Showing posts with label safety. Show all posts
Showing posts with label safety. Show all posts
Preauthorization vs Retroactive Audits for Patient Safety
Tuesday, March 25, 2014
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| "If youre telling the truth, hit 1; if not, hit 2. If youre not sure, please wait on the line....." |
Once again, the DMCB eschews common wisdom:
The reason why insurers have used small fonts in their coverage documents has been because their state regulators likewise use small font in their rule making and require full word-for-word disclosure to the beneficiaries. Think of lawyers run amok and youll understand the main reason for the arcane language.
The good news is that new regulations promise easy-to-understand "labeling." The DMCB thinks thats a step in the right direction, but that doesnt mean that a lack of preciseness wont lead to misinterpretation and wrong assumptions. Time will tell.
As for the opaque decision-making, check out (for example) Aetnas and Humanas open-access coverage documents. Yet, despite a high level of on-line transparency, critics may point out that commercial insurers will still require a hassle-laden preauthorization process.
That may be true, but the DMCB says who can blame them? There is literature here here and here that point out that physicians will readily resort to deception get a proposed treatment covered.
To really make the point, check out this just published Health Affairs article. Using a validated survey on a representative sample of physicians (obtained from the AMAs masterfile, which contains all practicing docs, not just AMA members), about 10% of the respondents indicated that, in the past year, they had lied to a patient. A whopping 50% admitted telling a patient that their prognosis was better than warranted.
Egads. This is not only driving medical costs, its increasing variation and exposing patients to unnecessary and potentially dangerous treatments.
Keep in mind that the fee-for-service Medicare program does not engage in "preauthorization" that can lead to a usal to pay for a treatment. Rather, Medicare generally pays all claims and then relies on retroactive audits to "claw back"any improper payments.
While that has shielded the Medicare program from being lumped in with all the allegedly evil commercial insurers, the DMCB asks two rhetorical questions about the few bad apples who are hurting the profession:
Which would you rather have for you, your parent or your child: an insurer that scrutinizes a proposed treatment ahead of time and doesnt necessarily take the docs word for it, or an insurer that lets things happen and uses hindsight after the damage is done?
And last but not least, how will the new payment mechanisms, like bundling and shared savings, reduce the likelihood of bad behavior?
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New Ad for Actos in Wake of Avandias Revised Safety Warning
Saturday, March 15, 2014
On the heels of Avandias new safety warning addressing a potential increased risk for heart attack (see previous post), Takeda, maker of Actos (pioglitazone), plans to launch a big advertising campaign using the headline:"If you have type 2 diabetes, Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke."The FDA reviewed cardiovascular data from Takedas PROactive study and approved this claim.
Avandia and Actos are the only drugs in the class of diabetes medications known as thiazolidinediones. They work by increasing insulin sensitivity.
Both drugs, however, may worsen heart failure, a condition in which the heart does not adequately pump blood, and are labeled as such. Below is Actos boxed warning regarding heart failure:
Thiazolidinediones (TZDs), including ACTOS, cause or exacerbate congestive heart failure (CHF) in some patients. After initiation of ACTOS and after dose increases, observe patients caully for signs and symptoms of heart failure (including excessive rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of ACTOS must be considered.
ACTOS is not recommended in patients with symptomatic heart failure. Initiation of ACTOS in patients with established NYHA Class III or IV heart failure is contraindicated.
Takedas press release responding to Avandias new safety warning:
Re. U.S. Food and Drug Administration Decision Summary
Institute of Medicine Agrees Health IT Poses Risks to Safety Here Are Their Recommendations
Friday, March 7, 2014
| A CAT scan. Wheres that big spleen? |
Approximately one year later the patient returned for an appointment. Thats when it was discovered that the CAT scan had never been scheduled. The DMCB was later told that the EHR wasnt configured to schedule tests 6 months in advance.*
Its on behalf of patients like this and their physicians that the DMCB welcomes this Institute of Medicine report on Health IT and Patient Safety. It recognizes what most front-line EHR-using physicians have known for years:
"The evidence in the literature about the impact of health information technology (IT) on patient safety, as opposed to quality, is mixed but shows that the challenges... involve people and clinical implementation as much as the technology. The literature describes significant improvements in some aspects of care in health care institutions with mature health IT. For example, the use of computerized prescribing and bar-coding systems has been shown to improve medication safety. But the generalizability of the literature across the health care system may be limited. While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk." (bolding from the DMCB)
In other words, selective reporting involving best case scenarios fail to account for the reality that the old safety issues of a paper-based system are being displaced by new safety issues of an IT system and, whats worse, we dont know the extent of the problem.
Here are the IOMs (paraphrased) recommendations to Health and Human Services (HHS):
1. HHS, working with the EHR vendors, should develop a health IT surveillance plan.
2. HHS should foster the free exchange of information and address the "legal clauses" in contracts that shift liability from the vendors to the doctors (The AMA has erred to these as "hold harmless" clauses).
3. Data is needed that allows health IT users to publicly compare and share experiences among multiple vendors.
4. "A Health IT Safety Council" that assesses and monitor health IT safety should be established.
5. A public register of all health IT vendors should be established.
6. Its time to specify those processes that reduce risk and make the vendors adopt them.
7. Health IT related deaths, serious injuries and unsafe conditions need to be centrally reported.
8. An independent federal entity should be established that is empowered to any investigate deaths, injuries or unsafe conditions.
9. HHS should report annually on its progress.
10 More cross-disciplinary research is needed to improve the design, testing and use of health IT.
Bravo says the DMCB, bravo!
*many of the facts are changed, but you get the gist
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