Skip to main content Back to Top


HHS Hears Pharmacy's Perspective on Regulatory Reform

Donna Young

Pharmacists should get involved in public policy decisions that affect patient care, adverse-event reporting, and other health care issues, said Michele M. Evink, pharmacy services director at Clarke County Hospital in Osceola, Iowa, and the only pharmacist to serve on the Department of Health and Human Services (HHS) Secretary's Advisory Committee on Regulatory Reform.

The committee, a 29-member panel created in December 2001 consisting of health care professionals, consumer advocates, and industry representatives, made 255 recommendations to HHS Secretary Tommy G. Thompson in November 2002 about simplifying complex and confusing health care-related government regulations.

In the course of its work, the committee held a series of teleconference meetings and regional public hearings in five cities: Miami, Florida; Phoenix, Arizona; Pittsburgh, Pennsylvania; Denver, Colorado; and Minneapolis, Minnesota.

EvinkAs a member of the committee, Evink was able to bring pharmacy's issues to the table.

"I am really happy that HHS chose to include pharmacy in the discussion," she said. "I hope that my involvement on this committee will help others see how much [their] involvement on similar committees can mean to pharmacy."

Pharmacy associations, she said, need to stay seriously committed to submitting names of pharmacists for consideration for state and federal advisory committees.

Pharmacists, she added, need to stay in touch with policy issues and build good relationships with their state and federal legislators.
Several states have legislators who are pharmacists, she noted, including Iowa Representative Robert Osterhaus (D-Maquoketa).

"We may not always see eye-to-eye politically," she said, "but he is a fair and good man and a strong voice for pharmacy."

Evink, who has served for four years on the Iowa Pharmacy Association's legislative committee, including two years as chair, and a former association speaker of the house, has been politically active for several years in state and federal issues that affect pharmacists and patients.

When Medicare implemented the hospital outpatient prospective pricing system (OPPS) in August 2000, Evink was "one of the few people ... saying that pharmacy needs to pay attention because this will have a huge impact on how things are billed and how things are reimbursed."
"We have been sounding the alarm for a while, but it was not until [hospitals] hit bottom that everybody realized what a serious issue this was," she said.

OPPS replaced the traditional payment method based on reasonable costs with a system in which the government sets the price for specific aspects of health care and tells providers how much they will be paid.

Many hospitals have reported that they are losing thousands, and in some cases millions, of dollars because of OPPS's complex billing requirements and payment rates that are well below a hospital's acquisition costs for drugs used for outpatient services.

"We've taken a terrible hit for Medicare reimbursement," Evink said. "It is a huge concern because it affects not only our ability to provide patient care but our ability to recruit" health care professionals.

The HHS advisory committee on which Evink served did not tackle OPPS as one of its reform issues, she said.

"The committee chose to not address issues of reimbursement," she said. "We decided it would be best to focus on policy regarding care instead of policy regarding reimbursement."

However, the committee did recommend that HHS develop some legislative proposals with Congress concerning Medicare and other issues.

As a pharmacist working in the Midwest, Evink was able to provide a rural perspective about several issues, including the difficulties involved in recruiting pharmacists and other health care providers to small-town hospitals.

A shortage of qualified health care professionals is one of the "most serious problems facing rural communities and their health care system," the advisory panel noted in its report.

However, Evink said, in its initial recommendation about rural work-force issues, the committee had focused on a shortage of physicians and nurses and not other health care professionals, such as pharmacists.

"One of the limitations I found in the initial recommendations is that we were not including pharmacy," she said. "I was instrumental in getting that wording changed to include all health care professionals."

One Iowa hospital, Evink noted, went two years without a pharmacy director.

"So if we can't recruit here in Iowa, how much more difficult is it in places like the Appalachian Mountains or Western Nebraska," she said.
One work-force issue the committee investigated, Evink noted, was the impact of tighter immigration regulations that have made it more difficult for rural hospitals to recruit foreign health care professionals.

As a member of the advisory panel's data and information subcommittee, Evink was able to highlight the need to automate the Medicare billing process.

"We are hindered as pharmacists because Medicare does not have the same type of online adjudication as Medicaid," she said. "Medicare is behind the times. Coverage issues could be resolved so much easier and quicker online."

Because not all states administer Medicaid the same, Evink said, the committee did not address Medicaid regulations in detail.

However, she said, issues regarding patients with dual coverage by Medicare and Medicaid were investigated.

"When a patient is Medicare and Medicaid eligible, from a facility standpoint, there can be a very long delay deciding whether a person should be covered under Medicare or Medicaid for a particular service," she said. "Some facilities were waiting up to two years for an answer about reimbursements, and that is tough because they have already spent the money on electricity, linens, and staff. It really diminishes your ability to provide care because cash flow has gone down."

The committee recommended that dual coverage issues should be reviewed and addressed within 45 days.

"We decided that 45 days is as long as anybody should be made to wait for an answer," she said.

Evink played a key role in the committee's recommendations regarding FDA issues, such as safe drug-product naming and labeling practices. She said she worked closely with the Institute for Safe Medication Practices and FDA staffers in crafting the language for those recommendations.

FDA should shift from conducting  name-safety testing, in most cases, to reviewing data from sponsors who follow protocols designed to evaluate the potential for look-alike and sound-alike errors with generic and proprietary names before approval, the committee recommended.

"Information gathered from the name-safety research should be used to improve patient safety by minimizing postmarketing medication errors linked to name similarity and practitioner confusion," the committee's report said.

Evink also influenced the advisory panel's recommendations about adverse-event reporting.

The committee recommended that FDA immediately launch an educational and information campaign to educate patients and all health care professionals about the current MedWatch system "to increase the number of adverse events reported."

Further, the committee recommended, FDA needs to evaluate its current information technology systems and study the feasibility of developing a national automatic system for reporting adverse events, adverse drug reactions, and medical errors.