Health Care Lawyer Blog

Last week the Centers for Medicare and Medicaid Services (CMS) released the new voluntary Self-Referral Disclosure Protocol (SRDP) for Stark violations. The SRDP is the counterpart to the OIG self-disclosure protocol, which allows providers to self-disclose violations of the Anti-Kickback Statute only, OR Stark violations that include a “colorable” AKS violation. The SRDP applies to Stark only violations.

The key take away-points are as follows:
- Pursuant to the SRDP, providers may self-report Stark violations resulting in overpayments via an electronic filing process. A disclosing party must provide a detailed description as to why the party believes a Stark violation has occurred, including a “complete legal analysis” of the application of the Stark law to the matter being disclosed.

- It is important for providers to realize that self-reporting under the SRDP does NOT guarantee them a "get out of jail free" card. While HHS is “authorized to reduce the amount due and owing for all violations under [Stark] to an amount less than that specified” if a provider self-reports, there is no requirement for HHS to do so. Whether such reduction will be made is based on a consideration of several factors, including:
(1) The nature and extent of the improper or illegal practice;
(2) The timeliness of the self-disclosure;
(3) The cooperation in providing additional information related to the disclosure;
(4) Other factors HHS may consider appropriate.
Additionally, CMS reserves the right to refer matters to “law enforcement for its consideration under its civil and/or criminal authorities.”

- It is also worth noting that the SRDP includes a provision requiring that CMS be granted access to all “supporting documents” and does NOT allow providers to assert privileges as to the same. This means that attorney/client privileged documents, if requested, must be turned over.

- What this all means that a provider may self-disclose, but still end up being hit with the same penalties as if he/she had not done so. Additionally, since there is no intent requirement for Stark, by admitting a violation a provider essentially proves the government’s case. Arguably, providers who self-disclose may protect themselves from being targeted by a qui tam whistleblower, but the SRDP as currently structured may cause some providers to think twice before self-disclosing.

This post is NOT meant to discourage providers from self-reporting, but only to provide a brief overview of the SRDP provisions. Providers who have specific questions relating to self-reporting, or any other Stark or Anti-Kickback issue, should contact an experienced health law attorney.

In a recent advisory opinion, the Health and Human Services Office for the Inspector General (“OIG”) evaluated a proposed arrangement whereby a hospital would compensate a sleep test provider on a “per click” basis for sleep testing equipment and services. The OIG concluded that while the arrangement could potentially generate prohibited remuneration under the anti-kickback statute (“AKS”) if the required intent was present, absent such a showing the OIG would not impose penalties.

In Advisory Opinion No. 10-14, the Requestor was a corporate entity (with no physician ownership) that provided sleep disorder diagnostic testing and related services in freestanding facilities and in hospital-owned facilities in multiple states. Under the proposed arrangement (“Arrangement”), the Requestor contracted with a hospital to provide the equipment, technicians, and staff necessary to operate a sleep-testing facility at the hospital. Patients are referral to the sleep-testing facility by physicians, and the hospital employees call patients to schedule overnight sleep studies, confirm insurance, and provide any pre-authorization that may be required.

The Requestor’s technicians perform the sleep studies for the hospital pursuant to a signed, written agreement that specifies all of the services to be provided and the material terms of the Arrangement. The Requestor then charges the hospital a set per-test fee, which Requestor and the Hospital negotiated through an arm’s-length bargaining process.

The Requestor sought an opinion from the OIG for the purpose of determining whether the arrangement would violate the AKS, which makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward referrals or items or services reimbursable by a federal health care program. While there are exceptions and safe harbors to the AKS, the OIG noted that the proposed arrangement did not fit within any of the safe harbors because the Hospital pays the requestor on a per-test basis, and therefore the aggregate amount to be paid is not set in advance.

After the jump - OIG analysis on the Arrangement

Continue reading "OIG OKs “Per Click” Fee Arrangement Between Sleep Testing Provider and Hospital" »

A recent Advisory Opinion issued by the Health and Human Services Office of Inspector General (OIG) set out that a proposed arrangement by a continuing care retirement community (CCRC) to provide gift cards to individuals who referred seniors to the CCRC would not violate the federal Anti-Kickback Statute.

The underlying facts of Advisory Opinion 10-05 are as follows: Requestor operated several CCRCs, which provided the following services to seniors:
- Independent living
- Assisted living
- Skilled nursing services

The Requestor proposed an arrangement whereby current CCRC residents or employees would receive a gift card (the amount of which was redacted from the Opinion) if they recommend a prospective resident to the independent living community only. To qualify for the gift card, the current resident/employee must submit the prospective resident’s contact info; the prospective resident much be eligible for services; and the prospective resident must tour the community within 90 days.

If the prospective resident moves into the community within 12 months of the tour, the resident will receive a one-time credit (if an employee made the referral, he/she would receive a check).

Continue reading "Anti-Kickback Law Not Triggered By Referrals by Non-Physicians for Independent Living Services" »