Penalties Flashcards
Penalties.
On April 24, 2020, the Office of Inspector General (“OIG”) published a proposed rule that would allow the OIG to impose a fine of up to $1,000,000 for information blocking. (85 FR 22979; proposed 42 C.F.R. § 1003.1410).
Under the proposed rule, the OIG would consider the following factors in determining the amount of the penalty:
(i) the nature and extent of the information blocking;
(ii) the resulting harm, including
(a) the number of patients affected,
(b) the number of providers affected, and
(c) the number of days the information blocking persisted. (85 FR 22991; proposed 42 C.F.R. § 1003.1420).
In the meantime, persons wishing to submit an information blocking complaint may do so through the
HealthIT.gov website at https://www.healthit.gov/topic/information-blocking.
Per the _________ _______ _____, health IT developers are liable for civil monetary penalties (CMPs) of up to $1 million per violation as determined by the HHS Office of Inspector General (OIG).
21st Century Cures Act
What type of developers are subject to penalties?
Only health IT developers who offer a certified product are subject to these penalties.
OIG’s proposed rule on civil monetary penalties for developers, published on April 24, 2020, outlines
1) enforcement priorities,
2) factors in determining penalty amounts and
3) what may constitute a single “violation.”
The process for determining information blocking penalties for providers (such as ASCs) is still yet to be determined. While OIG will have authority over determining whether information blocking occurred, they do not have the power to impose penalties. Instead, providers will
“be referred to the appropriate agency to be subject to appropriate disincentives.”
The secretary of HHS is supposed to define appropriate agencies and disincentives in future rulemaking, but it is unclear if that will occur before the compliance dates listed below.
On October 29, 2020, the United States Department of Health and Human Services (“HHS”) Office of the National Coordinator for Health Information Technology (“ONC”) released an interim final rule with comment period (“IFC”) that delays compliance dates for information blocking and other health information technology (“IT”) requirements under the 21st Century Cures Act (“Cures Act”) due to the COVID-19 Public Health Emergency (“PHE”).
True/ False
True
ONC had implemented these requirements in a final rule issued on
May 1, 2020 (“ONC Cures Act Final Rule”).
Health IT developers of certified health IT, health care providers, health information exchanges (“HIEs”), and health information networks (“HINs”) will now have until _____ to comply with the ONC Cures Act Final Rule’s information blocking provisions.
April 5, 2021
Health IT developers of certified health IT will also have additional time to comply with other requirements introduced in the ONC Cures Act Final Rule.
True/False
True
ONC issued the ___ “to offer the health care system additional flexibilities in furnishing services to combat the COVID-19 pandemic . . . while still maintaining a trajectory that will advance patients’ access to their health information, reduce the cost of care, and improve the quality of care.”
IFC
This Alert summarizes key provisions of the IFC with respect to information blocking. The IFC also delays compliance dates for other requirements introduced in the ONC Cures Act Final Rule, including Conditions and Maintenance of Certification Requirements for developers and new and updated 2015 Edition health IT certification criteria. The IFC includes tables to summarize the new compliance dates for these requirements (which are reproduced here).
What is it called?
“Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency,”
