Kusserow on Compliance: HHS OIG Spring 2018 semi-annual report on sanctions and exclusions

1,678 administrative sanctions

1,588 individuals and entities excluded

$35.5 million in CMPL penalties/assessments

The OIG released its first semi-annual report for 2018 that included the number of administrative sanctions, exclusion actions taken, and CMPL penalties imposed. There were a total of 1,588 individuals and entities 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 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 List of Excluded Individuals and Entities (LEIE). The OIG also imposed 1,678 administrative sanctions and Civil Monetary Penalty Law penalties and assessments involving more than $35.5 million.

Comments from experts concerning sanctions

Tom Herrmann, JD, served for 20 years in the OIG Counsel’s Office, including being the Chief of the Administrative Litigation Branch, responsible for 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. In almost all instances where the OIG’s imposition of program exclusion or CMPs is appealed, it is upheld by an Administrative Law Judge (ALJ), the Departmental Appeals Board (DAB), and federal courts. As such, it is absolutely essential to have ongoing sanction-screening of anyone engaged by a health care organization.

Jillian Bower-Concepcion 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 the OIG posts their exclusions on their LEIE and calls for screening of all individuals and entities engaged by or with whom they do business against that listing. CMS has also been very aggressive in calling for sanction screening, not only of the LEIE, but Debarments posted by the GSA, as well as pressuring state Medicaid Directors to establish exclusion databases and mandate monthly screening by their enrolled providers. 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 organizations from downloading the sanction databases of all the entities and developing their own search engine. 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.

 

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

Kusserow on Compliance: OIG Attorneys continue cross-designation with DOJ

The HHS OIG issued its Semi-Annual Report for the first half of fiscal year (FY) 2018 (October-March) and summarizes 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. Included in the report is a section referred to as the “Special Assistant U.S. Attorney Program.” Many are unaware of this program that unites under the DOJ attorneys and Special Agents of the OIG that are cross-designated as Special Assistant U.S. Attorneys. These OIG attorneys are detailed full time to the Fraud section of DOJ’s Criminal Division for temporary assignments, including assignments to the Health Care Fraud Strike Force. Other attorneys prosecute matters on a case-by-case basis. Both arrangements offer excellent litigation training for OIG attorneys and enhance collaboration between the departments in their efforts to fight fraud. Under this program, OIG attorneys have successfully litigated important criminal cases relating to the fraudulent billing of medical equipment and supplies, infusion therapy, and physical therapy, as well as other types of Medicare and Medicaid fraud.

In its report, the OIG cited as an example of how this program works in a Medicare fraud case in Texas where cross-designated Special Assistant U.S. Attorney prosecuted an individual for fraud. The individual owned and operated group homes in the Houston, Texas area and engaged in a scheme to defraud Medicare by receiving kickbacks in exchange for referring her group home residents for home health services. She pleaded guilty to making false statements to federal agents and was sentenced to 6 months in prison.

 

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

Kusserow on Compliance: OIG testifies on investigative results over last three years

Gary Cantrell, HHS OIG Deputy Inspector General for Investigations, testified before a Senate Special Committee hearing to highlight the results of the OIG’s enforcement activities, focusing many of his comments on the current Opiod Crisis. He noted that the OIG Special Agents have full law enforcement powers and collaborate with other federal, state, and local law enforcement partners to combine resources to detect and prevent health care fraud, waste, and abuse. Over the last three years, OIG investigations have resulted in more than $10.8 billion in investigative receivables; 2,650 criminal actions; 2,211 civil actions; and 10,991 program exclusions.

The OIG is a lead participant in the Medicare Fraud Strike Force, which combines the resources of the OIG and DOJ, including Main Justice, U.S. Attorneys’ Offices, and the Federal Bureau of Investigation (FBI), as well as State and local law enforcement, to fight health care fraud in geographic hot spots. 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. Last year, the Strike Force led the largest takedown ever in health care fraud enforcement. It resulted in 412 charged defendants across 41 federal districts, including 115 doctors, nurses, and other licensed medical professionals, for their alleged participation in health care fraud schemes involving approximately $1.3 billion in false billings.

