To embed, copy and paste the code into your website or blog:
In its final Advisory Opinion of 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) approved a pharmaceutical company’s request to provide financial assistance to patients who were prescribed a cancer drug that the company manufactured. In Advisory Opinion 20-09, the OIG determined it would not impose sanctions under the Anti-Kickback Statute (AKS) or beneficiary inducement provision of the Civil Monetary Penalties Law (CMP) for an arrangement where a pharmaceutical manufacturer covers the expenses for qualifying patients for travel, lodging and limited out-of-pocket expenses (i.e., meals) related to the treatment of the patient with the manufacturer’s drug. The drug is subject to a Risk Evaluation and Mitigation Strategy, which includes elements to assure safe use to mitigate the risks of life-threatening or fatal reactions and neurological toxicities. Treatment requires retrieval
Advertisement
OIG Issues Advisory Opinion Allowing Pharmaceutical Company’s Payment of Travel, Food and Lodging Expenses for Indigent and Rural Patients Thursday, January 14, 2021
In its final Advisory Opinion of 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) approved a pharmaceutical company’s request to provide financial assistance to patients who were prescribed a cancer drug that the company manufactured. In Advisory Opinion 20-09, the OIG determined it would not impose sanctions under the Anti-Kickback Statute (AKS) or beneficiary inducement provision of the Civil Monetary Penalties Law (CMP) for an arrangement where a pharmaceutical manufacturer covers the expenses for qualifying patients for travel, lodging and limited out-of-pocket expenses (i.e., meals) related to the treatment of the patient with the manufacturer’s drug. The drug is subject to a Risk Evaluation and Mitigation Strategy, which includes elements to
To embed, copy and paste the code into your website or blog:
From December 23, 2020 through December 31, 2020, the OIG issued several advisory opinions. The advisory opinions analyzed (1) a program for a pharmaceutical manufacturer to provide financial assistance to certain patients, (2) a proposal from a qualified health center to offer gift cards to incentivize certain patients to attend preventative appointments, (3) a proposed web-based platform where health care facilities and clinicians could remit to patients and payors a portion of claims for which payment may be made by the Medicare program as a secondary payor, and (4) a management company’s provision of below fair market value Medicaid enrollment application assistance services and affiliated skilled nursing facilities’ payments for those services.