Right now electronic signatures might seem like a distant memory for pharmacists, from a time, back in the pre-COVID-19 era, when things were "normal." For so long, the relatively simple practice of capturing a patient's signature to validate a pickup was just a routine, expected part of the point-of-sale process.
That all changed though, in late March, when the Centers for Medicare & Medicaid Services (CMS), followed by pharmacy benefit managers (PBMs) issued guidance urging all states, including boards of pharmacies and Medicaid agencies, to temporarily waive proof-of-receipt and signature delivery requirements. As the CMS noted in its guidance, "requiring a patient signature for receipt of medication could undermine current public health efforts to combat the spread of coronavirus."
Since then, home deliveries, curbside pickups and contactless transactions have become the preferred methods of prescription transactions, with most signature pads safely tucked away for another day.
When that day will come seems far away, as the pandemic shows no sign of abating and pharmacies focus their efforts on finding increasingly creative ways to prioritize patient and staff safety.
But when pharmacies return to the day when prescription pickups require signatures, pharmacists will be reminded that electronic signatures require compliance with multiple legislative and regulatory requirements, and that when it comes to the law, not all signatures are the same.
As confusing as this may seem, pharmacy managers can be assured that technology providers have kept pace with signature requirements, and that certain systems, including PrimeRx™ from Micro Merchant Systems, offer solutions that are easy to use, ensure seamless storage, facilitate regulatory compliance, and can be portable, for use with handheld devices.
First though, a quick overview of the legislative requirements affecting electronic signatures.
E-Signatures – Legislative History
E-prescribing for non-controlled substances became legal in all 50 states in 2007. But the 2008 development of what today is known as the "Surescripts Network Alliance," a national network that ensures seamless and secure transmission of prescription data, facilitated the process and helped drive its growth. Today, roughly 80 percent of all prescriptions are transmitted electronically.
But the stage had been set for health-related electronic
signature capture years before, with the enactment of three specific pieces of
Following is a brief overview of each:
Electronic Signatures in Global and National Commerce Act (E-SIGN)
E-SIGN was signed into law in 2000 by President William Clinton. According to the National Telecommunications and Information Administration (NTIA), E-SIGN essentially established the validity of an electronically signed document, and invalidated prior legislation requiring written documents.
An important tenet of E-SIGN, was the establishment of an official definition of an electronic signature. According to the law, "the term 'electronic signature' means an electronic sound, symbol, or process, attached to or logically associated with a contract or other record and executed or adopted by a person with the intent to sign the record."
According to analysis by FindLaw, the law does not mandate use of a particular technology, but instead "allows the parties to select the method of authentication that best suits their needs and security concerns.
Uniform Electronic Transactions Act (UETA)
UETA actually preceded E-SIGN, and was adopted by the National Conference of Commissioners on Uniform State Laws (NCCUSL) in 1999. NCCUSL recommended UETA to the states as model legislation for regulation of electronic transactions and to date, UETA has been adopted by 47 states. Only New York, Illinois and Washington have not adopted UETA but, according to Thomson Reuters, each has enacted similar laws.
Analysis by DocuSign notes "both UETA and the E-SIGN Act have four major requirements for an electronic signature to be recognized as valid under U.S. law." Those requirements include:
While both UETA and E-SIGN apply to contracts and transactions executed across a broad scope of industries, the need for requirements specific to the healthcare industry was addressed through provisions included in the Health Insurance Portability and Accountability Act (HIPAA).
Health Insurance Portability and Accountability Act (HIPAA)
HIPAA was signed into law in 1996 by President William Clinton, and according to the HIPAA Journal, a key aim of the original legislation was to improve the portability of health insurance coverage – ensuring employees retained health insurance coverage while between jobs. The law was subsequently modified to address patient privacy, most notably through enactment of the HIPAA Privacy Rule which became effective in 2003, and the HIPAA Security Rule which took effect in 2005.
A key pillar of HIPAA is the determination of acceptable uses and allowable disclosures of protected health information (PHI). With regard to pharmacies, the HIPAA Journal notes that the statute "sets standards for the secure storage and transmission of PHI, and gives patients the right to obtain copies of their PHI. "HIPAA compliance for pharmacies is not an option," the Journal advises. "The penalties for failing to comply with HIPAA can be severe."
Among the law's pharmacy-related provisions, is the requirement that all patients be provided with a copy of the pharmacy's "notice of privacy practices," and for patients to acknowledge receipt of that notice via a signature. More specifically, the pharmacy must make a "good faith effort" to obtain the patient's signature, and to document instances in which the patient either refused to sign, or due to extenuating circumstances, was unable to provide a signature.
HIPAA does not explicitly authorize the use of electronic signatures but, according to the HIPAA Journal, the practice is generally allowed, "provided that mechanisms are put in place to ensure the legality and security of the contract, document, agreement or authorization, and there is no risk to the integrity of PHI."
More specifically, the Department of Health and Human Services (HHS) website offers the following guidance: "Currently no standards exist under HIPAA for electronic signatures. In the absence of specific standards, covered entities must ensure any electronic signature used will result in a legally binding contract under applicable state or other law."
Despite the absence of statutory language, HIPAA offers guidance for "conditions necessary for e-signatures," which builds on provisions outlined in E-SIGN and UETA.
Those conditions include:
Not surprisingly, the complexity of these three statutes caused a degree of confusion among pharmacy managers and other stakeholders. Which is why a recommendation offered by FindLaw attorneys seems to make sense: "There is one safe rule to follow when determining which laws or regulations govern a particular healthcare transaction involving the use of electronic records or signatures: Closely consider all of them. Assuming each is consistent with E-SIGN, it is highly likely each will apply."
The NCPDP makes a few distinctions with regard to these different signature categories:
Technology Considerations in Selecting a Pharmacy Electronic Signature Solution
The typical pharmacy manager would not be alone in wondering how to implement an electronic signature program that satisfies these complex requirements. In fact, there are many pharmacy management systems that offer electronic signature functionality.
But not all have the same functionality, which means a pharmacy manager must take the time to carefully consider the capabilities and attributes of each system.
PrimeRx™ is a good example of a technology solution that is highly responsive to changing pharmacy needs, and continually offers innovative approaches for better, more efficient workflow management. PrimeRx™ serves as the core processing center, through which key pharmacy management systems and processes are accessed. But a suite of services, which seamlessly integrate with PrimeRx™, provide access to a wide range of processes and services.
With regard to electronic signature capture, PrimeRx™ capabilities include:
Seamless integration with Surescripts. Surescripts is the dominate provider of electronic health record management systems, and a vital partner in linking doctors, payers, and pharmacies. PrimeRx™ interfaces with the Surescripts Network Alliance to ensure seamless transmission of electronic prescriptions and timely, accurate processing of patient information.