Free Health Law Webinar–Internal and Government Investigation Strategies

It’s your last chance to register for the second free webinar in Wolters Kluwer Legal & Regulatory, U.S.’s four-part webinar series in partnership with Alston & Bird focusing on best practices for handling internal and external healthcare fraud and False Claims Act investigations.

“Internal and Government Investigation Strategies”, will discuss how companies can conduct cohesive internal investigations, what the government expects organizations to do and the investigative techniques that the government uses. To register, visit the link below:
Internal and Government Investigation Strategies 
Tuesday, December 4, 2018 at 2 PM EST
Moderator: Frank Sheeder, Partner at Alston & Bird
Featured speakers: Wade Miller, Partner, and Matt Dowell, Senior Associate at Alston & Bird

For information on the full webinar series, visit http://health.wolterskluwerlb.com/2018/10/wk-announces-free-webinar-series-on-healthcare-investigations/

Kusserow on Compliance: OIG issues annual report on top management challenges facing HHS

Annually, the OIG prepares a summary of the most significant management and performance challenges facing the Department of Health and Human Services. This summary is referred to as the Top Management Challenges (TMC). The OIG forecasts new and emerging issues HHS will face HHS in the years to come. The current TMCs are identified as follows:

  1. Preventing and Treating Opioid Misuse. The challenges includes (a) reducing inappropriate prescribing and misuse of opioids; (b) combating fraud and diversion of prescription opioids and potentiator drugs; (c) ensuring access to appropriate treatment for opioid use disorder; and (d) ensuring that funding for prevention and treatment is used appropriately

 

  1. Ensuring Program Integrity in Medicare Fee-for-Service and Effective Administration of Medicare. Medicare spending represents over 15 percent of all federal spending and it is estimated that the Trust Fund for Medicare Part A will be depleted by 2026. Challenges include (a) reducing improper payments; (b) combating fraud; (c) fostering prudent payment policies; and (d) maximizing the promise of health information technology.

 

  1. Ensuring Program Integrity and Effective Administration of Medicaid. Medicaid is the largest federal health care program, with 67 million individuals enrolled, and expenditures of $592 billion. Challenges include (a) improving the reliability of national Medicaid data; (b) reducing improper payments; (c) combating fraud; and (d) ensuring appropriate Medicaid eligibility determinations.

 

  1. Ensuring Value and Integrity in Managed Care and Other Innovative Healthcare Payment and Service Delivery Models. Managed care and other innovative models promote innovation and effectiveness. Challenges include (a) ensuring effectiveness and integrity in new models; (b) combating provider fraud and abuse; (c) fostering compliance by managed care organizations.

 

  1. Protecting the Health and Safety of Vulnerable Populations. HHS programs provide critical health and human services to many vulnerable populations in many different settings. Challenges include (a) ensuring the safety and security of unaccompanied children in HHS care; (b) addressing substandard nursing home care; (c) reducing problems in hospice care; (d) mitigating risks to individuals receiving home- and community-based services; (e) ensuring access to safe and appropriate services for children; and (f) addressing serious mental illness.

 

  1. Improving Financial and Administrative Management and Reducing Improper Payments. With annual outlays of over $1.1 trillion, HHS must also ensure the completeness, accuracy, and timeliness of any financial and program information provided to other entities. Challenges include (a) addressing weaknesses in financial management systems; (b) addressing Medicare trust fund issues/social insurance; (c) reducing improper payments; (d) improving contract management; and (d) implementing the DATA Act.

 

  1. Protecting the Integrity of HHS Grants. In FY 2017, HHS awarded $101 billion in grants (excluding CMS) that requires additional verification of existing controls and reporting requirements. Challenges include (a) ensuring appropriate and effective use of grant funds; (b) ensuring effective grant management at the department level; (c) ensuring program integrity and financial capability at the grantee level; and (d) combating fraud, waste, and abuse.

 

  1. Ensuring the Safety of Food, Drugs, and Medical Devices. FDA has the challenge of ensuring the safety and security of the nation’s food and medical products (including drugs, biological products, and medical devices), which directly affect the health of every American. Challenges include (a) ensuring food safety; (b) ensuring the safety, effectiveness, and quality of drugs and medical devices; and (c) ensuring the security of drug supply chains.

 

  1. Ensuring Quality and Integrity in Programs Serving American Indian/Alaska Native Populations. Many HHS programs provide health and human services to AI/ANs throughout the U.S. Challenges include (a) addressing deficiencies in IHS management, infrastructure, and quality of care; and (b) preventing fraud and misuse of HHS funds serving AI/AN populations.

