Section 111 Enforcement in 2013?
On October 2, 2012, the U.S. Department of Health & Human Services Office of Inspector General released its Fiscal Year 2013 Work Plan and, in it, announced its intent to determine whether “selected” NGHPs properly reported insurance coverage information to Medicare as required by Section 111 of the MMSEA of 2007. This is the first indication in five years that the government is finally prepared to audit for mandatory insurer reporting compliance.
Another point of interest in the OIG’s plan is the compendia utilized to determine Part D off-label exclusion exceptions. One compendia in particular basically publishes any study; therefore, few drugs are excluded from coverage despite lack of FDA approval for the specific use. Because the compendia are not required to publish conflict information, and it is unclear whether CMS conducts any oversight of the strength of the compendia’s conflict policies, the OIG will be looking next year to determine “the extent to which the prescription drug compendia oversee conflicts of interest through reporting requirements and/or mitigation policies and the number and nature of the compendia’s reported conflicts.” We can only hope that this might resolve that one study of 16 people that determined that Lidoderm patches were effective for treating general pain that causes us to have to fund them in MSAs for life.
See the 2013 Work Plan here.
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