Kusserow on Compliance: DOJ Policy for continued antitrust enforcement DOJ

At the American Bar Association’s Anti-Trust in Healthcare Conference, Deputy Attorney General Barry Nigro provided a wide ranging presentation regarding DOJ efforts to combat rising health care fraud. He noted that, in 2016, health care spending in the United States accounted for $3.3 trillion, or $10,348 per person—approximately 18 percent of Gross Domestic Product (GDP). At this level of spending, the economy can ill afford fraudulent activity to increase the cost of health care. Inasmuch as health care involves critical care, it means the DOJ is giving it a higher priority. DOJ is continuing to give this area a priority that includes rigorous investigation and prosecution of those engaged in Medicare provider fraud and price gouging by drug makers. The DOJ will carry on with questioning mergers and potential collusion among health systems and payers. This includes market allocation agreements, price fixing, and naked market allocation. Some of the topical areas covered in his address included the following:

  1. Criminal prosecutions related to price fixing and market allocation agreements
  2. Parties circumventing generic drug regulations
  3. Market allocation and no-poach agreements
  4. Limitations on exemptions and immunities from anti-trust laws
  5. Continued reliance on the Clayton Antitrust Act
  6. Urging states to consider negative effect on competition when passing laws
  7. Support for certificate of need provisions
  8. Urging states to consider laws that impose occupational licensing requirements
  9. Professionals being able to advertise receiving board certification to patients


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: Exit interviews as a compliance communication channel

Tom Herrmann, JD, had served in a senior capacity with the Office of Counsel to the Inspector General (OIG) at HHS. He pointed out that the OIG, in its compliance guidance, calls for the development of effective lines of communication with employees as very important to the successful implementation of a compliance program and the reduction of any potential for fraud, abuse and waste. This include implementation and use of hotlines (including anonymous hotlines), e-mails, written memoranda, newsletters, and other forms of information exchange to maintain these open lines of communication. One significant channel of communication is the use of exit interviews to debrief departing employees prior to their departure. A major factor influencing the advancement of exit interviews in connection with compliance programs has been the rise in the number of “whistleblowers.” Most of these come from people reporting on an organization they had recently left.  As such, there is great value in debriefing those departing the job that includes asking question about any observed violations of law, regulation, Code of Conduct, or policies. Optimally, an exit interview process should be done in time to permit possible remedial actions before they leave employment.  He has found that exit interviews can also be useful in avoiding other costly litigation involving unlawful harassment, discrimination, safety violations, etc.  It is very important to keep a record of the interviews conducted and responses.

Carrie Kusserow has been developing, enhancing and monitoring exit interview programs for over 15 years. She noted that many organizations conduct employee exit interviews (also called exit surveys) to gather data for improving working conditions and retaining employees. This has been common in human resource management for generations and this type of communication can be useful in taking actions to correct deficiencies, reduce turnover, identify potential compliance-related problems, and maintain a productive work environment. However, exit interviews may also be used to alert an organization to company compliance issues, potential whistle-blowers, or quality of care issues. At a minimum, an exit interview should include compliance program oriented questions that relate to compliance education, policies, anonymous reporting procedures, and attitudes towards the compliance program. The following are examples:

  1. How effective was your training on the compliance program, Code of Conduct and policies?
  2. Were you trained on how to report concern and problems confidentially or anonymously?
  3. Did you believe that those reporting compliance issues would be protected from retaliation?
  4. Are you aware of any ethical or compliance issues; and if so did you report them?
  5. How could the company strengthen its message regarding ethics and compliance?
  6. Is everyone in the work force treated fairly?
  7. Do you believe management fully supports the compliance program?
  8. Are you leaving due to any compliance concerns about your job or work environment?
  9. Are you aware of any improper or illegal conduct in the workplace? If so, who and what?
  10. Have you reported compliance issues or concerns that are unaddressed? If so, explain.


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 © 2018 Strategic Management Services, LLC. Published with permission.

Prohibition on paid referrals not limited to ‘relevant decisionmakers’

The Seventh Circuit affirmed the conviction of an individual under the Anti-Kickback Statute (AKS) (42 U.S.C. § 1320a-7b) whose referral agency had provided referrals to a home health company in exchange for $500 per referral. In affirming the lower court’s decision, the Seventh Circuit found that criminal liability under the AKS is not limited to relevant decisionmakers and that no safe harbors applied (U.S. v. George, August 14, 2018, Rovner, I.).

Referrals for money

The referrer was a certified homemaker employed by Help at Home, a home healthcare agency, beginning in 2007. In 2010, she decided to start a referral agency and signed a work for hire agreement with another home health service, Rosner Home Health Care, Inc. (Rosner), in which she agreed to convince providers, including doctors, case managers, discharge planners, and social workers, to refer patients to Rosner. In exchange, Rosner paid the referrer $500 for each patient referred. In 2015, the referrer was indicted and then found guilty of two counts of violating the AKS and one count of violating the general conspiracy statute (see Receipt of per-patient referrals, knowledge of illegality enough to overcome doubt, Health Law Daily, March 25, 2016).


Under the AKS, the government must demonstrate that the referrer knowingly and willfully solicited or received remuneration in return for referring an individual to Rosner to provide or arrange services paid at least in part under Medicare. The referrer appealed her conviction arguing that there was insufficient evidence to support the substantive counts of her conviction falling under the AKS. According to the court, rather than merely demonstrate that evidence could have supported a finding of innocence, the referrer must demonstrate on appeal that the evidence could not have allowed a reasonable trier of fact to find her guilty.

