The pharmacy protocol for forwarding unfilled e-Prescribed controlled substance prescriptions was recently clarified by the Drug Enforcement Agency (DEA). The DEA has specified that if for any reason one pharmacy cannot fill the original controlled substance e-Prescription, it may be forwarded to another DEA-registered pharmacy. This was clarified by the DEA’s associate section chief of the liaison and policy section of the DEA’s Diversion Control division Loren Miller in an email to National Association of Boards of Pharmacy CEO Carmen Catizone¹.

The email states, “As posted in the preambles of the [notice of proposed rulemaking] and the [interim final rule], an unfilled original EPCS prescription can be forwarded from one DEA registered retail pharmacy to another DEA registered retail pharmacy, and this includes Schedule II controlled substances.”

The National Association of Chain Drug Stores (NACDS) had contacted the DEA for clarification on the issue in May and applauded the response that was received.² “Simply put, this guidance encourages the use of electronic prescribing for controlled substances, and removes a substantial barrier to doing so,” NACDS president and CEO Steve Anderson, IOM, CAE said. “Electronic prescribing has significant advantages over other forms of transmitting a prescription because it reduces opportunities for fraud and abuse. NACDS is unwavering in its commitment to working with all parties to help find and implement solutions to opioid issues, while providing appropriate patient care. This has been, and remains, a top priority of NACDS, and we appreciate the DEA's action on this guidance, which we consider to be entirely consistent with patient care and with the proper handling of controlled substances.”

This is an important clarification that benefits both patients and prescribers by streamlining the process. It eliminates the need for a pharmacist to call the prescriber for a new prescription if it needs to be sent to a different pharmacy. This makes it quicker for patients to receive the medications they need and makes less work for the prescribers. This helps encourage prescribers to e-Prescribe which in turn improves prescription safety and prevents fraud and abuse.

1. http://www.ncbop.org/PDF/LMillerDEAGuidanceTransferofOnFileCSPrescriptions.pdf

2. NACDS Applauds DEA Guidance on Forwarding of Electronic Prescriptions for Controlled Substances  

https://www.nacds.org/news/nacds-applauds-dea-guidance-on-forwarding-of-electronic-prescriptions-for-controlled-substances/

Congressman Markwayne Mullin (R-OK) and Congresswoman Katherine Clark (D-MA) recently introduced legislation that would mandate Electronic Prescribing of Controlled Substances (EPCS) under Medicare Part D. The “Every Prescription Conveyed Securely Act”, H.R. 3528¹, was introduced into the House of Representatives.

It states that a prescription for a covered part D drug under a prescription drug plan for schedule II – V controlled substances must be transmitted electronically. If the bill passes, it would apply to coverage of drugs prescribed on or after January 1, 2020.

The aim of the legislation is to combat the national opioid epidemic. E-Prescribing does this by providing safer and more secure prescriptions. Electronic prescriptions can’t be forged or stolen like paper prescriptions. It also allows prescribers to easily track prescriptions and prevents patients from doctor shopping.

“Opioids claim nearly a hundred lives a day, and parents across the country worry they will be next to get the call their child has overdosed,” said Clark.  “Modernizing public health practices to include electronic prescriptions will curb the over-prescribing of opioids, eliminate the costs and inefficiencies of paperwork, and strengthen communication between doctors and patients.  Congress should come together to pass this commonsense solution to prevent overdoses and save lives.”

Mullen stated, “We need to ensure that patients are receiving opioids only when absolutely necessary and take precautionary measures to prohibit them from falling into the wrong hands.  Our bill, the EPCS Act, aims to close a dangerous loophole that has been fueling the problem of excessively prescribed opioids. By requiring all doctors and pharmacists to use an online database when prescribing these highly addictive drugs, we allow e-prescriptions to control, track, and monitor these highly addictive painkillers on a new level. This bill prevents patients from doctor shopping and prevents fraudulent, handwritten paper prescriptions.”

