Kusserow on Compliance: Huge fraud schemes involving telemedicine and DME

– Charges against two dozen people involving over $1.2 billion

 – Administrative Action against 130 DMEs submitting $1.7 Billion in claims

The DOJ announced charges against 24 defendants—including the CEOs, COOs, and others associated with five telemedicine companies, the owners of dozens of durable medical equipment (DME) companies, and three licensed medical professionals—associated with health care fraud schemes involving more than $1.2 billion. CMS and the Center for Program Integrity (CPI) have taken adverse administrative action against 130 DME companies that had submitted over $1.7 billion in claims and were paid over $900 million. The scheme involved payment of illegal kickbacks and bribes by DME companies in exchange for the referral of Medicare beneficiaries by medical professionals working with fraudulent telemedicine companies for back, shoulder, wrist, and knee braces that were medically unnecessary.

The DOJ alleges those charged with paying doctors to prescribe DME either without any patient interaction or with only a brief telephonic conversation with patients they had never met or seen. The proceeds of the fraudulent scheme were allegedly laundered through international shell corporations and used to purchase exotic automobiles, yachts, and luxury real estate in the United States and abroad. Some of the defendants obtained patients for the scheme by using an international call center that advertised to Medicare beneficiaries and “up-sold” the beneficiaries to get them to accept numerous “free or low-cost” DME braces, regardless of medical necessity. The international call center allegedly paid illegal kickbacks and bribes to telemedicine companies to obtain DME orders for these Medicare beneficiaries. The telemedicine companies then allegedly paid physicians to write medically unnecessary DME orders. Finally, the international call center sold the DME orders that it obtained from the telemedicine companies to DME companies, which fraudulently billed Medicare. Collectively, the CEOs, COOs, executives, business owners and medical professionals involved in the conspiracy are accused of causing over $1 billion in loss.

 

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 © 2019 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: New OIG Work Plan items

The HHS Office of Inspector General (OIG) recently issued updates to its Active Work Plan (Work Plan). The Work Plan outlines ongoing and planned audits and evaluations for the fiscal year and beyond. Recent additions related to Medicare/Medicaid include the following:

  1. Medicare Part D Rebates Related to Drugs Dispensed by 340B Pharmacies. Drug manufacturers often do not pay for Medicare Part D prescription rebates filled at 340B-covered entities and contract pharmacies because the manufacturer already provides a discount on the drug. The OIG will conduct a study to determine the potential rebate savings if Part B program sponsors and manufacturers could agree on eligible prescriptions filled at 340B pharmacies that receive rebates.

 

  1. Characteristics of Part D Beneficiaries at Serious Risk of Opioid Misuse or Overdose. An OIG data brief found that about 71,000 Medicare Part D beneficiaries were at serious risk of opioid misuse or overdose in 2017. The OIG will study: (1) the characteristics of these beneficiaries, including their demographics and diagnoses; (2) the opioid utilization of these beneficiaries; and (3) the extent to which these beneficiaries have had adverse health effects related to opioids and any overdose incidents.

 

  1. Ensuring Dual-Eligible Beneficiaries’ Access to Drugs Under Part D: Mandatory Review.

Part D plans that meet certain limitations have the discretion to include different Part D drugs and drug utilization tools in their formularies. Under the Affordable Care Act, the OIG conducts an annual study to review the extent to which Part D sponsors’ formularies include drugs commonly used by Medicaid and Medicare Part D beneficiaries.

 

  1. Nursing Facility Staffing: Reported Levels and CMS Oversight. CMS uses the Payroll Based Journal auditable daily staffing data to analyze staffing patterns and populate the staffing component of the Nursing Home Compare website. It aids the public determine the results of health and safety inspections, quality of care at nursing facilities, and staffing. The OIG will issue two reports to: (1) describe nursing staffing levels that facilities report to the Payroll-Based Journal; and (2) examine CMS efforts to ensure data accuracy and improve resident quality of care.

 

  1. Medicare Part B Payments for Podiatry and Ancillary Services. Medicare Part B covers podiatry services for medically necessary treatment of foot injuries, diseases, or other medical conditions affecting the foot, ankle, or lower leg. It does not cover routine foot-care services unless they are: (1) necessary and integral part of otherwise covered services; (2) for the treatment of warts on the foot; (3) in the presence of a systemic condition or conditions; or (4) for the treatment of infected toenails. The OIG will review Part B payments to determine whether podiatry and ancillary services were medically necessary and supported in accordance with Medicare requirements.

