OIG recently issued two favorable advisory opinions.  On August 12, 2015, OIG approved a program that provides a free cancer drug approved under the FDA’s Breakthrough Therapy Designation to patients who meet certain criteria whose insurance coverage of the drug has been delayed for at least 5 days.  The drug is provided free of charge for up to two 30-day periods.  On August 13, 2015, OIG approved a home health care provider’s policy to offer free introductory visits by licensed practical nurses to patients who have selected to receive home health care from the home health care provider.  Such introductory visit may occur in a hospital, physician’s office or the patient’s home.  

The Requestors in OIG Advisory Opinion No. 15-11 are drug manufacturers that co-promote the drug and run the program with a vendor and its affiliated specialty pharmacy that is licensed in all 50 states.  According to OIG, the specialty pharmacy only dispenses drugs for various client programs and is not open to the general public.  In finding that the program presented a low risk of abuse under the Anti-Kickback Statute, OIG cited the following factors:

• A low risk of overutilization because the drug is provided free of charge for a maximum of 60 days, the program only applies to on-label uses of the drug, and the program is not triggered if a patient’s insurance approves the drug within 5 days;
• The program is distinguishable from a “seeding” program because it is not actively marketed to patients, only applies in rare instances where insurance approval takes longer than 5 days, and there are limited drug alternatives;
• The prescriber does not receive any financial benefit;
• The arrangement is not likely to induce a beneficiary to use obtain drugs that are federally payable from the specialty pharmacy; and
• The arrangement does not impose any costs on federal healthcare programs.

In OIG Advisory Opinion No. 15-12, although the free introductory visit is provided by a licensed practical nurse liaison, OIG noted that the liaison does not provide any type of diagnostic or therapeutic services reimbursed by federal healthcare programs.  Rather, the primary purpose of the visit is to increase compliance with the post-acute care treatment plan by facilitating the patient’s transition to home health care.  OIG also noted that during this visit, the patients receive only information about the home health care experience and the patients’ care team members.  In issuing its decision, OIG stated that although these features do have intrinsic value to patients, that “intangible” value does not implicate the federal Anti-Kickback Statute or the civil monetary penalties law penalizing inducements provided to beneficiaries to influence their selection of providers. 

For a copy of OIG Advisory Opinion No. 15-11, click here.  A copy of OIG Advisory Opinion No. 15-12 is available here.

Reporter, Kate Stern, Atlanta, +1 404 572 4661, kstern@kslaw.com.