Kusserow on Compliance: OIG summarizes investigative accomplishments from last three years

The OIG testified before the House Committee on Ways and Means and reported that in the last 3 fiscal years, its investigations have resulted in more than $10.8 billion in investigative receivables (dollars ordered or agreed to be paid to Government programs as a result of criminal, civil, or administrative judgments or settlements); 2,650 criminal actions; 2,211 civil actions; and 10,991 program exclusions. Much of this work involving the Medicare and Medicaid programs is funded by the Health Care Fraud and Abuse Control Program (HCFAC).  The HCFAC provides funding resources to the Department of Justice (DOJ), HHS, and OIG, which are often used collaboratively to fight health care fraud, waste, and abuse. Since its inception in 1997, the HCFAC has returned more than $31 billion to the Medicare trust fund.

The OIG is a lead participant in the DOJ led Medicare Fraud Strike Force, which combines the resources of Federal, state, and local law enforcement entities to fight health care fraud across the country. The Strike Force operates in nine geographic hot spots, including Miami, Florida; Los Angeles, California; Detroit, Michigan; southern Texas; Brooklyn, New York; southern Louisiana; Tampa, Florida; Chicago, Illinois; and Dallas, Texas. Strike Force teams are led by the DOJ, includes the FBI and the OIG, along with state and local law enforcement. In 2017 alone Strike Force teams accounted for over 2,000 criminal actions with about 3,000 indictments, and accounted for monetary results of around $3 billion. Since its inception in March 2007, the Strike Force has charged more than 3,000 defendants who collectively billed the Medicare program more than $10.8 billion.

The OIG also collaborates with state Medicaid Fraud Control Units (MFCUs) to detect and investigate fraud, waste, and abuse in state Medicaid programs, as well as private sector stakeholders to enhance the relevance and impact of its work to combat health care fraud, as demonstrated by its leadership in the Healthcare Fraud Prevention Partnership (HFPP) and collaboration with the National Health Care Anti-Fraud Association (NHCAA). The OIG strives to cultivate a culture of compliance in the health care industry through various educational efforts, such as Pharmacy Diversion Awareness Conferences, public outreach, and consumer education.

 

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.

Kusserow on Compliance: OIG issues first 2017 Semi-Annual report—1,422 exclusions in first half of 2017

The OIG released is first semi-annual report for 2017 which included the number of exclusion actions taken. There were a total of 1,422 individuals and entities they excluded from Medicare, Medicaid, and other Federal health care programs. Most of the exclusions resulted from convictions for crimes relating to Medicare or Medicaid, for patient abuse or neglect, or as a result of license revocation. The OIG posts all such actions on its List of Excluded Individuals and Entities (LEIE).  In its compliance guidance, the OIG calls for screening of all individuals and entities engaged by or with whom they do business against the LEIE. CMS also makes such screening a condition of participation and enrollment. The OIG has a number of Administrative Sanction authorities whereby they have added steadily to the LEIE database. In the last three years the OIG added over 10,000 exclusions to the LEIE.

OIG Enforcement Authorities

Tom Herrmann, JD, is a nationally recognized health care compliance consultant.  He served for a number of years in the OIG Counsel’s Office as Chief of the Administrative Litigation Branch, and supervised the litigation of cases involving the imposition of civil monetary penalties and program exclusions. He explained that the OIG has been delegated the authorities to impose Civil Monetary Penalties, assessments, and program exclusion on health care providers and others determined to have engaged in defined wrongdoing. The effect of an OIG exclusion is that no payment may be made for any items or services furnished by an excluded individual or entity, or directed or prescribed by an excluded physician. He noted that in almost all instances where the OIG’s imposition of program exclusion or CMPs is appealed, it is upheld by a HHS Administrative Law Judge (ALJ), the HHS Departmental Appeals Board (DAB), and Federal Courts. As such, it is absolutely essential to have ongoing sanction-screening of anyone engaged by a healthcare organization.

Jillian Bower, is another highly experienced health care compliance consultant, who has assisted scores of clients in meeting the sanction-screening obligations through the Compliance Resource Center (CRC). She notes that CMS has been very aggressive in calling for sanction screening, not only of the LEIE, but Debarments posted by the General Services Administration (GSA), as well as pressuring State Medicaid Directors to establish exclusion databases and mandate monthly screening by their enrolled providers. Since then most states have moved to comply with the CMS direction. This has increased the sanction-screening burden greatly for not only for the compliance office, but also human resource management (HRM). Procurement is also affected by the number of vendors and contractors that also have to be screened. Medical credentialing is involved because physicians granted staff privileges have to be screened. In order to meet screening mandates, it is almost a necessity to use a vendor search engine tools to assist in sanction-screening. This saves downloading the sanction databases of all the entities and developing their own search engine. So using a vendor for this purpose is a step in the right direction; however the bulk of the work remains with the organization to do screening and resolving potential “hits” remains with the organization. Altogether this can be a considerable effort and many organizations have to dedicate one or many employees to meet all these obligations. Alternatively, many just outsource the entire process, including verification and certification of results to a vendor

Sanction-Screening Tips

  1. Ensure periodic sanction screening of employees, medical staff, contractors, and vendors against the LEIE, not just at time of engagement but periodically thereafter. An individual or entity may be pass a sanction screen at time of engagement, but later have a sanction imposed.

 

  1. Maintain a complete record of sanction screening to evidence meeting mandates with individual(s) responsible for sanction screening attesting to results each time screening has taken place. If using a vendor to conduct the sanction screening on behalf of the organization, they should provide a full certified report each time they perform their service.