We have seen several states including New York, Maine, Connecticut, Virginia, and North Carolina take a similar approach to combat opioid abuse by mandating e-Prescribing of controlled substances at the state level, but this would be the first bill passed at the national level. This is definitely a step in the right direction of fighting the national opioid epidemic and we are hopeful that Congress will recognize the benefits e-Prescribing can bring. We also urge prescribers and health IT vendors alike not to wait for such bills to be enacted and to start taking advantage of the benefits of EPCS now. Contact us for more information about EPCS for prescribers and integrating EPCS for vendors at info@mdtoolbox.com.

https://www.congress.gov/bill/115th-congress/house-bill/3528/text/ih?overview=closed&format=xml

Missouri Governor Eric Greitens recently signed Executive Order (EO) 17-18¹ directing the Missouri Department of Health and Senior Services (DHSS) to create a statewide Prescription Drug Monitoring Program (PDMP). Despite legislative efforts for more than a decade, Missouri is currently the only state lacking such a program.

The governor’s announcement of the statewide PDMP said that it will utilize de-identified data from private sector partners to target “pill mills” that pump out prescription drugs at dangerous and unlawful levels. It will monitor both prescribers and dispensers of Schedule II through Schedule IV controlled substances in an effort to go directly to the source of drug shoppers. Opioids are the main focus as the national plague is hitting hard in Missouri with over 900 deaths in 2016 being due to opioid overdoses.

The executive order received national praise. Richard Baum, Acting Director of National Drug Control Policy stated, “In the context of both the ongoing opioid epidemic and the health of Missourians, it’s vital to have safeguards in place to make sure that doctors aren’t overprescribing opioids that can be misused and patients aren’t doctor-shopping for multiple prescriptions that could be misused or diverted.” Secretary Tom Price of the U.S. Department of Health and Human Services also praised the Governor stating, “I commend Missouri Governor Eric Greitens for taking a strong step in fighting the opioid epidemic by joining other states in establishing a Prescription Drug Monitoring Program (PDMP). I commend Governor Greitens for his leadership in Missouri as we all work to detect and deter the abuse of prescription drugs.”

State statute prevents Missouri from identifying patients, so they will be focusing on the prescribers and the dispensers with data from pharmacy benefit management organizations. They plan to be live with data from Express Scripts Holding Co. later this summer and hope to contract with two additional pharmacy benefit management organizations as well.

Due to the lack of a statewide program, local counties, led by St. Louis County, took it upon themselves earlier this year to create a prescription monitoring program. The St. Louis County PDMP focuses at the patient level instead of on prescribers and dispensers. The county program has three goals listed on its website²:

   1) Improve controlled substance prescribing by providing critical information regarding a patient’s controlled substance prescription history
   2) Inform clinical practice by identifying patients at high-risk who would benefit from early interventions
   3) Reduce the number of people who misuse, abuse, or overdose while making sure patients have access to safe, effective treatment

The new statewide PDMP is hoped to be a companion to the county program which covers the majority of the state, not a replacement, as the two systems take different approaches to combating the opioid epidemic.

1.https://governor.mo.gov/news/archive/governor-eric-greitens-announces-statewide-prescription-drug-monitoring-program

2. http://www.stlouisco.com/HealthandWellness/PDMP

Implementing ways to fight the national opioid epidemic is at the forefront of many states’ legislative sessions.  As we’ve mentioned in several previous posts, a growing number of states are fighting the epidemic by requiring prescribers to electronically prescribe these controlled substances. A new study published by the Journal of Opioid Management shows that these lawmakers are on the right track. And it’s more than just increasing legibility and preventing prescription fraud.

Researchers from John Hopkins University analyzed 510 prescriptions for opioids looking for errors, discrepancies, and variations from ideal practice¹. The study included both handwritten and electronically generated prescriptions filled at an outpatient pharmacy. An alarming 89% of handwritten prescriptions contained errors. What’s more is that 41% of those prescriptions were noncompliant with DEA rules. Overall, 92% of handwritten prescriptions failed to meet ideal practice standards, contained errors, or were noncompliant with DEA rules.

