News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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UnitedHealth Launches Web-Based Patient Health Record Service, to Compete Against Google and Microsoft

On December 1, UnitedHealth Group (NYSE:UNH) unveiled its www.myoptumhealth.com solution. This is an upgraded web-based service that allows consumers to create and manage their own digital health record (DHR).

It’s widely accepted that conversion of medical records to digital format could improve medical outcomes and reduce healthcare costs dramatically. One unexpected development on that road to the universal electronic medical record (EMR) has been the well-financed efforts of companies like Google (NASDAQ:GOOG) and Microsoft (NASDAQ:MSFT) to offer digital personal health records (PHRs) to consumers via sophisticated Web sites. Now comes the major health insurer, UnitedHealth, with its DHR offering for consumers.

Like Google Health and Microsoft’s HealthVault, UnitedHealth’s myoptumhealth is free to consumers and allows them to create and manage their own digital health solution. However, unlike those two competitors, which have lined up affiliated services for its users, myoptumhealth is organized to offer consumers services provided by various UnitedHealth business entities.

Google Health and Microsoft’s HealthVault are partnering with medical providers to offer patients the ability to upload their records from provider files, and provide a host of online medical services, such as Allscripts ePrescribe, a free, Web-based prescription solution for physicians. The sites also provide consultation with medical experts; link patients with providers and related services, like TrialX, which matches patients with clinical trials; and provide a database of information on health topics.

HealthVault, which was launched in 2007, has more than 100 participating provider partners, including leaders in health information technology, such as Kaiser Permanente. Launched earlier this year, Google Health’s partner list is not yet as extensive but growing quickly, and includes medical technology leader, the Cleveland Clinic; national pharmacy chains CVS, Walgreens and Longs Drugs; and laboratory testing giant Quest Diagnostics Incorporated (NYSE:DGX).

It is still too early to gauge whether medical laboratories and imaging providers will be willing to partner with these Web-based DHR services. Because of the importance of lab test data for any patient’s health record, Google Health, HealthVault, and myoptumhealth recognize the need to have clinical laboratories and imaging providers upload test results to patients’ digital health records and digitally sign them as evidence of authenticity. Access to lab results increases the value of DHRs to patients, enabling them to leverage the data in healthcare applications, ask their medical providers informed questions, and monitor their own health status by comparing lab tests over time.

While only time will tell, a positive indicator of consumer support is increased interest in online health information. Visits to health Websites rose 21% last year-more than four times the rate of total U.S, Internet population, according to comScore, a Reston, Virginia-based firm that measures digital usage.

Related Information:
UnitedHealth Takes On Microsoft, Google With Online Health Venture

Google Health: Is It Good For You?

CMS Ready to Add Three More Items to “Never Events” No Pay Policy for Medical Errors

Hospitals, physicians, laboratories and others have until January 1, 2009, to provide comments on the proposal by the Centers for Medicare and Medicaid (CMS) on three National Coverage Determinations about preventable surgical errors, or “never events.”

Dark Daily readers know that, beginning October 1, CMS stopped paying hospitals for care or services associated with a list of eight “never events.” Other insurers, including Blue Cross and Blue Shield Association, Aetna, Cigna Corp and Wellpoint, have followed the CMS lead, implementing similar nonpayment policies for medical errors.

A never event is the industry term for a serious preventable medical incident occurring while the patient is under the care of a medical provider. The National Quality Forum (NQF) has developed a list of 28 never events, ranging from surgical and other procedural errors to sending an infant home with the wrong parents.

CMS is proposing to add these three categories of errors to its “no pay” list:

  • Wrong surgical or other invasive procedures performed on a patient
  • Surgical or other invasive procedures performed on the wrong body part; and,
  • Surgical or other invasive procedures performed on the wrong patient.

The CMS proposal to expand the number of “never events” on the no pay list is not without controversy. So far, the American Medical Association (AMA) and AHA have voiced disagreement with the proposal. The AMA opposes CMS using its National Coverage Determination process, which dictates procedures Medicare will or will not pay for, to fight surgical errors. Instead, the AMA suggests that the agency “develop a clear payment policy outlining the circumstances under which surgery would not be payable by Medicare.” The AHA also wants CMS to provide a clear definition of what costs or services would not be covered, but also wants the agency to describe how it would assign accountability for an error.

Meanwhile, there is support for the CMS “never event” policy from other sectors of healthcare. Researchers determined that, since CMS announced implementation of the first “never event” policy for eight conditions in August 2007, 23 state hospital associations had adopted policies forbidding or discouraging billing for serious preventable medical errors.

Large insurance companies quickly responded to the CMS announcement on “never events” by instituting their own no-pay policies for “never events. Aetna was first to publicize its policy. WellPoint and CIGNA soon announced similar policies.

