2023 stood out as one of the most active for oncology policy in decades. While there is much work ahead, oncology issues are now firmly in the focus of both federal and state governments.

Before delving into specific issues, it’s crucial to acknowledge the vast differences between the world of oncologists and policymakers. Oncologists are trained in the scientific method, which usually progresses linearly. Oncologists are accustomed to drug trials that move predictably from phase one to phase two, to phase three, and then potential drug approval. Politics, by design, operates differently. The system of checks and balances often results in initiatives being tossed back and forth before finally becoming law. Initiatives can jump from “phase one” to “phase three” and then revert to “phase two” on their way to becoming law. Those engaging with policymakers must adapt to this markedly different process, which demands patience.

OneOncology invests heavily into advocacy efforts to shape national and state level oncology issues. Private oncology practices compete directly with other oncology care models. These models, such as non-profit hospitals, operate under vastly different payment arrangements. Over the past two decades, the divergence of these payment models has shifted care from the more efficient, lower cost community setting to the less efficient, more expensive hospital setting. Policy decisions in Washington, D.C. and in state capitals are a major reason why care has shifted to hospitals. Reversing this trend requires community oncologists to remain active in policy debates and educate lawmakers about the high-value care that is delivered in our clinics daily.

Scrutiny Of Independent Physician Practice Models

Recent state and federal policy actions reflect an accelerating wildfire of scrutiny on private capital in healthcare, many of which directly target the OneOncology business model. This growing trend throughout 2023 has underpinned the importance of building the fire station before the fire breaks out, which requires investing time, effort and funding in the various mechanisms of effective advocacy. For example, OneOncology has become a founding member of the American Independent Medical Practice Association (AIMPA), for which Dr. David Eagle serves as Vice President. In addition, new state-level independent practice associations have been forged to educate policymakers on the how critical private capital-backed Management Service Organizations (MSOs) like OneOncology can buffer against recent trends in unrestricted hospital consolidation.

We should acknowledge that there have been bad actors (including some private equity-backed MSOs and non-profit hospitals alike) that deserve scrutiny for increasing the cost of care without measurably improving quality, access to care, or patient satisfaction. However, the credibility that OneOncology and its practices have built on other policy issues is helping differentiate OneOncology as a positive example of use of private capital in healthcare. This differentiation will help us and the AIMPA to educate policymakers on how private capital can play a constructive role in helping independent practices improve patient care through access to clinical trials, use of precision medicine tools, technology, and analytics that drive quality improvement.

Medically-integrated Dispensing

2023 was a big year for medically-integrated dispensing. This term highlights the difference between how patients get drugs from an oncology office compared to how they receive therapies from a pharmacy benefit manager. Oncology practices know the patient. The pharmacy team has real-time access to the EMR, which includes the labs and physician notes. Oncology practices understand that medications such as TKIs are not the same as blood pressure or cholesterol medications. Toxicity is common, and good medical practice often requires holding medications and/or adjusting the dose. PBMs do not know the patient or when their clinical situation changes, frequently sending 90-day supplies of medications — which often require dose adjustment. This is bad medicine and wasteful.

Regrettably, CMS failed to grasp this difference and disallowed drug mailing by oncology practices to patients through an unusual FAQ earlier this year. This decision represents not only poor policy, but also a flawed rule-making process. CMS's stance makes it more challenging for frail patients, especially in rural regions of the country, battling cancer to access their medications. The Community Oncology Alliance responded with a lawsuit, and Congress followed suit with a letter to CMS — culminating in a closed-door session between congressional members and CMS officials.

OneOncology practices responded to Dr. Patton’s call-to-action to support a bill moving through Congress to reverse this policy. This was the first grassroots mobilization effort by OneOncology physicians, and it was a tremendous success. Over 150 OneOncology physicians reached out to their Representatives and Senators. Well done team! Although CMS appears entrenched in its position, the pressure to reconsider continues to mount. This battle will persist into 2024, with potential solutions including CMS rescinding its position, the lawsuit prevailing, or the passage of legislation explicitly permitting drug mailing by practices.

On more positive news, the House of Representatives passed major legislation establishing PBM transparency. This is a big step for an institution that struggled to understand PBMs just five years ago. While this legislation still needs to move through the U.S. Senate, the committees of jurisdiction have already been drafting their own transparency legislation.

340B Reform

There has been increasing scrutiny of the unintended consequences of the 340B program on Capitol Hill throughout 2023. In July, a bipartisan committee investigating these adverse consequences of the program issued a formal Request for Information from stakeholders regarding a reasonable policy pathway for aligning the program to its original intent of supporting underserved communities. OneOncology was one of very first respondents to RFI, giving us a significant boost in credibility and influence on the issue. Several Senators are working on legislation that they may introduce in 2024 based on the OneOncology response to the Senate RFI.

Reformdrug Shortages

Throughout the dire period of drug shortages in 2023, OneOncology has been an important voice in the national conversation of much needed federal policy to prevent this continually recurring problem. The publication of Dr. Kristen Rice’s Op-Ed on this issue in June spawned a fury of print and podcast media attention on the problem and potential policy solutions. To be fair, drug shortages have been a recurring problem over the past several decades, the root causes of which are systemic and multifactorial. However, a fundamental cause-and-effect relationship remains: The economics of the supply chains for these drugs lack adequate incentives needed to establish resiliency in the face of inevitable supply chain disruptions. Federal and state policies have allowed unconstrained health plans and PBMs to negotiate prices down to a level in which the economic model and regulatory frameworks that underpin these supply chains prevent the resilience that we need to avoid shortages. This creates a paradox relative to policymakers stated intentions to reduce our healthcare system’s exposure to drug shortages while reducing the cost of drugs.