Relevant decisionmakers

The referrer argued that she could not be held liable, as the statute applied only to “relevant decisionmakers,” which she was not. In making this argument, the referrer relied on a previous Fifth Circuit decision in which the court held that payments to a marketing firm distributing advertisement brochures of a provider to physicians did not fall within the AKS because they were not payments made to the relevant decisionmaker in exchange for sending patients to the provider. However, the court cited a subsequent case rejecting an interpretation of that case limiting criminal liability to persons would could be deemed relevant decisionmakers.

Safe harbors

The referrer also argued that she had a reasonable basis to believe she fell within the safe harbor provision of the AKS applying to “any amount paid by an employer to an employee (who has a bona fide employment relationship with such employer) for employment in the provision of covered items or services. However, her written agreement with Rosner specifies that she was acting as an independent referral agency, not an employee. The court also noted that the referrer was paid for referrals, not for the provision of items or services covered by Medicare. Thus, the safe harbor provision did not apply.

Kusserow on Compliance: July/August 2018 Work Plan updates

The Office of Inspector General’s (OIG) work planning process is dynamic and adjustments are made throughout the year to meet priorities and to anticipate and respond to emerging issues with the resources available. Effective June, 2017, the OIG has been updating its Work Plan monthly. The following are the updates posted for July and August 2018:

  1. 3-Dimensional Conformal Radiation Therapy (3D-CRT). 3D-CRT is a radiation therapy technique that allows doctors to sculpt radiation beams to the shape of a patient’s tumor provided in two treatment phases: planning and delivery. Hospitals bill Medicare for developing a 3D-CRT treatment plan using Current Procedural Terminology code 77295. Automated prepayment edits prevent additional payments for separately billed radiation planning services if they are billed on the same date of service as the 3D-CRT treatment plan. However, Medicare allows additional payments if they are billed on a different date of service (e.g., 1 day before). For a form of radiation similar to 3D-CRT, Medicare requirements prohibit payments for separately billed radiation planning services when they are billed on a different date of service. OIG auditors will determine the extent of potential savings to Medicare if it had implemented the same requirements for 3D-CRT planning services.


  1. Identification of HHS Cybersecurity Vulnerabilities. The OIG will perform a series of IT audits at the HHS Operating Divisions in an effort to identify cybersecurity vulnerabilities and possible compromise of the HHS Office of the Secretary and its OPDIVs’ systems and networks.


  1. HRSA’s Oversight of Funds for Access Increases in Mental Health and Substance Abuse Services (AIMS). The Health Resources and Services Administration (HRSA) administers AIMS grants and last year HRSA awarded $200 million in AIMS grants to 1,178 health centers nation-wide intended to expand access for existing Health Center Program grant recipients to mental health and substance abuse services, focusing on the treatment, prevention, and awareness of opioid abuse. The OIG will review HRSA’s internal controls to determine whether they are suitable for (1) awarding AIMS grants and (2) monitoring AIMS grant recipients.


  1. Increased Payments For Transfer Claims With Outliers. While the transfer rule reduces the Diagnosis Related Group (DRG), Disproportionate Share Hospital (DSH), and Indirect Medical Education (IME) payments on a Medicare beneficiary’s claim, the methodology for calculating cost outlier payments can result in such payments being higher than what would have been paid in a nontransfer context. Under the transfer rule, CMS reduces the DRG payment by applying a graduated per diem payment on the Medicare claim of the hospital transferring the patient to another setting early in the patient’s hospital stay. Because DSH and IME payments are determined as a percentage of the reduced DRG payment, they are also reduced. By contrast, by reducing the threshold above which a claim qualifies as an outlier, the application of the outlier methodology at 42 CFR Sec. 412.80(b) can result in an increase in the outlier payment in transfer cases. The plans to produce a report describing the extent to which additional Medicare outlier payments negate the reduction in DRG, DSH, and IME payments of transfer claims.


  1. Review of Post-Operative Services Provided in the Global Surgery Period. Section 523 of Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) requires CMS to collect data on post-operative services included in global surgeries and requires OIG to audit and verify a sample of the data collected. The OIG will review a sample of global surgeries to determine the number of post-operative services documented in the medical records and compare it to the number of post-operative services reported in the data collected by CMS. The OIG plans to verify the accuracy of the number of post-operative visits reported to CMS by physicians and determine whether global surgery fees reflected the actual number of post-operative services that physicians provided to beneficiaries during the global surgery period


  1. SAMHSA’s Oversight of Accreditation Bodies for Opioid Treatment Programs. The Substance Abuse and Mental Health Services Administration (SAMHSA) estimates that 2.5 million people have an opioid use disorder related to prescription pain relievers and/or heroin. Medication-Assisted Treatment (MAT), provided by opioid treatment programs (OTPs), is a significant component of the treatment protocols for opioid use disorder and plays a large role in combating the opioid epidemic in the United States. SAMHSA issued final regulations to establish an oversight system for the treatment of substance use disorders with MAT. These regulations (42 CFR Part 8) established procedures for an entity to become an approved accreditation body, which evaluates OTPs and ensures SAMHSA’s opioid dependency treatment standards are met. The OIG plans to determine whether SAMHSA’s oversight of accreditation bodies complied with Federal requirements; and will include SAMHSA-approved accrediting bodies that have accredited OTPs


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.