Federal Opioid e-Prescribing Law Passes

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This week President Trump signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act1. The legislation is aimed at combating the opioid epidemic by focusing on several information technology tools that help prevent prescription fraud and abuse.

One of those tools is e-Prescribing. One of the more than 60 policies included is the Every Prescription Conveyed Securely Act. Beginning in January 2021, prescribers will be required to electronically prescribe controlled substances for Schedule II-V drugs covered under a Medicare Part D or Medicare Advantage prescription drug plan. While many states have enacted their own laws requiring e-Prescribing, this is the first federal mandate.

Another tool included in the law is electronic prior authorization. Also by January 2021, electronic prior authorization will be required for Medicare Part D covered drugs. Electronic prescription programs will be required to securely transmit the requests. A facsimile, proprietary payer portal, or an electronic form that does not meet the standards will not be counted as an electronic submission.

The legislation also contains provisions to enhance states’ Prescription Drug Monitoring Programs (PDMPs). The goal is to ensure each state has a PDMP, improve their functionality, make sure all prescribers are utilizing the systems, and foster data sharing between states. Beginning October 1, 2021 States must require health care providers to check their PDMP for a Medicaid enrollee's prescription drug history before prescribing controlled substances to the enrollee.

MDToolbox applauds this bipartisan legislation. We are continually encouraging providers to take advantage of the technologies we provide including Electronic Prescribing of Controlled Substances (EPCS) and Electronic Prior Authorization (e-PA) as they are important tools to use in fighting the devastating opioid epidemic. Putting these federal mandates in place is an important step towards fully utilizing the available technology to save lives. 

 

1. H.R.6 - SUPPORT for Patients and Communities Act https://www.congress.gov/bill/115th-congress/house-bill/6

 

Massachusetts To Require Electronically Prescribing Controlled Substances

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Massachusetts Governor Charlie Baker recently signed a bill that will require prescribers to electronically prescribe controlled substances.  The bill, An Act for Prevention and Access to Appropriate Care and Treatment of Addiction1, is intended to address the growing opioid problem. The opioid epidemic has claimed more than 2,000 lives in Massachusetts in both 2016 and 2017.

As the name of the new expansive law indicates, it’s focused on strengthening education and prevention efforts, strengthening intervention and harm reduction strategies, and improving access to treatment. Two focuses of prevention relate specifically to prescribers:

  • Mandates prescribers to send controlled substance prescriptions electronically starting January 1, 2020.
  • Requires prescribers to check the state prescription monitoring program (PMP) each time a prescription for a schedule II or III, or a benzodiazepine is issued.

“The opioid and heroin crisis has tragically claimed scores of lives and broken families across the Commonwealth, and this new bill will serve as our latest tool kit to address the public health crisis through increased access to treatment, education, and prevention,” Baker said. “While there is still much work to do, this bipartisan bill will support the fight against this horrible epidemic by holding providers more accountable for prescribing practices, taking stronger steps to intervene earlier in a person’s life, and expanding access to recovery coaches.”

MDToolbox urges prescribers to take full advantage of e-Prescribing and to not only send controlled substances electronically, but all prescriptions as soon as possible. The opioid epidemic continues to worsen and this is an easy way for prescribers to help combat it. Currently, a meager 15% of prescribers in Massachusetts are enabled for EPCS. Prescribers shouldn’t view it as a new technological burden, but as a tool they can use in their practice to aid in their day to day prescribing tasks.  By prescribing all prescriptions electronically in one easy workflow, both time and money will be saved. MDToolbox offers all prescribers a free 30 day trial to see just how beneficial e-Prescribing and EPCS can be. Contact us for more information.

1. https://malegislature.gov/Laws/SessionLaws/Acts/2018/Chapter208

Senate Passes Bill Requiring EPCS

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Earlier this week, the United States Senate passed The Opioid Crisis Response Act of 2018. The bill is focused on battling the opioid epidemic and was almost unanimously passed with a 99-1 vote. According to the Centers for Disease Control and Prevention, overdose deaths killed an estimated 72,000 Americans in 2017 and the total estimated "economic burden" of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement. The bill provides $3.8 billion in funding.

The bill contains a large number of different proposals from five Senate committees. One of those proposals requires prescribers to electronically prescribe controlled substance prescriptions for Medicare Part-D covered medications. The Centers for Medicare and Medicaid Services (CMS) would be responsible for specifying a list of exceptions and outlining the penalties for failing to comply with the e-prescribing requirement. 

