By Daniel G. Gottlieb
On April 2, the European Parliament voted overwhelmingly to repeal the current EU Directive on clinical trials of medicinal products for human use and replace it with a new Regulation. The primary goals of the new Regulation are to:
- Streamline the approval process for studies conducted across multiple Member states;
- Harmonize the regulation of clinical trials throughout the Member states; and
- Increase transparency of Clinical Trial results.
It was the European Parliament’s hope that accomplishing the first two goals would increase the number of clinical trials being conducted in the EU. The Regulation has streamlined the … Continue Reading
Now that we have sweeping new health care legislation, the Patient Protection and Affordable Care Act ("the Act"), let’s look at the rollout of the accountable care provisions–i.e., those changes to the payment and delivery system that hold the most long-term promise of improving quality and cost-efficiency. They are discussed in my most recent article: "The Timeline for Accountable Care: The Rollout of the Payment and Delivery Reform Provisions in the Patient Protection and Affordable Care Act and the Implications for Accountable Care Organizations," published last week in the BNA’s Health Law Reporter. Click here to read the full article … Continue Reading
Much of the work of the Commonwealth Fund and others seems to presume that payors are a necessary intermediary and should be the entities doling out population prepayment (aka capitation before it was a nasty word). However, it need not work out that way – particularly with House Dems’ concern that Medicare Advantage was profiteering.
It would be a small step for the new public plan likely to be created to make “population prepayments” directly to integrated health systems particularly because the covered lives under such a plan are likely to have the benefit of public reinsurance. Also, since … Continue Reading