 

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 © 2019 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: 2018 FCA enforcement and 10 tips for channeling whistleblowers internally

 New health care qui tam cases average 9 per week

$2.5 billion in recoveries from health care sector

75 percent of cases predicated by “Whistleblowers”

Whistleblowers are entitled to up to 25 percent of recoveries

The vast majority of False Claims Act cases are brought to the DOJ by “whistleblowers” (qui tam relators), under the qui tam provisions of the False Claims Act (FCA). In 2018, this continued to be the case. The DOJ’s Civil Division reported having 645 new qui tam actions initiated last year, at an average of 14 new cases per month. Of that total, 446 were health care cases—about nine a week average. Federal recoveries, including settlements and judgments, amounted to over $2.8 billion. Most of this, over $2.5 billion, related to health care and life sciences. FCA violations occur when someone knowingly submits a false or fraudulent claim for payment to the government.  The penalty for doing this is up to three times the amount of each claim, plus penalties as high as $21,563 per claim. Whistleblowers file cases with the DOJ on behalf of the United States as well as themselves and must provide all the evidence they have supporting the complaint. The DOJ decides to intervene (take over prosecution) or not. If the DOJ decides to intervene, the government takes the lead in prosecuting the case; and if not, the relator may proceed with the prosecution on their own in federal court.  The relator is entitled to 15 to 25 percent of the government’s recovery, plus attorneys’ fees and expenses.

The recovery results in 2108 marked the ninth consecutive years where recoveries have exceeded $2 billion. Of the health care recoveries, more than three quarters of that sum were as result of qui tam cases. Health care and life sciences settlements involved drug and device manufacturers, hospitals, Medicare Advantage plans, pharmacies, and laboratories. The largest settlement, for $625 million, was with AmerisourceBergen Corp. and its subsidiaries, and it involved resolution of allegations that it repackaged and resold cancer drugs to profit from “overfill” in the original packaging. The other major settlements also involve pharmaceutical manufacturers. In those cases, the FCA was violated as result of payment of kickbacks to induce the flow of business.  The largest case among providers involved an independent physician association that entered into a $270 million settlement with another case resulting in a $216 million settlement with the former hospital chain, Health Management Associates.

10 Tips: Channeling Whistleblowers Internally 

  1. Review/update hotline-related polices/procedures (confidentiality, anonymity, non-retaliation, duty to report, etc.)
  2. Promote the reporting of wrongdoing (newsletter, intranet, training programs, etc.)
  3. Find ways to provide feedback so that employees know reporting is taken seriously
  4. Consider engaging experts to evaluate compliance communication channels effectiveness
  5. Allegations of potential violations of law or regulations must be promptly investigated.
  6. Ensure that individuals are trained and competent to conduct prompt investigations.
  7. All cases where investigation indicates potential violations, disclose promptly
  8. Take appropriate disciplinary action against identified wrongdoers
  9. Understand CMS and OIG self-disclosure protocols that may avoid FCA investigation
  10. Ensue investigations finding of potential violations of law are promptly disclosed to the DOJ

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 © 2019 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Meeting sanction checking mandates

As the HHS Inspector General, I created what is now referred to as the List of Excluded Individuals and Entities (LEIE) that was followed by OIG compliance guidance documents which call for checking employees, physicians, vendors, and contractors against the LEIE. The OIG considers all claims and costs associated with an excluded party as potentially false and fraudulent and can lead to significant financial penalties and more. The OIG Special Advisory Bulletin on the Effect of Exclusion provides very useful information in assessing this risk area. CMS mandates, as a condition of enrollment, providers may not employ or contract with individuals or entities that are excluded from participation in any federal health care program and call for checking not only against the LEIE, but also the General Service Administration’s (GSA) Excluded Parties List System (EPLS), now part of the System for Award Management (SAM). CMS further called upon State Medicaid Directors to establish their own sanction data base and requires providers to check it on a monthly basis. To date, 40 states have moved to establish their own Medicaid sanction lists with other states in the process of doing the same. This has increased the sanction screening burden exponentially, not only for the compliance office but other departments as well. HR often has responsibility of sanction checking new hires and periodically current employees. Procurement is also affected because they handle the screening of vendors and contractors. The Medical Credentialing Office must ensure checking on physicians who have been granted staff privileges.  Other federal sanction databases worth screening are maintained by the DEA and FDA, as well as the Department of the Treasury Office of Foreign Assets Control (OFAC) Terrorist Watch List.

Daniel Peake, of the Compliance Resource Center (CRC), works with clients to provide a variety of CRC services that includes providing sanction checking services, as well as the investigation and resolution of potential hits. He noted that the time and resources necessary for developing and maintaining a search engine, along with regularly collecting and updating sanction information from many databases is not very cost effective. This high cost of using internal resources to develop and manage the sanction checking has resulted in the great majority of health care entities subscribing to a vendor service that provides a search engine to their established databases. Vendors can afford the high cost of maintaining the currency of the data because they amortize the costs over many clients. The problem is that that vendor quality, cost, and reliability can vary enormously.  From experience, he offered the following tips for those considering a vendor:

 

Tips on choosing a vendor search engine service

  1. Know the cost up front with a fixed rate, not based upon per click searches.
  2. Contract should permit cancelling without cause at any time, if dissatisfied.
  3. Ensure vendor has liability insurance ($ 1 to 3 million preferably).
  4. Determine other services included (e.g. policy templates, regulatory updates, etc.).
  5. Determine how much “help desk” assistance is available to resolve potential hits.

 

For more information, contact Daniel Peake at (dpeake@complianceresource.com) (703-236-9854).

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 © 2019 Strategic Management Services, LLC. Published with permission.