Supreme Court ACA Overturn Could Impact 340B, Gut HRSA Enforcement

On Nov. 10, the Supreme Court is scheduled to hear arguments over whether Congress, in scuttling the Affordable Care Act’s (ACA) individual mandate to buy health insurance, rendered the entire health care reform law unconstitutional. The ACA extended 340B eligibility to rural and free-standing cancer hospitals. It also told the U.S. Health and Human Services (HHS) secretary to recertify providers’ 340B eligibility annually, develop guidance on avoiding duplicate 340B discounts and Medicaid rebates, create a 340B ceiling price database, impose fines on drug manufacturers and providers for 340B program violations, develop a formal 340B dispute resolution process and conduct selective audits of drug manufacturers for 340B program compliance. The ACA also required a Government Accountability Office study of 340B that led to 340B covered entity audits. It also said the newly eligible 340B hospitals could not get 340B pricing on orphan drugs. All the health care reform law’s 340B provisions would be wiped out if the Supreme Court strikes down the entire law. Ruth Bader Ginsburg’s replacement with a conservative justice by Nov. 10 could increase the odds that the court will declare all of the ACA unconstitutional.