Issued August 3, 2009, and posted August 10, 2009
Written by Catherine Martin; reviewed by Claire Turcotte*
On August 10, 2009, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 09-11, addressing the provision of free blood pressure screenings to walk-in visitors at a hospital (Arrangement). OIG found that the Arrangement
(i) would not constitute grounds for the imposition of civil monetary penalties (CMP) under 42 U.S.C. 1320a-7a, and (ii) could implicate the anti-kickback statute, but would not result in civil monetary penalties or administrative sanctions under 42 U.S.C. 1320a-7b.
The requestor of Opinion 09-11 is a small, county-owned critical access hospital that provides routine blood pressure screenings (Screenings or Screening) free of charge to visitors that come to the hospital during the day and request a Screening. The hospital does not advertise the free Screenings; the Screenings are not conditioned on the visitor using any other goods or services from the hospital or any other particular healthcare provider or practitioner; and visitors are not offered discounts on follow-up services. Where the results of a Screening are outside the normal limits, the visitor is directed to their own healthcare professional unless the clinical circumstances require the visitor to be directed to the emergency room. The hospital does not bill the Screenings to any federal healthcare program or any other third-party payor.
In its analysis of the Arrangement under the CMP, OIG focused on the definition of remuneration for purposes of the CMP and the exception for incentives given to beneficiaries to promote the delivery of preventive medicine. While OIG has taken the position that incentives of nominal value (no more than $10 per item or $50 in the aggregate) do not constitute remuneration for purposes of the CMP, OIG concluded that the Screenings would implicate the CMP prohibiting inducements to beneficiaries, because there is no limit to the number of Screenings per visitor per year—which could result in the $50 threshold being exceeded. Next, OIG focused on the preventive care services exception to the CMP and found that the Screenings would constitute preventive care services.
Nevertheless, OIG still analyzed the Arrangement to determine whether the free care would promote the provision of other non-preventive care reimbursed by Medicare and Medicaid. OIG concluded that the Screenings were unlikely to have this effect, citing a similar permitted hypothetical arrangement discussed in the preamble to the final rule on the CMP relating to free blood screenings.
The OIG concluded that the Arrangement was crafted to appropriately avoid improper ties to the provision of other services because:
- Screenings are not conditioned on use of any other goods or services from the Hospital or any other particular healthcare practitioner or provider;
- Visitors are not directed to any particular healthcare practitioner or provider;
- Visitors are not offered special discounts on follow-up services; and
- Visitors with abnormal readings are directed to follow up with his or her own healthcare professional (unless clinical circumstances require otherwise).
For the same reasons set forth above, OIG also concluded that the Arrangement is unlikely to serve as a means of providing unlawful kickbacks, and therefore, administrative sanctions under the anti-kickback statute were unwarranted.
*The Fraud and Abuse Practice Group Leadership would like to thank Advisory Opinions Task Force members Catherine Martin, Esquire (Adelman Sheff & Smith LLC, Annapolis, MD), and Claire Turcotte, Esquire (Bricker & Eckler LLP, Cincinnati-Dayton, OH), for drafting and reviewing this summary, respectively.