Privacy rule guidance clarifies medication consent question
Legislation never meant to limit delivery of care, analyst says
The federal privacy rule won’t limit physicians’ ability to phone in prescriptions. Nor will it keep you from discussing a patient’s treatment with another health care professional.
Many pharmacists were concerned after learning the contents of the government’s medical privacy regulations. The regulations, which were released Dec. 20, 2000, are part of the requirements of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. These regulations are designed to limit the nonconsensual use and release of private health information and to give patients rights to access their medical records and to know who has access to them. The regulations will go into effect for most providers on April 14, 2003.
The U.S. Dept. of Health and Human Services (HHS) recently tried to clear up some confusion about the regulation by releasing the first of several "guidances," which explains and clarifies key provisions of the rule. This guidance is available at the HHS Office for Civil Rights web page, www.hhs.gov/ocr/hipaa, under the heading, Technical Assistance.
Notable to pharmacists is HHS’ intention to modify the rule to allow them to fill physicians’ phone-in prescriptions before obtaining patient consent. The guidance also says that pharmacists may give advice about over-the-counter medications without obtaining consent, as long as they do not set up personal records. In addition, friends or family members may pick up prescriptions for patients when pharmacists effectively verify that they are involved in the patient’s care.
Rule’s intention misunderstood
The rule never intended to cause concern about such issues, says Joseph L. Pokorney, vice president of Phoenix Health Systems in Montgomery Village, MD. "I don’t think there was anything in the original intent that was designed to limit the delivery of care in the sense of pharmacists speaking with patients about medications or anything else."
Pharmacists — either salaried or contractors — are covered under the rule if they operate and treat patients within their provider environment. "The intent was not to get separate consents for every department that deals with that patient," Pokorney says. "The intent was to get the consent for that covered entity." Under the definition of either treatment or operations, pharmacists would be covered in their routine dispensing of drugs, filling prescriptions, or giving advice to a patient.
But what about formal or informal conversations with other health care providers about drug therapy or patient treatment? "As long as the discussion is about a specific patient and progress or lack of progress of that patient to a drug therapy or any other sort of combination of treatments, there would be nothing in this regulation that would limit a pharmacist who is a care provider from discussing that with a physician or someone who was treating that same patient," says Pokorney. This is different from having a casual interest in how a particular drug seems to be working on a half-dozen patients without any focus or purpose to the conversation. "As long as [the communication] relates to treatment or a specific patient, it is going to be covered under that same definition of delivering care," he points out. The rule does require, however, that hospitals provide reasonable precautions to protect confidential information, such as using curtains or screens.
This guidance, which was published in early July, is the first in a series expected from HHS. Pokorney doesn’t anticipate any dramatic changes or delays in the remaining guidances. "I’m sure that sometime in the next few months, by the end of this year at the latest, [HHS] will probably go through the normal NPRM (Notice of Proposed Rulemaking) process of submitting some suggested changes — I don’t think they will be significant or dramatic. I believe [HHS] will want to get that process completed so that it does not impact the April 2003 date."
Some congressmen and medical groups, however, are trying to get the regulation halted altogether. For example, several bills have been introduced in Congress that would delay the HIPAA effective date. The South Carolina Medical Association in Columbia and the Louisiana State Medical Society in Metairie also have asked the U.S. District Court in South Carolina to overturn portions of the regulation. The suit argues that HHS’ issuance of the rule is an unconstitutional delegation of congressional authority. The suit also alleges that the HIPAA clause on pre-emption by more stringent state laws violates constitutional due process protection because it is too vague.
The Association of American Physicians and Surgeons (AAPS) in Tucson, AZ, has filed a lawsuit against HHS, too. This suit challenges the actual constitutionality of the regulations themselves based on the content and outcomes. The lawsuit claims that the regulations illegally violate the Constitution and Amendments, as well as the Paperwork Reduction Act.
Pokorney calls these lawsuits "delaying tactics" and doesn’t expect them to have any impact on the regulation. "I think there is a possibility that when the [HIPAA] security regulation is published, which will then give us a final date for security [implementation], there might be some move via a change in regulation to make all the effective dates the same. That could also take the form of just relaxed enforcement as opposed to an official changing of the compliance date."
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