With the March 27^th mandatory e-Prescribing deadline in New York State looming, the New York Commissioner of Health has waived the following exceptional circumstances from the requirements of electronic prescribing¹:

1. any practitioner prescribing a controlled or non-controlled substance, containing two (2) or more products, which is compounded by a pharmacist;
2. any practitioner prescribing a controlled or non-controlled substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion;
3. any practitioner prescribing a controlled or non-controlled substance that contains long or complicated directions;
4. any practitioner prescribing a controlled or non-controlled substance that requires a prescription to contain certain elements required by the federal Food and Drug Administration (FDA) that are not able to be accomplished with electronic prescribing;
5. any practitioner prescribing a controlled or non-controlled substance under approved protocols under expedited partner therapy, collaborative drug management or in response to a public health emergency that would allow a non-patient specific prescription;
6. any practitioner prescribing an opioid antagonist that would allow a non-patient specific prescription;
7. any practitioner prescribing a controlled or non-controlled substance under a research protocol;
8. a practitioner prescribing a controlled or non-controlled substance either through an Official New York State Prescription form or an oral prescription communicated to a pharmacist serving as a vendor of pharmaceutical services, by an agent who is a health care practitioner, for patients in nursing homes and residential health care facilities as defined in section twenty-eight hundred one of the public health law.
9. a pharmacist dispensing controlled and non-controlled substance compounded prescriptions, prescriptions containing long or complicated directions, and prescriptions containing certain elements required by the FDA or any other governmental agency that are not able to be accomplished with electronic prescribing;
10. a pharmacist dispensing prescriptions issued under a research protocol, or under approved protocols for expedited partner therapy, or for collaborative drug management;
11. a pharmacist dispensing non-patient specific prescriptions, including opioid antagonists, or prescriptions issued in response to a public health emergency issued; and
12. a pharmacist serving as a vendor of pharmaceutical services dispensing a controlled or non-controlled substance through an Official New York State Prescription form or an oral prescription communicated by an agent who is a health care practitioner, for patients in nursing homes and residential health care facilities as defined in section twenty-eight hundred one of the public health law.

Prescribers who issue prescriptions in any of these circumstances may use the Official New York State Prescription Form or issue the prescription orally. The waiver is effective until March 26, 2017. Before that time, the Commissioner of Health will reevaluate whether the e-Prescribing software available has adequate functionality for these exceptional circumstances. 

1. New York State Department of Health, Letter from the NYS Commissioner of Health to practictioners and pharmacists regarding a blanket waiver for additional exceptional circumstances related to electronic prescribing - March 16, 2016

http://www.health.ny.gov/professionals/narcotic/electronic_prescribing/docs/2016-03-16_blanket_waiver_letter.pdf

The New York State Internet System for Tracking Over-Prescribing (I-STOP) Act mandates that all prescriptions, both controlled and non-controlled, be sent electronically. Last year the deadline for prescribers to meet the regulation was postponed until March 27, 2016. This new deadline is fast approaching.

In order to comply with I-STOP, prescribers must select and use a certified electronic prescribing computer application that meets all federal requirements for electronic prescriptions for controlled substances (EPCS).  This includes going through Identity Proofing and setting up 2-Factor authentication. The practitioner must also register each unique certified computer application used to electronically prescribe controlled substances with the New York State Department of Health (DOH), Bureau of Narcotic Enforcement (BNE).

The BNE recently sent out a letter to all prescribers advising the following:

“Please be aware that implementation timelines for EPCS software vary and may be lengthy. If you have not already begun this process, BNE strongly recommends that you begin immediately. Prescribers who have certified EPCS software and have completed the registration process are highly encouraged to begin electronically prescribing instead of using paper, to allow for time to resolve technical or workflow issues prior to the mandate’s effective date.”

MDToolbox has a simple signup process for both standard e-Prescribing and to setup EPCS. Most prescribers can complete the required ID proofing and 2-Factor Authentication setup within one day, but we also urge prescribers in NY to get started as soon as possible. This will ensure time to complete the application process and get all staff setup and trained.

