CMS’ Electronic Signature Requirements - Article by Jeffrey S. Baird, JD and Jacque K. Steelman, JD
Source: Medtrade Monday 9/25/2023
Technology has come far in recent years. Electronic prescribing has changed what is considered a valid signature by CMS. DME suppliers should be mindful of what CMS considers a valid signature when it comes to orders or prescriptions by physicians.
Let’s look at what CMS requires regarding orders or prescriptions.
According to CMS, DMEPOS orders or prescriptions are required to have the following elements:
- The beneficiaries name or Medicare Beneficiary Identifier (MBI) number
- The description of the item
- The quantity, if applicable
- The treating practitioner’s name or National Provider Identifier (NPI)
- The date of the order
- Treating practitioner’s signature
The treating practitioner’s signature must comply with the CMS signature requirements outlined in the Medicare Program Integrity Manual Chapter 3, Section 22.214.171.124 (“Manual”).
According to the Manual, the MAC, CERT and UPIC are required to accept an e-prescribed order through a qualified e-prescribing system. A qualifying e-prescribing system must meet all the requirements in 42 CFR § 423.160.
42 CFR § 423.160(a)(2) states that prescribers and dispensers, that transmit prescriptions and prescription-related information using electronic media, must comply with the applicable standards in (b).
42 CFR § 423.160(b)(2)(iv) is what is applicable to prescriptions currently. It states that entities must comply with the NCPDP SCRIPT standard implementation guide approved July 28, 2017. The NCPDP SCRIPT is an implementation guide released by the National Council for Prescription Drug Programs, Inc. (“NCPDP”). It contains the best practices and a standardized field usage recommended by the NCPDP for Electronic Health Records and electronic prescribing vendors so that information on prescriptions will minimize confusion and possible patient harm.
There are different types of electronic signatures, but not all signatures are considered valid.
An “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 intending to sign the record.
A “digital signature” means an electronic signature based on cryptographic methods of originator authentication, and computed by using a set of rules and a set of parameters so that the identity of the signator and integrity of the data can be verified.
A “wet signature” is an original physical signature handwritten in ink on paper.
A “digitized signature” captures an image of a wet signature, reproduced electronically to create a computer-generated signature. A digitized signature looks like a wet signature, but it is computer-generated instead of handwritten in ink.
A wet signature is not a secure process for electronic transactions because scanned images are easily produced by unauthorized individuals. The difference between an electronic signature and a wet signature is that a wet signature is written on paper, while an electronic signature is created electronically on a computerized device. A wet signature is not an acceptable authentication method for electronic prescribing. Additionally, a digitized signature is not considered an acceptable authentication method because the NCPDP says it is similar to a rubber signature stamp.
Ultimately, the NCPDP recommends utilizing electronic signatures. The NCPDP also recommends having “electronically signed by” with a time stamp with all electronic signatures.
** Brown & Fortunato PC is an OAMES Associate Member.
Jeffrey S. Baird, JD is chairman of the Health Care Group at Brown & Fortunato, PC, a law firm based in Texas with a national health care practice. He represents pharmacies, infusion companies, HME companies, manufacturers, and other health care providers throughout the United States. Mr. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or firstname.lastname@example.org.
Jacque K. Steelman, JD is a member of the Health Care Group at Brown & Fortunato, PC, a law firm with a national health care practice based in Texas. She represents pharmacies, infusion companies, HME companies, manufacturers, and other health care providers throughout the United States. Ms. Steelman can be reached at (806) 345-6316 or email@example.com.