March 27, 2020

HHS Office of Civil Rights Enforcement Relaxes Enforcement Discretion on HIPAA

In light of the COVID-19 nationwide public health emergency, the HHS Office for Civil Rights (OCR) is exercising its enforcement discretion and, effective immediately, will not impose penalties on physicians using telehealth in the event of noncompliance with the regulatory requirements under the Health Insurance Portability and Accountability Act (HIPAA). Physicians may seek to communicate with patients and provide telehealth services through remote communications technologies. Some of these technologies, and their use, may not fully comply with the requirements of the HIPAA Rules. However, today’s announcement means that physicians who want to use audio or video communication technology to provide telehealth to patients during the COVID-19 nationwide public health emergency can use any non-public facing service that is available to communicate with patients. This exercise of discretion applies to telehealth provided for any […]
October 29, 2019

Health and Human Services Proposes Stark Law and Anti-Kickback Statute Reforms

On October 9, the Department of Health and Human Services (HHS) announced proposed changes to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the “Stark Law”) and the Federal Anti-Kickback Statute. The proposed rules seek to provide greater certainty for healthcare providers participating in value-based arrangements and providing coordinated care for patients. The proposals would ease the compliance burden for healthcare providers across the industry, while maintaining strong safeguards to protect patients and programs from fraud and abuse. The proposed rules are part of HHS’s “Regulatory Sprint to Coordinated Care,” which seeks to promote value-based care by examining federal regulations that impede efforts among providers to better coordinate care for patients. The Stark Law’s new value-based exceptions, […]
July 30, 2019

White House Announces Efforts to Promote Greater Price Transparency For Prescription Drugs

On June 25, the White House announced an initiative to encourage greater transparency in drug pricing. President Trump signed an Executive Order on June 25, entitled “Improving Price and Quality Transparency in American Healthcare to Put Patients First.” The purpose of the order is to direct federal agencies to issue regulations to improve the transparency of health care prices and quality in order to create a more competitive marketplace and provide consumers with the information they need to make informed purchasing decisions.  More specifically, the executive order: Directs the Secretary of Health and Human Services (HHS) to issue regulations within 60 days that would require hospitals to publicly post standard charge information, including information based on negotiated rates, in an […]
April 30, 2019

HHS Announces Extended Comment Period for Healthcare Interoperability Proposed Rules, Releases New HIPAA FAQs

The U.S. Department of Health and Human Services (HHS) announced that it would extend until June 3 the comment periods for CMS and the Office of the National Coordinator for Health Information Technology (ONC) proposed interoperability and information blocking rules. CMS also announced that as a result of public comments, it will adjust the effective dates of its policies to allow for adequate implementation timelines as appropriate. In addition, HHS released a set of frequently asked questions (FAQs) from the Office for Civil Rights (OCR), addressing HIPAA’s right of access as related to apps designated by individual patients and application programming interfaces (APIs) used by a health care provider’s electronic health record (EHR) system. The FAQs clarify, among other things, that once protected health […]