To sign up for a free 30 day e-Prescribing trial with EPCS: New York e-Prescribing Account

Once you have signed up, you can register the application at:          

http://www.health.ny.gov/professionals/narcotic/electronic_prescribing/ropes.htm

Electronic Prescribing of Controlled Substances (EPCS) is now legal in all 50 States.  Missouri and Vermont were the last two states to authorize electronic prescribing of controlled substances.  Missouri’s regulations became effective July 30^th, 2015.  Today, August 28^th, Vermont became the final state to allow prescribers to legally prescribe controlled substances electronically for schedule II-V drugs.  Prescribers can now electronically prescribe controlled substances at any participating pharmacy in the United States. 

National EPCS availability is a key step in combating prescription drug fraud and abuse.  With the adoption of EPCS, patients will no longer be able to forge paper prescriptions.  Drug seeking behaviors and patterns will also be easier to identify and respond to.  With the increased electronic connectivity of pharmacies, medication histories will be more readily available.  All of these factors will also create a much safer environment for patients. 

The state of New York has passed legislation requiring prescribers to do all of their prescribing electronically starting in March next year.  As that deadline draws near and potentially other states follow, it will be necessary to stay current and have a viable EPCS solution.  Currently, the national average of pharmacies enabled for EPCS is 80.3%. Now that EPCS is legal in all states and as more states make EPCS a requirement, we expect to see more and more pharmacies coming online and allowing receipt of EPCS. 

MDToolbox offers both a certified stand-alone e-Prescribing solution, as well as an integratable solution for EHR or PM systems to add full e-Prescribing capabilities or add on just EPCS capabilities. MDToolbox is ready to help prescribers and software companies through the DEA requirements to get fully prescribing controlled and non-controlled substances electronically. Check out our EPCS page or contact us at info@mdtoolbox.com for more info.  

Surescripts recently released its 2014 National Progress Report and one of the most startling findings is that only 1.4% of providers are enabled for Electronic Prescribing of Controlled Substances (EPCS).¹

A much larger percent of pharmacies are setup to utilize EPCS. The national average of pharmacies enabled for EPCS is 74.9%.  A state by state comparison of the percent of pharmacies with EPCS capability, can be found on our EPCS page.

Even though EPCS is now legal in 49 states and D.C., its growth has been rather slow compared to the rates of non-controlled e-Prescribing. Surescripts’ report also found that 67%, or 1.2 billion, of all new prescriptions in 2014 were e-Prescribed. However, while there was a 400% increase in controlled substance e-Prescribing from 2013 to 2014, the number of controlled substance prescriptions was only 1.67 million.

Out of almost 70,000 total pharmacies and more than half a million e-Prescribing prescribers, the amount of pharmacies utilizing EPCS far surpasses the amount of prescribers.

While the statistics are surprising considering EPCS has been legal since 2010, there are several factors involved in the low percentage of prescribers. These include issues such as their software not being ready to meet the DEA requirements, as well as the number of steps that prescribers must go through to be setup for EPCS.

Though the steps involved may seem complex, e-Prescribing vendors are doing their best to make the process as smooth as possible for prescribers to utilize this important technology. MDToolbox has created a simple 4-step process that walks prescribers through completing the DEA requirements for EPCS that can be completed within minutes.* We also provide this EPCS solution as an integration option so that EHRs and other technology vendors can add the streamlined process to their existing workflow.

There are several benefits of EPCS including increasing patient safety and security, as well as reducing fraud and abuse. The easier it is for prescribers to setup and use EPCS, the more likely they will be to take advantage of the benefits and increase their usage.

