Compliance Resources
HCR 460: Investigations and Disclosures in Health Care Compliance
There are two different types of investigations, internal and external investigations along with specific parties regarding both. An internal investigation involves the compliance officers, internal audit departments, outside counsel, or all (Josephs & Sheeder. N.d.). Such departments are separate from government investigations (Josephs & Sheeder. N.d.). The external investigations normally involve government organizations such as the DOJ, OIG-HHS, Attorneys General, and other Federal and State Agencies (Imperato & Glasser. N.d.). These can be initiated by turning in formal complaints (Imperato & Glasser. N.d.).
The purpose of these investigations is to obtain information on formal complaints and determine how the company and department(s) handle such complaints (Josephs & Sheeder. N.d.). However, in my opinion, auditing and monitoring can help reduce issues when it comes to internal and external investigations. When it comes to internal investigations, it does help the company respond to external investigations conducted by governmental organizations and what they find (Josephs & Sheeder. N.d.). Conducting internal investigations can also minimize potential criminal or civil liabilities (Josephs & Sheeder. N.d.). Internal investigations also prepare the company’s attorney(s) when it comes to information on legal defenses, potential legal pitfalls, and how to proceed with the case (Josephs & Sheeder. N.d.).
There are four types of evidence that could be used during a healthcare investigation. These four types of evidence are relevant, material, competent, and authentic/original (Imperato & Glaser. N.d.). This also includes hearsay evidence statements and business records (Imperato & Glaser. N.d.). Interviews can also be used as evidence material, but it does fall into the hearsay category as well (Josephs & Sheeder. N.d.). When it comes to business records, this can include but is not limited to, laboratory records involving corrective action plans, documenting of the processes, etc.
Outside counsel can conduct an internal investigation if they are collaborative with the company’s compliance officer (Josephs & Sheeder. N.d.). When it comes to wavering certain privileges, you must provide the government information you obtain during the internal investigation (Josephs & Sheeder. N.d.). There are advantages and disadvantages when it comes to internal investigations, however, they can be more efficient when conducting internal investigations. Another disadvantage to internal investigations is the government can still conduct its own investigation (Josephs & Sheeder. N.d.). Also, there is a waiver that can give private litigations access to company documents (Josephs & Sheeder. N.d.).
There are advantages to internal investigations such as influencing the scope and nature of the government’s investigation, but this may or may not be successful (Josephs & Sheeder. N.d.). Another advantage is implementing corrective action plans and interviewing your employees before the government does (Josephs & Sheeder. N.d.). Another advantage to internal investigation is to document activities made by the compliance department and in the program (Josephs & Sheeder. N.d.). The internal investigation should also be along the lines of the government investigation to define the issues and stay on the same track as what the government finds that you didn’t find (Josephs & Sheeder. N.d.). Attorneys are the only ones who can conduct privileged investigations, along with the people who work under them (Josephs & Sheeder. N.d.).
However, when it comes to waivers, the chances of passing are greater when the non-attorney is involved in the investigation, unfortunately (Josephs & Sheeder). To preserve privileges, you must identify the attorney(s) and who they represent (Josephs & Sheeder. N.d.). You should also avoid conflicts of interest (Josephs & Sheeder. N.d.). Also, you should only communicate on a “need to know” basis to avoid waiver issues (Josephs & Sheeder. N.d.).
When it comes to investigations, there are going to be specific witnesses you will need to interview. The interviewed witnesses should be the complainant, the parties that are identified in the complaint, people who are named in the allegation(s), and those who have relevant information to the investigation, etc. (Josephs & Sheeder. N.d.). If government agents show up at your front doors, you must get your attorney(s) involved as soon as possible (Josephs & Sheeder. N.d.). You should also follow the policies and procedures when it comes to external investigations (Josephs & Sheeder. N.d.). You must also be cooperative in external investigations which can help the investigation go smoothly and efficiently (Josephs & Sheeder. N.d.).
It is advised to make copies of all documents that will be obtained by the investigator just so you and the investigator can both have copies of all the needed documents (Josephs & Sheeder. N.d.). You should never obstruct justice which involves altering and destroying documents, falsifying reports to the government, and communicating with the employees or witnesses (Josephs & Sheeder. N.d.). When it comes to retaliation from a company and its employees there are some actions that can be taken to limit retaliation. Also, self-reporting can also limit whistleblowers in general (Josephs & Sheeder. N.d.). When it comes to self-reporting, there is a more public disclosure which can make a whistleblower not want to come forward due to public scrutiny (Josephs & Sheeder. N.d.).
There are laws that are created to protect whistleblowers from retaliation. However, this doesn’t mean retaliation doesn’t occur just because there are active laws in place. There is a law, the Military Whistleblower Protection Act, that was created to help protect whistleblowers from retaliation for public disclosures (HHS & OIG. N.d.). This also includes the healthcare parts of the military, and this also means they cannot be restricted from talking to the OIG or members of Congress (HHS & OIG. N.d.). There are specific criteria that must be met.
Since whistleblowers are part of internal and external investigations, I do want to touch base on whistleblowers, their roles in investigations, and other things regarding whistleblowers. There are two types of protected disclosures such as the Military Whistleblower Protection Act and the HHS Civilian Employees (HHS & OIG. N.d.). The criteria are the disclosure must be reasonable and truthful on wrongdoing and the disclosure must also be made to authorized personnel (HHS & OIG. N.d.). Things that whistleblowers can report are violations of any law, rule, or regulation, gross mismanagement, waste of funds, abuse, danger to public health and safety, censorship to scientific integrity, and authorized recipients (HHS & OIG. N.d.). Employees can disclose information to non-governmental or governmental persons (HHS & OIG. N.d.).
Resources
· Al Josephs & Frank Sheeder. N.d. Internal Investigations: Common Conundrums, Conflicting Agendas, and How to Deal with Them. Retrieved from https://assets.hcca-info.org/Portals/0/PDFs/Resources/library/Internal%20Investigations-%20Common%20Conundrums,%20Conflicting%20Agendas,%20and%20How%20to%20Deal%20With%20Them.pdf
· Gabriel L. Imperato & David M. Glaser. N.d. Internal and External Investigations. Retrieved from https://assets.hcca-info.org/Portals/0/PDFs/Resources/Conference_Handouts/Healthcare_Enforcement/2020/Wednesday/HRIV1020_W13_Handout1.pdf
· U.S. Department of Human and Health Services (HHS) & Office of Inspector General (OIG). N.d. Whistleblower Protection Information. Retrieved from https://oig.hhs.gov/fraud/report-fraud/whistleblower/