In contrast, none of the EHR computer-generated prescriptions contained errors and all of them were fully compliant with DEA rules. Electronic prescriptions are written using standard templates where most of the time the software will not even allow a prescriber to save the prescription without including necessary information such as the date, amount, and at least two patient identifiers. The software also aids in making sure any additional DEA rules and best practices are being followed.

The opioid epidemic needs to be tackled from several angles, including making sure the prescriptions that are being provided are accurate and safe for patients. Patient safety needs to be a top priority and prescribers need to make use of the tools available to aid them in following best practices and ensuring all DEA rules are abided by. Electronically prescribing has been shown time and time again to be a powerful resource. For more information on how to get started with e-Prescribing, contact us at info@mdtoolbox.com or 206-331-4420. 

  1.  An analysis of errors, discrepancies, and variation in opioid prescriptions for adult outpatients at a teaching hospital http://www.wmpllc.org/ojs-2.4.2/index.php/jom/article/view/556

North Carolina is the most recent state to pass a law requiring the use of e-Prescribing in an effort to combat opioid abuse. Governor Roy Cooper recently signed the Strengthen Opioid misuse Prevention (STOP) Act into law. The act requires that certain schedule II and schedule III controlled substances be electronically prescribed by January 1, 2020.

The act also sets a 5-day limit for initial prescriptions for acute pain and a 7-day limit for post-operative pain. It sets requirements for utilizing the North Carolina Controlled Substance Reporting System as well. The statewide reporting system tracks patients’ Schedule II-V controlled substance prescriptions so that prescribers can identify patients who may be misusing those controlled substances.

The opioid epidemic is hitting nationwide and North Carolina is no exception. There was a 73 percent increase in the number of opioid-related deaths from 2005 to 2015 in North Carolina with more than 13.000 opioid-related deaths during the period. 

North Carolina is the 5^th state to pass such legislation. New York, Virginia, Maine and Connecticut have similar laws requiring e-Prescribing. Several other states have pending legislation as well. All of these states hope to fight the opioid epidemic by reducing the number of opioids available and preventing the addictions from even starting.

E-Prescribing is an important tool in the opioid battle and we are happy to see so many states recognizing that. We are sure more and more states will join in the fight with this tool, but we also hope that prescribers will recognize the benefits and not wait for state mandates to start utilizing it. If you are a prescriber ready to start employing e-Prescribing of controlled substances in your practice, contact us to get started right away. 

E-Prescribing makes the prescribing process easier and safer for patients, prescribers, and pharmacists alike, so it comes as no surprise that e-Prescribing rates continue to surge each year. Surescripts recently released its 2016 National Progress Report¹ detailing the e-Prescribing growth they’ve seen on their network.

A total of 1.6 billion e-prescriptions were sent in 2016, up 12% from 1.4 billion in 2015. This accounts for 73% of all prescriptions being sent electronically.

The rates for e-Prescribing of Controlled Substances (EPCS) saw one of the biggest increases with a 256% jump from 2015. There were 45.3 million e-prescriptions for controlled substances sent in 2016 as compared to only 12.8 million in 2015. Part of this increase can be attributed to states such as New York, Minnesota and soon to be Maine mandating that all controlled substances be sent electronically.

The mandate helped New York be ranked number 1 in the Surescripts report with 72.1% of prescribers enabled for EPCS, 98.1% of pharmacies enabled, and 91.9% of controlled substances prescribed electronically. Minnesota, who doesn’t enforce their mandate, was ranked number 7 with 14.3% of prescribers enabled for EPCS, 93.8% of pharmacies enabled, and 19.8% of controlled substances prescribed electronically.

