Legislative Changes to I-STOP: Are They a Good Thing?
By Connie Sinclair, Senior Consultant
New York’s I-STOP (Internet System for Tracking Over-Prescribing) Act went into effect March 27. This tough law requires that most state physicians use electronic prescribing (ePrescribing) for both noncontrolled and almost all controlled substances (EPCS).
Now that the mandate has been in place for more than six months, prescribers and pharmacists have identified work-flow problems caused by the all-electronic requirement. Several pieces of legislation have been introduced to address such concerns raised by prescribers. Are these proposed changes needed refinements or are they a form of prescriber pushback? It depends.
The first bill, NY A 9335B, was signed into law September 29. It abolishes a rule requiring doctors to file reports with the state Health Department each time they issue verbal or written prescriptions when ePrescribing is not technically possible. Now, doctors can simply make a note in a patient’s record when such a circumstance occurs. We support the concept of this slight change to I-STOP. Doctors who are trying to do the right thing need the ability to make exceptions from time to time without being burdened by unnecessary red tape. For example, it can take weeks to months for a newly launched drug product to be added to the drug file in a prescriber site’s electronic health record. This is an instance for which a written prescription might be the only option. However, we are concerned it could create a loophole for those prescribers who might abuse the less restrictive scenario. Our bet is that New York will be monitoring for prescribers having a disproportionate amount of written or verbal prescriptions.
Two other bills were vetoed and we agree with Governor Cuomo that they should not have been enacted. Here’s why:
NY A 9837 would have authorized physicians to send electronic prescriptions to a website accessible by pharmacies. If a patient’s pharmacy is unable to access an electronic prescription, the prescriber may issue a hard copy of the prescription to the patient. In fact, this vaguely described prescription site in the cloud doesn’t exist and there are no industry standards or plans to create it, so this bill would have created a huge loophole for avoiding the mandate.
The other piece of proposed legislation, NY S 6778, would have created an exception to the ePrescribing mandate for nursing homes by allowing verbal prescribing if deemed in the best interest of a patient. The authors explained that such an ePrescribing exemption is needed because nursing home doctors often work offsite or part time. As a result, they may need to phone in prescription orders to nurses, who can quickly administer medications to residents. They apparently have not read I-STOP, which already contains provisions allowing doctors to phone in prescriptions on an emergency basis. Reading between the lines, this is yet another attempt to circumvent the law by those who wish to avoid or delay ePrescribing.
One more piece of legislation that is in the governor’s hands, NY A 10448, proposes what we believe is a good solution to a problematic situation. In the old world of paper prescriptions, whenever a patient went to his or her chosen pharmacy and found the prescribed drug to be out of stock, that patient would simply carry the paper prescription to another pharmacy. As is the case in most states, pharmacists may transfer a prescription to another pharmacy for subsequent refills, upon patient request, if the prescription has already been filled at least once by the transferring pharmacy. However, this creates a gap if an electronic prescription is delivered to the patient’s preferred pharmacy but that pharmacy is unable to fill it. The current law does not allow transfer of that new prescription because only refills may be transferred. This proposed change would fix that. The key to any modification of the original mandate is to take great care to reduce unnecessary work-flow burdens that might inadvertently be introduced, while maintaining the integrity of the mandate. Unintended consequences of getting this wrong are:
1. Weakening the I-STOP statute. Creating exemptions to a tough law generally is a bad idea. Exemptions start to weaken a law, as well as create implementation and enforcement challenges. It also creates discontent among those who have been compliant and made necessary technology and implementation investments only to learn they could have saved a lot of time and effort like the laggards to adoption.
2. Creating an appetite for more exemptions. Legislative success breeds legislative success. It is, however, a slippery slope. Once an interest group starts chipping away at legislative requirements, the momentum increases for it do more of the same. NY A 9837 and S 6778 were steps in that direction. Fortunately, they were vetoed. But now that the legislative ice has been broken, what other I-STOP provisions will face the legislative chopping block down the line?
3. Sending the wrong message to other states looking to follow New York’s lead. I-STOP is considered a national legislative model to prevent fraud and drug diversion by requiring mandatory ePrescribing for both noncontrolled and controlled substances. States play “follow the leader” in terms of legislation. Other states might get cold feet if they think the New York law has been watered down or enact similarly watered-down versions themselves. This could lead to lesser ePrescribing and EPCS requirements in other states, as well as weaken efforts to address fraud and drug diversion. We think this is a suboptimal result and bet law enforcement would agree.
Point-of-Care Partners is closely monitoring the impact of I-STOP in New York and the rise of similar legislation in other states. Our ePrescribing State Law Review was created to keep companies current with federal and state regulatory changes so they can proactively identify opportunities and modifications that may be needed. Subscribers receive ongoing, in-depth analyses of relevant prescribing rules and have access to our regulatory experts. An abbreviated summary, the ePrescribing State Law Capsule, is available on a complimentary basis.
Ms. Sinclair is director of the Point-of-Care Partners Regulatory Resource Center. She can be reached at connie.sinclair@pocp.com.
