Kusserow on Compliance: Tips on developing and revising the ‘Code of Conduct’

All compliance guidance from the U.S. Sentencing Commission to the HHS Office of Inspector General (OIG) and DOJ has called for having a Code of Conduct as a foundation document for any effective compliance program. However, many such codes are far out of date and fail to provide the needed guidance for employees on their obligations towards compliance. The initiation of compliance program guidance by the OIG was a major stimulant for having Codes of Conduct. In the early days of responding to such guidance, many organizations quickly developed a “Compliance Plan” that included all seven elements of the program, including a Code. Unfortunately, plans are statements of intent, not an operating program and converting them into fully functioning and effective programs has years. This has included reviewing, revising and updating their Code of Conduct and compliance-related policies.

Daniel Peake of the Compliance Resource Center (CRC) (dpeake@compliancereource.com (703)-236-9854) works with compliance officers to provide a variety of compliance related services that includes the Policy Resource Center (PRC) which provides templates for compliance-related documents, including Codes, charters, policies, audit guides, etc. He notes that the PRC offers Code templates, but it is important that the Code should reflect the organization’s spirit, tone, and culture. If it doesn’t ring true to staff, securing their participation and cooperation in the compliance program will be much more difficult. The Code should be tailored to be an extension the mission and vision of the organization. It needs to be part of an ongoing monitoring effort subject to periodic reviews to ensure it remains up to date with the ever-changing regulatory environment.  He offered the following tips:

11 tips for developing or revising the Code of Conduct

 

  1. Determine whether it is time to review and possibly update the Code. Answering the following will help in making that determination: (a) When the Code was last reviewed/revised? (b) Any significant changes in law, regulation, or guidance since last revision? (c) Any changes/updates to compliance policies since last revision?
  1. Review Code templates and examples of other similar organizations. It is useful to review the codes of other organization to help focus on what is needed; and this can save a lot of time and effort. However, copying a Code from another source may prove to be problematic, if it runs counter to the culture of the organization.
  1. Gain buy-in from executive leadership. This is critical and needs to include personal involvement of the Compliance Officer, as well as HRM and Legal Counsel.
  1. Introductory letter from the CEO. It is a best practice to have the CEO introduce and endorse the Code, along with stating that (a) everyone is equally obligated to adhere to it, (b) everyone has a duty to report potential violations without fear of retaliation, (c) a confidential hotline is available to report confidentially or anonymously, etc.
  1. Reference the Code against compliance-related policies. The Code must not conflict with policies and procedures, as it would risk potential liabilities.
  1. Consider using experts to facilitate process. No need to “reinvent the wheel.”  Code development/revision can be simplified, facilitated, and guided by compliance experts in this field; and can ensure inclusion of key concepts, including those called for by the HHS OIG.
  1. Determine Core Code Content. Key to developing a successful Code is to ensure that it addresses the needs of all stakeholders (i.e. management, employees, Board, regulatory agencies, etc.).
  1. Code must detail procedures for addressing compliance issues. Employees should feel comfortable in approaching his or her supervisor, other members of management, HR or the Compliance Office. In addition there must be an option to report to a confidential hotline.
  2. Dissemination of the Code. The Code must be made available to all covered persons through an Intranet, in hard copy with signature receipt, through compliance training, or a combination of all. If the Code is not new, but one that has been revised, then steps need to be made to stop dissemination of the old version.
  3. Translating Code into other languages. A decision is needed as to whether the Code is to be provided only in English, or with versions in other languages. If it will be disseminated in multiple languages, the challenge will be to ensure the Code is written in simple terms, avoiding slang or jargon that will create problems in translating to be equivalent in meaning.
  4. Ensure all out of date Codes are removed from the website and hard copies collected. Having more than one version of the Code in circulation at the same time is a formula for creating problems.

