Recent Regulations Continue Promotion of ePrescribing


By Michael Burger, Senior Consultant

The federal government continues to keep its foot on the gas to further the adoption and effectiveness of electronic prescribing (ePrescribing) through the rulemaking process.  We have seen this modus operando from statutory requirements related to ePrescribing with Medicare Part D. We are seeing it again in two recent regulations. The first is the Notice of Proposed Rulemaking (NPRM), which explains requirements for implementing the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The NPRM details the proposed future of the meaningful use (MU) program, including ePrescribing elements. The second regulation is last October’s final rule, which spells out the latest requirements of the electronic health record (EHR) certification program. ePrescribing is a core EHR functionality and the new regulation puts vendors in a tough spot.

ePrescribing and MACRA. Among its many features, MACRA creates a new program called the Merit-based Incentive Payment System (MIPS). MIPS is a carrot-and-stick incentive program in which physicians are measured on weighted metrics related to cost, quality, clinical practice improvement and a number of repurposed Meaningful Use measures. Results will be totaled to create a base score. The base score will be used by Medicare to increase or decrease a physician’s overall Medicare payments by certain percentages. Doctors can earn bonuses (or receive penalties) of up to 4% starting in 2019, a number that grows to 9% by 2022, depending on how well they perform. (For more information, see our article in this issue of HIT Perspectives.)

ePrescribing—along with other MU elements—is now contained in the Advancing Care Information (ACI) portion of MIPS (details start on page 208 of the NPRM). The ACI’s objectives count toward a quarter of the MIPS base score.

ACI’s criteria are essentially slightly tweaked versions of MU’s goals and objectives as spelled out in the EHR final certification rule. There are some slight differences in the measures, on which the government is seeking comment. MIPS eliminates the (MU) exclusion for low-volume users, so ePrescribing will be mandatory for all clinicians participating in MIPS. It remains to be seen how this will affect ePrescribing adoption, since an estimated 20% of physicians were not motivated by MU to adopt ePrescribing technology.

ePrescribing and EHR Certification.  The implementation of MACRA will continue in parallel with the previously established program for certifying EHRs run by the Office of the National Coordinator for Health Information Technology (ONC). In addition to the existing MU ePrescribing requirements, the 2015 version of the certification standards contains some new ePrescribing transactions. While these new transactions may not move the adoption needle, they will result in increased patient safety and provide additional clinical decision-making value. (Details begin on page 132 of the regulation.)

Going forward, EHRs will need to certify a new segment NCPDP SCRIPT v10.6 standard, Structured and Codified Sig. This segment will standardize dosing instructions for most prescriptions that are submitted electronically. Use of Structured and Codified Sig will improve productivity in physicians’ offices and pharmacies. The lack of a standardized way to electronically transmit Sig information to the pharmacy results in a volume of time consuming call-backs for clarification between providers and pharmacists. In addition, use of the Standardized and Codified Sig transaction will help eliminate the patient safety hazards caused the manual entry of this information in the free text field of the ePrescription and subsequent transcription by the pharmacist. This is a functionality that physicians can get behind and that has been requested by many provider groups to reduce telephone call-back volume.

EHRs also will have to handle three ePrescribing transactions that are seldom used today.  These are:

  • Change Prescription. This transaction is sent by the pharmacy to the prescriber when the pharmacy requests approval to switch from a drug originally prescribed to something different.
  • Cancel Prescription. This transaction is used by the prescriber to cancel an existing prescription.
  • Fill Status. This transaction is sent to the prescriber from the pharmacy and indicates the fill status of the prescription (dispensed, partially dispensed or not dispensed).

In addition to NewRx, Refill and Medication History, which were previously mandated for Meaningful Use, the government is clearly paving the way for the required use of these three new transactions by ensuring their availability in EHRS. More than likely, the government’s interest is in response to three patient safety-related issues: medication adherence compliance, biosimilar substitution and drug diversion.

