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The three most important Federal fraud and abuse laws that apply to audiologists include the False Claims Act (FCA), the Anti-Kickback Statute (AKS), and the Physician Self-Referral Law (Stark law). Government agencies, including the Department of Justice, the Department of Health & Human Services Office of Inspector General (OIG), and the Centers for Medicare & Medicaid Services (CMS), are charged with enforcing these laws, among other fraud and abuse laws.

False Claims Act

The FCA, 31 U.S.C. §§ 3729–3733, sets forth that it is illegal to submit claims for payment to Medicare or Medicaid that you know or should know are false or fraudulent. Filing false claims may result in fines of up to three times the programs’ loss plus $11,000 per claim filed. Under the civil FCA, each instance of an item or a service billed to Medicare or Medicaid counts as a claim.

Anti-Kickback Statute

Section 1128B(b) of the Social Security Act (42 U.S.C. 1320a-7b(b)), previously codified at sections 1877 and 1909 of the Act, provides criminal penalties (felony) for individuals or entities that directly or indirectly, knowingly and willfully offer, pay, solicit or receive remuneration in order to induce business reimbursed under the Medicare or State health care programs.

Stark Law

The Stark Law prohibits a physician (or an immediate family member) who has a “financial relationship” (including compensation and investment / ownership interests) with an entity from referring patients to the entity for “designated health services” covered by Medicare, unless an exception is available. In the event a proscribed referral is made and no exception is available, the entity performing the services is prohibited from submitting a claim for the services to Medicare program or billing any individual, third-party payer or other entity for the services. Certain aspects of the Stark Law also apply to state Medicaid programs. Stark has limited applicability for audiologists. Designated Health Services (DHS) include hospital inpatient/outpatient services + CPT codes 92507 & 92508 (SLP codes); referral can be oral, written or electronic.


Office of Inspector General Issues Advisory Opinion on Free Hearing Testing to Medicare Beneficiaries

On October 5, 2012, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion No. 12-13, which addresses a clinical situation in which a hearing aid supplier is offering free hearing tests to Medicare beneficiaries and would like to begin to offer audiometric testing to beneficiaries and bill- Medicare for that testing. OIG has for many years offered a process by which individual Requestors may apply for an Advisory Opinion regarding a specific factual scenario to learn how the federal fraud and abuse laws such as the Anti-kickback statute, False Claims Act, STARK law, and Civil Monetary Penalties statute, among others, would apply in a specific scenario. While the Requestor is known to the OIG, OIG redacts the Requestor Based on the facts presented, the OIG concluded that the applicable laws, the Civil Monetary Penalty (CMP) statute, and the Anti-Kickback statute, would not be implicated in the specific case as it was presented.

This is a very complex opinion. The American Academy of Audiology is closely reviewing the Hearing Testing Advisory Opinion and would caution audiologists facing similar practice circumstances to understand that the focus of this ruling is extremely narrow because the OIG issues Advisory Opinions only in response to the specific facts posed by one Requestor. OIG clearly states that even a slight change in the clinical scenario presented can alter the result; thus, outside readers should not draw assumptions about the legal conclusions offered in OIG Advisory Opinions.

The Academy urges members to consult an attorney regarding the implications of providing free hearing testing to Medicare beneficiaries while also billing Medicare for audiometric testing in your practice setting.

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