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 email@example.com.
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.
- 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
- 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.
- 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.
- 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).
- 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.
- 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.
By Tony Schueth
Didn’t make it to HIMSS16 in Vegas? If you did go but couldn’t make it to all the sessions or exhibits, the Point-of-Care Partners team has saved you some money and shoe leather. Here are our takes on the top 10 trends at HIMSS16 (for more detail, see our article in the April HIT Perspectives).
- The little guys got invited to the table. Historically, HIMSS has been dominated by large EHR and revenue cycle vendors. It was different this year. HIMSS16’s exhibits included many trend setters, innovators and start-ups, which showcased a lot of cool technology.
- Telehealth hits the big time. We’ve been saying for several years that telehealth is poised for broad growth. We feel validated because developments in telehealth technologies were a major focus of HIMSS16.
- Behavioral health is getting connected. Vendors focused on behavioral health services were newly evident this year — and in a big way. We believe this prominence marks a growing overall interest in —and need for — technologies to address the high cost and disjointed care of patients with various behavioral health issues.
- Expect more specialty-related EHRs. Behavioral health EHRs are demonstrative of the growth in specialty-specific EHRs. These continue to gain in popularity and are benefiting from the robust replacement EHR market as specialists abandon “general purpose” EHRs for systems designed specifically to their unique work flows.
- MU3 was MIA. We were surprised to see that meaningful use (MU) stage 3 was not on anyone’s lips at this gigantic meeting of EHRs and provider organizations. This may be because many stakeholders believe it is dead and have moved on. Not so fast. MU3 has effectively been folded as a component of the new Medicare Incentive Payment System (MIPS). (For details, see our article in the February 2016 issue of HIT Perspectives).
- There seemed to be fewer major announcements. HIMSS traditionally has been the place for major announcements about new initiatives and products. There were some at HIMSS16, but not as many as in the past.
- Yet some big announcements were made. Despite the size of the meeting and the noise surrounding it, some big initiatives were unveiled. These primarily were from the federal government and included:
- HHS announced an industry initiative to further health data interoperability, information sharing, and patient engagement.
- The Medicaid program is making funding available to promote HIE and encourage the adoption of certified EHR technology by Medicaid providers. “Seriously, this really is a B.F.D.,” tweeted Jon White, MD, ONC’s acting deputy director.
- ONC and the HHS also made a variety of announcements: a Proposed Rule to Support the Reliability, Transparency, Accountability, and Safety of Certified Health IT; the availability of $625,000 to spur the development of market-ready, user-friendly software applications for consumers and health care providers; and a new model privacy notice.
- There were no new buzzwords this year. HIMSS meetings usually have a dominant buzzword or two. Not this year. The big catchphrases and concepts from the past—like Big Data, transparency and precision medicine—didn’t disappear. Instead, stakeholders spent a lot of time explaining how these concepts are being translated into action.
- Data analytics is still going strong. The appetite for turning large data sets into actionable information was evident at HIMSS16, even though enthusiasm has waned for the “Big Data” buzzword. The usual and not-so-usual suspects are turning their focus to clinical data rather than concentrating on selling software. Nontraditional health companies are staking their claims, while others are reinventing themselves to make another run at this opportunity.
- Nontraditional stakeholders had a bigger presence. Pharmacies, pharmaceutical manufacturers and biotechnology firms continued to have an expanded presence at HIMSS16. We saw them on a mission to learn and absorb the details and benefits of health IT.
See you next year in Orlando!