New e-prescribing regulations are applauded by medical community

As part of the federal government’s ongoing push to make health care go paperless, the Centers for Medicare & Medicaid Services (CMS) recently adopted final standards for electronic prescribing under Part D, Medicare’s prescription drug benefit.

Related stories:

• Holding on to your prescription pad? Barriers to e-prescribing
• The legal pros and cons of e-prescribing

Under the new regs, which take effect April 1, 2009, any physician who electronically prescribes drugs covered under a Part D plan must comply with new CMS standards for• Communication of formulary and benefits information between providers and Part D plan sponsors;

• Communication between providers about a patient’s medication history; and

• Pharmacy-to-provider fill-status notifications.

The new regs also require physicians who are using e-prescribing to identify themselves using the National Provider Identifier (NPI).

While e-prescribing remains optional for physicians and pharmacies, Part D plans will be required to have the proper infrastructure in place to support e-prescribing. And any Part D plan that offers e-prescribing will be required to adhere to the new standards.

Physicians and health care attorneys laud these new standards as a positive development given the advantages of e-prescribing from a risk management and operational standpoint.

But they also say the standards don’t go far enough to achieve the government’s goal of universal e-prescribing under Medicare by 2011. Legislation that is currently pending in Congress would penalize physicians who are not prescribing electronically by that time. (See “Holding onto your prescription pad?” on page 8 and “The legal pros and cons of e-prescribing” on page 9.)

For example, standards for critical pieces such as structured and codified SIG (which would create standardized ways of writing directions for using medication), clinical drug terminology and prior authorization of certain drugs remain incomplete.

Meanwhile, the new standards don’t clear some of the government’s own roadblocks to complete implementation, such as its ban on e-prescribing of controlled substances.

“It’s a step in the right direction, but it’s not big enough,” says Steven J. Stack, head of the emergency department at St. Joseph’s Hospital East in Lexington, Ky., and chair of the American Medical Association’s Health Information Technology Advisory Group. “Far and away, physicians will embrace e-prescribing as a means to improve patient safety, improve efficiency and improve quality of care, but the government has to finish its homework first so the system will really work.”

Meanwhile, observers point to cost concerns and the lack of systems directly approved by CMS as additional barriers to widespread implementation.

“It would be nice if CMS would actually certify certain vendors as meeting their standards,” says Shrewsbury gynecologist Dale Magee, immediate past president of the Massachusetts Medical Society. “Doctors don’t buy computers and software that often and I would hate to see doctors being confused by vendors who overpromise what their product can deliver.”

The standards

The government’s push for e-prescribing began in 2003 with the Medicare Modernization Act, which gave birth to Part D, the voluntary Medicare prescription drug benefit. It also included provisions to foster e-prescribing by requiring certain standards and allowing third parties, such as hospitals, to offset the costs.

By the beginning of 2006, CMS had standards in place covering transactions for new prescriptions as well as requests for prescription refills, changes and cancellations. CMS also adopted standards for eligibility and benefits queries.

In November 2007, CMS published the results of pilot tests for five new standards: formulary and benefit information, medication history, prescription fill-status notification, structured and codified SIG and prior authorization.

CMS was satisfied with the standards for the first three tools but not the latter two. Accordingly, on April 2, 2008, it adopted those three standards only – in addition to mandating that providers use their NPI when prescribing electronically.

Here is a look at the benefits of e-prescribing systems that include the types of information covered by the new standards:

• Formulary and benefit information

An e-prescribing system that provides instant access to formulary and benefit information – such as informing a doctor that a particular drug isn’t covered or that a generic or off-patent drug will carry a lower co-pay – enables physicians to address coverage issues with the patient up front, says Boston health care attorney David Szabo, a partner at Nutter, McClennen & Fish LLP.

A doctor “can avoid the whole paper chase where a patient gets a prescription, goes to the pharmacy, is told it’s $50 a pill, gets upset, and calls you, forcing you to call the health plan or change the prescription,” he says. “Some systems may actually be able to provide a doctor with backup clinical information about alternative medications or a mechanism for the doctor to appeal for coverage of a higher-cost drug.”

Eric Poon, an internist at Brigham and Women’s Hospital in Boston, agreed. “Having formulary support is often very helpful,” says Poon, who is also the hospital’s director of clinical informatics.

However, he wonders if there’s enough technological integration at this point to make these systems work.

“It’s not clear how this will be implemented across all different Medicare Part D plans to make sure there’s good mapping between the e-prescribing system the physician will be using and what’s actually on the formulary,” Poon said. “The system needs to be able to recognize what the insurance company will pay for.”

• Medication history

The medication history standard is equally critical because the e-prescribing system will put doctors on notice of potentially bad drug interactions, says Szabo.

“You have a system that can show the doctor what drugs the patient has purchased in, say, the last six months,” he says. “Even if there’s no drug-drug interaction, the doctor might look at the list and say, ‘Boy, you’re taking a lot of pills here.’”

It’s also useful for medication reconciliation in cases where elderly, incompetent or other patients can’t clearly tell the doctor what medications they’re on, Szabo adds.

But on the flip side, Poon warns that this can potentially be too much of a good thing.

“It’s very easy for a system to over-alert,” he says. “Physicians may get too many alerts as they try to prescribe and may blow past all of them. They could throw the baby out with the bathwater and miss the one truly important interaction.”

• Fill-status notifications

Meanwhile, fill-status notifications can be a valuable tool to help physicians follow up on their patients, says Boston lawyer Colin Zick, who practices with Foley Hoag LLP.

“Let’s say you prescribe medicine for high blood pressure and they stop taking it, because they don’t like it, it costs too much and they’re taking half as much as they’re supposed to, or they share it with their spouse,” he says. “Now you have this compliance issue. Fill-status notification doesn’t tell you how to solve that problem, but at least you know an issue is there and you can try to address it.”

But Zick wonders whether this tool can create a legal obligation for the doctor to follow up. “And if you undertake the follow-up, do you have the additional duty to keep following up? I don’t know the answer, because this is brand new.”

David Harlow, an attorney and health care consultant in Newton, says he doesn’t know the answer either.

“But I’m sure a plaintiff’s attorney would certainly bring it to a patient’s attention,” he says. “As with any tool, if it’s available and you don’t use it, it’ll be held against you one way or another.”

Questions or comments should be directed to the editor at: reni.gertner@mamedicallaw.com