States taking the lead on drug pricing policy; will Congress enter the fray?

Last week, Vermont adopted the first state law that requires drug companies registering the highest hike in prices to justify the rationale for the increase.  Vermont policymakers are not alone pursuing laws that address rising drug prices.  California and Ohio are eyeing pricing-related bills and ballot initiatives. This begs the question:  If several states begin adopting a patchwork of drug pricing laws, what can or will happen at the federal level?

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OIG Releases Criteria for Implementing Exclusion Authority

On April 18, 2016, the Health and Human Services Office of Inspector General (OIG) released updated guidance related to the criteria it may use for evaluating its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act. This guidance replaces guidance previously released by the OIG in 1997. All of the OIG’s special advisory bulletins and guidance documents related to its exclusion authority can be found here.

The OIG stated that in determining where a person or entity falls on the “compliance risk spectrum”, thereby determining whether exclusion should be pursued, the OIG will consider the following four risk areas:

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Filed under Compliance, DHHS OIG, Fraud and Abuse, Government Enforcement, OIG Guidance

Washington Update: Senate proceeds towards “Cures”; CMS releases MA rates and Call Letter

Health care policy issues continue to stream out of Congress and the Administration.  The Senate held a markup of  various health bills as part of its effort to produce a companion to the House of Representatives-passed 21st Century Cures legislation and CMS released long awaited Medicare Advantage rates. Continue reading

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Filed under Coverage and Reimbursement, Medicare, Technology, Uncategorized

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

OCR Begins Phase 2 of HIPAA Audit Program

Source: OCR Begins Phase 2 of HIPAA Audit Program

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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

Cooley Client Alert: FDA Issues Draft Cybersecurity Guidance to Medical Device Manufacturers

Source: FDA Issues Draft Cybersecurity Guidance to Medical Device Manufacturers

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Filed under Cooley Alerts, FDA, Privacy and Security, Uncategorized