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February 21, 2025
Quarterly Opinion
Kristi Martin
Meena Seshamani
Dec 11, 2024
Dec 4, 2024
May 7, 2024
Back to The Milbank Quarterly Opinion
Addressing persistent and widespread challenges in any large organization necessitates implementation of policies and programs in ways that are organized, evidence-based, and responsive to external stakeholder input. Unfortunately, complicated processes, slow decision-making, and isolated silos plague all large organizations, public and private. Our experience in standing up new programs in the federal government has demonstrated how large organizations can break through these challenges to be nimble and effective.
Recently, we implemented the Medicare provisions of the Inflation Reduction Act — including establishing several new programs with nationwide impact under short timeframes, most notably the Medicare Drug Price Negotiation Program (the Negotiation Program). We drew on our experience and lessons learned from implementing the Affordable Care Act to take on the challenge. In particular, we sought to ensure that both policy and operations were deeply intertwined and that our workplace culture encouraged staff to raise issues early and often.
We discuss here three granular strategies that enabled successful implementation, namely: (1) employing an inclusive and nimble hiring strategy that prioritized both public and private sector experience; (2) identifying efficiencies and flexibilities to move quickly without sacrificing quality; and (3) defining goals early and reminding people throughout the process of what we are working toward and how we plan to do it. We utilized these strategies in the public sector, but they apply to any large organization looking to implement a new, innovative program or policy quickly and effectively.
Any new program should begin with the people who are committing to the challenge. Hiring for talent is key, yet the federal government often cannot compete with companies in the private sector on compensation. Thus, for the Negotiation Program, we had to lean into the sense of being part of a historical moment and convey a culture of valuing the unique expertise that someone coming from the private sector can provide in government. Given the ambitious initiative — the most consequential change to the Medicare Program since the inception of the Part D prescription drug benefit with an aggressive timeline to deliver in less than a year – we knew that hiring the right team was key.
From the start, we had a few guiding principles for our hiring efforts: prioritizing diversity in experience and qualifications; leveraging networks to pull from a broad group of candidates; creating a culture that values experience and expertise from the bottom up; and intentional efforts to have both public and private sector experience on the team.
We prioritized casting a wide net to recruit individuals with private sector experience for key positions to build a robust, multidisciplinary team with clinical expertise, industry experience, and real-world familiarity with patient care, clinical and cost-effectiveness research and drug price negotiations in several markets. This hiring strategy enabled us to bring in people with diverse perspectives and an understanding of how the private sector operates, including drug pricing experts and pharmacists with experience in the pharmaceutical and health insurance industries, as part of the team’s leadership.
Private sector expertise was critical, but we also needed a team with a deep understanding of how government works. At the start of the process, we identified people within the federal government with talent, strong leadership, and experience who could complement those with private sector experience. This would enable the team to hit the ground running. We sought out those with proven track records in implementing thoughtful and expedient policy and operations and who understood the challenges ahead. As such, we brought in people with expertise with CMS drug models, the Medicaid Drug Rebate Program, and the Medicare Part D and Part B programs, as well as expertise across other government agencies. We structured management teams to have individuals with public sector experience and those with private sector experience working together.
Our success in implementing the Negotiation Program was rooted in identifying efficiencies and flexibilities to move quickly without sacrificing the quality of the work. We worked backwards from statutory deadlines to develop policy and operational workplans. We addressed hitch points and expedited processes wherever possible.
Notably, the law directed us to use program instruction to set the requirements and parameters of the Negotiation Program in the initial years of implementation. Medicare payment policies are generally established through notice and comment rulemaking, in order to make sure there is sufficient public input into the process. This can take up to 18 months and consists of drafting a proposed rule, publishing it to solicit public comment, and finalizing the rule while addressing public comments received. The Inflation Reduction Act required CMS to issue program guidance, instead of notice and comment rulemaking, to implement the Negotiation Program for the first few years of the program.
While the law did not require CMS to solicit public comment for the Negotiation Program, we did not want to sacrifice the crucial feedback from interested parties and stakeholders necessary to implement the Negotiation Program in a thoughtful way. Strategic engagement across the health care ecosystem is vital — encompassing sharing implementation plans, opportunities for engagement, and keeping the door open to ideas, innovation, and concerns. Thus, we designed an approach that could move quickly to meet our deadlines while also creating opportunities for public input. Early on, we published a roadmap and timeline for implementing the Negotiation Program, which set expectations for how we would implement the first year of the program and identified key opportunities for the public to engage with us on guidance and information collection requests. We set up regular public listening sessions with interested parties, including patient organizations and drug manufacturers, and we also voluntarily published draft guidance and solicited comment before finalizing policies and operations when we could. All of these engagements helped to mitigate concerns and the unknowns of a new program, and allowed organizations and key parties to plan for what was to come. By streamlining and parallel tracking processes, when possible, we kept operations and policy on track while still obtaining public feedback.
