Is Pharma Rethinking Twitter?

A belated happy new year to all.

While we were away recharging our batteries to gear up for what is already an intense election season marked by increasing talk of drug pricing issues, we caught up on a few new developments regarding some drug marketing and promotion issues that we frequently address (in addition to managed markets issues).  In particular, we came across some interesting material on Twitter that merited a closer look to see how brands have been utilizing … Read More

Reminder For Manufacturers Offering Co-Pay Offset Programs in Massachusetts: The initial July 1, 2015 statutory expiration date has been extended to 2017

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 … Read More

The Future of Drug Coupons and Co-Pay Cards – Part 2

In our last post, we addressed a few key points regarding the possible use of drug coupons and co-pay cards by Medicare beneficiaries in connection with purchases of Part D covered drugs.   As our readers know, this issue was the subject of an OIG report and Special Advisory Bulletin that called into question whether drug manufacturers have implemented sufficient safeguards to ensure that Medicare beneficiaries do not use coupons or co-pay cards to obtain drugs paid for by the … Read More

The Future of Drug Coupons and Co-Pay Cards

Over the last several weeks, we’ve been following a number of developments around potential legal challenges to the use of drug coupons and co-pay cards. As many of our readers know, the battle between manufacturers and payers boils down to a fundamental issue: are manufacturers’ efforts to subsidize consumers’ out of pocket costs via drug coupons and co-pay cards as a means to promote new starts and/or product adherence appropriate when those approaches are viewed by insurers, plans and their … Read More

Some Thoughts on Apple’s Healthcare Play and the Challenges for Medical App Makers (and for Apple)

As if we needed any reminders, Apple has introduced a countdown clock for its September 9thspecial event” at which most observers believe the company will launch new versions of its iPhone, as well as a wearable device many are calling the iWatch.  True to form, Apple is not providing any formal pre-event details about the content of the announcement, but over the past few months a number of industry insiders have published nuggets of information purporting … Read More

The Importance of Medicare Coverage Gap Discount Agreements for New Pharma Companies Entering the Market

With rebate contracting season now well underway, we thought it might be a good time to return to an issue that we’ve discussed recently with a number of industry participants, including new pharmaceutical manufacturers bringing products to the market for the first time.

For many pharma companies waiting for FDA approval of their first NDA, the months leading up to agency approval are filled with a variety of activities ranging from investor meetings, pricing and reimbursement issues, manufacturing planning, and … Read More

In Apple’s Healthcare Play, Will BYOD = Bring Your Own Data?

By now, most interested observers are well aware of historical growth in the bring your own device (BYOD) movement, in which businesses permit their employees to bring their own devices to the workplace environment and connect them to corporate networks.  With this evolution well underway, we’ve lately been giving some thought to how this “bring your own” type of approach might work in other contexts.  Healthcare seemed like a reasonable place to start, particularly in light of the recent frenzy … Read More

Google, Apple and Mobile Medical Apps

Hey folks, sorry for the lack of posts lately.

We are doing our best to get back to our regularly scheduled programming, but we wanted to take a quick detour to address some recent events in an area that we also follow very closely.

Like a lot of people, we are really excited about the advances in mobile technology and how they can be applied in the healthcare environment to facilitate health and wellness in general, and more specifically, drive … Read More

Refill Reminders and HIPAA: Some Practical Considerations

By now, we suspect most if not all of our readers are aware of the final rules issued by HHS earlier this year to regulate sponsored refill reminder programs, the litigation initiated by Adheris, Inc. last month challenging those rules, and the subsequent, revised guidance on refill reminders and patient messaging programs issued by HHS on September 19th.  

For those unaware, the issue was essentially this:  under new HIPAA rules that were scheduled to go into effect on September … Read More

Follow up on the Use of Co-Pay Cards in Health Insurance Marketplaces

For those following along, we wrote an item last month that took the position that Qualified Health Plans (QHPs) offered through the health insurance exchanges did not appear to constitute a “Federal health care program” as would make those plans subject to the federal anti-kickback statute.

As a result, we thought that the use of drug co-pay cards and coupons would be permissible by individuals purchasing drugs covered under a QHP.   At that time, we also noted that it was … Read More

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