The Trump administration on Tuesday blocked community health centers from receiving future grant funds unless they charge low-income patients the acquisition price for insulin and Epi-Pens, plus an administration fee.
The final rule aims to lower patients' out-of-pocket costs by forcing community clinics to pass on their 340B drug discounts. It requires federally qualified health centers to give their discounts to the uninsured, patients with high cost-sharing for insulin or Epi-Pens or a high unmet deductible.
"We remain troubled by the administration's continued insistence on a rule that will make it harder for health centers to provide life-saving and affordable medications and services for patients in the midst of a pandemic. Our hope is that policymakers will recognize that a pandemic is no time to destabilize the safety net. Certainly, the high cost of prescriptions remains a national crisis – but health centers are the solution — not the problem," a National Association of Community Health Centers spokesperson said in an email.
Experts say the move probably won't make much of a dent in drug prices because it won't affect most providers or patients.
"Because this rule is limited in scope to two classes of drugs that are of particular need … HHS believes it will have minimal economic impact. The economic impact is also expected to be minimal given the rule is limited to only two drug categories, which are available under the 340B Program at significantly reduced prices," the rule said.
The rule goes into effect Jan. 22, just two days after President-elect Joe Biden takes office.
In the runup to November's election, President Donald Trump signed a flurry of executive orders meant to lower drug prices. Health centers were blindsided in July when he directed HHS to crackdown on their drug discounts.
Republican lawmakers have expressed concern about expanding the 340B drug discount program. But their complaints have generally centered around hospitals, not community health clinics. Federally qualified health centers are legally required to reinvest any savings from 340B in community services, a standard that does not apply to hospitals.
In comments on the proposed rule, providers argued the changes were unnecessary and could do more harm than good. NACHC said the rule reflected "a fundamental misunderstanding" of federally qualified health centers and the 340B program. And providers worried the regulation could reduce patients' access to care by cutting deeper into community health centers' thin operating margins.
HHS' Health Resources and Services Administration clarified the rule only applies to health center patients "who receive in-scope health center services beyond dispensing of drugs that are self-administered or administered at home." It also made clear that health centers don't have to provide discounts to underinsured patients if it would violate the terms of their insurance contracts.