How we engaged across the government and private sector to learn from others was also key to implementation. In every meeting, we asked three questions: (1) what were their recommendations for implementation? (2) what questions did they have for CMS? and (3) what clarifications did they need from CMS? We encouraged everyone to be as specific as possible. Engaging early and often in this transparent and collaborative way with all interested parties laid the foundation to identify challenges and solutions effectively. Our engagement efforts across a wide variety of stakeholders also helped those both inside and outside of the government to see that we were considering their feedback and concerns, thereby building legitimacy and trust in the program.
As a complement to our process, we defined our north star early — ensuring that people with Medicare have access to innovative cures and therapies they need at a price they can afford. Our transparent engagement process with stakeholders played a critical role in crystallizing this goal, and we embedded it throughout our processes so that everyone, from interested external parties to internal staff to leadership, knew what we were working toward. Establishing our goal at the outset helped to set expectations, gain consensus, and identify areas for further deliberation.
We continued to refer to our shared goal in external engagement and internal discussions to create a culture of continuous learning to get the best possible input from stakeholders and staff and to drive clear decision-making from leadership towards this north star. As a result, we were able to stand up the Negotiation Program in the most thoughtful way possible and within a compressed timeframe. This approach allowed CMS to reach agreement with all of the participating manufacturers on 10 drugs covered under Part D during the first cycle of negotiation, with a savings of $6 billion to the Medicare program, if the prices had been in effect in 2023. This process also sets the stage for future cycles of negotiation, with a team that can deliver savings and improved access thoughtfully balanced with the need for continued innovation.
The three key strategies of our implementation journey — inclusive and nimble hiring, balance of speed and quality, and early definition of goals — enabled us to overcome complicated processes, slow decision-making, and isolated silos that can plague all large organizations, public and private. They not only provide lessons on how government can work more effectively but also lessons for any large organization seeking to implement complex initiatives expediently.
Kristi Martin offers policy expertise and strategic counsel to advance impactful health policy, with a focus on improving health and well-being through practical solutions. She has dedicated over 20 years to this work, gaining valuable experience in the public sector, private sector, and philanthropy. Currently, she is a Director at Camber Collective — a strategy consulting firm that pairs analytic rigor and a human-centered approach grounded in equity to disrupt the status quo.
Throughout her career, Kristi has held significant roles that demonstrate her expertise. Most recently, she served as Chief of Staff and Senior Advisor to the Deputy Administrator in the Center for Medicare at the Centers for Medicare & Medicaid Services (CMS). In this capacity, she was instrumental in advancing regulatory policy in Medicare and implementing the Inflation Reduction Act, including the Medicare Drug Price Negotiation Program. Her efforts contributed to the successful negotiation of the first set of drug prices under the program, resulting in substantial savings for Medicare beneficiaries and the program. Prior to her role at CMS, Kristi served as the Vice President for Health Care at Arnold Ventures, where she led the philanthropy’s prescription drug pricing portfolio. She also held the position of Managing Director of Waxman Strategies’ health practice, working closely with Congressman Henry Waxman on health policy outcomes. Notably, as a Senior Advisor in the Obama administration’s Office of Health Reform, she oversaw the implementation of cross-cutting departmental public health and prevention initiatives under the Affordable Care Act.
Kristi is a proud Wildcat from the University of Kentucky earning a bachelor’s and a master’s degree in health communication as well as a Master of Public Administration from the George Washington University.
Meena Seshamani, MD, PhD most recently led the Medicare program at the US Department of Health and Human Services. She is an accomplished, strategic leader with a deep understanding of health care policy and operations, and a heart-felt commitment to outstanding patient care. Her diverse background as a health care executive, health economist, physician and health policy expert has given her a unique perspective on how health care policy and operations impact the real lives of patients. As Deputy Administrator and Director of the Center for Medicare at the Centers for Medicare & Medicaid Services, Dr. Seshamani led her nearly 1,000 person team through historic transformation to further the agency’s goals to address health care disparities, expand access to coverage and care, drive innovation for high-quality, whole-person care, and promote affordability and sustainability of the Medicare program for generations to come. She has driven bold initiatives including transforming the Physician Fee Schedule to pay for more holistic care including community health services, care navigation, caregiver training, and behavioral health that is integrated with primary care; streamlined prior authorization in Medicare Advantage (MA) and rejected more than 1500 misleading TV ads to ensure that MA serves its 33 million enrollees; and stood up the historic Medicare Drug Price Negotiation program, which in its first year successfully negotiated the first 10 high cost drugs with an estimated savings of $6 billion.
Dr. Seshamani is a Hopkins-trained surgeon and Oxford-trained PhD economist, where she was a Marshall Scholar. Prior to joining CMS, she served as Vice President of Clinical Care Transformation at MedStar Health, where she conceptualized, designed and implemented population health initiatives and served on the senior leadership of the 10 hospital, 300+ outpatient care site health system. Her work to rapidly scale senior services, palliative care and community health initiatives as part of leading the health system’s COVID-19 efforts was nationally recognized. She also cared for patients as a head and neck surgeon at MedStar Georgetown University Hospital and at Kaiser Permanente in San Francisco. Her work is routinely published in journals including New England Journal of Medicine, JAMA, and Health Affairs, and has been featured in the New York Times, Wall Street Journal, Washington Post, Bloomberg, Politico, Stat News, and most major TV news networks.