Click here for more on EPCS for prescribers

Click here for more on EPCS for technology vendors

*Time varies based on token selection and results of identity verification

1.  2014 National Progress Report http://surescripts.com/news-center/national-progress-report-2014#public

New York State has officially delayed the requirement to send all prescriptions electronically one year until March 27, 2016. The delay came just two weeks before the original I-STOP mandate was set to go into effect. Under I-STOP, providers will be required to send both non-controlled and controlled substances electronically. Paper prescriptions will no longer be allowed.

The main reason for the delay was stated as a lack of software vendors being ready.  While most software has the ability to electronically send non-controlled prescriptions, some are still lacking the ability to electronically prescribe controlled substances (EPCS). EPCS capability requires completing an audit by a DEA-approved auditor to prove that certain security measures are in place. 

The advantages of e-Prescribing are plentiful from patient safety to efficiency in prescribing to combatting doctor shopping. However, many of these benefits could be lost by either using software that isn’t truly ready or rushing into trying to use software that is complex. The additional time will be beneficial for prescribers. Providers can now pick the solution that is right for them without being rushed and get their practice adjusted to e-prescribing more slowly.

The delay will also take some of the pressure off those vendors who are still trying to add EPCS capabilities. While MDToolbox was one of the first vendors to be approved by the DEA for sending controlled substances, we understand the complexities involved in becoming an approved vendor. It is not an easy process. This additional year will give EHRs and other software vendors the necessary time to implement the requirements as smoothly as possible into their workflows and ensure they do not lose their providers to other vendors. Many vendors have chosen to partner with other vendors to help them meet the requirements. This is a great way to integrate EPCS and the required features such as Identity Proofing, 2-factor authentication, and Permissions without having to exert many resources. Having all of the required features come together in a package that can seamlessly integrate takes a lot of the legwork, expenses, and stress out of the process.

Whatever path vendors and prescribers choose to take, they must seize this opportunity to guarantee they are fully ready when the new deadline comes around.

Click here for further information on adding MDToolbox EPCS to your software

Click here for further information on MDToolbox standalone e-Prescribing software

The recent rescheduling of hydrocodone combination products and the requirement to use special approved prescription paper for Schedule II drugs in Texas, has caused many prescribers to turn to e-Prescribing as an alternative. As prescribers look to this electronic alternative, there are several questions that come up as the Texas Department of Public Safety (Texas DPS) has given out some state specific guidelines. Here’s what prescribers need to know:

Is e-Sending Schedule II drugs allowed in Texas?

In October of 2013 the Texas DPS accepted the same requirements, with a few updates of their own, as the DEA in regards to sending Schedule II controlled substances electronically. ¹

What are the Texas State Guidelines?

In order to comply with the Texas DPS guidelines, there are several things prescribers must be aware of and know before they start using an EPCS program. Prescribers must make sure that their vendor is certified by the DEA, meaning that they passed the required third party audit. Prescribers will also want to be sure that the vendor has EPCS capability activated for their state. Prescribers must also make sure that all their necessary credentials are included when e-Sending a prescription.

DPS, DEA and APN Numbers

The numbers prescribers now put down for paper prescriptions, their DPS, DEA and APN numbers for advanced practice nurses must also be on their electronic prescriptions as well. When prescribers are setting up their e-prescribing account they want to make sure that this information can be entered in the appropriate fields.

APNs will also enter their prescriptive authority identification number for all prescriptions written.  APNs and physicians assistants with prescriptive authority should also keep in mind they must include the DEA and DPS number of their supervising practitioner on all prescriptions schedules III-V.²

Control Numbers

Paper prescriptions written in the state of Texas for schedule II drugs require that each prescription be printed on DPS required paper that has a unique Control Number listed for the pharmacy to record. With e-prescribing all control number information, locating, and documenting is now handled entirely on the pharmacies end electronically.

What Does This Mean Now?

Texas DPS completed their beta testing of EPCS March 1, 2014. The purpose of which was to monitor Schedule II prescriptions for abuse, prescribing patterns, patients attempting to get prescriptions from multiple doctors, and fraudulent prescriptions. Also, to make sure all reporting on both the provider’s end and the pharmacy’s end was done accurately and in a timely manner.

