The Trump Administration’s triad of HHS Secretary Alex Azar, FDA Commissioner Scott Gottlieb and CMS Administrator Seema Verma represents an exciting policy wonk triple play. All three are idea-driven innovators and nowhere is this more vividly on display than in the American Patients First Blueprint to lower drug prices and reduce out-of-pocket costs.
On May 14th, HHS issued a request for information (RFI) on the administration's blueprint, seeking input from stakeholders on a wide range of policy proposals. Responses are due on or before July 16, 2018. This is not an exercise.
The Blueprint is both a directional document of free-market principles and a high-stakes exam for America’s healthcare leadership. Why an exam? Precisely because in it the Administration asks a series of tough, intriguing, challenging and precise questions on a series of interesting potential pathways for reform. It’s not a final exam – but it certainly is a high stakes one for all involved.
The headline message is that incremental change isn’t enough. Dynamic, discontinuous and disruptive ideas are the order of the day. Attention American healthcare leaders: It’s time to lead, follow or get out of the way. And, as the Beltway adage reminds us, “If you’re not at the table, you’re on the menu.”
As America’s best and brightest cogitate on their RFI responses, here are some things to consider:
Drug Manufacturers: Are you ready to facilitate generic drug development by becoming part of the solution, ceasing the shenanigans that prevent quicker development programs? Straightforwardly, are you ready to come to the table to discuss the real problems with the CREATES Act – and solve them?
Pharmacy Benefit Managers: Are you ready to stop putting profits in front of patients? Will you pass along more of your double-digit discounts to patients in the forms of lower co-pays and co-insurance? Will you stop using restrictive formularies, co-pay accumulators, and prior authorization to pad your own pocket? Are you willing to accept fiduciary responsibility for your actions? If not – better get ready for Uncle Sam to take away your anti-kickback exemption.
Administrator Verma: Are you prepared to grant more states waivers for more aggressive reform pilot programs? How can you insert more market-based forces into Part B while retaining existing price transparency? How can you help to drive more competitive benefit design options both inside and outside of government programs?
Commissioner Gottlieb: FDA’s senior leadership is saying all the right things. Legislation has given the agency broader authority to do more things in new ways. How can you convince, cajole and empower line review staff to get with the program?
Secretary Azar: You’ve accused insurers of “keeping customers in the dark.” How can you use both your authority and bully pulpit to help propel more sunlight (the best disinfectant) into this and other systemic issues that are trying to hide in the shadows of industry lobbyists? How soon can we eradicate the Gag Rule and set pharmacists free to help patients lower their out-of-pocket costs?
Congress: Unfortunately, the less you understand about the healthcare ecosystem, the more simplistic, politically popular sound bite-driven solutions seem like the order of the day. Drug importation, patent expropriation and “single payer” for example, are bad ideas that many in both Houses (and state legislatures) support even though they have been shown, time and again to be not just non-starters but replete with dangerous unintended consequences. Rather than looking for people to blame and punish, how about looking for ways to solve the problem?
And when it comes to the 340B imbroglio, how about a more realistic definition of a "patient?"
Yes, the exam questions are difficult, time is short and the stakes are high. But with sound national leadership, a more open-kimono ecosystem and continued political pressure to develop disruptive solutions that deliver lower costs for patients while enhancing innovation, we can expect more than a passing grade. We can expect real progress.
On May 14th, HHS issued a request for information (RFI) on the administration's blueprint, seeking input from stakeholders on a wide range of policy proposals. Responses are due on or before July 16, 2018. This is not an exercise.
The Blueprint is both a directional document of free-market principles and a high-stakes exam for America’s healthcare leadership. Why an exam? Precisely because in it the Administration asks a series of tough, intriguing, challenging and precise questions on a series of interesting potential pathways for reform. It’s not a final exam – but it certainly is a high stakes one for all involved.
The headline message is that incremental change isn’t enough. Dynamic, discontinuous and disruptive ideas are the order of the day. Attention American healthcare leaders: It’s time to lead, follow or get out of the way. And, as the Beltway adage reminds us, “If you’re not at the table, you’re on the menu.”
As America’s best and brightest cogitate on their RFI responses, here are some things to consider:
Drug Manufacturers: Are you ready to facilitate generic drug development by becoming part of the solution, ceasing the shenanigans that prevent quicker development programs? Straightforwardly, are you ready to come to the table to discuss the real problems with the CREATES Act – and solve them?
Pharmacy Benefit Managers: Are you ready to stop putting profits in front of patients? Will you pass along more of your double-digit discounts to patients in the forms of lower co-pays and co-insurance? Will you stop using restrictive formularies, co-pay accumulators, and prior authorization to pad your own pocket? Are you willing to accept fiduciary responsibility for your actions? If not – better get ready for Uncle Sam to take away your anti-kickback exemption.
Administrator Verma: Are you prepared to grant more states waivers for more aggressive reform pilot programs? How can you insert more market-based forces into Part B while retaining existing price transparency? How can you help to drive more competitive benefit design options both inside and outside of government programs?
Commissioner Gottlieb: FDA’s senior leadership is saying all the right things. Legislation has given the agency broader authority to do more things in new ways. How can you convince, cajole and empower line review staff to get with the program?
Secretary Azar: You’ve accused insurers of “keeping customers in the dark.” How can you use both your authority and bully pulpit to help propel more sunlight (the best disinfectant) into this and other systemic issues that are trying to hide in the shadows of industry lobbyists? How soon can we eradicate the Gag Rule and set pharmacists free to help patients lower their out-of-pocket costs?
Congress: Unfortunately, the less you understand about the healthcare ecosystem, the more simplistic, politically popular sound bite-driven solutions seem like the order of the day. Drug importation, patent expropriation and “single payer” for example, are bad ideas that many in both Houses (and state legislatures) support even though they have been shown, time and again to be not just non-starters but replete with dangerous unintended consequences. Rather than looking for people to blame and punish, how about looking for ways to solve the problem?
And when it comes to the 340B imbroglio, how about a more realistic definition of a "patient?"
Yes, the exam questions are difficult, time is short and the stakes are high. But with sound national leadership, a more open-kimono ecosystem and continued political pressure to develop disruptive solutions that deliver lower costs for patients while enhancing innovation, we can expect more than a passing grade. We can expect real progress.
