This guest blog was written by Christie Bloomquist is a partner in health practice at Hogan Lovells, a global legal practice firm based in Washington DC.
I’ll admit it, I had trouble sleeping this week, knowing that we’d finally know what the Supreme Court thought about the Constitutionality of key Affordable Care Act (ACA) provisions. Mostly, I wondered if the law that I had spent the last few years of my life working on during its debate in Congress and throughout implementation would be the same at the end of the day as it was at the beginning and what this would mean for the pharmaceutical industry. Call me nerdy, but I suspect that I wasn’t alone in my tossing and turning all week.
And now that the speculation is over, what’s clear is that the Supreme Court’s decision means status quo for the industry. Pharmaceutical manufacturers will continue to do what they’ve been doing for over 2 years – implementing ACA. They’ll continue to process discounts in the Part D coverage gap, they’ll continue to work through the expansion of the Medicaid drug rebate program, they’ll continue to pay the industry excise fee, they’ll continue to think ahead to the implementation of a pathway for biosimilars – and, most importantly, they’ll continue to do all of these things while pursuing innovation of life-improving medicines.
I suspect that today’s ruling will also feel a bit like hitting the fast forward button. For several months, implementation of ACA has been mired in the will it or won’t it debate, slowing down implementation efforts aimed at establishing state exchanges and the like. Now, with everyone realizing that a lot of work needs to be done in relatively short order, the pharmaceutical industry will spend significant time on ensuring appropriate coverage and access to their products. These are issues that will require a deep understanding of a complex law with interrelated provisions. After all, there is a reason why ACA didn’t include a severability clause. In addition, the industry will continue to parse through the Supreme Court’s decision on the Medicaid expansion to determine any potential impact.
Separately, with the Supreme Court’s decision now officially behind us, the countdown to the next big event – the November elections – will commence. The industry will continue to look for policymakers in Congress that value the work industry does. And, while it won’t change the pace of ACA implementation, the November elections will continue the speculation on the fate of the law and future legislative efforts. All of these activities will take place at the same time as an even bigger countdown clock continues to wind down, the clock for reconsideration of deficit reduction measures, likely at the beginning of 2013. The pharmaceutical industry is acutely aware of potential pay-for measures having lived through the rise and fall of the Super Committee and calls for the industry to provide even deeper discounts in federal health care programs. They will continue to be aware that navigating those issues requires expertise and sharp attention to detail. Given those realities, more sleepless nights certainly lay ahead.