Legislative Update: Week of August 5, 2019

Aug 05, 2019


On Tuesday, CMS Administrator Seema Verma announced its new pilot program for doctors, “Data at the Point of Care” (DPC), part of the MyHealthEData initiative that strives to give Americans access to their medical information so they can make better medical decisions. The program will give doctors access to Medicare claims data as they are preparing to see patients to provide a clearer picture of each patients’ medical history to avoid duplication and support more personalized care. Furthering the effort to bring healthcare into the 21st century, CMS also announced that Blue Button will be upgraded to Blue Button 2.0, an API that enables Medicare beneficiaries to connect their claims data to preferred applications, services, and research programs.

The Trump administration outlined a plan on Wednesday to allow the United States to import drugs from Canada. Under this plan, there are two potential pathways to allow for importation from foreign markets. Under Pathway 1, HHS and the FDA would issue a proposed regulation to import certain drugs from Canada “that are versions of FDA-approved drugs that are manufactured consistent with the FDA approval.”  States, wholesalers or pharmacists would develop the projects and submit them to HHS for review. Through Pathway 2, the FDA would issue guidance providing recommendations to “manufacturers of FDA-approved drugs who seek to import into the U.S. versions of those drugs they sell in foreign countries.”  HHS indicates manufacturers would “use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require.” While the proposal is still in its preliminary stages, it could have significant consequences for patients. Any importation policy opens the door for fake or counterfeit drugs, threatening the safety of the nation’s drug supply. Additionally, the costs associated with importing drugs will likely outweigh the expected savings.  

On the state front, Massachusetts Governor Baker signed and approved the FY2020 budget language presented by the Conference Committee on Wednesday that included a major reform to MassHealth drug pricing. Additionally, last week Massachusetts became the latest state to receive a State Plan Amendment (SPA) that authorizes the state to enter value- or outcome-based supplemental rebate agreements with drug manufacturers for drugs provided to the Medicaid program. CMS Administrator Seema Verma tweeted her support for Massachusetts’s proposal, welcoming other states to follow suit in an effort to receive better drug prices.


Both Congress and the State Legislature have left for August recess, bringing all focus to the fall where both Federal and State legislators will reconvene to discuss new and ongoing legislation around drug pricing.

See all MassBio News