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