Kusserow on Compliance: Changes in the Stark Law

Over the years, the Stark law has evolved considerably from regulatory requirements to use by the DOJ in enforcement of the False Claims Act. Unlike the Anti-Kickback Statute, which is enforced by the OIG, the Stark law is considered regulatory and under CMS jurisdiction. The Stark law was designed to prohibit doctors from referring Medicare patients to hospitals, labs, and colleagues with whom they have financial relationships, unless they fall under certain exceptions. Stark prevents hospitals from paying providers more when they meet certain quality measures, such as reducing hospital-acquired infections, while paying less to those who miss the goals. Providers have registered numerous concerns that the Stark Law is inhibiting their ability to participate in Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) reforms. The CMS Administrator, Verma, has acknowledged the difficulty of reconciling the Stark Law’s restrictions with the current shift to value based payment structures, noting that that the Stark Law “was developed a long time ago” with current payment systems and operations being different, requiring some changes in the rules. This is not the first time CMS has tried to move the easing of rules concerning the Stark law. In 2015, CMS published a Proposed rule relaxing aspects of the Stark law, including easing of some of the strict liability features of the law and the CMS burden in dealing with the interpretation of key terms, requirements, and other issues.  After reviewing an enormous amount of self-disclosures, CMS realized that a large part of its docket involved arrangements that may technically violate the statute but do not actually pose significant risks of abuse, thus necessitating some changes and clarifications.

Inter-Agency Group formed to focus on easing Stark Barriers

During a January, 2018 American Hospital Association webinar, the CMS Administrator announced plans to convene an inter-agency group consisting of CMS, the OIG, HHS General Counsel, and the DOJ to focus on how to minimize the regulatory barriers of the Stark law that began in 1989 and underwent expansion in the 1990s. Verma noted that the review is in line with CMS’s “Patients Over Paperwork” initiative, which is in accord with the President’s Executive Order that directs federal agencies to “cut the red tape” to reduce burdensome regulations.

Congress Acts

Regardless of the results of the inter-agency review, the fact remains that only so much can be done by regulatory policy changes. All real changes must be made in the law will necessarily have to come from Congress. The Bipartisan Budget Act of 2018 imposed changes on laws related to health care fraud and abuse. On one side they quadrupled fines and doubled potential prison time from five to ten years for violation of the Anti-Kickback Statute.  The Civil Monetary Penalties (CMP) law penalties were doubled. On the other side, Congress moved to reduce some of the burdens by codifying CMS regulatory guidance. Some specific relief involved expired leases and personal services contracts that, if otherwise compliant, will remain protected as long as the terms and conditions continue unchanged.


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: Oncology remains high federal enforcement priority

Oncology continues to be a high enforcement priority for the DOJ, OIG, FBI, and CMS.  The latest fraud investigation by the DOJ involves CCS Oncology, large and prominent providers of cancer care. The reported question being investigated relates to possible billing irregularities involving Medicare and Medicaid. As with most cases related to oncology irregularities, the predication was by a “whistleblower.” The complaint alleges CCS billed for more expensive procedures than were actually performed, billed for procedures that never were performed, and performed medically unnecessary procedures on patients, among other violations, according to the source. The stream of cases is long enough to outline key factors that have led to settlements with the DOJ and OIG. Compliance Officers, whose portfolio of responsibilities include oncology services may wish to review the following to ensure none of these factors are at work in a manner that may trigger investigation.

