e-prescribing and controlled substances

In 2012, the New York State Department of Health issued a mandate requiring all providers to prescribe medications electronically—no more paper script pads or call-ins. Providers were given until March 27, 2015, to comply.

Most script-related software companies had no trouble complying with such a mandate, except in one case: controlled substances. Even by fall 2014, two years after the legislation had been enacted, less than one percent of prescribers in New York state had the certified technology to handle the electronic prescribing of controlled substances, noted New York law firm Nixon Peabody. Under petitions from providers and information system vendors, New York state extended its March 27 compliance deadline for one year.

Other states have experienced similar, earlier hurdles. Minnesota enacted an e-prescribing mandate in 2008, with a compliance date of 2011. As the compliance date approached, the Minnesota Department of Health (MDH) acknowledged that some providers and pharmacies still were not ready to meet the compliance date, noting in its 2011 guidance: “It is critical that these providers and pharmacies demonstrate progress toward implementing an EHR with e-prescribing functionality in order to meet the intent of the mandate.”

Interestingly, Minnesota’s original legislation excluded long-term care (LTC) providers. But, as the MDH noted in 2011: “because LTC is such a vital part of our care delivery system, the Minnesota e-Health Advisory Committee, which includes representation from LTC associations, recommends that these facilities also make progress toward implementing a fully functional EHR that includes e-prescribing.”

Meanwhile, the e-prescribing rules changed for LTC and post-acute care providers specifically in November 2014, mandating a change to National Council for Prescription Drug Programs (NCPDP) SCRIPT 10.6 (or higher) protocols, in order to be paid under Medicare Part D.

“The NCPDP requirement affects prescriptions and medication orders to an outside pharmacy (a separate legal entity) using other standards such as HL7 or computer-generated fax (eFax),” says Majd Alwan, executive director of LeadingAge’s Center for Aging Services Technologies, in an explanation of the change. “Prescriptions and medication orders being sent using anything other than NCPDP SCRIPT 10.6 will no longer be compliant electronic communications regulations after Nov. 1.”

So the lesson is on the table: If e-prescribing (including of controlled substances) isn’t already mandated by your state, it’s probably coming soon.

How ready is your facility for e-Rx?

Can your LTC facility send electronic script orders for antibiotics, diabetes drugs and heart medications? Most likely. Pharmacy systems vendors have been doing this for years, and most electronic medical record (EHR) systems with e-prescribing features can handle these scripts just fine. But can your system transact electronic scripts for pain-controlling opioids such as hydrocodone, tramadol or codeine? Maybe not.

Today, many e-prescribing systems still are struggling to handle the specific requirement needed to handle the electronic prescribing of controlled substances, including pain medications used by skilled nursing, hospice and palliative care organizations. The requirements for exchanging electronic prescriptions—those without paper script pads or phone calls—are much more stringent for controlled substances than for other classes of drugs, for obvious reasons.

The Drug Enforcement Administration (DEA) governs the rules for e-prescribing controlled substances for providers. The DEA’s certification requirements are listed under the Code of Federal Regulations, Part 1311.

Due to the nature of controlled substances and the risks of prescription abuse, the certified e-prescribing of controlled substances requires several extra steps, including the electronic identification of each prescriber, a two-factor authentication process and an internal audit trail of prescriptions, among other things.

The DEA has approved several organizations as third-party certifiers for system compliance for electronic prescribing of controlled substances (ESPCS) among e-prescribing software companies. But for LTC organizations, the important job is to discover whether the pharmacy-ordering component used by the organization is able to comply with the DEA rules—and if not now, when that compliance can be expected. This can be even more important for organizations that outsource pharmacy script order processes to a third party, since alternative, already-compliant partners may be available.

For LTC organizations that are new to e-prescribing, the Office of the National Coordinator for Health IT (ONC) has released a big-picture guide for providers on the e-prescribing process. For those LTC organizations who are working with acute-care partners, keep in mind that e-prescribing is a big part of the meaningful use Stage 2 goals.

How LTC facilities can prepare

LTC organizations can prepare for the e-prescribing mandate trend in two basic ways: Get your e-prescribing system (especially if scripts are done through your EHR) certified for controlled substances or partner with an entity that already has.

SigmaCare integrated its EHR solution with DrFirst, an e-medication management software company specializing in controlled-substance pain medications, a deal that gained SigmaCare’s compliance under the New York controlled substance e-prescribing mandates. “The New York state e-prescribing mandate will be a game-changer for providers and is likely a precedent for similar legislation across the country,” says Steve Pacicco, SigmaCare’s CEO.

Additional resources

Guidelines for opiod use in older residents (California)

DEA e-prescribing certification process for controlled substances

DEA rules for e-prescribing

ONC guide on e-prescribing

AOD Software sought its own system certification by the DEA for its EHR’s pharmacy components, announcing its certification approval in March. “With state regulations moving toward requiring electronic exchange of prescriptions—specifically, controlled substances—LTC organizations will need to be ready,” says Doc DeVore, director of clinical informatics and industry relations at AOD Software.

The bottom line: Mandates for e-prescribing are coming across the country, and if your LTC facility isn’t involved in state mandates yet, there’s a good chance it will be in the future.

Topics: Articles , Regulatory Compliance