[Updated with comments from George Diamond, Amit Khera, and PK Shah]– The SHAPE-inspired bill requiring reimbursement for MI screening has passed all the stages required to become law in Texas and will go into effect on September 1. The bill was first proposed two years ago, with strong support from the Society for Heart Attack Prevention and Eradication (SHAPE).
The law provides legal backing to the equally controversial SHAPE guidelines, published in 2006 in a supplement to the American Journal of Cardiology sponsored by Pfizer. Despite the presence of many well-respected senior cardiologists on the list of authors, the guidelines were roundly criticized, as they did not represent the findings of a government agency or one of the major cardiology organizations.
In March of this year, when the bill was introduced, SHAPE initially claimed that the bill had been endorsed by the AHA, but this claim was denied by the AHA after CardioBrief asked them to comment. (You can read our editorial about this episode and the ensuing controversy.)
George Diamond, who it should be noted is a member of the SHAPE Task Force, provided the following response to the new legislation:
“This shortsighted legislation encourages the identification of risk but does nothing to encourage the management of that risk. By increasing health care costs today with no assurance of any improvement in outcome tomorrow, it reduces the overall value of care. This will likely have a chilling effect on the future willingness of insurers to pay for proven preventive strategies. I’d much prefer attaching evidence-based incentives to treatment rather than tests.”
Amit Khera sent this response:
“The aim towards increasing reimbursement for preventive strategies for
heart disease is laudable. As the field of atherosclerosis imaging
evolves, we are realizing the potential value of tests such as coronary
artery calcium scanning. Thus, the bill signed by Governor Perry is an
important step towards expanding awareness for heart disease screening
and advancing the potential use of atherosclerosis imaging. However, as
they say, the devil is in the details, and more detailed assessment of
the appropriate group for screening should have occurred prior to
expanding coverage to a large proportion of Texas, especially when costs
and radiation exposure, as well as incidental findings are considered.
For example, the bill mandates coverage for screening men and women
older than 45 and 55 years respectively who also have diabetes or are
intermediate risk or greater by the Framingham Risk Score. Currently,
those who are diabetic or who are greater than intermediate risk by the
Framingham score (ie: high risk) are already treated as coronary risk
equivalents, so atherosclerosis imaging would not change treatment other
than to potentially downgrade risk which has not been studied
sufficiently to know if this is appropriate. Thus, the only group for
which the bill could enhance detection of subclinical atherosclerosis is
the intermediate risk group in the age ranges specified. This is a
logical approach which could improve risk assessment in this group.
However, as we recently demonstrated (Patel M AHJ 2009;157:1001-9),
imaging the “intermediate risk” group in women has very low yield as
few women in the population are in this group.
“It is a telling tale of the political process when this bill on a still
evolving scientific area endorsed by a few individuals passes while the
efforts to pass a statewide comprehensive smoking ordinance with broad
PK Shah told CardioBrief he is “a believer in imaging and atherosclerosis” and that he supports the Texas bill for the following reasons:
“There is plenty of published data , including the MESA trial, that shows that knowledge of subclinical atherosclerosis provides incremental prognostic value over and above Framingham risk in intermediate risk patients, and that a coronary calcium score of zero carries an extremely low risk.”
“We also know that the higher the baseline risk the greater the benefit from risk preventing interventions, and therefore identifying risk when coupled to preventive interventions has the potential to reduce risk. I agree that this has not been tested in a randomized trial, but neither has Framingham risk been tested in a similar fashion.”
“I do agree with George Diamond that risk prediction must be coupled to risk modification in order for screening to be of value, but reasonable inferences can be drawn in the absence of randomized trial data; Medicine cannot simply be practiced only with randomized trial data.”