Common Oncology Enforcement Issues

  1. Employees knowingly submitted false records to Medicare and Medicaid to increase revenue
  2. Claims submitted for services performed without required physician supervision
  3. Offering unnecessary treatments and services to patients
  4. Recruitment and treatment of terminal patients that should have been referred to hospice care
  5. Re-treatment of patients in excess of prescribed dosage limits
  6. Claims for services when physician reviews had not taken place
  7. Claims where treatment occurred without prior required IGRT scan
  8. Physicians allowed registered nurses to fill out prescriptions for medications
  9. Offering inducements (“kickbacks”) to patients by waiving their co-pays
  10. Conducting not necessary fluorescence in situ hybridization (FISH) tests for bladder cancer
  11. Filing payment claims for GAMMA functions by improperly trained physicians and staff
  12. Seeking payments for tests whose results doctors had not reviewed
  13. Billing E&M services on the same day as a related procedure
  14. Double and over-billing Medicare for services that lacked supporting documentation
  15. Improperly billing for radiation treatment without proper physician supervision
  16. Submitting false claims for magnetic resonance imaging (MRI) services
  17. Billing for services that were not documented in the patients’ medical records
  18. Billing twice for the same services
  19. Misrepresentation of the level of a service provided to increase reimbursement
  20. Routinely waived patient copayments as an inducement, then billing Medicare for them.
  21. Claims for services not performed, medically necessary, and/or properly documented
  22. Claims for services rendered to patients referred by physicians benefiting from referral
  23. Purchasing cancer treatments from unlicensed sources for oncology practice
  24. Diluting patients’ chemotherapy treatments and delivering in a manner designed to extend period of treatment time
  25. Claims for medically unnecessary or properly documented intensity-modulated radiation therapy (IMRT)
  26. Unsupported add-on claims for “special treatment procedures” and “specialty physics consults”
  27. Violating the Stark Laws and Anti-Kickback statute by rewarding referring physicians


Kusserow on Compliance: Summary of OIG fraud and abuse actions first half of 2017

The HHS OIG issued their Semi-Annual report for first half of fiscal year (FY) 2017 and summarized key accomplishments, significant problems, abuses, deficiencies, and investigative outcomes relating to the administration of HHS programs and operations that were disclosed during the reporting period. The following summarizes reported statistical accomplishments.

Criminal Actions (468). OIG reported 468 criminal actions against individuals or entities that engaged in crimes against HHS programs and 461 civil actions, which include false claims and unjust-enrichment lawsuits filed in Federal district court, civil monetary penalties (CMP) settlements, and administrative recoveries related to provider self-disclosure matters.  During the first half of FY 2017, OIG reported expected investigative recoveries of over $2.04 billion.

Health Care Strike Force (152 Criminal Actions). The Health Care Fraud Strike Force teams brought charges against 45 individuals or entities, 152 criminal actions, and $267 million in recoveries through investigations.

State Medicaid Fraud Control Units (MFCUs) (1,564 Criminal Actions).  The OIG has oversight responsibility for MFCUs and administers grants that provide federal funding for their operations. There are 50 MFCUs (in 49 States and the District of Columbia) totaled almost $259 million. The MFCUs employed 1,965 individuals. MFCUs reported 18,730 investigations, of which 15,509 were related to Medicaid fraud and 3,221 were related to patient abuse and neglect, including misappropriation of patients’ private funds. The cases resulted in criminal charges or indictments involving 1,721 individuals, including 1,249 for fraud and 472 for patient abuse and neglect. In total, 1,564 convictions were reported in FY 2016, of which 1,160 were related to Medicaid fraud and 404 were related to patient abuse and neglect. Civil judgments and settlements for FY 2016 totaled 998, and monetary recoveries in civil cases totaled over $1.5 billion. During this reporting period, OIG special agents partnered with MFCUs in conducting joint investigations on 714 criminal cases.

Program Exclusions (1,422). During this semiannual reporting period, OIG excluded 1,422 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, for patient abuse or neglect, or as a result of license revocation. OIG is also responsible for reinstating providers who apply and have met the requirements of their exclusions.

Sanction Authorities and Other Administrative Actions (1,504).  OIG sanctions include the exclusion of individuals and entities from federal health care programs and the imposition of CMPs for submitting false and fraudulent claims to a federal health care program or for violating the Anti-kickback statute, the Stark law, or the Emergency Medical Treatment and Labor Act (EMTALA), also known as the patient dumping statute. During this semiannual reporting period, OIG imposed 1,504 administrative sanctions in the form of program exclusions or administrative actions for alleged fraud or abuse or other activities that posed a risk to federal health care programs and their beneficiaries.

Civil Monetary Penalties Law (CMPL) ($26 million0. The CMPL authorizes OIG to impose administrative penalties on and assessments 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. In addition to administrative penalties and assessments, OIG can also exclude individuals for engaging in conduct prohibited by the CMPL. During this semiannual reporting period, OIG concluded cases involving more than $26.3 million in CMPs and assessments.