Other provisions in the Opioid Crisis Response Act of 2018 include:

1.       The STOP ACT—to stop illegal drugs, including fentanyl, at the border
2.       New non-addictive painkillers, research and fast-track
3.       Blister packs for opioids, such as a 3 or 7-day supply
4.       More medication–assisted treatment
5.       Prevent “doctor-shopping” by improving state prescription drug monitoring programs
6.       More behavioral and mental health providers
7.       Support for comprehensive opioid recovery centers
8.       Help for babies born in opioid withdrawal
9.       Help for mothers with opioid use disorders
10.     More early intervention with vulnerable children who have experienced trauma

This bill comes after similar legislation passed through the House in June. Senate Health, Education, Labor and Pensions Committee Chairman, Lamar Alexander, R-Tennessee, said he is working to combine the bills "into an even stronger law to fight the nation’s worst public health crisis, and there is a bipartisan sense of urgency to send the bill to the President quickly." A combined version is expected to reach President Donald Trump’s desk for signing by early October.

Oklahoma Latest State to Require E-Prescribing to Prevent Opioid Abuse

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Oklahoma recently became the latest state to enact an e-prescribing law in order to prevent opioid abuse. Governor Mary Fallin signed into law House Bill 29311 which will require prescribers in Oklahoma to electronically prescribe Schedule II through V controlled substances starting January 1, 2020.

The bill allows for a few exemptions in certain circumstances such as for veterinarians or prescriptions that are administered through an on-site pharmacy at facilities like nursing homes. It also states that waivers or extensions can be granted through the licensing board. There aren’t any details on what will constitute a waiver or extension at this time though. Other states who offer waivers and extensions will grant them for reasons like a lack of proper technology such as internet or computers.

If a prescriber is granted an e-prescribing waiver, they will be required to use official prescription forms provided by the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control. Pharmacists will not be required to verify that a prescription falls under an exception.

Currently, only 12% of prescribers in Oklahoma are enabled for EPCS. However, 96% of pharmacies are able to receive electronic controlled substance prescriptions.

Attorney General Mike Hunter is convinced requiring e-Prescribing “will have a material impact on this leakage of opioids into the hands of addicts.” E-prescribing can help put a stop to prescriptions being forged which an opioid task force found out could easily be done. During their research, a real prescription was scanned, altered, and printed on security paper. Almost all experts, including pharmacists and DEA agents, were fooled by the fake prescription. Tulsa County Director of Governmental Affairs Terry Simonson said, “It was so easy. It was just kind of mind-boggling that that's all it took.”

E-Prescribing offers many benefits in addition to preventing forged prescriptions. MDToolbox can help prescribers in Oklahoma, as well as nationwide, start utilizing all of those benefits. See Oklahoma E-Prescribing for more information or to request a free trial to start e-Prescribing today.

 

   1. http://webserver1.lsb.state.ok.us/cf_pdf/2017-18%20ENR/hB/HB2931%20ENR.PDF

Electronic Prescription Directions Vary Greatly in Content and Quality

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Electronic prescriptions allow for providers to enter any free-text directions (Sig) they wish, just as if they were writing a paper prescription. The patient directions are one of the most critical parts of a prescription. It’s a huge safety risk if patients do not understand how to use their prescription or if a pharmacist has to try to interpret what the provider means. In a recent study that analyzed 25,000 electronic prescriptions issued by 22,152 community-based prescribers using 501 e-prescribing software applications, it was found that there was a large number of variations in the electronic prescription directions1. The quality of the directions also varied greatly.

The study was conducted by Yuze Yang, PharmD, from Surescripts and colleagues, and published online in the Journal of Managed Care & Specialty Pharmacy. Out of the 25,000 e-prescriptions, there were 3,797 unique Sigs concepts identified in the Sig text strings. However, more than half of all patient directions could be classified into just 25 unique Sig concepts. There were large numbers of variation of even what would be considered simple and straightforward directions found. For example, over 800 permutations of words and phrases used to convey "take one tablet by mouth once daily" were identified.

The researchers not only looked at the variations, they also analyzed the Sig text strings for quality-related events which were defined as “Sig text content that could impair accurate and unambiguous interpretation by staff at receiving pharmacies.” The biggest quality issue observed was incomplete Sigs. Prescriptions were commonly missing relevant dosages or administration frequency/timing information. They found that more than one in ten prescriptions contained some sort of quality issue.  Considering the number of electronic prescriptions that are sent and the not only time-wasting potential but possibly catastrophic results that could come from such quality issues, that figure is way too high.