After the results of the testing came back, the outcome was clear. Provider’s information was safer, as their DPS and DEA numbers were no longer floating around on written prescriptions for people to try to forge prescriptions with. The DPS information is also now easier and faster to track with everything being electronic. Patients’ information was also safer and relayed faster as there was no longer the constant need to rely on a phone or fax for patient information that may or may not have made it to the desired party on the other end.

Electronically prescribing controlled substances has proven to not only be a viable alternative to paper prescriptions in Texas, but an improvement. To get more information on EPCS or to start sending controlled substance electronically contact us at info@mdtoolbox.com or visit our EPCS page.

1. https://www.pharmacy.texas.gov/EPCS.asp
2. http://www.dps.texas.gov/RSD/ControlledSubstances/News/index.htm.

DEA ISSUES FINAL RULING FOR HCPs TO BE RESCHEDULED FROM CLASS III TO CLASS II

The DEA has officially ruled that all hydrocodone combination products or HCPs (ex: Vicodin and Lortab) are to be rescheduled, moving them from Schedule III to II based on the Controlled Substances Act¹. The ruling was made official August 22, 2014 and will be put into effect starting October 6, 2014.

HOW DOES THIS EFFECT PRESRCIBING?

Starting next week, all HCPs will be schedule II controlled substances (CS). This will cause several things to change and impact providers, as well as patients alike. Providers will no longer be able to write prescriptions for HCPs with refills and they will be limited to a 3 month supply at most (the rule also mandates that doctors must write the prescriptions in 30-day increments that can only be filled sequentially). Pain patients using the drugs will have to visit their doctors every three months for a new prescription. The rule also limits which providers in certain states can write these prescriptions, as well as how they can be sent.

Due to HCPs now being a schedule II CS, only practitioners registered with the DEA will be able to prescribe the drugs. However, some states have separate laws in place that limit this even further.  For example, in the states of Alabama, Georgia, Missouri, and South Carolina nurse practitioners are not allowed to prescribe, administer, or dispense schedule II CSs.

Providers are only left with two options for prescribing these schedule II drugs:

Paper Prescriptions 

According to the DEA, prescriptions for schedule II CSs cannot be phoned in or faxed to a pharmacy with the exception of emergency situations. In the case one of the situations comes to pass, the provider that authorized the emergency oral prescription has 7 days to produce a paper prescription to the pharmacy, which can be hand delivered or mailed if post marked within the 7 day period. If a prescription is faxed, it cannot be dispensed until a physical copy of the prescription is presented and reviewed. A prescription for a schedule II CS must be written with ink, indelible pencil, typed, or generated by an electronic system on tamper-proof prescription forms and hand signed if they are to be hand delivered to the pharmacy.

Electronic Prescriptions

The second way that a provider can prescribe a schedule II drug is through e-Prescribing. EPCS, or Electronic Prescribing of Controlled Substances, offers a viable solution for prescribers to not only meet the DEA requirements for schedule II prescriptions, but increase their workflow and patient safety at the same time.   With Electronic Prescriptions, the prescriber also must sign each prescription but instead of using ink, he uses a digital signature that is generated with a two-factor sign-off credential.  When the prescription is sent electronically the pharmacist can see that the order was electronically signed and knows that it came from the prescriber and was not forged.    EPCS is approved for Prescribers in 49 states for Schedule III-V and in 47 States for Schedule II drugs, meaning in most of the U.S. prescribers can use EPCS to safely send Vicodin and other schedule II drugs.

MDToolbox has made the process easy and straightforward for providers.  When a provider first signs up for EPCS, they will go through an identity proofing process and set up their two factor credentials. Once set up is complete, writing and sending a prescription for a CS is just as easy as a non CS, the only difference being entering the two-factor signing credentials that assures it is the doctor authorizing the prescription.   To get more information on how EPCS works, or to find out about signing up for our EPCS Stand Alone or EHR Integration Add on, contact us at info@mdtoolbox.com or visit our EPCS page.