States are putting these mandates in place in an effort to combat substance abuse and increase patient safety. With software, like MDToolbox-Rx, incorporating EPCS into the existing e-Prescribing workflows, it really leaves little reason for those prescribers who are already e-Prescribing not to electronically prescribe controlled substances as well.

The ability to access patient medication histories electronically at the point of prescribing also plays an important role in patient safety. It allows prescribers the ability to see a more complete history and avoid adverse drug events. The amount of providers accessing medical histories on the Surescripts network also increased in 2016. More than 1.08 billion medication histories were accessed.

2016 also saw a 22% increase in the number of healthcare professional connected to the Surescripts network with 1.3 million healthcare professionals connecting. However, although the number of prescribers connected increased by 7%, it’s somewhat surprising that 36% of prescribers are still not connected. We are confident that the number of prescribers who connect will continue to increase though, as prescribers continue to realize the value of e-Prescribing and the ease of use provided by software like MDToolbox-Rx.

1. Surescripts 2016 National Progress Report http://surescripts.com/news-center/national-progress-report-2016/

Connecticut just passed Public Act No. 17-131¹ which mandates that prescribers must electronically prescribe controlled substances by January 1, 2018. The legislation was unanimously passed.

The law was originally proposed by Governor Dannel Malloy in an effort to combat opioid abuse and addiction. By requiring controlled substances prescriptions to be sent electronically, it allows the prescriptions to be tracked and prevents fraud from forged or stolen paper prescriptions.

The law also increases the ability of state agencies to share data on opioid abuse, as well as allows patients to insert a form in their medical records refusing to be prescribed opioids.

Most pharmacies appear ready, but it’s going to be a change for the majority of prescribers in the state. According to Surescripts’ EPCS State Readiness page², 96.7% of pharmacies are enabled for e-Prescribing of controlled substances in Connecticut, but only 5% of prescribers are currently enabled. Surescripts National Progress Report also showed that in 2016 only 6% of controlled substances were prescribed electronically in Connecticut.

Connecticut is the fourth state to enact a mandate requiring electronic prescriptions for controlled substances (EPCS). Minnesota, New York, and Maine were the first three states to pass similar laws. Several other states are considering similar legislation as well.

We are pleased that many states have seen the benefits of EPCS and are taking action to combat the ever growing opioid crisis in our nation with this important tool. Find out more about EPCS and start e-Prescribing controlled substances today.

   1.  Public Act No. 17-131: An Act Preventing Prescription Opioid Diversion and Abuse. https://www.cga.ct.gov/2017/ACT/pa/2017PA-00131-R00HB-07052-PA.htm

   2.  Surescripts State Readiness and Local Search Tool http://surescripts.com/products-and-services/e-prescribing-of-controlled-substances

   3. Surescripts National Progress Report 2016 http://surescripts.com/news-center/national-progress-report-2016/#/EPCS-readiness-by-state

Prescribers in Maine have less than 3 weeks until the mandate requiring all opioid prescriptions be sent electronically goes into effect. As of July 1^st, 2017, licensed practitioners in Maine may no longer write paper prescriptions for opioid medications according to Public Law Chapter 488¹.

As we wrote about earlier, the mandate was put in place in an effort to combat opiate abuse and heroin addiction. E-Prescribing prevents forged prescriptions, eliminates errors from illegible handwriting and misunderstood oral prescriptions, and helps prevent overprescribing of pain medications. It’s hoped that by limiting the pain pills, it will prevent people from even trying heroin to begin with.  

The Office of Substance Abuse and Mental Health Services in Maine produced a document “Electronic Prescribing in Maine: A Guide to Understanding E-Prescribing and its Benefits²,” which addresses some frequently asked questions about the mandate.  Among the FAQs, it’s stated that an electronic prescription will be required for any amount of opioid medication being prescribed, even those for fewer than 7 days. Sending a prescription via facsimile will also not meet the requirements. Opioid prescriptions must be sent electronically using software that meets all of the federal security requirements and has been approved by the DEA for EPCS.