The authors' recommendations for reducing the quality issues and variations include:

  • Enhancing e-prescribing application user interfaces and Sig creation tools
  • Improving end-user training and usability testing for optimal use of system functionalities
  • Adopting and implementing the currently available Structured and Codified Sig format by both prescriber and pharmacy systems to facilitate improved standardization and interoperability

At MDToolbox, patient safety and ease of use for prescribers are two of our main focuses when designing our directions input fields. We offer several options designed to make entering quality directions as easy as possible:

  • Sig builder – build complete directions in just a few easy clicks
  • Common Sigs – choose from the most commonly used Sigs already available in the system
  • Saved favorite directions – prescribers can enter directions that they commonly use and save them as a favorite with a shortcut that can be quickly accessed
  • Free-text directions – although free-text directions open it up to possible quality errors, MDToolbox has implemented quality checkers to ensure that free-text directions are not missing any of the information the contributes to many of the quality issues such as “how much” or “how often” the prescription should be used.

MDToolbox is also constantly looking for ways like our quality checkers to enhance these areas even more. Part of the way we do this is by conducting usability tests and end-user trainings in order to get feedback from users and ensure users are taking advantage of the available tools. We share a goal with Surescripts to have zero-error e-prescribing and are continually striving towards this goal.

 

  1. Quality and Variability of Patient Directions in Electronic Prescriptions in the Ambulatory Care Setting https://www.jmcp.org/doi/10.18553/jmcp.2018.17404 

Iowa Considering Mandated E-Prescribing

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Iowa is the latest state to consider legislation that would require electronic prescribing. The Iowa Board of Pharmacy suggested Senate Study Bill 30741 which would require all prescriptions to be sent electronically. Like several other states with similar enacted and proposed legislation, lawmakers in Iowa hope to curb the opioid epidemic with this bill.

Executive director of the Iowa Board of Pharmacy, Andrew Funk, informed senators that currently 65% of Iowa prescriptions for non-addictive drugs are sent electronically, but only 9% of prescriptions for addictive drugs are electronic. This leaves a lot of room for fraudulent prescriptions.

Iowa Senator Tom Greene, a former pharmacist, is all too familiar with forged paper prescriptions. "A patient presented me with a prescription for sleeping medication-a controlled substance," said Greene. "And the doctor had ordered ten tablets. Well, the patient changed the one-zero to a four-zero. There are cases like that out there, and again electronic prescribing and the electronic transmission of that information is very accurate." Lawmakers hope that in addition to preventing phony prescriptions, it would also help with mistakes caused by handwritten prescriptions. Prescriptions sent electronically eliminate the possibilities for patients to alter them, as well as remove the potential for pharmacists to misinterpret illegible prescriptions.

The bill allows for providers to ask for temporary exemptions if they aren’t able to meet the requirements in time, but any prescriber without an exemption would be subject to $250 fines per violation of the law, up to $5,000 per year. There are also exemptions for prescriptions for patients in nursing homes, long-term care facilities, or jail, as well as veterinary prescriptions. In addition, the bill states the requirements do not apply to compound prescriptions containing two or more components and prescriptions requiring “information that makes electronic submission impractical, such as complicated or lengthy directions for use or attachments.”

As the bill is written now, it would begin July 1, 2019. Some lobbyists, however, feel that this is too soon especially for rural hospitals and physicians. They are pushing for the date to moved to July 1, 2020. Senator Greene and two other senators on the subcommittee were said to informally agree to a compromise of January 1, 2020.

One of the great things about our stand-alone web-based e-Prescribing products is that there is not a lot of setup needed. As long as a prescriber has a device that can access the internet (computer, tablet, or phone), they can send their prescriptions electronically. While sending controlled substances electronically does require a 2nd device to electronically sign the prescription, it is as simple as using a phone or key fob.  Most prescribers can get setup and start e-Prescribing with MDToolbox in just a matter of minutes. There is no need to stress about putting complex systems in place or wait until the deadline. To see how quick and easy it is, sign up for a free trial or request a demo here.

 

1.  https://www.legis.iowa.gov/legislation/BillBook?ba=SSB3074

Arizona to Require E-Prescribing to Fight Opioid Abuse

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Last week, Arizona Governor Doug Ducey called a special legislative session to pass the Arizona Opioid Epidemic Act1. In record speed, the Arizona Legislature voted unanimously to approve it and Ducey signed it into law on Friday.

The act is aimed at combating the opioid epidemic in Arizona, where in just the last 6 months there have been more than 800 opioid-related deaths. The focus of the act is to reduce opioid misuse, promote safe prescribing and dispensing, and improve access to treatment.

