In early December, the Wisconsin Department of Safety and Professional Services mailed a brochure to dentists and other health care practitioners summarizing the requirements of Wisconsin’s new Prescription Drug Monitoring Program. In that brochure, the Department stated that all pharmacies and health care practitioners licensed to dispense monitored prescription drugs to patients in Wisconsin, even those who never actually dispensed those drugs, would need to submit weekly reports to Wisconsin’s Prescription Drug Monitoring Program unless they applied for, and obtained, an exemption.
In late December, however, the Department changed its position on whether non-dispensing practitioners would need to apply for an exemption in order to avoid the PDMP’s weekly reporting requirements. In this second announcement, the Department stated that practitioners who do not dispense monitored prescription drugs “are not bound by the requirements of the PDMP and DO NOT have to file anything with the PDMP,” including, but not limited to, an application for exemption.
While this announcement was, no doubt, greeted with relief by many health care practitioners, I think it may not be the last word on the subject. This is because the conflicting statements by the Department were not, I believe, simply the result of a mistake in the Department’s interpretation of the new rules but were, instead, the result of significant drafting errors in the rules themselves. As a result of these errors, whole sections of the new rules, if read literally, are rendered meaningless. Consequently, anyone interpreting those rules must decide if they will look to the legislative intent, when interpreting the rules, in order to make every section meaningful, or if, instead, they will simply read the rules literally, even if, as a result, whole sections of the rules no longer make sense.
In the brochure mailed to dentists and health care practitioners in early December, the Department took the first approach to interpreting the rules while the Department’s subsequent announcement took the second. Unfortunately, because of the underlying ambiguity in the rules, neither approach is clearly correct, which means either approach could be subject to challenge in the future.
The problem in interpreting the new rules comes from the way in which two important terms are defined and used in those rules. Under the rules, a “practitioner” is defined as any person licensed to prescribe and administer drugs in Wisconsin. A “dispenser,” on the other hand, is defined as a practitioner or pharmacy who actually dispenses a monitored prescription drug. In other words, in its definitions, the rules recognize that not every person licensed to dispense monitored prescription drugs will actually do so and that different obligations should apply to “practitioners” who do, and do not, dispense.
The rules go on to state that it is “dispensers,” not “practitioners,” who must compile dispensing data and submit it to the PDMP within seven days of dispensing any monitored prescription drug. This makes sense, since “practitioners” who are not “dispensers” would have no data to report. In addition to this data reporting requirement, however, the rules also create a second requirement (found in Phar 18.06), to file a report (called a “zero report”) whenever no monitored prescription drugs are dispensed for a seven day period, and it is in the zero report requirement that the drafting errors in the rules first become apparent.
The rules state that “dispensers” are obligated to file zero reports, although, by definition, a “dispenser” is someone who actually dispenses (present tense, not someone who has dispensed in the past), so a true “dispenser” could never file a report stating that they had dispensed no monitored prescription drugs for seven days. Someone who does not dispense monitored prescription drugs for seven days, but is licensed to do so, would be a “practitioner,” not a “dispenser,” during that seven day period. Consequently, under a literal reading of this section, no one would ever be required to file zero reports.
If, however, you substitute the word “practitioner” for the word “dispenser” in Phar 18.06, everything falls into place. All “practitioners” would be required to file a report with the PDMP every seven days, either disclosing the monitored prescription drugs that were dispensed during that seven day period or stating that no such drugs were dispensed during that time (i.e. a zero report).. In other words, the inclusion of a zero report requirement does not make sense unless all “practitioners” who are licensed to prescribe monitored prescription drugs have a duty to file weekly reports, whether they do, or do not, actually dispense those drugs. .
In addition, without this change, Phar 18.08, which provides for exemptions from the weekly reporting requirements for non-dispensers, does not make sense. If “practitioners” who do not dispense have no obligation to file weekly reports, why would anyone need to file for an exemption from the weekly reporting requirements? “Practitioners” who are “dispensers” would not qualify for an exemption, and “practitioners” who are not “dispensers” would have no obligation to file weekly reports, in the first place, and would not need an exemption.
It is also important to note that Phar 18.08, the exemption section, misuses the terms “practitioner” and “dispenser,” just as Phar 18.06 does. Phar 18.08 states that a “dispenser” is eligible for an exemption from compiling and submitting data and zero reports if the dispenser provides sufficient evidence that it does not dispense monitored prescription drugs. Since a “dispenser,” by definition, is someone who dispenses these drugs, no such evidence could ever be provided and no such exemption could ever be obtained. If, however, you substitute the word “practitioner” for the word “dispenser” in this section, once again, everything falls into place. A “practitioner” would be eligible for an exemption if the “practitioner” submitted evidence sufficient to prove it was not a “dispenser.”
The Department’s most recent announcement regarding the applicability of the PDMP relies, I believe, on these drafting errors, to limit the applicability of the PDMP to “dispensers” and, as a result, conclude that non-dispensers do not need to do anything to comply with the PDMP. Since, however, this interpretation relies on drafting errors, it may be subject to challenge, in the future, or the rules may simply be amended in the future, correcting the errors and, as a result, making it clear that all “practitioners,” not just “dispensers,” must comply with the PDMP. If this happens, the Department’s current interpretation of the rules might again be reversed, and dentists and practitioners might, once again, be required to file weekly reports unless they obtain an exemption.
For the moment, I think dentists and other health care practitioners can do little other than follow the most recent guidance issued by the Department regarding compliance with the PDMP. Non-dispensing dentists and other health care practitioners who filed for, and obtained, an exemption prior to the Department’s most recent announcement need do nothing more, at the moment. They should be exempt until their next license renewal date, no matter which interpretation of the rules ultimately prevails. Dentists and other health care providers who did not file for an exemption, however, will not necessarily benefit from applying for one now. Since the Department’s current position is that such exemptions are unnecessary, it is unclear if the Department would review such an application, at this point, or if it would grant such an exemption, if requested. Regardless of whether you have or have not filed for an exemption, however, I would advise all “practitioners” to monitor developments regarding these rules, closely, over the next few months, to make sure that they are, at all times, in compliance with Wisconsin’s new PDMP, no matter what the future may bring.
This article was written by Janice L. Gauthier, Esq. Ms. Gauthier has an A.B. from Harvard University and a J.D. from Harvard Law School. She is the owner of The Gauthier Law Group, LLC, a boutique law firm that represents dentists, physicians, health care providers, professional service practices and other businesses and business owners in Wisconsin and Illinois. You can contact Ms. Gauthier at 414-270-3857 or by email. To learn more about Ms. Gauthier’s background and experience, visit her Google or LinkedIn profiles.
© 2013 The Gauthier Law Group, LLC