Lifetime Citizen Portal Access — AI Briefings, Alerts & Unlimited Follows
Experts urge Congress to cut health‑care barriers: certificates of need, licensing recognition and biosimilar rules
Loading...
Summary
Witnesses and senators discussed state certificate‑of‑need laws, certificate‑of‑public‑advantage immunities, licensing recognition across states, and barriers to biosimilar competition and generic entry created by patent listings in the FDA Orange Book.
Senators and witnesses spent a substantial portion of the hearing on how healthcare regulations at both state and federal levels impede competition and raise costs for patients.
Why it matters: Health care was repeatedly cited by witnesses as a sector where both private and public rules can suppress entry, raise prices and reduce availability — particularly in rural and underserved areas.
Doha Mecky, a senior fellow at UC Berkeley, told senators “certificate of need laws…in about 35 states” require bureaucratic permission before providers can enter or expand — a barrier she said incumbents exploit to block entry, raise prices and reduce patient access. Mecky urged Congress to incentivize repeal or otherwise reduce these state requirements.
Panelists also discussed certificate‑of‑public‑advantage laws, which can give state governments the power to immunize private mergers; witnesses said those laws have been used to bless hospital consolidations that reduce competition. Professor Daniel Francis urged federal interventions to protect interstate mobility of professionals and suggested a range of measures — from federal incentives for interstate license recognition to a federal right to work across state lines in certain cases.
On drug competition, senators and witnesses highlighted that over‑listing patents in the FDA’s Orange Book can trigger stays that delay generic entry. As one witness put it, an administrative check of patents listed in the Orange Book would reduce abuse: “We should let the PTO check that’s not being abused,” Francis said.
Senators asked for specific fixes: repeal or reform of certificate of need rules, scrutiny of state immunities that allow anti‑competitive mergers, incentives or federal programs to ease license recognition across states, and administrative or statutory remedies to prevent abuse of Orange Book listings that delay cheaper biosimilars and generics.
Several witnesses also recommended boosting resources for federal enforcers and using both antitrust litigation and careful regulatory change to open health care markets while preserving safety protections.
The subcommittee requested additional materials and written suggestions for statutory language and agency coordination, and no bills were voted on during the hearing.