1. http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/fr0822.htm

With only three states left to approve EPCS and a few others working on their final requirements, EPCS is gaining great traction in 2014.  As more and more pharmacies come online every day, MDToolbox is excited to be at the forefront of helping HIT vendors and physicians take the next step – and send ALL prescriptions electronically.     

What states are we still watching? 

And then there were 3 - Arkansas, Montana, and Rhode Island

Arkansas, Montana, and Rhode Island are the three states where EPCS still remains unavailable as their state governments sort out the differences in the State Laws versus the DEA rulings.  Arkansas made progress by passing Act 1331 in April of 2013 to clarify that electronic prescribing of controlled substances is permitted.  Furthermore, the Arkansas State Board of Pharmacy had a public hearing scheduled to discuss the changes in February 2014, but it was postponed until March due to poor weather conditions.  Rhode Island also passed a similar bill, SB 647, in June of 2013 which states, “A practitioner may sign and transmit electronic prescriptions for controlled substances.”  However, further clarification is still needed from all three states before EPCS is allowed.  Stay tuned as we will post any updates as soon as we get them!   

Oregon

While Oregon is listed as allowing Schedule II-V substances to be sent electronically on the Surescripts map, Schedule II substances can actually only be legally e-Prescribed in emergency situations.    A bill was introduced on February 3, 2014, that if approved would allow all controlled substances including Schedule II drugs to be electronically sent in non-emergency situations as well.

New York

All eyes are on New York as they are leading the way by being the first state to mandate that all prescriptions be sent electronically.  It was almost a year ago that EPCS became legal in the state of New York.  As of March 27, 2013, amendments to Title 10 NYCRR Part 80 Rules and Regulations on Controlled Substances went into effect, technically allowing providers in New York to electronically prescribe Schedule II-V drugs¹.  However, the actual implementation of EPCS has been slower than expected as the state of New York was overdue finalizing its registration process.  Pharmacies and providers are still currently struggling to meet all the requirements. 

It was not until January 23, 2014 that Surescripts was able to turn on EPCS functionality for the State of New York.  Currently, out of 5,579 registered New York pharmacies there are only about 850 listed as being able to receive electronic controlled substance prescriptions on the Surescripts network.  As we mentioned in our post about the Evolution of EPCS, pharmacy software must go through a DEA Certification or third-party audit to verify they comply with the strict regulations put in place by the DEA and through a Surescripts certification.  In addition, pharmacies in New York are also required to submit dispensing data for controlled substances using the American Society for Automation in Pharmacy (ASAP) format Version 4.2 or greater². 

It is not only the pharmacies in New York that have to go through extra steps to use EPCS, the prescribers do as well.  The New York State Department of Health, Bureau of Narcotic Enforcement (BNE) recently released registration packets that are required for each prescriber who would like to transmit electronic prescriptions for controlled substances.  All prescribers must register their electronic prescribing software and be able to provide proof of a DEA certification or third party audit verifying the software meets the federal security requirements for transmitting controlled substance prescriptions electronically.  The DEA requires that all prescribers go through strict identity proofing and receive two-factor authentication credentials for EPCS.  Prescribers must attest that they have personally met these federal requirements when registering with the BNE as well. 

With the New York I-STOP Law mandating that ALL prescriptions be electronically sent by March 27, 2015 with limited exceptions, providers only have a little over a year to register and begin using EPCS certified software.

MDToolbox is prepared and ready to help any providers meet this fast approaching deadline.   We are currently offering free EPCS software tokens for a year to any providers that sign up.  Check out our EPCS page and contact us at info@mdtoolbox.com for more information. 

1. https://www.health.ny.gov/regulations/recently_adopted/docs/2013-02-13_electronic_prescribing_dispensing_and_recordkeeping_of_controlled_substances.pdf
2. https://www.health.ny.gov/professionals/narcotic/electronic_prescribing/

Electronic prescribing of controlled substances (EPCS) is just starting to gain ground.  The Drug Enforcement Agency (DEA) rule allowing prescribers to electronically write prescriptions for controlled substances actually went into effect over three years ago.  However, its adoption has been slow. 

