The U.S. Department of Health and Human Services’ (HHS) Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule to implement requirements of the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Specifically, this proposed rule would adopt standards for “healthcare attachments” transactions, which would support both healthcare claims and prior authorization transactions, and a standard for electronic signatures to be used in conjunction with healthcare attachments transactions. CMS has stated that it believes the proposed rule would result in significant cost savings and a reduction in administrative paperwork, allowing healthcare providers to allocate more time on direct patient care.
The HIPAA Administrative Simplification rule is designed to ensure consistent electronic communication across healthcare systems and promote efficient transfer of administrative data between health plans, healthcare providers, and clearinghouses. This regulation requires HIPAA-covered entities to adopt standards for transactions involving the electronic exchange of healthcare data and specifies standards to be used in all HIPAA-covered transactions.
Healthcare attachments are documents that provide additional information to aid in the healthcare payment decision-making process. This information typically includes patient or case-related information, patient test results, and medical records. The proposed rule would mandate a standard format for the transmission of healthcare attachments between HIPAA-regulated entities to support electronic healthcare claims and prior authorization transactions, which currently lack an efficient and uniform method of sending attachments.
Additionally, the proposed rule includes several changes to existing regulations pertaining to electronic signatures. Specifically, CMS proposes to expand the indications recognized as electronic signatures through a new provision under 45 CFR § 162.103 which would provide that an “electronic signature” is “an electronic sound, symbol, or process, attached to or logically associated with attachment information and executed by a person with the intent to sign the attachment information.” CMS also proposes to adopt a new standard format for the transmission of electronic signatures, which would allow them to be sent, received, and interpreted without interruption. The use of the standard format will be required for the submission of claims and referral certifications as part of prior authorization processes. HIPAA-covered entities that use electronic records will be impacted by the anticipated finalization of this rule and are encouraged to submit comments to the proposed rule through March 21, 2023. If CMS finalizes the rule, it had said it would give plans and providers 24 months before the changes would take effect.
For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in navigating regulation of the corporate practice of medicine. If you or your healthcare entity has any questions pertaining to HIPAA compliance or healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or firstname.lastname@example.org.