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On December 10, 2020, the Office for Civil Rights (OCR) at the United States Department of Health and Human Services (HHS) announced proposed changes to the regulations implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The proposed changes, which are set out in the Notice of Proposed Rulemaking (NPRM), are a part of the broader initiative to promote value-based care, enable better coordination among healthcare providers, and facilitate patient autonomy and engagement. This article discusses some of the proposed changes and recent updates contained in the NPRM.
Increased Access to Individuals’ Protected Health Information (PHI)
One of the primary goals of the NPRM is to increase patients’ access to their protected health information (PHI) and enhance individuals’ engagement in their healthcare decisions. Accordingly, there are several proposed changes within the NPRM that are designed to facilitate thi
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On December 10, 2020, the Office for Civil Rights of the Department of Health and Human Services ( HHS ) released a proposed rule that amends provisions in the Health Insurance Portability and Accountability Act ( HIPAA ) Privacy Rule to facilitate individuals’ engagement in their care, remove barriers to coordinated care and reduce administrative burdens on the health care industry.
In 2018, HHS launched the “Regulatory Sprint to Coordinated Care,” an initiative to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary obstacles” to coordinated care. On November 20, 2020, HHS and Centers for Medicare & Medicaid Services (“CMS”) each issued a sweeping set of final regulations that introduced significant new value-based terminology, safe harbors and exceptions, as well as clarifications of existing requirements, under the federal anti-kickback statute (“AKS”) and fed
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On Thursday, December 17, 2020, senior representatives of the US Department of Health and Human Services’ Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) delivered a virtual presentation to American Health Law Association members and other health industry stakeholders to explain and elaborate on significant new regulations that become final on January 19, 2021. OIG Senior Counselor for Policy, Vicki Robinson, OIG Industry Guidance Branch Chief, Susan Edwards, and OIG Senior Counsel, Samantha Flanzer, discussed OIG’s recently issued final rules amending current and adding new safe harbors to the Anti-Kickback Statute (“AKS”). CMS Senior Technical Advisors, Lisa Wilson and Catherine Martin, discussed CMS’s recently issued final rules amending current and adding new exceptions to the Physician Self-Referral Law (“Stark Law”).
Individual.
Reasonable cost-based fee, limited to labor for making copies, supplies for copying, actual postage and shipping, and costs of preparing a summary or explanation as agreed to by the individual.
Receiving an electronic copy of PHI through a non-internet-based method in response to an access request (e.g., by sending PHI copied onto electronic media through the US Mail or via certified export functionality).
Individual.
Reasonable cost-based fee, limited to labor for making copies and costs of preparing a summary or explanation as agreed to by the individual.
Electronic copies of PHI in an EHR received in response to an access request to direct such copies to a third party.