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OIG Expresses Concern about Laboratory Specimen Collection Payments to Hospitals in AO 22-09

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a...more

Indictment of Pharmacy Marketer Reveals Unsuccessful Efforts to Conceal Kickbacks

The U.S. Department of Justice and U.S. Health and Human Services Office of Inspector General recently announced the indictment of a pharmacy marketer who allegedly received and paid kickbacks in violation of the federal...more

HHS Further Amends 42 CFR Part 2, Easing Some, But Not All, Burdens on Substance Use Disorder Treatment Providers

The U.S. Department of Health and Human Services (HHS) recently released a final rule further amending 42 CFR Part 2 regulations (Part 2) to allow greater sharing of patient records related to substance use disorder (SUD)...more

OCR Exercises HIPAA Enforcement Discretion for Telehealth Services During the Coronavirus Emergency

The Department of Health and Human Services (HHS) has taken many actions to loosen or waive requirements on the provision of health care during the current coronavirus pandemic, as we discussed yesterday and Tuesday. In...more

Congress Loosens Telehealth Reimbursement Restrictions in Response to Coronavirus, but State Law Practice Requirements Remain

Telehealth is going to play a critical role in the delivery of care in the coming weeks and months as health care providers respond to the COVID-19 pandemic. As the CDC and other public health agencies continue to recommend...more

Health Care Data Breaches Are Increasing Both in Number and Cost

It feels like we’ve been seeing a lot more health care breaches caused by hackers and other IT security incidents, and there’s a good reason why: a recent report by cloud security company Bitglass confirms that both the...more

A Tale of Two False Claims Act Settlements Involving EHR Vendors

Last week the Department of Justice (DOJ) announced a $57 million settlement with electronic health record (EHR) software vendor Greenway Health LLC (Greenway). According to DOJ, Greenway violated the False Claims Act (FCA)...more

HIPAA and Health Care Data Privacy - 2018 Year-in-Review

Today, we’re looking back at HIPAA and other privacy and security developments in 2018. This past year saw continued HIPAA enforcement (including the largest ever fine for a HIPAA breach), reminders from the OCR on best...more

Changes Ahead for HIPAA?

As we discussed last week, the Department of Health and Human Services (HHS) recently published its semi-annual regulatory agenda. In addition to the proposed rules on fraud and abuse, drug pricing, digital health, and...more

HIPAA Enforcement Survives Closure of Business

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently announced a $100,000 settlement with a company that is no longer in business. Filefax, Inc. (Filefax) was an Illinois company that...more

In the Wake of Harvey and Irma, OCR Reminds Providers of HIPAA Rules

As Texas, Florida, and the Caribbean rebuild after the latest string of deadly hurricanes and prepare for the possibility of future storms, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR)...more

DOJ and OIG Announce Largest Ever National Health Care Fraud Takedown; Focus on Opioids

Continuing its annual tradition, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services (“HHS”) announced last week the largest ever health care fraud enforcement action by the Medicare...more

OCR Publishes Checklist and Infographic for Cyber Attack Response

OCR released a simple checklist and infographic last week to assist Covered Entities and Business Associates with responding to potential cyber attacks. As cybersecurity remains a pressing concern for health care entities,...more

Memorial Hermann’s Use of Patient Name in Press Release Leads to $2.4 Million HIPAA Settlement

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced another large HIPAA-related settlement last week with Memorial Hermann Health System (Memorial Hermann), the largest not-for-profit...more

Trump Executive Orders Create Uncertainty for Health Care & Pharmaceutical Industries

As we’ve previously discussed on Health Law and Policy Matters, agencies within the Department of Health and Human Services (DHHS) pushed through several final rules towards the end of the Obama Administration. However, since...more

OCR Reminds Companies that Authentication is Key

In non-election news, the Office for Civil Rights (OCR) at the Department of Health and Human Services recently released its November Cyber Awareness Newsletter. This month’s newsletter focuses on the topic of...more

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