The DEA requirements for EPCS include:

• Using certified software that has gone through a 3^rd Party Audit – software systems must show that they meet the DEA requirements for signing, transmitting, and processing controlled substances prescriptions

• Identity proofing – all prescribers must prove they are who they say they are and have the proper credentials to prescribe controlled substances

• 2-Factor Authentication – prescribers must use 2-factor authentication to sign controlled substance prescriptions electronically. This involves using 2 of the following: something you know (a password), something you have (most commonly a software or hardware token), or something you are (biometric information).

While the requirements can make it seem overwhelming, MDToolbox has simplified the process. Signing up for MDToolbox-Rx e-Prescribing with EPCS is a simple process with only a few steps that can be completed within minutes. Once signed up, utilizing the software is just as easy with an intuitive workflow.

Although it’s quick and easy to get started with MDToolbox, we do not recommend waiting any longer. If you prescribe opioids in Maine and still need e-Prescribing software to meet the mandate, contact us today at info@mdtoolbox.com or 206-331-4420! We are ready to answer any questions you have and help make your transition to EPCS as smooth as possible.

1.  https://legislature.maine.gov/legis/bills/bills_127th/chapters/PUBLIC488.asp

2. Electronic Prescribing in Maine, A Guide to Understanding E-Prescribing and its Benefits. http://www.maine.gov/dhhs/samhs/osa/data/pmp/Electronic-Prescribing.pdf

Massachusetts, New Hampshire, New York and Texas are the four most recent states to join the prescription monitoring program (PMP) run by the National Association of Boards of Pharmacy (NABP) – NABP PMP InterConnect¹. This brings the total number of states connected to 37, making it the largest prescription data sharing network. Over 3.9 million requests and 8.2 million responses are processed through the system each month.

The complete list of connected states includes: Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New Jersey, New Hampshire, New Mexico, New York, North Dakota, Ohio, Oklahoma, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, West Virginia and Wisconsin.

It is expected that other states will be joining soon too. “We’re excited about the growth and response to PMP InterConnect,” said NABP President Hal Wand, MBA, RPh. “Our goal is to reach every state with a PMP to guarantee a true connection across our country in an effort for greater medical knowledge and our patients’ safety.”

There is no charge to the states to use the system and it’s setup to enforce each state’s data-access rules. Authorized healthcare professionals including physicians and pharmacists in each of the connected states are able to access multi-state histories of their patients’ controlled substance prescriptions. This is an important tool in combating prescription drug abuse and identifying potential problems by allowing providers to see a comprehensive history, especially for those patients who cross state lines.

1. "Four States Join NABP PMP InterConnect, the Nation’s Largest Prescription Data Sharing Network," National Association of Boards of Pharmacy (NABP) https://nabp.pharmacy/four-states-join-nabp-pmp-interconnect-nations-largest-prescription-data-sharing-network/

As we ring in the new year, medical providers now can say goodbye to the CMS’s “Meaningful Use Incentive Program” (MU) and start preparing for the new Medicare incentive program.

Providers who used qualified systems in 2016 can still attest to Meaningful Use for the 2016 year (you must have been a “meaningful user” of certified electronic medical record system(s) for the minimum reporting period. Visit this website for more info on how the previous year’s MU programs worked and deadlines for attesting: 

https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/2016ProgramRequirements.html

Now in 2017, Meaningful Use will become one of four components of the new “Merit-Based Incentive Payment System” or MIPS. MIPS is part of the bigger Medicare Access and CHIP Reauthorization or MACRA.² 

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) ended the Sustainable Growth Rate formula, which threatened clinicians participating in Medicare with potential payment penalties for 13 years.  

The MACRA program introduces two paths that Medicare providers can choose from for participation:

• Advanced Alternative Payment Models (APMs) (providers apply for a special payment model program) or
• The Merit-based Incentive Payment System (MIPS)  (a performance-based program)

Who Does this Affect?