Hospital laboratories are already experiencing the impact of the first round of the CMS “never event” policy that took effect on October 1, 2008. Among the eight conditions were nosocomial infections and administering incompatible blood products to a patient. In both cases, laboratory test services play a key role in providing clinicians with information to properly diagnose the patient and chose the appropriate course of treatment.

Related Information:
CMS Proposes Three National Coverage Determinations to Protect Patients from Preventable Surgical Errors

What Are Never Events and Why Do They Matter?

Good News/Bad News with Massachusetts’ Universal Coverage Health Reform

Now in its second year, the closely-watched mandate for universal health coverage in Massachusetts is a mix of good news/bad news. Because this is a potential model for national healthcare reform, the Massachusetts universal health insurance program is also viewed as an opportunity to work out the bugs in finance and care delivery before rolling out a national program. First, the good news. From a public policy standpoint, the universal healthcare mandate is successful. Roughly half the state’s estimated uninsured residents, or 440,000 people, are now enrolled in either a state, an employer-sponsored, or a private insurance plan.

Second, the bad news. The financial costs of the program exceed the original budget estimates upon which caused Massachusetts Democrats and Republicans to come together and pass this unprecedented legislation. For year two, the Massachusetts’ program mandates that all adults enroll in a health plan or pay a state income tax penalty. For 2008, that penalty was increased to $912, a jump of 416% from the $219 penalty that was assessed in 2007.

Additionally, businesses with more than 10 full-time employees must either provide their employees with health insurance, or pay the state $295 per employee per year. Critics claim this per-employee payment falls far short of covering the true costs of the mandate. Employer contributions only generated $6 million last year, even as the “play or pay” mandate expanded employer-sponsored health coverage to 85,000 workers.

Cost overruns plague the universal healthcare program. For 2007, the cost exceeded the budget by $100 million, due, in part, to a failure to enroll young, healthy members who can pay their own way. It is also now clear that lawmakers originally underestimated the program’s actual costs. Costs estimates were based on a low estimate of uninsured residents who require premium subsidies and did not figure on double-digit increases in the price of health insurance.

Over the last three years, the state-sponsored plans created by the universal coverage mandate offered enrollees an exclusive network of four insurers. These insurers raised premiums at near double-digit rates during the first two years. Rates increased by 9% in 2008, according to Jon Kingsdale, executive director of the state’s health insurance Connector Authority, who notes that while the increase was well above the 2% cap the Connector staff had proposed, costs should not exceed this year’s budget of $869 million.

In a report, Striving for Universal, Affordable Health Care: Lessons From Massachusetts,  State Attorney General Martha Coakley, who oversees the Connector Authority, notes that rising healthcare costs must be addressed to achieve universal health coverage. In an effort to cut costs, stabilize premiums and pay carriers fair rates, the Massachusetts Healthcare Connector will open the state health insurance program to competitive bidding for the next budget year, which begins in July 2009. However, new rules will apply to the upcoming bidding process: carriers will be limited to offering plans with a maximum monthly premium of $404, which represents a 2% percent increase over this fiscal year and includes $35 for administrative fees.

Because the Massachusetts’ mandate for universal coverage is only now completing its second year, it is too early to determine whether clinical laboratory services in the Commonwealth have been negatively affected. However, pathologists and laboratory administrators will want to keep an eye on unfolding events in the Bay State. Universal health coverage may be one of the first priorities for the new President and Congress, and the Massachusetts experience may be used as a guide in crafting federal legislation to tackle this issue.

Related Information:
Massachusetts Reform Has the Blues

Striving for Universal, Affordable Health Care: Lessons From Massachusetts

LabCorp CEO Reshuffles Executive Team to Set New Direction

Come January 1, 2009, Laboratory Corporation of America (NYSE:LH) will have new players on its executive team. These changes demonstrate that David King, who took the reins as LabCorp’s new President and CEO about two years ago, is actively reshaping senior leadership to better fit his vision for the nation’s second largest clinical laboratory company.

As of January 1, Bradford T. Smith is retiring from his position as Executive Vice President, Corporate Affairs and Chief Legal Officer. Smith has had long and continuous service at LabCorp, as well as at Roche Biomedical Laboratories prior to its acquisition by LabCorp. Another significant change to the executive line-up at LabCorp is the departure of Myla Lai-Goldman M.D., who has served as Executive Vice President, Chief Scientific Officer, and Medical Director since 1998. Lai-Goldman also has deep roots at LabCorp, having established the advanced molecular diagnostics laboratory at Research Triangle Park for Roche Biomedical Laboratories back in the 1980s.

