Reflex: August 31, 2011

Regulatory inflexibility has depressed enrollment into the high-risk pool, according to a story by Arthur Delaney (Huffington Post): “The Government Accountability Office reported that the government has so far spent just 2 percent of the $5 billion allocated [… for] the Pre-Existing Condition Insurance Plan.” The requirement to be uninsured for six months and the definition of “creditable coverage” are among the factors blamed for low enrollment. Austin’s comment: This story illustrates the role regulators can play in the success or failure of a program. If HHS had sufficient statutory flexibility to adjust eligibility rules and if it used that flexibility, things might be different. It’s not all about premiums, though they obviously matter. The question is, how will the remainder of the $5 billion be put to good use?

Gov. Sam Brownbeck’s administration confirms that Kansas will not set up a health insurance exchangereports Scott Rothschild. They want to wait until the Supreme Court fully rules on the constitutionality of the PPACA. Aaron’s Comment: As I’ve written before, this is a real gamble. If the law holds and states don’t have an exchange, the federal government is going to run one for them. A number of Republican governors have decided not to take this chance.

The Presidential Commission for the Study of Bioethical Issues studied the research ethics debacle in Guatamala from 1946-48 and joins the chorus suggesting more uniform standards in the rapidly globalizing world of clinical trials.  At WaPo, Rob Stein focuses on one small aspect of the Report, a recommendation for no-fault compensation for people injured in clinical research.  Kevin’s comment: The compensation suggestion is not a major focus of the Report. It appears to be geared to clinical trial participants injured in low- and middle-income countries. I’m not sold yet – see the trovafloxacin (Trovan) litigation from Nigeria, which would never have seen the light of day if a no-fault system had been in place. As for the main thrust of the Report, I agree fully.  Globalized standards raise costs but avoid a race to the bottom. Implementation doesn’t require global agreements; the FDA and EMEA can unilaterally act as gatekeepers, else the data won’t be submittable to these agencies. 

(H/t, Dylan Matthews)

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