WASHINGTON -- With the passage of the patient privacy rule of the Health Insurance Portability and Accountability Act of 1996 on April 12, retail pharmacists have two years to gather their patients' signed consent forms as required by the regulation.The Bush administration and the U.S. Department of Health and Human Services implemented the final privacy regulations in HIPAA despite strong opposition

WASHINGTON -- With the passage of the patient privacy rule of the Health Insurance Portability and Accountability Act of 1996 on April 12, retail pharmacists have two years to gather their patients' signed consent forms as required by the regulation.

The Bush administration and the U.S. Department of Health and Human Services implemented the final privacy regulations in HIPAA despite strong opposition from retail pharmacists and related groups, including the Food Marketing Institute, also based here. The rule, which went into effect April 14, will begin enforcement on April 14, 2003.

However, Tommy G. Thompson, secretary of HHS, indicated that further changes to the regulation will be forthcoming, including creating clear guidelines for the "written prior consent" requirement, a mandate that pharmacies obtain signed written consent from patients prior to providing treatment or requesting payment from them. The retail pharmacy community maintains this would be a tremendous administrative burden to them.

"It's better to do it now than wait, provided it can be modified to a usable format," said Dan Alder, vice president of pharmacy operations, Farm Fresh, Virginia Beach, Va. While the modification would ease the "monstrous backflow," Alder said, "what good is the rule if you have to make exceptions? It needs more thought process as to what has been applied to it."

Alder agreed that there should be a degree of patient confidentiality. He gave an example of a patient privacy rule that has been implemented at all 31 Farm Fresh stores for the past two years. According to Alder, every patient has the option of allowing other family members to pick up their medication and obtain their medical record if needed. If they do not want their history made available to other family members, a note is placed on their record, and only the patient can pick up the medication, and his or her medical history cannot be disclosed to anyone.

"Those are the things we should be putting in place, rather than putting cogs in the wheels of the prescription-filling process," he said.

HHS addressed various concerns expressed in some 24,000 comments submitted during a 30-day open comment period, and it is exploring necessary definitive guidelines or recommended modifications. Thompson said this is to ensure that "patient care will be delivered in a timely and efficient manner and not be unduly hampered by confusing requirements surrounding consent forms." He added that "pharmacists will be able to fill prescriptions over the phone and serve their customers in a timely manner."

To execute such modifications, Thompson must put the changes through the Administrative Procedures Act (APA), which includes publishing them in the Federal Register, making them available for public comment for 60 days, and responding to those comments, according to Jeanne Scott, director of government relations for NDCHealth, a health information services company based in McLean, Va.

"The secretary will address the problems pharmacists have raised," she said. "The APA is a lengthy process, so [Thompson] has to get started within six months" if the modifications are to be made by the two-year mark, Scott said.

"President Bush wants strong patient privacy protections put in place now -- our citizens must not wait any longer for protection of the most personal of all information -- their health records," Thompson said in a press statement.

Among the 24,000 comments was a joint letter from 10 pharmacy organizations, including the American Pharmaceutical Association here, as well as FMI and the National Association of Chain Drug Stores, Alexandria, Va.

In the letter, they stated their support of privacy of patient records and their concern over the "prior written consent" requirement.

The letter said, in part, "the new final regulations, if implemented in their current form, are unworkable and will have unintended consequences for pharmacies, pharmacists, and the patients that we serve."

The letter also said this requirement will inconvenience patients due to increased waiting time, and it could potentially hinder their quality of care.

Thompson said they "will keep these [24,000] comments in mind as we continue to make sure patients receive the highest-quality care and begin the process of issuing guidelines on how this rule should be implemented."

This hotly debated component of HIPAA also caused reaction from other retailers and professional organizations.

Dave Hardin, director of pharmacy operations, Food City Pharmacy, the pharmacy arm of K-VA-T Food Stores, Abingdon, Va., voiced concern over the final rule. "I'm opposed to the regulation because of the impact on pharmacy efficiency," he said. "It will impair pharmacists to a point where we cannot effectively counsel patients."

Susan Winckler, group director of policy and advocacy for APhA, said, "The core message has been heard, and we have to be vigilant that the changes made will be good for pharmacists and their patients."

Otherwise, this rule will create even more paperwork for supermarket pharmacists, according to Winckler. She said the problem primarily lies with call-in prescriptions by physicians, where without a signed consent on file, pharmacists' hands are tied and they cannot begin to prepare the prescription.

"We're very interested in supporting privacy protections, but we have to make sure it's done well," Winckler said. For supermarket pharmacists, "it would be a substantial administrative burden, because it would not only be securing the consent, but also tracking it -- I wouldn't know of a pharmacist who wants any more paperwork right now."

Ty Kelley, director of government relations for FMI, had similar reservations. "We're trying every avenue conceivable to get the 'prior consent' requirement out of the regulation," he said before Thompson's announcement. "This prior consent is a disaster for the community pharmacy; it just won't work." He also said another part of HIPAA, which would require documentation of all oral communications, is also unworkable.

"The administrative burden would be tremendous," he said.

NACDS supported the decision to move forward with the rule, albeit a modified version of it. "We have shared our concerns about going forward with a regulation that could limit a patient or caregiver's ability to get needed prescriptions in a timely, efficient and safe manner that will promote their health," said Craig Fuller, president and chief executive officer for NACDS in a press statement.

"In finalizing the regulation," he continued, "Secretary Thompson recognizes the importance of balancing the objectives of medical confidentiality" so pharmacists will not be hindered by these consent forms.

He also said that chain community pharmacies are committed to working with Thompson.

In a seminar at the Supermarket Pharmacy Conference in early April, Scott said, "The issue of one patient, one doctor has changed -- we need a single national rule." According to the pharmacy organizations' join letter, licensed pharmacists must abide by patient privacy standards on a state level, but no state by law requires prior consent by patients.

Winckler said the initial proposed rule, which did not require consent for patient treatment, is much preferable.

"It's got to go back to something closer to the proposed rule," she said before the announcement was made. "If you're going to use patient information for anything outside the pharmacist-patient relationship, it would probably be a good idea to authorize it."

Scott said retailers should be prepared -- and also prepare their employees -- for this regulation, such as designating a senior management sponsor to internally address and review privacy issues.

"Some were shocked in the industry. They thought they had it in the bag that Secretary Thompson would delay the date," said Scott. "April 14, 2003, is a firm-looking date."