CMS issues 2009 IPPS, takes another look at the "stand in the shoes" rule and solicits thoughts on gainsharing exceptions

On April 30, CMS published its draft 2009 IPPS regulation.  The inpatient prospective payment system reg is loaded down, as usual, with additional regulatory changes. 

Among the most highly touted are the quality of care initiatives. 

One of the CMS fact sheets on the reg highlights two other standout provisions — the "stand in the shoes" and gainsharing proposals:

The physician self-referral rules prohibit physicians from making referrals for eleven types of designated health services (DHSs) furnished in facilities in which the physician or an immediate family member of a physician has an ownership interest or compensation arrangement, and prohibits the entity from billing Medicare or any other entity for services that were referred in violation of the ban.  The proposed rule would:

• Modify the physician self-referral “stand in the shoes” provisions in the definition of indirect compensation arrangement to: (1) accommodate certain financial transactions made between physicians and academic medical centers or integrated healthcare delivery systems; and (2) require a DHS entity to stand in the shoes of an organization in which it has a 100% ownership interest.
• Revise the definitions of "physician" and "physician organization."
• Clarify the period of time for which a physician would be prohibited from referring Medicare patients to an entity for DHS and for which the DHS entity would be prohibited from billing for such DHS (the “period of disallowance”) where a financial relationship between the physician and the entity failed to satisfy the requirements of an exception to the prohibition on physician self-referral.
• Solicit public comment on gainsharing arrangements and physician-owned implant companies about the extent to which these arrangements pose a risk for program abuse.

The federales’ previous cut at a "stand in the shoes" rule was put on ice late last year, since it would have rendered impermissible many current relationships involving support payments between components of academic medical centers and integrated delivery systems.  The new version, which would be finalized by August, and take effect October 1, is described in greater detail in the Federal Register document, at page 23685 (page 159 of the linked document).

On the gainsharing front, there is no specific proposal — rather, the federales are looking for suggestions (page 23694):

At this time, we decline to issue a specific proposal concerning an exception for gainsharing arrangements, but rather are soliciting comments as to whether we should establish an exception for gainsharing arrangements, and, if so, what safeguards should be included in the exception. Specifically, we are interested in receiving comments on: (1) What types of requirements and safeguards should be included in any exception for gainsharing arrangements; and (2) whether certain services, clinical protocols, or other arrangements should not qualify for the exception.

Gainsharing has been a topic of particular interest to me, and I look forward to seeing a wide variety of proposed models for gainsharing, and ultimately a regulatory exception broad enough to encompass them all.  Before a general exception is promulgated, however, it would be nice if CMS would actually grant final approval to the gainsharing demonstration projects (646 and 5007) for which it has granted preliminary approval; after all, experience in the demonstration projects was supposed to inform the ultimate decisions about broader exceptions.

— David Harlow