The requirements are supposed to go into effect on April 14 -- most providers would then have two years to comply -- but that date may well slip.
Pres. George W. Bush's Health Secretary Tommy Thompson has opened up the rules for additional public comments; in the coming weeks, the Administration may delay the effective date and rework the rules.
According to CVS pharmacy executive Carlos Ortiz, who testified Thursday at a congressional hearing on the rules, the standards would require pharmacies to obtain written consent from patients before filling any of their prescriptions. The rules are a "prescription for chaos," he said, since 40% of prescriptions are dropped off and picked up by someone other than the patient. To continue serving patients, CVS would have to prepare patients for the written consent requirement. That would cost more than $60 million, Ortiz claimed.
Not true, says Goldman, who also participated in Thursday's hearing. She tells WebMD, "They are overreacting. For prescriptions to be filled and for relatives to pick up prescriptions, the government intended that, and they say that [in the rule]."
Moreover, she says, pharmacies are not directly treating patients and do not need to get written consent. "If the doctor gives the prescription to the pharmacist, or if they send it with a patient, that then creates an indirect treatment relationship," she says.
According to John Clough, MD, director of health affairs for the Cleveland Clinic Foundation, by requiring that patients give their consent for release of their records, "routine practices by providers will be disrupted, from sending out reminder notices about appointments to conducting disease management and maintaining quality assurance programs."
But Goldman tells WebMD, "The regulation is very clear that you can get consent as it's practical to get it after the two-year period, that you get it as you can get it. The next time a patient comes in for care, you can get it. In the meantime, you can use their information."
Health providers are also raising cost concerns. John Melski, MD, a medical director at Wisconsin's Marshfield Clinic, said, "We will have to explain the consent and notice to each patient. We wonder who will explain these forms to our patients. We suspect that we will need to hire and train informed consent counselors who must staff our regional centers on a full-time basis."