Kusserow on Compliance: Continued confusion regarding the CMS preclusion list

Those on list are prohibited from MA Plans or Part D Sponsors payment

Questions continue arise concerning the CMS Preclusion List final rule. The Preclusion List is a list generated by CMS that contains the names of prescribers, individuals, and entities that are unable to receive payment for Medicare Advantage (MA) items and service and or Part D drugs prescribed or provided to Medicare beneficiaries. The rule mandates Part D sponsors, or their pharmacy benefit managers, to screen against the Preclusion List and reject any pharmacy claim prescribed by an individual or entity on it. MA plans must deny payment for a health care item or service furnished by an individual or entity on the list. Plans and sponsors must also notify impacted beneficiaries who received care or a prescription from a provider on the Preclusion List in the last twelve months. The list includes those who are currently revoked from Medicare, are under an active reenrollment bar, and whose underlying conduct CMS has determined to be detrimental to the Medicare program; or have engaged in behavior for which CMS could have revoked the prescriber and determined the underlying conduct would have led to the revocation. Such conduct includes, but is not limited to: felony convictions and OIG exclusions. CMS indicated that individuals or entities appearing on the List of Excluded Individuals/Entities (LEIE) and/or the System for Award Management (SAM) list would also be placed on the Preclusion List.

MA plans and Part D sponsors are required to access the list through an Enterprise Identity Data Management (EIDM) account with CMS. The list is updated monthly.  The causes for most of the confusion is that only plans approved by CMS are granted access to the Preclusion List. As a result, many if not most, organizations use a vendor for sanction screening services. However, the vendors are not always given access to the List.  The way around this obstacle has been for Plans to give their vendor the list and have them include it in their screening services. Another point of confusion is that technically, it is not a sanction list. It includes many parties who have not been formally sanctioned to be included on the OIG LEIE, although many on the list are also on the LEIE.

 

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 © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Why encourage anonymous hotline calls?

The are in your best interest

Encouraging anonymity with hotline callers may at first seem a bad practice, however, it is not.  It is a sound policy and in the best interest of the organization. However, many believe no calls should be accepted without an individual disclosing his or her identity. Those individuals are wrong. First, the HHS OIG, Sentencing Commission, DOJ, and Sarbanes-Oxley Act all promote anonymous reporting. The OIG in its compliance guidance state “At a minimum, comprehensive compliance programs should include…a hotline, to receive complaints, and the adoption of procedures to protect the anonymity of complainants and to protect whistleblowers from retaliation.  Failing to provide for and encourage anonymity undercuts the perceived effectiveness of the compliance program. There are other positive reasons for having anonymous reporting:

  1. Not allowing anonymity discourages reporting for fear of becoming a victim of retribution or retaliation. The result is that an individual may give information to someone else like an attorney, the media, government agencies, or simply not tell anyone which may lead to a growing exposure to liability to the organization. As a rule, the more serious the complaint or allegation, the less likely callers will be willing to identify themselves.
  2. The disclosure of an individual’s identity creates a burden for the organization to protect the caller’s identity (“confidentiality) once it is known. Failure to protect identified callers may result in unprotected reprisals or retaliation and serious consequences for the organization that may draw in attorneys, government, and regulatory agencies. There are many cases of litigation for reprisals or wrongful discharge where the company was put in the awkward position of trying to evidence the call did not contribute to the adverse action or termination. This is not a burden if the caller was anonymous.
  3. It is also useful to keep in mind that many callers may want to self-disclose their identity, in order to achieve a protection as a “Whistleblower” to forestall performance or conduct-based actions by trying to invoke the organization’s non-retribution/non-reprisal policy. For some, calling the hotline may be an attempt to block the adverse personnel action.

In some cases, it is desirable, and perhaps even necessary, to learn the identity of the caller in order to properly act on the information offered. There are circumstances where having the identity is essential to act upon a serious allegation. In such cases, callers can be encouraged to identify themselves, noting that their confidentiality will be protected. As such, it is important to also have a Confidentiality Policy, along with the Anonymity Policy.  Both such policies are called for in the OIG compliance guidance documents.

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.

Connect with Richard Kusserow on LinkedIn.

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Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OIG Civil Monetary Penalties Law enforcement actions for the second half of 2019

Many remain unaware of the Civil Monetary Penalties Law (CMPL). It comes into action when the DOJ believes false claim cases don’t rise to a level sufficient for prosecution in the courts. The OIG is authorized under the CMPL to impose administrative penalties, assessments, and exclusions against a person who, among other things, submits, or causes to be submitted, claims to a federal health care program that the person knows, or should know, are false or fraudulent. The exclusions statute also authorizes OIG to exclude a person who violates the CMPL. Those who appeal the OIG imposed penalties can appeal to an HHS Administrative Law Judge (ALJ). It is rare that an ALJ has overturned the OIG. During this semiannual reporting period, the OIG concluded cases involving more than $30 million in CMPs and assessments.