Another new member of the executive team is William Bonello, who joined LabCorp on December 8, 2008, as Senior Vice President of Investor Relations. Bonello is familiar to clients of The Dark Report because of his coverage of the clinical laboratory industry as a Managing Director and Senior Equity Research Analyst for Wachovia Capital Markets, LLC for the past six years.

The investor relations position became available when Eric Lindblom, who had held that position, was given new management responsibilities by King. Lindblom is now responsible for several strategic responsibilities, including the LabCorp 2010 initiative.

When LabCorp was originally created by the merger of National Health Laboratories and Roche Biomedical Laboratories in 1995, it experienced some management turnover as executives from both companies adjusted to responsibilities in a single corporation. However, by the late 1990s, LabCorp has enjoyed relative stability in its executive management team. Even since David King’s appointment as CEO at the time that Thomas MacMahon moved to Chairman at the end of 2006, the management line-up at LabCorp has remained stable.

Pathologists and laboratory directors will want to watch how the evolution from LabCorp’s old guard to its new guard shows up in the company’s competitive stance in the marketplace and in new business strategies.

Multi-Modality Diagnosis Is New Trend That Integrates Imaging and Lab Testing

Today Dark Daily wants to introduce you to the emerging medical discipline of “multi-modality diagnosis.” Advances in genetics and molecular technologies are actively breaking down the traditional scope of practice for several medical specialists. At ground zero in this new area of medicine are pathology and radiology.

Multi-modality diagnosis can be defined in a simple manner. It is the use of several different types of clinical data-in an integrated fashion-to make a diagnosis. “Integration” is the key concept here, since physicians have always assembled information about the patient from several sources as they proceeded to evaluate the patient and make a diagnosis.

As doctors and researchers learn more about genetics and the role of DNA, RNA, and proteomics in various illnesses and ailments, there are huge increases in the volume of data now relevant in assessing the patient’s condition and determining the most accurate diagnosis. At the same time, medical specialties, particularly those of radiology and pathology, that formerly could work somewhat independently to evaluate the patient and provide the referring clinician with a report that was rather straightforward and simple, now face a new challenge. The expanding knowledge base of genetic and molecular information means that their evaluation of the patient needs to incorporate the findings of other medical specialists if the final assessment is to be accurate and useful to the referring clinician.

In other words, genetic medicine is the active catalyst that is already motivating different medical specialties to interact more closely to assess and diagnose certain types of diseases. At the forefront of this trend are progressive radiologists and pathologists-specifically those working with molecular imaging and molecular pathology. For example, in leading academic centers, it is growing ever more common for the neuropathologist and the neuroradiologist to review each other’s images before signing out their respective cases. In some laboratory settings, these two subspecialists are already developing a single, integrated report that goes to the referring physician.

Healthcare informatics is another channel of innovation propelling multi-modality diagnostics forward. Independent of pathology and radiology, there are informaticians pulling together disparate sets of patient data, then running this data through sophisticated software algorithms to develop diagnostic information that gives the patient’s physician new knowledge. Within the field of healthcare informatics, these innovators constantly describe their work as bringing together multiple modalities of data. Dark Daily readers should note that this effort is happening outside of the pathology and radiology specialties. It is an external trend to both professions.

Those interested in learning more about multi-modality diagnosis have two resources. In a recent issue of The Dark Report, a detailed intelligence briefing was published on this topic under the title “Multi-Modality Diagnosis Heading for Lab Medicine.” Dark Daily subscribers who would like a complementary copy of this intelligence briefing should contact Ron Martin at rbmatin@darkreport.com.

The second resource for learning more about multi-modality diagnosis is the upcoming Molecular Summit on the Integration of In Vivo and In Vitro Diagnostics http://www.molecular-summit.com On February 10-11, 2009, national and world leaders in molecular imaging, molecular diagnostics, and integrated informatics will be leading strategic sessions and case studies on this subject. Location is the Sheraton Society Hill Hotel in Philadelphia, Pennsylvania.

Speakers from such organizations as Massachusetts General Hospital, Stanford University Medical Center, MD Anderson Medical Center, UCLA Medical Center, Siemens, and the Institute for Systems Biology will provide the latest innovations in the integration of in vivo and in vitro diagnostics. Last year’s Molecular Summit attracted 225 attendees, along with editors and reporters from 15 healthcare publications. This next Molecular Summit has compelling case studies of how molecular diagnostics, when integrated with molecular imaging and other data sets, is giving clinicians powerful new insights for making diagnoses, identifying appropriate therapies, and monitoring patient progress.

The full agenda and speaker line-up for this year’s Molecular Summit can be viewed here (or paste this URL into your browser: http://www.molecular-summit.com/agenda.htm )

Make your plans to join us at Molecular Summit 2009 to learn how your laboratory can benefit from multi-modality diagnostics.

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