OCR Reveals Information about Upcoming HIPAA Audits

At the Healthcare Information and Management Systems Society (“HIMSS”) Privacy and Security Forum this week, health information privacy senior advisor for the Office for Civil Rights (“OCR”) Linda Sanches revealed certain additional information about upcoming HIPAA audits. Continue reading

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

CMS Issues Final Rule on Marketplace Auto-Enrollment

On September 5, 2014, the Centers for Medicare and Medicaid Services (CMS) published a final rule, effective October 6, 2014, that, among other things, specifies the auto-enrollment process for consumers who receive health insurance coverage through a qualified health plan offered under a federally-facilitated marketplace (Marketplace). According to a fact sheet released by CMS, “[a]s part of the renewal process in the [Marketplace], generally, if consumers do nothing, they will be auto-enrolled in the same plan with the same premium tax credit and other financial assistance, if applicable, as the 2014 plan year.” According to the CMS Administrator, Marilyn Tavenner, this streamlined process is available to those “consumers who are happy with their plan and have no changes to their income or family situation.” Continue reading

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Filed under Health Reform, The Affordable Care Act

Is CMS Feeling the Sunshine Heat? – Part 2

As follow-up to our recent post on the issues that the Centers for Medicare & Medicaid Services (CMS) is experiencing with its Open Payments database, there is new information that additional data also may be excluded when the payments are made public this month.  Last week, ProPublica published an article that states: “Now, a source familiar with the matter tells ProPublica that CMS won’t disclose another batch of payments: research grants made by pharmaceutical companies to doctors through intermediaries, such as contract research organizations. In these cases, doctors apparently have not been given a chance to verify and dispute payments attributed to them, as required by law.”  CMS has not yet provided this information directly to industry, further highlighting concerns raised by the American Medical Association and other physician organizations regarding widespread confusion and poor communication related to the public release of the data this month.

We will continue to monitor and provide updates as CMS’ publication deadline nears.

 

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NIH Releases Final Guidance on Genomic Data Sharing

The National Institute of Health (NIH) recently released its final policy related to sharing human and non-human genomic data (GDS Policy).  The GDS Policy applies to all NIH-funded research, regardless of the level of funding, that generates large-scale human or non-human genomic data, including the use of the data for subsequent research.  The effective date of the GDS Policy is (i) grant applications with due dates on or after January 25, 2015; (ii) contracts submitted on or after January 25, 2015; and (iii) intramural research projects generating genomic data on or after January 25, 2015.  In conjunction with the GDS Policy, NIH also released supplemental information regarding the scope of the GDS Policy.

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Filed under Clinical Trials

HIPAA Omnibus Rule Deadline for BAAs Approaches

The Final HIPAA Omnibus Rule (the “Omnibus Rule”), published in the Federal Register on January 25, 2013, made various important changes to how entities must comply with privacy and security requirements.  While most deadlines stemming from the Omnibus Rule have passed, one is imminent: the final requirement to update Business Associate Agreements (“BAAs”).  Certain BAAs may need to be updated by September 22, 2014. Continue reading

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Filed under Health Information Privacy, HIPAA, HIPAA Omnibus Rule, Privacy and Security

Cooley Communications Blog Post re: New FCC Rules for Medical Body Area Networks

Cooley’s Communications Regulatory group posted on its blog an article titled, New FCC Rules for Medical Body Area Networks.  According to the Federal Communications Commission, Medical Body Area Networks (MBANs) technology allows for “the wireless networking of multiple body-worn sensors used for measuring and recording physiological parameters and other patient information or for performing diagnostic or therapeutic functions, primarily in health care facilities.”  The article is a must read for any companies that work with, or are considering, digital medical devices.

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Filed under Medical Devices, Mobile Health, Technology

Is CMS Feeling the Sunshine Heat?

As we told you about here, the Centers for Medicare & Medicaid Services (CMS) has been dealing with issues related to its Open Payments database of payments and transfers of value reported by manufacturers and group purchasing organizations (GPOs).  This data is scheduled for public release by CMS on September 30, 2014. CMS announced yesterday that the Open Payments database will be unavailable for two more days for upcoming routine maintenance and, therefore, the current review and dispute process will be further extended to September 10th and the correction period will be extended to September 25th.

CMS continues to hold steadfast to its September 30th publication deadline despite the Open Payments database issues and calls from industry groups to delay publication.  This week, the Pharmaceutical Research & Manufacturers of America (PhRMA) issued a statement “ask[ing] CMS [to] provide additional transparency around the decision to remove one-third of the data from the site.”  This statement follows a letter earlier this month from the American Medical Association (AMA) and over 100 physician groups, requesting a publication delay of six months due to concerns regarding the system’s readiness and accuracy, and a July letter from PhRMA, Biotechnology Industry Organization (BIO) and several other industry groups, requesting additional information related to publication of the data and simplification of the physician registration process to increase data review prior to publication.

The open question: how will CMS explain the data and its limitations to the public when it publishes the data next month?

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Filed under Federal Transparency