When I founded Applied Policy nearly fifteen years ago, my goal was not only to assemble a team capable of delivering exceptional value to our clients but also to address a more profound concern. Having worked at the Centers for Medicare & Medicaid Services (CMS), in a major pharmaceutical company, and on Capitol Hill, I had seen firsthand how various forces often hinder the American public’s access to high-quality, affordable care. This experience shaped my most important mission in founding and growing Applied Policy: to improve the lives of patients who put their trust in those who deliver their care.<\/p>\n
The December edition of our newsletter highlights some of the most significant victories we have achieved on behalf of our clients this year. These accomplishments will ultimately help Americans access medications at better prices, prevent essential drug shortages, and provide safer non-opioid pain relief options to reduce the risk of addiction. Through our efforts, patients receiving end-stage renal disease treatment in hospital-based facilities will benefit from simplified payment structures. We also supported our clients in complying with state-mandated reporting requirements for the cost of caring for undocumented immigrants, ensuring they could continue meeting the needs of these often vulnerable patients. Additionally, we assisted nursing homes in meeting compliance and third-party ownership regulations, helping to ensure that elderly residents can continue to live in safe and secure environments. Achieving these goals\u2014and others like them\u2014has made 2024 a successful year and serves as our inspiration as we look ahead to 2025.<\/p>\n
To all who are reading this, to those who helped us achieve these victories and those who benefited from them, we wish you a joyous holiday season and a healthy New Year!<\/p>\n
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As 2024 comes to a close, the Applied Policy team is proud to be able to reflect on a year of impactful work across the healthcare sector. <\/span>We have helped our clients navigate complex regulatory landscapes and achieve critical milestones through strategic insights, tailored policy support, and effective advocacy, solidifying their positions in an ever-evolving industry.<\/p>\n Our accomplishments in the last year span a range of high-impact initiatives. They include:<\/p>\n Advancing Reimbursement Strategies<\/strong><\/p>\n \u2022 Supported individual medical device, pharmaceutical, and health services clients in successfully navigating Healthcare Common Procedure Coding System (HCPCS) coding and reimbursement pathways. Ensuring Access for Patients<\/strong><\/p>\n \u2022 Overcame challenges to client drug coverage under Medicare Part D, securing 100% formulary inclusion for a protected-class product incorrectly excluded from certain formularies. Navigating New Policies and Regulations<\/strong><\/p>\n \u2022 Guided pharmaceutical clients through the intricate requirements of the Inflation Reduction Act, including enrollment in the Medicare Part D Manufacturer Discount Program and strategies to mitigate inflation rebate penalties. Managing Unexpected Challenges<\/strong><\/p>\n \u2022 Assisted a medical device client in addressing unanticipated coding changes initiated by CMS contractors by bridging communication gaps between stakeholders, including PDAC and Durable Medical Equipment Medicare Administrative Contractors (DME MACs), to mitigate the impact on patient access.<\/p>\n Advocating for Client Interests<\/strong><\/p>\n \u2022 Facilitated impactful responses to Requests for Information on critical issues such as drug shortages, MAC consolidation, and the boundary between DME and pharmacy coverage, ensuring clients’ perspectives were effectively communicated to policymakers.<\/p>\n Driving Policy Change<\/strong><\/p>\n \u2022 Contributed to national efforts to address the opioid crisis by supporting medical device and pharmaceutical manufacturers in advancing innovative non-opioid pain relief solutions. Achievements included proactive engagement with CMS that led the agency to incorporate client-recommended payment methodology for a pharmaceutical innovation in the relevant proposed rule.<\/p>\n Enhancing Healthcare System Initiatives<\/strong><\/p>\n \u2022 Ensured healthcare services clients’ compliance with state-mandated reporting requirements for undocumented immigrant care costs. Supporting Healthcare Leadership<\/strong><\/p>\n \u2022 Facilitated strategic relationships with key stakeholders, including CFOs, CMOs, and external partners, to align on health services priorities. Managing Critical Operational Needs<\/strong><\/p>\n \u2022 Provided healthcare systems rapid response analysis and guidance on emerging policy issues. Applied Policy\u2019s ability to deliver exceptional outcomes is rooted in our understanding of healthcare policy and our commitment to advancing our clients’ goals with discretion and professionalism. As we prepare for the opportunities and challenges ahead, these successes demonstrate our capacity to provide unparalleled strategic guidance in a dynamic policy environment.<\/p>\n","protected":false},"excerpt":{"rendered":" When I founded Applied Policy nearly fifteen years ago, my goal was not only to assemble a team capable of delivering exceptional value to our clients but also to address a more profound concern. Having worked at the Centers for Medicare & Medicaid Services (CMS), in a major pharmaceutical company, and on Capitol Hill, I […]<\/p>\n","protected":false},"author":10,"featured_media":7903,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"nf_dc_page":"","ap4_related_services":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-8838","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"\n
\n\u2022 Delivered tailored strategies to optimize product positioning and reimbursement opportunities. This included securing separate Medicare Part B payment and a unique HCPCS code for a pharmaceutical innovation and providing comprehensive analyses of Medicare rules and payment structures for end-stage renal disease (ESRD) hospital-based facilities.<\/p>\n
\n\u2022 Developed forward-looking strategies to address trial-and-failure policies affecting pipeline products, safeguarding future patient access.
\n\u2022 Orchestrated recognition of a client device as opiate sparing and therefore eligible for separate payment under the Hospital Outpatient Prospective Payment System.<\/p>\n
\n\u2022 Provided clients critical insights and guidance on the Medicare Drug Rebate Program final rule, the 2025 Inpatient Prospective Payment System interim final rule, and the 2026 Notice of Benefits and Payment Parameters proposed rule.
\n\u2022Provided guidance on expectations and risks for the Transforming Episode Accountability Model (TEAM), a mandatory CMS initiative. Clarified regulatory requirements for provider and supplier types that qualify as TEAM collaborators.
\n\u2022 Collaborated with clients to ensure compliance with Medicare and other payer coverage, coding, and billing requirements for a range of established durable medical equipment (DME) and healthcare services.
\n\u2022 Supported clients with innovative services and devices for which compliance expectations were unpublished, including services addressing social determinants of health and innovative devices.<\/p>\n
\n\u2022 Delivered programmatic summaries of CMS initiatives such as Acute Care Hospital Care at Home and Medicaid\/CHIP partnerships.<\/p>\n
\n\u2022 Contributed and participated in presentations and recorded sessions on key initiatives, including the Increasing Organ Transplant Access model and HTI2 rule.<\/p>\n
\n\u2022 Researched and submitted requirements for compliance with nursing home transparency and third-party ownership regulations.<\/p>\n