As stated in the Governor’s news release outlining the act, the policy includes:

  • Identifying gaps in and improving access to treatment, including for uninsured or underinsured Arizonans, with a new $10 million investment;
  • Expanding access to the overdose reversal drug Naloxone for law enforcement or corrections officers currently not authorized to administer it;
  • Holding bad actors accountable by ending pill mills, increasing oversight mechanisms, and enacting criminal penalties for manufacturers who defraud the public about their products;
  • Enhancing continuing medical education for all professions that prescribe or dispense opioids;
  • Enacting a Good Samaritan law to allow people to call 911 for a potential opioid overdose;
  • Cracking down on forged prescriptions by requiring e-prescribing;
  • Requiring all pharmacists to check the Controlled Substances Prescription Monitoring Program prior to dispensing an opioid or benzodiazepine;
  • And limiting the first-fill of an opioid prescription to five days for all opioid naïve patients and limiting dosage levels to align with federal prescribing guidelines. These proposals contain important exemptions to protect chronic pain suffers, cancer, trauma or burn patients, hospice or end-of-life patients, and those receiving medication assisted treatment for substance use disorder.

The e-Prescribing requirement will begin January 1, 2019 and mandates schedule II controlled substances must be sent electronically. There is some concern that those in rural areas do not have the necessary technology for e-Prescribing. Therefore, the act gives those providers additional time and outlines that e-Prescribing will not be mandated until July 1, 2019 for counties with less than 150,000. It also allows for the Board of Pharmacy to grant waivers to prescribers with a lack of broadband Internet access or other hardships.

At MDToolbox, we urge providers not to wait until the mandate and to e-Prescribe all prescriptions. In addition to preventing forged prescriptions and helping combat opioid abuse, e-Prescribing provides many other benefits for providers and patients. Contact us to get started with a free trial today.

 

1.       Arizona Opioid Epidemic Act Policy Primer https://azgovernor.gov/sites/default/files/related-docs/arizona_opioid_epidemic_act_policy_primer.pdf

MIPS Deadlines Approaching Fast

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As 2017 comes to a close, the deadline for providers to avoid a Medicare penalty in 2019 is approaching and the 2018 reporting periods are about to begin. The Centers for Medicare & Medicaid Services (CMS) has designed the Quality Payment Program (QPP) with two tracks clinicians can take under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) - Advanced Alternative Payment Models (APMs) or Merit-based Incentive Payment System (MIPS). As we mentioned at the beginning of this year, the well-known Meaningful Use program has been added as a part of MIPS. There are four components to MIPS: Quality, Improvement Activities, Advancing Care Information (ACI), and Cost. Meaningful Use is part of the ACI component. Providers have until March 31, 2018 to send in their data for 2017 which will increase, decrease, or keep their 2019 Medicare payments the same. The reporting period for 2018 starts January 1, 2018. CMS is taking a gradual approach to implementing the program so the requirements for each year differ.

2017 Requirements:

CMS offers “pick your pace” options in 2017. These include:

  • Zero participation – receive a 4% penalty in 2019
  • Test – submit a minimum of one quality measure, one improvement activity, or the four required ACI measures and avoid a negative payment adjustment.
  • Partial participation – Submit at least 90 days of 2017 data for more than one quality measure, OR more than one improvement activity, OR more than the four required ACI measures and avoid a negative payment adjustment and possibly receive a positive payment adjustment.
  • Full participation - Submit at least 90 days of data for all required quality measures, AND all required improvement activities, AND all four required ACI measures and earn a positive payment adjustment.
  • Advanced Alternative Payment Model - receive 25% of Medicare payments or see 20% of Medicare patients through an Advanced APM in 2017, and earn a 5% incentive payment in 2019.

Certified Electronic Health Record Technology (CEHRT) Requirements:

  • Use either 2014 or 2015 Edition CEHRT or a combination

 

2018 Requirements:

  • Zero participation – penalty increases to 5% in 2020
  • MIPS Participation Minimum Performance Periods

o   Quality – 12 months

o   Cost – 12 months

o   Improvement Activities – 90 days

o   Advancing Care Information – 90 days

  • To meet the point threshold to avoid a negative payment adjustment, clinicians must:

o   Report all required Improvement Activities.

o  Meet the Advancing Care Information base score and submit 1 Quality measure that meets data completeness.

o  Meet the Advancing Care Information base score, by reporting the 5 base measures, and submit one medium-weighted Improvement Activity.

o   Submit 6 Quality measures that meet data completeness criteria.

