nowingly” submit false claims, but instead did its best to make sure that the claims were accurate.Are You Sure Your Company is Compliant? Can it Prove Compliance?In the fiscal year of 2022, the federal government committed over $694 billion to contracts. That rose by 9.5% to a record $765 billion in the fiscal year of 2023. There is no doubt that working with the federal government can be a highly lucrative business. However, that comes at a cost. Government contracting is one of the most heavily regulated industries, and as discussed above, the government is getting stricter, not more flexible with compliance.If you faced an audit right now and the Government found that you submitted false claims, could you prove that you were not deliberately ignorant of the fact that they were false? Would you not prefer to know that you have all you need to prove that you are compliant? https://www.justice.gov/opa/pr/deputy-attorney-general-lisa-o-monaco-announces-new-civil-cyber-fraud-initiative 31 U.S.C. § 3729(a)(G). https://www.justice.gov/opa/pr/false-claims-act-settlements-and-judgments-exceed-268-billion-fiscal-year-2023https://www.justice.gov/usao-ct/pr/connecticut-companies-pay-52-million-resolve-allegations-false-claims-act-violations; https://washingtontechnology.com/opinion/2022/06/you-are-never-too-small-draw-dojs-ire/368523/https://www.justice.gov/usao-id/pr/star-woman-pleads-guilty-false-statement-case-involving-more-11-million-government; https://www.justice.gov/usao-id/pr/star-woman-sentenced-14-months-making-false-statements-obtain-11-million-governmentU.S. ex rel. Schutte v. SuperValu Inc., 143 S. Ct. 1391, 1404, 216 L. Ed. 2d 1 (2023).https://www.gao.gov/blog/snapshot-government-wide-contracting-fy-2022[View source.]

xclusion laws. Thus, a provider or facility that employs or contracts with an excluded individual should be able to establish that: (1) federal healthcare programs do not pay, directly or indirectly, for the items or services being provided by the excluded individual, or (2) that the excluded individual furnished items or services solely to non-federal healthcare program beneficiaries. This may be difficult to establish in most healthcare settings.PenaltiesIf an individual or entity employs or contracts with an excluded individual, it may face a variety of civil and criminal penalties. This includes denial of payment for items or services provided in violation of the exclusion laws, and repayment of amounts improperly received in violation of the exclusion laws. Under the Affordable Care Act, providers must generally report and repay overpayments within 60 days or risk False Claims Act penalties, which include fines of $5,500 to $11,000 per claim, treble damages and program exclusion. 31 USC § 3729; 42 USC § 1320a-7k(d). Entities also risk being subject to Civil Monetary Penalties of $10,000 for each item or service provided by the excluded entity or individual for which payment is submitted to government payers, and an assessment of up to three times the amount claimed for such items or services. 42 C.F.R. §§ 1001.1901(b)(3) and 1003.102(a)(2)-(3).In addition to federal penalties, violators may also be subject to state exclusions, payment holds, recoupment and overpayment recoveries, damages and penalties, and may be required to submit extensive documentation in order to apply for eventual reinstatement. Significant reputational damage can also result from OIG or state investigations related to employing or contracting with an excluded entity. The OIG regularly publishes notifications of enforcement actions and settlements, and such actions are frequently covered in major media and healthcare industry publications.How to Check for Excluded Individuals or EntitiesThe OIG List of

