October 2011

News read or heard lately

Ten potential ACO mistakes

Management and measurement hold the keys to the success or failure of an accountable care organization, say Sara Singer, PhD, MBA, and Stephen M. Shortell, PhD, MPH, MBA, writing in the Aug. 17 Journal of the American Medical Association.

In their commentary (306:758–759), Drs. Singer and Shortell list the 10 potential mistakes that organizations may experience in becoming ACOs. Dr. Singer is with the Department of Health Policy and Management, Harvard School of Public Health; Department of Medicine, Harvard Medical School; and Mongan Institute of Public Health, Massachusetts General Hospital. Dr. Shortell is with the Division of Health Policy and Management, School of Public Health, University of California, Berkeley.

The potential mistakes:

1. Overestimating the ability to manage risk. “This is perhaps the major lesson to be drawn from the experimentation with capitated managed care in the 1990s,” write the authors, who say: “The challenge will be to merge hospital and physician capabilities” to manage and measure ambulatory and inpatient care.
2. Overestimating the ability to use electronic health records, which they say will be “more challenging than most believe.”
3. Overestimating the ability to report performance measures. “Experience with pay-for-performance programs suggests the challenge of collecting, analyzing, and reporting performance data,” the authors say.
4. Overestimating the ability to implement standardized care management protocols. “For protocols to work,” Drs. Singer and Shortell write, “clinicians must be substantially involved in their development…and in the haste to qualify as an ACO, there is the temptation to shortchange the degree of involvement needed.”
5. Failing to balance interests of hospitals, primary care physicians, and specialists in creating government and management processes to adjudicate differences. Hospital-physician relationships have historically been strained, the authors note. “Whether new incentives will mitigate or exacerbate conflicts and whether sufficient managerial and clinical leadership exists to deal with the challenges are empirical questions.”
6. Failing to sufficiently engage patients in self-care management and self-determination. Patients need to be a part of the care team, and “Many potential ACOs have little experience with this degree of patient engagement.”
7. Failing to make contractual relationships with the most cost-effective specialists. “Specialists are not required to limit their activity to a single ACO under the proposed rules. Nor are patients confined to a single ACO. Thus, referral relationships become critically important to overall ACO performance.”
8. Failing to navigate the new regulatory and legal environment. “Understanding the ‘safety zone’ for exemption from antitrust, Stark antikickback legislation, and related regulatory and legal constraints to the formation of ACOs will be challenging.”
9. Failing to integrate beyond the structural level. The structural and contractual mechanisms may be in place for coordinated care, they say, but ACOs may not have the change management and implementation skills needed to improve care.
10. Failing to recognize the interdependence and therefore the cumulative “race to the bottom” of the other nine mistakes.

Imaging suite for infectious agents

The Methodist Hospital Research Institute and Philips Healthcare are collaborating to develop imaging technology that could be used to help identify the start and cause of an infectious disease epidemic.

King Li, MD, chair of the Department of Radiology at The Methodist Hospital and the project’s leader, and other Methodist scientists will use an $8.6 million imaging suite that includes an MRI, PET-CT scanner, SPECT-CT scanner, and X-ray device called a C-arm to study patterns of tissue damage and metabolic disarray caused by different infectious disease agents, without exposing the devices or suite rooms to such agents. The purpose of the suite is to study pathogens that require biosafety level 3 containment. Work on the suite was completed recently.

“The ability to have imaging suites that can handle high-level infectious agents allows us to be more prepared in the community for these types of events and, more importantly, allows us to study ways to deal with their consequences,” Dr. Li said in a statement.

Airtight containment vessels make it possible for samples and infected research models to be imaged without risking exposure to patients, researchers, or staff. Advanced technology also allows for rapid image scanning, so time-series imagery is possible.

Methodist will be the sole practical test site for the development of the technology.

“This imaging facility will be the first of its kind,” James M. Musser, MD, PhD, chair of the Department of Pathology and Laboratory Medicine and director of the Center for Molecular and Translational Human Infectious Diseases Research at The Methodist Hospital, said in a statement. “Our facility will permit us to translate critical new discoveries into the clinic, permitting accelerated development of novel diagnostic strategies and assessment of new therapeutic agents and vaccines.”

One of the project’s ultimate goals, Dr. Li said, is to develop a similar facility that is equipped to diagnose infectious diseases in a large influx of patients. “If the partnership with Philips is successful, The Methodist Hospital Research Institute can take the next steps toward creating the only clinic in the world expressly designed to image patients with infectious agents, such as multidrug-resistant TB,” Dr. Li said.

Partnering for companion tests

Qiagen is partnering with Pfizer and Eli Lilly to offer companion molecular diagnostic tests for compounds the drug companies are developing.

Pfizer’s investigational compound is for treatment of non-small cell lung cancer. Lilly’s investigational compound, called a JAK2 inhibitor, targets the JAK2 gene.

Pfizer’s investigational compound, dacomitinib, is an oral inhibitor of HER1 (EGFR), HER2, and HER4 tyrosine kinases. Qiagen’s proposed companion diagnostic will be based on its KRAS assay technology. Because EGFR inhibitors are generally effective in patients without KRAS mutations, the Qiagen assay can be useful in identifying patients most appropriate for EGFR-inhibitor therapies. The test is being developed specifically for use in lung-cancer tissue.

Under terms of the Lilly deal, Qiagen will develop a companion test that will provide qualitative and quantitative results for JAK2 V617F. The assay is intended to identify patients most likely to benefit from treatment with inhibitors of the pathway. The partnership is for the development and use of Qiagen’s JAK2 assay during clinical trials and covers manufacturing and joint commercialization of the diagnostic product in parallel with the Lilly compound.

Peanut allergen component test

Phadia’s uKnow peanut allergen component test is now available in the U.S. through the Phadia Immunology Reference Laboratory. The test reports specific IgE results to five FDA-cleared peanut allergen components, one FDA-cleared whole peanut allergen extract, and one carbohydrate cross-reactive determinant assay, a lab-developed test.

With the uKnow peanut test, physicians can detect the allergic sensitization to the specific allergen components within the whole peanut to help assess the risk that a patient will experience a severe anaphylactic reaction.

A study published in the January 2010 Journal of Allergy and Clinical Immunology (Custovic, et al., 125:191–197) estimated that nearly 80 percent of children diagnosed with peanut allergy were not truly allergic. In the study, results from Phadia’s peanut allergen component tests were 95 percent correlated to an allergic reaction.

Final clinical study of OTC HIV test

OraSure Technologies has closed enrollment in its multi-site clinical study of its OraQuick Advance rapid HIV-1/2 test for sale in the U.S. over-the-counter market.

In December 2010, the company initiated the final phase of clinical testing for an in-home HIV self-test kit. This phase consists of a multi-visit, blinded, unobserved user study in which individuals conduct unsupervised oral fluid self-testing using the investigational OTC version of the OraQuick Advance rapid HIV-1/2 test. Once all subject visits are completed and study results are unblinded, the performance of the OraQuick Advance rapid HIV-1/2 antibody test in an OTC setting will be compared with FDA-approved blood-based assay performance. One study objective that the FDA specified was to identify at least 100 HIV-infected but undiagnosed individuals. To meet this requirement, OraSure enrolled in the study about 5,700 participants across 20 clinical sites.

Caliper to merge with PerkinElmer

Caliper Life Sciences and PerkinElmer have reached an agreement under which Caliper will merge with PerkinElmer. The transaction is expected to close by the end of this year. The merger enables Caliper to broaden the adoption of its technologies and accelerate expansion into molecular diagnostics and environmental health markets, areas where PerkinElmer has established market positions.