We spoke to Katherine Chaurette, Vice President Healthcare Law and Compliance at Blueprint Medicines, about the main impacts from the Biden Administration, the House and the Senate in the next few years on pricing and contracting, as well as the major hurdles over the next 5 – 10 years for professionals in the industry.
What do you think will be the main impact from the Biden Administration, the House and the Senate in the next few years to this industry?
"If anything gets passed by the House and the Senate, the most likely are adoption of an inflation penalty in Part D and providing voter pleasing out-of-pocket relief to Medicare patients, followed by the less likely passage of Medicare negotiation for some number of drugs with the highest Part D budget impact. I think we should be on the lookout for the possible return of a Most Favored Nation reference pricing scheme but modified from the Trump Administration’s almost-rescinded Interim Final Rule. That said, I think the main impact from the Biden Administration and Congress will be a narrowing of longer term possibilities as we see what ideas have significant bipartisan support but do not make it to the finish line now. Those ideas will be better positioned to come back under consideration in the future."
What will be the major hurdles over the next 5 – 10 years for professionals in pricing & contracting?
"This in part depends on what, if anything, Congress and the Administration enact through law or regulation. In any event, one hurdle will be the continuing consolidation both vertically and horizontally among payers, PBMs, wholesalers/distributors, pharmacies, HCPs and GPOs, and the emergence of PBM GPOs. The number and complexity of corporate affiliations affects pricing and contracting in a variety of ways, for example, a greater imbalance in price negotiation leverage, expansion of sites eligible for 340B pricing, considerations related to stacking of discounts in BP and whether service fees paid to one corporate entity are passed along to another, challenges with isolating contract negotiations across affiliated entities to avoid GP and anti-kickback entanglement. Another hurdle will be keeping up with state initiatives. Where are the states headed with price transparency reporting and affordability boards? How might proliferating state laws be used to cap or otherwise impact reimbursement and net prices and create the need for additional state-specific contracts?"
What was your biggest takeaway, key point, or most interesting talk from MDRP 2021?
"There were so many interesting talks and key takeaways, it is hard to choose. Being a lawyer, for “most interesting talk” I’ll have to go with the several discussions about the December 2020 CMS Final Rule and most notably those concerning CMS’s evolving interpretation of how to treat copay programs in AMP and BP and the complex burden placed on manufacturers (effective January 2023 pending outcome of ongoing industry legal challenge) to “ensure that” payers and PBMs do not appropriate the value of copay support using accumulator programs. I also enjoyed reminiscing during the “Abbreviated History of How this Community has Helped Shape the Policies and Standards of Government Pricing Program”. The many state price transparency sessions were super-informative and my key takeaway is from those sessions and it is to develop an assumptions document for state price transparency operations."
Just for fun . . . What profession other than your own, have you always wanted to attempt and why?
"ER doctor, Secret Service Agent, Meteorologist"
What is your favorite city for business travel and why?
"London and Paris so that I can also visit friends, and Athens for two reasons: It is an exciting city, and I all-around love Greece, its antiquity and mythology."