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      Headlines - July 11, 2005
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R. Lewis Dark: Using OIG Advisory Opinions to Level Playing Field

TWICE DURING THE PAST 12 MONTHS, the Office of the Inspector General (OIG) has issued a negative opinion on a marketplace arrangement between a laboratory company and a physician group. The most recent was OIG Advisory Opinion 05-08, released on June 13, 2005 and responding to a request to evaluate how a lab might reimburse a physician for phlebotomy services performed by his office. (See pages 5-6.)

The earlier opinion was OIG Advisory Opinion 04-17. It was released on December 17, 2004 and addressed a request to evaluate a model of"anatomic pathology laboratory condominium" services between a laboratory company and a physician group. (See TDR, January 3, 2005.)

Having carefully read both opinions, I believe they share something in common. I believe both opinions were requested by laboratory companies that actually wanted the OIG to issue a negative opinion in response to the business scenario described in their original request letters. In both cases, if the requesting lab company got a negative advisory opinion from the OIG, that opinion, now on public record, would inhibit laboratory competitors from engaging overtly and aggressively in that type of behavior.

I consider this to be an interesting strategy for labs that want to"level the field" against competitors. It gives them a way to respond, legally,when they observe a competing laboratory offering physicians inducements, benefits, or business arrangements that can be argued to be in violation of Medicare statutes. A negative OIG opinion on that particular marketing practice certainly gives the requesting laboratory a credible document to show physicians and educate them about the compliance risks they assume should they participate in an arrangement that the OIG has deemed to be in violation of Medicare laws.

Since we've seen two of these types of advisory opinions issued past 12 months by the OIG, it may be that an increasing number laboratory executives and pathologists are willing to use this approach counter what they consider egregious marketing practices by laboratory competitors. In this sense, labs requesting these opinions are proactive approach to Medicare compliance. They are initiating regulatory rulings on abusive marketing practices in the lab industry.



Nichols Diagnostics Stops Product Sales

Are"Black Belts" getting a"black eye" from significant manufacturing problems?

CEO SUMMARY: It's an odd story. One of the nation's most respected names in diagnostics quietly ceases delivering products—and no one in the laboratory industry pays much attention. Last month, Nichols Institute Diagnostics, acknowledging production problems it has not yet resolved, announced to its laboratory customers throughout the United States that deliveries of its diagnostic kits would cease.



New OIG Opinion 05-08 On Phlebotomy Fees

This advisory opinion tackles lab payments to compensate physicians who draw blood

CEO SUMMARY: At the request of a yet-unidentified laboratory, the Office of the Inspector General issued Advisory Opinion 05-08 last month. It is a negative opinion on a proposed arrangement where a laboratory would reimburse client physicians as much as $6 for each blood draw performed by the physician and/or his staff. It is unlikely that many laboratories will be affected by this negative opinion.



Michel Wins Investigative Reporting Award from Peers

2004's coverage of anatomic pathology lab condos earns recognition in national journalism contest

CEO SUMMARY: State certification of phlebotomists is under way in the Golden State. By April 9, 2006, all plebotomists in California will need to maintain state certification. This development adds complexity to laboratory management in California. However, there are no signs that other states intend to follow California's lead in requiring certification of phlebotomists.



Payer Consolidation: United Buys Pacificare

Consolidation may be a result of larger trends soon to pressure health insurance companies

CEO SUMMARY: For the second time in nine months, a health insurer company has spent around $9 billion to grow by acquisition. This time, it is UnitedHealth Group purchasing PacifiCare Health Systems. These types of deals impact local labs and pathology groups as existing contracts expire. However, the most interesting wild card is consumer- driven healthcare and how payers intend to respond.


Consumer-Directed Healthcare by Mango

Former lab industry executive generates national attention with his strategic analysis

CEO SUMMARY: This former laboratory executive declares that Consumer-Driven Healthcare Plans (CDHPs) are"the most significant development in health insurance since the widespread introduction of HMOs in the 1980s." Paul Mango, now at McKinsey & Co., has plenty of good news for lab managers and pathologists. He predicts that CDHPs will drive deep reforms across the American healthcare system.


Techniques to Defend Against Patient ID Theft

Legal experts recommend laboratories take proactive steps to close the door on this crime

CEO SUMMARY: It's a crime that can strike anyone anywhere— and usually without warning. In fact, identity theft is the July 4 cover story in Newsweek Magazine. However, clients of THE DARK REPORT got the lab industry's first warnings on this fast growing crime months ago. To help labs prepare to deal with this threat, Attorneys John R. Christiansen and Thomas Bartrum offer nine specific recommendations.


Info Technology Update: Amazing New IT Products Arriving in Healthcare Market

How about cell phones as"pulse oximeters"? Advances in info technology drive this trend

INTELLIGENCE:

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