pproval obtained in advance” by the Federal agency, a pass-through entity, or an authorized official. But it remains within a Federal agency’s reasonable discretion to retroactively provide prior approval under a Federal award in specific cases.Subpart B200.111 – English Language. Federal agencies are no longer required to exclusively use English in all notices, applications, and reports. OMB has now granted agencies “discretion” on when to deviate from English -- for example, when working in an “international environment.”200.113 – Mandatory Disclosure. In a significant development, OMB revised the mandatory disclosure obligations to require an applicant, recipient, or subrecipient of a Federal award to “promptly disclose” whenever, in connection with the Federal award (including any activities or subawards thereunder), it has “credible evidence” of violation of Federal criminal law involving fraud, conflict of interest, bribery, or gratuity violations, or the civil False Claims Act (31 U.S.C. 3729–3733). The previous requirement required disclosure of actual violations of Federal criminal law; with OMB’s revisions, the mandatory disclosure obligation more closely aligns with the Federal Acquisition Regulation (FAR) requirement for government contractors.Subpart C200.204; Appendix 1 – Notices of Funding Opportunities. OMB instructed Federal agencies to simplify Notices of Funding Opportunities (NOFOs) “in consideration of applicants with less experience applying for Federal financial assistance, such as applicants from underserved communities.” All NOFOs must now include an Executive Summary and use plain language to clearly and specifically articulate program requirements.Subpart D – Post Federal Award Requirements200.317–200.327 – Procurement Standards. OMB revised the general procurement standards to include a “board member” as an individual who could have a potential conflict of interest related to selection, award, and administration of contracts. In terms of competition require

Americans spend more than $3 trillion per-year on healthcare-related expenses. Of that, the National Health Care Anti-Fraud Association estimates that between $60-250 billion is lost to fraud every year.[1] Not all of those losses, however, relate to taxpayer-funded health insurance programs—such as state and federal Medicaid/Medicare—but involve losses to private payers and other non-traditional funding sources.To combat fraud occurring beyond the scope of taxpayer-funded healthcare plans—where laws such as the Anti-Kickback Statute and the Stark Law don’t reach—the Department of Justice (“DOJ”) has become increasingly creative. One of DOJ’s most creative avenues is the utilization of honest services fraud (18 U.S.C. § 1346) to prosecute bribes, kickbacks, and other improper payments in the health care industry.Traditionally, the Anti-Kickback Statute (42 U.S.C. § 1320a-7b)—alone or in conjunction with the Federal False Claims Act (31 U.S.C. § 3729 et seq.)—has been the primary mechanism for prosecuting healthcare bribes and kickbacks. The Anti-Kickback Statute works to ensure that decisions regarding purchasing, delivering, or providing healthcare-related services are not driven by improper financial arrangements. As written, the Anti-Kickback Statute does well to prohibit those arrangements, but it only applies to federally funded healthcare programs; meaning, it has very limited application, if any, to private payers or other non-traditional payment platforms.Honest Services Fraud—a Novel ApproachCodified as 18 U.S.C. § 1346, honest services fraud prohibits “schemes to defraud” that “deprive another of the intangible right of honest services.” In plain English, a person commits honest services fraud when, in violation of a fiduciary duty, that person participates in a bribery or kickback scheme. See Skilling v. United States, 561 U.S. 358, 407 (2010).Because an underlying fiduciary duty is a predicate for honest services frau

tain high ethical standards and prevent wrongdoing. For compliance officers, this means that they need to be even more proactive and vigilant in creating a culture of openness and communication within their organizations. They need to ensure that employees are aware of the policies and procedures for reporting misconduct internally, and that they feel comfortable and safe doing so. They also need to respond promptly and effectively to any concerns or complaints that arise and take appropriate corrective actions when necessary. By taking these steps, employees are more likely to keep their concerns internal, rather than knocking on the door of the DOJ.Deputy Attorney General Lisa Monaco Delivers Keynote Remarks at the American Bar Association’s 39th National Institute on White Collar Crime, Office of Public Affairs U.S. Department of Justice (March 7, 2024) https://www.justice.gov/opa/speech/deputy-attorney-general-lisa-monaco-delivers-keynote-remarks-american-bar-associationsId.Id.Id. 31 U.S.C. §§ 3729 – 3733. §§ 3729(a)(1)(A) and (B).The False Claims Act, Civil Division, U.S. Department of Justice (updated Feb. 23, 2024) https://www.justice.gov/civil/false-claims-act.False Claims Act Settlements and Judgments Exceed $2.68 Billion in Fiscal Year 2023, Office of Public Affairs U.S. Department of Justice (Feb. 22, 2024) https://www.justice.gov/opa/pr/false-claims-act-settlements-and-judgments-exceed-268-billion-fiscal-year-2023.False Claims Act Insights, Husch Blackwell, https://www.huschblackwell.com/false-claims-act-insights-podcast#page_1.SDNY Whistleblower Pilot Program, United States Attorney’s Office Southern District of New York (updated Feb. 13, 2024) https://www.justice.gov/usao-sdny/sdny-whistleblower-pilot-program#:~:text=The%20Office%20has%20launched%20an,in%20certain%20non%2Dviolent%20offensesVoluntary Self Disclosure and Monitor Selection Policies, U.S. Department of Justice (updated March 8, 2024) https://www.justice.gov/corporate-crime/voluntary-self-disclosure-and-mon