 

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: DOJ Policy for continued antitrust enforcement DOJ

At the American Bar Association’s Anti-Trust in Healthcare Conference, Deputy Attorney General Barry Nigro provided a wide ranging presentation regarding DOJ efforts to combat rising health care fraud. He noted that, in 2016, health care spending in the United States accounted for $3.3 trillion, or $10,348 per person—approximately 18 percent of Gross Domestic Product (GDP). At this level of spending, the economy can ill afford fraudulent activity to increase the cost of health care. Inasmuch as health care involves critical care, it means the DOJ is giving it a higher priority. DOJ is continuing to give this area a priority that includes rigorous investigation and prosecution of those engaged in Medicare provider fraud and price gouging by drug makers. The DOJ will carry on with questioning mergers and potential collusion among health systems and payers. This includes market allocation agreements, price fixing, and naked market allocation. Some of the topical areas covered in his address included the following:

  1. Criminal prosecutions related to price fixing and market allocation agreements
  2. Parties circumventing generic drug regulations
  3. Market allocation and no-poach agreements
  4. Limitations on exemptions and immunities from anti-trust laws
  5. Continued reliance on the Clayton Antitrust Act
  6. Urging states to consider negative effect on competition when passing laws
  7. Support for certificate of need provisions
  8. Urging states to consider laws that impose occupational licensing requirements
  9. Professionals being able to advertise receiving board certification to patients

 

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: Congressional hearing on Medicare fraud

The HHS Deputy Inspector General for Audit Services provided Congressional testimony related to Medicare fraud and began by noting that Medicare spending $700 billion annually on behalf of 59 million beneficiaries has grown to the point where it is more than 15 percent of all federal spending. With increasing number of beneficiaries and rising health care costs, it is estimated that Part A Trust Fund will be depleted by 2026; and spending for Medicare Part B will grow by more than 8 percent over the next 5 years, outpacing the U.S. economy. Medicare and Medicaid improper payments reported by HHS was $90 billion a year with two thirds involving Medicare fee-for-service payments due to errors associated with insufficient or no documentation. Although improper payments may occur in all types of health care, home health, skilled nursing facility (SNF), and inpatient rehabilitation facility (IRF) are areas of particular concern, representing 33 percent of the overall estimated improper payment rate for Medicare fee-for-service.

Responding to this high level of improper payments, the OIG is using advanced data analytics help the agency more effectively assess risk and pinpoint oversight efforts. The OIG uses data analytics to analyze millions of claims and billions of data points. At the macro level, the OIG analyzes data patterns to assess fraud and other types of risk across Medicare services, provider types, and geographic locations to prioritize our work and more effectively deploy our resources. At the micro level, the OIG uses data analytics, including near- real-time data, to identify potential fraud suspects for more in-depth analysis and to efficiently target investigations. OIG enforcement efforts involve a three-pronged approach that focuses on prevention, detection, and enforcement. The CMS’s Fraud Prevention System (FPS) was cited as serving an important tool with data analytics and predictive analytics for fraud-detection.  Once suspected fraud is identified, the OIG investigate the facts and pursue enforcement to hold perpetrators accountable and recover misspent taxpayer dollars.

 

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: U.S. Sentencing Commission Federal Register Notice seeking public comment

This is time sensitive for those interested in making comments

The U.S. Sentencing Commission published a request for comment in the Federal Register seeking public comment and feedback on its list of tentative priorities for the amendment cycle ending on May 1, 2019. This is part of the annual amendment cycle, during which the Commission reviews and revises its guidelines. This year, the Commission is focusing on whether the time has come to prioritize amending Chapter Eight to cover drug-related offenses. Broadly defined, those offenses might include drug trafficking offenses, misbranding and adulteration of drugs, the sale of unapproved drugs, and dispensing certain drugs without a prescription. The Commission will not make final decisions on this subject until it has heard from the public. As such, those that have thoughts on this topic should consider weighing in with this opportunity of giving them feedback. If adopted, this priority could lead to guideline changes with a potential impact on the pharmaceutical, health care, and certain retail industries.  This may in turn impact the seven standard elements of an effective compliance program, and, in turn, the work of compliance officers.

Therefore, those that have thoughts about the proposed changes have the opportunity to have their ideas brought before the Commission. This includes whether this should be a priority for them now and, if so, how broad or narrow they should be on this issue. One area to consider is whether there are ideas and suggestions as to how the Commission should study this issue area over the next couple of years. At any rate, the Commission has opened the door for public feedback, ideas, and suggestions; however this is time sensitive in that the Commission will make its final decision on priorities at a public meeting in August, after considering all the public comments. If this is something of interest, more information is available at the Commission’s website.

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.