The need to be able to send controlled substances electronically is definitely there.  Approximately 11% of all prescriptions written are for controlled substances and 90% of prescribers write prescriptions for such drugs¹.  If these prescriptions can’t be sent electronically, prescribers must handwrite or print them.  This can be a big interruption and slowdown in a prescriber’s workflow.  In addition, EPCS increases safety and decreases fraud.  So why is it taking so long for EPCS to become a norm? 

The DEA’s Interim Final Rule (IFR) first approved electronic sending and receiving of controlled substances in March 2010, and it went into effect on June 1, 2010.  Though in order to actually use EPCS, prescribers, e-Prescribing software, and pharmacy software must meet strict regulations.  Prescribers are required to go through stringent identity proofing and receive two-factor authentication credentials.  Each time they send a controlled substance, prescribers must use their two-factor authentication.  The two-factor has to be two of the following three items:

1) Something only the prescriber KNOWS, like a password or an answer to a challenge question

2) Something the prescriber IS, biometric data such as a fingerprint or 

3) Something the prescriber HAS like a device or token separate from the computer he is prescribing on.   

E-Prescribing software and pharmacy software must go through a DEA Certification or third-party audit to verify they comply with the regulations.  The IFR requires e-Prescribing software to have a two-factor authentication protocol, have access controls so only prescribers with the proper permissions can send controlled substance prescriptions, and put extra security and auditing measures in place.  Pharmacy software is also required to have access controls and stricter security measures, as well as additional features to be able to receive electronic controlled substance prescription orders.

In addition to the Federal DEA requirements, each state has their own laws and regulations concerning EPCS.  While 47 states have approved EPCS, there is still a small percentage of pharmacies in each of these states that are able to receive electronic prescriptions for controlled substances. 

It is clear that meeting all of these requirements can be challenging and takes ample time and money for all involved.  This has caused the progression to be quite slow.  Here’s how it looks on a year-by-year basis:

2010: DEA IFR goes into effect and states begin aligning their rules with those of the DEA.

2011: Software vendors working to meet requirements.

2012: First e-Prescribing and pharmacy software vendors certified.  Surescripts® reports a “modest number of EPCSs” transmitted in eight states as of May 2012.   

2013: About 14,000 pharmacy stores signed up for EPCS in 44 states, but only about 1,000 prescribers nationwide using EPCS as of Mid-2013.

2014: About 20,000 pharmacy stores signed up for EPCS in 47 states.  However, only 14 e-Prescribing systems certified for EPCS out of over 600 prescribing applications on the Surescripts® network. ²

Out of almost 70,000 total pharmacies and more than half a million e-Prescribing prescribers, the numbers of those using EPCS are still small.  However, that’s changing as EPCS growth takes off.

As one of the 14 certified Prescriber EPCS systems, MDToolbox is at the forefront of the EPCS movement.  We see now as the time that EPCS is going to take off.  MDToolbox is offering both standalone EPCS for prescribers and EPCS plug-in modules for EHRs looking for a quick and inexpensive way to get on-board with the movement.  With laws like New York’s I-STOP mandating ALL prescriptions be sent by March 27, 2015, we believe EPCS will see huge growth in 2014. 

What do you think?  We would love to hear from you and get your feedback, comments and questions. Leave a comment below or feel free to contact us at info@mdtoolbox.com.     

1. Rannazzisi JT. A Prescription for Waste: Controlled Substance Abuse in Medicaid. Drug Enforcement Administration (DEA). September 30, 2009. www.justice.gov/dea/pr/speeches-testimony/2012-2009/ct093009.pdf. Accessed January 27,2014.
2. Surescripts - http://www.surescripts.com/medication-network-services/e-prescribing-of-controlled-substances/regulatory-status-map