Posts Tagged ‘CMP’
OIG Gives Okay to Cost-Sharing Subsidy in Clinical Trial
A company that makes a medical device that uses a patient’s cells to treat ischemic systolic heart failure – a life-threatening cardiac condition – would not face sanctions if it paid Medicare participants’ cost-sharing obligations they would otherwise owe for reimbursable items and services provided during the 2-year study. That was the finding of a…
Read MoreOIG Opinion: Drug Maker Can Provide Free Medication
On March 23, the Department of Health and Human Services Office of the Inspector General issued a favorable ruling to a drug manufacturer looking to provide a free medication to patients in need of a one-time treatment made from their own cells. The drug maker (Requestor) makes the FDA-approved drug for two indications that is…
Read MoreOIG Offers Advisory Opinions on COVID-19-Related Arrangements, But …
The COVID-19 pandemic has resulted in a unique set of circumstances for many healthcare providers. Delivering quality patient care, while at the same time trying to navigate existing laws and regulations, has many providers questioning whether the arrangements they are making in response to this public health emergency will not get them into trouble with…
Read MoreBlame it on Inflation: Civil Monetary Penalties Increase
The U.S. Department of Health and Human Services (HHS) has published an interim final rule that adjusts for inflation the maximum civil monetary penalties (CMP) that HHS agencies are authorized to assess or enforce. The changes became effective Sept. 6, and are applicable only to civil penalties assessed after Aug. 1, 2016, whose associated violations…
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