Practical Implementation of the DEA Hydrocodone Schedule II Rules

Dan Bragg

The complication of implementing the new rule from the DEA that took effect on October 6, 2014, reclassifying hydrocodone and hydrocodone-containing products (HCP) as Schedule II controlled substances, is immense. The new rule prohibits refill prescriptions from being called or faxed in to the patient’s pharmacy, and in some states non-physician providers who have prescriptive authority may have a significant change to their prescribing authority or not be able to continue prescribing HCPs at all. Also, most practices do not have the ability to electronically prescribe Schedule II medications through their Electronic Health Record due to the increased biometric security requirement and the inability of pharmacies to receive and administer.

The question is how a neurosurgical practice develops workflows and communication tools to implement the new rule. Neurosurgery Executives’ Resource Value & Education Society (NERVES) members participating in its listserv have had a great deal of discussion on how to proceed. We want to share with you some of the ideas that other administrators have developed for their practices.

One question discussed was whether or not a practice needs to use tamper-free paper for the Schedule II prescriptions. Again, each state has its own set of rules, but CMS does mandate that Medicaid Schedule II prescriptions be written on tamper-proof paper. It seems to be the consensus that for ease of administration, all Schedule II prescriptions should be printed on tamper-free paper. This paper is expensive, so discussion as to having the ability to print to different printers might be beneficial (e.g., one printer loaded only with tamper-proof paper and another printer loaded with normal paper for non- Schedule II medications, or a two-drawer printer with one drawer loaded with tamper-proof paper and the other drawer loaded with normal paper).

Obtaining original signatures for post-operative pain medication refills will increase the length of time needed to process the prescription on behalf of the patient. Communication to our patients is essential in reducing anxiety and frustration in the refill process. Practices must determine the length of time they need to process refills, and communicate the process and timeline to patients. Posting the practice policy in each exam room, at the front desk, and on the practice website is essential.

All appropriate staff should be properly trained to explain the new rule to patients with whom they may interact. For example, you may have your switchboard operator inform patients at the time of their Rx refill calls of the new prescribing rule and the longer timeframes involved. In addition, you may wish to modify your patient appointment forms to inform patients of the new rule and to ensure written acknowledgment of compliance with your new policies, including modified patient narcotic or pain management compliance agreements. You may also wish to add language in your contracts notifying your patients of the longer timeframes involved in managing their pain medication.

Your practice must also determine how patients obtain the written renewal prescription. Many practices have decided to require the patient to come into the office to provide identification and obtain the prescription. When picking up the written prescription, the patient must sign a form acknowledging the pick-up, and the form must be placed or scanned into their medical record. You may need to rewrite your practice’s internal policies to address who can pick up written narcotic prescriptions on behalf of the patient.

Many neurosurgical practices serve patients in a wide geographic region, which means that many of their patients live more than 20 miles (and in some cases many hundreds of miles) away and cannot easily pick up their prescriptions. Mailing the prescriptions to patients could actually cause the effect that the new rule is meant to alleviate. Patients may claim that they did not receive the written prescription in the mail and request another one, while the practice has no way of knowing whether or not the prescription actually reached the patient and whether they have refilled it at one pharmacy and then used the second requested prescription at another pharmacy. Although many states have set up database prescription-drug-monitoring programs, the timeframe for identifying problem patients is not immediate and could take several months. During this discussion on the NERVES listserv, it was suggested and heartily endorsed that prescriptions be mailed to the pharmacy of choice for patients who cannot pick up their written prescriptions. While there may be some initial pushback from pharmacies, this seems to be the best solution at this time. Another suggestion is for patients who do not live near your practice to obtain their refill pain management medications through their local primary care physician.

The new rules allow your providers to write prescriptions for HCPs for up to 90 days in three sequential 30-day increments. You may want to have a discussion, however, on whether your providers are comfortable with these quantities and, if not, come to an agreement and put in writing the amounts your practice feels is appropriate.

Neurosurgeons may call in a 72-hour emergency prescription to a pharmacy, followed up with a written prescription to the pharmacist within seven days. We believe that most practices do not allow weekend prescriptions to be called in, but this can be done in an emergency situation. Again, your pain management agreements and patient registration forms should inform patients of the new rules.

The new requirements may increase the manual processes that practices are trying to alleviate. Be especially aware of changes you may need to make with securing your Rx paper. Additional paper trading hands means a higher possibility of misuse. Many offices have multiple printer locations with Rx paper in each drawer. Secure your Rx paper, both handwritten and electronic, at night and on weekends in a locked drawer. Avoid “pre-signing” prescriptions for narcotics, and avoid the use of generic Rx stamps. Written narcotics prescriptions awaiting pickup by the patient must be secured, and you may need to establish additional policies on who can handle them, how they are tracked, and what to do if they are not picked up.

We have provided a template (at right) that each practice can customize for their own procedures as a tool to communicate to patients.

THE NEW RULE PROHIBITS REFILL PRESCRIPTIONS FROM BEING CALLED OR FAXED INTO THE PATIENT’S PHARMACY, AND IN SOME STATES NON-PHYSICIAN PROVIDERS WHO HAVE PRESCRIPTIVE AUTHORITY MAY HAVE A SIGNIFICANT CHANGE TO THEIR PRESCRIBING AUTHORITY OR NOT BE ABLE TO CONTINUE PRESCRIBING HCPS AT ALL.

DEA Final Rule Concerning All Hydrocodone Combination Products

How this impacts you:
Effective October 6, 2014, a federal law change was implemented, and it impacts the way hydrocodone-containing products (HCP) can be prescribed and dispensed. These medications include Hydrocodone, Norco, Vicodin, Lortab, and Vicodin ES.
Beginning October 6, 2014, all new prescriptions that contain hydrocodone can no longer have refills on the prescription.
A new written prescription must be obtained from your doctor each time. Fax transmission is not allowed. Prescriptions for HCPs cannot be called into a pharmacy. Prescriptions for HCPs must be written on a hard copy with an original physician signature.
If you live near our office and you require a refill prescription, we will do so within 48 hours of your request. The prescription will need to be picked up at our office by you with a valid identification.
If you are not able to come to our office due to distance or convenience, we will create a written refill prescription and mail it to the pharmacy of your choice. This will require 5 working days to be obtained by your pharmacy. Our recommendation for our patients that do not live in the area is that they obtain their refill pain medication directly from their family physician in the town in which the patient resides.
We are very sorry for the inconvenience this rule causes, but we have no alternative but to follow the DEA federal rules. If you wish to file a comment or grievance on this regulation, please contact your legislator.