As efforts at the federal and individual states level evolve every day at almost a breakneck pace to address challenges and needs related to the COVID-19 outbreak, here is a updated running list of some of the top actions taken at the federal level that we thought would be helpful to the healthcare industry (Caveat, this is not an exhaustive list):
Last Friday, the Office for Civil Rights (OCR) issued new Guidance on how HIPAA permits covered entities and their business associates to use health information exchanges (HIEs) to disclose PHI for the public health activities of a Public Health Authority (PHA). Specifically, it provides examples relevant to the COVID-19 public health emergency. OCR Director, Roger Severino, specifically notes that the Guidance was issued:
“to highlight how HIPAA supports the use of health information exchanges in sharing health data to improve the public’s health, particularly during the COVID-19 public health emergency.”.
Although much of the Guidance document simply reiterates the controlling HIPAA Privacy Rule provisions and definitions which have always afforded a mechanism through which covered entities (CE) and their contracted business associates (BA) can share ePHI with a public health authority for public health purposes, there are a few notable new take-away nuggets.
Seton Hall Law’s Institute for Privacy Protection and Gibbons Institute of Law, Science & Technology is hosting a Virtual Event on September 17th with legal academics, practitioners, and government officials who will evaluate the impact of the COVID-19 pandemic on privacy and intellectual property. Panel One speakers will discuss balancing privacy & public health; Panel Two will discuss Intellectual Property – incentives to access to vaccines & treatments.
The award will allocate $2.5M to fund up to 5 awards (in the amount of up to $500K EACH) with a period of performance of up to 2 years in the form of cooperative agreements with funding contingent upon availability of funds, satisfactory completion of milestones, and a determination that continued funding is in the best interest of the federal government and the public. SHORT TURN AROUND! Deadline is September 1, 2020 to get Applications in.
Need access to current information about COVID-19 and Medicare? CMS is holding stakeholder engagement calls to provide an opportunity for hospitals, health systems, and providers. The Webcast sessions are intended to provide updates, share best practices among peers, and offer attendees an opportunity to ask questions of CMS and other subject matter experts.
The FDA has issued guidance for IRB review of individual patient expanded access requests, as well as updated guidance for managing clinical trials during the COVID-19 public health emergency. Originally issued in March, the FDA’s updated “Guidance on Conduct of Clinical Trials of Medical Products...
Late last week, HHS published new Guidance that specifies what additional data must be reported by laboratories along with COVID-19 test results. Reporting of certain data elements by laboratories are legally required, while reporting of other identifiable demographic data is encouraged but not mandatory. The Guidance notes that state and local privacy standards apply to the collection of identifiable demographic data. Importantly, HHS expressly supports health information exchanges (HIEs) being leveraged to facilitate required data collection and reporting.
The Exposure Notification Privacy Act (“ENPA”) was introduced in the Senate on June 1 in an effort to regulate the growth of contact tracing applications and similar automated notification tracking. The ENPA aims to regulate websites, apps and similar services...
As hospitals and providers continue to struggle in response to the COVID-19 pandemic, CMS has announced several efforts to provide assistance under the Promoting Interoperability Programs and Quality Payment Program.
For the Quality Payment Program, CMS had previously extended the deadline for MIPS eligible clinicians to submit data and reopened the application period for MIPS eligible clinicians to file for a hardship exception for the 2019 payment year. Additionally, CMS announced that any individual MIPS eligible clinician who did not submit data or which submitted data for only one performance category for the 2019 payment year by April 30 will automatically receive a neutral payment instead of a negative payment adjustment (this “extreme and uncontrollable circumstances” policy is not available to groups/virtual groups). If a MIPS eligible clinician is able to submit data, CMS noted that the data submission would override the automatic “extreme and uncontrollable circumstances” policy and the clinician could be eligible for negative, neutral or positive payment adjustments based on the data submission.
As efforts at the federal and individual states level evolve every day at almost a breakneck pace to address challenges and needs related to the COVID-19 outbreak, here is a running list of some of the top actions taken at the federal level that we thought would be helpful to the healthcare industry (Caveat, this is not an exhaustive list): [updated: July, 28, 2021]
On April 9th, HHS announced a new Notification of Enforcement Discretion Regarding COVID-19 Community Based Testing Sites. The Notification of Enforcement Discretion has a retroactive date to March 13, 2020. The HHS Notification informs the public that it is exercising its discretion...
On April 2nd, HHS announced a new “Notification of Enforcement Discretion Under HIPAA to Allow Uses and Disclosures of PHI by Business Associates for Public Health and Health Oversight Activities in Response to COVID-19” (published in 85 Fed. Reg 193292 (April 7, 2020)). Government officials...
Last night, the State of New Jersey announced Departmental actions being taken to expand access to Telehealth and Tele-Mental Health services in response to COVID-19 outbreak. By Department, here they are: Department of Human Services, Division of Medical Assistance and Health Services ...
The events unfolding with respect to COVID-19 are unprecedented. There is a lot going on, and for those out there on the front lines of health care – like my husband who is an ER doc – I know that your first priority is helping patients and ensuring everyone around you is safe and healthy. ...