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.

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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.

Kusserow on Compliance: Three new projects added to the OIG Work Plan in April

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 to the OIG’s audits and evaluations that are planned or underway. 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., the GAO); management’s actions to implement OIG recommendations from previous reviews; and potential for positive impact.

New Projects Added

  1. Medicaid Nursing Home Supplemental Payments will be reviewed by the Office of Audit Services for completion in fiscal year (FY) 2019. Prior OIG and GAO audits have found that Federal supplemental payments often benefit the state and local governments more than the nursing homes. The OIG plans to review the nursing home supplemental payment program’s flow of funding and determine how the funds are being used. CMS approved a nursing home supplemental payment program in certain states that pays the difference between Medicare and Medicaid rates for nursing home services. In some of these programs, local governments fund the states’ share of the supplemental payments through intergovernmental transfers.

 

  1. The OIG plans to review the extent to which drug formularies developed by Part D sponsors include drugs commonly used by dual-eligible beneficiaries as required. The Patient Protection and Affordable Care Act (ACA), under Section 3313, requires OIG to conduct this review annually. This will be the eighth report issued. The work will be performed by the Office of Evaluation and Inspections with a target completion date of FY 2018.

 

  1. Audit of CMS Medicare Overpayment Recoveries Related to Prior OIG Recommendations, targeted for completion in FY 2019. In the last couple of years, the OIG issued 153 audit reports that related to the Medicare program, containing 193 monetary recommendations totaling $648 million. Of the $648 million in recommended overpayment recoveries, CMS agreed to collect $566 million applicable to 190 recommendations. The OIG plans to determine the extent to which CMS: (1) collected agreed upon Medicare overpayments identified in OIG audit reports and (2) took corrective action in response to the recommendations in a prior audit report examining CMS’ overpayment recoveries (A-04-10-03059). In that report, OIG recommended CMS enhance its systems and procedures for recording, collecting, and reporting overpayments. The OIG also recommended that CMS provide guidance to its contractors on how to document that overpayments were actually collected.

 

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.

Kusserow on Compliance: Using sanction-screening tools vs. outsourcing the entire process

In order to save time and costs, more and more health care organizations have been moving to outsource functions that are not core business activities. Compliance programs have been part of that trend: (1) 80 percent of compliance offices use vendors to provide hotline services, (2) 50 percent of compliance offices use vendors to provide policy development tools, and (3) two-thirds of compliance offices use vendors to provide E-learning tools. Included in the growing list of outsourced tasks has been the movement to address the rapidly growing cost and time commitment obligations related to sanction-screening. Two-thirds of compliance offices use a vendor search engine tools to assist in sanction-screening that saves an organization from downloading the sanction databases and developing a search engine. This is a trend driven by the rapid development of many new databases against which to screen employees, medical professionals, contractors, vendors, etc., including the following:

  • OIG List of Excluded Individuals and Entities (LEIE)
  • GSA Excluded Parties List System (EPLS)
  • 40 Medicaid states now have sanction data bases requiring monthly screening
  • Drug Enforcement Administration (DEA)
  • FDA

All this has increased the burden of sanction-screening exponentially, not only for the compliance office, but also human resource management for new hires and periodic screening of current employees and procurement with vendors and contractors. Medical credentialing is involved as result of having to screen physicians who are granted staff privileges. Using vendors has been a great help, but the most difficult part of the process is resolving “potential hits.” This can be a considerable effort and many organizations have to dedicate staff for investigation and resolution of these hits. It is complicated by the fact that most sanction data does not provide sufficient information to make positive identification. As a result of this heavy burden, many have moved beyond simply using a vendor tool to outsourcing the entire process to vendors. The following address selecting a sanction-screening vendor and outsourcing the process.

 

Tips for selecting sanction-screening vendor

 

Tips for outsourcing the sanction-screening process

  • Determine the cost of moving from use of a vendor search engine tool to outsourcing the screening, along with investigation and resolution of “potential hits.”
  • Inquire as to the methodology they follow in resolving potential “hits,” a critical part of any screening effort.
  • Ensure the vendor provides a certified report of the results that can be made part of the compliance office records.
  • Review an example of the type of reports they would provide to determine if it meets the documentary needs of the organization.

 

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.