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HRSA just finalized a rule implementing a Trump drug pricing EO. The rule requires community health centers to pass along 340B discounts for insulin & injectable epinephrine (Epipens) to qualifying patients below 350% of poverty ($76K for family of 3). 1/9 https://public-inspection.federalregister.gov/2020-28483.pdf
The rule is being finalized without big changes from what was proposed, despite HRSA saying that 175 of the 222 comments it got were opposed to the rule or wanted it delayed. 2/9
The rule will take effect in about 30 days. At that point, passing along 340B discounts for insulin and epinephrine will be a condition of future HRSA grants to CHCs. CHCs will likely fall under this requirement within a year since their operating grants are annual. 3/9
CHCs are already required to provide free care (including Rx) to patients <100% FPL and to have a sliding fee scale up to 200% FPL so patients from 200-350% FPL will get the most help from this change. 4/9
To qualify for the new cost sharing protections, patients <350% FPL also need to have high cost sharing (defined as >20% of what the CHC is charging patients), a high unmet deductible or be uninsured to qualify. 5/9
This rule will likely help some patients struggling to afford insulin and epinephrine – but it won’t be a silver bullet since people only qualify for the discounts if they are patients at the CHCs (just filling a script there doesn’t cut it). 6/9
Since HRSA grants require that CHCs reinvest any money they make off of the spread between 340B acquisition cost and payment for the Rx, this policy could leave CHCs with fewer resources to help other patients struggling to afford care. 7/9
This policy could have had a broader reach if it had included 340B hospitals. CHCs and other HRSA grantees represent less than 20% of 340B sales (78% are from DSH hospitals). 8/9 http://medpac.gov/docs/default-source/reports/may-2015-report-to-the-congress-overview-of-the-340b-drug-pricing-program.pdf?sfvrsn=0
The policy only impacts CHCs b/c the regulations don’t rely on HRSA authority under the 340B statute. That may be b/c HHS thought it didn't have regulatory authority. We will have to watch and see how the Biden administration interprets its authority over 340B. 9/9
