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       Headlines - December 31, 2007 *Special Expanded Issue*
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R. Lewis Dark: Is CMS Playing 'Bait and Switch' in San Diego?

ATTEMPTING TO WRITE THE ASSESSMENT of the Medicare Clinical Lab Services Competitive Demonstration Project that you will read in this issue earned a unique distinction: since our founding in 1995, this has been the single most difficult story we have ever tried to explain to our clients and regular readers.

At the same time, it is likely to be one of the most important stories in the laboratory medicine profession in the past two decades. The Centers for Medicare & Medicaid Services (CMS) is now just six weeks away from collecting bids from labs hoping to preserve their access to Medicare fee-for-service patients in the San Diego-Carlsbad-San Marcos MSA (metropolitan services area).

You’ve probably read lots of news items about this competitive bidding demonstration. But what you haven’t read is a serious, detailed critique about its design, its operation, and the ways it is likely to change how laboratories serve Medicare patients in the San Diego MSA. That’s because it is a complex, subjective, and opaque scheme. CMS and RTI have delivered a demonstration project that lacks clear, objective standards. But that’s only part of the story.

CMS is preparing to conduct a multi-step bidding auction. After opening the bids and evaluating the applications (using non-price criteria that are not objectively defined), it will begin a second round of bidding and negotiating with laboratories it has selected. Thus, labs will find themselves in an open-ended selection process. Not only do they not understand the criteria upon submitting their bids, but they don’t know the precise terms and conditions of the provider contract CMS will require them to sign should they be selected.

Why all this obfuscation and not a transparent, objective bidding process? Smarter minds than I are dissecting the CMS/RTI scheme to implement the San Diego MSA pilot site in an attempt to answer that question. Many of us have come to a similar conclusion: CMS officials involved in designing the pilot demonstration had another agenda beyond meeting the Congressional mandate of finding a lower price while maintaining beneficiary access and service. Rather, their motive seems to use the demonstration as a way to extract bids from laboratories facing total loss of access to Medicare beneficiaries. CMS will then use these bids as a prototype for a new national Part B laboratory test fee schedule. If this proves to be true, then the laboratory industry is likely to feel like it was the victim of a CMS “bait and switch” tactic.



San Diego Bid Demo Pilot Is Industry Turning Point

Forget the San Diego MSA demonstration pilot, these lab bids may be used to set national prices

CEO SUMMARY: In just six weeks, laboratories serving Medicare patients in the San Diego-Carlsbad-San Marcos MSA (metropolitan statistical area) will submit their bids to the Centers for Medicare & Medicaid Services (CMS). They may think they are bidding for access to patients in the San Diego MSA for the three-year duration of the demonstration pilot. But comments by a CMS official at the December bidders’ meeting indicates that CMS may want to use these bids as the prototype for new national Part B pricing.



Analyzing Lab Bid Demo To Predict Its Outcome

San Diego-Carlsbad-San Marcos MSA is about to become a Medicare guinea pig

CEO SUMMARY:After two decades of study and preparation, the Centers for Medicare & Medicaid Services (CMS) is pushing the laboratory profession toward the first pilot site in the Congressionally- mandated Medicare Clinical Laboratory Services Competi tive Demonstration Project. Designed to drive down the price Medicare pays for laboratory tests, the plan CMS described at the December 5 bidders’ conference is likely to disappoint ev - ery one—from patients and doctors to Medicare itself.



Anticipate Access/Service Decline for S.D. Patients

Three levels of access to lab testing services not addressed in design of the lab bidding demo

CEO SUMMARY: In its primary push to use the Medicare Laboratory Competitive Bidding Demonstration Project as a tool to drive down the price Medicare pays for Part B laboratory testing services, CMS is giving secondary attention to patients’ needs. In particular, CMS seems to place little value on the multiyear relationship and loyalty many elderly patients have with their existing laboratories, nor on the professional relationship the patients’ doctors have with their laboratory providers.



Local San Diego Lab Fights Bias In CMS Bid Demo

San Diego’s only local lab illustrates why CMS/RTI’s scheme intentionally excludes small labs

CEO SUMMARY: Meet Internist Laboratory of Oceanside, California. For 18 years, its owners, Gary and Christine Stevens, have provided a high level of laboratory testing services to office-based physicians in Northern San Diego County. Now Internist Laboratory is the perfect poster child for all the flaws and bias built into the Medicare Laboratory Competitive Bidding Demo. If denied access to serving Medicare beneficiaries for three years, it will face a financial crisis with no solution.



Numerous Issues Identified With Bid Demo’s 303 Tests

National expert in coding and billing predicts some confusion during the pilot demonstration

CEO SUMMARY: One experienced expert in billing and coding was surprised at the list of 303 tests to be included in the Medicare Laboratory Competitive Bidding Demonstration Project. He notes that the list of 303 tests includes a number of codes and descriptions that are not consistent with CPT codes used by laboratories to prepare and submit claims to Medicare. This may cause some confusion for labs that plan to bid for the San Diego demonstration pilot site.



Three Strikes Against CMS Before Bid Demo Begins

CMS fails to engage voices of patients, of physicians, of lab profession in demo’s design

CEO SUMMARY: There’s a touch of irony in the fact that the Medicare program is a national leader in encouraging hospitals, physicians, and other providers to pay greater attention to the voice of patients. Yet within the Centers for Medicare & Medicaid Services (CMS), officials tasked with developing the laboratory competitive demonstration project seem to have ignored the voices of Medicare beneficiaries, the physicians who serve them, as well as the laboratory medicine profession.



Using a 1997 Bid Model In a 2007 Health Market

San Diego Demo Plan was created in 1997; Doesn’t reflect current lab marketplace realities

CEO SUMMARY: It’s been a long path from concept to implementation for a competitive bidding demonstration involving clinical lab services. It was in the mid-1980s when CMS commenced work on designing such a demonstration. In the 1990s, RTI International continued development of the concept and, in 1998, it published a paper on the plan it had developed for the laboratory competitive bidding demonstration project. This 1998 plan forms the basis for the upcoming 2008 demo pilot in the San Diego MSA.



Call to Action Is Needed For Lab Test Profession

Passive cooperation failed to engage CMS/RTI during development of competitive bidding demo

CEO SUMMARY: Is a laboratory test simply a commodity, like wheat or coal? Or is it a complex scientific service of unique value that delivers personalized results and clinical knowledge on behalf of millions of patients every day in the United States? The fundamental assumption of competitive bidding for clinical laboratory testing is that one lab’s test result is equal to another. It is time for the laboratory medicine profession to come together and tell its story to the public and elected officials.



Speculating On How Labs Might Respond to Demo

Consequences of the bidding demonstration may swiftly alter national Medicare Part B prices

CEO SUMMARY: Statements and actions by CMS officials responsible for the laboratory competitive bidding demonstration project reveal the likelihood that they are using it as a Trojan Horse. While talking about implementation of a three-year demonstration project in the San Diego MSA, CMS dropped hints that it will use the bids submitted on February 15 as a prototype for a new national Medicare Part B schedule for implementation as early as next fall, at the start of fiscal year 2009.


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