Restrictions in GINA could muddy payors' disease risk prediction models, though it remains to be seen the degree to which the law will "deteriorate" those predictions, Derek van Amerongen, chief medical officer of Humana Health Plans of Ohio, said last week at a conference.
The healthcare reform bill includes a section on comparative effectiveness research that creates the Patient-Centered Outcomes Research Institute. Seen as a victory for personalized medicine, the institute will study the utility of medical products in "various subpopulations," including groups differentiated by genetic and molecular subtypes.
The healthcare reform bill, expected to be signed into law by President Obama on March 23, includes a section on comparative effectiveness research that creates the Patient-Centered Outcomes Research Institute.
In an attempt to help guide healthcare stakeholders who wish to issue public comments to the interim final GINA rule, Johns Hopkins University's Genetics & Public Policy Center released a model document discussing GINA's underwriting restrictions and how they impact health risk assessments and wellness programs.
While DMAA and employer groups are urging for a moratorium on GINA fearing that the law's restrictions on "underwriting" activities will harm enrollment in wellness programs, personalized medicine advocates are concerned that any delay in implementing the law as is would harm adoption of personalized medicine and hinder participation in genetic research studies.
The Supreme Court Justices' comments imply they are looking for a way to uphold the lower court's "machine-or-transformation" test in Bilski v. Kappos while minimizing the impact on the technology and medical device industries.
A US district court decided this week that the lawsuit challenging the legality and constitutionality of BRCA gene patents owned by the University of Utah and exclusively licensed to Myriad has sufficient merit to be heard.
Although SACGHS has yet to finalize its recommendations to exempt diagnostic developers from infringing on gene-association patents, last week's meeting ignited a debate on whether such a recommendation can be acted upon by the HHS Secretary, whether this would harm innovation, and whether the committee's conclusions about gene patents' deleterious impact on patient access was support by evidence.
The SACGHS task force has suggested that genetic testing patents are not necessary for innovation and may, in some cases, block patient access. However, the recommendations are not final and are being discussed at a meeting in Washington, DC, this week.
In an interview with Pharmacogenomics Reporter this week, Hakan Sakul provided a snapshot of Pfizer's efforts in personalized medicine, the company's stance on regulatory issues, and its overall focus on "omics"-guided medicine.
At the public meeting, speakers from groups representing employers and employees pointed out the need for the EEOC to clarify "inadvertent acquisition" of genetic information under which employers would not be held in violation of the law and to provide specific examples of the types of genetic information linked to "manifested diseases" which the law does not protect.