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: DOJ reports more than two-thirds of $4B civil fraud recoveries in 2017 from health sector

In an end of the year report, the Department of Justice (DOJ) Civil Division announced that it recovered over $3.7 billion from civil False Claims Act (FCA) cases for the fiscal year. Significantly, nearly two thirds of the total settlements and judgments involved the health care industry, including drug companies, hospitals, pharmacies, laboratories, and physicians. What is really noteworthy is the fact that ninety-three percent of the total came from qui tam relators (whistleblower) cases, whose rewards amounted to almost $400 million. There were 491 new such health care cases filed during the year at a rate of about ten per week. The great majority of civil fraud cases implicated the Anti-Kickback Statute. Also most major settlements with DOJ are referred to the HHS Office of Inspector General (OIG) for Corporate Integrity Agreements.

It is noted that settlements for 2017 were $1 billion less than 2016. This is the eighth consecutive year that the department’s civil health care fraud settlements and judgments have been the leading area of settlements and judgments, exceeding $2 billion. The recoveries reported reflect only federal losses and they were instrumental in recovering additional millions of dollars for state Medicaid programs. The largest recoveries involving the health care industry this past year came from Shire Pharmaceuticals LLC which paid $350 million; drug manufacturer Mylan Inc. which paid approximately $465 million; Life Care Centers of America Inc. and its owner which agreed to pay $145 million; and eClinicalWorks (ECW) and certain of its employees which paid $155 million.

In second place in terms of industry recoveries was $543 million from housing and mortgage fraud cases, which was only about twenty percent of the level for the health care sector. In third place was the Defense arena which had cases that resulted in $220 million in settlements and recoveries, which is only about one tenth the level of the health care sector.

The “Yates Memo” emphasized DOJ’s intent to focus on “individual accountability for corporate wrongdoing” through civil and criminal enforcement actions. This emphasis on singling out individual recoveries was in evidence this last year with DOJ recovering $60 million directly from individuals, without joint and several liability with any corporate entity. The DOJ identified several individual owners and executives of private corporations agreed to be held jointly and severally liable for settlement payments.

The DOJ obtained more than $3.7 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending September 2017.

Recoveries since 1986, when Congress substantially strengthened the FCA, now total more than $56 billion.

 

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: 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.

Kusserow on Compliance: OIG proposed budget for 2018 cites accomplishments

The HHS OIG submitted their fiscal year (FY) 2018 proposed budget for a total of $359 million that includes $291 million to support oversight of the Medicare and Medicaid programs.  In justifying their request, the OIG reported expected recoveries of more than $5.66 billion for FY 2016 that includes $4.46 billion in investigative receivables and approximately $82 million in CMPs. The OIG’s work also prevents fraud and abuse through industry outreach and guidance and recommendations to HHS to remedy program vulnerabilities. Additionally, OIG reported on its role as a Health Care Fraud and Abuse Control (HCFAC) program participant in returning $5 to the Medicare Trust Funds for every $1 invested in FY 2016. The OIG reported 844 criminal actions against individuals or organizations that engaged in crimes against HHS programs and 708 civil and administrative enforcement actions, including False Claims Act lawsuits filed in Federal district court, and Civil Monetary Penalty (CMP) law settlements. The OIG excluded 3,635 individuals and organizations from participation in Federal health care programs. The OIG is also part of Health Care Fraud Strike Force teams that coordinate operations conducted jointly by Federal, State, and local law enforcement entities that resulted in filing of charges against 255 individuals or entities, 207 criminal actions, and $321 million in investigative receivables.

Over the last five years, the OIG’s expected recoveries have averaged $5.3 billion annually. Changes in the amount of expected recoveries from year to year are due to the particular mix of cases resolved in a given year, as well as continued efforts to work with operating divisions to implement OIG recommendations.

 

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.