As you may have heard from reports in the media the Biden Administration froze a recent regulation on insulin. Want to know what the headlines mean? Read on to get all the details.
On January 21, the Biden Administration placed a freeze on all newly published regulations set forth by the previous Administration that had not yet been implemented. This includes a regulation that will require community health centers (CHCs) to pass certain discounts for insulin directly to people with diabetes. But this had not gone into effect yet, so the freeze has no immediate impact on the cost of insulin.
This insulin-specific rule wasn’t the only one affected, rather the freeze applied to all rules established late in the previous Administration that had not yet taken effect. This practice is common between administrations, and especially if the new President is from a different party than their predecessor. This freeze, or review period, will last 60 days and allows the new Administration the opportunity to fully evaluate these rules before deciding whether to make changes, roll out as-is, or nullify.
So, what would this proposed rule do? It would require CHCs to pass the discounts they receive on insulin through to their patients whose income is at or below 350% of the Federal Poverty Level (FLP). CHCs already offer discounted drug pricing, and the proposed rule would expand the people eligible for the discounted pricing to those with a household income between 200% – 350%. For reference, for a family of four 200% – 350% FPL equates to $52,400 – $91,700 respectively. Said another way, this rule does not apply broadly to all those using insulin, but is limited to those who receive their care at a CHC and have income at/below 350% of the Federal Poverty Level (FPL).
It is worth noting – prior to the last Administration publishing this rule – several key CHC stakeholders raised objections to the complexity of the rule compared to its limited impact, highlighting that most CHC patients already receive discounted drug prices. In other words, even without this rule in effect, today, people with diabetes can access low-cost insulin at CHCs.
Breakthrough T1D includes information on this low-cost option and other means for securing affordable insulin in our T1D Health Insurance Guide.
As an organization founded by family members of those with T1D, insulin access is a top priority. We are committed to pursuing and supporting comprehensive and systemic reforms that reduce out-of-pocket costs of insulin for everyone with T1D. As Breakthrough T1D engages the new Administration and the new Congress, we will continue to advocate for legislation and policies that make insulin more affordable.
We’ll be monitoring the status of the delay to this proposed rule and update this blog with anything new.
Update*
On October 1, the Biden Administration formally rescinded the rule adopted by the Trump Administration requiring community health centers (CHCs) to pass through insulin savings directly to their patients.
When HHS asked for additional feedback on the rule in March, Breakthrough T1D submitted comments requesting the Biden Administration find a solution to the administrative challenges raised by stakeholders and implement the rule in order to ensure access to life-saving insulin. We believe it is vital that policies that can remove barriers to insulin affordability, even if narrow in their impact, be pursued given the life-saving nature of insulin.
We are disappointed by the Administration’s decision to repeal this rule. We are committed to pursuing and supporting comprehensive and systemic reforms that reduce out-of-pocket costs of insulin for everyone with T1D. JDRF continues to work with the Administration and Congress to ensure that no one should suffer or die because they cannot afford insulin.
