In This Issue...


CBO Report Questions Impact of Coordinated Care Demo’s To Save Money

On January 18, 2012, the Congressional Budget Office (CBO), the nonpartisan economic and budgetary group for the House and Senate, released a report, “Lessons from Medicare’s Demonstration Projects on Disease Management, Care Coordination, and Value-Based Payment,” which evaluated the outcomes of ten major demonstration projects seeking to improve program care and efficiency.

Most of the programs did not result in Medicare savings; the CBO stated: “In nearly every program involving disease management and care coordination, spending was either unchanged or increased relative to the spending that would have occurred in the absence of the program, when the fees paid to the participating organizations were considered.”

CBO suggests that “substantial changes to payment and delivery systems” will have to be made for such demonstrations to meet their objectives. 

FDA CDRH Releases 2012 Priorities

The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) recently released a listing of the Center’s strategic priorities for 2012. CDRH identifies 35 specific goals it plans to achieve before the end of 2012, including:

  • Publish a proposed rule to clarify the circumstances under which CDRH could rely on clinical studies conducted in or for other countries (by December 31, 2012);
  • Finalize all guidance documents issued as part of the plan to improve premarket programs (by December 31, 2012);
  • Clear within CDRH the final guidance on Companion Diagnostics (by June 30, 2012); and
  • Clear within CDRH draft guidance on co-development of drugs or biologics and devices (by December 31, 2012).

Conspicuously missing from the list was any mention of the three guidance documents under development by the agency on regulatory oversight of laboratory-developed tests (LDTs). Reportedly, the agency is working on: 1) separate guidance to provide general oversight of LDTs; 2) standards for FDA notification and medical device reporting, and 3) quality system requirements. In recent months, the agency has stopped speculating about when these guidance documents might be released.

Still a wildcard in this discussion is legislation introduced by Rep. Michael Burgess, MD (R-TX), H.R.3207, the “Modernizing Laboratory Test Standards for Patients Act,” shifting all responsibility for overseeing LDTs to CMS under the CLIA’88 standards, while establishing new regulatory requirements. The new requirements for these tests include:

  • Submitting detailed information regarding each LDT to a national test registry, including data on the analytical and clinical validity of a test;
  • Submitting a premarket notification to HHS regarding the intent to introduce a new LDT, also including clinical validity data (labs can perform the test until they get a determination from HHS on the status of the test); and
  • Creating an expedited review of premarket notifications of LDTs’ rare diseases and conditions (this process can be waived, however, HHS using its discretionary authority).

All LDT submissions would be paid for by user fees assessed on the clinical laboratories conducting the tests. There is no data available yet on the potential costs of this legislation.

For a copy of the CDRH 2012 Strategic Priorities, please visit the agency Web site. To see the legislation, please go to the congressional Web site, THOMAS.

PCORI Releases Research Priority Agenda

The Patient-Centered Outcomes Research Institute (PCORI), a public-private evidence-based medicine research center created by the 2010 health care reform law, released its draft National Priorities for Research and Research Agenda for public comment. Once finalized, it will guide the group in funding comparative effectiveness research. Initially, PCORI is recommending that the panel focus on these five key areas:

  • Assessing options for prevention, diagnosis, and treatment;
  • Improving health care systems;
  • Communicating and disseminating research;
  • Addressing disparities; and
  • Accelerating patient-centered outcomes research and methodological research.

The document is available on the PCORI Web site. The research group will accept comments through March 15, 2012.

AMA Urges Congress to Stop Implementation of ICD-10 Coding System


The American Medical Association has urged House and Senate congressional leaders to stop the implementation of the ICD-10 coding system, scheduled to take effect on October 1, 2013. This change has long been supported by HHS and the American Hospital Association, which have argued that the current ICD-9 coding system is running out of codes and doesn’t provide enough specific patient data to measure health care services, including the quality and safety of patient care.

The AMA asserts that the implementation of ICD-10 “will create significant burdens on the practice of medicine with no direct benefit to individual patient care, and will compete with other costly transactions associated with quality and health IT reporting programs.” Further, the medical society estimates that the cost of adopting the new system to group practices will be anywhere from $83,290 to more than $2.7 million, depending on the size of the practice. A copy of the AMA letter is available on its Web site.