eves the minimum score necessary to be certified, the contractor has a Conditional Certification Assessment; if the contractor meets the minimum score and has no POA&M, then it has a Final Certification Assessment. Where a POA&M is used, it must be closed out within 180 days of the initial assessment by arranging for the DMCA DIBCAC to perform a closeout inspection.During the assessment, the DCMA DIBCAC may perform checks to ensure that all Level 2 security requirements are MET for in-scope assets. If the DCMA DIBCAC determines that a Level 2 security requirement is NOT MET, the assessment may be placed on hold or terminated (32 C.F.R § 170.18(c)(ii)).REQUIRED AFFIRMATIONSLike CMMC Levels 1 and 2, CMMC Level 3 introduces a requirement for affirmations that must be provided by a contractor’s senior official who is responsible for ensuring the contractor’s compliance with the CMMC Program.These affirmations present a heightened risk to Federal contractors of False Claims Act violations (31 U.S.C. §§ 3729-3733). The annual affirmation, in particular, requires Federal contractors to be vigilant in maintaining their assessed environments, to identify and surface any changes that would affect the environment’s compliance with CMMC requirements and to have a process to ensure that the senior officials making the affirmations have accurate and complete information regarding the entity’s CMMC compliance.EXTERNAL SERVICE PROVIDERSLike CMMC Level 2, an External Service Provider (ESP) must be certified to the level of the contractor utilizing it. For Level 3, this means a contractor must only use an ESP that has a Level 3 Final Certification Assessment (32 C.F.R. § 170.19(c)(2)).KEY TAKEAWAYSODPs are no longer defined by each organization, but instead by DoD.ESPs that exist outside of the Federal contracting ecosystem and have clients who seek to become CMMC Level 3 certified may have a substantial amount of work ahead of them, including getting on the DCMA DIBCAC’s schedule for CMMC Level 3 assessm

The False Claims Act, sometimes referred to as the FCA, is an integral part of U.S. whistleblower law. By providing an avenue for individuals to blow the whistle on false or fraudulent claims that are being committed against the United States government, the False Claims Act essentially deputizes private individuals by letting them enforce federal anti-fraud laws.For whistleblowers, the False Claims Act is generally the best way to proceed with their case, as it provides them with workplace protections against retaliation as well as some of the most lucrative whistleblower awards available. What is the False Claims Act?The False Claims Act (31 U.S.C. §§ 3729 et seq.) is a federal whistleblower law that lets private individuals report and prosecute fraud against a government program. It was enacted during the Civil War in reaction to fraudsters who were demanding compensation or a false or fraudulent claim from the federal government for wartime goods or services that they did not actually provide. Now, the False Claims Act is the primary weapon for prosecuting fraud and publicly disclosed allegations that has been committed against a government program. Just a few examples of the government programs that can be defrauded and lead to false claim cases are:Healthcare programs, like Medicaid, Medicare, or TricareThe Paycheck Protection Program (PPP)Federal grantsGovernment contracts, including those with defense contractorsThe False Claims Act can also be used to pursue reverse false claims and deliberate ignorance of the truth, or instances where someone or a company owes money to the government but is not paying it. This often stems from s

