In an effort to reconcile the differences between the House-passed Affordable Health Care for America Act (HR 3962) and the Senate-passed Patient Protection and Affordable Care Act (HR 3590), it appears that Congress will bypass a formal conference committee and rely instead on a procedure commonly referred to as “ping pong.”  Democratic leaders from both bodies met with President Obama on January 13, 2010, to try to reach accord.

Differences between House and Senate legislation are often ironed out in a conference committee where key members of each house are chosen to negotiate a unified legislative package that each body would ultimately vote upon for final passage.  Noting that the Senate only passed its health insurance reform bill by the narrowest margin possible (60-39 on December 24, 2009), Democratic leaders appear to prefer to transfer the Senate-passed version to the House for a vote and then, if any changes are made, back to the Senate for final passage.  If the House makes no adjustments to the Senate bill, then the House vote will be enough to send the bill to the President for his signature. 

The Health Information Security and Privacy Collaboration at the US Department of Health and Human Services released on January 13, 2010, a new report analyzing state laws and regulations that detail to whom clinical laboratories may release test results. The document, Releasing Clinical Laboratory Test Results: Report on Survey of State Laws, also examined whether states allow patients direct access to their clinical test results.

According to the findings, most state laws require clinical laboratories to release test results only to the ordering health care provider.  Patients usually do not have the right to obtain their test results directly from a laboratory.  Since this report was conducted to ascertain how state rules and laws impact electronic health information exchanges, it was noted that the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), along with state laws, provide a potential barrier to future technological advances.  If patients are not legally permitted to obtain test results directly from a laboratory, then electronic health information exchanges must configure their structure accordingly.

The Institute of Medicine (IOM) is conducting a consensus study on the public health effectiveness of the Food and Drug Administration’s premarket approval process, known as 510(k) in reference to the relevant section of the Federal Food, Drug, and Cosmetic Act.  The IOM committee charged with review will examine what legislative and regulatory changes might be necessary for the 510(k) process to best protect patients and promote innovation.  The current process requires medical device manufacturers to notify the FDA at least 90 days in advance of their intent to market a medical device.  This period allows the agency time to evaluate whether a device is similar to an existing one and, therefore, may bypass the premarket approval process.  The final report is anticipated in 2011.

A draft guidance, Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval, was issued by the Food and Drug Administration on January 13, 2010.  The document recommends to institutional review boards (IRB) how to continue their review to assure protection for clinical investigation subjects.  Comments on the guidance are due by March 15, 2010.  Once finalized, the guidance will replace a 1998 agency information sheet on the same topic.