As the future of American health care is weighed by the US Supreme Court this week, a few lesser-noticed provisions of the health-reform law being considered by the justices bear on scientists and on biotechnology companies, who may be affected by the court’s decision.
Enacted in 2010, the Patient Protection and Affordable Care Act (ACA) is a sweeping reform of the US health-care system championed by US President Barack Obama and vehemently opposed by conservative politicians and activists. Various challenges to the legislation have worked their way through the court system, ultimately leading to the case now before the Supreme Court. Today marks the third and final day that the court has been hearing oral arguments; a ruling is expected in June.
The issue before the court today was the “severability” of the act — that is, whether the whole law must be thrown out if the nine justices decide that its central provision, which requires most Americans to buy health insurance, is unconstitutional. The Obama administration is arguing that the court can’t sever this so-called individual mandate from the rest of the law; individual states that are challenging the law are arguing that it can.
If the court decides that the whole law needs to be overturned as a package, then four provisions that touch the biomedical-research enterprise would be gutted, too.
The future of the programmes “will turn on severability,” says Kathleen Noonan, a clinical associate professor of law at the University of Wisconsin Law School in Madison and an expert in health law and policy. However, she adds, “most expert observers believe the entire law will not go away because even the lower courts that have struck the individual mandate have held that the other parts of the law are constitutional.”
Nature wrote here about several of these programmes when the ACA became law.
One of them, the Cures Acceleration Network, is a small but symbolic piece of the new National Center for Advancing Translational Sciences at the US National Institutes of Health (NIH). The unprecedented programme was authorized in the health-reform law, and if it ever receives more than the US$10 million that Congress gave it in funding this year, it will dish out individual, $15-million grants to develop cures judged as “high need” by the NIH director. The ACA says that the programme can be funded at up to $500 million, and that awardees, with few exceptions, must match every three government dollars they receive with one of their own. The law also gives the NIH unusual flexibility with 20% of the money, allowing it, for instance, to quickly de-fund grants that aren’t performing.
Because Congress has now funded the programme with the real dollars delivered by an appropriation — even if it is only $10 million — it may be protected even if the law is overturned, some proponents argue.
The ACA also created a new authority for the Food and Drug Administration (FDA) to approve “biosimilar” drugs — generic versions of complex biological drugs such as enzymes and antibodies. At the same time, it protects brand-name biologics makers from generic competition for 12 years.
The long-awaited guidance on how companies should go about getting into this market was issued by FDA just last month — although some constituents felt that it was short on specifics.
That complaint will be a moot point if the entire ACA is overturned, says Tom DiLenge, the general counsel for the Biotechnology Industry Organization (BIO), which represents biotechnology companies. “If the Supreme Court throws out the entire ACA, then the pathway for the approval of biosimilars would have to be re-enacted, either separately or as part of a package of health-care reforms,” says DiLenge. But he adds that BIO thinks that outcome is “highly unlikely.” His reasoning: “There are so many aspects of ACA that have nothing to do with the central focus of the constitutional dispute [over the individual mandate]. Biosimilars is one such aspect.”
The health-reform law also launched the Patient-Centered Outcomes Research Institute (PCORI) to coordinate comparative-effectiveness research — the comparing of treatments to see which is most effective. (The research is a bugbear for conservatives who see it as a first step towards rationing health care.) Like the other programmes established by the ACA, the institute is young: it released its draft research agenda only in January. How old it grows to be is in the court’s hands now.
Finally, the Physician Payment Sunshine Act, authored by Senator Charles Grassley, an Iowa Republican, is also part of the ACA. It requires drug and device companies to publicly post all payments to physicians and teaching hospitals, in cash and kind, of over $10 — and even those under $10 if they cumulatively reach $100 in a given year. Grassley could not be reached for a comment on the risks he perceives to the sunshine law as the high court weighs the ACA. An excellent fact sheet on the law from the Pew Prescription Project is available here.