THE CMPL can be thought of as the administrative version of the False Claims Act. This means that any person who submits, or causes to be submitted, to a federal health care program a claim for items and services that the person knows, or should know, is false or fraudulent is subject to a penalty of up to $15,270 for each item or service falsely or fraudulently claimed, an assessment of up to three times the amount falsely or fraudulently claimed, and exclusion.

For the purposes of the CMPL, “should know” is defined to mean that the person acted in reckless disregard or deliberate ignorance of the truth or falsity of the claim. The law and its implementing regulations also authorize actions for a variety of other violations, including submission of claims for items or services furnished by an excluded person; requests for payment in violation of an assignment agreement; violations of rules regarding the possession, use, and transfer of biological agents and toxins; and payment or receipt of remuneration in violation of the anti-kickback statute.

Additional authorities for the OIG use of CMPL have been added in recent years. The Patient Protection and Affordable Care Act (ACA) added more grounds for imposing CMPs. These include, among other types of conduct, knowingly making, or causing to be made, any false statements or omissions in any application, bid, or contract to participate as a provider in a federal health care program (including Medicare and Medicaid managed care programs and Medicare Part D). The ACA authorizes a penalty of up to $55,262 for each false statement, as well as activities relating to fraudulent marketing by MCOs, their employees, or their agents. The 21st Century Cures Act added more grounds for imposing CMPs, assessments, and exclusion from federal health care programs for fraudulent conduct in an HHS grant, contract, or other agreement. The OIG may assess CMPs of up to $10,000 per claim and assessments of up to three times the amount claimed for knowingly presenting a false or fraudulent claim. In addition, the OIG may impose a penalty of up to $50,000 and assessments of up to three times the amount of funds at issue: (1) for each instance of knowingly making a false statement in a document required to be submitted in order to receive funds under an HHS contract, grant, or other agreement; (2) for knowingly making or using a false record or statement that is material to a false or fraudulent claim; and (3) for knowingly making or using a false record or statement material to an obligation to pay or transmit funds or property owed to HHS. The OIG may impose a penalty of up to $10,000 per day and assessments of up to three times the amount at issue for knowingly concealing, or knowingly and improperly avoiding or decreasing, an obligation owed to HHS with respect to an HHS grant, contract, or other agreement. Finally, The OIG may impose a penalty of up to $15,000 per day for failing to grant timely access to OIG upon reasonable request for audits or to carry out other statutory functions in matters involving an HHS grant, contract, or other agreement.

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.

Connect with Richard Kusserow on LinkedIn.

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Copyright © 202o Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OIG program exclusions reported for second half of 2019

Total of 2640 new exclusions added to the LEIE in 2019

Under the Social Security Act, the HHS Office of Inspector General (OIG) is able to exclude individuals and entities from participation in Medicare, Medicaid, and other Federal health care programs. Exclusions are required (mandatory exclusion) for individuals and entities convicted of the following types of criminal offenses: (1) Medicare or Medicaid fraud; (2) patient abuse or neglect; (3) felonies for other health care fraud; and (4) felonies for illegal manufacture, distribution, prescription, or dispensing of controlled substances. The OIG is also authorized (permissive exclusion) to exclude individuals and entities on several other grounds, including misdemeanors for other health care fraud (other than Medicare or Medicaid); suspension or revocation of a license to provide health care for reasons bearing on professional competence, professional performance or financial integrity; provision of unnecessary or substandard services; submission of false or fraudulent claims to a federal health care program; or engaging in unlawful kickback arrangements. The Patient Protection and Affordable Care Act (ACA) added another basis for imposing a permissive exclusion, that is, knowingly making, or causing to be made, any false statements or omissions in any application, bid, or contract to participate as a provider in a federal health care program, including managed care programs under Medicare and Medicaid, as well as Medicare’s prescription drug program.

During this semiannual reporting period, the OIG excluded 1,347 individuals and entities from Medicare, Medicaid, and other federal health care programs. Most of the exclusions resulted from convictions for crimes relating to Medicare or Medicaid, patient abuse or neglect, financial misconduct, controlled substances, or as a result of license revocation. The OIG completed the deployment of a new service for State Medicaid Fraud Control Units (MFCUs) to report convictions through a central web-based portal for exclusion. This improved reporting from those agencies. A list of excluded individuals and entities can be found at https://exclusions.oig.hhs.gov/.

 

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.

Connect with Richard Kusserow on LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2020 Strategic Management Services, LLC. Published with permission.