2) a written decision of the health care entity, including a statement of the basis for the decision.