Introduction:
I have a vivid memory of sitting next to my father in an elementary school principal’s office. The facts were: (1) three “student of the week” ice cream vouchers had gone missing from my teacher’s desk; (2) I was a somewhat portly child; and (3) I had tried, albeit unsuccessfully, to cash in one of those illicit vouchers at lunch that day. The problem was not that I had cashed in the absconded ice cream ticket, the problem was that my best friend Billy had given me that ticket in exchange for my box of chocolate milk earlier that afternoon.
The bottom line: (1) I knew that Billy had no business with a student of the week ice cream voucher when I traded my chocolate milk; (2) I did not inform school officials when I had the chance; and (3) I was now seated next to my father in the principal’s office.
Had I disclosed the illicit ice cream voucher, my losses would have been limited to the chocolate milk. But instead of picking the high road, I succumbed to my insatiable appetite for ice cream and was now faced with my father’s version of a corporate integrity agreement.
Moral(s) of the story: (1) Self-disclosure can save you; and (2) Billy is not your friend.
The Recent Update:
Earlier this week, the Office of the Inspector General (OIG) released its 2013 update to the Provider Self-Disclosure Protocol (SDP). The SDP establishes a process for health care providers to voluntarily identify, disclose, and resolve instances of potential fraud involving the Federal health care programs (as defined in section 1128B(f) of the Social Security Act (the Act), 42 U.S.C. 1320a-7b(f). The SDP provides guidance on how to investigate potential fraud, quantify damages, and collaborate with the OIG to resolve and minimize provider liability.
The Benefits of Self-Disclosure:
According to the SDP, the potential benefits of provider self-disclosure include:
- a presumption against costly corporate integrity agreements;
- limiting baseline financial exposure to 1.5 times single damages (however, there is a minimum $ 50,000 settlement value for all Anti-Kickback violations);
- mitigating / avoiding additional civil monetary penalties (CMP) available under section 1128J(d) of the Act, 42 U.S.C.§ 1320a-7k(d); and
- a twelve month resolution window.
The Necessary Elements of Self-Disclosure:
To take advantage of these benefits, the disclosing party must include the following information in its submission:
- the disclosing party’s name, address, provider type, identification numbers;
- an organizational chart describing the pertinent relationships, names and addresses of any related entities, and any affected corporate divisions, departments, or branches;
- the name, street address, phone number, and email address of the disclosing party’s designated representative for purposes of the voluntary disclosure as well as the name of an individual authorized to enter into a settlement agreement on behalf of the disclosing party;
- a concise statement of all details relevant to the conduct disclosed, including, at minimum, the types of claims, transactions, or other conduct giving rise to the matter; the period during which the conduct occurred; and the names of entities and individuals believed to be implicated, including an explanation of their roles in the matter;
- a statement of the Federal criminal, civil, or administrative laws that are potentially violated by the disclosed conduct;
- the Federal health care programs affected by the disclosed conduct;
- a calculation of actual damages to each Federal health care program relevant to the disclosed conduct, or where necessary, a certification that an estimate will be completed and submitted to OIG within 90 days;
- a description of the disclosing party’s corrective action upon discovery of the conduct;
- a statement of whether the disclosing party has knowledge that the matter is under current inquiry by a Government agency or contractor; and
- a certification stating that to the best of the disclosing party’s knowledge, the submission contains truthful information and is based on a good faith effort to bring the matter to the Government’s attention for the purpose of resolving potential liability to the Government and to assist OIG in its resolution of the disclosed matter.
Calculating Damages:
If the disclosure involves the submission of improper claims, the disclosing party must estimate the total value of improper payments. In performing this estimation of damages, the disclosing party must review either: (1) all claims affected by the disclosed matter; or (2) a statistically significant, random sample of 100 claims.
In addition to the baseline calculation of damages, the report must include a full description of the:
- objective of the review;
- population;
- characteristics measured;
- source of the reviewed data; and
- individuals who performed the review.
- If a random sample was employed, the following additional items are required:
- sampling unit;
- sampling frame;
- sample size;
- source of random numbers;
- method of selecting sampling units;
- sample design;
- missing sample items; and an
- estimation.
Conduct Involving Excluded Persons:
If the submission involves information related to the employment of individuals who appear on the OIG’s List of Excluded Individuals and Entities, the following information must be provided:
- the excluded individual’s name and provider identification number;
- the job duties performed;
- the dates of the individual’s employment or contractual relationship;
- a description of any and all background checks;
- a description of the disclosing party’s screening process and perceived breakdown that led to the hiring of the excluded individual;
- a description of how the conduct was discovered;
- a description of any corrective action to prevent future hiring of excluded individuals; and
- a calculation of the total amounts billed for and collected on excluded individuals.
Requirements for Potential Anti-Kickback Statute Violations:
While not an all-inclusive list, the OIG suggests the following five items be disclosed when reporting potential Anti-Kickback violations:
- a fair market value calculation (if applicable);
- why required payments from referral sources, under leases or other contracts, were not timely made or collected or did not conform to the negotiated agreement and how long such lapses exists;
- why the arrangement was arguably not commercially reasonable;
- why payments were made for services not performed or documented;
- whether referring physicians received payments from Designated Health Services entities that varied with, or took into account, the volume or value of referrals with; and
- the corrective action taken to remedy the suspect arrangements, as well as any safeguards implemented by the disclosing party to prevent the conduct from reoccurring.
Conclusion:
While self-disclosure may seem like a somewhat daunting and arduous task, consider the words of the Deputy Chief of the Administrative and Civil Remedies Branch of the OIG’s Office of Counsel, Tony Maida: A provider who self discloses “is in a very different position than one who is under investigation because of a whistleblower complaint or other leads. “When you disclose a problem in good faith” you communicate to the OIG that your organization “embraces a culture of compliance,” thereby minimizing the potential for financial and operational sanctions. Stated otherwise, think long and hard about turning in that ice-cream voucher; it might just keep you out of the principal’s office.
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1 Note: Claim payment errors resulting in potential overpayments should be handled with individual Medicare Contractors. Additionally, all potential Stark violations should be reported via the Centers for Medicare and Medicaid Services, Provider Self-Referral Disclosure Protocol.