Tag Archives: HHS

Price Confirmed for HHS Secretary, other key agency and department positions next to be filled

Around 2 a.m., the Senate voted along party lines to confirm Representative Tom Price to become Secretary of the Department of Health and Human Services.  The vote was 52-47 with no Democrats voting in favor.  With repeated attacks on his policy record and questions about stock purchases, Price’s nomination was among the most controversial of President Trump’s cabinet selections.  With Price in place, now comes the work to fill out other key roles at HHS and develop the administrative process repeal and replace of Obamacare. Continue reading

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Filed under Medicaid, Medicare, The Affordable Care Act, Uncategorized

OIG Issues Final Rule Re: Exclusion Authority

The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), was released last week. The Proposed Rule was issued previously by the OIG in May 2014. The effective date of the Final Rule is February 13, 2017.

Noteworthy changes made by the Final Rule include the following key items:

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Filed under Fraud and Abuse, Government Enforcement, OIG Guidance

Washington’s 2016 healthcare agenda remains unfinished, leaving plenty for 2017

As Washington speeds towards Election Day on November 8th, it is a good time to examine the status of the key legislative and policy issues impacting the healthcare and life sciences sectors.  Congress has few legislative working days remaining in 2016, but could make some headway on legislation to promote innovation as well as prevent certain rulemakings like the Medicare Part B demonstration project.  In addition to closing out existing priories, Congress will turn its attention to new and recurring issues such as increasing the amount of generic drugs.  Here is an overview of what’s left to be done this year during the “lame duck” session that begins in mid-November and what is on the horizon for 2017.

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Filed under 340B, FDA, Litigation, Technology, Uncategorized

Advocate Data Breaches Result in Largest HIPAA Settlement To Date

On August 8th, 2016, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued the largest Health Insurance Portability and Accountability Act (HIPAA) settlement to date with Advocate Health Care System (Advocate).  Advocate agreed to pay $5.55 million to settle a variety of HIPAA violations.  Advocate is the largest health system in Illinois and operates more than 400 sites of care with 12 acute care hospitals.  This settlement comes in the wake of a series of recent HIPAA violation settlements and other enforcement activities by OCR, including phase 2 of the HIPAA audit program.

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Filed under HIPAA, HITECH Act, Privacy and Security

FTC Announces Guidance for Developers of Mobile Health Apps

Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of new guidance directed towards developers of mobile health apps (the “Guidance”), while speaking today at the International Association of Privacy Professionals (IAPP) conference in Washington, DC.  The Guidance is a tool created in collaboration with the FTC, the U.S. Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA) to assist app developers in determining what laws and regulations apply to their products. Continue reading

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Filed under FDA, Health Care, Health Information Privacy, Health IT, HIPAA, Medical Devices, Mobile Health, Privacy and Security

HHS Releases Crosswalk Between HIPAA Security Rule and NIST Framework

The U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR)  recently released a “crosswalk” developed with the National Institute of Standards and Technology (NIST) mapping  the Health Insurance Portability and Accountability Act (HIPAA) Security Rule and the NIST Framework for Improving Critical infrastructure Cybersecurity (the Framework).  This crosswalk was developed in order to assist healthcare organizations improve cybersecurity preparedness by using the Framework as a common language.  The crosswalk also includes mappings to other commonly used security frameworks.

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Filed under Health Care, Health Information Privacy, Health IT, HIPAA, Privacy and Security, Technology

Heath Provisions in President’s Budget Take Aim at Drug Prices and Opioid Abuse

Today, the President sent Congress the $4 trillion Fiscal Year 2017 Budget Proposal – his last while in office.  While the Budget on the whole is dead on arrival in the Republican-controlled Congress, there are provisions worth noting because of their current newsworthiness and possible reemergence in future policy debates.  Moreover, proposals directed at addressing the problems associated with opioid abuse could attract bipartisan cooperation this year. Continue reading

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Filed under FDA, Health Care, Medicaid, Medicare, Part D, Uncategorized