On Friday, October 14th, the Center for Medicare & Medicaid Services (CMS) released the long-anticipated final rule with 60-day comment period (Rule) for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Quality Payment Program (QPP). The QPP provides incentive payments for participation in Advanced Alternative Payment Models (Advanced APM). The provisions of the 2,400 page Rule take effect January 1, 2017. When fully implemented, the Rule will generally transition providers from the current fee-for-service payment system into new value-based payment models. Continue reading
On Monday, the Government Accountability Office (“GAO”) released a report (the “Report”) criticizing the U.S. Department of Health and Human Services (“HHS”) security and privacy guidance and oversight in protecting electronic protected health information (“ePHI”) from cybersecurity attacks. The Report noted that HHS does not adequately address cybersecurity elements outlined by other agencies in published guidance and fails to address how key National Institute of Standards and Technology (“NIST”) cybersecurity framework (“Cybersecurity Framework”) can be implemented in the operations of covered entities and business associates. The GAO claims that the lack of adequate guidance by HHS, leaves health information vulnerable to cybersecurity attacks.
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.
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.
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.
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.
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: