Wayne J. Miller, of the Compliance Law Group in Thousand Oaks, CA, has had a 26-year career in health care law. His firm has exclusively represented health care providers--physicians, institutional and DME providers--particularly in transactional and regulatory matters, including Medicare fraud and abuse and self-referral prohibition (also known as "Stark") laws. Mr. Miller's expertise has led him to conduct many audio conferences for health care providers. (The next conference will be on February 19, 2009, through audioeducator.com.)

Mr. Miller spoke to DOTmed News about his take on provider responses to the recent Stark Law and anti-markup final rule changes and related issues.

Miller says that the practitioners affected by the latest Stark and anti-markup changes--such as physicians or groups that contract for in-house diagnostic services and mobile imaging providers serving physician practices, are struggling with how to respond to the final rules, all of which are effective in 2009. They don't know if the new Obama Administration is going to enforce or change the rules, Miller says. There is some early indication that the Administration will be reviewing the rules, and possibly halting enforcement until the review is completed. Right now, Miller notes, many in the industry are waiting for a new Secretary of Health and Human Services to be nominated and confirmed before taking further action. So many providers are in a "wait and see" mode till further developments unfold.

The Law Now

Miller cautions providers that the rule changes are effective for now and should be treated as implemented. Enforcement may be delayed, but waiting is a risky approach. His recommendation is to act on the rules now.

Miller explains that the Stark laws have been around for 13 years, and every few years CMS has issued new interpretations of the rules. In 2008 Medicare issued a number of changes specifically concerning the Stark law and the anti-markup rule, and these have been identified as final, except for a few remaining issues. Miller believes that CMS is gearing up for full enforcement of the Stark and anti-markup laws later in 2009.

The latest anti-markup rule impacts those who hire physicians or other practitioners to provide diagnostic tests or interpretations for their offices. Depending on the arrangement, the group may be able to bill the full fee schedule amount to Medicare, or alternatively may have to bill on a cost basis. In the latest iteration, there are two approaches: whether the contractor performs services at the group's office or is sharing his practice with the hiring group. The hiring group can bill at the full schedule amount for a contractor who either performs on site or is found to be sharing a practice. The difficulty is in interpreting the two tests.

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