 

  1. Develop a compliance policy and applications requiring as a condition of employment, gaining staff privileges, or engagement, attestation that the individual has not been, nor are they now, the subject of an investigation by any duly authorized regulatory or enforcement agency. It is also advisable to add a condition of engagement that employees must promptly report any notice of investigation that involves them.

 

  1. Care should be taken to meet state Medicaid screening requirements in addition to checking the LEIE. For those organizations that cross state lines, it is particularly important to ensure compliance with state sanction screening mandates that differ from state to state.

 

  1. Inasmuch as most exclusions in the LEIE arise from another underlying court, state agency, or licensure board action, it is critical as part of the credentialing process to verify that health care professionals are duly licensed and not until any restrictions. Engaging or giving staff privileges to individuals who are restricted in their license may be considered by CMS as violating conditions of participation.

 

  1. Educate and inform management and employees on their obligation to promptly report any notification of an adverse action by any duly authorized regulatory or enforcement agency. Policies should be implemented to reinforce this.

 

  1. Consider using a vendor tool to assist in sanction-screening, but compare services and costs to avoid unnecessary expenditures; and consider the cost-benefits of outsourcing then entire sanction-screening process.

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 Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

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

Structure call coverage arrangements to avoid Stark & AKS issues

When compensating physicians for the time they spend on-call, hospitals should draft call coverage agreements with care to avoid potential problems implicating federal laws prohibiting physician self-referral (Stark Law) and kickbacks (Anti-Kickback Statute (AKS)). In a webinar presented by the Health Care Compliance Association (HCCA), Robert G. Homchick, partner at Davis Wright Tremaine LLP, and Scott M. Safriet and Adam S. Polsky, partners at HealthCare Appraisers, Inc., discussed changes to the call coverage risk analysis based on court opinions and changes in government implementation of rules.

As with most physician compensation arrangements, the Stark Law (42 U.S.C. §1395nn) is the threshold issue when analyzing call coverage agreements; additionally, if the agreement passes muster under Stark, the AKS (42 U.S.C. §1320a-7b) risks should be relatively modest. Both analyses contain some of the same considerations, such as fair market value (FMV) and commercial reasonableness.

Homchick, Safriet, and Polsky noted the following concerns for call coverage:

  • on-call coverage is becoming more expensive, but hospitals are facing decreased reimbursement; and
  • because traditional methods of securing call coverage no longer apply to all situations, hospitals are becoming more creative to obtain coverage.

To effectively secure coverage, hospitals should consider many options, and determine which is best applied in their situation. Potential coverage options include concurrent coverage, telemedicine, bundling on-call coverage with services beyond the emergency room, on-call coverage payment for employed physicians, and use of the “activation fee” concept.

However, the webinar cautioned that not all arrangements are the same, and in situations where it is truly difficult to secure coverage, a different approach may be necessary. Additionally, hospitals should look into the underlying reasons of why securing that coverage has been difficult—for example, are there shortened response times, a physician shortage in the marketplace, or is coverage restricted or quasi-restricted.

Kusserow on Compliance: OIG expanded exclusion authorities go into effect

On February 13, 2017, the HHS Office of Inspector General (OIG) Final rule amending the regulations related to its exclusion authority goes into effect. It incorporates recent statutory changes, early reinstatement provisions, and recent policy changes, and clarifies existing regulatory provisions. It is the most substantial revision to the exclusion regulations in many years and reflects changes made by the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) in 2010 and the Medicare Modernization Act (MMA) in 2003, as well as informal practices that the OIG has now codified in regulations. Most of the changes in the final rule are largely technical in nature; however they significantly expand and solidify the OIG’s authority to exclude providers.

The scope of OIG oversight now will move beyond claims submission based on the ACA’s permissive exclusion authority over an individual or entity that knowingly makes or causes to be made any false statement, omission, or misrepresentation of material fact in any application, agreement, bid, or contract to participate or enroll as a provider of services or supplier under a federal health care program. Under the new rules, the OIG’s authority has been extended to exclude based on the following:

  • conviction relating to obstruction of an investigation or audit;
  • failure to provide payment information by individuals who “order, refer for furnishing, or certify the need for” items or services paid for by Medicare or state health care programs;
  • those who refer patients or certify the need for items or services, even if they do not provide the items or services; and
  • making false statements or misrepresenting material facts in applications to participate as a provider or supplier under a federal health care program.

The OIG also will now consider materials obtained from various entities, including CMS, state Medicaid agencies, fiscal agents or contractors, private insurance companies, state or local licensing or certification authorities, and law enforcement. This information may be considered in determining the length of exclusion.  Also, a number of technical changes were made regarding key terms, such as replacing the language “who submit claims to” with “who request or receive payment from” in the definitions of “directly” and “indirectly,” thereby clarifying the scope of individuals and entities subject to oversight by the OIG.

The OIG may impose exclusion up to a 10-year period from the time the conduct occurred. It may consider a request for a waiver from a federal health care program administrator, as opposed to only waivers submitted by state health care program administrators. It also makes several changes to the aggravating and mitigating factors that the agency considers in determining whether to increase the length of exclusion above the minimum required. Mitigating factors are only considered if OIG has established one or more aggravating factors. Other changes include:

  • updating the dollar amounts for aggravating and mitigating factors that consider the financial loss to federal health care programs as a result of the misconduct from $15,000 to $50,000;
  • reworking the existing aggravating factors regarding other offenses to include considering adverse actions based on offenses separate from those forming the basis of the exclusion and adverse actions based on the same offenses; and
  • removing the mitigating factor related to availability of alternative sources of the type of health care items or services furnished by the person.