f misconduct often requires an insider’s access in a pharmaceutical company, pharmaceutical whistleblowers are usually employed by companies that manufacture, sell, or market prescription drugs. 2. Retaliating Against a Whistleblower is ProhibitedBecause so many whistleblowers get access to the incriminating information through their employment relationship, one of the most pressing concerns in whistleblower law is how to protect them from workplace retaliation. That is why nearly every whistleblower statute includes provisions that forbid whistleblower retaliation or discrimination.It is important to note, though, that the details differ between many of these laws, and those details can have a huge impact in your workplace rights and what you can recover if your employer violates them after you report pharmaceutical fraud.The good news for pharmaceutical whistleblowers is that many instances of pharmaceutical company fraud, waste, or abuse are covered by the federal False Claims Act (31 U.S.C. §§ 3729 et seq.) because they implicate a federal healthcare programs, like Medicare or Medicaid, or a government contract. The False Claims Act’s anti-retaliation provision, 31 U.S.C. § 3730(h), is among the most potent out of all of the federal whistleblower laws.This provision does not just cover retaliation that leads to your discharge. It also forbids workplace:HarassmentDiscriminationDemotionSuspensionYour employer violates the Act’s anti-retaliation provision if they even threaten to retaliate against you for reporting pharmaceutical fraud.If your employer retaliates anyway, the Act provides legal recourse in the form of a wrongful retaliation or termination lawsuit. Unlike other, similar lawsuits, those that stem from False Claims Act retaliation can recover:Back wages, plus interestA civil penalty equal to twice your back wagesOther losses, like emotional distress or lost reputation, caused by the retaliationCourt costs and attorneys’ fees associated with the retaliation lawsuitIn ad

y attributes have not been separately sold, transferred, or retired as opposed to EACs that are procured independently from the agency’s purchases of physical power, often referred to as ‘unbundled’ EACs.” The GSA issued a similar RFI last year, which we covered here.We wrote about Executive Order 14057 and other related Executive Orders here. A domestically-manufactured solar panel for the purposes of the RFI is one in which 65% of the cost of all of its components are for components mined, produced or manufactured within the United States consistent with the definition of a domestic end product at Federal Acquisition Regulation (FAR) 25.003. For example, under the Obama Administration the Defense Logistics Agency Energy (“DLA”) entered into a number of renewable power procurement contracts in support of the Army, the Navy and the Air Force. Federal agencies may also acquire public utility services through interagency agreements, which do not appear to be relevant to the present RFI. 31 U.S.C. § 3729. “Energy communities,” as defined by the Inflation Reduction Act of 2022 (“IRA”), include brownfield sites, coal communities and areas with substantial extraction, processing and transport of coal, oil or natural gas and a high unemployment rate. “Energy justice communities” are generally defined as communities that have borne the brunt of air, water and soil pollution.

During a March 7, 2024, speech at the American Bar Association’s 39th National Institute on White Collar Crime, Deputy Attorney General Lisa Monaco announced that the United States Department of Justice (“DOJ”) is launching a pilot whistleblower program intended to fill gaps in the existing framework of federal whistleblower programs. Monaco explained that there would be a “90-day sprint” to develop and implement the pilot program, with a formal start date scheduled for later this year. While the details of the program will be developed over the next 90 days, the DOJ will likely replicate requirements seen in the False Claims Act (31 U.S.C. §§ 3729-3733) and other federal whistleblower programs. Like other whistleblower initiatives, the DOJ’s program will focus on incentivizing disclosure of misconduct, fraud and abuse, and reward whistleblowers who provide original and meaningful information to the government. The new program expands on existing DOJ initiatives aimed at encouraging companies to self-disclose violations by offering incentives for proactively reporting violations. To qualify for a reward, a whistleblower must disclose original information that helps the DOJ discover significant corporate or financial misconduct that is otherwise unknown to the DOJ, and the whistleblower must be “the first in the door.” As a result of the information provided, a whistleblower may qualify to receive a portion of the resulting forfeiture. However, this new pilot program is distinguishable from other federal whistleblower initiatives in that it represents the first instance where the DOJ is incorporating monetary rewards as a fundamental