Medication adherence has mushroomed to become a major concern to payers, providers and pharmacies. Some 3.8 billion prescriptions are written every year in the US, yet over half are taken incorrectly or not at all.  A study of over 75,000 commercially insured patients found that 30 percent failed to fill a new prescription, and new prescriptions for chronic conditions such as high blood pressure, diabetes, and high cholesterol were not filled 20-22 percent of the time. The result: rampant medication noncompliance creates an estimated 100,000 unnecessary fatalities and costs $200 billion each year in unnecessary hospital and doctor visits, lost productivity and premature deaths.

The use any of ePrescribing (and especially a Fill Status) can help physicians identify patients who are not filling their prescriptions or are not taking their medications as directed. This will enable the physician to have the necessary conversation with the patient and address the root causes of non-adherence.

Another issue is notifying physicians about a biosimilar substitution. Interest is growing in a technology solution now that nearly two-thirds of states have enacted — or are considering enacting — legislation requiring that physicians be notified when a biosimilar substitution is made.  (Our Regulatory Resource Center is tracking state and federal regulatory actions related to biosimilars.)  ePrescribing (and especially Change Prescription and Fill Status) could be used to indicate to a prescriber that a substitution was made and which biosimilar was dispensed. This is important information should an adverse event occur.  (Read more in HIT Perspectives.)

A third issue is that of diversion. Use of the Cancel Prescription transaction will alert the pharmacist that a therapy has been cancelled by the prescriber. This will prevent subsequent fills of cancelled prescriptions from being dispensed, and potentially be diverted. Cancel Prescription will not only enhance patient safety, but also reduce costs related to dispensing medications that have been discontinued.

Impact on EHRs.  The 2015 EHR certification regulation puts EHR vendors in a tough spot by requiring that EHRs support functionality for which there is little demand today.  Further, there is no MACRA/MIPS or Meaningful Use requirement that physicians use these new transactions. The If-EHRs-Build-It-Physicians-Will-Use-It approach has been unsuccessful in the past, unless coupled with rulemaking. For that reason, we see more regulations on the horizon—either in the next iteration of the EHR certification rule or additional MACRA regulations, not to mention those for Medicare Part D. In the meantime, EHR vendors are being asked to build (and certify) new features for which there is no corresponding requirement for physicians to use them.

I am a vocal advocate of introduction of features that leverage the power of information technology to make physicians’ jobs easier and aid in care quality improvement. Let’s hope that we get a legislative “nudge” to kick start the adoption of these new ePrescribing transactions.


Biosimilar Legislative Trend Means Big Changes for EHRs


By Connie Sinclair, Director, Regulatory Resource Center

Biosimilars are starting to enter the market in the United States and are generating interest because of their significant cost-savings potential and patient care implications. Biosimilars are to biological drugs as generics are to conventional drugs. Even though biosimilars are very new to the US market (the first was launched domestically in 2015, and the second just recently), states already are concerned about their impact on patient safety. In response, nearly two-thirds have enacted — or are considering enacting — legislation on how prescribers can prohibit substitution as well as require the pharmacy to notify the prescriber that a substitution has been made. The reason: the drug that was prescribed is not necessarily identical to what was dispensed. This has patient safety considerations when it comes to biosimilars.

Biologic drugs are made from living organisms and are different in chemical composition than conventional medications, typically developed after the original biologic goes off patent. They mimic the activity of the biologic, but by nature are not exactly the same. For this reason, the physician needs to know which biosimilar product was dispensed so that outcomes and adverse reactions can be tracked. EHRs and Pharmacy system vendors, take note. This will require a new type of interoperability than what is in practice today. Incidentally, one state has recently passed an unrelated opiate statute that also requires a dispensing notification from the pharmacy to the prescriber.


State legislative rundown. As of the publication of this blog, 19 states and Puerto Rico have enacted biosimilar substitution legislation. The legislation generally follows the same basic model, as described below, although there are some differences.

