FDA Announces Critical Off-Label Forum for Drugs and Devices

A notice was published today in the Federal Register regarding a two day public hearing that will be held on November 9-10, 2016 by the U.S. Food and Drug Administration (FDA) to obtain input from a wide range of stakeholders regarding communications by industry related to unapproved uses of FDA-regulated drugs, biological products and medical devices (collectively, “Medical Products”). The announcement noted that FDA has been engaged in a comprehensive review of its regulations and policies related to off-label communications of approved or cleared Medical Products since 2014, and input from the meeting will further inform FDA’s policy development.

Continue reading

Leave a comment

Filed under FDA

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.

Continue reading

Leave a comment

Filed under HIPAA, HITECH Act, Privacy and Security

All is Well:  FDA to Host Webinar on its Final Guidance for Low-Risk General Wellness Devices on September 1, 2016

The U.S. Food and Drug Administration (FDA) recently released final version of its guidance, General Wellness:  Policy for Low-Risk Devices (Policy), with a webinar slated for September 1st as part of the rollout.  While not much has changed from the 2015 draft guidance, the number of mobile apps and general wellness products that are pushing the limits of what the FDA believes could be “devices” under the Food, Drug, and Cosmetic Act (FDCA) increases daily.

In order to fit under the FDA Policy, the product needs to both solely marketed for general wellness and present a low risk of safety to the user and other persons. The guidance provides useful examples that anticipate the desire to help  “reduce the risk of” or “live well with” chronic conditions, the most interesting boundaries of the Policy for those wishing to differentiate themselves within the wellness industry.

Agency metrics on the 513(g) Requests for Information may provide some feedback on the impact of the Policy since its draft issuance, and future enforcement needs to be monitored for defining the limits of the Policy.

Leave a comment

Filed under FDA Final Guidance, Health IT, Medical Devices

Open Payments Changes On the Horizon?

The Centers for Medicare & Medicaid Services (CMS) recently announced in the 2017 Physician Fee Schedule proposed rule that since publication and implementation of the Open Payments Final Rule and the 2015 Physician Fee Schedule, various stakeholders have provided feedback to CMS regarding aspects of the Open Payment program, including identification of certain areas that may benefit from revision. Thus, CMS is soliciting comments to inform future rulemaking, but made it clear that it was not intending to finalize any Open Payments requirements directly as a result of the 2017 Physician Fee Schedule.

To further discuss the topics listed in the 2017 Physician Fee Schedule, CMS held today a Special Open Door Forum for industry stakeholders “to inform future rulemaking and other enhancements” to the Open Payments program. CMS provided a presentation slide deck for the Open Door Forum, which outlined various topics in which it was soliciting stakeholder feedback, including:

Continue reading

Leave a comment

Filed under Federal Transparency

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?

Continue reading

Leave a comment

Filed under Health Care

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:

Continue reading

Leave a comment

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

1 Comment

Filed under Coverage and Reimbursement, Medicare, Technology, Uncategorized