At the core of ongoing discussion and debate surrounding the Center for Medicare & Medicaid Services (CMS) FAQ on the physician self-referral law (the Stark Law) is ensuring the best possible care for patients. As a Mission-driven, member organization, NCODA believes that the current approach creates barriers that are needless and can negatively impact the health of cancer patients across the United States. The benefits of integrated care are well established and include reducing prescription abandonment, medication errors, and waste associated with medication changes while increasing medication compliance.  

“The implementation of regulation should never be placed before the healthcare outcomes of those that we collectively serve,” stated Michael Reff, RPh, MBA, and NCODA Founder and Executive Director. “NCODA will continue to work through all available channels to support our members and their commitment to the patients they serve.”  

NCODA is aware of legal actions taken by advocates for changing the enforcement of the Stark Law. We will monitor that suit closely while remaining focused on the work of our members in order to amplify their voices in the pursuit of essential access to best-in-class oncology care for the patients they serve.  

We are particularly concerned about the impact that the Stark Law will have on the most vulnerable patient population, where the distance to oncology care and pharmacy services can add additional stress and physical strain. While the CMS effort is designed to eliminate the potential for self-referrals, it opens even more potential care issues by replacing the integrated pharmacy team with access to the patient’s comprehensive health record within the Electronic Health Record (EHR) with large mail-order pharmacies that are not closely tied to the specific treatment needs of cancer patients.

“The enforcement of Stark has resulted in prescriptions for anti-cancer medications being sent out to large PBM owned mail-order pharmacies. This is done at the expense of ideal patient care which is particularly frustrating at a time when we’ve seen so many life-changing advances,” said Debra Patt, MD, PhD, MBA, a practicing medical oncologist and an Executive Vice President of Texas Oncology. Dr. Patt is an active leader in breast cancer research in healthcare informatics.  

“Transportation and physical access to appointments is a tremendous challenge for many patients dealing with a cancer diagnosis, specifically for the elderly and those with end-stage disease,” said Stephen Schleicher, MD, MBA, Chief Medical Officer of Tennessee Oncology. “It doesn’t make sense that patients may have no other option but to have their oncolytic medication filled by someone that does not have access to their medical records. Moreover, a PBM-owned mail-order pharmacy has never communicated to me about a mutual patient case in my time as a medical oncologist. This completely disrupts the continuity of coordinated patient care.” 

During a recent NCODA Executive Council meeting, members met with licensed pharmacist / U.S. Representative, Buddy Carter (R-GA), to review recent efforts on the Stark situation and oncology drug shortages. The time spent together provided NCODA leadership a platform to provide perspective on these issues directly from medically integrated oncology practices. NCODA’s longstanding relationship with Representative Carter has proven to be positive, and will continue as the hard work to bring movement with policymakers must be consistent and always at the forefront.  

Next week, NCODA will be hosting the Oncology Institute on Wednesday, August 16 in Minneapolis.  This annual meeting brings together all stakeholders across the oncology landscape to elevate collective understanding of obstacles impacting patient care, identify actions and collaborate to effect positive change to the future of patient care. The Oncology Institute will feature a panel presentation that will discuss key legislative and policy issues, including Stark.  

On Thursday, August 24 at 5:30pm ET, NCODA will be hosting a live Virtual Town Hall meeting on Zoom. The Virtual Town Hall will include insights on the impact of Stark Law changes from national pharmacy leaders Neal Dave, PharmD (Texas Oncology), Kyle Kitchen, PharmD (Utah Cancer Specialists), and Eric Soong (South Carolina Oncology Associates). Questions can be submitted prior to the event or during the live event moderated by Stacey McCullough, PharmD, Director of Clinical Corporate Strategy at NCODA. 

Neal Dave, PharmD

Executive Director of Pharmacy & Admix Services

Texas Oncology

Kyle Kitchen, PharmD

Senior Director of Pharmacy and Clinical Services
Utah Cancer Specialists

Eric Soong, PharmD

Director of Pharmacy
South Carolina Oncology Associates


Stacey McCullough, PharmD

Director of Clinical & Corporate Partner Strategy

If you missed the Stark Law Town Hall, please subscribe to NCODA’s legislative newsletter to stay up-to-date.

The format of the live Stark Law Town Hall will include brief updates and overviews from the panelists, in addition to the majority of time spent on answering questions. Please use the form below to submit a question for our panelists. All questions submitted are anonymous. If you would like, you can state your name and organization in the submission box.

Town Hall Question Submission Form



About NCODA:

NCODA is a leading non-profit organization dedicated to empowering medically integrated oncology practices to deliver positive, patient-centered outcomes by providing leadership, expertise, quality standards, and best practices. For more information about NCODA visit or follow @NCODA on LinkedIn.

Media Contact:
Katie Edmiston