Providers who are in an Advanced APM or who bill Medicare for more than $30,000 a year and care for more than 100 Medicare patients a year are affected. Providers with less than that are not affected and not part of the program.³  This includes:

• Physician
• Physician assistant
• Nurse practitioner
• Clinical nurse specialist
• Certified registered nurse anesthetist

Advanced Alternative Payment Models (APMs)

The Advanced APMs program allows certain providers to apply for the APM track. This gives added incentive payments to provide high-quality and cost-efficient care. See the APM website for more information on the special programs and how providers can apply:

https://qpp.cms.gov/learn/apms

The Merit-based Incentive Payment System (MIPS)

Most Medicare Providers will be part of MIPS. They will earn a payment adjustment based on evidence-based and practice-specific quality data submitted. According to CMS, the Quality Payment Program policy will reform Medicare payments for more than 600,000 clinicians across the U.S.

Providers participating in the program in 2017 will submit their data by March 2018 and based on submission, their 2019 Medicare payments will be adjusted up, down, or not at all. 

MIPS is broken down into four categories and is setup so that the more Providers participate (and attest to), the higher score (and incentive) providers will get. A Medicare provider who does not participate at all (0%) may see up to 4% negative adjustment in 2019. A provider with a minimal amount of participation (e.g. submit one measure) may be able to avoid adjustment. For partial submission (submit the minimums for a partial year) they will see neutral or positive adjustments, and submit a full year and earn a positive payment adjustment.

If we take a quick look at how each category works:

•  Quality
•  Most Providers will report up to 6 quality measures (including an outcome type measure). Quality measures selected should be focused based on type of care and specialty as appropriate.
•  Reporting period must be a minimum of 90 days.
• There are over 250 quality measures available, be sure to check your health record software system to see which ones they support (can help gather data for you) when planning.
• Measures go across many specialties and problem sets:  For example, “Age Appropriate Screen Colonoscopy” – Report the percentage of patients greater than 85 years old seen by the Provider who received a colonoscopy screening Jan 1 to December 31.

•  Improvement Activities
• Most Providers will attest to completing a minimum of 4 improvement activities for at least 90 days.
• As of the writing of this blog, the CMS tools shows 92 activities to choose from.
• Activities range from care coordination, patient safety changes and beneficiary engagements.
• Examples: Join and participate (for a minimum of 6 months) in your States Prescription Monitoring Program (PMP). Or another example: Engage patients, family and caregivers in developing a plan of care and prioritizing their goals for action, documented in the certified EHR technology.

• Advancing Care Information
• Use a qualified (certified) product (or products) for a minimum of 90 days.
• There are two different programs to pick from depending on your Electronic Health Record Software Certification. For 2017, you will be able to use either a 2014 Certified Product (previously called Stage 2 MU Certification) or a 2015 certified product (certified for the MU Final Ruling criteria). Attest to a minimum of:

• E-Prescribing
• Provide Patient Access
• Send Summary of Care Records
• Receive Summary of Care Records
• Report up to 9 additional measures for bonus credits
• Cost
• No actions required: Cost will be computing from your claims
• The cost category will be calculated in 2017, but will not be used to determine your payment adjustment. In 2018, CMS will start using the cost category to determine your payment adjustment.

Medicare Providers will want to research the programs and decide their level of participation early in 2017. Full year participation would require making sure their Electronic Health Record system is setup for minimal data tracking and other required features like E-Prescribing and Direct Messaging.

References

1. 2017 Program requirements:

   https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/2017ProgramRequirements.html

2. MIPS and MACRA:

   http://www.impact-advisors.com/meaningful-use/mips-macra-mu-the-next-evolution-of-healthcare-payment-reform/#sthash.vMkVGSvN.dpuf

3. https://qpp.cms.gov/docs/Quality_Payment_Program_Overview_Fact_Sheet.pdf

4. MIPS Quality Payment Program Website: 

   https://qpp.cms.gov/measures/performance