The OIG also collaborates with state Medicaid Fraud Control Units (MFCUs) to detect and investigate fraud, waste, and abuse in state Medicaid programs.  Another investigative partner is the Healthcare Fraud Prevention Partnership and the National Healthcare Anti-Fraud Association—a public–private partnership that addresses health care fraud by sharing data and information for the purposes of detecting and combating fraud and abuse in health care programs.

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 Work Plan items for May 2018

The OIG regularly updates its Work Plan as it continues to assess relative risks in HHS programs and operations that may lead to new projects. The most recent changes involved adding six new projects. In making these additions, the OIG considered a number of factors, including mandates set forth in laws, regulations, or other directives; requests by Congress, HHS management, or the Office of Management and Budget; top management and performance challenges facing HHS; work performed by other oversight organizations (e.g., GAO); management’s actions to implement OIG recommendations from previous reviews; and potential for positive impact.

New Projects Added

  1. The Impact of Authorized Generics on Medicaid Drug Rebates. Under final rules implementing the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), CMS directed primary manufacturers to include in their calculation of average manufacturer price (AMP) the sale of authorized generic drugs to secondary manufacturers in some circumstances (42 C.F.R. Sec. 447.506(b)). OIG plans to examine selected drugs with authorized generics and determine how including the sales of authorized generic drugs to secondary manufacturers affects Medicaid drug rebates.

 

  1. Noninvasive Home Ventilators – Compliance with Medicare Requirements. For items such as noninvasive home ventilators (NHVs) and respiratory assist devices (RADs) to be covered by Medicare, they must be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Depending on the severity of the beneficiary’s condition, an NHV or RAD may be reasonable and necessary. NHVs can operate in several modes, i.e., traditional ventilator mode, RAD mode, and basic continuous positive airway pressure (CPAP) mode. The higher cost of the NHVs’ combination of noninvasive interface and multimodal capability creates a greater risk that a beneficiary will be provided an NHV when a less expensive device such as a RAD or CPAP device is warranted for the patient’s medical condition. The OIG will determine whether claims for NHVs were medically necessary for the treatment of beneficiaries’ diagnosed illnesses and whether the claims complied with Medicare payment and documentation requirements.

 

  1. States’ Procurement of Private Contracting Services for the Medicaid Management Information System (MMIS). MMIS is an integrated group of procedures and computer processing operations designed to meet principal objectives such as processing medical claims. Medicaid reimburses states’ MMIS administrative costs at enhanced rates of 90 and 75 percent. Many states use private contractors to design, develop, and operate their MMIS. When procuring MMIS contracting services, states are required to follow the same policies and procedures used for procurements paid with non-federal funds. Additionally, states must receive CMS’s prior approval to receive enhanced federal matching funds for MMIS administrative costs related to private contractors. OIG plans to determine if selected states followed applicable federal and state requirements related to procuring private MMIS contracting services and claiming federal Medicaid reimbursement.

 

  1. Monitoring Medicare Payments for Clinical Diagnostic Laboratory Tests – Mandatory Review. Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA) requires CMS to replace its current system of determining payment rates for Medicare Part B clinical diagnostic laboratory tests with a new market-based system that will use rates paid to laboratories by private payers. Pursuant to PAMA, OIG is required to conduct an annual analysis of the top 25 laboratory tests by Medicare payments and analyze the implementation and effect of the new payment system. The OIG plans to analyze Medicare payments for clinical diagnostic laboratory tests performed in 2016 and monitor CMS implementation of the new Medicare payment system for these tests.

 

  1. Ensuring Dual-Eligible Beneficiaries’ Access to Drugs Under Part D: Mandatory Review. Dual-eligible beneficiaries are enrolled in Medicaid but qualify for prescription drug coverage under Medicare Part D. As long as Part D plans meet certain limitations outlined in 42 C.F.R. Sec. 423.120, plan sponsors have the discretion to include different Part D drugs and drug utilization tools in their formularies. The OIG is required to review annually the extent to which drug formularies developed by Part D sponsors include drugs commonly used by dual-eligible beneficiaries as required.

 

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.