 

  1. Protecting HHS Data, Systems, and Beneficiaries from Cybersecurity Threats. Challenges include (a) protecting data on internal systems; (b) overseeing the cybersecurity of data in cloud environments; (c) ensuring that providers, grantees, and contractors are adhering to sound cybersecurity principles; (d) securing HHS’s data and systems; and (e) advancing cybersecurity within the healthcare ecosystem.

 

  1. Ensuring that HHS Prescription Drug Programs Work as Intended. HHS oversees coverage of prescription drugs under various programs operated by the Department. Challenges include (a) protecting the integrity of prescription drug programs; (b) fostering prudent payments for prescription drugs; and (b) ensuring appropriate access to prescription drugs.

 

  1. Ensuring Effective Preparation and Response to Public Health Emergencies. HHS is responsible for ensuring both it and its State and local partners are prepared to respond to, and recover from, public health emergencies efficiently and effectively. Challenges include ensuring (a) access to health and human services during and after emergencies: (b) effective use and oversight of funding; and (c) effective and timely responses to infectious disease threats.

 

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: Understanding and addressing whistleblowers

The vast majority of the cases resolved by the Civil Division of the Department of Justice (DOJ) were cases brought by “whistleblowers” under the qui tam provision of the False Claims Act (FCA). Whistleblowers are responsible for an even higher percentage of cases resulting in OIG Corporate Integrity Agreements (CIAs). Although most compliance officers are well aware of this program, many remain unclear as to how the process works. Tom Herrmann, J.D., who served over 20 years in the Office of Counsel to the OIG and as an Appellate Judge for the Medicare Appeals Board, explained that Congress permitted a whisltleblower called the “Relator” to file a case with the DOJ under the FCA.  Since this provision of law went into effect in 1986, there have been over 10,000 qui tam cases filed with a current average of one such case being filed every day of the year. The intent was to create incentives for private parties to detect and pursue fraud under the FCA. In return for reporting this information, Relators receive a portion (usually about 15 to 25 percent) of any recovered damages.  Once the lawsuit is filed, it is placed “under seal”, meaning that it is kept secret from everyone but the government, in order to give the DOJ enough time to investigate the allegations in deciding whether to join (“intervene”) in the case. Intervention by the DOJ occurs only in about one in five qui tam lawsuits, leaving whistleblowers the option to pursue cases on their own, however the chances of success are much lower than in cases when the government joins. Most successful qui tam cases are resolved through settlement negotiations rather than a court trial, although trials may occur.

Kash Chopra, J.D., noted that the overwhelming number of cases that result in a CIA, arise from whistleblowers and these, in turn, are based upon violations of the federal Anti-Kickback Statute (AKS). It is the government’s position that all claims arising from a corrupt arrangement violating the AKS or in some cases, the Stark Law, are considered fraudulent. This is even when the services rendered were needed and provided appropriately.  She advises here clients that the best ways to manage the whistleblower risk is to ensure that they are channeled through internal communication channels and their complaints are promptly evaluated, investigated, and resolved.  It is worth considering the following:

  1. Using outside experts to independently audit arrangements with physicians and evaluate compliance communication channel effectiveness.
  2. Ensuring a 24/7 hotline operated externally by experts in recognizing health care compliance issues.
  3. Reviewing/updating hotline-related polices/procedures (confidentiality, anonymity, non-retaliation, duty to report, etc.).
  4. Making sure that the duty to report suspected wrongdoing is explained in the Code, policies and training.
  5. Having trained and competent people on hand to conduct prompt and competent investigations of matters raised through the hotline.
  6. Moving quickly to use CMS and OIG self disclosure protocols when there is credible evidence of violations; and not wait until the DOJ gets involved.

For more information on this subject, Kashish Parikh-Chopra can be reached at kchopra@strategicm.com or via telephone at (703) 535-1413.

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.

Free Health Law Webinar–Steps to Take When a Fraud, Waste, or Abuse Issue is Discovered

It’s your last chance to register for the first free webinar in Wolters Kluwer Legal & Regulatory, U.S.’s four-part webinar series in partnership with Alston & Bird focusing on best practices for handling internal and external healthcare fraud and False Claims Act investigations.

“Steps to Take When a Fraud, Waste, or Abuse Issue Is Discovered”, will cover the essential elements of a comprehensive investigation plan that prudent organizations should develop as a first step when fraud, waste, or abuse is discovered. To register, visit the link below:
Steps to Take When a Fraud, Waste or Abuse Issue is Discovered
Thursday, November 1, 2018 at 3 PM EST
Moderator: Frank Sheeder, Partner at Alston & Bird
Featured speakers: Jason Popp, Partner, and Brad Smyer, Senior Associate at Alston & Bird

For information on the full webinar series, visit http://health.wolterskluwerlb.com/2018/10/wk-announces-free-webinar-series-on-healthcare-investigations/