America is in the throes of an opioid epidemic, which is shattering lives nationwide with record-breaking overdose deaths and levels of addiction. The result: an onslaught of new state requirements for electronic health record (EHR) vendors that are coming fast and furiously but which lack consistency. In addition, there are potential mandates from the federal government regarding meaningful use and the Medicare and CHIP Reauthorization Act (MACRA). All these laws and requirements create many challenges for EHR vendors, who must keep up or risk declining market share or even product survival.
Trends affecting opioids and EHRs. Five trends related to the opioid epidemic directly affect EHRs: mandatory electronic prescribing (ePrescribing) of controlled substances (EPCS), mandatory use of prescription drug monitoring programs (PDMPs), EHR integration with PDMPs, interoperability and quantity limits on controlled substance prescriptions.
Mandatory EPCS. Many states are now requiring EPCS to fight the opioid epidemic. This trend began with New York’s Internet System for Tracking Over-Prescribing (I-STOP) program in 2016. It is gathering steam as Maine now has a mandate for EPCS for opiates; several other states have passed legislation that become effective over the next couple of years. The move toward mandatory EPCS at the federal level also is likely. HR 3528 was recently introduced in the US House of Representatives, which would require EPCS for all such prescriptions covered by Medicare Part D. Consequently, EHR vendors will need to ensure their products are compliant with all federal and state requirements for EPCS, which could be a challenge due to lack of consistency.
Mandatory PDMP use. States are beginning to mandate the use of PDMPs, which are statewide databases of controlled substance prescriptions. This trend for requiring prescribers to review the PDMP before writing for controlled substances began in 2012 and has been slowly building. So far, more than 30 states have some form of required access; however, details vary greatly, creating challenges for EHR implementation.
An interesting aspect of this trend is that beyond simply requiring it, states are getting much more specific about the “who, what, when and how” of PDMP access. No consistent pattern is emerging. Access might be based upon the prescribed drug class, days’ supply to be prescribed and/or the maximum morphine equivalent (MME) of dosing. Requirements may also vary by type of pain, diagnosis, practice setting or prescriber type. Vendors may be pressured to incorporate these requirements into their ePrescribing modules, which will, again, be difficult as a result of significant differences among the states. EHR vendors are also being leaned upon to enable efficient and timely access to PDMPs to facilitate compliance.
EHR Integration. PDMP use typically has been outside the provider’s workflow, requiring a separate login to access the statewide controlled substance prescription information. Stakeholders agree this creates an inefficient, burdensome process that needs to be altered. Such changes are being implemented through guidance and statute.
There are numerous examples on the policy side. For example, 43 governors signed the Compact to Fight Opioid Addiction in 2016, which included a commitment to build on their efforts to fight opioid addiction by integrating use of PDMPs into EHRs. On the legislative side, a growing number of states are facilitating integration of PDMP access with EHRs. Michigan is an example. Michigan’s PDMP, the Michigan Automated Prescription System, will soon be connected with EHRs from such major vendors as Cerner, McKesson and Epic.
That said, many states still have statutes barring the integration of PDMP data with EHRs and local medication profiles. Some are beginning to remove that barrier. EHR vendors must stay on their toes to keep abreast of such rapidly changing developments and ensure their products are compliant. They also will need to be on the lookout for guidance and related laws on the docket in state legislatures.
Interoperability. Stakeholders are calling for increased interoperability of EHRs and PDMPs to address the opioid crisis. This is important because of pressure for states to share data across state lines—especially in border areas where patients receive care in one state and fill prescriptions in another.Despite progress that has been made, work remains to make PDMPs and EHRs interoperable. For example, fewer than half of states are actively exchanging PDMP information with other states and such authorized users as hospitals and providers, according to data from the National Alliance for Model State Drug Laws. Again, some states prohibit data sharing by statute. A draft report from a new high-level federal commission recommended that PDMPs become completely interoperable in less than 12 months—and that such federal health care systems as the Veterans Administration exchange data with PDMPs. This means that pressure will be put on EHRs and PDMPs to become fully interoperable sooner rather than later—especially because high-level recommendations often are translated into policy and legislation.
Limits on Controlled Substance Prescriptions. Controlled substance prescribing limits are quickly being enacted to guide prescribers to be more intentional about prescribing the minimum amount needed to address patient pain. Examples include days’ supply limits; MME limits; and non-opiate directive forms that must be documented in medical records. Again, there is no consistency in how the states are implementing these requirements. Prescribers will need new forms of decision support to guide them, which may need to be developed and incorporated into EHR offerings. Prescriber patterns are being monitored by state boards and there are serious consequences for noncompliance. Provider organizations will likely look to their vendors to help facilitate compliance.
Keeping up with developments. We expect to see new state legislation aimed at making PDMPs an even more valuable tool in fighting the opioid abuse epidemic. Point-of-Care Partners (POCP) is on top of those efforts. Our ePrescribing State Law Review service was created to keep companies up to date 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 POCP regulatory experts. For a current, point-in-time summary of state laws, check out our recently launched ePrescribing State Law On-Demand.
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