CEHRT Requirements:

  • Use either 2014 or 2015 Edition CEHRT or a combination
  • Receive a 10% bonus if only use 2015 Edition CEHRT

 

There are only a couple days left in 2017 to make sure you have at least met the requirements for the “Test” option to avoid the penalty in 2019. It’s also important to note that 2018 requires 12 months of reporting for Quality and Cost measures meaning that reporting period is also starting in just a couple days. It’s vital to make sure you are using a product or combination of products that are certified. MDToolbox was one of the only stand-alone e-Prescribing vendors to certify on the 2015 edition CEHRT requirements earlier this year. We are certified for e-Prescribing and Patient Education and are able to integrate with many other products to meet all of the requirements. Contact us for more info on how we can help you meet the MIPS requirements.

Opioid Commission Recommends Increased Electronic Prescribing

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President Donald Trump declared the opioid epidemic a national public health emergency on October 26, 2017. In his address, Trump called opioids the “worst drug crisis in American history.”

After the President’s declaration, the President’s Commission on Combating Drug Addiction and the Opioid Crisis issued its final report1. In the Chairman’s letter written by Governor Chris Christie, he points out that 175 Americans are dying a day from this epidemic. The 131-page report goes on to include more than 50 recommendations.

One of the most prudent recommendations is that the Office of National Drug Control Policy (ONDCP) and the DEA increase electronic prescribing to prevent diversion and forgery. They also recommend that the DEA revise the Interim Final Rule which lays out the requirements for electronically prescribing controlled substances in order to make registration and using EPCS easier.

Other recommendations include mandatory PDMP checks, the creation of a Department of Justice-led data-sharing hub, and integrated PDMP data in EHRs. The report suggests passing the Prescription Drug Monitoring (PDMP) Act of 2017 which mandates using PDMPs in states that receive federal funding. This Act also directs the Department of Justice (DOJ) to fund the establishment and maintenance of a data-sharing hub so information could be shared across states. The Commission points out that many providers resist using PDMPs because they don’t integrate well into EHRs, so they believe improving these integrations is necessary to increase effectiveness.

While these are great strides in the right direction, there is still a huge issue at hand. Trump did not mention any specific actions the administration will take or how they will be funded. With only declaring it a national public health emergency as opposed to a national emergency, there is not much more funding available. The commission’s report urges Congress and the Administration to block grant federal funding for opioid-related and SUD-related activities to the states. However, the report does not address the amount of funding needed for their recommendations.

1. https://www.whitehouse.gov/sites/whitehouse.gov/files/images/Final_Report_Draft_11-1-2017.pdf

National E-Prescribing of Controlled Substances Bill Gaining Traction

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Congressman Markwayne Mullin (R-OK) and Congresswoman Katherine Clark (D-MA) are confident the Every Prescription Conveyed Securely (EPCS) Act they proposed will be passed. The bill mandates electronic prescribing of controlled substances for Medicare patients nationwide.

When speaking at a forum in Washington, DC, the representatives said the bill has five cosponsors and the strong bipartisan support needed to become law.1 They want to pass it in whatever way necessary - either as a stand-alone bill or attached to another piece of legislation. Clark emphasized the importance of the bill stating, “we will put it on any vehicle that we see, and I hope we can do it in the next few months.”

The EPCS Act is meant to combat the opioid epidemic by helping providers detect fraud and abuse by patients who may be seeking the same prescriptions from multiple sources. Mullin pointed out that currently only about 14% of opioids are e-Prescribed. This leaves a huge amount of handwritten prescriptions that can be easily forged.

The bill sponsors said that opioid manufacturers and distributors as well as pharmacy benefit managers are in full support of the bill. Steve Miller, MD, the chief medical officer of one of the nation’s largest pharmacy benefit managers, Express Scripts, expressed his support of mandator e-Prescribing at the forum stating, “We're really excited the federal government is getting into the act.” He pointed out a few of the many benefits of e-Prescribing for Medicare patients – increasing convenience, improving access to needed pain medications, and eliminating fraud and abuse.

There has been some resistance from healthcare providers and hospitals due to the expenses that would go along with implementing e-Prescribing. While there is a cost associated with e-Prescribing controlled substances, we have seen the benefits of e-Prescribing for providers more than make up for this cost. Clark stated that e-Prescribing is a “critical tool going forward” in the fight against the opioid epidemic that’s worth the cost.

The law would also not go into effect until 2020, leaving plenty of time for prescribers to prepare. In addition, there would be a number of exemptions including economic hardship and technologic limitations for up to a year, during public health emergencies or in clinical trials.

Find out more about Electronic Prescribing of Controlled Substances.

   1.  e-Prescribing Bill for Controlled Substances May Soon Be Law - Medscape - Oct 24, 2017