Self-Disclosure Programs ($23 million). Health care providers, suppliers, or other individuals or entities subject to CMPs can apply for acceptance into the Provider Self-Disclosure Protocol, a program created in 1998, to voluntarily disclose self-discovered evidence of potential fraud. During this semiannual reporting period, self-disclosure cases resulted in more than $23 million in HHS receivables.


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.

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

Kusserow on Compliance: Factors OIG considers in deciding exclusions

The HHS Office of Inspector General (OIG) has authority exclude any individual or entity engaging in prohibited activities from participation in the federal health care programs, and add him or her to their List of Excluded Individuals and Entities (LEIE). The effect of this 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. This authority is anchored in legislation going back to 1977; the OIG was delegated authority to impose civil monetary penalties (CMPs), assessments, and program exclusion on health care providers and others determined to have submitted, or caused the submission of, false or fraudulent claims to the Medicare or Medicaid programs. During my 11-year tenure as Inspector General (IG), the administrative remedies were broadened to address additional types of misconduct. This has continued over the years.  Passage of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) amended and expanded the existing authority for the OIG to impose CMPs and exclusions.

 Factors in exclusion decisions

The LEIE database is very large, with 3,000 new exclusions being added annually. About half of the exclusions included in the database are for criminal convictions related to health care programs and for patient abuse or neglect. These are mandatory exclusion.  In addition, the OIG has discretionary authority to exclude for other types of misconduct, such as license revocation or suspension, exclusion or suspension from another federal or state health care program, provision of unnecessary or substandard services, fraud or kickbacks, and default on a health education loan.

Tom Herrmann, J.D. served over 20 years in the Office of Counsel to the Inspector General. He explained that when exercising its discretionary authority to exclude, the OIG takes into consideration a number of factors, including the following:

  • Nature and circumstances of conduct. This includes determining adverse physical, mental, financial, or other impact to program beneficiaries, recipients, or other patients.
  •  Financial loss. Conduct  that (1) was part of a pattern of wrongdoing; (2) occurred over a substantial period of time; (3) was continual or repeated; and (4) continued until or after the person learned of the Government’s investigation indicates higher risk.
  • Leadership role. If the individual organized, led, or planned the unlawful conduct.
  • History of prior fraudulent conduct. History of judgments, convictions, decisions, or settlements in prior enforcement actions, as well as (1) refusal to have entered into a corporate integrity agreement (CIA), (2) breach of a prior CIA, or (3) lies or failure to cooperate with the OIG while under a CIA.
  • Conduct during investigation. Any (1) obstruction in the investigation or audit; (2) taking any steps to conceal the conduct from the government; or (3) failure to comply with a subpoena.
  • Resolution. The inability to pay an appropriate monetary amount (including damages, assessments, and penalties) to resolve a fraud case.
  • Absence of compliance program. Absence of a compliance program that incorporates the seven elements of an effective compliance program.

Avoiding exclusion

There are a number of steps that can be taken to reduce the likelihood of the OIG exercising its discretion to exclude parties and put them on the LEIE. These include being able to evidence:

  1. Initiating internal investigation and sharing results before the government gets involved;
  2. Self-disclosing an internal investigation;
  3. Cooperating with the government, if it initiate an investigation;
  4. Taking appropriate disciplinary action against individuals responsible for bad conduct;
  5. Implementing an effective compliance program, prior to government investigation;
  6. Devoting increased/improved support for the compliance program; and
  7. Having in the past self-disclosed overpayments in good faith to the OIG and CMS.

LEIE sanction screening

Screening individuals and entities prior to engagement and periodically thereafter is not optional–it is a necessity.   The best practice is to screen monthly against the LEIE and any state exclusion database where business is conducted, in that CMS has set this as a standard for Medicaid Directors.   In addition to screening against the LEIE, most states require screening against their database of sanction parties. Often there are delays in resolution of cases, so that a party may not be included in a sanction database at time of engagement, but is added later. Furthermore, inasmuch as most state Medicaid Fraud Control Units report their criminal actions to the OIG, that in turn includes them in the LEIE, resulting in frequent cases of multiple hits for the same underlying action. This is further complicated by the fact that there are delays when actions by state agencies are reported to the OIG for their determination to add them to 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.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

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