HHS Increases Civil Money Penalties for HIPAA Noncompliance, Effective October 11, 2018 | Practical Law

HHS Increases Civil Money Penalties for HIPAA Noncompliance, Effective October 11, 2018 | Practical Law

The Department of Health and Human Services (HHS) has issued final regulations that include the agency's annual inflation adjustments to civil money penalties assessed under its regulations, as required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The final regulations, which are effective October 11, 2018, include updated penalties for certain violations of the Health Insurance Portability and Accountability Act (HIPAA).

HHS Increases Civil Money Penalties for HIPAA Noncompliance, Effective October 11, 2018

by Practical Law Employee Benefits & Executive Compensation
Published on 15 Oct 2018USA (National/Federal)
The Department of Health and Human Services (HHS) has issued final regulations that include the agency's annual inflation adjustments to civil money penalties assessed under its regulations, as required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The final regulations, which are effective October 11, 2018, include updated penalties for certain violations of the Health Insurance Portability and Accountability Act (HIPAA).
HHS has issued final regulations containing inflation adjustments to civil money penalties that HHS administers, including penalties for violations of HIPAA's "administrative simplification" rules (83 Fed. Reg. 51369 (Oct. 11, 2018); see HIPAA Privacy, Security, and Breach Notification Toolkit and Practice Note, HIPAA Enforcement: Penalties and Investigations). (Administrative simplification generally refers to HIPAA's privacy and security requirements and its rules to standardize how health plan data is exchanged.)
The inflation adjustments are required under the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Inflation Adjustment Act). The Inflation Adjustment Act revised the method for calculating inflation adjustments for penalty increases, including to:
  • Provide an initial "catch-up" adjustment for civil money penalties.
  • Require HHS to annually adjust the penalties for inflation (under a cost-of-living formula), by January 15 of each year.
In September 2016, HHS issued interim final regulations establishing an initial catch-up for civil money penalties that HHS administers (81 Fed. Reg. 61538 (Sept. 2, 2016); see Legal Update, HHS Increases Penalties for HIPAA Noncompliance, Effective August 1). The adjustments were required to take effect by August 1, 2016, and HHS's interim final regulations were effective on September 6, 2016. In February 2017, HHS published final regulations with HHS's 2017 annual inflation adjustment to its civil money penalties (82 Fed. Reg. 9174 (Feb. 3, 2017)).
The final regulations issued in October 2018 include HHS's 2018 annual inflation adjustment to its civil money penalties.

Effective Date of 2018 Annual Adjustments

The final regulations are effective October 11, 2018. The adjusted penalty amounts apply to penalties assessed on or after October 11, 2018, if the violation occurred on or after November 2, 2015 (that is, the Inflation Adjustment Act's enactment date). The penalty amounts in effect before September 6, 2016, apply if either:
  • The violation occurred before November 2, 2015.
  • The penalty was assessed before September 6, 2016.
The final regulations were not subject to notice-and-comment rulemaking requirements under the Administrative Procedure Act (APA) (5 U.S.C. § 553).

Adjustment Process and Calculation

The annual adjustment is based on the Consumer Price Index for all Urban Consumers (CPI-U). In general, an adjustment is calculated using the percent change between the:
  • October CPI-U preceding the date of the adjustment.
  • Prior year's October CPI-U.
The cost-of-living adjustment multiplier for 2018, based on the CPI-U for October 2017, not seasonally adjusted, is 1.02041. To calculate the 2018 annual adjustment, HHS multiplied the most recent penalty amount for each applicable penalty by the multiplier, 1.02041, and rounded to the nearest dollar.

Table of Adjusted Civil Money Penalties for 2018

The following table reflects certain of HHS's annual inflation adjustments to the civil money penalties for HHS-administered provisions, effective October 11, 2018.
Statutory and Regulatory Provisions
Description of Violation
2018 Penalty (As Adjusted)
Pre-February 18, 2009 violations of HIPAA's administrative simplification provisions. 
(February 18, 2009 was the effective date of certain increased penalties for HIPAA violations under the Health Information Technology for Economic and Clinical Health Act (HITECH Act).)
$155
$38,954 (calendar year cap)
February 18, 2009 or later violations of HIPAA's administrative simplification provisions, if it is established that a covered entity (CE) or business associate (BA) did not know (and by exercising reasonable diligence would not have known) that the CE or BA violated the provision.
$114 (minimum)
$57,051 (maximum)
$1,711,533 (calendar year cap)
February 18, 2009 or later violations of HIPAA's administrative simplification provisions, if it is established that the violation was due to reasonable cause and not willful neglect.
$1,141 (minimum)
$57,051 (maximum)
$1,711,533 (calendar year cap)
February 18, 2009 or later violations of HIPAA's administrative simplification provisions, if it is established that the violation was due to willful neglect and was corrected during the 30-day period beginning on the first date the CE or BA knew (or by exercising reasonable diligence would have known) that the violation occurred.
$11,410 (minimum)
$57,051 (maximum)
$1,711,533 (calendar year cap)
February 18, 2009 or later violations of HIPAA's administrative simplification provisions, if it is established that the violation was due to willful neglect and was not corrected during the 30-day period beginning on the first date the CE or BA knew (or by exercising reasonable diligence would have known) that the violation occurred.
$57,051 (minimum)
$1,711,533 (maximum)
$1,711,533 (calendar year cap)
Failure to provide summaries of benefits and coverage (SBCs) (see Practice Note, Summaries of Benefits and Coverage under the ACA).
$1,128
Violations of the Affordable Care Act's (ACA's) medical loss ratio reporting and rebating rules (see Legal Update, Guidance on Plan Asset Implications of Medical Loss Ratio Rebates).
$113
An employer or other entity offering any financial or other incentive for an individual entitled to benefits not to enroll under a group health plan or larger group health plan that would be a primary plan.
$9,239
Failure of an entity serving as an insurer, third-party administrator (TPA), or fiduciary for a group health plan to provide information identifying situations where the group health plan is (or was) a primary plan to Medicare to HHS.
$1,181
Failure to comply with the requirements of the Public Health Services Act (PSHA) or violations of rules or standards of behavior associated with insurer participation in the ACA's federally facilitated health insurance exchanges (see Article, Health Insurance Exchange and Related Requirements under the ACA).
$155
Providing false information on an exchange application
$28,195
Knowingly or willfully providing false information on an exchange application.
$281,949
Knowingly or willfully disclosing protected information from the exchange.
$28,195

Practical Impact

Although HHS often resolves enforcement actions with HIPAA CEs and BAs through its corrective action plan process (which typically involves payment of a monetary amount), the agency has also imposed civil money penalties in recent years, for example, in situations involving ongoing patterns of noncompliance or if a CE or BA is nonresponsive to the enforcement process. For examples of civil money penalties being imposed, see Legal Updates:
These annual inflation adjustments to civil money penalties are now part of the benefits landscape under the Inflation Adjustment Act, and the Department of Labor has also been issuing annual adjustments for the provisions it administers (see Legal Update, DOL Increases Civil Money Penalties for 2018, Effective January 2, 2018).