Today, the US Supreme Court ruled to uphold President Obama’s Patient Protection and Affordable Care Act in a 5-4 vote.
This includes the controversial provision requiring uninsured people to buy health insurance or face a penalty. On this so called ‘individual mandate,’ Chief Justice John Roberts writes [pdf]:
Those subject to the individual mandate may lawfully forgo health insurance and pay higher taxes, or buy health insurance and pay lower taxes. The only thing they may not lawfully do is not buy health insurance and not pay the resulting tax.
With the law upheld, the following provisions relevant to biomedical research and commercialization are preserved, Nature News explains:
- The establishment of an abbreviated approval pathway at the US Food and Drug Administration for ‘biosimilar’ drugs: generic versions of large, protein-based drugs whose makers have long lobbied to be able to compete with makers of brand names.
- The authorization of the Cures Acceleration Network at the National Institutes of Health (NIH). This is an effort to speed high-needs cures from lab to bedside. The network is a flagship component of the agency’s new National Center for Advancing Translational Sciences. While authorized to receive up to $500 million annually, in 2012 Congress appropriated just $10 million for the network.
- The establishment and funding of the Patient-Centered Outcomes Research Institute (PCORI) for conducting comparative effectiveness research (explained in detail below). PCORI issued its first grants, worth a total of $30 million, earlier this month.
- The launch of a new requirement that drug and device companies publicly post all payments to physicians of $10 or more in cash or kind. Called the Physician Payment Sunshine Act, it’s expected to go into effect in late 2014.
- Also preserved, a $153 billion in Medicare and Medicaid payment cuts to teaching hospitals over 10 years ending in 2021.
Because teaching hospitals at academic medical centers provide a disproportionate amount of charity care, lawmakers reasoned that, with an insurance mandate in place, they will begin to be paid for that care, allowing the government to recoup the $153 billion.
And just a bit more on PCORI… it goes back to the question, what kind of care patients would receive with their insurance? New Scientist explains.
Evidence-based medicine is when medical procedures are performed because there is good scientific evidence that they can make a difference. Many standard practices – like annual physicals – are largely unjustified, but they’re performed because of a pay structure that incentivizes physicians to offer more tests and procedures.
So the plan is to use ‘comparative effectiveness research’ to assess how useful common medical practices really are: comparing 2 similar drugs or 2 different methods, like surgery and a drug. PCORI will target areas lacking solid scientific knowledge and fund projects to help clarify which methods are the most effective and how patient care in those areas can be improved.
Image: Public Law