Most legislation requires prescriber notifications to include drug product name and manufacturer. The notification must be done electronically through the prescriber’s electronic health record (EHR), although fax, phone or other means may be used as a backup if the EHR is offline for some reason. Passed legislation does not require the biosimilar lot number to be included in the prescriber notification, however, this is recommended and may be reflected in future bills. There is variability among the states as to the window for notification, such as 48 hours versus 5 business days. A popular provision requires the pharmacist and the physician to retain records of substituted biosimilar medications. Eight states have pending legislation. There could be movement among the remaining states as biosimilars continue to capture legislators’ attention.

Going forward. The time is right for the range of stakeholders to address the opportunities and challenges created by the entrance of biosimilars in the United States. This landscape will rapidly evolve, which makes it imperative that stakeholders keep current with what is legal in their respective states and markets when it comes to biosimilar substitution. Check out our regulatory resource center, which makes it easy for you to keep up with state and federal regulatory actions related to biosimilars. I’m happy to give you an overview and explain the value proposition for your situation. Call me at 404-915-2881, or email me at  


Integrating EHRs and PDMPs: How Vendors Can Get Ahead of the Curve


By Michael Burger, Senior Consultant

Prescription drug monitoring programs (PDMPs) were created in 2002 as a tool to help address the growing problems of prescription drug abuse and diversion. PDMPs are independent, state-run databases of controlled substance prescriptions from the range of dispensers. Data include quantities of and to whom controlled substance medications have been dispensed. All states, except Missouri, have a PDMP. Despite their promise, PDMPs are data silos and lack interoperability. (For more information, see the article in the April HIT Perspectives.)

States are increasing requirements to check the PDMP before a prescription is written or dispensed. State and federal policymakers also have begun to recognize that it’s time to make PDMPs more interoperable and useful in fighting the war against substance abuse.

Here are six things EHR vendors can do to get ready for integration with PDMPs.

  1. Keep current with growing mandates. EHR vendors should be aware of rapidly emerging state and federal PDMP activities and regulations to ensure their products are compliant. By being proactive, vendors reduce the risk of being caught short and potentially losing revenue and market share. A challenge for prescribers is that PDMP access is typically via a standalone web portal, not a built-in feature of the EHR work flow. As demand for easier access grows due to regulatory requirements, EHRs should soon begin to be interoperable with individual states’ PDMP databases to both meet customer demand and regulatory compliance
  2. Know who’s in charge. Because PDMPs are state sponsored, a variety of state agencies are responsible for their administration. EHR vendors need to know who’s in charge in the states where their products are used so they can keep abreast of the evolving regulatory requirements.
  3.  What about the PMIX? Instead of the transactions and data exchange standards normally used by EHRs, PDMPs use the Prescription Drug Monitoring Program Information Exchange (PMIX). PMIX is a national, interoperable architecture that supports the sharing of PDMP data by various “hubs.” EHR vendors need to be mindful of how their products will integrate with the PMIX architecture and related standards until the federal government promulgates a national interoperability standard, which won’t happen anytime soon.
  4. Keep up with harmonization efforts. There are inherent differences in PDMPs from state to state, including when and how they may be accessed and the use of PMIX to share data. Recognizing these differences and the challenges they present, the federal government has initiated standards and harmonization efforts through the S&I Framework (see the web page for more information).
  5.  Check business agreements. As EHRs need to connect with PDMPs and share data, vendors may need to create or revisit business agreements with individual PDMPs and data hubs. They should address data collection, use, privacy, disclosure, storage and other aspects of PDMP data exchange.
  6. Don’t forget about EPCS. Electronic prescribing of controlled substances can be a useful tool to help prescribers identify potential substance abuse and doctor shopping — before the PDMP is checked and prescriptions are written electronically through the EHR. Medication history often will provide valuable information about previous controlled substance prescriptions paid for by insurance as well as where they were filled. This makes EHRs a powerful, value-add tool, which physicians and policymakers can get behind.

Point-of-Care Partners can help you keep up with current events regarding PDMP, including state mandates and what needs to be done to integrate EHRs and PDMPs. For starters, check out our regulatory resource center, which makes it easy for you to stay current with state and federal regulatory actions.