The major provisions of this Act include:




Definition: Sets the federal incidence definition of rare cancer at <6 diagnoses per 100,000 people per year in the United States.

Currently, the U.S. has no agreed upon incidence definition for rare cancer or rare disease. The goal of using a more conservative and consistent definition is to bring clarity to allocation of resources and ensure that truly underserved cancers and cancer patients are receiving adequate research and development funding.

Molecular Diagnostics: Mandates coverage for molecular diagnostics and genetic counseling at the time of diagnosis for patients on Medicare.


Molecular diagnostics are a critical component of providing accurate diagnoses using modern methods for cancer classification and enabling the use of next-generation targeted therapies. Medicaid already reimburses molecular diagnostics for recurrent and metastatic cancers, and this bill extends that coverage to all new cancer patients at the time of diagnosis.

Collaboration: Health and Human Services (HHS) will report on ways to facilitate the development of treatments for rare cancers by addressing the cost and restrictions hindering access, fostering culture of collaboration, exchanging data and scientific understanding.


The legislation expands the relationships between HHS, DoD and VA to ensure data repositories are centralized, open-source, anonymized and publicly available for research use at affordable pricing. HHS will also coordinate the existing cancer databases and create an overarching directory that is posted on a public website, which indicates which specific form of cancer is included in each database.

For more information about SHEPHERD Foundation and our work, please contact: 

Catharine Young, Executive Director, SHEPHERD Foundation

For specific inquiries related to this bill and other bills, please contact:
Liz Powell, Esq., MPH, Founder G2G Consulting