As many readers will recall, in 2012 Massachusetts became the last state in the US to allow its residents to participate in co-pay assistance or drug coupon programs offered by pharmaceutical manufacturers. A provision contained within the commonwealth’s 2013 budget legislation relaxed the otherwise rigid statutory anti-kickback prohibition to allow the use of drug co-pay cards and coupons by individuals with health care and prescription drug benefits funded by any health care insurer, except for drug products that have AB rated generic equivalents. Under the 2013 budget legislation, the exception was due to expire on July 1, 2015.

At the beginning of 2015, however, new legislation was enacted that extended the sunset provision of the co-pay assistance exception until July 1, 2017.

As a result, brand manufacturers that had been administering coupon, rebate and co-pay assistance programs over the past couple of years – and that wish to continue running such programs after July 1, 2015 – should consider a number of steps to minimize possible disruption and confusion among consumers, pharmacies and claims processors.

First, manufacturers and their program administrators should ensure that any literature disseminated to or accessible by patients and prescribers, such as hard copy materials or website pages, reflects an appropriate expiration date. Existing vouchers, coupons or other materials designating a July 1, 2015 expiration date may be met with confusion by patients as well as by pharmacists.

Second, manufacturers and their program administrators should contact relevant claims processors to ensure that any adjudication edits reflecting a July 1, 2015 expiration date for existing offset programs are updated if the programs are to continue. Without an updated program expiration date, secondary claims applicable to the offset programs will likely reject, thereby causing confusion and frustration to patients, prescribers and pharmacists.

Finally, in the event that the changes above cannot be implemented in a timely fashion, manufacturers and their program administrators should expect an uptick in patient, prescriber and pharmacist call volume and other communications as they attempt to ascertain whether a coupon or voucher opportunity is still available.