The problem with healthcare innovators is that when they engage a complex, bureaucratic behemoth like Medicare their newfangled idea might actually be against the law.
From the very beginnings of Medicare it has been a crime for individuals or other entities “that knowingly and willfully offer, pay, solicit, or receive remuneration to induce or reward business reimbursable under the Federal health care programs,” according to the watchdog of the U.S. Department of Health and Human Services, the Office of Inspector General. Violating this law carries fines up to $25,000 and up to 5 years in prison, in addition to civil penalties.
“Since the statute on its face is so broad, concern has been expressed for many years that some relatively innocuous commercial arrangements may be subject to criminal prosecution or administrative sanction,” the OIG writes. One man’s kickback, therefore, could be another man’s method of incentivising greater efficiency in delivering healthcare. To prevent this, Congress passed Section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to create “safe harbors” for such programs, and every year the Inspector General solicits comments and suggestions from the public about new areas to be considered.
This year is no different, and the OIG is looking to add to the Safe Harbor provisions, specifically in the following areas:
- Access to health care services;
- The quality of health care services;
- Patient freedom of choice among health care providers;
- Competition among health care providers;
- The cost to Federal health care programs;
- The potential over-utilization of health care services, and;
- The ability of health care facilities to provide services in medically underserved areas or to medically underserved populations.
“In addition, we will also take into consideration other factors, including, for example, the existence (or nonexistence) of any potential financial benefit to health care professionals or providers that may take into account their decisions whether to (1) order a health care item or service or (2) arrange for a referral of health care items or services to a particular practitioner or provider,” the OIG writes.
The OIG is soliciting comments through Feb. 26. For more information, see the OIG’s announcement in the Federal Register.
Think you might be violating Medicare anti-kickback regulations? A complete list of the programs listed under the Safe Harbor provisions can be downloaded here: (You must be logged in to download this file. Don't have an account? Register for free and you'll be returned to this page.)